Index 
Texts adopted
Wednesday, 27 March 2019 - Strasbourg 
Resources for the specific allocation for the Youth Employment Initiative ***I
 General arrangements for excise duty (recast) *
 Products eligible for exemption from or a reduction in dock dues *
 Neighbourhood, Development and International Cooperation Instrument ***I
 Instrument for Pre-accession Assistance (IPA III) ***I
 Framework for the recovery and resolution of central counterparties ***I
 European Crowdfunding Service Providers (ECSP) for business ***I
 Markets in financial instruments: crowdfunding service providers ***I
 European Regional Development Fund and Cohesion Fund ***I
 Emission performance standards for new passenger cars and for new light commercial vehicles ***I
 Reduction of the impact of certain plastic products on the environment ***I
 EU fertilising products ***I
 Protection of workers from the risks related to exposure to carcinogens or mutagens at work ***I
 Common rules for certain types of combined transport of goods between Member States ***I
 Disclosure of income tax information by certain undertakings and branches ***I
 Common provisions on the European Regional Development Fund, the European Social Fund Plus, the Cohesion Fund, and the European Maritime and Fisheries Fund and financial rules for those ***I
 Asylum, Migration and Integration Fund
 Instrument for financial support for external borders and visa
 Genetically modified soybean MON 87751 (MON-87751-7)
 Genetically modified maize 1507 × NK603 (DAS-Ø15Ø7-1 × MON-ØØ6Ø3-6)
 Certain uses of bis(2-ethylhexyl) phthalate (DEHP) (DEZA a.s.)
 Certain uses of bis(2-ethylhexyl) phthalate (DEHP) (Grupa Azoty Zakłady Azotowe Kędzierzyn S.A.)
 Certain uses of chromium trioxide
 Post-Arab Spring: way forward for the Middle East and North Africa (MENA) region

Resources for the specific allocation for the Youth Employment Initiative ***I
PDF 143kWORD 48k
Resolution
Consolidated text
European Parliament legislative resolution of 27 March 2019 on the proposal for a regulation of the European Parliament and of the Council amending Regulation (EU) No 1303/2013 as regards the resources for the specific allocation for the Youth Employment Initiative (COM(2019)0055 – C8-0041/2019 – 2019/0027(COD))
P8_TA-PROV(2019)0295A8-0085/2019

(Ordinary legislative procedure: first reading)

The European Parliament,

–  having regard to the Commission proposal to Parliament and the Council (COM(2019)0055),

–  having regard to Article 294(2) and Article 177 of the Treaty on the Functioning of the European Union, pursuant to which the Commission submitted the proposal to Parliament (C8‑0041/2019),

–  having regard to Article 294(3) of the Treaty on the Functioning of the European Union,

–  having regard to the opinion of the European Economic and Social Committee of 22 March 2019(1),

–  after consulting the Committee of the Regions,

–  having regard to Rule 59 of its Rules of Procedure,

–  having regard to the report of the Committee on Regional Development and also the opinion of the Committee on Budgets (A8-0085/2019),

A.  Whereas for reasons of urgency it is justified to proceed to the vote before the expiry of the deadline of eight weeks laid down in Article 6 of Protocol No 2 on the application of the principles of subsidiarity and proportionality;

1.  Adopts its position at first reading hereinafter set out;

2.  Calls on the Commission to refer the matter to Parliament again if it replaces, substantially amends or intends to substantially amend its proposal;

3.  Instructs its President to forward its position to the Council, the Commission and the national parliaments.

Position of the European Parliament adopted at first reading on 27 March 2019 with a view to the adoption of Regulation (EU) 2019/… of the European Parliament and of the Council amending Regulation (EU) No 1303/2013 as regards the resources for the specific allocation for the Youth Employment Initiative

P8_TC1-COD(2019)0027


THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the Functioning of the European Union, and in particular Article 177 thereof,

Having regard to the proposal from the European Commission,

After transmission of the draft legislative act to the national parliaments,

Having regard to the opinion of the European Economic and Social Committee(2),

After consulting the Committee of the Regions,

Acting in accordance with the ordinary legislative procedure(3),

Whereas:

(1)  Regulation (EU) No 1303/2013 of the European Parliament and of the Council(4) lays down the common and general rules applicable to the European Structural and Investment Funds.

(2)  The European Union’s general budget for the financial year 2019(5) amended the total amount of resources for the Youth Employment Initiative ('YEI') by increasing commitment appropriations for the specific allocation for the YEI in 2019 by EUR 116,7 million in current prices and increasing the total amount of commitment appropriations for the specific allocation for the YEI for the entire programming period to EUR 4 527 882 072 in current prices.

(3)  For 2019, the additional resources of EUR 99 573 877 in 2011 prices are funded by the Global Margin for Commitments within the margin of the multiannual financial framework for the years 2014-2020.

(4)  It is appropriate to provide for specific measures to facilitate the implementation of the YEI, due to the advanced stage of implementation of the operational programmes for the 2014-2020 programming period.

(5)  Given the urgency of amending the programmes which support the YEI in order to include the additional resources for the specific allocation for the YEI before the end of 2019, this Regulation should enter into force on the day following that of its publication in the Official Journal of the European Union.

(6)  Regulation (EU) No 1303/2013 should therefore be amended accordingly,

HAVE ADOPTED THIS REGULATION:

Article 1

Regulation (EU) No 1303/2013 is amended as follows:

(1)  in Article 91, paragraph 1 is replaced by the following:"

‘1. The resources for economic, social and territorial cohesion available for budgetary commitment for the period 2014 - 2020 shall be EUR 330 081 919 243 in 2011 prices, in accordance with the annual breakdown set out in Annex VI, of which EUR 325 938 694 233 represents the global resources allocated to the ERDF, the ESF and the Cohesion Fund, and EUR 4 143 225 010 represents a specific allocation for the YEI. For the purposes of programming and subsequent inclusion in the budget of the Union, the amount of resources for economic, social and territorial cohesion shall be indexed at 2 % per year.’;

"

(2)  in Article 92, paragraph 5 is replaced by the following:"

‘5. Resources for the YEI shall amount to EUR 4 143 225 010 from the specific allocation for the YEI, of which EUR 99 573 877 constitutes the additional resources for 2019. Those resources shall be complemented by ESF targeted investment in accordance with Article 22 of the ESF Regulation.

Member States who benefit from the additional resources for the specific allocation for the YEI for 2019 as referred to in the first subparagraph may request the transfer of up to 50 % of the additional resources for the specific allocation for the YEI to the ESF in order to constitute the corresponding ESF targeted investment as required by Article 22 of the ESF Regulation. Such a transfer shall be made to the respective categories of region corresponding to the categorisation of the regions eligible for the increase of the specific allocation for the YEI. Member States shall request the transfer in the request for amendment of the programme in accordance with Article 30(1) of this Regulation. Resources allocated to past years may not be transferred.

The second subparagraph of this paragraph shall apply to any additional resources for specific allocation for the YEI increasing the resources to above EUR 4 043 651 133.’;

"

(3)  Annex VI is replaced by the text set out in the Annex to this Regulation.

Article 2

This Regulation shall enter into force on the day following that of its publication in the Official Journal of the European Union.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at,

For the European Parliament For the Council

The President The President

ANNEX

‘ANNEX VI

ANNUAL BREAKDOWN OF COMMITMENT APPROPRIATIONS FOR THE YEARS 2014 TO 2020

Adjusted annual profile (including the YEI top-up)

 

2014

2015

2016

2017

EUR, 2011 prices

34 108 069 924

55 725 174 682

46 044 910 736

48 027 317 164

 

2018

2019

2020

Total

EUR, 2011 prices

48 341 984 652

48 811 933 191

49 022 528 894

330 081 919 243

(1) Not yet published in the Official Journal.
(2)Opinion of 22 March 2019 (not yet published in the Official Journal)
(3) Position of the European Parliament of 27 March 2019.
(4)Regulation (EU) No 1303/2013 of the European Parliament and of the Council of 17 December 2013 laying down common provisions on the European Regional Development Fund, the European Social Fund, the Cohesion Fund, the European Agricultural Fund for Rural Development and the European Maritime and Fisheries Fund and laying down general provisions on the European Regional Development Fund, the European Social Fund, the Cohesion Fund and the European Maritime and Fisheries Fund and repealing Council Regulation (EC) No 1083/2006 (OJ L 347, 20.12.2013, p. 320).
(5)OJ L 67, 7.3.2019, p. 1.


General arrangements for excise duty (recast) *
PDF 125kWORD 42k
European Parliament legislative resolution of 27 March 2019 on the proposal for a Council directive laying down the general arrangements for excise duty (recast) (COM(2018)0346 – C8-0381/2018 – 2018/0176(CNS))
P8_TA-PROV(2019)0296A8-0117/2019

(Special legislative procedure – consultation – recast)

The European Parliament,

–  having regard to the Commission proposal to the Council (COM(2018)0346),

–  having regard to Article 113 of the Treaty on the Functioning of the European Union, pursuant to which the Council consulted Parliament (C8‑0381/2018),

–  having regard to the Interinstitutional Agreement of 28 November 2001 on a more structured use of the recasting technique for legal acts(1),

–  having regard to the letter of 22 February 2019 from the Committee on Legal Affairs to the Committee on Economic and Monetary Affairs in accordance with Rule 104(3) of its Rules of Procedure,

–  having regard to Rules 104 and 78c of its Rules of Procedure,

–  having regard to the report of the Committee on Economic and Monetary Affairs (A8-0117/2019),

A.  whereas, according to the Consultative Working Party of the legal services of the European Parliament, the Council and the Commission, the Commission proposal does not include any substantive amendments other than those identified as such in the proposal and whereas, as regards the codification of the unchanged provisions of the earlier acts together with those amendments, the proposal contains a straightforward codification of the existing texts, without any change in their substance;

1.  Approves the Commission proposal as adapted to the recommendations of the Consultative Working Party of the legal services of the European Parliament, the Council and the Commission;

2.  Calls on the Council to notify Parliament if it intends to depart from the text approved by Parliament;

3.  Asks the Council to consult Parliament again if it intends to substantially amend the text approved by Parliament;

4.  Instructs its President to forward its position to the Council, the Commission and the national parliaments.

(1) OJ C 77, 28.3.2002, p. 1.


Products eligible for exemption from or a reduction in dock dues *
PDF 128kWORD 42k
European Parliament legislative resolution of 27 March 2019 on the proposal for a Council decision amending Decision No 940/2014/EU as regards products eligible for exemption from or a reduction in dock dues (COM(2018)0825 – C8-0034/2019 – 2018/0417(CNS))
P8_TA-PROV(2019)0297A8-0112/2019

(Special legislative procedure – consultation)

The European Parliament,

–  having regard to the Commission proposal to the Council (COM(2018)0825),

—  having regard to Article 349 of the Treaty on the Functioning of the European Union, pursuant to which the Council consulted Parliament (C8-0034/2019),

—  having regard to Rule 78c of its Rules of Procedure,

—  having regard to the report of the Committee on Regional Development (A8-0112/2019),

1.  Approves the Commission proposal;

2.  Calls on the Council to notify Parliament if it intends to depart from the text approved by Parliament;

3.  Asks the Council to consult Parliament again if it intends to substantially amend the text approved by Parliament;

4.  Instructs its President to forward its position to the Council, the Commission and the national parliaments.


Neighbourhood, Development and International Cooperation Instrument ***I
PDF 629kWORD 213k
European Parliament legislative resolution of 27 March 2019 on the proposal for a regulation of the European Parliament and of the Council establishing the Neighbourhood, Development and International Cooperation Instrument (COM(2018)0460 – C8-0275/2018 – 2018/0243(COD))
P8_TA(2019)0298A8-0173/2019

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Instrument for Pre-accession Assistance (IPA III) ***I
PDF 306kWORD 93k
European Parliament legislative resolution of 27 March 2019 on the proposal for a regulation of the European Parliament and of the Council establishing the Instrument for Pre-accession Assistance (IPA III) (COM(2018)0465 – C8-0274/2018 – 2018/0247(COD))
P8_TA(2019)0299A8-0174/2019

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Framework for the recovery and resolution of central counterparties ***I
PDF 518kWORD 162k
European Parliament legislative resolution of 27 March 2019 on the proposal for a regulation of the European Parliament and of the Council on a framework for the recovery and resolution of central counterparties and amending Regulations (EU) No 1095/2010, (EU) No 648/2012, and (EU) 2015/2365 (COM(2016)0856 – C8-0484/2016 – 2016/0365(COD))
P8_TA(2019)0300A8-0015/2018

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European Crowdfunding Service Providers (ECSP) for business ***I
PDF 270kWORD 85k
European Parliament legislative resolution of 27 March 2019 on the proposal for a regulation of the European Parliament and of the Council on European Crowdfunding Service Providers (ECSP) for Business (COM(2018)0113 – C8-0103/2018 – 2018/0048(COD))
P8_TA(2019)0301A8-0364/2018

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Markets in financial instruments: crowdfunding service providers ***I
PDF 153kWORD 47k
European Parliament legislative resolution of 27 March 2019 on the proposal for a directive of the European Parliament and of the Council amending Directive 2014/65/EU on markets in financial instruments (COM(2018)0099 – C8-0102/2018 – 2018/0047(COD))
P8_TA(2019)0302A8-0362/2018

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European Regional Development Fund and Cohesion Fund ***I
PDF 293kWORD 91k
European Parliament legislative resolution of 27 March 2019 on the proposal for a regulation of the European Parliament and of the Council on the European Regional Development Fund and on the Cohesion Fund (COM(2018)0372 – C8-0227/2018 – 2018/0197(COD))
P8_TA(2019)0303A8-0094/2019

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Emission performance standards for new passenger cars and for new light commercial vehicles ***I
PDF 391kWORD 141k
Resolution
Consolidated text
European Parliament legislative resolution of 27 March 2019 on the proposal for a regulation of the European Parliament and of the Council setting emission performance standards for new passenger cars and for new light commercial vehicles as part of the Union's integrated approach to reduce CO2 emissions from light-duty vehicles and amending Regulation (EC) No 715/2007 (recast) (COM(2017)0676 – C8-0395/2017 – 2017/0293(COD))
P8_TA-PROV(2019)0304A8-0287/2018

(Ordinary legislative procedure – recast)

The European Parliament,

–  having regard to the Commission proposal to Parliament and the Council (COM(2017)0676),

–  having regard to Article 294(2) and Article 192(1) of the Treaty on the Functioning of the European Union, pursuant to which the Commission submitted the proposal to Parliament (C8-0395/2017),

–  having regard to the opinion of the Committee on Legal Affairs on the proposed legal basis,

–  having regard to Article 294(3) of the Treaty on the Functioning of the European Union,

–  having regard to the opinion of the European Economic and Social Committee of 14 February 2018(1),

–  after consulting the Committee of the Regions,

–  having regard to the Interinstitutional Agreement of 28 November 2001 on a more structured use of the recasting technique for legal acts(2),

–  having regard to the letter of 3 May 2018 sent by the Committee on Legal Affairs to the Committee on the Environment, Public Health and Food Safety in accordance with Rule 104(3) of its Rules of Procedure,

–  having regard to the provisional agreement approved by the committee responsible under Rule 69f(4) of its Rules of Procedure and the undertaking given by the Council representative by letter of 16 January 2019 to approve Parliament’s position, in accordance with Article 294(4) of the Treaty on the Functioning of the European Union,

–  having regard to Rules 104 and 59 of its Rules of Procedure,

–  having regard to the report of the Committee on the Environment, Public Health and Food Safety and the opinion of the Committee on Transport and Tourism (A8-0287/2018),

A.  whereas, according to the Consultative Working Party of the legal services of the European Parliament, the Council and the Commission, the Commission proposal does not include any substantive amendments other than those identified as such in the proposal and whereas, as regards the codification of the unchanged provisions of the earlier acts together with those amendments, the proposal contains a straightforward codification of the existing texts, without any change in their substance;

1.  Adopts its position at first reading hereinafter set out, taking into account the recommendations of the Consultative Working Party of the legal services of the European Parliament, the Council and the Commission(3);

2.  Takes note of the Commission statement annexed to this resolution;

3.  Calls on the Commission to refer the matter to Parliament again if it replaces, substantially amends or intends to substantially amend its proposal;

4.  Instructs its President to forward its position to the Council, the Commission and the national parliaments.

Position of the European Parliament adopted at first reading on 27 March 2019 with a view to the adoption of Regulation (EU) 2019/… of the European Parliament and of the Council setting CO2 emission performance standards for new passenger cars and for new light commercial vehicles, ▌and repealing Regulations (EC) No 443/2009 and (EU) No 510/2011 (recast)

P8_TC1-COD(2017)0293


(Text with EEA relevance)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the Functioning of the European Union, and in particular Article 192(1) thereof,

Having regard to the proposal from the European Commission,

After transmission of the draft legislative act to the national parliaments,

Having regard to the opinion of the European Economic and Social Committee(4),

After consulting the Committee of the Regions,

Acting in accordance with the ordinary legislative procedure(5),

Whereas:

(1)  Regulation (EC) No 443/2009 of the European Parliament and of the Council(6) and Regulation (EU) No 510/2011 of the European Parliament and of the Council(7) have been substantially amended several times. Since further amendments are to be made, those Regulations should be recast in the interests of clarity.

(2)  In order to provide a coherent and efficient transition following the recast and repeal of Regulations (EC) No 443/2009 and (EU) No 510/2011, this Regulation should apply from 1 January 2020. However, it is appropriate to maintain the CO2 emission performance standards and the modalities for achieving them as set out in those Regulations without changes until 2024.

(3)  The Paris Agreement(8) sets out, inter alia, a long-term goal in line with the objective to keep the global average temperature increase well below 2 °C above pre-industrial levels and to pursue efforts to keep it to 1,5 °C above pre-industrial levels. The latest scientific findings reported by the Intergovernmental Panel on Climate Change (IPCC) in its special report on the impacts of global warming of 1,5 °C above pre-industrial levels and related global greenhouse gas emission pathways unequivocally confirm the negative impacts of climate change. That special report concludes that emissions reductions in all sectors are crucial to limit global warming.

(4)  In order to contribute to the objectives of the Paris Agreement, the transformation of the entire transport sector towards zero emissions needs to be accelerated, considering the Commission´s communication of 28 November 2018 entitled “A Clean Planet for all – a European strategic long-term vision for a prosperous, modern, competitive and climate neutral economy”, which outlines a vision of the economic and societal transformations required, engaging all sectors of the economy and society, to achieve the transition to net-zero greenhouse gas emissions by 2050. Emissions of air pollutants from transport that significantly harm our health and the environment need also to be drastically reduced without delay. Emissions from conventional combustion engine vehicles will need to be further reduced after 2020. Zero- and low-emission vehicles will need to be deployed and gain significant market share by 2030. Further CO2 emissions reductions for passenger cars and light commercial vehicles will be necessary beyond 2030.

(5)  The Commission´s communications of 31 May 2017 entitled "Europe on the move - An agenda for a socially fair transition towards clean, competitive and connected mobility for all" and of 8 November 2017 entitled "Delivering on low-emission mobility - A European Union that protects the planet, empowers its consumers and defends its industry and workers" highlight that the CO2 emission performance standards for passenger cars and light commercial vehicles are a strong driver for innovation and efficiency and will contribute to strengthening competitiveness of the automotive industry and pave the way for zero- and low-emission vehicles in a technology-neutral way.

(6)  This Regulation provides a clear pathway for CO2 emissions reductions from the road transport sector and contributes to the binding target of at least a 40 % domestic reduction in economy-wide greenhouse gas emissions by 2030 compared to 1990, as was endorsed in the European Council conclusions of 23-24 October 2014, and approved as the Intended Nationally Determined Contribution of the Union and its Member States under the Paris Agreement at the Environment Council meeting on 6 March 2015.

(7)  Regulation (EU) 2018/842 of the European Parliament and of the Council(9) lays down obligations on Member States to fulfil the Union’s target of reducing its greenhouse gas emissions by 30 % below 2005 levels in 2030 for the sectors that are not part of the European Union Emissions Trading System established by Directive 2003/87/EC of the European Parliament and of the Council(10). Road transport is a major contributor to the emissions from those sectors ▌. Moreover, emissions from road transport show an increasing trend, and ▌remain significantly above 1990 levels. If road transport emissions increase further, such increases will continue to counteract emissions reductions made by other sectors to combat climate change.

(8)  The European Council conclusions of 23-24 October 2014 highlighted the importance of reducing greenhouse gas emissions and risks related to fossil fuel dependency in the transport sector through a comprehensive and technology neutral approach for the promotion of emissions reduction and energy efficiency in transport, for electric transportation and for renewable energy sources in transport also after 2020.

(9)  In order to give consumers in the Union secure, sustainable, competitive and affordable energy, energy efficiency contributing to moderation of demand is one of the five mutually-reinforcing and closely interrelated dimensions set out in the Commission's communication of 25 February 2015 entitled "A Framework Strategy for a Resilient Energy Union with a Forward-Looking Climate Change Policy". That communication states that, while all economic sectors must take steps to increase the efficiency of their energy consumption, transport has a huge energy efficiency potential, which can be realised also with a continued focus on tightening CO2 emission performance standards for passenger cars and light commercial vehicles in a 2030 perspective.

(10)  An evaluation of Regulations (EC) No 443/2009 and (EU) No 510/2011 in 2015 concluded that those Regulations have been relevant, broadly coherent, and have generated significant emissions savings, whilst being more cost-effective than originally anticipated. They have also generated significant added value for the Union that could not have been achieved to the same extent through national measures. However, the benefits of those Regulations have been eroded due to the increasing discrepancy between the CO2 emissions measured under the New European Driving Cycle (NEDC) and the CO2 emissions emitted from vehicles driven under real-world conditions.

(11)  It is, therefore, appropriate to pursue the objectives of Regulations (EC) No 443/2009 and (EU) No 510/2011 by setting new EU fleet-wide CO2 emissions reduction targets for passenger cars and light commercial vehicles for the period up to 2030. In defining the levels of those targets, account has been taken of their effectiveness in delivering a cost-effective contribution to reducing emissions of the sectors covered by Regulation (EU) 2018/842 by 2030, of the resulting costs and savings for society, manufacturers and vehicle users, as well as of their direct and indirect implications for employment, competitiveness and innovation and the co-benefits generated in terms of reduced air pollution and energy security. Considering that the market share and, consequently, the overall contribution of CO2 emissions from passenger cars are significantly higher than those of light commercial vehicles, a differentiated approach between passenger cars and light commercial vehicles is considered appropriate.

(12)  A socially acceptable and just transition towards zero-emission mobility should be ensured. It is important, therefore, to take into account the social effects of such transition throughout the whole automotive value chain and to address proactively the implications on employment. Targeted programmes at Union, national and regional levels are therefore to be considered for the re-skilling, up-skilling and redeployment of workers, as well as education and job-seeking initiatives in adversely affected communities and regions, in close dialogue with the social partners and competent authorities. As part of that transition, women’s employment, as well as equal opportunities in this sector, should be strengthened.

(13)  A successful transition to zero-emission mobility requires an integrated approach and the right enabling environment to stimulate innovation and maintain the Union’s technological leadership in this sector. That includes public and private investments in research and innovation, the increasing supply of zero- and low-emission vehicles, the roll-out of recharging and refuelling infrastructure, integration into the energy systems, as well as the sustainable materials supply and sustainable production, re-use and recycling of batteries in Europe. That requires coherent action at Union, national, regional and local levels.

(14)  As part of the implementation of Regulation (EC) No 715/2007 of the European Parliament and of the Council(11), a new test procedure for measuring CO2 emissions from, and fuel consumption of, passenger cars and light commercial vehicles, the Worldwide Harmonised Light Vehicles Test procedure (‘WLTP’), set out in Commission Regulation (EU) 2017/1151(12), started to apply in 2017. That ▌test procedure provides CO2 emission and fuel consumption values that are more representative of real-world conditions. It is appropriate, therefore, that the new CO2 emissions targets should be based on the CO2 emissions determined on the basis of that test procedure. Considering, however, that WLTP-based CO2 emissions will be available for target compliance purposes from 2021, it is appropriate that the new CO2 emission performance standards should be defined as reduction levels set in relation to the 2021 targets calculated on the basis of the CO2 emissions measured for the purpose of the WLTP emissions test. In order to ensure the robustness and representativeness of the values used as the starting point for defining the emissions reduction targets to be applied in 2025 and 2030, the conditions for performing those measurements have been clarified as part of the implementation of Commission Implementing Regulations (EU) 2017/1152(13) and (EU) 2017/1153(14).

(15)  It is important that the setting of CO2 emissions reduction requirements continue to provide Union-wide predictability and planning security for vehicle manufacturers across their new passenger car and light commercial vehicle fleets in the Union.

(16)  The Commission’s evaluation of Directive 1999/94/EC of the European Parliament and of the Council(15) in 2016 identified a need for further clarification and simplification of that legislative act, which could increase its relevance, effectiveness, efficiency and coherence. The Commission should, therefore, review that Directive no later than 31 December 2020 and, where appropriate, put forward a relevant legislative proposal. In order to support the uptake of the most fuel efficient and environmentally friendly vehicles, that review should in particular consider the inclusion of light commercial vehicles and the need for better designed and further harmonised Union requirements on labelling that could provide consumers with comparable, reliable and user friendly information about the benefits of zero- and low-emission vehicles, including information concerning air pollutants.

(17)  Emissions reduction targets for the Union-wide fleets of new passenger cars and light commercial vehicles should, therefore, be set for 2025 and for 2030, taking into account the vehicle fleet renewal time and the need for the road transport sector to contribute to the 2030 climate and energy targets. That stepwise approach also provides a clear and early signal for the automotive industry not to delay the market introduction of energy efficient technologies and zero- and low-emission vehicles.

(18)  The CO2 emission performance standards set out in this Regulation apply to new passenger cars and new light commercial vehicles. With regard to the existing fleet of such vehicles, including second-hand vehicles, additional measures aimed at reducing emissions may also be taken, inter alia, at national and Union level. For instance, measures may be taken to encourage a higher fleet renewal rate, in order to replace as fast as possible older, more emitting vehicles by more performant ones. Access to more affordable zero- and low-emission vehicles could stimulate consumer behaviour change and faster deployment of low-emission technologies.

(19)  While the Union is among the world's major producers of motor vehicles and demonstrates technological leadership in the global automotive sector, competition is increasing and this sector is changing rapidly through new innovations in electrified powertrains, and cooperative, connected and automated mobility. In order to retain its global competitiveness and access to markets, the Union needs a regulatory framework, including a particular incentive in the area of zero- and low-emission vehicles, which will contribute to creating a large domestic market and support technological development and innovation.

(20)  A dedicated incentive mechanism should be introduced to facilitate a smooth transition towards zero-emission mobility. That mechanism should be designed so as to promote the deployment on the Union market of zero- and low-emission vehicles. Also, a specific transitional measure should be put in place to enable access to zero- and low-emission vehicles to consumers from Member States with low levels of market penetration of such vehicles.

(21)  Setting appropriate benchmarks for the share of zero- and low-emission vehicles in the EU fleet, together with a well-designed mechanism for adjusting a manufacturer's specific emissions target based on the share of zero- and low-emission vehicles in the manufacturer's own fleet, should provide a strong and credible signal for the development, deployment and marketing of such vehicles while still allowing for the further improvement of the efficiency of the conventional internal combustion engines.

(22)  In determining the credits for the zero- and low-emission vehicles, it is appropriate to account for the difference in CO2 emissions between the vehicles. As concerns passenger cars, the role of low-emission vehicles, in particular of plug-in hybrid vehicles, in the transition towards zero-emission vehicles should be recognised. The adjustment mechanism should ensure that a manufacturer exceeding the benchmark level would benefit from a higher specific emissions target. In order to ensure a balanced approach, limits should be set to the level of adjustment possible within that mechanism. This will provide for incentives, promoting a timely roll-out of recharging and refuelling infrastructure and yielding high benefits for consumers, competitiveness and the environment.

(23)  The legislative framework for implementing the EU fleet-wide target should ensure competitively neutral, socially equitable and sustainable emissions reduction targets which take account of the diversity of European automobile manufacturers and avoid any unjustified distortion of competition between them.

(24)  In order to maintain the diversity of the market for passenger cars and light commercial vehicles and its ability to cater for different consumer needs, specific emissions targets should be defined according to the utility of the vehicles on a linear basis. Maintaining mass as the utility parameter is considered coherent with the existing regime. In order to better reflect the mass of vehicles used on the road, the parameter should be changed ▌, with effect from 2025, from mass in running order to the vehicle's test mass, as specified in the WLTP.

(25)  It should be avoided that the EU fleet-wide targets are altered due to changes in the average mass of the fleet. Changes in the average mass should therefore be reflected without delay in the specific emissions target calculations, and the adjustments of the average mass value that is used to this end should take place every two years with effect from 2025.

(26)  In order to distribute the emissions reduction effort in a competitively neutral and fair way that reflects the diversity of the market for passenger cars and light commercial vehicles, and in view of the change in 2021 to WLTP-based specific emissions targets, it is appropriate to determine the slope of the limit value curve on the basis of the specific emissions of CO2 of all new vehicles registered in that year, and to take into account the change in the EU fleet-wide targets between 2021, 2025 and 2030 with a view to ensuring an equal emissions reduction effort of all manufacturers. With regard to light commercial vehicles, the same approach as that for passenger car manufacturers should apply to manufacturers of lighter, car derived vans, while for manufacturers of vehicles falling within the heavier segments, a higher and fixed slope should be set for the whole target period.

(27)  ▌This Regulation aims to achieve its objectives by, inter alia, creating incentives for the automotive industry to invest in new technologies. This Regulation actively promotes eco-innovation and provides a mechanism that should be able to acknowledge future technological development. Experience shows that eco-innovations have successfully contributed to the cost-effectiveness of Regulations (EC) No 443/2009 and (EU) No 510/2011 and to the reduction of real-world CO2 emissions. This modality should, therefore, be maintained and the scope should be extended to incentivise efficiency improvements in air-conditioning systems.

(28)  A balance should be ensured, however, between incentives given to eco-innovations and those technologies for which the emissions reduction effect is demonstrated on the official test procedure. As a consequence, it is appropriate to maintain a cap on the eco-innovation savings that a manufacturer may take into account for target compliance purposes. The Commission should have the possibility to review the level of that cap, in particular, to take into account the effects of the change in the official test procedure. It is also appropriate to clarify how the savings should be calculated for target compliance purposes.

(29)  Sustainable light-weight components are important in reducing the energy consumption and CO2 emissions of new vehicles. Their further development and deployment should support the transition towards zero- and low-emission mobility.

(30)  Directive 2007/46/EC of the European Parliament and of the Council(16) established a harmonised framework containing the administrative provisions and general technical requirements for approval of all new vehicles within its scope. The entity responsible for complying with this Regulation should be the same as the entity responsible for all aspects of the type-approval process in accordance with Directive 2007/46/EC and for ensuring conformity of production.

(31)  For the purposes of type-approval, specific requirements apply for special-purpose vehicles, as defined in Annex II to Directive 2007/46/EC, and they should therefore be excluded from the scope of this Regulation.

(32)  In cases where zero-emission light commercial vehicles with a reference mass exceeding 2 610 kg or 2 840 kg, as the case may be, would fall outside the scope of this Regulation due only to the mass of the energy storage system, it is appropriate to allow those vehicles to be counted as falling within the scope.

(33)  It is not appropriate to use the same method to determine the emissions reduction targets for large-volume manufacturers as for small-volume manufacturers that are considered as independent on the basis of the criteria set out in this Regulation. Those small-volume manufacturers should have the possibility to apply for alternative emissions reduction targets relating to the technological potential of a given manufacturer's vehicles to reduce their specific emissions of CO2 and consistent with the characteristics of the market segments concerned.

(34)  In recognition of the disproportionate impact on the smallest manufacturers that would result from compliance with specific emissions targets defined on the basis of the utility of the vehicle, the high administrative burden of the derogation procedure, and the marginal resulting benefit in terms of CO2 emissions reduction from the vehicles sold by those manufacturers, manufacturers responsible for fewer than 1 000 new passenger cars and new light commercial vehicles registered annually in the Union should be excluded from the scope of the specific emissions target and the excess emissions premium. However, where a manufacturer that is covered by an exemption nevertheless applies for, and is granted, a derogation, it is appropriate that such manufacturer should be required to comply with that derogation target.

(35)  The procedure for granting derogations from the 95 g CO2/km EU fleet-wide target to niche car manufacturers ensures that the emissions reduction effort required by those niche manufacturers is consistent with that of large-volume manufacturers with regard to that target. It is appropriate to continue to provide those niche manufacturers with the possibility of being granted a derogation also from the targets applicable from 2025, until 2028.

(36)  In determining the average specific emissions of CO2 for all the new passenger cars and new light commercial vehicles registered in the Union for which manufacturers are responsible, all passenger cars and light commercial vehicles should be taken into account irrespective of their mass or other characteristics, as the case may be. Although Regulation (EC) No 715/2007 does not cover passenger cars and light commercial vehicles with a reference mass exceeding 2 610 kg and to which type-approval is not extended in accordance with Article 2(2) of that Regulation ▌, the emissions for these vehicles should be measured in accordance with the same measurement procedures as specified pursuant to Regulation (EC) No 715/2007, notably the procedures set out in Commission Regulation (EC) No 692/2008(17) and in Regulation (EU) 2017/1151, and the correlation procedures adopted on the basis of Regulations (EC) No 443/2009 and (EU) No 510/2011, in particular Implementing Regulations (EU) 2017/1152 and (EU) 2017/1153. The resulting CO2 emission values should be entered in the certificate of conformity of the vehicle in order to enable their inclusion in the monitoring scheme.

(37)  The specific emissions of CO2 of completed light commercial vehicles should be allocated to the manufacturer of the base vehicle.

(38)  Consideration should be given to the specific situation of manufacturers of light commercial vehicles producing incomplete vehicles that are type-approved in multiple stages. While those manufacturers are responsible for meeting the CO2 emissions targets, they should have the possibility to predict with reasonable certainty the CO2 emissions of the completed vehicles. The Commission should ensure that those needs are appropriately reflected in the implementing measures adopted pursuant to Regulation (EC) No 715/2007.

(39)  In order to provide for flexibility for the purposes of meeting their targets under this Regulation, manufacturers may agree to form a pool on an open, transparent and non-discriminatory basis. An agreement to form a pool should not exceed five years but should be able to be renewed. Where manufacturers form a pool, they should be deemed to have met their targets under this Regulation provided that the average emissions of the pool as a whole do not exceed the specific emissions target for the pool.

(40)  The possibility for manufacturers to form pools has proven a cost-effective way to achieve compliance with the CO2 emissions targets, in particular facilitating compliance for those manufacturers that produce a limited range of vehicles. In order to improve competitive neutrality, the Commission should have the powers to clarify the conditions on which independent manufacturers may form a pool in order to allow them to be placed in a position equivalent to connected undertakings.

(41)  A robust compliance mechanism is necessary in order to ensure that the targets under this Regulation are met.

(42)  For achieving the CO2 emissions reductions required under this Regulation, it is also essential that the emissions of vehicles in use are in conformity with the CO2 values determined at type-approval. It should therefore be possible for the Commission to take into account in the calculation of the average specific emissions of CO2 of a manufacturer any systemic non-conformity found by type-approval authorities with regard to the CO2 emissions of vehicles in use.

(43)  The Commission should have the powers to establish and implement a procedure for verifying the correspondence between the CO2 emissions of ▌vehicles in-service, as determined in accordance with the WLTP, and the CO2 emission values recorded in the certificates of conformity. In developing that procedure, particular consideration should be given to identifying methods, including the use of data from on-board fuel and/or energy consumption monitoring devices, for detecting strategies through which a vehicle's CO2 performance is artificially improved in the type-approval test procedure. Where deviations or strategies that artificially improve a vehicle’s CO2 performance are found in the course of such verifications, those findings are to be considered as sufficient reason to suspect that there is a serious risk of non-compliance with regard to the requirements laid down in Regulation (EU) 2018/858 of the European Parliament and of the Council(18) and Regulation (EC) No 715/2007, and Member States should on that basis take the necessary measures pursuant to Chapter XI of Regulation (EU) 2018/858.

(44)  The specific emissions of CO2 from new passenger cars and light commercial vehicles are measured on a harmonised basis in the Union in accordance with the WLTP. To minimise the administrative burden of this Regulation, compliance should be measured by reference to data on registrations of new passenger cars and light commercial vehicles in the Union collected by Member States and reported to the Commission. To ensure the consistency of the data used to assess compliance, the rules for the collection and reporting of that data should be harmonised as far as possible. The competent authorities' responsibility to provide correct and complete data should, therefore, be clearly stated as well as the need for an effective cooperation between those authorities and the Commission in addressing data quality issues.

(45)  Manufacturers’ compliance with the targets set out in this Regulation should be assessed at Union level. Manufacturers whose average specific emissions of CO2 exceed those permitted under this Regulation should pay an excess emissions premium with respect to each calendar year. The amounts of the excess emissions premium should be considered as revenue for the general budget of the Union. The Commission should, in its 2023 review, evaluate the possibility of allocating the amounts of the excess emissions premium to a specific fund or a relevant programme that aims to ensure a just transition towards zero-emission mobility and to support re-skilling, up-skilling and other skills training of workers in the automotive sector.

(46)  Any national measure that Member States may maintain or introduce in accordance with Article 193 of the Treaty on the Functioning of the European Union (TFEU) should not, in consideration of the purpose of, and procedures established in, this Regulation, impose additional or more stringent penalties on manufacturers who fail to meet their targets under this Regulation.

(47)  This Regulation should be without prejudice to the full application of Union competition rules.

(48)  The effectiveness of the targets set out in this Regulation in reducing CO2 emissions in reality is strongly dependent on the real-world representativeness of the official test procedure. In accordance with scientific opinion 1/2016 of the Scientific Advice Mechanism (SAM) entitled "Closing the gap between light-duty vehicle real-world CO2 emissions and laboratory testing" and the European Parliament recommendation of 4 April 2017 to the Council and the Commission following its inquiry into emission measurements in the automotive sector(19), a mechanism should be put in place to assess the real-world representativeness of vehicle CO2 emissions and energy consumption values determined in accordance with the WLTP. The most reliable way to ensure the real-world representativeness of type-approval values is by using data from the on-board fuel and/or energy consumption monitoring devices. The Commission should, therefore, have the powers to ▌develop the procedures needed for ▌collecting and processing fuel and energy consumption data required for making such assessments and to ensure the public availability of such data, whilst providing for the protection of any personal data. Moreover, it is appropriate, in order to ensure the availability of fuel and energy consumption data from battery electric vehicles and vehicles with power trains using gaseous fuels, including hydrogen, that the work on standardisation of the on-board fuel and/or energy consumption monitoring devices for such vehicles will be pursued without delay as part of the implementation of Regulation (EU) 2017/1151.

(49)  The Commission should, moreover, assess how fuel and energy consumption data may help to ensure that the vehicle CO2 emissions determined in accordance with the WLTP remain representative of real-world emissions over time for all manufacturers and, more precisely, how such data can be used to monitor the gap between laboratory and real-world CO2 emissions and, where necessary, to prevent this gap from increasing.

(50)  It is important to assess the full life-cycle emissions from passenger cars and light commercial vehicles at Union level. To that end, the Commission should no later than 2023 evaluate the possibility of developing a common Union methodology for the assessment and the consistent data reporting of the full life-cycle CO2 emissions of such vehicles placed on the Union market. The Commission should adopt follow-up measures, including, where appropriate, legislative proposals. 

(51)  In 2024, a review of the progress achieved under Regulation (EU) 2018/842 and Directive 2003/87/EC will take place. It is ▌therefore appropriate to review comprehensively the effectiveness of this Regulation in 2023 to allow a coordinated and coherent assessment of the measures implemented under all those instruments. In that review of 2023, the Commission should also identify a clear pathway for further CO2 emissions reductions for passenger cars and light commercial vehicles beyond 2030 in order to significantly contribute to achieving the long-term goal of the Paris Agreement. Where appropriate, the report on that review should be accompanied by a proposal to amend this Regulation.

(52)  In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission in relation to the specification of detailed conditions for pooling arrangements, adoption of detailed rules on the procedures for monitoring and reporting of data on average emissions and on the application of Annexes II and III, adoption of detailed rules on the procedures for reporting of deviations found, as a result of verifications, in the CO2 emissions of vehicles in-service and taking those deviations into account in the calculation of the average specific emissions of CO2 of a manufacturer, determination of the means for collecting excess emissions premiums, publication of performance of manufacturers, adoption of detailed provisions for a procedure to approve the innovative technologies or innovative technology packages, adoption of a detailed procedure for collecting and processing the parameters relating to real-world CO2 emissions and fuel or energy consumption of passenger cars and light commercial vehicles, determination of the procedures for performing the verifications (i) that the CO2 emission and fuel consumption values recorded in the certificates of conformity correspond to the CO2 emissions from, and fuel consumption of, vehicles in-service, and (ii) the presence of any strategies on board or relating to the sampled vehicles that artificially improve the vehicle’s performance in the tests performed for the purpose of type-approval, and determination of the correlation parameters necessary in order to reflect any change in the regulatory test procedure for the measurement of specific emissions of CO2. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council(20).

(53)  In order to amend ▌or supplement, as appropriate, non-essential elements of the provisions of this Regulation, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of amending data requirements and data parameters set out in Annexes II and III of this Regulation , laying down rules, as regards the interpretation of the eligibility criteria for derogations for certain manufacturers, the content of the applications for a derogation, and the content and assessment of programmes for the reduction of specific emissions of CO2, ▌amending Part A of Annex I of this Regulation for the purpose of setting out the calculation formulae of the derogation targets for niche manufacturers, adjusting the cap for total contribution of innovative technologies to reducing the average specific emissions of CO2 of a manufacturer with effect from 2025 onwards, setting out the guiding principles and criteria for defining the procedures for performing the verifications, establishing the measures for adjustment of M0 and TM0 values, and adapting the formulae for calculating the specific emissions targets to reflect the change in the regulatory test procedure. . It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making(21). In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council ▌receive all documents at the same time as Member States' experts, and their experts ▌systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts.

(54)  Regulations (EC) No 443/2009 and (EU) No 510/2011 should be repealed with effect from 1 January 2020.

(55)  Since the objectives of this Regulation, namely the establishment of CO2 emissions performance requirements for new passenger cars and new light commercial vehicles, cannot be sufficiently achieved by the Member States, but can rather, by reason of their scale and effects, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve those objectives,

HAVE ADOPTED THIS REGULATION:

Article 1

Subject matter and objectives

1.  This Regulation establishes CO2 emissions performance requirements for new passenger cars and for new light commercial vehicles in order to contribute to achieving the Union's target of reducing its greenhouse gas emissions, as laid down in Regulation (EU) 2018/842, and the objectives of the Paris Agreement and to ensure the proper functioning of the internal market.

2.  From 1 January 2020, this Regulation sets an EU fleet-wide target of 95 g CO2/km for the average emissions of new passenger cars and an EU fleet-wide target of 147 g CO2/km for the average emissions of new light commercial vehicles registered in the Union, as measured until 31 December 2020 in accordance with Regulation (EC) No 692/2008 together with Implementing Regulations (EU) 2017/1152 and (EU) 2017/1153, and from 1 January 2021 measured in accordance with Regulation (EU) 2017/1151.

3.  This Regulation will, until 31 December 2024, be complemented by additional measures corresponding to a reduction of 10 g CO2/km as part of the Union 's integrated approach referred to in the Commission´s Communication of 7 February 2007 entitled “Results of the review of the Community Strategy to reduce CO2 emissions from passenger cars and light-commercial vehicles”.

4.  From 1 January 2025, the following EU fleet-wide targets shall apply:

(a)  for the average emissions of the new passenger car fleet, an EU fleet-wide target equal to a 15 % reduction of the target in 2021determined in accordance with point 6.1.1 of Part A of Annex I;

(b)  for the average emissions of the new light commercial vehicles fleet, an EU fleet-wide target equal to a 15 % reduction of the target in 2021 determined in accordance with point 6.1.1 of Part B of Annex I.

5.  From 1 January 2030, the following EU fleet-wide targets shall apply:

(a)  for the average emissions of the new passenger car fleet, an EU fleet-wide target equal to a 37,5 % reduction of the target in 2021 determined in accordance with point 6.1.2 of Part A of Annex I;

(b)  for the average emissions of the new light commercial vehicles fleet, an EU fleet- wide target equal to a 31 % reduction of the target in 2021 determined in accordance with point 6.1.2 of Part B of Annex I.

6.  From 1 January 2025, a zero- and low-emission vehicles' benchmark equal to a 15 % share of the respective fleets of new passenger cars and new light commercial vehicles shall apply in accordance with points 6.3 of Parts A and B of Annex I, respectively.

7.  From 1 January 2030, the following zero- and low-emission vehicles' benchmarks shall apply in accordance with points 6.3 of Parts A and B of Annex I, respectively:

(a)  a benchmark equal to a 35 % share of the fleet of new passenger cars, and

(b)  a benchmark equal to a 30 % share of the fleet of new light commercial vehicles.

Article 2

Scope

1.  This Regulation shall apply to the following motor vehicles:

(a)  category M1 as defined in Annex II to Directive 2007/46/EC (‘passenger cars’)which are registered in the Union for the first time and which have not previously been registered outside the Union (‘new passenger cars’);

(b)  category N1 as defined in Annex II to Directive 2007/46/EC with a reference mass not exceeding 2 610 kg, and vehicles of category N1 to which type-approval is extended in accordance with Article 2(2) of Regulation (EC) No 715/2007 (‘light commercial vehicles’), which are registered in the Union for the first time and which have not previously been registered outside the Union (‘new light commercial vehicles’). In the case of zero-emission vehicles of category N with a reference mass exceeding 2 610 kg or 2 840 kg, as the case may be, they shall, from 1 January 2025, for the purposes of this Regulation and without prejudice to Directive 2007/46/EC and Regulation (EC) No 715/2007, be counted as light commercial vehicles falling within the scope of this Regulation if the excess reference mass is due only to the mass of the energy storage system.

2.  A previous registration outside the Union made less than three months before registration in the Union shall not be taken into account.

3.  This Regulation shall not apply to special purpose vehicles as defined in point 5 of Part A of Annex II to Directive 2007/46/EC.

4.  Article 4, points (b) and (c) of Article 7(4), Article 8 and points (a) and (c) of Article 9(1) shall not apply to a manufacturer which, together with all of its connected undertakings, is responsible for fewer than 1 000 new passenger cars or for fewer than 1 000 new light commercial vehicles registered in the Union in the previous calendar year, unless that manufacturer applies for and is granted a derogation in accordance with Article 10.

Article 3

Definitions

1.  For the purposes of this Regulation, the following definitions apply:

(a)  ‘average specific emissions of CO2’ means, in relation to a manufacturer, the average of the specific emissions of CO2 of all new passenger cars or of ▌all new light commercial vehicles of which it is the manufacturer;

(b)  ‘certificate of conformity’ means the certificate of conformity referred to in Article 18 of Directive 2007/46/EC;

(c)  ‘completed vehicle’ means a light commercial vehicle where type-approval is granted following completion of a process of multi-stage type-approval in accordance with Directive 2007/46/EC;

(d)  ‘complete vehicle’ means any light commercial vehicle which does not need to be completed in order to meet the relevant technical requirements of Directive 2007/46/EC;

(e)  ‘base vehicle’ means any light commercial vehicle which is used at the initial stage of a multi-stage type-approval process;

(f)  ‘manufacturer’ means the person or body responsible to the approval authority for all aspects of the EC type-approval procedure in accordance with Directive 2007/46/EC and for ensuring conformity of production;

(g)  ‘mass in running order’ or 'M' means the mass of the passenger car or light commercial vehicle with bodywork in running order as stated in the certificate of conformity and defined in point 2.6 of Annex I to Directive 2007/46/EC;

(h)  ‘specific emissions of CO2’ means the CO2 emissions of a passenger car or a light commercial vehicle measured in accordance with Regulation (EC) No 715/2007 and its implementing Regulations and specified as the CO2 mass emissions (combined) in the certificate of conformity of the vehicle. For passenger cars or light commercial vehicles which are not type-approved in accordance with Regulation (EC) No 715/2007, ‘specific emissions of CO2’ means the CO2 emissions measured pursuant to Regulation (EC) No 715/2007, notably in accordance with the same measurement procedure as specified in Regulation (EC) No 692/2008 until 31 December 2020, and from 1 January 2021 in Regulation (EU) 2017/1151, or in accordance with procedures adopted by the Commission to establish the CO2 emissions for such vehicles;

(i)  ‘footprint’ means the average track width multiplied by the wheelbase as stated in the certificate of conformity and defined in points 2.1 and 2.3 of Annex I to Directive 2007/46/EC;

(j)  ‘specific emissions target’ means, in relation to a manufacturer, the annual target determined in accordance with Annex I or, if the manufacturer is granted a derogation in accordance with Article 10, the specific emissions target determined according to that derogation;

(k)  'EU fleet-wide target' means the average CO2 emissions of all new passenger cars or all new light commercial vehicles to be achieved in a given period;

(l)  'test mass' or 'TM' means the test mass of a passenger car or light commercial vehicle as stated in the certificate of conformity and as defined in point 3.2.25 of Annex XXI to Regulation (EU) 2017/1151;

(m)  'zero- and low-emission vehicle' means a passenger car or a light commercial vehicle with tailpipe emissions from zero up to 50 g CO2/km, as determined in accordance with Regulation (EU) 2017/1151;

(n)  ‘payload’ means the difference between the technically permissible maximum laden mass pursuant to Annex II to Directive 2007/46/EC and the mass of the vehicle.

2.  For the purposes of this Regulation, ‘a group of connected manufacturers’ means a manufacturer and its connected undertakings. In relation to a manufacturer, ‘connected undertakings’ means:

(a)  undertakings in which the manufacturer has, directly or indirectly:

(i)  the power to exercise more than half the voting rights; or

(ii)  the power to appoint more than half the members of the supervisory board, board of management or bodies legally representing the undertaking; or

(iii)  the right to manage the undertaking's affairs;

(b)  undertakings which directly or indirectly have, over the manufacturer, the rights or powers referred to in point (a);

(c)  undertakings in which an undertaking referred to in point (b) has, directly or indirectly, the rights or powers referred to in point (a);

(d)  undertakings in which the manufacturer together with one or more of the undertakings referred to in point (a), (b) or (c), or in which two or more of the latter undertakings, jointly have the rights or powers referred to in point (a);

(e)  undertakings in which the rights or the powers referred to in point (a) are jointly held by the manufacturer or one or more of its connected undertakings referred to in points (a) to (d) and one or more third parties.

Article 4

Specific emissions targets

1.  The manufacturer shall ensure that its average specific emissions of CO2 do not exceed the following specific emissions targets:

(a)  for the calendar year 2020, the specific emissions target determined in accordance with points 1 and 2 of Part A of Annex I in the case of passenger cars, or points 1 and 2 of Part B of Annex I in the case of light commercial vehicles, or where a manufacturer is granted a derogation under Article 10, in accordance with that derogation;

(b)  for each calendar year from 2021 until 2024, the specific emissions targets determined in accordance with points 3 and 4 of Part A or B of Annex I, as appropriate, or, where a manufacturer is granted a derogation under Article 10, in accordance with that derogation and point 5 of Part A or B of Annex I;

(c)  for each calendar year, starting from 2025, the specific emissions targets determined in accordance with point 6.3 of Part A or B of Annex I, or, where a manufacturer is granted a derogation under Article 10, in accordance with that derogation.

2.  In the case of light commercial vehicles, where the specific emissions of CO2 of the completed vehicle are not available, the manufacturer of the base vehicle shall use the specific emissions of CO2 of the base vehicle for determining its average specific emissions of CO2.

3.  For the purposes of determining each manufacturer’s average specific emissions of CO2, the following percentages of each manufacturer’s new passenger cars registered in the relevant year shall be taken into account:

—  95 % in 2020,

—  100 % from 2021 onwards.

Article 5

Super-credits

In calculating the average specific emissions of CO2, each new passenger car with specific emissions of CO2 of less than 50 g CO2/km shall be counted as:

—  2 passenger cars in 2020,

—  1,67 passenger cars in 2021,

—  1,33 passenger cars in 2022,

—  1 passenger car from 2023,

for the year in which it is registered in the period from 2020 to 2022, subject to a cap of 7,5 g CO2/km over that period for each manufacturer, as calculated in accordance with Article 5 of Implementing Regulation (EU) 2017/1153.

Article 6

Pooling

1.  Manufacturers, other than manufacturers which have been granted a derogation under Article 10, may form a pool for the purposes of meeting their obligations under Article 4.

2.  An agreement to form a pool may relate to one or more calendar years, provided that the overall duration of each agreement does not exceed five calendar years, and must be entered into on or before 31 December in the first calendar year for which emissions are to be pooled. Manufacturers which form a pool shall file the following information with the Commission:

(a)  the manufacturers who will be included in the pool;

(b)  the manufacturer nominated as the pool manager who will be the contact point for the pool and will be responsible for paying any excess emissions premium imposed on the pool in accordance with Article 8;

(c)  evidence that the pool manager will be able to fulfil the obligations under point (b);

(d)  the category of vehicles registered as M1 or N1, for which the pool shall apply.

3.  Where the proposed pool manager fails to meet the requirement to pay any excess emissions premium imposed on the pool in accordance with Article 8, the Commission shall notify the manufacturers.

4.  Manufacturers included in a pool shall jointly inform the Commission of any change of pool manager or of its financial status, in so far as this may affect its ability to meet the requirement to pay any excess emissions premium imposed on the pool in accordance with Article 8, and of any changes to the membership of the pool or the dissolution of the pool.

5.  Manufacturers may enter into pooling arrangements provided that their agreements comply with Articles 101 and 102 TFEU and that they allow open, transparent and non-discriminatory participation on commercially reasonable terms by any manufacturer requesting membership of the pool. Without prejudice to the general applicability of Union competition rules to such pools, all members of a pool shall in particular ensure that neither data sharing nor information exchange may occur in the context of their pooling arrangement, except in respect of the following information:

(a)  the average specific emissions of CO2;

(b)  the specific emissions target;

(c)  the total number of vehicles registered.

6.  Paragraph 5 shall not apply where all the manufacturers included in the pool are part of the same group of connected manufacturers.

7.  Except where notification is given under paragraph 3 of this Article, the manufacturers in a pool in respect of which information is filed with the Commission shall be considered as one manufacturer for the purposes of meeting their obligations under Article 4. Monitoring and reporting information in respect of individual manufacturers as well as any pools will be recorded, reported and made available in the central register referred to in Article 7(4).

8.  The Commission may specify, by means of implementing acts, the detailed conditions that shall apply for a pooling arrangement set up pursuant to paragraph 5 of this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 16(2).

Article 7

Monitoring and reporting of average emissions

1.  For each calendar year, each Member State shall record information for each new passenger car and each new light commercial vehicle registered in its territory in accordance with Parts A of Annexes II and III to this Regulation. That information shall be made available to the manufacturers and their designated importers or representatives in each Member State. Member States shall make every effort to ensure that reporting bodies operate in a transparent manner. Each Member State shall ensure that the specific emissions of CO2 of passenger cars which are not type-approved in accordance with Regulation (EC) No 715/2007 are measured and recorded in the certificate of conformity.

2.  By 28 February of each year, each Member State shall determine and transmit to the Commission the information listed in Parts A of Annexes II and III in respect of the preceding calendar year. The data shall be transmitted in accordance with the format specified in Part B of Annex II and Part C of Annex III.

3.  On request from the Commission, a Member State shall also transmit the full set of data collected pursuant to paragraph 1.

4.  The Commission shall keep a central register of the data reported by Member States under this Article, and by 30 June of each year, shall provisionally calculate the following for each manufacturer:

(a)  the average specific emissions of CO2 in the preceding calendar year;

(b)  the specific emissions target in the preceding calendar year;

(c)  the difference between its average specific emissions of CO2 in the preceding calendar year and its specific emissions target for that year.

The Commission shall notify each manufacturer of its provisional calculation for that manufacturer. The notification shall include data for each Member State on the number of new passenger cars and of new light commercial vehicles registered and their specific emissions of CO2.

The register shall be publicly available.

5.  Manufacturers may, within three months of being notified of the provisional calculation under paragraph 4, notify the Commission of any errors in the data, specifying the Member State in which they consider that the error occurred.

The Commission shall consider any notifications from manufacturers and shall, by 31 October, either confirm or amend the provisional calculations under paragraph 4.

6.  Member States shall designate a competent authority for the collection and communication of the monitoring data in accordance with this Regulation and shall inform the Commission of the competent authority designated.

The designated competent authorities shall ensure the correctness and completeness of the data transmitted to the Commission, and shall provide a contact point that is to be available to respond quickly to requests from the Commission to address errors and omissions in the transmitted datasets.

7.  The Commission shall adopt, by means of implementing acts, detailed rules on the procedures for monitoring and reporting of data under paragraphs 1 to 6 of this Article, and on the application of Annexes II and III. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 16(2).

8.  The Commission is empowered to adopt delegated acts in accordance with Article 17 in order to amend the data requirements and data parameters set out in Annexes II and III.

9.  Type-approval authorities shall without delay report to the Commission deviations found in the CO2 emissions of vehicles in-service as compared to the specific emissions of CO2  indicated in the certificates of conformity as a result of verifications performed in accordance with Article 13.

The Commission shall take those deviations into account for the purpose of calculating the average specific emissions of CO2 of a manufacturer.

The Commission shall adopt, by means of implementing acts, detailed rules on the procedures for reporting such deviations and for taking them into account in the calculation of the average specific emissions of CO2. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 16(2).

10.  The Commission shall no later than 2023 evaluate the possibility of developing a common Union methodology for the assessment and the consistent data reporting of the full life-cycle CO2 emissions of passenger cars and light commercial vehicles that are placed on the Union market. The Commission shall transmit to the European Parliament and to the Council that evaluation, including, where appropriate, proposals for follow-up measures, such as legislative proposals.

11.  Member States shall also collect and report data, in accordance with this Article, on registrations of vehicles in categories M2 and N2, as defined in Annex II to Directive 2007/46/EC, with a reference mass not exceeding 2 610 kg, and vehicles to which type-approval is extended in accordance with Article 2(2) of Regulation (EC) No 715/2007.

Article 8

Excess emissions premium

1.  In respect of each calendar year, the Commission shall impose an excess emissions premium on a manufacturer or pool manager, as appropriate, where a manufacturer's average specific emissions of CO2 exceed its specific emissions target.

2.  The excess emissions premium under paragraph 1 shall be calculated using the following formula:

(Excess emissions × EUR 95) × number of newly registered vehicles.

For the purposes of this Article, the following definitions shall apply:

—  ‘excess emissions’ means the positive number of grams per kilometre by which a manufacturer's average specific emissions of CO2, taking into account CO2 emissions reductions due to innovative technologies approved in accordance with Article 11, exceeded its specific emissions target in the calendar year or part thereof to which the obligation under Article 4 applies, rounded to the nearest three decimal places, and

—  ‘number of newly registered vehicles’ means the number of new passenger cars or new light commercial vehicles counted separately of which it is the manufacturer and which were registered in that period according to the phase-in criteria as set out in Article 4(3).

3.  The Commission shall determine, by means of implementing acts, the means for collecting excess emissions premiums imposed under paragraph 1 of this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 16(2).

4.  The amounts of the excess emissions premium shall be considered as revenue for the general budget of the Union.

Article 9

Publication of performance of manufacturers

1.  By 31 October of each year, the Commission shall publish, by means of implementing acts, a list indicating:

(a)  for each manufacturer, its specific emissions target for the preceding calendar year;

(b)  for each manufacturer, its average specific emissions of CO2 in the preceding calendar year;

(c)  the difference between the manufacturer's average specific emissions of CO2 in the preceding calendar year and its specific emissions target in that year;

(d)  the average specific emissions of CO2 for all new passenger cars and new light commercial vehicles registered in the Union in the previous calendar year;

(e)  the average mass in running order for all new passenger cars and new light commercial vehicles registered in the Union in the preceding calendar year until 31 December 2020;

(f)  the average test mass of all new passenger cars and new light commercial vehicles registered in the Union in the preceding calendar year.

2.  The list published under paragraph 1 of this Article shall also indicate whether the manufacturer has complied with the requirements of Article 4 with respect to the preceding calendar year.

3.  The list referred to in paragraph 1 of this Article shall, for the publication by 31 October 2022, also indicate the following:

(a)  the 2025 and 2030 EU fleet-wide targets referred to in Article 1(4) and (5), respectively, calculated by the Commission in accordance with points 6.1.1 and 6.1.2 of Parts A and B of Annex I;

(b)  the values for a2021, a2025 and a2030 calculated by the Commission in accordance with points 6.2 of Parts A and B of Annex I.

Article 10

Derogations for certain manufacturers

1.  An application for a derogation from the specific emissions target calculated in accordance with Annex I may be made by a manufacturer of fewer than 10 000 new passenger cars or 22 000 new light commercial vehicles registered in the Union per calendar year, and which:

(a)  is not part of a group of connected manufacturers; or

(b)  is part of a group of connected manufacturers that is responsible in total for fewer than 10 000 new passenger cars or 22 000 new light commercial vehicles registered in the Union per calendar year; or

(c)  is part of a group of connected manufacturers but operates its own production facilities and design centre.

2.  A derogation applied for under paragraph 1 may be granted for a maximum period of five calendar years, which is renewable. An application shall be made to the Commission and shall include:

(a)  the name of, and contact person for, the manufacturer;

(b)  evidence that the manufacturer is eligible for a derogation under paragraph 1;

(c)  details of the passenger cars or light commercial vehicles which it manufactures including the test mass and specific emissions of CO2 of those passenger cars or light commercial vehicles; and

(d)  a specific emissions target consistent with its reduction potential, including the economic and technological potential to reduce its specific emissions of CO2 and taking into account the characteristics of the market for the type of passenger car or light commercial vehicle manufactured.

3.  Where the Commission considers that the manufacturer is eligible for a derogation applied for under paragraph 1 and is satisfied that the specific emissions target proposed by the manufacturer is consistent with its reduction potential, including the economic and technological potential to reduce its specific emissions of CO2, and taking into account the characteristics of the market for the type of passenger car or light commercial vehicle manufactured, the Commission shall grant a derogation to the manufacturer.

The application shall be submitted at the latest by 31 October of the first year in which the derogation shall apply.

4.  An application for a derogation from the specific emissions target calculated in accordance with points 1 to 4 and 6.3 of Part A of Annex I may be made by a manufacturer which is responsible, together with all of its connected undertakings, for between 10 000 and 300 000 new passenger cars registered in the Union per calendar year.

Such application may be made by a manufacturer in respect of itself or in respect of itself together with any of its connected undertakings. An application shall be made to the Commission and shall include:

(a)  all of the information referred to in points (a) and (c) of paragraph 2,including, where relevant, information about any connected undertakings;

(b)  in relation to applications referring to points 1 to 4 of Part A of Annex I, a target which is a 45 % reduction on the average specific emissions of CO2 in 2007 or, where a single application is made in respect of a number of connected undertakings, a 45 % reduction on the average of those undertakings’ average specific emissions of CO2 in 2007;

(c)  in relation to applications referring to point 6.3 of Part A of Annex I to this Regulation, a target applicable in the calendar years 2025 to 2028 which is the reduction specified in point (a) of Article 1(4) of this Regulation on the target calculated in accordance with point (b) of this paragraph taking into account the CO2 emissions measured pursuant to Regulation (EU) 2017/1151.

Where information on a manufacturer's average specific emissions of CO2 does not exist for the year 2007, the Commission shall determine an equivalent reduction target based upon the best available CO2 emissions reduction technologies deployed in passenger cars of comparable mass and taking into account the characteristics of the market for the type of car manufactured. That target shall be used by the applicant for the purposes of point (b) of the second subparagraph.

The Commission shall grant a derogation to the manufacturer where it is demonstrated that the criteria for the derogation referred to in this paragraph have been met.

5.  A manufacturer which is subject to a derogation in accordance with this Article shall notify the Commission immediately of any change which affects or may affect its eligibility for a derogation.

6.  Where the Commission considers, whether on the basis of a notification under paragraph 5 or otherwise, that a manufacturer is no longer eligible for the derogation, it shall revoke the derogation with effect from 1 January of the next calendar year and shall notify the manufacturer thereof.

7.  Where the manufacturer does not attain its specific emissions target, the Commission shall impose the excess emissions premium on the manufacturer, as set out in Article 8.

8.  The Commission is empowered to adopt delegated acts in accordance with Article 17 laying down rules to supplement paragraphs 1 to 7 of this Article, as regards the interpretation of the eligibility criteria for derogations, the content of the applications, and the content and assessment of programmes for the reduction of specific emissions of CO2.

The Commission is also empowered to adopt delegated acts in accordance with Article 17 to amend Part A of Annex I for the purpose of setting out the calculation formulae of the derogation targets referred to in point (c) of the second subparagraph of paragraph 4 of this Article.

9.  Applications for a derogation, including the information supporting it, notifications under paragraph 5, revocations under paragraph 6, any imposition of an excess emissions premium under paragraph 7 and measures adopted pursuant to paragraph 8, shall be made publicly available, subject to Regulation (EC) No 1049/2001 of the European Parliament and of the Council(22).

Article 11

Eco-innovation

1.  Upon application by a supplier or a manufacturer, CO2 savings achieved through the use of innovative technologies or a combination of innovative technologies (‘innovative technology packages’) shall be considered.

Such technologies shall be taken into consideration only if the methodology used to assess them is capable of producing verifiable, repeatable and comparable results.

The total contribution of those technologies to reducing the average specific emissions of CO2 of a manufacturer may be up to 7 g CO2/km.

The Commission is empowered to adopt delegated acts in accordance with Article 17 in order to amend this Regulation by adjusting the cap referred to in the third subparagraph of this paragraph with effect from 2025 onwards to take into account technological developments while ensuring a balanced proportion of the level of that cap in relation to the average specific emissions of CO2 of manufacturers.

2.  The Commission shall adopt, by means of implementing acts, detailed provisions for a procedure to approve the innovative technologies or innovative technology packages referred to in paragraph 1 of this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 16(2). Those detailed provisions shall be based on the following criteria for innovative technologies:

(a)  the supplier or manufacturer must be accountable for the CO2 savings achieved through the use of the innovative technologies;

(b)  the innovative technologies must make a verified contribution to CO2 reduction;

(c)  the innovative technologies must not be covered by the standard test cycle CO2 measurement;

(d)  the innovative technologies must not:

(i)  be covered by mandatory provisions due to complementary additional measures complying with the 10 g CO2/km reduction referred to in Article 1(3) or

(ii)  be mandatory under other provisions of Union law.

With effect from 1 January 2025, the criterion referred to in point (d)(i) of the first subparagraph shall not apply with regard to efficiency improvements for air conditioning systems.

3.  A supplier or a manufacturer that applies for a measure to be approved as an innovative technology or innovative technology package shall submit a report, including a verification report undertaken by an independent and certified body, to the Commission. In the event of a possible interaction of the measure with another innovative technology or innovative technology package already approved, that report shall mention that interaction and the verification report shall evaluate to what extent that interaction modifies the reduction achieved by each measure.

4.  The Commission shall attest the reduction achieved on the basis of the criteria set out in paragraph 2.

Article 12

Real-world CO2 emissions and fuel or energy consumption

1.  The Commission shall monitor and assess the real-world representativeness of the CO2 emissions and fuel or energy consumption values determined pursuant to Regulation (EC) No 715/2007.

Furthermore, the Commission shall regularly collect data on the real-world CO2 emissions and fuel or energy consumption of passenger cars and light commercial vehicles using on-board fuel and/or energy consumption monitoring devices, starting with new passenger cars and new light commercial vehicles registered in 2021.

The Commission shall ensure that the public is informed of how that real-world representativeness evolves over time.

2.  For the purpose referred to in paragraph 1, starting from 1 January 2021, the Commission shall ensure that the following parameters relating to real-world CO2 emissions and fuel or energy consumption of passenger cars and light commercial vehicles are made available at regular intervals to it, from manufacturers, national authorities or through direct data transfer from vehicles, as the case may be:

(a)  vehicle identification number;

(b)  fuel and/or electric energy consumed;

(c)  total distance travelled;

(d)  for externally chargeable hybrid electric vehicles, the fuel and electric energy consumed and the distance travelled distributed over the different driving modes;

(e)  other parameters necessary to ensure that the obligations set out in paragraph 1 can be met.

The Commission shall process the data received under the first subparagraph to create anonymised and aggregated datasets, including per manufacturer, for the purposes of paragraph 1. The vehicle identification numbers shall be used only for the purpose of that data processing and shall not be retained longer than needed for that purpose.

3.  In order to prevent the real-world emissions gap from growing, the Commission shall, no later than 1 June 2023, assess how fuel and energy consumption data may be used to ensure that the vehicle CO2 emissions and fuel or energy consumption values determined pursuant to Regulation (EC) No 715/2007 remain representative of real-world emissions over time for each manufacturer.

The Commission shall monitor and report annually on how the gap referred to in the first subparagraph evolves over the period 2021 to 2026 and shall, with the view to preventing an increase in that gap, assess, in 2027, the feasibility of a mechanism to adjust the manufacturer's average specific emissions of CO2 as of 2030, and, if appropriate, submit a legislative proposal to put such a mechanism in place.

4.  The Commission shall adopt, by means of implementing acts, the detailed procedure for collecting and processing the data referred to in paragraph 2 of this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 16(2).

Article 13

Verification of the CO2 emissions of vehicles in-service

1.  Manufacturers shall ensure that the CO2 emission and fuel consumption values recorded in the certificates of conformity correspond to the CO2 emissions from, and fuel consumption of, vehicles in-service as determined in accordance with Regulation (EU) 2017/1151.

2.  Following the entry into force of the procedures referred to in the first subparagraph of paragraph 4, type-approval authorities shall verify for those vehicle families for which they are responsible for the type-approval, on the basis of appropriate and representative vehicle samples, that the CO2 emission and fuel consumption values recorded in the certificates of conformity correspond to the CO2 emissions from, and fuel consumption of, vehicles in-service as determined in accordance with Regulation (EU) 2017/1151 while considering, inter alia, available data from on-board fuel and/or energy consumption monitoring devices.

Type-approval authorities shall also verify the presence of any strategies on board or relating to the sampled vehicles that artificially improve the vehicle’s performance in the tests performed for the purpose of type-approval by, inter alia, using data from on-board fuel and/or energy consumption monitoring devices.

3.  Where a lack of correspondence of CO2 emission and fuel consumption values or the presence of any strategies artificially improving a vehicle’s performance is found as a result of the verifications performed pursuant to paragraph 2, the responsible type-approval authority shall, in addition to taking the necessary measures set out in Chapter XI of Regulation (EU) 2018/858, ensure the correction of the certificates of conformity.

4.  The Commission shall determine, by means of implementing acts, the procedures for performing the verifications referred to in paragraph 2 of this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 16(2).

The Commission is empowered, prior to adopting the implementing acts referred to in the first subparagraph of this paragraph, to adopt a delegated act in accordance with Article 17 in order to supplement this Regulation by setting out the guiding principles and criteria for defining the procedures referred to in the first subparagraph of this paragraph.

Article 14

Adjustment of M0 and TM0  values

1.  The M0 and TM0 values referred to in Parts A and B of Annex I shall be adjusted as follows:

(a)  by 31 October 2020, the M0 value in point 4 of Part A of Annex I shall be adjusted to the average mass in running order of all new passenger cars registered in 2017, 2018, and 2019. That new M0 value shall apply from 1 January 2022 until 31 December 2024;

(b)  by 31 October 2022, the M0 value in point 4 of Part B of Annex I shall be adjusted to the average mass in running order of all new light commercial vehicles registered in 2019, 2020 and 2021. That new M0 value shall apply in 2024;

(c)  by 31 October 2022, the indicative TM0 value for 2025 shall be determined as the respective average test mass of all new passenger cars and new light commercial vehicles registered in 2021;

(d)  by 31 October 2024, and every second year thereafter, the TM0 value in point 6.2 of Parts A and B of Annex I shall be adjusted to the respective average test mass of all new passenger cars and new light commercial vehicles registered in the preceding two calendar years, starting with 2022 and 2023. The new TM0 values shall apply from 1 January of the calendar year following the date of the adjustment.

2.  The Commission is empowered to adopt delegated acts in accordance with Article 17 in order to supplement this Regulation by establishing the measures referred to in paragraph 1 of this Article.

Article 15

Review and report

1.  The Commission shall, in 2023, thoroughly review the effectiveness of this Regulation and submit a report to the European Parliament and to the Council with the result of the review.

2.  In the report referred to in paragraph 1, the Commission shall consider, inter alia, the real-world representativeness of the CO2 emission and fuel or energy consumption values determined pursuant to Regulation (EC) No 715/2007; the deployment on the Union market of zero- and low-emission vehicles, in particular with respect to light commercial vehicles; the roll-out of recharging and refuelling infrastructure reported under Directive 2014/94/EU of the European Parliament and of the Council(23), including their financing; the potential contribution of the use of synthetic and advanced alternative fuels produced with renewable energy to emissions reductions; the CO2 emissions reduction actually observed at the existing fleet level; the functioning of the incentive mechanism for zero- and low-emission vehicles; the potential effects of the transitional measure set out in point 6.3 of Part A of Annex I; the impact of this Regulation on consumers, particularly on those on low and medium incomes; as well as aspects to further facilitate an economically viable and socially fair transition towards clean, competitive and affordable mobility in the Union.

The Commission shall, in that report, also identify a clear pathway for further CO2 emissions reductions for passenger cars and light commercial vehicles beyond 2030 in order to significantly contribute to achieving the long-term goal of the Paris Agreement.

3.  The report referred to in paragraph 2 shall, where appropriate, be accompanied by a proposal for amending this Regulation, in particular, the possible revision of the EU fleet-wide targets for 2030 in light of the elements listed in paragraph 2, and the introduction of binding emissions reduction targets for 2035 and 2040 onwards for passenger cars and light commercial vehicles to ensure the timely transformation of the transport sector towards achieving net-zero emissions in line with the objectives of the Paris Agreement.

4.  As part of the review referred to in paragraph 1 of this Article, the Commission shall assess the feasibility of developing real-world emission test procedures using portable emission measurement systems (PEMS). The Commission shall take into account that assessment as well as those made pursuant to Article 12 of this Regulation and may, where appropriate, review the procedures for measuring CO2 emissions as set out under Regulation (EC) No 715/2007. The Commission shall, in particular, make appropriate proposals to adapt those procedures to reflect adequately the real-world CO2 emissions of passenger cars and light commercial vehicles.

5.  As part of the review referred to in paragraph 1 of this Article, the Commission shall evaluate the possibility to assign the revenue from the excess emissions premiums to a specific fund or a relevant programme, with the objective to ensure a just transition towards a climate-neutral economy as referred to in Article 4.1 of the Paris Agreement, in particular to support re-skilling, up-skilling and other skills training and reallocation of workers in the automotive sector in all affected Member States, in particular in the regions and the communities most affected by the transition. The Commission shall, if appropriate, make a legislative proposal to that effect by 2027 at the latest.

6.  By 31 December 2020, the Commission shall review Directive 1999/94/EC considering the need to provide consumers with accurate, robust and comparable information on the fuel consumption, CO2 emissions and air pollutant emissions of new passenger cars placed on the market, as well as evaluate the options for introducing a fuel economy and CO2 emissions label for new light commercial vehicles. The review shall, where appropriate, be accompanied by a legislative proposal.

7.  The Commission shall, by means of implementing acts, determine the correlation parameters necessary in order to reflect any change in the regulatory test procedure for the measurement of specific emissions of CO2 referred to in Regulations (EC) No 715/2007 and (EC) No 692/2008 and, where applicable, Regulation (EU) 2017/1151. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 16(2) of this Regulation.

8.  The Commission is empowered to adopt delegated acts in accordance with Article 17 in order to amend this Regulation by adapting the formulae set out in Annex I, using the methodology adopted pursuant to paragraph 7 of this Article, while ensuring that reduction requirements of comparable stringency for manufacturers and vehicles of different utility are required under the old and new test procedures.

Article 16

Committee procedure

1.  The Commission shall be assisted by the Climate Change Committee referred to in point (a) of Article 44(1) of  Regulation (EU) 2018/1999 of the European Parliament and of the Council(24). That committee shall be a committee within the meaning of Regulation (EU) No 182/2011.

2.  Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply.

3.  Where the committee delivers no opinion, the Commission shall not adopt the draft implementing act and the third subparagraph of Article 5(4) of Regulation (EU) No 182/2011 shall apply.

Article 17

Exercise of the delegation

1.  The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article.

2.  The power to adopt delegated acts referred to in ▌Article 7(8), Article 10(8), the fourth subparagraph of Article 11(1), Article 13(4), Article 14(2) and ▌Article 15(8) shall be conferred on the Commission for a period of six years from ... [date of entry into force of this Regulation]. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the six-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period.

3.  The delegation of power referred to in ▌Article 7(8), Article 10(8), the fourth subparagraph of Article 11(1), Article 13(4), Article 14(2) and ▌Article 15(8) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force.

4.  Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making.

5.  As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.

6.  A delegated act adopted pursuant to ▌Article 7(8), Article 10(8), the fourth subparagraph of Article 11(1), Article 13(4), Article 14(2) and ▌Article 15(8) shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of two months of notification of that act to the European Parliament and to the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council.

Article 18

Repeal

Regulations (EC) No 443/2009 and (EU) No 510/2011 are repealed with effect from 1 January 2020.

References to the repealed Regulations shall be construed as references to this Regulation and shall be read in accordance with the correlation table in Annex V.

Article 19

Entry into force

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

It shall apply from 1 January 2020.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at,

For the European Parliament For the Council

The President The President

ANNEX I

PART A. SPECIFIC EMISSIONS TARGETS FOR PASSENGER CARS

1.  For the calendar year 2020, the specific emissions of CO2 for each new passenger car shall, for the purposes of the calculations in this point and in point 2, be determined in accordance with the following formula:

Specific emissions of CO2 = 95 + a · (M – M0)

where:

M

=

Mass in running order of the vehicle in kilograms (kg)

M0

=

1 379,88

a

=

0,0333

2.  The specific emissions target for a manufacturer in 2020 shall be calculated as the average of the specific emissions of CO2 determined according to point 1, of each new passenger car registered in that calendar year of which it is the manufacturer.

3.  The specific emissions reference target for a manufacturer in 2021 shall be calculated as follows:

WLTP specific emissions reference target = WLTPCO2 · 20190327-P8_TA-PROV(2019)0304_EN-p0000002.png

where:

WLTPCO2 is the average specific emissions of CO2 in 2020 determined in accordance with Annex XXI to Regulation (EU) 2017/1151 and calculated in accordance with the  second  indent of Article 4(3)  of this Regulation, without including CO2 savings resulting from the application of Articles 5 and 11 of this Regulation;

NEDCCO2 is the average specific emissions of CO2 in 2020 determined in accordance with Implementing Regulation (EU) 2017/1153 and calculated in accordance with the second indent of Article 4(3) of this Regulation, without including CO2 savings resulting from the application of Articles 5 and 11 of this Regulation;

NEDC2020target is the 2020 specific emissions target calculated in accordance with points 1 and 2.

4.  For the calendar years 2021 to 2024, the specific emissions target for a manufacturer shall be calculated as follows:

Specific emissions target = WLTPreference target + a [(Mø-M0) – (Mø2020 – M0,2020)]

where:

WLTPreference target is the 2021 WLTP specific emissions reference target calculated in accordance with point 3;

a is 0,0333;

Mø is the average of the mass in running order (M) of the new passenger cars of the manufacturer registered in the relevant target year in kilograms (kg);

M0 is 1 379,88 in 2021, and as defined in point (a) of Article 14(1) for the years 2022, 2023 and 2024;

2020 is the average of the mass in running order (M) of the new passenger cars of the manufacturer registered in 2020 in kilograms (kg);

M0,2020 is 1 379,88.

5.  For a manufacturer that has been granted a derogation with regard to a specific NEDC based emissions target in 2021, the WLTP based derogation target shall be calculated as follows:

Derogation target2021 = WLTPCO2 ·20190327-P8_TA-PROV(2019)0304_EN-p0000003.png

where:

WLTPCO2 is WLTPCO2 as defined in point 3;

NEDCCO2 is NEDCCO2 as defined in point 3;

NEDC2021target is the 2021 derogation target granted by the Commission pursuant to Article 10.

6.  From 1 January 2025, the EU fleet-wide targets and the specific emissions targets for a manufacturer shall be calculated as follows:

6.0.  EU fleet-wide target2021

EU fleet-wide target2021 is the average, weighted by the number of new passenger cars registered in 2021, of the reference-values2021 determined for each individual manufacturer for which a specific emissions target applies in accordance with point 4.

The reference-value2021 shall be determined, for each manufacturer, as follows:

20190327-P8_TA-PROV(2019)0304_EN-p0000004.png

where,

WLTPCO2,measured is the average, for each manufacturer, of the measured CO2 emissions combined of each new passenger car registered in 2020, as determined and reported in accordance with Article 7a of Implementing Regulation (EU) 2017/1153;

NEDC2020,Fleet Target is 95 g/km;

NEDCCO2 is as defined in point 3;

M2021 is the average of the mass in running order of the new passenger cars of the manufacturer registered in 2021 in kilograms (kg);

M0,2021 is the average mass in running order in kilograms (kg) of all new passenger cars registered in 2021 of those manufacturers for which a specific emissions target applies in accordance with point 4;

a is as defined in point 4.

6.1.  EU fleet-wide targets for 2025 and 2030

6.1.1.  EU fleet-wide target for 2025 to 2029

EU fleet-wide target2025 = EU fleet-wide target2021 · (1 - reduction factor2025)

where,

EU fleet-wide target2021 is as defined in point 6.0;

reduction factor2025 is the reduction specified in point (a) of Article 1(4).

6.1.2.  EU fleet-wide target for 2030 onwards

EU fleet-wide target2030 = EU fleet-wide target2021 · (1 - reduction factor2030)

where,

EU fleet-wide target2021 is as defined in point 6.0;

reduction factor2030 is the reduction specified in point (a) of Article 1(5).

6.2.  Specific emissions reference targets from 2025 onwards

6.2.1.  Specific emissions reference targets for 2025 to 2029

The specific emissions reference target = EU fleet-wide target2025 + a2025 · (TM-TM0)

where,

EU fleet-wide target2025 is as determined in accordance with point 6.1.1;

a2025 is 20190327-P8_TA-PROV(2019)0304_EN-p0000005.png

where,

a2021 is the slope of the best fitting straight line established by applying the linear least squares fitting method to the test mass (independent variable) and the specific emissions of CO2 (dependent variable) of each new passenger car registered in 2021;

average emissions2021 is the average of the specific emissions of CO2 of all new passenger cars registered in 2021 of those manufacturers for which a specific emissions target is calculated in accordance with point 4;

TM is the average test mass in kilograms (kg) of all new passenger cars of the manufacturer registered in the relevant calendar year;

TM0 is the value in kilograms (kg) determined in accordance with point (d) of Article 14(1).

6.2.2.  Specific emissions reference targets for 2030 onwards

The specific emissions reference target = EU fleet-wide target2030 + a2030 · (TM-TM0)

where,

EU fleet-wide target2030 is as determined in accordance with point 6.1.2;

a2030 is 20190327-P8_TA-PROV(2019)0304_EN-p0000006.png

where,

a2021 is as defined in point 6.2.1;

average emissions2021 is as defined in point 6.2.1;

TM is as defined in point 6.2.1;

TM0 is as defined in point 6.2.1.

6.3.  Specific emissions targets from 2025 onwards

Specific emissions target = specific emissions reference target · ZLEV factor

where,

specific emissions reference target is the specific emissions reference target of CO2 determined in accordance with point 6.2.1 for the period 2025 to 2029 and point 6.2.2 for 2030 onwards;

ZLEV factor is (1+y-x), unless this sum is larger than 1,05 or lower than 1,0 in which case the ZLEV factor shall be set to 1,05 or 1,0, as the case may be;

where,

y is the share of zero- and low-emission vehicles in the manufacturer's fleet of new passenger cars calculated as the total number of new zero- and low-emission vehicles, where each of them is counted as ZLEVspecific in accordance with the following formula, divided by the total number of new passenger cars registered in the relevant calendar year:

20190327-P8_TA-PROV(2019)0304_EN-p0000007.png

For new passenger cars registered in Member States with a share of zero- and low-emission vehicles in their fleet below 60 % of the Union average in the year 2017(25) and with less than 1 000 new zero- and low-emission vehicles registered in 2017, ZLEVspecific shall, until and including 2030, be calculated in accordance with the following formula:

20190327-P8_TA-PROV(2019)0304_EN-p0000008.png

Where the share of zero- and low-emission vehicles in a Member State's fleet of new passenger cars registered in a year between 2025 and 2030 exceeds 5 %, that Member State shall not be eligible for the application of the multiplier of 1,85 in the subsequent years;

x is 15 % in the years 2025 to 2029 and 35 % from 2030 onwards.

PART B.  SPECIFIC EMISSIONS TARGETS FOR LIGHT COMMERCIAL VEHICLES

1.  For the calendar year 2020, the specific emissions of CO2 for each new light commercial vehicle shall, for the purposes of the calculations in this point and in point 2, be determined in accordance with the following formula:

Specific emissions of CO2 = 147 + a · (M - M0)

where:

M

=

Mass in running order of the vehicle in kilograms (kg)

M0

=

1 766,4

a

=

0,096

2.  The specific emissions target for a manufacturer in 2020 shall be calculated as the average of the specific emissions of CO2 determined according to point 1 of each new light commercial vehicle registered in that calendar year of which it is the manufacturer.

3.  The specific emissions reference target for a manufacturer in 2021 shall be calculated as follows:

WLTP specific emissions reference target =20190327-P8_TA-PROV(2019)0304_EN-p0000009.png

where:

WLTPCO2 is the average specific emissions of CO2 in 2020 determined in accordance with Annex XXI to Regulation (EU) 2017/1151 without including CO2 savings resulting from the application of Article 11 of this Regulation;

NEDCCO2 is the average specific emissions of CO2 in 2020 determined in accordance with Implementing Regulation (EU) 2017/1152, without including CO2 savings resulting from the application of Article 11 of this Regulation;

NEDC2020target is the 2020 specific emissions target calculated in accordance with points 1 and 2.

4.  For the calendar years 2021 to 2024, the specific emissions target for a manufacturer shall be calculated as follows:

Specific emissions target = WLTPreference target + a [(Mø-M0) – (Mø2020 – M0,2020)]

where:

WLTPreference target is the 2021 WLTP specific emissions reference target calculated in accordance with point 3;

a is 0,096;

Mø is the average of the mass in running order (M) of the new light commercial vehicles of the manufacturer registered in the relevant target year in kilograms (kg);

M0 is 1 766,4 in 2020 and, for the years 2021, 2022 and 2023, the value adopted pursuant to Article 13(5) of Regulation (EU) No 510/2011, and for 2024 the value adopted pursuant to point (b) of Article 14(1) of this Regulation;

Mø2020 is the average of the mass in running order (M) of the new light commercial vehicles of the manufacturer registered in 2020 in kilograms (kg);

M0,2020 is 1 766,4.

5.  For a manufacturer that has been granted a derogation with regard to a specific NEDC based emissions target in 2021, the WLTP based derogation target shall be calculated as follows:

Derogation target2021 = WLTPCO2 ·(20190327-P8_TA-PROV(2019)0304_EN-p0000010.png )

where:

WLTPCO2 is WLTPCO2 as defined in point 3;

NEDCCO2 is NEDCCO2 as defined in point 3;

NEDC2021target is the 2021 derogation target granted by the Commission pursuant to Article 10.

6.  From 1 January 2025, the EU fleet-wide targets and the specific emissions targets for a manufacturer shall be calculated as follows:

6.0.  EU fleet-wide target2021

EU fleet-wide target2021 is the average, weighted by the number of new light commercial vehicles registered in 2021, of the reference-values2021 determined for each individual manufacturer for which a specific emissions target applies in accordance with point 4.

The reference-value2021 shall be determined, for each manufacturer, as follows:

20190327-P8_TA-PROV(2019)0304_EN-p0000011.png

where,

WLTPCO2,measured is the average, for each manufacturer, of the measured CO2 emissions combined of each new light commercial vehicle registered in 2020, as determined and reported in accordance with Article 7a of Implementing Regulation (EU) 2017/1152;

NEDC2020,Fleet Target is 147 g/km;

NEDCCO2 is as defined in point 3;

M2021 is the average of the mass in running order of the new light commercial vehicles of the manufacturer registered in 2021 in kilograms (kg);

M0,2021 is the average mass in running order in kilograms (kg) of all new light commercial vehicles registered in 2021 of those manufacturers for which a specific emissions target applies in accordance with point 4;

a is as defined in point 4.

6.1.  The EU fleet-wide targets for 2025 and 2030

6.1.1.  EU fleet-wide target for 2025 to 2029

EU fleet-wide target2025 = EU fleet-wide target2021 · (1 - reduction factor2025)

where,

EU fleet-wide target2021 is as defined in point 6.0;

reduction factor2025 is the reduction specified in point (b) of Article 1(4).

6.1.2.  EU fleet-wide target for 2030 onwards

EU fleet-wide target2030 = EU fleet-wide target2021 · (1 - reduction factor2030)

where,

EU fleet-wide target2021 is as defined in point 6.0;

reduction factor2030 is the reduction specified in point (b) of Article 1(5).

6.2.  Specific emissions reference targets from 2025 onwards

6.2.1.  Specific emissions reference targets for 2025 to 2029

The specific emissions reference target = EU fleet-wide target2025 + α · (TM-TM0)

where,

EU fleet-wide target2025 is as determined in accordance with point 6.1.1;

α is a2025 where the average test mass of a manufacturer's new light commercial vehicles is equal to or lower than TM0 determined in accordance with point (d) of Article 14(1) and a2021 where the average test mass of a manufacturer's new light commercial vehicles is higher than TM0 determined in accordance with point (d) of Article 14(1);

where,

a2025 is 20190327-P8_TA-PROV(2019)0304_EN-p0000012.png

a2021 is the slope of the best fitting straight line established by applying the linear least squares fitting method to the test mass (independent variable) and the specific emissions of CO2 (dependent variable) of each new light commercial vehicle registered in 2021;

average emissions2021 is the average of the specific emissions of CO2 of all new light commercial vehicles registered in 2021 of those manufacturers for which a specific emissions target is calculated in accordance with point 4;

TM is the average test mass in kilograms (kg) of all new light commercial vehicles of the manufacturer registered in the relevant calendar year;

TM0 is the value in kilograms (kg) determined in accordance with point (d) of Article 14(1).

6.2.2.  Specific emissions reference targets from 2030 onwards

The specific emissions reference target = EU fleet-wide target2030 + α · (TM-TM0)

where,

EU fleet-wide target2030 is as determined in accordance with point 6.1.2;

α is a2030 where the average test mass of a manufacturer's new light commercial vehicles is equal to or lower than TM0 determined in accordance with point (d) of Article 14(1) and a2021 where the average test mass of a manufacturer's new light commercial vehicles is higher than TM0 determined in accordance with point (d) of Article 14(1);

where,

a2030 is 20190327-P8_TA-PROV(2019)0304_EN-p0000013.png

a2021 is as defined in point 6.2.1;

average emissions2021 is as defined in point 6.2.1;

TM is as defined in point 6.2.1;

TM0 is as defined in point 6.2.1.

6.3.  Specific emissions targets from 2025 onwards

6.3.1.  Specific emissions targets for 2025 to 2029

The specific emissions target = (specific emissions reference target – (øtargets – EU fleet-wide target2025)) · ZLEV factor

where,

specific emissions reference target is the specific emissions reference target for the manufacturer determined in accordance with point 6.2.1;

øtargets is the average, weighted on the number of new light commercial vehicles of each individual manufacturer, of all the specific emissions reference targets determined in accordance with point 6.2.1;

ZLEV factor is (1+y-x), unless this sum is larger than 1,05 or lower than 1,0 in which case the ZLEV factor shall be set to 1,05 or 1,0, as the case may be;

where,

y is the share of zero- and low-emission vehicles in the manufacturer's fleet of new light commercial vehicles calculated as the total number of new zero- and low-emission vehicles, where each of them is counted as ZLEVspecific in accordance with the following formula, divided by the total number of new light commercial vehicles registered in the relevant calendar year:

20190327-P8_TA-PROV(2019)0304_EN-p0000014.png

x is 15%.

6.3.2.  Specific emissions targets from 2030 onwards

The specific emissions target = (specific emissions reference target – (øtargets – EU fleet-wide target2030)) · ZLEV factor

where,

specific emissions reference target is the specific emissions reference target for the manufacturer determined in accordance with point 6.2.2;

øtargets is the average, weighted on the number of new light commercial vehicles of each individual manufacturer, of all the specific emissions reference targets determined in accordance with point 6.2.2;

ZLEV factor is (1+y-x), unless this sum is larger than 1,05 or lower than 1,0 in which case the ZLEV factor shall be set to 1,05 or 1,0, as the case may be;

where,

y is the share of zero- and low-emission vehicles in the manufacturer's fleet of new light commercial vehicles calculated as the total number of new zero- and low-emission vehicles, where each of them is counted as ZLEVspecific in accordance with the following formula, divided by the total number of new light commercial vehicles registered in the relevant calendar year:

20190327-P8_TA-PROV(2019)0304_EN-p0000015.png

x is 30 %.

ANNEX II

MONITORING AND REPORTING OF EMISSIONS FROM NEW PASSENGER CARS

PART A — Collection of data on new passenger cars and determination of CO2 emissions monitoring information

1.  Member States shall, for each calendar year, record the following detailed data for each new passenger car registered as an M1 vehicle in their territory:

(a)  the manufacturer;

(b)  the type-approval number and its extension;

(c)  the type, variant, and version (where applicable);

(d)  make and commercial name;

(e)  category of vehicle type-approved;

(f)  total number of new registrations;

(g)  mass in running order;

(h)  the specific emissions of CO2 (NEDC and WLTP);

(i)  footprint: the wheel base, the track width of the steered axle and the track width other axle;

(j)  the fuel type and fuel mode;

(k)  engine capacity;

(l)  electric energy consumption;

(m)  code for the innovative technology or group of innovative technologies and the CO2 emissions reduction due to that technology (NEDC and WLTP);

(n)  maximum net power;

(o)  vehicle identification number;

(p)  WLTP test mass;

(q)  deviation and verification factors referred to in point 3.2.8 of Annex I to Implementing Regulation (EU) 2017/1153;

(r)  category of vehicle registered;

(s)  vehicle family identification number;

(t)  electric range, where applicable.

Member States shall make available to the Commission, in accordance with Article 7, all data listed in this point, in the format as specified in Section 2 of Part B.

2.  The detailed data referred to in point 1 shall be taken from the certificate of conformity of the relevant passenger car. In the case of bi-fuelled vehicles (petrol/gas), the certificates of conformity of which bear specific emissions of CO2 values for both types of fuel, Member States shall use only the value measured for gas.

3.  Member States shall, for each calendar year, determine:

(a)  the total number of new registrations of new passenger cars subject to EC type-approval;

(b)  the total number of new registrations of new individually approved passenger cars;

(c)  the total number of new registrations of new passenger cars subject to national type-approval of small series.

PART B  — Format for the transmission of data

For each year, Member States shall report the information specified in points 1 and 3 of Part A in the following formats:

Section 1 - Aggregated monitoring data

Member State(26)

 

Year

 

Total number of new registrations of new passenger cars subject to EC type-approval

 

Total number of new registrations of new individually approved passenger cars

 

Total number of new registrations of new passenger cars subject to national type-approval of small series

 

Section 2 – Detailed monitoring data – one vehicle record

Reference to point 1 of Part A

Detailed data per vehicle registered

(a)

Manufacturer name EU standard denomination

Manufacturer name OEM declaration

Manufacturer name in Member State registry(1)

(b)

Type-approval number and its extension

(c)

Type

Variant

Version

(d)

Make and commercial name

(e)

Category of vehicle type-approved

(f)

Total number of new registrations

(g)

Mass in running order

(h)

Specific emissions of CO2 (combined)

NEDC value until 31 December 2020 except for vehicles that fall within the scope of Article 5 for which the NEDC value shall be determined until 31 December 2022 in accordance with Article 5 of Implementing Regulation (EU) 2017/1153

Specific emissions of CO2 (combined)

WLTP value

(i)

Wheel base

Track width steered axle (Axle 1)

Track width other axle (Axle 2)

(j)

Fuel type

Fuel mode

(k)

Engine capacity (cm3)

(l)

Electric energy consumption (Wh/km)

(m)

Code of the eco-innovation(s)

Total NEDC CO2 emissions savings due to the eco-innovation(s) until 31 December 2020

Total WLTP CO2 emissions savings due to the eco-innovation(s)

(n)

Maximum net power

(o)

Vehicle identification number

(p)

WLTP test mass

(q)

Deviation factor De (where available)

Verification factor (where available)

(r)

Category of vehicle registered

(s)

Vehicle family identification number

(t)

Electric range, where available

Notes:

(1)   In the case of national type-approval of small series (NSS) or individual approval (IVA), the manufacturer´s name shall be provided in the column "Manufacturer name in Member State registry" whilst in the column "Manufacturer name EU standard denomination" either of the following shall be indicated: "AA-NSS" or "AA-IVA", as the case may be.

ANNEX III

MONITORING AND REPORTING OF EMISSIONS FROM NEW LIGHT COMMERCIAL VEHICLES

A.  Collection of data on new light commercial vehicles and determination of CO2 emissions monitoring information

1.  Detailed data

1.1.  Complete vehicles registered as N1

In the case of EC type-approved complete vehicles registered as N1, Member States shall, for each calendar year, record the following detailed data for each new light commercial vehicle the first time that it is registered in their territory:

(a)  the manufacturer;

(b)  the type-approval number and its extension;

(c)  the type, variant, and version;

(d)  make;

(e)  category of vehicle type-approved;

(f)  category of vehicle registered;

(g)  the specific emissions of CO2 (NEDC and WLTP);

(h)  mass in running order;

(i)  technically permissible maximum laden mass;

(j)  footprint: the wheel base, the track width steered axle and the track width other axle;

(k)  the fuel type and fuel mode;

(l)  engine capacity;

(m)  electric energy consumption;

(n)  code of the innovative technology or group of innovative technologies and the CO2 emissions reduction due to that technology (NEDC and WLTP);

(o)  the vehicle identification number;

(p)  WLTP test mass;

(q)  deviation and verification factors referred to in point 3.2.8 of Annex I to Implementing Regulation (EU) 2017/1152;

(r)  vehicle family identification number determined in accordance with point 5.0 of Annex XXI to Regulation (EU) 2017/1151;

(s)  electric range, where applicable.

Member States shall make available to the Commission, in accordance with Article 7, all data listed in this point, in the format as specified in Section 2 of Part C of this Annex.

1.2.  Vehicles approved in a multi-stage process and registered as N1 vehicles

In the case of multi-stage vehicles registered as N1 vehicles, Member States shall, for each calendar year, record the following detailed data with regard to:

(a)  the base (incomplete) vehicle: the data specified in points (a), (b), (c), (d), (e), (g), (h), (i), (n) and (o) of point 1.1, or, instead of the data specified in points (h) and (i), the default added mass provided as part of the type-approval information specified in point 2.17.2 of Annex I to Directive 2007/46/EC;

(b)  the base (complete) vehicle: the data specified in points (a), (b), (c), (d), (e), (g), (h), (i), (n) and (o) of point 1.1;

(c)  the completed vehicle: the data specified in points (a), (f), (g), (h), (j), (k), (l), (m) and (o) of point 1.1.

Where any of the data referred to in points (a) and (b) of the first subparagraph cannot be provided for the base vehicle, the Member State shall provide data with regard to the completed vehicle instead.

The format set out in Section 2 of Part C shall be used for completed N1 vehicles.

The vehicle identification number referred to in point (o) of point 1.1 shall not be made public.

2.  The details referred to in point 1 shall be taken from the certificate of conformity. In the case of bi-fuelled vehicles (petrol/gas) the certificates of conformity of which bear specific emissions of CO2 values for both types of fuel, Member States shall use only the value measured for gas.

3.  Member States shall, for each calendar year, determine:

(a)  the total number of new registrations of new light commercial vehicles subject to EC type-approval;

(b)  the total number of new registrations of new light commercial vehicles subject to multi-stage type-approval, where available;

(c)  the total number of new registrations of new light commercial vehicles subject to individual approval;

(d)  the total number of new registrations of new light commercial vehicles subject to national type-approval of small series.

B.  Methodology for determining CO2 monitoring information for new light commercial vehicles

Monitoring information which Member States are required to determine in accordance with points 1 and 3 of Part A shall be determined in accordance with the methodology in this Part.

1.  Number of new light commercial vehicles registered

Member States shall determine the number of new light commercial vehicles registered within their territory in the respective monitoring year divided into vehicles subject to EC type-approval, individual approval and national type-approval of small series and, where available, subject to multi-stage type-approval.

2.  Completed vehicles

In the case of multi-stage vehicles, the specific emissions of CO2 of completed vehicles shall be allocated to the manufacturer of the base vehicle.

In order to ensure that the values of CO2 emissions, fuel efficiency and mass of completed vehicles are representative, without placing an excessive burden on the manufacturer of the base vehicle, the Commission shall come forward with a specific monitoring procedure and shall, where appropriate, make the necessary amendments to the relevant type-approval legislation.

Notwithstanding that for the purpose of the calculation of the 2020 target in accordance with point 2 of Part B of Annex I the default added mass shall be taken from Part C of this Annex, where that mass value cannot be determined, the mass in running order of the completed vehicle may be used for the provisional calculation of the specific emissions target referred to in Article 7(4).

Where the base vehicle is a complete vehicle, the mass in running order of that vehicle shall be used for the calculation of the specific emissions target. However, where that mass value cannot be determined, the mass in running order of the completed vehicle may be used for the provisional calculation of the specific emissions target.

C.  Formats for transmission of data

For each year, Member States shall report the information specified in points 1 and 3 of Part A in the following format:

Section 1 — Aggregated monitoring data

Member State(27)

 

Year

 

Total number of new registrations of new light commercial vehicles subject to EC type-approval

 

Total number of new registrations of individually approved new light commercial vehicles

 

Total number of new registrations of new light commercial vehicles subject to national type-approval of small series

 

Total number of new registrations of new light commercial vehicles subject to multi-stage type-approval (where available)

 

Section 2 — Detailed monitoring data — one vehicle record

Reference to point 1.1 of Part A

Detailed data per vehicle registered(1)

(a)

Manufacturer name EU standard denomination(2)

Manufacturer name OEM declaration

COMPLETE VEHICLE/BASE VEHICLE(3)

Manufacturer name OEM declaration

COMPLETED VEHICLE(3)

Manufacturer name in Member State registry(2)

(b)

Type-approval number and its extension

(c)

Type

Variant

Version

(d)

Make

(e)

Category of vehicle type-approved

(f)

Category of vehicle registered

(g)

Specific emissions of CO2 (combined)

NEDC value until 31 December 2020

Specific emissions of CO2 (combined)

WLTP value

(h)

Mass in running order

BASE VEHICLE

Mass in running order

COMPLETED VEHICLE/COMPLETE VEHICLE

(i)(4)

Technically permissible maximum laden mass

(j)

Wheel base

Axle width steered axle (Axle 1)

Axle width other axle (Axle 2)

(k)

Fuel type

Fuel mode

(l)

Engine capacity (cm3)

(m)

Electric energy consumption (Wh/km)

(n)  

Code of the eco-innovation(s)

Total NEDC CO2 emissions savings due to the eco-innovation(s) until 31 December 2020

Total WLTP CO2 emissions savings due to the eco-innovation(s)

(o)

Vehicle identification number

(p)

WLTP test mass

(q)

Deviation factor De (where available)

Verification factor (where available)

(r)

Vehicle family identification number

(s)

Electric range, where available

Point 2.17.2 of Annex I to Directive 2007/46/EC(5)

Default added mass (where applicable in the case of multi-stage vehicles)

Notes:

(1)  Where, in the case of multi-stage vehicles, data cannot be provided for the base vehicle, the Member State shall as a minimum provide the data specified in this format for the completed vehicle.

(2)  In the case of national type-approval of small series (NSS) or individual approval (IVA), the manufacturer´s name shall be provided in the column ‘Manufacturer name in Member State registry’ whilst in the column ‘Manufacturer name EU standard denomination’ either of the following shall be indicated: ‘AA-NSS’ or ‘AA-IVA’, as the case may be.

(3)  In the case of multi-stage vehicles the base (incomplete/complete) vehicle manufacturer shall be indicated. If the base vehicle manufacturer is not available, the manufacturer of the completed vehicle only shall be indicated.

(4)  In the case of multi-stage vehicles, the technically permissible maximum laden mass of the base vehicle shall be indicated.

(5)  In the case of multi-stage vehicles, the mass in running order and the technically permissible maximum laden mass of the base vehicle may be replaced by the default added mass specified in the type-approval information in accordance with point 2.17.2 of Annex I to Directive 2007/46/EC.

ANNEX IV

Repealed Regulations with lists of their successive amendments

Regulation (EC) No 443/2009 of the European Parliament and of the Council

(OJ L 140, 5.6.2009, p. 1)

Commission Regulation (EU) No 397/2013

(OJ L 120, 1.5.2013, p. 4)

Regulation (EU) No 333/2014 of the European Parliament and of the Council

(OJ L 103, 5.4.2014, p. 15)

Commission Delegated Regulation (EU) 2015/6

Commission Delegated Regulation (EU) 2017/1502

Commission Delegated Regulation (EU) 2018/649

(OJ L 3, 7.1.2015, p. 1)

(OJ L 221, 26.8.2017, p. 4)

(OJ L 108, 27.4.2018, p. 14)

Regulation (EU) No 510/2011 of the European Parliament and of the Council

(OJ L 145, 31.5.2011, p. 1)

Commission Delegated Regulation (EU) No 205/2012

(OJ L 72, 10.3.2012, p. 2)

Regulation (EU) No 253/2014 of the European Parliament and of the Council

(OJ L 84, 20.3.2014, p. 38)

Commission Delegated Regulation (EU) No 404/2014

(OJ L 121, 24.4.2014, p. 1)

Commission Delegated Regulation (EU) 2017/748

Commission Delegated Regulation (EU) 2017/1499

(OJ L 113, 29.4.2017, p. 9)

(OJ L 219, 25.8.2017, p. 1)

ANNEX V

Correlation Table

Regulation (EC) No 443/2009

Regulation (EU) No 510/2011

This Regulation

Article 1, first paragraph

Article 1(1)

Article 1(1)

Article 1, second paragraph

Article 1(2)

Article 1(2)

Article 1, third paragraph

Article 1(3)

Article 1(4)

-

-

Article 1(5)

-

-

Article 1(6)

-

-

Article 1(7)

Article 2(1)

Article 2(1)

Article 2(1)

Article 2(2)

Article 2(2)

Article 2(2)

Article 2(3)

Article 2(3)

Article 2(3)

Article 2(4)

Article 2(4)

Article 2(4)

Article 3(1), introductory wording

Article 3(1), introductory wording

Article 3(1), introductory wording

Article 3(1), points (a) and (b)

Article 3(1), points (a) and (b)

Article 3(1), points (a) and (b)

Article 3(1), points (c), (d) and (e)

Article 3(1), points (c), (d) and (e)

Article 3(1), points (c) and (d)

Article 3(1), points (f) and (g)

Article 3(1), points (f) and (g)

Article 3(1), points (f)

Article 3(1), point (h)

Article 3(1), point (h)

Article 3(1), point (e)

Article 3(1), point (j)

Article 3(1), points (i)

Article 3(1), point (g)

Article 3(1), point (i)

Article 3(1), points (j)

Article 3(1), points (k), (l) and (m)

 

Article 3(1), point (k)

Article 3(1), point (n)

Article 3(2)

Article 3(2)

Article 3(2)

Article 4, first paragraph

Article 4, first paragraph

Article 4(1), introductory wording and points (a) and (b)

Article 4(1), point (c)

Article 4, second paragraph

Article 4(2)

Article 4, second paragraph

Article 4, third paragraph

Article 4(3)

Article 5

Article 5

Article 5a

Article 5

Article 6

Article 6

Article 7(1)

Article 7(1)

Article 6(1)

Article 7(2), points (a), (b) and (c)

Article 7(2), points (a), (b) and (c)

Article 6(2), points (a), (b) and (c)

Article 6(2), point (d)

Article 7(3)

Article 7(3)

Article 6(3)

Article 7(4)

Article 7(4)

Article 6(4)

Article 7(5)

Article 7(5)

Article 6(5)

Article 7(6)

Article 7(6)

Article 6(6)

Article 7(7)

Article 7(7)

Article 6(7)

Article 8(1)

Article 8(1)

Article 7(1)

Article 8(2)

Article 8(2)

Article 7(2)

Article 8(3)

Article 8(3)

Article 7(3)

Article 8(4), first and second subparagraphs

Article 8(4), first and second subparagraphs

Article 7(4), first and second subparagraphs

Article 8(4), third subparagraph

Article 8(4), first subparagraph

Article 7(4), third subparagraph

Article 8(5), first subparagraph

Article 8(5)

Article 7(5) first subparagraph

Article 8(5), second subparagraph

Article 8(6)

Article 7(5), second subparagraph

Article 8(6)

Article 8(7)

Article 8(7)

Article 8(8)

Article 7(6), first subparagraph

Article 7(6), second subparagraph

Article 8(8)

Article 8(9), first subparagraph

Article 8(9), first subparagraph

Article 7(7)

Article 8(9), second subparagraph

Article 8(9), second subparagraph

Article 7(8)

–  

–  

Article 7(9)

Article 7(10)

Article 8(10)

Article 7(11)

Article 9(1)

Article 9(1)

Article 8(1)

Article 9(2), first subparagraph, introductory wording

Article 9(2), first subparagraph, introductory wording

Article 8(2), first subparagraph, first part

Article 9(2), first subparagraph, point (a)

Article 9(2), first subparagraph, point (a)

Article 9(2), first subparagraph, point (b)

Article 9(2), first subparagraph, point (b)

Article 8(2), first subparagraph, second part

Article 9(2), second subparagraph

Article 9(2), second subparagraph

Article 8(2), second subparagraph

Article 9(3)

Article 9(3)

Article 8(3)

Article 9(4)

Article 9(4)

Article 8(4)

Article 10(1), introductory wording

Article 10(1), introductory wording

Article 9(1), introductory wording

Article 10(1), points (a) to (e)

Article 10(1), points (a) to (e)

Article 9(1), points (a) to (e)

Article 9(1), point (f)

Article 10(2)

Article 10(2)

Article 9(2)

Article 9(3)

Article 11(1)

Article 11(1)

Article 10(1)

Article 11(2)

Article 11(2)

Article 10(2)

Article 11(3)

Article 11(3)

Article 10(3), first subparagraph

Article 10(3), second subparagraph

Article 11(4), first subparagraph

Article 10(4), first subparagraph

Article 11(4), second subparagraph, introductory wording

Article 10(4), second subparagraph, introductory wording

Article 11(4), second subparagraph, point (a)

Article 10(4), second subparagraph, point (a)

Article 11(4), second subparagraph, point (b)

Article 11(4), second subparagraph, point (c)

Article 10(4), second subparagraph, point (b)

Article 10(4), second subparagraph, point (c)

Article 11(4), third and fourth subparagraphs

Article 10(4), third and fourth subparagraphs

Article 11(5)

Article 11(4)

Article 10(5)

Article 11(6)

Article 11(5)

Article 10(6)

Article 11(7)

Article 11(6)

Article 10(7)

Article 11(8)

Article 11(7)

Article 10(8)

Article 11(9)

Article 11(8)

Article 10(9)

Article 12(1), first subparagraph

Article 12(1), first subparagraph

Article 11(1), first subparagraph

Article 12(1), second subparagraph

Article 11(1), second subparagraph

Article 12(1), third subparagraph

Article 12(1), second subparagraph

Article 11(1), third subparagraph

Article 11(1), fourth subparagraph

Article 12(2)

Article 12(2)

Article 11(2), introductory wording, points (a), (b) and (c) and point (d), first part

Article 11(2), point (d), last part

Article 12(3)

Article 12(3)

Article 11(3)

Article 12(4)

Article 12(4)

Article 11(4)

Article 12

Article 13

Article 13(1)

Article 13(1)

Article 14, title

Article 14(1), first subparagraph, introductory wording

Article 13(2), first and second subparagraphs

Article 14(1) point (a)

Article 13(5)

Article 14(1), point (b)

 

 

Article 14(1), points (c) and (d)

Article 13(2), third subparagraph

Article 13(5)

Article 14(2)

Article 15(1)

Article 15(2)

Article 15(3)

Article 13(2)

Article 15(4), first part

Article 13(3)

Article 13(6), first subparagraph

Article 15(4), second part

Article 13(4)

Article 13(4)

Article 13(6), second subparagraph

Article 13(5)

Article 13(6)

Article 13(3)

Article 15(5)

Article 15(6)

Article 13(7), first subparagraph

Article 13(6), third subparagraph

Article 15(7)

Article 13(7), second subparagraph

Article 13(6), fourth subparagraph

Article 15(8)

Article 14(1)

Article 14(1)

Article 16(1)

Article 14(2)

Article 14(2)

Article 16(2)

Article 14(3)

Article 14(2a)

Article 16(3)

Article 14a(1)

Article 15(3)

Article 17(1)

Article 14a(2)

Article 15(1)

Article 17(2)

Article 14a(3)

Article 16

Article 17(3)

Article 14a(4)

Article 15(2)

Article 17(4)

Article 14a(5)

Article 17

Article 17(5)

Article 15

–-

Article 18

Article 16

Article 18

Article 19

Annex I

Annex I, part A, points 1 to 5

Annex I, part A, point 6

Annex I

Annex I, part B, points 1 to 5

Annex I, part B, point 6

Annex II, part A

Annex II, part A

Annex II, parts B

Annex II, part C

Annex II, part B

Annex II

Annex III

Annex IV

Annex V

ANNEX TO THE LEGISLATIVE RESOLUTION

Commission statement on Article 15

During the review provided for in Article 15 and when proposing, if appropriate, a legislative amendment to this Regulation, the Commission will carry out the relevant consultations in accordance with the Treaties. It will, in particular, consult the European Parliament and the Member States in that context.

As part of that review, the Commission will also examine the appropriateness of the cap of 5% specified in point 6.3 of Part A of Annex I in view of the need to accelerate the promotion of zero- and low-emission vehicles in the concerned Member States.

(1) OJ C 227, 28.6.2018, p. 52.
(2) OJ C 77, 28.3.2002, p. 1.
(3) This position replaces the amendments adopted on 3 October 2018 (Texts adopted, P8_TA-PROV(2018)0370).
(4) OJ C 227, 28.6.2018, p. 52.
(5) Position of the European Parliament of 27 March 2019.
(6)Regulation (EC) No 443/2009 of the European Parliament and of the Council of 23 April 2009 setting emission performance standards for new passenger cars as part of the Community's integrated approach to reduce CO2 emissions from light-duty vehicles (OJ L 140, 5.6.2009, p. 1).
(7)Regulation (EU) No 510/2011 of the European Parliament and of the Council of 11 May 2011 setting emission performance standards for new light commercial vehicles as part of the Union's integrated approach to reduce CO2 emissions from light-duty vehicles (OJ L 145, 31.5.2011, p. 1).
(8) OJ L 282, 19.10.2016, p. 4.
(9) Regulation (EU) 2018/842 of the European Parliament and of the Council of 30 May 2018 on binding annual greenhouse gas emission reductions by Member States from 2021 to 2030 contributing to climate action to meet commitments under the Paris Agreement and amending Regulation (EU) No 525/2013 (OJ L 156, 19.6.2018, p. 26).
(10) Directive 2003/87/EC of the European Parliament and of the Council of 13 October 2003 establishing a system for greenhouse gas emission allowance trading within the Union and amending Council Directive 96/61/EC (OJ L 275 25.10.2003, p. 32).
(11)Regulation (EC) No 715/2007 of the European Parliament and of the Council of 20 June 2007 on type approval of motor vehicles with respect to emissions from light passenger and commercial vehicles (Euro 5 and Euro 6) and on access to vehicle repair and maintenance information (OJ L 171, 29.6.2007, p. 1).
(12)Commission Regulation (EU) 2017/1151 of 1 June 2017 supplementing Regulation (EC) No 715/2007 of the European Parliament and of the Council on type-approval of motor vehicles with respect to emissions from light passenger and commercial vehicles (Euro 5 and Euro 6) and on access to vehicle repair and maintenance information, amending Directive 2007/46/EC of the European Parliament and of the Council, Commission Regulation (EC) No 692/2008 and Commission Regulation (EU) No 1230/2012 and repealing Commission Regulation (EC) No 692/2008 (OJ L 175, 7.7.2017, p.1).
(13)Commission Implementing Regulation (EU) 2017/1152 of 2 June 2017 setting out a methodology for determining the correlation parameters necessary for reflecting the change in the regulatory test procedure with regard to light commercial vehicles and amending Implementing Regulation (EU) No 293/2012 (OJ L 175, 7.7.2017, p. 644).
(14)Commission Implementing Regulation (EU) 2017/1153 of 2 June 2017 setting out a methodology for determining the correlation parameters necessary for reflecting the change in the regulatory test procedure and amending Regulation (EU) No 1014/2010 (OJ L 175, 7.7.2017, p. 679).
(15) Directive 1999/94/EC of the European Parliament and of the Council of 13 December 1999 relating to the availability of consumer information on fuel economy and CO2 emissions in respect of the marketing of new passenger cars (OJ L 12, 18.1.2000, p. 16).
(16) Directive 2007/46/EC of the European Parliament and of the Council of 5 September 2007 establishing a framework for the approval of motor vehicles and their trailers, and of systems, components and separate technical units intended for such vehicles (Framework Directive) (OJ L 263 9.10.2007, p. 1).
(17)Commission Regulation (EC) No 692/2008 of 18 July 2008 implementing and amending Regulation (EC) No 715/2007 of the European Parliament and of the Council on type-approval of motor vehicles with respect to emissions from light passenger and commercial vehicles (Euro 5 and Euro 6) and on access to vehicle repair and maintenance information (OJ L 199, 28.7.2008, p. 1).
(18) Regulation (EU) 2018/858 of the European Parliament and of the Council of 30 May 2018 on the approval and market surveillance of motor vehicles and their trailers, and of systems, components and separate technical units intended for such vehicles, amending Regulations (EC) No 715/2007 and (EC) No 595/2009 and repealing Directive 2007/46/EC (OJ L 151, 14.6.2018, p. 1).
(19) OJ C 298, 23.8.2018, p. 140.
(20)Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission's exercise of implementing powers (OJ L 55, 28.2.2011, p. 13).
(21)OJ L 123, 12.5.2016, p. 1.
(22)Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents (OJ L 145, 31.5.2001, p. 43).
(23) Directive 2014/94/EU of the European Parliament and of the Council of 22 October 2014 on the deployment of alternative fuels infrastructure (OJ L 307, 28.10.2014, p. 1).
(24)Regulation (EU) 2018/1999 of the European Parliament and of the Council of 11 December 2018 on the Governance of the Energy Union and Climate Action, amending Regulations (EC) No 663/2009 and (EC) No 715/2009 of the European Parliament and of the Council, Directives 94/22/EC, 98/70/EC, 2009/31/EC, 2009/73/EC, 2010/31/EU, 2012/27/EU and 2013/30/EU of the European Parliament and of the Council, Council Directives 2009/119/EC and (EU) 2015/652 and repealing Regulation (EU) No 525/2013 of the European Parliament and of the Council (OJ L 328, 21.12.2018, p. 1).
(25) The share of zero- and low-emission vehicles in the new passenger car fleet of a Member State in 2017 is calculated as the total number of new zero- and low-emission vehicles registered in 2017 divided by the total number of new passenger cars registered in the same year.
(26)ISO 3166 alpha-2 codes with the exception of Greece and the United Kingdom for which the codes are ‘EL’ and ‘UK’, respectively.
(27)ISO 3166 alpha-2 codes with the exception of Greece and the United Kingdom for which the codes are ‘EL’ and ‘UK’, respectively.


Reduction of the impact of certain plastic products on the environment ***I
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Resolution
Consolidated text
European Parliament legislative resolution of 27 March 2019 on the proposal for a directive of the European Parliament and of the Council on the reduction of the impact of certain plastic products on the environment (COM(2018)0340 – C8-0218/2018 – 2018/0172(COD))
P8_TA-PROV(2019)0305A8-0317/2018

(Ordinary legislative procedure: first reading)

The European Parliament,

–  having regard to the Commission proposal to Parliament and the Council (COM(2018)0340),

–  having regard to Article 294(2) and Article 192(1) of the Treaty on the Functioning of the European Union, pursuant to which the Commission submitted the proposal to Parliament (C8-0218/2018),

–  having regard to Article 294(3) of the Treaty on the Functioning of the European Union,

–  having regard to the opinion of the European Economic and Social Committee of 17 October 2018(1),

–  having regard to the opinion of the Committee of the Regions of 10 October 2018(2),

–  having regard to the provisional agreement approved by the committee responsible under Rule 69f(4) of its Rules of Procedure and the undertaking given by the Council representative by letter of 18 January 2019 to approve Parliament’s position, in accordance with Article 294(4) of the Treaty on the Functioning of the European Union,

–  having regard to Rule 59 of its Rules of Procedure,

–  having regard to the report of the Committee on the Environment, Public Health and Food Safety and the opinions of the Committee on Economic and Monetary Affairs, the Committee on Industry, Research and Energy, the Committee on Agriculture and Rural Development and the Committee on Fisheries (A8-0317/2018),

1.  Adopts its position at first reading hereinafter set out(3);

2.  Calls on the Commission to refer the matter to Parliament again if it replaces, substantially amends or intends to substantially amend its proposal;

3.  Instructs its President to forward its position to the Council, the Commission and the national parliaments.

Position of the European Parliament adopted at first reading on 27 March 2019 with a view to the adoption of Directive (EU) 2019/… of the European Parliament and of the Council on the reduction of the impact of certain plastic products on the environment

P8_TC1-COD(2018)0172


(Text with EEA relevance)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the Functioning of the European Union, and in particular Article 192(1) thereof,

Having regard to the proposal from the European Commission,

After transmission of the draft legislative act to the national parliaments,

Having regard to the opinion of the European Economic and Social Committee(4),

Having regard to the opinion of the Committee of the Regions(5),

Acting in accordance with the ordinary legislative procedure(6),

Whereas:

(1)  The high functionality and relatively low cost of plastic means that this material is increasingly ubiquitous in everyday life. While plastic plays a useful role in the economy and provides essential applications in many sectors, its growing use in short-lived applications, which are not designed for re-use or cost-effective recycling, means that related production and consumption patterns have become increasingly inefficient and linear. Therefore, in the context of the Circular Economy Action Plan laid down in the Communication of the Commission of 2 December 2015 entitled "Closing the loop – An EU action plan for the Circular Economy", the Commission concluded in the European Strategy for Plastics laid down in its Communication of 16 January 2018 entitled "A European Strategy for Plastics in a Circular Economy" that the steady increase in plastic waste generation and the leakage of plastic waste into the environment, in particular into the marine environment, must be tackled in order to achieve a ▌ circular life cycle for plastics. The European Strategy for Plastics is a step towards establishing a circular economy in which the design and production of plastics and plastic products fully respect re-use, repair and recycling needs and in which more sustainable materials are developed and promoted. The significant negative environmental, health and economic impact of certain plastic products calls for the setting up of a specific legal framework to effectively reduce those negative effects.

(2)  This Directive promotes circular approaches that give priority to sustainable and non-toxic re-usable products and re-use systems rather than to single-use products, aiming first and foremost to reduce the quantity of waste generated. Such waste prevention is at the pinnacle of the waste hierarchy enshrined in Directive 2008/98/EC of the European Parliament and of the Council(7). This Directive will contribute to the achievement of United Nations (UN) Sustainable Development Goal 12 to ensure sustainable consumption and production patterns, which is part of the 2030 Agenda for Sustainable Development adopted by the UN General Assembly on 25 September 2015. By retaining the value of products and materials for as long as possible and generating less waste, the economy of the Union can become more competitive and more resilient, while reducing pressure on precious resources and the environment.

(3)  Marine litter is transboundary in nature and is recognised as a growing global problem. Reducing marine litter is a key action for the achievement of UN Sustainable Development Goal 14 which calls to conserve and sustainably use the oceans, seas and marine resources for sustainable development ▌. The Union must play its part in preventing and tackling marine litter and aim to be a standard setter for the world. In that context, the Union is working with partners in many international fora such as G20, G7 and the UN to promote concerted action and this Directive is part of the Union's efforts in that regard. In order for those efforts to be effective, it is also important that exports of plastic waste from the Union do not result in increased marine litter elsewhere.

(4)  In accordance with the United Nations Convention on the Law of the Sea of 10 December 1982 (UNCLOS)(8), the Convention on the Prevention of Marine Pollution by Dumping of Wastes and Other Matter of 29 December 1972 (“London Convention”) and its 1996 Protocol (“London Protocol”), Annex V to the International Convention for the Prevention of Pollution from Ships 1973 (MARPOL), as modified by the Protocol of 1978 relating thereto, and the Basel Convention on the Control of Transboundary Movements of Hazardous Wastes and Their Disposal of 22 March 1989(9) and with Union waste legislation, namely Directive 2008/98/EC and Directive 2000/59/EC of the European Parliament and of the Council(10), Member States are required to ensure environmentally sound waste management to prevent and reduce marine litter from both sea and land sources. In accordance with Union water legislation, namely Directives 2000/60/EC(11) and 2008/56/EC(12) of the European Parliament and of the Council, Member States are also required to tackle marine litter where it undermines the attainment of good environmental status of their marine waters, including as a contribution to UN Sustainable Development Goal 14.

(5)  In the Union, 80 to 85 % of marine litter, measured as beach litter counts, is plastic, with single-use plastic items representing 50 % and fishing-related items representing 27 % of the total. Single-use plastic products include a diverse range of commonly used fast-moving consumer products that are discarded after having been used once for the purpose for which they were provided, are rarely recycled, and are prone to becoming litter. A significant proportion of the fishing gear placed on the market is not collected for treatment. Single-use plastic products and fishing gear containing plastic are therefore a particularly serious problem in the context of marine litter, pose a severe risk to marine ecosystems, to biodiversity and ▌ to human health and damage activities such as tourism, fisheries and shipping.

(6)  Proper waste management remains essential for the prevention of all litter, including marine litter. Existing Union legislation, namely Directives 2008/98/EC, 2000/59/EC, 2000/60/EC and 2008/56/EC and Council Regulation (EC) No 1224/2009(13), and policy instruments provide some regulatory responses to address marine litter. In particular, plastic waste is subject to overall Union waste management measures and targets, such as the recycling target for plastic packaging waste laid down in European Parliament and Council Directive 94/62/EC(14) and the objective in the European Strategy for Plastics to ensure that by 2030 all plastic packaging placed on the Union market is re-usable or easily recycled. However, the impact of those measures on marine litter is not sufficient and there are differences in the scope and the level of ambition amongst national measures to prevent and reduce marine litter. In addition, some of those measures, in particular marketing restrictions for single-use plastic products, could create barriers to trade and distort competition in the Union.

(7)  To focus efforts where they are most needed, this Directive should cover only those single-use plastic products that are found the most on beaches in the Union as well as fishing gear containing plastic and products made from oxo-degradable plastic. The single-use plastic products covered by measures under this Directive are estimated to represent around 86 % of the single-use plastics found, in counts, on beaches in the Union. Glass and metal beverage containers should not be covered by this Directive as they are not among the single-use plastic products that are found the most on beaches in the Union.

(8)  Microplastics do not fall directly within the scope of this Directive, yet they contribute to marine litter and the Union should therefore adopt a comprehensive approach to that problem. The Union should encourage all producers to strictly limit microplastics in their formulations.

(9)  Terrestrial pollution and contamination of soil by larger items of plastic and resulting fragments or microplastics can be significant and such plastic can leak into the marine environment.

(10)  This Directive is a lex specialis in relation to Directives 94/62/EC and 2008/98/EC. In the event of a conflict between those Directives and this Directive, this Directive should prevail within the scope of its application. That is the case for restrictions on placing on the market. In particular with regard to consumption reduction measures, product requirements, marking requirements and extended producer responsibility, this Directive supplements Directives 94/62/EC and 2008/98/EC and Directive 2014/40/EU of the European Parliament and of the Council(15).

(11)  Single-use plastic products can be manufactured from a wide range of plastics. Plastics are usually defined as polymeric materials to which additives may have been added. However, that definition would cover certain natural polymers. Unmodified natural polymers, within the meaning of the definition of "not chemically modified substances" in point 40 of Article 3 of Regulation (EC) No 1907/2006 of the European Parliament and of the Council(16), should not be covered by this Directive as they occur naturally in the environment. Therefore, for the purposes of this Directive, the definition of polymer in point 5 of Article 3 of Regulation (EC) No 1907/2006 ▌ should be adapted and a separate definition should be introduced. Plastics manufactured with modified natural polymers, or plastics manufactured from bio-based, fossil or synthetic starting substances are not naturally occurring and should therefore be addressed by this Directive. The adapted definition of plastics should therefore cover polymer-based rubber items and bio-based and biodegradable plastics regardless of whether they are derived from biomass or are intended to biodegrade over time. Paints, inks and adhesives should not be addressed by this Directive and therefore these polymeric materials should not be covered by the definition.

(12)  In order to clearly define the scope of this Directive, the term "single-use plastic product" should be defined. The definition should exclude plastic products that are conceived, designed and placed on the market to accomplish within their life span multiple trips or rotations by being refilled or reused for the same purpose for which they are conceived. Single-use plastic products are typically intended to be used just once or for a short period of time before being disposed of. Wet wipes for personal care and domestic use should also be within the scope of this Directive, whereas industrial wet wipes should be excluded. To further clarify whether a product is to be considered a single-use plastic product for the purposes of this Directive, the Commission should develop guidelines on single-use plastic products. In view of the criteria set out in this Directive, examples of food containers to be considered as single-use plastic products for the purposes of this Directive are fast-food containers or meal, sandwich, wrap and salad boxes with cold or hot food, or food containers of fresh or processed food that does not need further preparation, such as fruits, vegetables or desserts. Examples of food containers that are not to be considered as single-use plastic products for the purposes of this Directive are food containers with dried food or food that is sold cold requiring further preparation, containers containing food in more than single-serve portions or single-serve portion-sized food containers sold in more than one unit. Examples of beverage containers to be considered as single-use plastic products are beverage bottles or composite beverage packaging used for beer, wine, water, liquid refreshments, juices and nectars, instant beverages or milk, but not cups for beverages as these are a separate category of single-use plastic products for the purposes of this Directive. As they are not among the single-use plastic products that are found the most on beaches in the Union, glass and metal beverage containers should not be covered by this Directive. However, the Commission should, in the context of the review of this Directive, evaluate inter alia caps and lids made of plastic used for glass and metal beverage containers.

(13)  Single-use plastic products covered by this Directive should be addressed by one or several measures, depending on various factors, such as the availability of suitable and more sustainable alternatives, the feasibility of changing consumption patterns, and the extent to which they are already covered by existing Union legislation.

(14)  For certain single-use plastic products, suitable and more sustainable alternatives are not yet readily available and the consumption of most such single-use plastic products is expected to increase. To reverse that trend and to promote efforts towards more sustainable solutions, Member States should be required to take the necessary measures, for example by setting national consumption reduction targets, to achieve an ambitious and sustained reduction in the consumption of those products, without compromising food hygiene, food safety, good hygiene practices, good manufacturing practices, consumer information, or traceability requirements set out in Regulations (EC) No 178/2002(17), (EC) No 852/2004(18) and (EC) No 1935/2004(19) of the European Parliament and of the Council and other relevant legislation related to food safety, hygiene and labelling. Member States should have the highest possible ambition for those measures, which should induce a substantial reversal of increasing consumption trends and lead to a measurable quantitative reduction. Those measures should take into account the impact of products throughout their life cycle, including when they are found in the marine environment, and should respect the waste hierarchy. Where Member States decide to implement that obligation through marketing restrictions, they should ensure that such restrictions are proportionate and non-discriminatory. Member States should encourage the use of products that are suitable for multiple use and that are, after having become waste, suitable for preparing for re-use and recycling.

(15)  For other single-use plastic products, suitable and more sustainable alternatives that are also affordable are readily available. In order to limit the adverse impact of such single-use plastic products on the environment, Member States should be required to prohibit their placing on the ▌ market. By doing so, the use of those readily available and more sustainable alternatives as well as of innovative solutions towards more sustainable business models, re-use alternatives and substitution of materials would be promoted. The restrictions on placing on the market introduced in this Directive should also cover products made from oxo-degradable plastic, as that type of plastic does not properly biodegrade and thus contributes to microplastic pollution in the environment, is not compostable, negatively affects the recycling of conventional plastic and fails to deliver a proven environmental benefit. Furthermore, in view of the high prevalence of expanded polystyrene litter in the marine environment and the availability of alternatives, single-use food and beverage containers and cups for beverages made of expanded polystyrene should also be restricted.

(16)  Tobacco product filters containing plastic are the second most found single-use plastic items on beaches in the Union. The huge environmental impact caused by post-consumption waste of tobacco products with filters containing plastic, discarded directly into the environment, needs to be reduced. Innovation and product development are expected to provide viable alternatives to filters containing plastic and need to be accelerated. Extended producer responsibility schemes for tobacco products with filters containing plastic should also encourage innovation leading to the development of sustainable alternatives to tobacco product filters containing plastic. Member States should promote a wide range of measures to reduce litter from post-consumption waste of tobacco products with filters containing plastic.

(17)  Caps and lids ▌ made of plastic which are used for beverage containers are among the single-use plastic items that are found the most on beaches in the Union. Therefore, beverage containers that are single-use plastic products should only be allowed to be placed on the market if they fulfil specific product design requirements that significantly reduce the dispersal into the environment of beverage container caps and lids made of plastic. For beverage containers that are both single-use plastic products and packaging, that requirement is in addition to the essential requirements on the composition and the re-usable and recoverable, including recyclable, nature of packaging set out in Annex II to Directive 94/62/EC. In order to facilitate conformity with the product design requirement and to ensure the smooth functioning of the internal market, it is necessary to develop a harmonised standard adopted in accordance with Regulation (EU) No 1025/2012 of the European Parliament and of the Council(20), and compliance with that standard should give rise to a presumption of conformity with those requirements. Therefore, the timely development of a harmonised standard is of the highest priority in ensuring effective implementation of this Directive. Sufficient time should be envisaged for the development of a harmonised standard and to allow the producers to adapt their production chains in relation to the implementation of the product design requirement. In order to ensure the circular use of plastics, the market uptake of recycled materials needs to be promoted. It is therefore appropriate to introduce requirements for a mandatory minimum content of recycled plastic in beverage bottles.

(18)  Plastic products should be manufactured taking into account their entire life span. The design of plastic products should always take into account the production and use phase and the reusability and recyclability of the product. In the context of the review to be undertaken pursuant to Article 9(5) of Directive 94/62/EC, the Commission should take into account the relative properties of different packaging materials, including composite materials, on the basis of life cycle assessments, addressing in particular waste prevention and design for circularity.

(19)  The presence of hazardous chemical substances in sanitary towels, tampons and tampon applicators should be avoided in the interest of women’s health. In the framework of the restrictions process under Regulation (EC) No 1907/2006, it is appropriate for the Commission to assess further restrictions on such substances.

(20)  Certain single-use plastic products end up in the environment as a result of inappropriate disposal through the sewer system or other inappropriate release into the environment. Disposal through the sewer system can in addition cause substantial economic damage to sewer networks by clogging pumps and blocking pipes. For these products, there is frequently a significant lack of information about the material characteristics of the product or the appropriate means of waste disposal. Therefore, single-use plastic products that are frequently disposed of through the sewer system or otherwise inappropriately disposed of should be subject to marking requirements. The marking should inform consumers about appropriate waste management options for the product or which waste disposal means are to be avoided for the product in line with the waste hierarchy, and ▌ about the presence of plastics in the product as well as the resulting negative environmental impact of littering or of other inappropriate means of disposal of the product. The marking should, as appropriate, be either on the packaging of the product or directly on the product itself. The Commission should be empowered to establish ▌harmonised specifications for the marking and when doing so should, where appropriate, test the perception of the proposed marking with representative groups of consumers to ensure that it is effective and easily understandable. Marking requirements are already required for fishing gear pursuant to Regulation (EC) No 1224/2009.

(21)  With regard to single-use plastic products for which no suitable and more sustainable alternatives are readily available, Member States should, in line with the polluter-pays principle, also introduce extended producer responsibility schemes to cover the necessary costs of waste management and clean-up of litter as well as the costs of awareness raising measures to prevent and reduce such litter. Those costs should not exceed the costs that are necessary to provide those services in a cost-efficient way and should be established in a transparent way between the actors concerned.

(22)  Directive 2008/98/EC lays down general minimum requirements for extended producer responsibility schemes. Those requirements should apply to the extended producer responsibility schemes established by this Directive, irrespective of whether their mode of implementation is by legislative act or by means of agreements under this Directive. The relevance of some requirements depends on the characteristics of the product. Separate collection is not required to ensure proper treatment in line with the waste hierarchy for tobacco products with filters containing plastic, wet wipes and balloons. Therefore setting up separate collection for those products should not be mandatory. This Directive ▌ should establish extended producer responsibility requirements in addition to those laid down by Directive 2008/98/EC, for example, the requirement for producers of certain single-use plastic products to cover the costs of cleaning up litter. It should also be possible to cover the costs of the setting up of specific infrastructure for collection of post-consumption waste of tobacco products, such as appropriate waste receptacles in common litter hotspots. The calculation methodology for the costs of cleaning up litter should take into account considerations of proportionality. To minimise administrative costs Member States should be able to determine financial contributions towards the costs of cleaning up litter by setting appropriate multiannual fixed amounts.

(23)  The large percentage of plastic stemming from ▌discarded fishing gear, including abandoned and lost fishing gear, in marine litter indicates that the existing legal requirements laid down in Regulation (EC) No 1224/2009, Directive 2000/59/EC and Directive 2008/98/EC do not provide sufficient incentives to return such fishing gear to shore for collection and treatment. The indirect fee system set up under Directive (EU) 2019/… of the European Parliament and of the Council(21)(22) provides a system for removing the incentive for ships to discharge their waste at sea, and ensures a right of delivery. That system should, however, be supplemented by further financial incentives for fishermen to bring their waste fishing gear on shore to avoid any potential increase in the indirect waste fee to be paid. As plastic components of fishing gear have high recycling potential, Member States should, in line with the polluter-pays principle, introduce extended producer responsibility for fishing gear and components of fishing gear containing plastic to ensure separate collection of waste fishing gear and to finance environmentally sound waste management of waste fishing gear, in particular recycling.

(24)  In the framework of an extended producer responsibility for fishing gear containing plastic, Member States should monitor and assess, in line with the reporting obligations laid down in this Directive, fishing gear containing plastic.

(25)  While all marine litter containing plastic poses a risk to the environment and to human health and should be tackled, proportionality considerations should also be taken into account. Therefore, the fishermen themselves and artisanal makers of fishing gear containing plastic should not be considered as producers and should not be held responsible for fulfilling the obligations of the producer related to the extended producer responsibility.

(26)  Economic and other incentives to support sustainable consumer choices and promote responsible consumer behaviour can be an effective tool for achieving the objectives of this Directive.

(27)  Beverage bottles that are single-use plastic products are one of the marine litter items that are found the most on beaches in the Union. This is due to ineffective separate collection systems and low participation in those systems by consumers. It is necessary to promote more effective separate collection systems. Therefore, a minimum separate collection target should be established for beverage bottles that are single-use plastic products. While the obligation to separately collect waste requires that waste be kept separate by type and nature, it should be possible to collect certain types of waste together provided that this does not impede high-quality recycling in line with the waste hierarchy in accordance with Article 10(2) and point (a) of Article 10(3) of Directive 2008/98/EC. The setting of the separate collection target should be based on the amount of single-use plastic beverage bottles placed on the market in a Member State or alternatively on the amount of waste single-use plastic beverage bottles generated in a Member State. The calculation of the amount of waste generated in a Member State should take due account of all waste single-use plastic beverage bottles generated, including those which become litter instead of being disposed of through waste collection systems. Member States should be able to achieve that minimum target by setting separate collection targets for beverage bottles that are single-use plastic products in the framework of the extended producer responsibility schemes, by establishing deposit-refund schemes or by any other measure that they find appropriate. That will have a direct, positive impact on the collection rate, the quality of the collected material and the quality of the recyclates, offering opportunities for the recycling business and the market for the recyclates. It will support reaching the recycling targets for packaging waste set in Directive 94/62/EC.

(28)  In order to prevent littering and other inappropriate means of waste disposal resulting in marine litter containing plastic, it is necessary for consumers of single-use plastic products and users of fishing gear containing plastic to be properly informed about the availability of re-usable alternatives and re-use systems, the most appropriate waste management options available and/or which waste disposal options are to be avoided, about best practices with regard to sound waste management and the environmental impact of bad disposal practices, as well as about the plastic content in certain single-use plastic products and fishing gear and the impact of inappropriate waste disposal on the sewer network. Member States should therefore be required to take awareness raising measures ensuring that such information is provided to those consumers and users. The information should not contain any promotional content encouraging the use of single-use plastic products. Member States should be able to choose the measures which are the most appropriate based on the nature of the product or its use. Producers of single-use plastic products and fishing gear containing plastic should cover the costs of the awareness raising measures as part of their extended producer responsibility obligations.

(29)  The aim of this Directive is to protect the environment and human health. As the Court of Justice has held on numerous occasions, it would be incompatible with the binding effect which the third paragraph of Article 288 of the Treaty on the Functioning of the European Union ascribes to a Directive, to exclude, in principle, the possibility of an obligation imposed by a Directive from being relied on by persons concerned. That consideration applies particularly in respect of a Directive which has as its objective to prevent and reduce the impact of certain plastic products on the aquatic environment.

(30)  It is important to monitor the levels of marine litter in the Union in order to assess the implementation of this Directive. In accordance with Directive 2008/56/EC, Member States are required to regularly monitor the properties and quantities of marine litter, including plastic marine litter. That monitoring data is also to be communicated to the Commission.

(31)  Member States should lay down rules on penalties applicable to infringements of national provisions adopted pursuant to this Directive and should take all measures necessary to ensure that they are implemented. The penalties provided for should be effective, proportionate and dissuasive.

(32)  Pursuant to paragraph 22 of the Interinstitutional Agreement of 13 April 2016 on Better Law-Making(23), the Commission should carry out an evaluation of this Directive. That evaluation should be based on experience gathered and data collected during the implementation of this Directive and data collected under Directives 2008/56/EC and 2008/98/EC. The evaluation should provide the basis for an assessment of possible further measures, including the setting of Union-wide reduction targets for 2030 and beyond, and an assessment whether, in view of monitoring of marine litter in the Union, the Annex listing single-use plastic products needs to be reviewed and whether the scope of this Directive can be broadened to other single-use products.

(33)  In order to ensure uniform conditions for the implementation of this Directive, implementing powers should be conferred on the Commission in respect of the methodology for the calculation and verification of the annual consumption of single-use plastic products for which consumption reduction objectives have been set, the rules for the calculation and verification of the attainment of the targets on minimum recycled content for single-use plastic beverage bottles, the specifications for the marking to be affixed on certain single-use plastic products, the methodology for the calculation and verification of the collection targets of single-use plastic products for which separate collection targets have been set and the format for the reporting of data and information on the implementation of this Directive. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council(24).

(34)  It is appropriate to allow Member States to choose to implement certain provisions of this Directive by means of agreements between the competent authorities and the economic sectors concerned, provided that certain requirements are met.

(35)  The fight against litter is a shared effort between competent authorities, producers and consumers. Public authorities, including the Union institutions, should lead by example.

(36)  Since the objectives of this Directive, namely to prevent and to reduce the impact of certain single-use plastic products, products made from oxo-degradable plastic and fishing gear ▌containing plastic on the environment and on human health, and to promote the transition to a circular economy, including the fostering of innovative and sustainable business models, products and materials, thus also contributing to the efficient functioning of the internal market, cannot be sufficiently achieved by the Member States but can rather, by reason of the scale and effects of the action, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality as set out in that Article, this Directive does not go beyond what is necessary in order to achieve those objectives,

HAVE ADOPTED THIS DIRECTIVE:

Article 1

Objectives

The objectives of this Directive are to prevent and reduce the impact of certain plastic products on the environment, in particular the aquatic environment, and on human health, as well as to promote the transition to a circular economy with innovative and sustainable business models, products and materials, thus also contributing to the efficient functioning of the internal market.

Article 2

Scope

1.  This Directive applies to the single-use plastic products listed in the Annex, to products made from oxo-degradable plastic and to fishing gear containing plastic.

2.  Where this Directive conflicts with Directive 94/62/EC or 2008/98/EC, this Directive shall prevail.

Article 3

Definitions

For the purposes of this Directive, the following definitions apply:

(1)  'plastic' means a material consisting of a polymer as defined in point (5) of Article 3 of Regulation (EC) No 1907/2006, to which additives or other substances may have been added, and which can function as a main structural component of final products, with the exception of natural polymers that have not been chemically modified;

(2)  'single-use plastic product' means a product that is made wholly or partly from plastic and that is not conceived, designed or placed on the market to accomplish, within its life span, multiple trips or rotations by being returned to a producer for refill or re-used for the same purpose for which it was conceived;

(3)  'oxo-degradable plastic' means plastic materials that include additives which, through oxidation, lead to the fragmentation of the plastic material into micro-fragments or to chemical decomposition;

(4)  'fishing gear' means any item or piece of equipment that is used in fishing or aquaculture to target, capture or rear marine biological resources or that is floating on the sea surface, and is deployed with the objective of attracting and capturing or of rearing such marine biological resources;

(5)  'waste fishing gear' means any fishing gear covered by the definition of waste in point 1 of Article 3 of Directive 2008/98/EC, including all separate components, substances or materials that were part of or attached to such fishing gear when it was discarded, including when it was abandoned or lost;

(6)  ‘placing on the market’ means the first making available of a product on ▌ the market of a Member State;

(7)  ‘making available on the market’ means any supply of a product for distribution, consumption or use on the market of a Member State in the course of a commercial activity, whether in return for payment or free of charge;

(8)  ‘harmonised standard’ means a harmonised standard as defined in point (1)(c) of Article 2 of Regulation (EU) No 1025/2012;

(9)  ‘waste’ means waste as defined in point 1 of Article 3 of Directive 2008/98/EC;

(10)  'extended producer responsibility scheme' means extended producer responsibility scheme as defined in point 21 of Article 3 of Directive 2008/98/EC;

(11)  'producer' means:

(a)  any natural or legal person established in a Member State that professionally manufactures, fills, sells or imports, irrespective of the selling technique used, including by means of distance contracts as defined in point (7) of Article 2 of Directive 2011/83/EU of the European Parliament and of the Council(25), and places on the market of that Member State single-use plastic products, filled single-use plastic products or fishing gear containing plastic, other than persons carrying out fishing activities as defined in point (28) of Article 4 of Regulation (EU) No 1380/2013 of the European Parliament and of the Council(26); or

(b)  any natural or legal person established in one Member State or in a third country that professionally sells in another Member State directly to private households or to users other than private households, by means of distance contracts as defined in point (7) of Article 2 of Directive 2011/83/EU, single-use plastic products, filled single-use plastic products or fishing gear containing plastic, other than persons carrying out fishing activities as defined in point (28) of Article 4 of Regulation (EU) No 1380/2013;

(12)  'collection' means collection as defined in point 10 of Article 3 of Directive 2008/98/EC;

(13)  ‘separate collection’ means separate collection as defined in point 11 of Article 3 of Directive 2008/98/EC;

(14)  'treatment' means treatment as defined in point 14 of Article 3 of Directive 2008/98/EC;

(15)  'packaging' means packaging as defined in point 1 of Article 3 of Directive 94/62/EC;

(16)  'biodegradable plastic' means a plastic capable of undergoing physical, biological decomposition, such that it ultimately decomposes into carbon dioxide (CO2), biomass and water, and is, in accordance with European standards for packaging, recoverable through composting and anaerobic digestion;

(17)  'port reception facilities' means port reception facilities as defined in point (e) of Article 2 of Directive 2000/59/EC;

(18)  ‘tobacco products’ means tobacco products as defined in point (4) of Article 2 of Directive 2014/40/EU.

Article 4

Consumption reduction

1.  Member States shall take the necessary measures to achieve an ambitious and sustained reduction in the consumption of the single-use plastic products listed in Part A of the Annex, in line with the overall objectives of the Union’s waste policy, in particular waste prevention, leading to a substantial reversal of increasing consumption trends. Those measures shall achieve a measurable quantitative reduction in the consumption of the single-use plastic products listed in Part A of the Annex on the territory of the Member State by 2026 compared to 2022.

By … [two years after the date of entry into force of this Directive], Member States shall prepare a description of the measures which they have adopted pursuant to the first subparagraph, notify the description to the Commission and make it publicly available. Member States shall integrate the measures set out in the description into the plans or programmes referred to in Article 11 upon the first subsequent update of those plans or programmes in accordance with the relevant legislative acts of the Union governing those plans or programmes, or into any other programmes drawn up specifically for that purpose.

The measures may include national consumption reduction targets, measures ensuring that re-usable alternatives to the single-use plastic products listed in Part A of the Annex are made available at the point of sale to the final consumer, economic instruments such as instruments ensuring that those single-use plastic products are not provided free of charge at the point of sale to the final consumer and agreements as referred to in Article 17(3). Member States may impose marketing restrictions in derogation from Article 18 of Directive 94/62/EC for the purposes of preventing such products from becoming litter in order to ensure that they are substituted with alternatives that are re-usable or do not contain plastic. Those measures may vary depending on the environmental impact of those single-use plastic products over their life cycle, including when they become litter.

Measures adopted pursuant to this paragraph shall be proportionate and non-discriminatory. Member States shall notify the Commission of those measures in accordance with Directive (EU) 2015/1535 of the European Parliament and of the Council(27) where so required by that Directive.

In order to comply with the first subparagraph of this paragraph, each Member State shall monitor the single-use plastic products listed in Part A of the Annex placed on the market and the reduction measures taken and shall report on progress made to the Commission in accordance with paragraph 2 of this Article and Article 13(1) with a view to the establishment of binding quantitative Union targets for consumption reduction.

2.  By … [18 months after the date of entry into force of this Directive], the Commission shall adopt an implementing act laying down the methodology for the calculation and verification of the ambitious and sustained reduction in the consumption of the single-use plastic products listed in Part A of the Annex. That implementing act shall be adopted in accordance with the examination procedure referred to in Article 16(2).

Article 5

Restrictions on placing on the market

Member States shall prohibit the placing on the market of the single-use plastic products listed in Part B of the Annex and of products made from oxo-degradable plastic.

Article 6

Product requirements

1.  Member States shall ensure that single-use plastic products listed in Part C of the Annex that have caps and lids ▌made of plastic may be placed on the market only if the caps and lids remain attached to the containers during the products’ intended use stage.

2.  For the purposes of this Article, metal caps or lids with plastic seals shall not be considered to be made of plastic.

3.  By … [3 months after the date of entry into force of this Directive], the Commission shall request the European standardisation organisations to develop harmonised standards relating to the requirement referred to in paragraph 1. Those standards shall in particular address the need to ensure the necessary strength, reliability and safety of beverage container closures, including those for carbonated drinks.

4.  From the date of publication of the references to harmonised standards referred to in paragraph 3 in the Official Journal of the European Union, single-use plastic products referred to in paragraph 1 which are in conformity with those standards or parts thereof shall be presumed to be in conformity with the requirement laid down in paragraph 1.

5.  With regard to beverage bottles listed in Part F of the Annex, each Member State shall ensure that:

(a)  from 2025, beverage bottles listed in Part F of the Annex which are manufactured from polyethylene terephthalate as the major component ("PET bottles") contain at least 25 % recycled plastic, calculated as an average for all PET bottles placed on the market on the territory of that Member State; and

(b)  from 2030, beverage bottles listed in Part F of the Annex contain at least 30 % recycled plastic, calculated as an average for all such beverage bottles placed on the market on the territory of that Member State.

By 1 January 2022, the Commission shall adopt implementing acts laying down the rules for the calculation and verification of the targets established in the first subparagraph of this paragraph. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 16(2).

Article 7

Marking requirements

1.  Member States shall ensure that each single-use plastic product listed in Part D of the Annex placed on the market bears a conspicuous, clearly legible and indelible marking on its packaging or on the product itself informing consumers ▌ of the following:

(a)  appropriate waste management options for the product or waste disposal means to be avoided for that product, in line with the waste hierarchy; and

(b)  the presence of plastics in the product and the resulting negative impact of littering or other inappropriate means of waste disposal of the product on the environment.

The harmonised marking specifications shall be established by the Commission in accordance with paragraph 2.

2.  By … [12 months after the date of entry into force of this Directive], the Commission shall adopt an implementing act establishing harmonised specifications for the marking referred to in paragraph 1 that:

(a)  provide that the marking of single-use plastic products listed in points (1), (2) and (3) of Part D of the Annex shall be placed on the sales and grouped packaging of those products. Where multiple sales units are grouped at the point of purchase, each sales unit shall bear a marking on its packaging. The marking shall not be required for packaging with a surface area of less than 10 cm2;

(b)  provide that the marking of single-use plastic products listed in point (4) of Part D of the Annex shall be placed on the product itself; and

(c)  consider existing sectoral voluntary approaches and pay particular attention to the need to avoid information that misleads consumers.

That implementing act shall be adopted in accordance with the examination procedure referred to in Article 16(2).

3.  The provisions of this Article concerning tobacco products are in addition to those laid down in Directive 2014/40/EU.

Article 8

Extended producer responsibility

1.  Member States shall ensure that extended producer responsibility schemes are established for all single-use plastic products listed in Part E of the Annex which are placed on the market of the Member State, in accordance with Articles 8 and 8a of Directive 2008/98/EC.

2.  ▌ Member States shall ensure that the producers of the single-use plastic products listed in Section I of Part E of the Annex to this Directive cover the costs pursuant to the extended producer responsibility provisions in Directives 2008/98/EC and 94/62/EC and, insofar as not already included, cover the following costs:

(a)  the costs of the awareness raising measures referred to in Article 10 of this Directive regarding those products;

(b)  the costs of waste collection for those products that are discarded in public collection systems, including the infrastructure and its operation, and the subsequent transport and treatment of that waste; and

(c)  the costs of cleaning up litter resulting from those products and the subsequent transport and treatment of that litter.

3.  Member States shall ensure that the producers of the single-use plastic products listed in Sections II and III of Part E of the Annex cover at least the following costs:

(a)  the costs of the awareness raising measures referred to in Article 10 regarding those products;

(b)  the costs of cleaning up litter resulting from those products and the subsequent transport and treatment of that litter; and

(c)  the costs of data gathering and reporting in accordance with point (c) of Article 8a(1) of Directive 2008/98/EC.

With regard to the single-use plastic products listed in Section III of Part E of the Annex to this Directive, Member States shall ensure that the producers cover, in addition, the costs of waste collection for those products that are discarded in public collection systems, including the infrastructure and its operation, and the subsequent transport and treatment of that waste. The costs may include the setting up of specific infrastructure for the waste collection for those products, such as appropriate waste receptacles in common litter hotspots.

4.  The costs to be covered referred to in paragraphs 2 and 3 shall not exceed the costs that are necessary to provide the services referred to therein in a cost-efficient way and shall be established in a transparent way between the actors concerned. The costs of cleaning up litter shall be limited to activities undertaken by public authorities or on their behalf. The calculation methodology shall be developed in a way that allows for the costs of cleaning up litter to be established in a proportionate way. To minimise administrative costs, Member States may determine financial contributions towards the costs of cleaning up litter by setting appropriate multiannual fixed amounts.

The Commission shall publish guidelines for criteria, in consultation with Member States, on the costs of cleaning up litter referred to in paragraphs 2 and 3.

5.  Member States shall define in a clear way the roles and responsibilities of all relevant actors involved.

With regard to packaging, those roles and responsibilities shall be defined in line with Directive 94/62/EC.

6.  Each Member State shall allow the producers established in another Member State and placing products on its market to appoint a legal or natural person established on its territory as an authorised representative for the purposes of fulfilling the obligations of a producer related to extended producer responsibility schemes on its territory.

7.  Each Member State shall ensure that a producer established on its territory, which sells single-use plastic products listed in Part E of the Annex and fishing gear containing plastic in another Member State in which it is not established, appoints an authorised representative in that other Member State. The authorised representative shall be the person responsible for fulfilling the obligations of that producer pursuant to this Directive on the territory of that other Member State.

8.  Member States shall ensure that extended producer responsibility schemes are established for fishing gear containing plastic placed on the ▌ market of the Member State, in accordance with Articles 8 and 8a of Directive 2008/98/EC.

Member States that have marine waters as defined in point 1 of Article 3 of Directive 2008/56/EC shall set a national minimum annual collection rate of waste fishing gear containing plastic for recycling.

Member States shall monitor fishing gear containing plastic placed on the market of the Member State as well as waste fishing gear containing plastic collected and shall report to the Commission in accordance with Article 13(1) of this Directive with a view to the establishment of binding quantitative Union collection targets.

9.  With regard to the extended producer responsibility schemes established pursuant to paragraph 8 of this Article, Member States shall ensure that the producers of fishing gear containing plastic cover the costs of the separate collection of waste fishing gear containing plastic that has been delivered to adequate port reception facilities in accordance with Directive (EU) 2019/…(28) or to other equivalent collection systems that fall outside the scope of that Directive and the costs of its subsequent transport and treatment. The producers shall also cover the costs of the awareness raising measures referred to in Article 10 regarding fishing gear containing plastic.

The requirements laid down in this paragraph supplement the requirements applicable to waste from fishing vessels in Union law on port reception facilities.

Without prejudice to technical measures laid down in Council Regulation (EC) No 850/98(29), the Commission shall request the European standardisation organisations to develop harmonised standards relating to the circular design of fishing gear to encourage preparing for re-use and facilitate recyclability at end of life.

Article 9

Separate collection

1.  Member States shall take the necessary measures to ensure the separate collection for recycling:

(a)  by 2025, of an amount of waste single-use plastic products listed in Part F of the Annex equal to 77 % of such single-use plastic products placed on the market in a given year by weight;

(b)  by 2029, of an amount of waste single-use plastic products listed in Part F of the Annex equal to 90 % of such single-use plastic products placed on the market in a given year by weight.

Single-use plastic products listed in Part F of the Annex placed on the market in a Member State may be deemed to be equal to the amount of waste generated from such products, including as litter, in the same year in that Member State.

In order to achieve that objective, Member States may inter alia:

(a)  establish deposit-refund schemes;

(b)  establish separate collection targets for relevant extended producer responsibility schemes.

The first subparagraph shall apply without prejudice to point (a) of Article 10(3) of Directive 2008/98/EC.

2.  The Commission shall facilitate the exchange of information and sharing of best practices among Member States on the appropriate measures to meet the targets laid down in paragraph 1, inter alia on deposit-refund schemes. The Commission shall make the results of such exchange of information and sharing of best practices publicly available.

3.  By … [12 months after the date of entry into force of this Directive], the Commission shall adopt an implementing act laying down the methodology for the calculation and verification of the separate collection targets laid down in paragraph 1 of this Article. That implementing act shall be adopted in accordance with the examination procedure referred to in Article 16(2).

Article 10

Awareness raising measures

Member States shall take measures to inform consumers and to incentivise responsible consumer behaviour, in order to reduce litter from products covered by this Directive, and shall take measures to inform consumers of the single-use plastic products listed in Part G of the Annex and users of fishing gear containing plastic about the following:

(a)  the availability of re-usable alternatives, re-use systems and waste management options for those single-use plastic products and for fishing gear containing plastic as well as best practices in sound waste management carried out in accordance with Article 13 of Directive 2008/98/EC;

(b)  the impact of littering and other inappropriate waste disposal of those single-use plastic products and of fishing gear containing plastic on the environment, in particular on the marine environment; and

(c)  the impact of inappropriate means of waste disposal of those single-use plastic products on the sewer network.

Article 11

Coordination of measures

Without prejudice to the first subparagraph of Article 4(1) of this Directive, each Member State shall ensure that the measures taken to transpose and implement this Directive form an integral part of and are consistent with its programmes of measures established in accordance with Article 13 of Directive 2008/56/EC for those Member States that have marine waters, the programmes of measures established in accordance with Article 11 of Directive 2000/60/EC, waste management plans and waste prevention programmes established in accordance with Articles 28 and 29 of Directive 2008/98/EC and the waste reception and handling plans established under Directive (EU) 2019/…(30).

The measures that Member States take to transpose and implement Articles 4 to 9 of this Directive shall comply with Union food law to ensure that food hygiene and food safety are not compromised. Member States shall encourage the use of sustainable alternatives to single-use plastic where possible for materials intended to come into contact with food.

Article 12

Specifications and guidelines on single-use plastic products

In order to determine whether a food container is to be considered as a single-use plastic product for the purposes of this Directive, in addition to the criteria listed in the Annex as regards food containers, its tendency to become litter, due to its volume or size, in particular single-serve portions, shall play a decisive role.

By … [one year after the date of entry into force of this Directive], the Commission shall publish guidelines, in consultation with Member States, including examples of what is to be considered a single-use plastic product for the purposes of this Directive, as appropriate.

Article 13

Information systems and reporting

1.  Member States shall, for each calendar year, report to the Commission the following:

(a)  the data on single-use plastic products listed in Part A of the Annex that have been placed on the ▌ market of the Member State each year, to demonstrate the consumption reduction in accordance with Article 4(1);

(b)  information on the measures taken by the Member State for the purposes of Article 4(1);

(c)  the data on single-use plastic products listed in Part F of the Annex that have been separately collected in the Member State each year, to demonstrate the attainment of the separate collection targets in accordance with Article 9(1);

(d)  data on fishing gear containing plastic placed on the market and on waste fishing gear collected in the Member State each year;

(e)  information on recycled content in beverage bottles listed in Part F of the Annex to demonstrate the attainment of the targets laid down in Article 6(5); and

(f)  data on the post-consumption waste of single-use plastic products listed in Section III of Part E of the Annex that has been collected in accordance with Article 8(3).

Member States shall report the data and information electronically within 18 months of the end of the reporting year for which they were collected. The data and information shall be reported in the format established by the Commission in accordance with paragraph 4 of this Article.

The first reporting period shall be the calendar year 2022, with the exception of points (e) and (f) of the first subparagraph for which the first reporting period shall be the calendar year 2023.

2.  The data and information reported by Member States in accordance with this Article shall be accompanied by a quality check report. The data and information shall be reported in the format established by the Commission in accordance with paragraph 4.

3.  The Commission shall review the data and information reported in accordance with this Article and publish a report on the results of its review. The report shall assess the organisation of the collection of the data and information, the sources of data and information and the methodology used in Member States as well as the completeness, reliability, timeliness and consistency of that data and information. The assessment may include specific recommendations for improvement. The report shall be drawn up after the first reporting of the data and information by the Member States and thereafter at the intervals envisaged in Article 12(3c) of Directive 94/62/EC.

4.  By … [18 months after the date of entry into force of this Directive], the Commission shall adopt implementing acts laying down the format for reporting data and information in accordance with points (a) and (b) of paragraph 1 and with paragraph 2 of this Article.

By … [12 months after the date of entry into force of this Directive], the Commission shall adopt implementing acts laying down the format for reporting data in accordance with points (c) and (d) of paragraph 1 and with paragraph 2 of this Article.

By 1 January 2022, the Commission shall adopt implementing acts laying down the format for reporting data and information in accordance with points (e) and (f) of paragraph 1 and with paragraph 2 of this Article.

Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 16(2). The format developed according to Article 12 of Directive 94/62/EC shall be taken into consideration.

Article 14

Penalties

Member States shall lay down the rules on penalties applicable to infringements of national provisions adopted pursuant to this Directive and shall take all measures necessary to ensure that they are implemented. The penalties provided for shall be effective, proportionate and dissuasive. Member States shall, by … [2 years after the date of entry into force of this Directive], notify the Commission of those rules and those measures and shall notify it of any subsequent amendment affecting them.

Article 15

Evaluation and review

1.  The Commission shall carry out an evaluation of this Directive by … [eight years after the date of entry into force of this Directive]. The evaluation shall be based on the information available in accordance with Article 13. Member States shall provide the Commission with any additional information necessary for the purposes of the evaluation and the preparation of the report referred to in paragraph 2 of this Article.

2.  ▌The Commission shall submit a report on the main findings of the evaluation carried out in accordance with paragraph 1 to the European Parliament, the Council and the European Economic and Social Committee. The report shall be accompanied by a legislative proposal, if appropriate. That proposal shall, if appropriate, set binding quantitative consumption reduction targets and set binding collection rates for waste fishing gear.

3.  The report shall include:

(a)  an assessment of the need to review the Annex listing single-use plastic products, including as regards caps and lids made of plastic which are used for glass and metal beverage containers;

(b)  a study of the feasibility of establishing binding collection rates for waste fishing gear and binding quantitative Union targets for the consumption reduction of, in particular, single-use plastic products listed in Part A of the Annex, taking into account consumption levels and already achieved reductions in Member States;

(c)  an assessment of the change in materials used in the single-use plastic products covered by this Directive as well as of new consumption patterns and business models based on re-usable alternatives; this shall, wherever possible, include an overall life cycle analysis to assess the environmental impact of such products and their alternatives; and

(d)  an assessment of the scientific and technical progress concerning criteria or a standard for biodegradability in the marine environment applicable to single-use plastic products within the scope of this Directive and their single-use substitutes which ensure full decomposition into carbon dioxide (CO2), biomass and water within a timescale short enough for the plastics not to be harmful for marine life and not to lead to an accumulation of plastics in the environment.

4.  As part of the evaluation carried out pursuant to paragraph 1, the Commission shall review the measures taken under this Directive as regards single-use plastic products listed in Section III of Part E of the Annex and shall submit a report on the main findings. The report shall also consider the options for binding measures for the reduction of the post-consumption waste of single-use plastic products listed in Section III of Part E of the Annex, including the possibility of setting binding collection rates for that post-consumption waste. The report shall, if appropriate, be accompanied by a legislative proposal.

Article 16

Committee procedure

1.  The Commission shall be assisted by the Committee established by Article 39 of Directive 2008/98/EC. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011.

2.  Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply.

Where the committee delivers no opinion, the Commission shall not adopt the draft implementing act and the third subparagraph of Article 5(4) of Regulation (EU) No 182/2011 shall apply.

Article 17

Transposition

1.  Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by … [2 years after the date of entry into force of this Directive]. They shall immediately inform the Commission thereof.

However, the Member States shall apply the measures necessary to comply with ▌

–  Article 5 from … [2 years after the date of entry into force of this Directive],

–  Article 6(1) from … [5 years after the date of entry into force of this Directive],

–  Article 7(1) from … [2 years after the date of entry into force of this Directive],

–  Article 8 by 31 December 2024 but, in relation to extended producer responsibility schemes established before 4 July 2018 and in relation to single-use plastic products listed in Section III of Part E of the Annex, by 5 January 2023.

When Member States adopt the measures referred to in this paragraph, they shall contain a reference to this Directive or shall be accompanied by such a reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States.

2.  Member States shall communicate to the Commission the text of the main measures of national law which they adopt in the field covered by this Directive.

3.  Provided that the waste management targets and objectives set out in Articles 4 and 8 are achieved, Member States may transpose the provisions set out in Articles 4(1) and 8(1) and (8), except as regards single-use plastic products listed in Section III of Part E of the Annex, by means of agreements between the competent authorities and the economic sectors concerned.

Such agreements shall meet the following requirements:

(a)  agreements shall be enforceable;

(b)  agreements need to specify objectives with the corresponding deadlines;

(c)  agreements shall be published in the national official journal or an official document equally accessible to the public and transmitted to the Commission;

(d)  the results achieved under an agreement shall be monitored regularly, reported to the competent authorities and to the Commission and made available to the public under the conditions set out in the agreement;

(e)  the competent authorities shall make provisions to examine the progress reached under an agreement; and

(f)  in case of non-compliance with an agreement Member States shall implement the relevant provisions of this Directive by legislative, regulatory or administrative measures.

Article 18

Entry into force

This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

Article 19

Addressees

This Directive is addressed to the Member States.

Done at …

For the European Parliament For the Council

The President The President

ANNEX

Part A

Single-use plastic products covered by Article 4 on consumption reduction

(1)  Cups for beverages, including their covers and lids;

(2)  Food containers, i.e. receptacles such as boxes, with or without a cover, used to contain food which:

(a)  is intended for immediate consumption, ▌ either on-the-spot or take-away,

(b)  is typically consumed from the receptacle, and

(c)  is ready to be consumed without any further preparation, such as cooking, boiling or heating,

including food containers used for fast food or other meal ready for immediate consumption, except beverage containers, plates and packets and wrappers containing food.

Part B

Single-use plastic products covered by Article 5 on restrictions on placing on the market

(1)  Cotton bud sticks, except if they fall within the scope of Council Directive 90/385/EEC(31) or Council Directive 93/42/EEC(32);

(2)  Cutlery (forks, knives, spoons, chopsticks);

(3)  Plates;

(4)  Straws, except if they fall within the scope of Directive 90/385/EEC or Directive 93/42/EEC;

(5)  Beverage stirrers;

(6)  Sticks to be attached to and to support balloons, except balloons for industrial or other professional uses and applications that are not distributed to consumers, including the mechanisms of such sticks;

(7)  Food containers made of expanded polystyrene, i.e. receptacles such as boxes, with or without a cover, used to contain food which:

(a)  is intended for immediate consumption, either on-the-spot or take-away,

(b)  is typically consumed from the receptacle, and

(c)  is ready to be consumed without any further preparation, such as cooking, boiling or heating,

including food containers used for fast food or other meal ready for immediate consumption, except beverage containers, plates and packets and wrappers containing food;

(8)  Beverage containers made of expanded polystyrene, including their caps and lids;

(9)  Cups for beverages made of expanded polystyrene, including their covers and lids.

Part C

Single-use plastic products covered by Article 6(1) to (4) on product requirements

(1)  Beverage containers with a capacity of up to three litres, i.e. receptacles used to contain liquid, such as beverage bottles including their caps and lids and composite beverage packaging including their caps and lids, but not:

(a)  glass or metal beverage containers that have caps and lids made from plastic,

(b)  beverage containers intended and used for food for special medical purposes as defined in point (g) of Article 2 of Regulation (EU) No 609/2013 of the European Parliament and of the Council(33) that is in liquid form.

Part D

Single-use plastic products covered by Article 7 on marking requirements

(1)  Sanitary towels (pads), tampons and tampon applicators;

(2)  Wet wipes, i.e. pre-wetted personal care and domestic ▌ wipes;

(3)  Tobacco products with filters and filters marketed for use in combination with tobacco products;

(4)  Cups for beverages.

Part E

I.  Single -use plastic products covered by Article 8(2) on extended producer responsibility

(1)  Food containers, i.e. receptacles such as boxes, with or without a cover, used to contain food which:

(a)  is intended for immediate consumption, ▌ either on-the-spot or take-away,

(b)  is typically consumed from the receptacle, and

(c)  is ready to be consumed without any further preparation, such as cooking,

boiling or heating,

including food containers used for fast food or other meal ready for immediate consumption, except beverage containers, plates and packets and wrappers containing food;

(2)  Packets and wrappers made from flexible material containing food that is intended for immediate consumption from the packet or wrapper without any further preparation;

(3)  Beverage containers with a capacity of up to three litres, i.e. receptacles used to contain liquid such as beverage bottles including their caps and lids and composite beverage packaging including their caps and lids, but not glass or metal beverage containers that have caps and lids made from plastic;

(4)  Cups for beverages, including their covers and lids;

(5)  Lightweight plastic carrier bags as defined in point 1c of Article 3 of Directive 94/62/EC.

II.  Single-use plastic products covered by Article 8(3) on extended producer responsibility

(1)  Wet wipes, i.e. pre-wetted personal care and domestic ▌ wipes;

(2)  Balloons, except balloons for industrial or other professional uses and applications that are not distributed to consumers.

III.  Other single-use plastic products covered by Article 8(3) on extended producer responsibility

Tobacco products with filters and filters marketed for use in combination with tobacco products.

Part F

Single-use plastic products covered by Article 9 on separate collection and by Article 6(5) on product requirements

Beverage bottles with a capacity of up to three litres, including their caps and lids, but not:

(a)  glass or metal beverage bottles that have caps and lids made from plastic,

(b)  beverage bottles intended and used for food for special medical purposes as defined in point (g) of Article 2 of Regulation (EU) No 609/2013 that is in liquid form.

Part G

Single-use plastic products covered by Article 10 on awareness raising

(1)  Food containers, i.e. receptacles such as boxes, with or without a cover, used to contain food which:

(a)  is intended for immediate consumption, ▌ either on-the-spot or take-away,

(b)  is typically consumed from the receptacle, and

(c)  is ready to be consumed without any further preparation, such as cooking, boiling or heating,

including food containers used for fast food or other meal ready for immediate consumption, except beverage containers, plates and packets and wrappers containing food;

(2)  Packets and wrappers made from flexible material containing food that is intended for immediate consumption from the packet or wrapper without any further preparation;

(3)  Beverage containers with a capacity of up to three litres, i.e. receptacles used to contain liquid such as beverage bottles including their caps and lids and composite beverage packaging including their caps and lids, but not glass or metal beverage containers that have caps and lids made from plastic;

(4)   Cups for beverages, including their covers and lids;

(5)  Tobacco products with filters and filters marketed for use in combination with tobacco products;

(6)  Wet wipes, i.e. pre-wetted personal care and domestic ▌ wipes;

(7)  Balloons, except balloons for industrial or other professional uses and applications that are not distributed to consumers;

(8)  Lightweight plastic carrier bags as defined in point 1c of Article 3 of Directive 94/62/EC;

(9)  Sanitary towels (pads), tampons and tampon applicators.

(1) OJ C 62, 15.2.2019, p. 207.
(2) OJ C 461, 21.12.2018, p. 210.
(3) This position replaces the amendments adopted on 24 October 2018 (Texts adopted, P8_TA-PROV(2018)0411).
(4)OJ C 62, 15.2.2019, p. 207.
(5)OJ C 461, 21.12.2018, p. 210.
(6) Position of the European Parliament of 27 March 2019.
(7)Directive 2008/98/EC of the European Parliament and of the Council of 19 November 2008 on waste and repealing certain Directives (OJ L 312, 22.11.2008, p. 3).
(8) OJ L 179, 23.6.1998, p. 3.
(9) OJ L 39, 16.2.1993, p. 3.
(10)Directive 2000/59/EC of the European Parliament and of the Council of 27 November 2000 on port reception facilities for ship-generated waste and cargo residues (OJ L 332, 28.12.2000, p. 81).
(11) Directive 2000/60/EC of the European Parliament and of the Council of 23 October 2000 establishing a framework for Community action in the field of water policy (OJ L 327, 22.12.2000, p. 1).
(12)Directive 2008/56/EC of the European Parliament and of the Council of 17 June 2008 establishing a framework for community action in the field of marine environmental policy (Marine Strategy Framework Directive) (OJ L 164, 25.6.2008, p. 19).
(13)Council Regulation (EC) No 1224/2009 of 20 November 2009 establishing a Union control system for ensuring compliance with the rules of the common fisheries policy, amending Regulations (EC) No 847/96, (EC) No 2371/2002, (EC) No 811/2004, (EC) No 768/2005, (EC) No 2115/2005, (EC) No 2166/2005, (EC) No 388/2006, (EC) No 509/2007, (EC) No 676/2007, (EC) No 1098/2007, (EC) No 1300/2008, (EC) No 1342/2008 and repealing Regulations (EEC) No 2847/93, (EC) No 1627/94 and (EC) No 1966/2006 (OJ L 343, 22.12.2009, p. 1).
(14)European Parliament and Council Directive 94/62/EC of 20 December 1994 on packaging and packaging waste (OJ L 365 31.12.1994, p. 10).
(15) Directive 2014/40/EU of the European Parliament and of the Council of 3 April 2014 on the approximation of the laws, regulations and administrative provisions of the Member States concerning the manufacture, presentation and sale of tobacco and related products and repealing Directive 2001/37/EC (OJ L 127, 29.4.2014, p. 1).
(16)Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 396, 30.12.2006, p. 1).
(17)Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (OJ L 31, 1.2.2002, p. 1).
(18) Regulation (EC) No 852/2004 of the European Parliament and of the Council of 29 April 2004 on the hygiene of foodstuffs (OJ L 139, 30.4.2004, p. 1).
(19) Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004 on materials and articles intended to come into contact with food and repealing Directives 80/590/EEC and 89/109/EEC (OJ L 338, 13.11.2004, p. 4).
(20)Regulation (EU) No 1025/2012 of the European Parliament and of the Council of 25 October 2012 on European standardisation, amending Council Directives 89/686/EEC and 93/15/EEC and Directives 94/9/EC, 94/25/EC, 95/16/EC, 97/23/EC, 98/34/EC, 2004/22/EC, 2007/23/EC, 2009/23/EC and 2009/105/EC of the European Parliament and of the Council and repealing Council Decision 87/95/EEC and Decision No 1673/2006/EC of the European Parliament and of the Council (OJ L 316, 14.11.2012, p. 12).
(21) Directive (EU) 2019/… of the European Parliament and of the Council of … on port reception facilities for the delivery of waste from ships, amending Directive 2010/65/EU and repealing Directive 2000/59/EC (OJ. …).
(22)+ OJ: Please insert in the text the number of the Directive contained in document PE-CONS 85/18 (2018/0012 (COD)) and insert the number, date and OJ reference of that Directive in the footnote.
(23)OJ L 123, 12.5.2016, p. 1.
(24)Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission’s exercise of implementing powers (OJ L 55, 28.2.2011, p. 13).
(25)Directive 2011/83/EU of the European Parliament and of the Council of 25 October 2011 on consumer rights, amending Council Directive 93/13/EEC and Directive 1999/44/EC of the European Parliament and of the Council and repealing Council Directive 85/577/EEC and Directive 97/7/EC of the European Parliament and of the Council (OJ L 304, 22.11.2011, p. 64).
(26)Regulation (EU) No 1380/2013 of the European Parliament and of the Council of 11 December 2013 on the Common Fisheries Policy, amending Council Regulations (EC) No 1954/2003 and (EC) No 1224/2009 and repealing Council Regulations (EC) No 2371/2002 and (EC) No 639/2004 and Council Decision 2004/585/EC (OJ L 354, 28.12.2013, p. 22).
(27)Directive (EU) 2015/1535 of the European Parliament and of the Council of 9 September 2015 laying down a procedure for the provision of information in the field of technical regulations and of rules on Information Society services (OJ L 241, 17.9.2015, p. 1).
(28)+ OJ: Please insert the number of the Directive contained in document PE-CONS 85/18 (2018/0012 (COD)).
(29)Council Regulation (EC) No 850/98 of 30 March 1998 for the conservation of fishery resources through technical measures for the protection of juveniles of marine organisms (OJ L 125, 27.4.1998, p. 1).
(30)+ OJ: Please insert the number of the Directive contained in document PE-CONS 85/18 (2018/0012 (COD)).
(31) Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices (OJ L 189, 20.7.1990, p. 17).
(32) Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (OJ L 169, 12.7.1993, p. 1).
(33) Regulation (EU) No 609/2013 of the European Parliament and of the Council of 12 June 2013 on food intended for infants and young children, food for special medical purposes, and total diet replacement for weight control and repealing Council Directive 92/52/EEC, Commission Directives 96/8/EC, 1999/21/EC, 2006/125/EC and 2006/141/EC, Directive 2009/39/EC of the European Parliament and of the Council and Commission Regulations (EC) No 41/2009 and (EC) No 953/2009 (OJ L 181, 29.6.2013, p. 35).


EU fertilising products ***I
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Resolution
Consolidated text
European Parliament legislative resolution of 27 March 2019 on the proposal for a regulation of the European Parliament and of the Council laying down rules on the making available on the market of CE marked fertilising products and amending Regulations (EC) No 1069/2009 and (EC) No 1107/2009 (COM(2016)0157 – C8-0123/2016 – 2016/0084(COD))
P8_TA-PROV(2019)0306A8-0270/2017

(Ordinary legislative procedure: first reading)

The European Parliament,

–  having regard to the Commission proposal to Parliament and the Council (COM(2016)0157),

–  having regard to Article 294(2) and Article 114 of the Treaty on the Functioning of the European Union, pursuant to which the Commission submitted the proposal to Parliament (C8‑0123/2016),

–  having regard to Article 294(3) of the Treaty on the Functioning of the European Union,

–  having regard to the opinion of the European Economic and Social Committee(1),

–  having regard to the provisional agreement approved by the committee responsible under Rule 69f(4) of its Rules of Procedure and the undertaking given by the Council representative by letter of 12 December 2018 to approve Parliament’s position, in accordance with Article 294(4) of the Treaty on the Functioning of the European Union,

–  having regard to Rule 59 of its Rules of Procedure,

–  having regard to the report of the Committee on the Internal Market and Consumer Protection and the opinions of the Committee on the Environment, Public Health and Food Safety, the Committee on Agriculture and Rural Development and the Committee on International Trade (A8-0270/2017),

1.  Adopts its position at first reading hereinafter set out(2);

2.  Calls on the Commission to refer the matter to Parliament again if it replaces, substantially amends or intends to substantially amend its proposal;

3.  Instructs its President to forward its position to the Council, the Commission and the national parliaments.

Position of the European Parliament adopted at first reading on 27 March 2019 with a view to the adoption of Regulation (EU) 2019/… of the European Parliament and of the Council laying down rules on the making available on the market of EU fertilising products and amending Regulations (EC) No 1069/2009 and (EC) No 1107/2009 and repealing Regulation (EC) No 2003/2003

P8_TC1-COD(2016)0084


(Text with EEA relevance)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the Functioning of the European Union, and in particular Article 114 thereof,

Having regard to the proposal from the European Commission,

After transmission of the draft legislative act to the national parliaments,

Having regard to the opinion of the European Economic and Social Committee(3),

Acting in accordance with the ordinary legislative procedure(4),

Whereas:

(1)  The conditions for making fertilisers available on the internal market have been partially harmonised through Regulation (EC) No 2003/2003 of the European Parliament and of the Council(5), which almost exclusively covers fertilisers from mined or chemically produced, inorganic materials. There is also a need to make use of recycled or organic materials for fertilising purposes. Harmonised conditions for making fertilisers made from such recycled or organic materials available on the entire internal market should be established in order to provide an important incentive for their further use. Promoting increased use of recycled nutrients would further aid the development of the circular economy and allow a more resource-efficient general use of nutrients, while reducing Union dependency on nutrients from third countries. The scope of the harmonisation should therefore be extended in order to include recycled and organic materials.

(2)  Certain products are being used in combination with fertilisers for the purpose of improving nutrition efficiency, with the beneficial effect of reducing the amount of fertilisers used and hence their environmental impact. In order to facilitate their free movement on the internal market, not only fertilisers, i.e. products intended to provide plants with nutrient, but also products intended to improve plants' nutrition efficiency, should be covered by the harmonisation.

(3)  Regulation (EC) No 765/2008 of the European Parliament and of the Council(6) lays down rules on the accreditation of conformity assessment bodies, provides a framework for the market surveillance of products and for controls on products from third countries, and lays down the general principles of the CE marking. That Regulation should be applicable to products covered by ▌ this Regulation in order to ensure that products benefiting from the free movement of goods within the Union fulfil requirements providing a high level of protection of public interests such as human, animal and plant health ▌, safety ▌ and the environment.

(4)  Decision No 768/2008/EC of the European Parliament and of the Council(7) lays down common principles and reference provisions intended to apply across sectoral legislation in order to provide a coherent basis for revision or recasts of that legislation. Regulation (EC) No 2003/2003 should therefore be replaced by this Regulation, drafted to the extent possible in accordance with those common principles and reference provisions.

(5)  Contrary to most other product harmonisation measures in Union law, Regulation (EC) No 2003/2003 does not prevent non-harmonised fertilisers from being made available on the internal market in accordance with national law and the general free movement rules of the Treaty on the Functioning of the European Union (TFEU). In view of the very local nature of certain product markets, this possibility should remain. Compliance with harmonised rules should therefore remain optional, and should be required only for products, intended to provide plants with nutrient or improve plants' nutrition efficiency, which are CE marked when made available on the market. This Regulation should therefore not apply to products which are not CE marked when made available on the market.

(6)  Different product functions warrant different product safety and quality requirements adapted to their different intended uses. EU fertilising products should therefore be divided into different product function categories, which should each be subject to specific safety and quality requirements.

(7)  An EU fertilising product might have more than one of the functions described in the product function categories set out in this Regulation. Where only one of those functions is claimed, it should be sufficient for the EU fertilising product to comply with the requirements of the product function category describing that claimed function. By contrast, where more than one of those functions are claimed, the EU fertilising product should be regarded as a blend of two or more component EU fertilising products, and compliance should be required for each of the component EU fertilising products with respect to its function. A specific product function category should therefore cover such blends.

(8)  A manufacturer using one or more EU fertilising products that have already been subject to a conformity assessment, by that manufacturer or another manufacturer, might wish to rely on that conformity assessment. For the purpose of reducing the administrative burden to a minimum, the resulting EU fertilising product should also be regarded as a blend of two or more component EU fertilising products, and the additional conformity requirements for the blend should be limited to the aspects that are warranted by the blending.

(9)  Different component materials warrant different process requirements and control mechanisms adapted to their different potential hazardousness and variability. Component materials for EU fertilising products should therefore be divided into different categories, which should each be subject to specific process requirements and control mechanisms. It should be possible to make available on the market an EU fertilising product composed of several component materials from various component material categories, where each material complies with the requirements of the category to which the material belongs.

(10)  Contaminants in EU fertilising products, such as cadmium, could pose a risk to human ▌, animal or plant health, to safety or to the environment as they accumulate in the environment and enter the food chain. Their content should therefore be limited in such products. Furthermore, impurities in EU fertilising products derived from bio-waste, in particular polymers but also metal and glass, should be either prevented or limited to the extent technically feasible by detection of such impurities in separately collected bio-waste before processing.

(11)  Several Member States have in place national provisions limiting cadmium content in phosphate fertilisers on grounds relating to the protection of human health and of the environment. Should a Member State deem it necessary to maintain such national provisions after the adoption of harmonised limit values under this Regulation, and until those harmonised limit values are equal to or lower than the national limit values already in place, it should notify them to the Commission in accordance with Article 114(4) TFEU. Furthermore, in accordance with Article 114(5) TFEU, if a Member State deems it necessary to introduce new national provisions, such as provisions limiting cadmium content in phosphate fertilisers, based on new scientific evidence relating to the protection of the environment or the working environment on grounds of a problem specific to that Member State arising after the adoption of this Regulation, it should notify the Commission of the envisaged provisions as well as the grounds for introducing them. In either case, the Commission should verify in accordance with Article 114(6) TFEU whether or not the notified national provisions are a means of arbitrary discrimination, a disguised restriction on trade or an obstacle to the functioning of the internal market.

(12)  In view of the fact that certain Member States have been granted derogations from Article 5 of Regulation (EC) No 2003/2003 in accordance with TFEU relating to cadmium content in fertilisers on the grounds, inter alia, of the protection of human health and the environment in the context of particular soil and climactic conditions prevailing in those Member States, and since the factual circumstances that led to the granting of those derogations by the Commission remain valid, those Member States should be able to continue to apply their national limit values for cadmium content until such time as harmonised limit values for cadmium content in phosphate fertilisers which are equal to or lower than those limit values are applicable at Union level.

(13)  In order to facilitate the compliance of phosphate fertilisers with the requirements of this Regulation and to boost innovation, sufficient incentives should be provided for the development of relevant technologies, particularly decadmiation technology, and for the management of cadmium-rich hazardous waste in the form of relevant financial resources such as those available under Horizon Europe, the Circular Economy Finance Support Platform or through the European Investment Bank. Those incentives should target cadmium removal solutions that will be economically viable on an industrial scale and allow appropriate treatment of the waste generated.

(14)  An EU fertilising product complying with the requirements of this Regulation should be allowed to move freely on the internal market. Where one or more of the component materials is a derived product ▌ within the meaning of Regulation (EC) No 1069/2009 of the European Parliament and of the Council(8), but has reached a point in the manufacturing chain beyond which it no longer poses any significant risk to human, animal or plant health, to safety or to the environment (the 'end point in the manufacturing chain'), to continue subjecting the product to the provisions of that Regulation would represent an unnecessary administrative burden. Such fertilising products should therefore be excluded from the requirements of that Regulation. Regulation (EC) No 1069/2009 should therefore be amended accordingly.

(15)  For each component material category which includes derived products within the meaning of Regulation (EC) No 1069/2009, the end point in the manufacturing chain should be determined ▌ in accordance with the procedures laid down in that Regulation. Where such an end point is reached before the EU fertilising product is placed on the market but after the manufacturing process regulated under this Regulation has started, the process requirements of both Regulation (EC) No 1069/2009 and this Regulation should apply cumulatively to EU fertilising products, which means application of the stricter requirement in case both Regulations regulate the same parameter.

(16)  Derived products within the meaning of Regulation (EC) No 1069/2009 which are already placed on the market and used in the Union as organic fertilisers and soil improvers in accordance with that Regulation constitute promising raw materials for the production of innovative fertilising products in a circular economy. As soon as an end point in the manufacturing chain has been determined for the respective derived product, the EU fertilising products containing such derived products in accordance with this Regulation should be granted free movement on the internal market without being subject to the requirements of Regulation (EC) No 1069/2009. For this purpose, the Commission should, without undue delay, carry out a first assessment to check whether an end point in the manufacturing chain can be determined.

(17)  In the event of risks to public or animal health from fertilising products derived from animal by-products, recourse to safeguard measures in accordance with Regulation (EC) No 178/2002 of the European Parliament and of the Council(9) should be possible, as is the case for other categories of products derived from animal by-products.

(18)  The making available on the market of an animal by-product or a derived product within the meaning of Regulation (EC) No 1069/2009 for which no end point in the manufacturing chain has been determined, or for which the determined end point has not been reached at the time of making available on the market, is subject to the requirements of that Regulation. Therefore, it would be misleading to provide for the product's CE marking under this Regulation. Any product containing or consisting of such an animal by-product or derived product should therefore be excluded from the scope of this Regulation. Untreated animal by-products should not be subject to this Regulation.

(19)  For certain recovered wastes, such as struvite, biochar and ash-based products, within the meaning of Directive 2008/98/EC of the European Parliament and of the Council(10), a market demand for their use as fertilising products has been identified. Furthermore, certain requirements are necessary for the waste used as input in the recovery operation and for the treatment processes and techniques, as well as for fertilising products resulting from the recovery operation, in order to ensure that the use of those fertilising products does not lead to overall adverse environmental or human health impacts. For EU fertilising products, those requirements should be laid down in this Regulation. Therefore, as of the moment of compliance with all the requirements of this Regulation, such products should cease to be regarded as waste within the meaning of Directive 2008/98/EC, and it should, therefore, be possible for fertilising products containing or consisting of such recovered waste materials to access the internal market. To ensure legal certainty, take advantage of technical developments, and further stimulate the incentive among producers to make more use of valuable waste streams, the scientific analyses and the setting of recovery requirements at Union level for such products should start immediately after the entry into force of this Regulation. Accordingly, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of defining, without unnecessary delay, larger or additional categories of component materials eligible for use in the production of EU fertilising products.

(20)  Certain by-products within the meaning of Directive 2008/98/EC are currently used by manufacturers as components of fertilising products or can be expected to be used in future emerging markets. For such components, specific requirements should be laid down in a separate component material category in Annex II to this Regulation.

(21)  Certain substances and mixtures, commonly referred to as inhibitors, improve the nutrient release pattern of a nutrient in a fertiliser by delaying or stopping the activity of specific groups of micro-organisms or enzymes. For inhibitors made available on the market with the intention of them being added to fertilising products, the manufacturer should be responsible for ensuring that those inhibitors fulfil certain efficacy criteria. Therefore, those inhibitors should be considered as EU fertilising products under this Regulation. Furthermore, EU fertilising products containing such inhibitors should be subject to certain efficacy, safety and environmental criteria. Such inhibitors should therefore also be regulated as component materials for EU fertilising products.

(22)  Certain substances, mixtures and micro-organisms, ▌referred to as plant biostimulants, are not as such inputs of nutrients, but nevertheless stimulate plants' natural nutrition processes. Where such products aim solely at improving the plants' nutrient use efficiency, tolerance to abiotic stress, ▌ quality traits or increasing the availability of confined nutrients in the soil or rhizosphere, they are by nature more similar to fertilising products than to most categories of plant protection products. They act in addition to fertilisers, with the aim of optimising the efficiency of those fertilisers and reducing the nutrient application rates. Such products should therefore be eligible for CE marking under this Regulation and excluded from the scope of Regulation (EC) No 1107/2009 of the European Parliament and of the Council(11). Regulation (EC) No 1107/2009 should therefore be amended accordingly.

(23)  Products with one or more functions, one of which is covered by the scope of Regulation (EC) No 1107/2009, are plant protection products falling within the scope of that Regulation. Those products should remain under the control developed for such products and provided for by that Regulation. Where such products also have the function of a fertilising product, it would be misleading to provide for their CE marking under this Regulation, since the making available on the market of a plant protection product is contingent on a product authorisation valid in the Member State concerned. Therefore, such products should be excluded from the scope of this Regulation.

(24)  This Regulation should not prevent the application of existing Union legislation relating to aspects of protection of human, animal and plant health, of safety and of the environment not covered by this Regulation. This Regulation should therefore apply without prejudice to Council Directive 86/278/EEC(12), Council Directive 89/391/EEC(13), Council Directive 91/676/EEC(14), Directive 2000/60/EC of the European Parliament and of the Council(15), Directive 2001/18/EC of the European Parliament and of the Council(16), Regulation (EC) No 852/2004 of the European Parliament and of the Council(17), Regulation (EC) No 882/2004 of the European Parliament and of the Council(18), Regulation (EC) No 1907/2006 of the European Parliament and of the Council(19), Commission Regulation (EC) No 1881/2006(20), Council Regulation (EC) No 834/2007(21), Regulation (EC) No 1272/2008 of the European Parliament and of the Council(22), Regulation (EU) No 98/2013 of the European Parliament and of the Council(23), ▌ Regulation (EU) No 1143/2014 of the European Parliament and of the Council(24), Regulation (EU) 2016/2031 of the European Parliament and of the Council(25), Directive (EU) 2016/2284 of the European Parliament and of the Council(26) and Regulation (EU) 2017/625 of the European Parliament and of the Council(27).

(25)  In line with common practice, nitrogen , phosphorus and potassium should be referred to as ‘primary macronutrients’, and calcium, magnesium , sodium and sulphur should be referred to as ‘secondary macronutrients’. Also in line with common practice, fertilisers should be referred to as ‘straight’ when they contain either only one macronutrient – regardless whether it is primary or secondary – or only one primary macronutrient in combination with one or more secondary macronutrients. In line with the same practice, fertilisers should be referred to as ‘compound’ when they contain either more than one primary macronutrient – regardless whether they also contain one or more secondary macronutrients – or contain no primary macronutrient but more than one secondary macronutrient.

(26)  Where an EU fertilising product contains a substance or mixture within the meaning of Regulation (EC) No 1907/2006, the safety of its constituent substances for the intended use should be established through registration pursuant to that Regulation. The information requirements should ensure that the safety of the intended use of the EU fertilising product is demonstrated in a manner comparable to that achieved through other regulatory regimes for products intended for use on arable soil or crops, notably Member States' national fertiliser legislation and Regulation (EC) No 1107/2009. Therefore, where the actual quantities placed on the market are lower than 10 tonnes per company per year, the information requirements determined by Regulation (EC) No 1907/2006 for the registration of substances in quantities of 10 to 100 tonnes should exceptionally apply as a condition for use in EU fertilising products. Those information requirements should apply to the actual substances contained in the EU fertilising product, as opposed to the precursors used for the manufacturing of those substances. The precursors themselves, such as sulphuric acid used as a precursor for the production of single superphosphate, should not be regulated as component materials for the purpose of this Regulation, since chemical safety will be better ensured by regulating as component materials the substances formed from the precursors and actually contained in the EU fertilising product. The obligation to comply with all the requirements of a component material category should therefore apply to those substances.

(27)  Where the actual quantities of substances in EU fertilising products regulated by this Regulation are higher than 100 tonnes, the additional information requirements laid down in Regulation (EC) No 1907/2006 should apply directly by virtue of that Regulation. The application of the other provisions of Regulation (EC) No 1907/2006 should also remain unaffected by this Regulation.

(28)  Economic operators should be responsible for the compliance of EU fertilising products with this Regulation, in relation to their respective roles in the supply chain, so as to ensure a high level of protection of the aspects of public interest covered by this Regulation, and also to guarantee fair competition on the internal market. Whenever appropriate, manufacturers and importers should carry out sample testing of the EU fertilising products that they have made available on the market, in order to protect the health and safety of consumers and the environment.

(29)  It is necessary to provide for a clear and proportionate distribution of obligations which correspond to the role of each economic operator in the supply and distribution chain.

(30)  The manufacturer, having detailed knowledge of the design and production process, is best placed to carry out the conformity assessment procedure. Conformity assessment of EU fertilising products should therefore remain solely the obligation of the manufacturer.

(31)  It is necessary to ensure that EU fertilising products from third countries that enter the internal market comply with this Regulation, and in particular that the appropriate conformity assessment procedures have been carried out by manufacturers with regard to those EU fertilising products. Provision should therefore be made for importers to make sure that EU fertilising products which they place on the market comply with the requirements of this Regulation and that they do not place on the market EU fertilising products which do not comply with such requirements or present a risk to human, animal or plant health, to safety or to the environment. Provision should also be made for such importers to make sure that conformity assessment procedures have been carried out and that marking of EU fertilising products and documentation drawn up by manufacturers are available for inspection by the competent national authorities.

(32)  When placing an EU fertilising product on the market, importers should indicate on the packaging of the EU fertilising product their name, registered trade name or registered trade mark and the postal address at which they can be contacted, in order to enable market surveillance.

(33)  Since distributors make an EU fertilising product available on the market after it has been placed on the market by the manufacturer or the importer, they should act with due care to ensure that their handling of the EU fertilising product does not adversely affect the compliance of that EU fertilising product with this Regulation.

(34)  Economic operators who either place an EU fertilising product on the market under their own name or trade mark or modify an EU fertilising product in such a way that compliance with this Regulation may be affected should be considered to be manufacturers and should assume the obligations of manufacturers. In other cases, economic operators who only package or repackage EU fertilising products already placed on the market by other economic operators should be able to prove that compliance with the requirements of this Regulation has not been affected, by indicating their identity on the package and by keeping a copy of the original labelling information.

(35)  Since distributors and importers are close to the market place, they should be involved in market surveillance tasks carried out by competent national authorities, and should be required to participate actively and provide those authorities with all necessary information relating to the EU fertilising product.

(36)  Ensuring traceability of an EU fertilising product throughout the whole supply chain helps to make market surveillance simpler and more efficient. An efficient traceability system facilitates market surveillance authorities’ task of tracing economic operators who made non-compliant EU fertilising products available on the market. When keeping the information required for the identification of other economic operators, economic operators should not be required to update such information in respect of other economic operators who have either supplied them with an EU fertilising product or to whom they have supplied an EU fertilising product, since such updated information is normally not available to them.

(37)  In order to facilitate the assessment of conformity with the requirements of this Regulation it is necessary to provide for a presumption of conformity for EU fertilising products which are in conformity with harmonised standards that are adopted in accordance with Regulation (EU) No 1025/2012 of the European Parliament and of the Council(28) or with common specifications adopted in accordance with this Regulation.

(38)  In order to enable economic operators to demonstrate and the competent authorities to verify that EU fertilising products made available on the market comply with the requirements of this Regulation, it is necessary to provide for conformity assessment procedures. Decision No 768/2008/EC establishes modules for conformity assessment procedures, from the least stringent to the most stringent, in proportion to the level of risk involved and the level of safety required. In order to ensure inter-sectoral coherence and to avoid ad-hoc variants, conformity assessment procedures should be chosen from among those modules. It should be possible for manufacturers to choose a more stringent conformity assessment procedure for the assessment of an EU fertilising product eligible for a less stringent procedure, since this might enable the manufacturers to streamline their administration without jeopardising the conformity of the EU fertilising product. Furthermore, it is necessary to adapt the modules established by Decision No 768/2008/EC in order to reflect specific aspects of fertilising products. In particular, it is necessary to reinforce the quality systems and the involvement of notified bodies for the conformity assessment of certain EU fertilising products derived from recovered waste.

(39)  In order to ensure that ammonium nitrate fertilisers of high nitrogen content do not endanger safety, and that such fertilisers are not used for purposes other than those for which they are intended, for example as explosives, such fertilisers should be subject to specific requirements relating to detonation resistance testing and to traceability.

(40)  To ensure effective access to information for market surveillance purposes, information regarding conformity with all Union acts applicable to EU fertilising products should be given in the form of a single EU declaration of conformity. In order to reduce the administrative burden on economic operators, it should be possible for that single EU declaration of conformity to be a dossier made up of relevant individual declarations of conformity.

(41)  The CE marking, indicating the conformity of an EU fertilising product with this Regulation, is the visible consequence of a whole process comprising conformity assessment in a broad sense. General principles governing the CE marking and its relationship to other markings are set out in Regulation (EC) No 765/2008. Specific rules governing the affixing of the CE marking in the case of EU fertilising products should be laid down.

(42)  Certain conformity assessment procedures set out in this Regulation require the intervention of conformity assessment bodies, which are notified by the Member States to the Commission.

(43)  It is essential that all notified bodies perform their functions to the same level and under conditions of fair competition. That requires the setting of obligatory requirements for conformity assessment bodies wishing to be notified in order to provide conformity assessment services.

(44)  If a conformity assessment body demonstrates conformity with the criteria laid down in harmonised standards it should be presumed to comply with the corresponding requirements set out in this Regulation.

(45)  In order to ensure a consistent level of quality in the performance of conformity assessment of EU fertilising products, it is also necessary to set requirements for notifying authorities and other bodies involved in the assessment, notification and monitoring of notified bodies.

(46)  The system set out in this Regulation should be complemented by the accreditation system provided for in Regulation (EC) No 765/2008. Since accreditation is an essential means of verifying the competence of conformity assessment bodies, it should also be used for the purposes of notification.

(47)  Due to the variable nature of certain component materials of EU fertilising products, and the potentially irreversible nature of some of the damage to which soil and crop exposure to impurities could lead, transparent accreditation as provided for in Regulation (EC) No 765/2008, ensuring the necessary level of confidence in certificates of conformity of EU fertilising products ▌, should be the only means of demonstrating the technical competence of conformity assessment bodies.

(48)  Conformity assessment bodies frequently subcontract parts of their activities linked to the assessment of conformity or have recourse to a subsidiary. In order to safeguard the level of protection required for EU fertilising products to be placed on the market, it is essential that conformity assessment subcontractors and subsidiaries fulfil the same requirements as notified bodies in relation to the performance of conformity assessment tasks. Therefore, it is important that the assessment of the competence and the performance of bodies to be notified and the monitoring of bodies already notified cover also activities carried out by subcontractors and subsidiaries.

(49)  It is necessary to provide for an efficient and transparent notification procedure and, in particular, to adapt it to new technologies so as to enable online notification.

(50)  Since the services offered by notified bodies in a Member State might relate to EU fertilising products made available on the market throughout the Union, it is appropriate to give the other Member States and the Commission the opportunity to raise objections concerning a notified body. It is therefore important to provide for a period during which any doubts or concerns as to the competence of conformity assessment bodies can be clarified before they start operating as notified bodies.

(51)  In the interests of easing market access, it is crucial that notified bodies apply the conformity assessment procedures without creating unnecessary burdens for economic operators. For the same reason, and to ensure equal treatment of economic operators, consistency in the technical application of the conformity assessment procedures needs to be ensured. That can best be achieved through appropriate coordination and cooperation between notified bodies.

(52)  In order to ensure legal certainty, it is necessary to clarify that rules on internal market surveillance and control of products entering the internal market provided for in Regulation (EC) No 765/2008 apply to EU fertilising products covered by this Regulation. This Regulation should not prevent Member States from choosing the competent authorities to carry out those tasks.

(53)  EU fertilising products should be placed on the market only if they are sufficiently effective and do not present a risk to human, animal or plant health, to safety or to the environment when properly stored and used for their intended purpose, or under conditions of use which can be reasonably foreseen, that is when such use could result from lawful and readily predictable human behaviour. ▌.

(54)  Regulation (EC) No 2003/2003 provides for a safeguard procedure allowing the Commission to examine the justification for a measure taken by a Member State against EC fertilisers considered to constitute a risk ▌. In order to increase transparency and to reduce processing time, it is necessary to improve the existing safeguard procedure, with the view to making it more efficient and drawing on the expertise available in Member States.

(55)  The existing system should be supplemented by a procedure under which interested parties are informed of measures intended to be taken with regard to EU fertilising products presenting a risk to human, animal or plant health, to safety or to the environment. It should also allow market surveillance authorities, in cooperation with the relevant economic operators, to act at an early stage in respect of such EU fertilising products.

(56)  The obligations of market surveillance authoritiesunder this Regulation to require economic operators to take corrective actions should only apply to fertilising products bearing the CE marking when they are made available on the market. Those obligations should therefore be without prejudice to any possibility existing under national law to allow the economic operator to remove the CE marking and to legally place the product on the market as a product not falling within the scope of this Regulation.

(57)  In order to achieve the objectives of this Regulation, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of adaptation to technical progress, in particular in the field of production of fertilising products derived from animal by-products and in the field of waste recovery, as well as in the agricultural sector and the agro-food industry.

(58)  Promising technical progress is being made in the field of recycling of waste, such as phosphorus recycling from sewage sludge, and fertilising product production from animal by-products, such as biochar. It should be possible for products containing or consisting of such materials to access the internal market without unnecessary delay when the manufacturing processes have been scientifically analysed and process requirements have been established at Union level. For that purpose, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of defining and introducing additional ▌ component materials eligible for use in the production of EU fertilising products and corresponding contaminant limit values in such products. That empowerment should only apply to the extent justified by technical progress established after the adoption of this Regulation, and not for the purpose of amending any elements of this Regulation in the absence of new evidence of such progress. In order to base the introduction of new contaminant limit values in EU fertilising products on full consideration of the direct and indirect impact on food and feed safety and on the environment, scientific opinions of the European Food Safety Authority, the European Chemicals Agency or the Commission’s Joint Research Centre, as relevant, should be taken into account prior to the adoption of new contaminant limit values. For derived products within the meaning of the Regulation (EC) No 1069/2009, component material categories should be expanded or added only to the extent that an end point in the manufacturing chain has been determined in accordance with the procedures laid down in that Regulation , since derived products for which no such end point has been determined are in any event excluded from the scope of this Regulation.

(59)  Since micro-organisms are not subject to registration under Regulation (EC) No 1907/2006 or any other horizontal Union legislation requiring manufacturers to demonstrate that the intended use is safe, they should be eligible as component materials for EU fertilising products only to the extent that they have been clearly identified and supported by data demonstrating that their use is safe, and indicated in an exhaustive list adopted on that basis. The power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of adding new micro-organisms to that exhaustive list on the same basis.

(60)  An EU fertilising product can contain polymers other than nutrient polymers. However, this should be limited to cases where the purpose of the polymer is that of controlling the release of nutrients or increasing the water retention capacity or wettability of the EU fertilising product. It should be possible for innovative products containing such polymers to access the internal market. In order to minimise risks to human health, to safety or to the environment that may be posed by polymers other than nutrient polymers, the criteria for their biodegradability, so that they are capable of undergoing physical and biological decomposition, should be established. For that purpose, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission in respect of defining the criteria for the conversion of polymeric carbon into carbon dioxide and a related testing method. Polymers which do not comply with those criteria should be prohibited after a transitional period.

(61)  Furthermore, it should be possible to react immediately to new scientific evidence and to new risk assessments regarding human, animal or plant health, safety or the environment. For that purpose, the power to adopt acts in accordance with Article 290 TFEU should be delegated to the Commission to amend the requirements applicable to various categories of EU fertilising products.

(62)  When adopting delegated acts under this Regulation, it is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making(29). In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and ▌ the Council receive all documents at the same time as Member States' experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts.

(63)  In order to ensure uniform conditions for the implementation of this Regulation, implementing powers to adopt acts should be conferred on the Commission in order to determine whether measures taken by Member States in respect of non-compliant EU fertilising products are justified or not. Since those acts will relate to the question of whether national measures are justified, such acts should not be subject to control by the Member States.

(64)  In order to further ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council(30).

(65)  The advisory procedure should be used for the adoption of implementing acts requiring the notifying Member State to take the necessary corrective measures in respect of notified bodies that do not meet or no longer meet the requirements for their notification.

(66)  The examination procedure should be used for the adoption of implementing acts laying down in common specifications uniform conditions for implementing the requirements of this Regulation and tests for verifying the conformity of EU fertilising products where harmonised standards have not been adopted, or do not satisfy the requirements of this Regulation, or where there are undue delays in the process of adopting or updating these standards; amending or repealing common specifications where non-compliance of EU fertilising products can be attributed to shortcomings in those common specifications; determining whether a national measure taken in respect of a compliant EU fertilising product that presents a risk to human, animal or plant health, to safety or to the environment is justified or not.

(67)  The Commission should adopt immediately applicable implementing acts determining whether a national measure taken in respect of a compliant EU fertilising product that presents a risk is justified or not where, in duly justified cases relating to the protection of human, animal or plant health, safety or the environment, imperative grounds of urgency so require.

(68)  Member States should lay down rules on penalties applicable to infringements of this Regulation and ensure that those rules are enforced. The penalties provided for should be effective, proportionate and dissuasive.

(69)  In view of the need to ensure a high level of environmental protection and the need to take into account new developments based on scientific facts, the Commission should submit to the European Parliament and to the Council a report which includes a review of the limit values for cadmium content.

(70)  It is necessary to provide for transitional arrangements that allow the making available on the market of EC fertilisers that have been placed on the market in accordance with Regulation (EC) No 2003/2003 before the date of application of this Regulation without those products having to comply with further product requirements. Distributors should therefore be able to supply EC fertilisers that have been placed on the market, namely stock that is already in the distribution chain, before the date of application of this Regulation.

(71)  It is necessary to provide for sufficient time for economic operators to comply with their obligations under this Regulation, and for Member States to set up the administrative infrastructure necessary for its application. The application should therefore be deferred to a date where those preparations can reasonably be finalised.

(72)  Since the objective of this Regulation, namely to guarantee the functioning of the internal market while ensuring that EU fertilising products on the market fulfil the requirements providing for a high level of protection of human, animal, and plant health, of safety and of the environment, cannot be sufficiently achieved by the Member States but can rather, by reason of its scale and effects, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve that objective,

HAVE ADOPTED THIS REGULATION:

CHAPTER I

GENERAL PROVISIONS

Article 1

Scope

1.  This Regulation applies to EU fertilising products.

This Regulation does not apply to:

(a)  animal by-products or derived products which are subject to the requirements of Regulation (EC) No 1069/2009 when made available on the market;

(b)  plant protection products covered by the scope of Regulation (EC) No 1107/2009.

2.  This Regulation does not affect the application of the following legal acts:

(a)  Directive 86/278/EEC;

(b)  Directive 89/391/EEC;

(c)  Directive 91/676/EEC;

(d)  Directive 2000/60/EC;

(e)  Directive 2001/18/EC;

(f)  Regulation (EC) No 852/2004;

(g)  Regulation (EC) No 882/2004;

(h)  Regulation (EC) No 1881/2006;

(i)  Regulation (EC) No 1907/2006;

(j)  Regulation (EC) No 834/2007;

(k)  Regulation (EC) No 1272/2008;

(l)  Regulation (EU) No 98/2013

(m)  Regulation (EU) No 1143/2014;

(n)  Regulation (EU) 2016/2031;

(o)  Directive (EU) 2016/2284;

(p)  Regulation (EU) 2017/625.

Article 2

Definitions

For the purposes of this Regulation, the following definitions apply:

(1)  ‘fertilising product’ means a substance, mixture, micro- ▌organism or any other material, applied or intended to be applied on plants or their rhizosphere or on mushrooms or their mycosphere, or intended to constitute the rhizosphere or mycosphere, either on its own or mixed with another material, ▌ for the purpose of providing the plants or mushrooms with nutrient or improving their nutrition efficiency;

(2)  ‘EU fertilising product’ means a fertilising product which is CE marked when made available on the market;

(3)  ‘substance’ means a substance as defined in point 1 of Article 3 of Regulation (EC) No 1907/2006;

(4)  ‘mixture’ means a mixture as defined in point 2 of Article 3 of Regulation (EC) No 1907/2006;

(5)  ‘micro-organism’ means a micro-organism as defined in point 15 of Article 3 of Regulation (EC) No 1107/2009;

(6)  ‘liquid form’ means a suspension or a solution, where a suspension is a two-phase dispersion in which solid particles are maintained in suspension in the liquid phase, and a solution is a liquid that is free of solid particles, or a gel and includes pastes;

(7)  ‘solid form’ means form characterised by structural rigidity and resistance to changes of shape or volume and in which the atoms are tightly bound to each other, either in a regular geometric lattice (crystalline solids) or in an irregular manner (an amorphous solid);

(8)  ‘% by mass’ means a percentage of the mass of the entire EU fertilising product in the form in which it is made available on the market;

(9)  ‘making available on the market’ means any supply of an EU fertilising product for distribution or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge;

(10)  ‘placing on the market’ means the first making available of an EU fertilising product on the Union market;

(11)  ‘manufacturer’ means any natural or legal person who manufactures an EU fertilising product or has an EU fertilising product designed or manufactured, and markets that EU fertilising product under his or her name or trademark;

(12)  ‘authorised representative’ means any natural or legal person established within the Union who has received a written mandate from a manufacturer to act on his or her behalf in relation to specified tasks;

(13)  ‘importer’ means any natural or legal person established within the Union who places an EU fertilising product from a third country on the Union market;

(14)  ‘distributor’ means any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes an EU fertilising product available on the market;

(15)  ‘economic operators’ means the manufacturer, the authorised representative, the importer and the distributor;

(16)  ‘technical specification’ means a document that prescribes technical requirements to be fulfilled by an EU fertilising product, by its production process or by the methods for its sampling and analysis;

(17)  ‘harmonised standard’ means harmonised standard as defined in point 1(c) of Article 2 of Regulation (EU) No 1025/2012;

(18)  ‘accreditation’ means accreditation as defined in point 10 of Article 2 of Regulation (EC) No 765/2008;

(19)  ‘national accreditation body’ means national accreditation body as defined in point 11 of Article 2 of Regulation (EC) No 765/2008;

(20)  ‘conformity assessment’ means the process demonstrating whether the requirements of this Regulation relating to an EU fertilising product have been fulfilled;

(21)  ‘conformity assessment body’ means a body that performs conformity assessment activities including testing, certification and inspection;

(22)  ‘recall’ means any measure aimed at achieving the return of an EU fertilising product that has already been made available to the end-user;

(23)  ‘withdrawal’ means any measure aimed at preventing an EU fertilising product in the supply chain from being made available on the market;

(24)  ‘Union harmonisation legislation’ means any Union legislation harmonising the conditions for the marketing of products;

(25)  ‘CE marking’ means a marking by which the manufacturer indicates that the EU fertilising product is in conformity with the applicable requirements set out in Union harmonisation legislation providing for its affixing.

Article 3

Free movement

1.  Member States shall not impede, for reasons relating to composition, labelling or other aspects covered by this Regulation, the making available on the market of EU fertilising products which comply with this Regulation.

2.  By way of derogation from paragraph 1 of this Article, a Member State which, on … [one day before the date of entry into force of this Regulation] benefits from a derogation from Article 5 of Regulation (EC) No 2003/2003 in relation to cadmium content in fertilisers granted in accordance with Article 114(4) TFEU may continue to apply the national limit values for cadmium content in fertilisers which are applicable in that Member State on … [one day before the date of entry into force of this Regulation] to EU fertilising products until such time as harmonised limit values for cadmium content in phosphate fertilisers which are equal to or lower than the limit values applicable in the Member State concerned on … [one day before the date of entry into force of this Regulation] are applicable at Union level.

3.  This Regulation shall not prevent Member States from maintaining or adopting provisions for the purpose of protecting human health and the environment which are in compliance with the Treaties, concerning the use of EU fertilising products, provided that those provisions do not require modification of EU fertilising products which are in compliance with this Regulation and do not influence the conditions for making them available on the market.

Article 4

Product requirements

1.  An EU fertilising product shall:

(a)  meet the requirements set out in Annex I for the relevant product function category;

(b)  meet the requirements set out in Annex II for the relevant component material category or categories; and

(c)  be labelled in accordance with the labelling requirements set out in Annex III.

2.  For any aspects not covered by Annex I or II, EU fertilising products shall not present a risk to human, animal or plant health, to safety or to the environment.

3.  By … [one year after the date of entry into force of this Regulation], the Commission shall publish a guidance document for manufacturers and market surveillance authorities with clear information and examples concerning the visual appearance of the label referred to in Annex III.

Article 5

Making available on the market

EU fertilising products shall only be made available on the market if they comply with this Regulation.

CHAPTER II

OBLIGATIONS OF ECONOMIC OPERATORS

Article 6

Obligations of manufacturers

1.  When placing EU fertilising products on the market, manufacturers shall ensure that they have been designed and manufactured in accordance with the requirements set out in Annexes I and II.

2.  Before placing EU fertilising products on the market, manufacturers shall draw up the technical documentation and carry out the relevant conformity assessment procedure referred to in Article 15, or have it carried out.

Where compliance of an EU fertilising product with the applicable requirements laid down in this Regulation has been demonstrated by that conformity assessment procedure, manufacturers shall draw up an EU declaration of conformity and affix the CE marking ▌.

3.  Manufacturers shall keep the technical documentation and the EU declaration of conformity for 5 years after the EU fertilising product covered by those documents has been placed on the market.

On request, manufacturers shall make a copy of the EU declaration of conformity available to other economic operators.

4.  Manufacturers shall ensure that procedures are in place for EU fertilising products that are part of a series production to remain in conformity with this Regulation. Changes in the production process or in the characteristics of those EU fertilising products and changes in the harmonised standards, common specifications referred to in Article 14 or other technical specifications by reference to which conformity of an EU fertilising product is declared or by application of which its conformity is verified shall be adequately taken into account.

When deemed appropriate with regard to the performance of, or the risks presented by, an EU fertilising product, manufacturers shall carry out sample testing of such EU fertilising products made available on the market, investigate, and, if necessary, keep a register of complaints, of non-conforming EU fertilising products and recalls of such EU fertilising products, and shall keep distributors informed of any such monitoring.

5.  Manufacturers shall ensure that the packaging of the EU fertilising products which they have placed on the market bears a type number, batch ▌ number or other element allowing their identification or, where the EU fertilising products are supplied without packaging, that the required information is provided in a document accompanying each fertilising product.

6.  Manufacturers shall indicate their name, registered trade name or registered trade mark and the postal address at which they can be contacted on the packaging of the EU fertilising product or, where the EU fertilising product is supplied without packaging, in a document accompanying the EU fertilising product. The postal address shall indicate a single point at which the manufacturer can be contacted. Such information shall be in a language easily understood by end-users and market surveillance authorities and shall be clear, understandable and legible.

7.  Manufacturers shall ensure that EU fertilising products are accompanied by the information required under Annex III. Where an EU fertilising product is supplied in a package, the information shall appear on a label which is affixed to that package. Where the package is too small to contain all the information, the information that cannot be provided on the label shall be provided in a separate leaflet accompanying that package. Such a leaflet shall be regarded as part of the label. Where the EU fertilising product is supplied without packaging, all the information shall be provided in a leaflet. The label and the leaflet shall be accessible for inspection purposes when the EU fertilising product is made available on the market. The information shall be in a language which can be easily understood by end-users, as determined by the Member State concerned, and shall be clear, understandable and intelligible.

8.  Manufacturers who consider or have reason to believe that an EU fertilising product which they have placed on the market is not in conformity with this Regulation shall immediately take the corrective measures necessary to bring that EU fertilising product into conformity, to withdraw it or to recall it, as appropriate. Furthermore, where manufacturers consider or have reason to believe that an EU fertilising product which they have placed on the market presents a risk to human, animal or plant health, to safety or to the environment, they shall immediately inform the competent national authorities of the Member States in which they made the EU fertilising product available on the market to that effect, giving details, in particular, of any non-compliance and of any corrective measures taken.

9.  Manufacturers shall, further to a reasoned request from a competent national authority, provide it with all the information and documentation, in paper or electronic form, necessary to demonstrate the conformity of the EU fertilising product with this Regulation, in a language which can be easily understood by that authority. They shall cooperate with that authority, at its request, on any action taken to eliminate the risks posed by an EU fertilising product which they have placed ▌ on the market.

Article 7

Authorised representative

1.  A manufacturer may, by a written mandate, appoint an authorised representative.

The obligations laid down in Article 6(1) and the obligation to draw up technical documentation referred to in Article 6(2) shall not form part of the authorised representative's mandate.

2.  An authorised representative shall perform the tasks specified in the mandate received from the manufacturer. The mandate shall allow the authorised representative to do at least the following:

(a)  keep the EU declaration of conformity and the technical documentation at the disposal of national market surveillance authorities for 5 years after the EU fertilising product covered by those documents has been placed on the market;

(b)  further to a reasoned request from a competent national authority, provide that authority with all the information and documentation necessary to demonstrate the conformity of an EU fertilising product;

(c)  cooperate with the competent national authorities, at their request, on any action taken to eliminate the risks posed by EU fertilising products covered by the authorised representative's mandate.

Article 8

Obligations of importers

1.  Importers shall place only compliant EU fertilising products on the market.

2.  Before placing an EU fertilising product on the market, importers shall ensure that the appropriate conformity assessment procedure referred to in Article 15 has been carried out by the manufacturer. They shall ensure that the manufacturer has drawn up the technical documentation, that the EU fertilising product is accompanied by ▌ the required documents, and that the manufacturer has complied with the requirements set out in Article 6(5) and (6).

Where an importer considers or has reason to believe that an EU fertilising product is not in conformity with this Regulation, the importer shall not place the EU fertilising product on the market until it has been brought into conformity. Furthermore, where the EU fertilising product presents a risk to human, animal or plant health, to safety or to the environment, the importer shall inform the manufacturer and the market surveillance authorities to that effect.

3.  Importers shall indicate their name, registered trade name or registered trade mark and the postal address at which they can be contacted on the packaging of the EU fertilising product or, where the EU fertilising product is supplied without packaging, in a document accompanying the EU fertilising product. The contact details shall be in a language easily understood by end-users and market surveillance authorities.

4.  Importers shall ensure that EU fertilising products are accompanied by the information required under Annex III. Where an EU fertilising product is supplied in a package, the information shall appear on a label which is affixed to that package.Where the package is too small to contain all the information, the information that cannot be provided on the label shall be provided in a separate leaflet accompanying that package. Such a leaflet shall be regarded as part of the label. Where the EU fertilising product is supplied without packaging, all the information shall be provided in a leaflet. The label and the leaflet shall be accessible for inspection purposes when the EU fertilising product is made available on the market. The information shall be in a language which can be easily understood by end-users, as determined by the Member State concerned.

5.  Importers shall ensure that, while an EU fertilising product is under their responsibility, its storage or transport conditions do not jeopardise its compliance with the ▌ requirements set out in Annex I or III.

6.  When deemed appropriate with regard to the performance of, or the risks presented by an EU fertilising product, importers shall carry out sample testing of such EU fertilising products made available on the market, investigate, and, if necessary, keep a register of complaints, of non-conforming EU fertilising products and recalls of such EU fertilising products, and shall keep distributors informed of any such monitoring.

7.  Importers who consider or have reason to believe that an EU fertilising product which they have placed on the market is not in conformity with this Regulation shall immediately take the corrective measures necessary to bring that EU fertilising product into conformity, to withdraw it or to recall it, as appropriate. Furthermore, where importers consider or have reason to believe that an EU fertilising product which they have placed on the market presents a risk to human, animal or plant health, to safety or to the environment, they shall immediately inform the competent national authorities of the Member States in which they made the EU fertilising product available on the market to that effect, giving details, in particular, of any non-compliance and of any corrective measures taken.

8.  Importers shall, for 5 years after the EU fertilising product has been placed on the market, keep a copy of the EU declaration of conformity at the disposal of the market surveillance authorities and ensure that the technical documentation can be made available to those authorities, upon request.

On request, importers shall make a copy of the EU declaration of conformity available to other economic operators.

9.  Importers shall, further to a reasoned request from a competent national authority, provide it with all the information and documentation, in paper or electronic form, necessary to demonstrate the conformity of the EU fertilising product with this Regulation in a language which can be easily understood by that authority. They shall cooperate with that authority, at its request, on any action taken to eliminate the risks posed by an EU fertilising product which they have placed on the market.

Article 9

Obligations of distributors

1.  When making an EU fertilising product available on the market distributors shall act with due care in relation to the requirements of this Regulation.

2.  Before making an EU fertilising product available on the market distributors shall verify that it is accompanied by the ▌ required documents, including the information referred to in Article 6(7) or Article 8(4) provided in the manner specified therein, in a language which can be easily understood by end-users in the Member State in which the EU fertilising product is to be made available on the market, and that the manufacturer and the importer have complied with the requirements set out in Article 6(5) and (6) and Article 8(3) respectively.

Where a distributor considers or has reason to believe that an EU fertilising product is not in conformity with this Regulation, the distributor shall not make the EU fertilising product available on the market until it has been brought into conformity. Furthermore, where the EU fertilising product presents a risk to human, animal or plant health, to safety or to the environment, the distributor shall inform the manufacturer or the importer to that effect as well as the market surveillance authorities.

3.  Distributors shall ensure that, while an EU fertilising product is under their responsibility, its storage or transport conditions do not jeopardise its compliance with the ▌ requirements set out in Annex I or III.

4.  Distributors who consider or have reason to believe that an EU fertilising product which they have made available on the market is not in conformity with this Regulation shall make sure that the corrective measures necessary to bring that EU fertilising product into conformity, to withdraw it or to recall it, as appropriate, are taken. Furthermore, where distributors consider or have reason to believe that an EU fertilising product which they have made available on the market presents a risk to human, animal or plant health, to safety or to the environment, they shall immediately inform the competent national authorities of the Member States in which they made the EU fertilising product available on the market to that effect, giving details, in particular, of any non-compliance and of any corrective measures taken.

5.  Distributors shall, further to a reasoned request from a competent national authority, provide it with all the information and documentation, in paper or electronic form, necessary to demonstrate the conformity of the EU fertilising product with this Regulation. They shall cooperate with that authority, at its request, on any action taken to eliminate the risks posed by EU fertilising products which they have made available on the market.

Article 10

Cases in which obligations of manufacturers apply to importers and distributors

An importer or distributor shall be considered a manufacturer for the purposes of this Regulation, and shall be subject to the obligations of the manufacturer under Article 6, where that importer or distributor places an EU fertilising product on the market under his or her name or trademark or modifies an EU fertilising product already placed on the market in such a way that compliance with this Regulation may be affected.

Article 11

Packaging and repackaging by importers and distributors

Where an importer or distributor packages or repackages an EU fertilising product and is not considered a manufacturer pursuant to Article 10, that importer or distributor shall:

(a)  ensure that the packaging bears his or her name, registered trade name or registered trade mark and postal address preceded by the words ‘packaged by’ or ‘repackaged by’; and

(b)  keep a specimen of the original information referred to in Article 6(7) or Article 8(4) at the disposal of the market surveillance authorities for 5 years after having made the EU fertilising product available on the market.

Article 12

Identification of economic operators

1.  Economic operators shall, on request, identify the following to the market surveillance authorities:

(a)  any economic operator who has supplied them with an EU fertilising product;

(b)  any economic operator to whom they have supplied an EU fertilising product.

2.  The economic operators shall be able to present the information referred to in the first paragraph for 5 years after they have been supplied with the EU fertilising product and for 5 years after they have supplied the EU fertilising product.

CHAPTER III

CONFORMITY OF EU FERTILISING PRODUCTS

Article 13

Presumption of conformity

1.  EU fertilising products which are in conformity with harmonised standards or parts thereof, the references of which have been published in the Official Journal of the European Union, shall be presumed to be in conformity with the requirements set out in Annexes I, II and III covered by those standards or parts thereof.

2.  Tests for verifying the conformity of EU fertilising products with the requirements set out in Annexes I, II and III shall be performed in a reliable and reproducible manner. Tests which are in conformity with harmonised standards or parts thereof, the references of which have been published in the Official Journal of the European Union, shall be presumed to be reliable and reproducible to the extent that the tests are covered by those standards or parts thereof.

Article 14

Common specifications

1.  The Commission may adopt implementing acts laying down common specifications for the requirements set out in Annex I, II or III or tests referred to in Article 13(2) where:

(a)  those requirements or tests are not covered by harmonised standards or parts thereof, the references of which have been published in the Official Journal of the European Union;

(b)  the Commission observes undue delays in the adoption of requested harmonised standards; or

(c)  the Commission has decided in accordance with the procedure referred to in Article 11(5) of Regulation (EU) No 1025/2012 to maintain with restriction or to withdraw the references to the harmonised standards or parts thereof by which those requirements or tests are covered.

Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 45(3).

2.  EU fertilising products which are in conformity with common specifications or parts thereof shall be presumed to be in conformity with the requirements set out in Annexes I, II and III covered by those common specifications or parts thereof.

3.  Tests for verifying the conformity of EU fertilising products with the requirements set out in Annexes I, II and III which are in conformity with common specifications or parts thereof shall be presumed to be reliable and reproducible to the extent that the tests are covered by those common specifications or parts thereof.

Article 15

Conformity assessment procedures

1.  Conformity assessment of an EU fertilising product with the requirements laid down in this Regulation shall be carried out under the applicable conformity assessment procedure in accordance with Annex IV.

2.  Records and correspondence relating to conformity assessment procedures shall be drawn up inthe official language or languages of the Member State where the notified body carrying out the conformity assessment procedures is established, or in a language accepted by that body.

Article 16

EU declaration of conformity

1.  The EU declaration of conformity shall state that the fulfilment of the requirements laid down in this Regulation has been demonstrated.

2.  The EU declaration of conformity shall have the model structure set out in Annex V, shall contain the elements specified in the relevant modules set out in Annex IV and shall be continuously updated. It shall be translated into the language or languages required by the Member State in which the EU fertilising product is placed or made available on the market.

3.  Where an EU fertilising product is subject to more than one Union act requiring an EU declaration of conformity, a single EU declaration of conformity shall be drawn up in respect of all such Union acts. That declaration shall state the Union acts concerned and their publication references. It may be a dossier made up of relevant individual EU declarations of conformity.

4.  By drawing up the EU declaration of conformity, the manufacturer shall assume responsibility for the compliance of the EU fertilising product with the requirements laid down in this Regulation.

Article 17

General principles of CE marking

The CE marking shall be subject to the general principles set out in Article 30 of Regulation (EC) No 765/2008.

Article 18

Rules and conditions for affixing the CE marking

1.  The CE marking shall be affixed visibly, legibly and indelibly to the packaging of the EU fertilising product or, where the EU fertilising product is supplied without packaging, to a document accompanying the EU fertilising product.

2.  The CE marking shall be affixed before the EU fertilising product is placed on the market.

3.  The CE marking shall be followed by the identification number of the notified body, where required under Annex IV ▌.

The identification number of the notified body shall be affixed by the body itself or, under its instructions, by the manufacturer or his or her authorised representative.

4.  Member States shall build upon existing mechanisms to ensure correct application of the regime governing the CE marking and shall take appropriate action in the event of improper use of that marking.

Article 19

End-of-waste status

This Regulation lays down criteria in accordance with which material that constitutes waste, as defined in Directive 2008/98/EC, can cease to be waste, if it is contained in a compliant EU fertilising product. In such cases, the recovery operation under this Regulation shall be performed before the material ceases to be waste, and the material shall be considered to comply with the conditions laid down in Article 6 ▌ of that Directive ▌ and ▌ therefore ▌ to have ceased to be waste from the moment that the EU declaration of conformity was drawn up.

CHAPTER IV

NOTIFICATION OF CONFORMITY ASSESSMENT BODIES

Article 20

Notification

Member States shall notify the Commission and the other Member States of bodies authorised to carry out third-party conformity assessment tasks under this Regulation.

Article 21

Notifying authorities

1.  Member States shall designate a notifying authority that shall be responsible for setting up and carrying out the necessary procedures for the assessment and notification of conformity assessment bodies and the monitoring of notified bodies, including compliance with Article 26.

2.  Member States may decide that the assessment and monitoring referred to in paragraph 1 of this Article shall be carried out by a national accreditation body within the meaning of and in accordance with Regulation (EC) No 765/2008.

3.  Where the notifying authority delegates or otherwise entrusts the assessment, notification or monitoring referred to in paragraph 1of this Article to a body which is not a governmental entity, that body shall be a legal entity and shall comply mutatis mutandis with the requirements laid down in Article 22. In addition that body shall have arrangements to cover liabilities arising out of its activities.

4.  The notifying authority shall take full responsibility for the tasks performed by the body referred to in paragraph 3.

Article 22

Requirements relating to notifying authorities

1.  A notifying authority shall be established in such a way that no conflict of interest with conformity assessment bodies occurs.

2.  A notifying authority shall be organised and operated so as to safeguard the objectivity and impartiality of its activities.

3.  A notifying authority shall be organised in such a way that each decision relating to notification of a conformity assessment body is taken by competent persons different from those who carried out the assessment.

4.  A notifying authority shall not offer or provide any activities that conformity assessment bodies perform or consultancy services on a commercial or competitive basis.

5.  A notifying authority shall safeguard the confidentiality of the information it obtains.

6.  A notifying authority shall have a sufficient number of competent personnel at its disposal for the proper performance of its tasks.

Article 23

Information obligation on notifying authorities

Member States shall inform the Commission of their procedures for the assessment and notification of conformity assessment bodies and the monitoring of notified bodies, and of any changes thereto.

The Commission shall make that information publicly available.

Article 24

Requirements relating to notified bodies

1.  For the purposes of notification, a conformity assessment body shall meet the requirements laid down in paragraphs 2 to 11.

2.  A conformity assessment body shall be established under the national law of a Member State and have legal personality.

3.  A conformity assessment body shall be a third-party body independent of the organisation or the EU fertilising products it assesses.

4.  A conformity assessment body, its top level management and the personnel responsible for carrying out the conformity assessment tasks shall not be the designer, manufacturer, supplier, purchaser, owner or user of fertilising products nor the representative of any of those parties. This shall not preclude the use of fertilising products that are necessary for the operations of the conformity assessment body or the use of fertilising products for personal purposes.

A conformity assessment body, its top level management and the personnel responsible for carrying out the conformity assessment tasks shall not be directly involved in the design, manufacture, marketing or use of fertilising products or represent the parties engaged in those activities. They shall not engage in any activity that may conflict with their independence of judgement or integrity in relation to conformity assessment activities for which they are notified. This shall in particular apply to consultancy services.

Conformity assessment bodies shall ensure that the activities of their subsidiaries or subcontractors do not affect the confidentiality, objectivity or impartiality of their conformity assessment activities.

5.  Conformity assessment bodies and their personnel shall carry out the conformity assessment activities with the highest degree of professional integrity and the requisite technical competence in the specific field and shall be free from all pressures and inducements, particularly financial, which might influence their judgement or the results of their conformity assessment activities, especially as regards persons or groups of persons with an interest in the results of those activities.

6.  A conformity assessment body shall be capable of carrying out all the conformity assessment tasks assigned to it by Annex IV and in relation to which it has been notified, whether those tasks are carried out by the conformity assessment body itself or on its behalf and under its responsibility.

At all times and for each conformity assessment procedure and each kind or category of EU fertilising products in relation to which it has been notified, a conformity assessment body shall have at its disposal the necessary:

(a)  personnel with technical knowledge and sufficient and appropriate experience to perform the conformity assessment tasks;

(b)  descriptions of procedures in accordance with which conformity assessment is carried out, ensuring the transparency and the ability of reproduction of those procedures. It shall have appropriate policies and procedures in place that distinguish between tasks it carries out as a notified body and other activities;

(c)  procedures for the performance of activities which take due account of the size of an undertaking, the sector in which it operates, its structure, the degree of complexity of the product technology in question and the mass or serial nature of the production process.

A conformity assessment body shall have the means necessary to perform the technical and administrative tasks connected with the conformity assessment activities in an appropriate manner and shall have access to all necessary equipment or facilities.

7.  The personnel responsible for carrying out the conformity assessment tasks shall have the following:

(a)  sound technical and vocational training covering all the conformity assessment activities in relation to which the conformity assessment body has been notified;

(b)  satisfactory knowledge of the requirements of the assessments they carry out and adequate authority to carry out those assessments;

(c)  appropriate knowledge and understanding of the requirements set out in Annexes I, II and III, of the applicable harmonised standards referred to in Article 13 and common specifications referred to in Article 14 and of the relevant provisions of Union harmonisation legislation and of national legislation;

(d)  the ability to draw up certificates, records and reports demonstrating that assessments have been carried out.

8.  The impartiality of the conformity assessment bodies, their top level management and of the personnel responsible for carrying out the conformity assessment tasks shall be guaranteed.

The remuneration of the top level management and personnel responsible for carrying out the conformity assessment tasks of a conformity assessment body shall not depend on the number of assessments carried out or on the results of those assessments.

9.  Conformity assessment bodies shall take out liability insurance unless liability is assumed by the State in accordance with national law, or the Member State itself is directly responsible for the conformity assessment.

10.  The personnel of a conformity assessment body shall observe professional secrecy with regard to all information obtained in carrying out their tasks under Annex IV, except in relation to the competent authorities of the Member State in which its activities are carried out. Proprietary rights shall be protected.

11.  Conformity assessment bodies shall participate in, or ensure that their personnel responsible for carrying out the conformity assessment tasks are informed of, the relevant standardisation activities and the activities of the notified body coordination group established under Article 36 and shall apply as general guidance the administrative decisions and documents produced as a result of the work of that group.

Article 25

Presumption of conformity of notified bodies

Where a conformity assessment body demonstrates its conformity with the criteria laid down in the relevant harmonised standards or parts thereof the references of which have been published in the Official Journal of the European Union it shall be presumed to comply with the requirements set out in Article 24 in so far as the applicable harmonised standards cover those requirements.

Article 26

Subsidiaries of and subcontracting by notified bodies

1.  Where a notified body subcontracts specific tasks connected with conformity assessment or has recourse to a subsidiary, it shall ensure that the subcontractor or the subsidiary meets the requirements set out in Article 24 and shall inform the notifying authority accordingly.

2.  Notified bodies shall take full responsibility for the tasks performed by subcontractors or subsidiaries wherever these are established.

3.  Activities may be subcontracted or carried out by a subsidiary only with the agreement of the client.

4.  Notified bodies shall keep at the disposal of the notifying authority the relevant documents concerning the assessment of the qualifications of the subcontractor or the subsidiary and the work carried out by them under Annex IV.

Article 27

Application for notification

1.  A conformity assessment body shall submit an application for notification to the notifying authority of the Member State in which it is established.

2.  The application for notification shall be accompanied by a description of the conformity assessment activities, the conformity assessment module or modules and the EU fertilising product or products for which that body claims to be competent, as well as by an accreditation certificate issued by a national accreditation body attesting that the conformity assessment body fulfils the requirements laid down in Article 24.

Article 28

Notification procedure

1.  Notifying authorities may notify only conformity assessment bodies which have satisfied the requirements laid down in Article 24.

2.  They shall notify the Commission and the other Member States using the electronic notification tool developed and managed by the Commission.

3.  The notification shall include full details of the conformity assessment activities, the conformity assessment module or modules and EU fertilising product or products concerned and the accreditation certificate referred to in Article 27(2).

4.  The body concerned may perform the activities of a notified body only where no objections are raised by the Commission or the other Member States within two weeks of a notification.

Only such a body shall be considered a notified body for the purposes of this Regulation.

5.  The notifying authority shall notify the Commission and the other Member States of any subsequent relevant changes to the notification.

Article 29

Identification numbers and lists of notified bodies

1.  The Commission shall assign an identification number to a notified body.

It shall assign a single such number even where the body is notified under several Union acts.

2.  The Commission shall make publicly available the list of the bodies notified under this Regulation, including the identification numbers that have been assigned to them and the activities for which they have been notified.

The Commission shall ensure that the list is kept up to date.

Article 30

Changes to notifications

1.  Where a notifying authority has ascertained or has been informed that a notified body no longer meets the requirements laid down in Article 24 or that it is failing to fulfil its obligations, the notifying authority shall restrict, suspend or withdraw notification as appropriate, depending on the seriousness of the failure to meet those requirements or fulfil those obligations. It shall immediately inform the Commission and the other Member States accordingly.

2.  In the event of restriction, suspension or withdrawal of notification, or where the notified body has ceased its activity, the notifying Member State shall take appropriate steps to ensure that the files of that body are either processed by another notified body or kept available for the responsible notifying and market surveillance authorities at their request.

Article 31

Challenge of the competence of notified bodies

1.  The Commission shall investigate all cases where it doubts, or doubt is brought to its attention regarding, the competence of a notified body or the continued fulfilment by a notified body of the requirements and responsibilities to which it is subject.

2.  The notifying Member State shall provide the Commission, on request, with all information relating to the basis for the notification or the maintenance of the competence of the notified body concerned.

3.  The Commission shall ensure that all sensitive information obtained in the course of its investigations is treated confidentially.

4.  Where the Commission ascertains that a notified body does not meet or no longer meets the requirements for its notification, it shall adopt an implementing act requiring the notifying Member State to take the necessary corrective measures, including withdrawal of notification if necessary.

That implementing act shall be adopted in accordance with the advisory procedure referred to in Article 45(2).

Article 32

Operational obligations of notified bodies

1.  Notified bodies shall carry out conformity assessments in accordance with the conformity assessment procedures provided for in Annex IV.

2.  Conformity assessments shall be carried out in a proportionate manner, avoiding unnecessary burdens for economic operators. Notified bodies shall perform their activities taking due account of the size of an undertaking, the sector in which it operates, its structure, the degree of complexity of the product technology in question and the mass or serial nature of the production process.

In so doing they shall nevertheless respect the degree of rigour and the level of protection required for the compliance of the EU fertilising product with this Regulation.

3.  Where a notified body finds that the requirements set out in Annex I, II or III, or corresponding harmonised standards, common specifications referred to in Article 14 or other technical specifications, have not been met by a manufacturer, it shall require that manufacturer to take appropriate corrective measures and shall not issue a certificate or approval decision.

4.  Where, in the course of the monitoring of conformity following the issue of a certificate or an approval decision, a notified body finds that an EU fertilising product no longer complies, it shall require the manufacturer to take appropriate corrective measures and shall suspend or withdraw the certificate or the approval decision, if necessary.

5.  Where corrective measures are not taken or do not have the required effect, the notified body shall restrict, suspend or withdraw any certificates or approval decisions, as appropriate.

Article 33

Appeal against decisions of notified bodies

Member States shall ensure that an appeal procedure against decisions of the notified bodies is available.

Article 34

Information obligation on notified bodies

1.  Notified bodies shall inform the notifying authority of the following:

(a)  any refusal, restriction, suspension or withdrawal of a certificate or approval decision;

(b)  any circumstances, affecting the scope of or conditions for notification;

(c)  any request for information which they have received from market surveillance authorities regarding conformity assessment activities;

(d)  on request, conformity assessment activities performed within the scope of their notification and any other activity performed, including cross-border activities and subcontracting.

2.  Notified bodies shall provide the other bodies notified under this Regulation carrying out similar conformity assessment activities covering the same EU fertilising products with relevant information on issues relating to negative and, on request, positive conformity assessment results.

Article 35

Exchange of experience

The Commission shall provide for the organisation of exchange of experience between the Member States' national authorities responsible for notification policy.

Article 36

Coordination of notified bodies

The Commission shall ensure that appropriate coordination and cooperation between bodies notified under this Regulation are put in place and properly operated in the form of a sectoral group of notified bodies.

Notified bodies shall participate in the work of that group, directly or by means of designated representatives.

CHAPTER V

UNION MARKET SURVEILLANCE, CONTROL OF EU FERTILISING PRODUCTS ENTERING THE UNION MARKET AND UNION SAFEGUARD PROCEDURE

Article 37

Union market surveillance and control of EU fertilising products entering the Union market

Articles 16 to 29 of Regulation (EC) No 765/2008 shall apply to EU fertilising products.

Article 38

Procedure at national level for dealing with EU fertilising products presenting a risk ▌

1.  Where the market surveillance authorities of one Member State have sufficient reason to believe that an EU fertilising product presents a risk to human, animal or plant health, to safety or to the environment, they shall carry out an evaluation in relation to the EU fertilising product concerned covering all relevant requirements laid down in this Regulation. The relevant economic operators shall cooperate as necessary with the market surveillance authorities for that purpose.

Where, in the course of the evaluation referred to in the first subparagraph, the market surveillance authorities find that the EU fertilising product does not comply with the requirements laid down in this Regulation, they shall without delay require the relevant economic operator to take all appropriate corrective action, within a reasonable period prescribed by the market surveillance authorities and commensurate with the nature of the risk, to bring the EU fertilising product into compliance with those requirements, to withdraw the EU fertilising product from the market or to recall it ▌.

The market surveillance authorities shall inform the relevant notified body accordingly.

Article 21 of Regulation (EC) No 765/2008 shall apply to the measures referred to in the second subparagraph of this paragraph.

2.  Where the market surveillance authorities consider that non-compliance is not restricted to their national territory, they shall inform the Commission and the other Member States of the results of the evaluation and of the actions which they have required the economic operator to take.

3.  The economic operator shall ensure that all appropriate corrective action is taken in respect of all the EU fertilising products concerned that the economic operator has made available on the market throughout the Union.

4.  Where the relevant economic operator does not take adequate corrective action within the period referred to in the second subparagraph of paragraph 1, the market surveillance authorities shall take all appropriate provisional measures to prohibit or restrict the EU fertilising product being made available on their national market, to withdraw the EU fertilising product from that market or to recall it.

The market surveillance authorities shall inform the Commission and the other Member States, without delay, of those measures.

5.  The information referred to in the second subparagraph of paragraph 4 shall include all available details, in particular the data necessary for the identification of the non-compliant EU fertilising product, the origin of that EU fertilising product, the nature of the non-compliance alleged and the risk involved, the nature and duration of the national measures taken and the arguments put forward by the relevant economic operator. In particular, the market surveillance authorities shall indicate whether the non-compliance is due to any of the following:

(a)  failure of the EU fertilising product to meet the requirements set out in Annex I, II or III;

(b)  shortcomings in the harmonised standards referred to in Article 13;

(c)  shortcomings in the common specifications referred to in Article 14.

6.  Member States other than the Member State initiating the procedure under this Article shall without delay inform the Commission and the other Member States of any measures adopted and of any additional information at their disposal relating to the non-compliance of the EU fertilising product concerned, and, in the event of disagreement with the adopted national measure, of their objections.

7.  Where, within three months of receipt of the information referred to in the second subparagraph of paragraph 4, no objection has been raised by either a Member State or the Commission in respect of a provisional measure taken by a Member State, that measure shall be deemed justified.

8.  Member States shall ensure that appropriate restrictive measures, such as withdrawal of the EU fertilising product from the market, are taken without delay in respect of the EU fertilising product concerned.

9.  Obligations of the market surveillance authorities under this Article shall be without prejudice to the possibility for Member States to regulate fertilising products which are not EU fertilising products.

Article 39

Union safeguard procedure

1.  Where, on completion of the procedure set out in Article 38(3) and (4), objections are raised against a measure taken by a Member State, or where the Commission considers a national measure to be contrary to Union law, the Commission shall without delay enter into consultation with the Member States and the relevant economic operator or operators and shall evaluate the national measure. On the basis of the results of that evaluation, the Commission shall adopt an implementing act in the form of a decision determining whether the national measure is justified or not.

If the national measure is considered justified, the decision shall order all Member States to take the necessary measures to ensure that the non-compliant EU fertilising product is withdrawn from their market, and to inform the Commission accordingly.

If the national measure is considered unjustified, the decision shall order the Member State concerned to withdraw that measure.

The Commission shall address its decision to all Member States and shall immediately communicate it to them and the relevant economic operator or operators.

2.  Where the national measure is considered justified and the non-compliance of the EU fertilising product is attributed to shortcomings in the harmonised standards referred to in point (b) of Article 38(5) of this Regulation, the Commission shall apply the procedure provided for in Article 11 of Regulation (EU) No 1025/2012.

3.  Where the national measure is considered justified and the non-compliance of the EU fertilising product is attributed to shortcomings in the common specifications referred to in point (c) of Article 38(5), the Commission shall, without delay, adopt implementing acts amending or repealing the common specifications concerned.

Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 45(3).

Article 40

Compliant EU fertilising products which present a risk

1.  Where, having carried out an evaluation under Article 38(1), a Member State finds that although an EU fertilising product is in compliance with this Regulation it presents a risk to human, animal or plant health, to safety or to the environment, it shall without delay require the relevant economic operator to take all appropriate measures, within a reasonable period prescribed by the market surveillance authority and commensurate with the nature of the risk, to ensure that the EU fertilising product concerned, when made available on the market, no longer presents that risk, to withdraw the EU fertilising product from the market or to recall it.

2.  The economic operator shall ensure that corrective action is taken in respect of all the EU fertilising products concerned that the economic operator has made available on the market throughout the Union.

3.  The Member State shall immediately inform the Commission and the other Member States. That information shall include all available details, in particular the data necessary for the identification of the EU fertilising product concerned, the origin and the supply chain of that EU fertilising product, the nature of the risk involved and the nature and duration of the national measures taken.

4.  The Commission shall without delay enter into consultation with the Member States and the relevant economic operator or operators and shall evaluate the national measures taken. On the basis of the results of that evaluation, the Commission shall adopt an implementing act in the form of a decision determining whether the national measure is justified or not, and where necessary, ordering appropriate measures.

Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 45(3).

On duly justified imperative grounds of urgency relating to the protection of human, animal or plant health, safety or the environment, the Commission shall adopt immediately applicable implementing acts in accordance with the procedure referred to in Article 45(4).

5.  The Commission shall address its decision to all Member States and shall immediately communicate it to them and the relevant economic operator or operators.

Article 41

Formal non-compliance

1.  Without prejudice to Article 38, where a Member State makes one of the following findings with regard to an EU fertilising product, it shall require the relevant economic operator to put an end to the non-compliance concerned:

(a)  the CE marking has been affixed in violation of Article 30 of Regulation (EC) No 765/2008 or of Article 18 of this Regulation;

(b)  the identification number of the notified body has been affixed in violation of Article 18 or has not been affixed, where required by Article 18;

(c)  the EU declaration of conformity has not been drawn up or has not been drawn up correctly;

(d)  the technical documentation is either not available or not complete;

(e)  the information referred to in Article 6(6) or Article 8(3) is absent, false or incomplete;

(f)  any other administrative requirement provided for in Article 6 or Article 8 is not fulfilled.

2.  Where the non-compliance referred to in paragraph 1 persists, the Member State concerned shall take all appropriate measures to restrict or prohibit the EU fertilising product being made available on the market or ensure that it is recalled or withdrawn from the market ▌.

Obligations of Member States in this respect shall be without prejudice to the possibility for them to regulate fertilising products which are not EU fertilising products.

CHAPTER VI

DELEGATED POWERS AND COMMITTEE PROCEDURE

Article 42

Amendments of Annexes

1.  The Commission is empowered to adopt delegated acts in accordance with Article 44 amending Annex I, with the exception of cadmium limit values and the definitions, or other elements relating to the scope, of product function categories, and amending Annexes II, III and IV, for the purposes of adapting those Annexes to technical progress and of facilitating internal market access and free movement for EU fertilising products:

(a)  which have the potential to be the subject of significant trade on the internal market, and

(b)  for which there is scientific evidence that they:

(i)  do not present a risk to human, animal or plant health, to safety or to the environment, and

(ii)  ensure agronomic efficiency.

When adopting delegated acts which introduce new contaminant limit values in Annex I, the Commission shall take into account scientific opinions of the European Food Safety Authority, the European Chemicals Agency or the Commission’s Joint Research Centre, as relevant.

Where the Commission adopts delegated acts in order to add or review component material categories so as to include materials that can be considered to be recovered waste or by-products within the meaning of Directive 2008/98/EC, those delegated acts shall explicitly exclude such materials from component material categories 1 and 11 of Annex II to this Regulation.

When adopting delegated acts under this paragraph, the Commission shall prioritise in particular animal by-products, by-products within the meaning of Directive 2008/98/EC, and recovered waste, in particular from the agricultural sector and the agro-food industry, as well as materials and products already lawfully placed on the market in one or more Member States.

2.  Without undue delay after … [date of the entry into force of this Regulation], the Commission shall assess struvite, biochar and ash-based products. If that assessment concludes that the criteria in point (b) of paragraph 1 are fulfilled, the Commission shall adopt delegated acts pursuant to paragraph 1 to include those materials in Annex II.

3.  The Commission may only adopt delegated acts pursuant to paragraph 1 amending Annex II to this Regulation to include in the component material categories materials that cease to be waste following a recovery operation if recovery rules in that Annex, adopted no later than the inclusion, ensure that the materials comply with the conditions laid down in Article 6 of Directive 2008/98/EC.

4.  The Commission may only adopt delegated acts pursuant to paragraph 1amending Annex II to add new micro-organisms or strains of micro-organisms, or additional processing methods to the component material category for such organisms after having verified which strains of the additional micro-organism fulfil the criteria in point (b) of paragraph 1, on the basis of the following data:

(a)  name of the micro-organism;

(b)  taxonomic classification of the micro-organism: genus, species, strain and procurement method;

(c)  scientific literature reporting about safe production, conservation and use of the micro-organism;

(d)  taxonomic relation to micro-organism species fulfilling the requirements for a Qualified Presumption of Safety as established by the European Food Safety Authority;

(e)  information on the production process, including, where relevant, processing methods such as spray drying, fluid-bed drying, static drying, centrifugation, deactivation by heat, filtration and grinding; ▌

(f)  information on the identity and residue levels of residual intermediates, toxins or microbial metabolites in the component material; and

(g)  natural occurrence, survival and mobility in the environment.

5.  The Commission may only adopt delegated acts pursuant to paragraph 1 amending Annex II to this Regulation to add derived products within the meaning of Regulation (EC) No 1069/2009 in the component material categories where an end point in the manufacturing chain has been determined ▌ in accordance with Article 5(2) of that Regulation.

The Commission shall assess such derived products with respect to relevant aspects not taken into account for the purpose of determining an end point in the manufacturing chain in accordance with Regulation (EC) No 1069/2009. If that assessment concludes that the criteria in point (b) of paragraph 1 of this Article are fulfilled, the Commission shall adopt delegated acts pursuant to paragraph 1 of this Article to include those materials in the table in component material category 10 in Part II of Annex II to this Regulation without undue delay whenever such an end point is determined.

6.  By … [five years after the date of entry into force of this Regulation], the Commission shall assess biodegradability criteria for polymers referred to in point 2 of component material category 9 in Part II of Annex II and test methods to verify compliance with those criteria and, where appropriate, shall adopt delegated acts pursuant to paragraph 1 which lay down those criteria.

Such criteria shall ensure that:

(a)  the polymer is capable of undergoing physical and biological decomposition in natural soil conditions and aquatic environments across the Union, so that it ultimately decomposes only into carbon dioxide, biomass and water;

(b)  the polymer has at least 90 % of the organic carbon converted into carbon dioxide in a maximum period of 48 months after the end of the claimed functionality period of the EU fertilising product indicated on the label, and as compared to an appropriate standard in the biodegradation test; and

(c)  the use of polymers does not lead to accumulation of plastics in the environment.

7.  By … [3 years after the date of entry into force of this Regulation], the Commission shall adopt delegated acts in accordance with Article 44 supplementing point 3 of component material category 11 in Part II of Annex II to this Regulation by laying down criteria on agronomic efficiency and safety for the use of by-products within the meaning of Directive 2008/98/EC in EU fertilising products. Such criteria shall reflect present product manufacturing practices, technological developments and the latest scientific evidence.

8.  The Commission is empowered to adopt delegated acts in accordance with Article 44 amending Annex I, with the exception of cadmium limit values, and Annexes II, III and IV in the light of new scientific evidence. The Commission shall use this empowerment where, based on a risk assessment, an amendment proves necessary to ensure that any EU fertilising product complying with the requirements of this Regulation does not, under normal conditions of use, present a risk to human, animal, or plant health, to safety or to the environment.

Article 43

Separate delegated acts for separate component material categories

When exercising its power to adopt delegated acts pursuant to Article 42, the Commission shall adopt a separate delegated act in respect of each component material category in Annex II. Those delegated acts shall include any amendments to Annexes I, III and IV which are necessary as a consequence of amendments to Annex II.

Article 44

Exercise of the delegation

1.  The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article.

2.  The power to adopt delegated acts referred to in Article 42 shall be conferred on the Commission for a period of five years from … [date of entry into force of this Regulation]. The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period.

3.  The delegation of power referred to in Article 42 may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force.

4.  Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making.

5.  As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.

6.  A delegated act adopted pursuant to Article 42 shall enter into force only if no objection has been expressed either by the European Parliament or the Council within a period of three months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by three months at the initiative of the European Parliament or of the Council.

Article 45

Committee procedure

1.  The Commission shall be assisted by the Committee on fertilising products. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011.

2.  Where reference is made to this paragraph, Article 4 of Regulation (EU) No 182/2011 shall apply.

3.  Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply.

4.  Where reference is made to this paragraph, Article 8 of Regulation (EU) No 182/2011, in conjunction with Article 5 thereof, shall apply.

CHAPTER VII

AMENDMENTS

Article 46

Amendments to Regulation (EC) No 1069/2009

▌ Regulation (EC) No 1069/2009 is amended as follows:

(1)  in Article 5, paragraphs 2 and 3 are replaced by the following:"

"2. For derived products referred to in Articles 32, 35 and 36 which no longer pose any significant risk to public or animal health, an end point in the manufacturing chain may be determined, beyond which they are no longer subject to the requirements of this Regulation. ▌

Those derived products may subsequently be placed on the market without restrictions under this Regulation and shall no longer be subject to official controls in accordance with this Regulation.

The Commission is empowered to adopt delegated acts in accordance with Article 51a supplementing this Regulation by determining an end point in the manufacturing chain, beyond which derived products referred to in this paragraph are no longer subject to the requirements of this Regulation.

3.  In the event of risks to public or animal health, Articles 53 and 54 of Regulation (EC) No 178/2002 concerning emergency health measures shall apply mutatis mutandis to the derived products referred to in Articles 32, 33 and 36 of this Regulation.

4.  Within six months after … [date of entry into force of this Regulation](31), the Commission shall initiate a first assessment of derived products referred to in Article 32 that are already widely used in the Union as organic fertilisers and soil improvers. This assessment shall cover at least the following products: meat meal, bone meal, meat-and-bone meal, hydrolysed proteins of Category 3 materials, processed manure, compost, biogas digestion residues, feather meal, glycerine and other products of Category 2 or 3 materials derived from the production of biodiesel and renewable fuels, as well as petfood, feed and dog chews that have been refused for commercial reasons or technical failures, and derived products from blood of animals, hides and skins, hoofs and horns, guano of bats and birds, wool and hair, feather and downs, and pig bristles. Where the assessment concludes that those derived products no longer pose any significant risk to public or animal health, the Commission shall determine an end point in the manufacturing chain pursuant to paragraph 2 of this Article without undue delay and in any case no later than six months after the assessment is finalised.";

"

(2)  the following Article is inserted:"

"Article 51a

Exercise of the delegation

1.  The power to adopt delegated acts is conferred on the Commission subject to the conditions laid down in this Article.

2.  The power to adopt delegated acts referred to in Article 5(2) shall be conferred on the Commission for a period of five years from ... [date of entry into force of this Regulation] (32). The Commission shall draw up a report in respect of the delegation of power not later than nine months before the end of the five-year period. The delegation of power shall be tacitly extended for periods of an identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period.

3.  The delegation of power referred to in Article 5(2) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force.

4.  Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making *.

5.  As soon as it adopts a delegated act, the Commission shall notify it simultaneously to the European Parliament and to the Council.

6.  A delegated act adopted pursuant to Article 5(2) shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of two months of notification of that act to the European Parliament and the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by two months at the initiative of the European Parliament or of the Council.

__________________

* OJ L 123, 12.5.2016, p. 1."

"

Article 47

Amendments to Regulation (EC) No 1107/2009

Regulation (EC) No 1107/2009 is amended as follows:

(1)  in Article 2(1), point (b) is replaced by the following:"

"(b) influencing the life processes of plants, such as substances influencing their growth, other than as a nutrient or a plant biostimulant;";

"

(2)  in Article 3, the following point is added:

▌"34. "plant biostimulant" means a product stimulating plant nutrition processes independently of the product's nutrient content with the sole aim of improving one or more of the following characteristics of the plant or the plant rhizosphere:

(a)  nutrient use efficiency;

(b)  tolerance to abiotic stress;

(c)  ▌ quality traits;

(d)  availability of confined nutrients in soil or rhizosphere.";

(3)  in Article 80, the following paragraph is added:"

"8. To a product which was granted an authorisation under Article 32(1) based on an application submitted before … [date of entry into force of this Regulation ] (33), and which after that date falls under the definition in point 34 of Article 3, this Regulation shall continue to apply for the duration provided in the authorisation.".

"

CHAPTER VIII

TRANSITIONAL AND FINAL PROVISIONS

Article 48

Penalties

Member States shall lay down rules on penalties applicable to infringements of this Regulation and shall take all measures necessary to ensure that they are implemented. The penalties provided for shall be effective, proportionate and dissuasive. Member States shall, without delay, notify the Commission of those rules and of those measures and shall notify it, without delay, of any subsequent amendment affecting them.

Article 49

Report

By … [seven years after the date of entry into force of this Regulation], the Commission shall submit to the European Parliament and to the Council a report assessing the application of this Regulation and its overall impact as to the attainment of its objectives, including the impact on small and medium-sized enterprises. That report shall include:

(a)  an assessment of the functioning of the internal market for fertilising products, including conformity assessment and market surveillance effectiveness and an analysis of the effects of optional harmonisation on production, market shares and trade flows of EU fertilising products and fertilising products placed on the market under national rules;

(b)  a review of the limit values for cadmium content in phosphate fertilisers, with a view to assessing the feasibility of reducing these limit values to a lower appropriate level on the basis of available technologies and scientific evidence on cadmium exposure and accumulation in the environment, taking into account environmental factors, in particular in the context of soil and climatic conditions, health factors, as well as socio-economic factors, including considerations of security of supply;

(c)  an assessment of the application of restrictions on levels of contaminants set out in Annex I and an assessment of any new relevant scientific information as regards the toxicity and carcinogenicity of contaminants that becomes available, including the risks from uranium contamination in fertilising products.

The report shall take due account of technological progress and innovation as well as standardisation processes affecting production and use of fertilising products. It shall be accompanied, if appropriate, by a legislative proposal.

Article 50

Biodegradability review

By … [five years after the date of entry into force of this Regulation], the Commission shall carry out a review in order to assess the possibility of determining biodegradability criteria of mulch films, and the possibility of incorporating them into component material category 9 in Part II of Annex II.

Article 51

Repeal of Regulation (EC) No 2003/2003

Regulation (EC) No 2003/2003 is repealed with effect from … [3 years after the date of entry into force of this Regulation].

References to the repealed Regulation shall be construed as references to this Regulation.

Article 52

Transitional provisions

Member States shall not impede the making available on the market of products which were placed on the market as fertilisers designated "EC fertiliser" in conformity with Regulation (EC) No 2003/2003 before … [three years after the date of entry into force of this Regulation]. However, Chapter V of this Regulation shall apply mutatis mutandis to such products.

Article 53

Entry into force and application

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

It shall apply from … [three years after the date of entry into force of this Regulation].

However:

(a)  Articles 4(3), 14,  42, 43, 44, 45, 46 and 47 shall apply from … [date of entry into force of this Regulation]; and

(b)  Articles 20 to 36 shall apply from … [nine months after the date of entry into force of this Regulation].

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at …,

For the European Parliament For the Council

The President The President

ANNEX I

Product Function Categories (PFCs) of EU fertilising products

Part I

Designation Of PFCs

1.  Fertiliser

A.  Organic fertiliser

I.  Solid organic fertiliser

II.  Liquid organic fertiliser

B.  Organo-mineral fertiliser

I.  Solid organo-mineral fertiliser

II.  Liquid organo-mineral fertiliser

C.  Inorganic fertiliser

I.  Inorganic macronutrient fertiliser

(a)  Solid inorganic macronutrient fertiliser

(i)  Straight solid inorganic macronutrient fertiliser

(A)  Straight solid inorganic macronutrient ammonium nitrate fertiliser of high nitrogen content

(ii)  Compound solid inorganic macronutrient fertiliser

(A)  Compound solid inorganic macronutrient ammonium nitrate fertiliser of high nitrogen content

(b)  Liquid inorganic macronutrient fertiliser

(i)  Straight liquid inorganic macronutrient fertiliser

(ii)  Compound liquid inorganic macronutrient fertiliser

II.  Inorganic micronutrient fertiliser

(a)  Straight inorganic micronutrient fertiliser

(b)  Compound inorganic micronutrient fertiliser

2.  Liming material

3.  Soil improver

A.  Organic soil improver

B.  Inorganic soil improver

4.  Growing medium

5.  Inhibitor

A.   Nitrification inhibitor

B.  Denitrification inhibitor

C.  Urease inhibitor

6.  Plant biostimulant

A.  Microbial plant biostimulant

B.  Non-microbial plant biostimulant

7.  Fertilising product blend

Part II

Requirements related to PFCs

1.  This Part sets out the requirements related to the PFCs to which EU fertilising products belong by virtue of their claimed function.

2.  The requirements laid down in this Annex for a given PFC apply to EU fertilising products in all subcategories of that PFC.

3.  The claim that an EU fertilising product complies with the function set out in this Annex for the relevant PFC shall be supported by the product's mode of action, the relative content of its various components, or any other relevant parameter.

4.  Where compliance with a given requirement (such as absence of a given contaminant) follows certainly and uncontestably from the nature or manufacturing process of an EU fertilising product, that compliance can be presumed in the conformity assessment procedure without verification (such as testing), at the responsibility of the manufacturer.

5.  Where the EU fertilising product contains a substance for which maximum residue limit values for food and feed have been established in accordance with:

(a)  Council Regulation (EEC) No 315/93(34),

(b)  Regulation (EC) No 396/2005 of the European Parliament and of the Council(35),

(c)  Regulation (EC) No 470/2009 of the European Parliament and of the Council(36), or

(d)  Directive 2002/32/EC of the European Parliament and of the Council(37)

the use of the EU fertilising product as specified in the use instructions must not lead to the exceedance of those limit values in food or feed.

6.  Phosphonates shall not be intentionally added to any EU fertilising product. Unintentional presence of phosphonates shall not exceed 0,5 % by mass.

7.  The requirements in this Annex are expressed in oxidised form for certain nutrients. Where compliance is assessed based on the presence of the nutrient in question in its elemental form, the following conversion factors shall be used:

phosphorus (P) = phosphorus pentoxide (P2O5) × 0,436;

potassium (K) = potassium oxide (K2O) × 0,830;

calcium (Ca) = calcium oxide (CaO) × 0,715;

magnesium (Mg) = magnesium oxide (MgO) × 0,603;

sodium (Na) = sodium oxide (Na2O) × 0,742;

sulphur (S) = sulphur trioxide (SO3) × 0,400.

8.  The requirements in this Annex are expressed by reference to organic carbon (Corg). Where compliance is assessed based on organic matter the following conversion factor applies:

organic carbon (Corg) = organic matter × 0,56.

PFC 1: Fertiliser

A fertiliser shall be an EU fertilising product the function of which is to provide nutrients to plants or mushrooms.

PFC 1(A): Organic fertiliser

1.  An organic fertiliser shall contain:

–  organic carbon (Corg) and

–  nutrients

of solely biological origin ▌.

An organic fertiliser may contain peat, leonardite and lignite, but no other material which is fossilized or embedded in geological formations.

2.  Contaminants in an organic fertiliser must not exceed the following limit values:

(a)  cadmium (Cd): 1,5 mg/kg dry matter,

(b)  hexavalent chromium (Cr VI): 2 mg/kg dry matter,

(c)  mercury (Hg): 1 mg/kg dry matter,

(d)  nickel (Ni): 50 mg/kg dry matter,

(e)  lead (Pb): 120 mg/kg dry matter, and

(f)  inorganic arsenic (As): 40 mg/kg dry matter.

Biuret (C2H5N3O2) must not be present in an organic fertiliser.

3.  The copper (Cu) content in an organic fertiliser must not exceed 300 mg/kg dry matter, and the zinc (Zn) content in an organic fertiliser must not exceed 800 mg/kg dry matter.

4.  Pathogens in an organic fertiliser must not exceedthe limits set out in the following table:

Micro-organisms to be tested

Sampling plans

Limit

n

c

m

M

Salmonella spp.

5

0

0

Absence in 25 g or 25 ml

Escherichia coli or Enterococcaceae

5

5

0

1 000 in 1 g or 1 ml

Where:

n = number of samples to be tested,

c = number of samples where the number of bacteria expressed in colony forming units (CFU) is between m and M,

m = threshold value for the number of bacteria expressed in CFU that is considered satisfactory,

M = maximum value of the number of bacteria expressed in CFU.

PFC 1(A)(I): Solid organic fertiliser

1.  A solid organic fertiliser shall be in solid form.

2.  A solid organic fertiliser shall contain at least one of the following declared primary nutrients: nitrogen (N), phosphorus pentoxide (P2O5) or potassium oxide (K2O).

Where a solid organic fertiliser contains only one declared primary nutrient, that nutrient content shall be at least the following:

(a)   2,5 % by mass of total nitrogen (N),

(b)  2 % by mass of total phosphorus pentoxide (P2O5), or

(c)   2 % by mass of total potassium oxide (K2O).

Where a solid organic fertiliser contains more than one declared primary nutrient, those nutrient contents shall be at least the following:

(a)  1 % by mass of total nitrogen (N),

(b)  1 % by mass of total phosphorus pentoxide (P2O5), or

(c)  1 % by mass of total potassium oxide (K2O).

The sum of those nutrient contents shall be at least 4 % by mass.

3.  Organic carbon (Corg) content in a solid organic fertiliser shall be at least 15 % by mass.

PFC 1(A)(II): Liquid organic fertiliser

1.  A liquid organic fertiliser shall be in liquid form.

2.  A liquid organic fertiliser shall contain at least one of the following declared primary nutrients: nitrogen (N), phosphorus pentoxide (P2O5) or potassium oxide (K2O).

Where a liquid organic fertiliser contains only one declared primary nutrient, that nutrient content shall be at least the following:

(a)  2 % by mass of total nitrogen (N),

(b)  1 % by mass of total phosphorus pentoxide (P2O5), or

(c)  2 % by mass of total potassium oxide (K2O).

Where a liquid organic fertiliser contains more than one declared primary nutrient, those nutrient contents shall be at least the following:

(a)  1 % by mass of total nitrogen (N),

(b)  1 % by mass of total phosphorus pentoxide (P2O5), or

(c)  1 % by mass of total potassium oxide (K2O).

The sum of those nutrient contents shall be at least 3 % by mass.

3.  Organic carbon (Corg) content in a liquid organic fertiliser shall be at least 5 % by mass.

PFC 1(B): Organo-mineral fertiliser

1.  An organo-mineral fertiliser shall be a co-formulation of:

(a)   one or more inorganic fertilisers, as specified in PFC 1(C), and

(b)  one or more materials containing:

–  organic carbon (Corg); and

–  nutrients

of solely biological origin ▌.

An organo-mineral fertiliser may contain peat, leonardite and lignite, but no other material which is fossilized or embedded in geological formations.

2.  Where one or more of the inorganic fertilisers in the co-formulation is a straight or compound solid inorganic macronutrient ammonium nitrate fertiliser of high nitrogen content, as specified in PFC 1(C)(I)(a)(i-ii)(A), an organo-mineral fertiliser shall not contain 16 % or more by mass of nitrogen (N) as a result of ammonium nitrate (NH4NO3).

3.  Contaminants in an organo-mineral fertiliser must not exceed the following limit values:

(a)  cadmium (Cd):

(i)  where an organo-mineral fertiliser has a total phosphorus (P) content of less than 5 % phosphorus pentoxide (P2O5)-equivalent by mass: 3 mg/kg dry matter, or

(ii)  where an organo-mineral fertiliser has a total phosphorus (P) content of 5 % phosphorus pentoxide (P2O5)-equivalent or more by mass ('phosphate fertiliser'): 60 mg/kg phosphorus pentoxide (P2O5);

(b)  hexavalent chromium (Cr VI): 2 mg/kg dry matter;

(c)  mercury (Hg): 1 mg/kg dry matter;

(d)  nickel (Ni): 50 mg/kg dry matter;

(e)  lead (Pb): 120 mg/kg dry matter;

(f)  inorganic arsenic (As): 40 mg/kg dry matter; and

(g)  biuret (C2H5N3O2): 12 g/kg dry matter.

4.  The copper (Cu) content in an organo-mineral fertiliser must not exceed  600 mg/kg dry matter, and the zinc (Zn) content in an organo-mineral fertiliser must not exceed 1 500 mg/kg dry matter. However, these limit values shall not apply where copper (Cu) or zinc (Zn) has been intentionally added to an organo-mineral fertiliser for the purpose of correcting a soil micronutrient deficiency and is declared in accordance with Annex III.

5.  Pathogens in an organo-mineral fertiliser must not exceed the limits set out in the following table:

Micro-organisms to be tested

Sampling plans

Limit

n

c

m

M

Salmonella spp.

5

0

0

Absence in 25 g or 25 ml

Escherichia coli or Enterococcaceae

5

5

0

1 000 in 1 g or 1 ml

Where:

n = number of samples to be tested,

c = number of samples where the number of bacteria expressed in CFU is between m and M,

m = threshold value for the number of bacteria expressed in CFU that is considered satisfactory,

M = maximum value of the number of bacteria expressed in CFU.

PFC 1(B)(I): Solid organo-mineral fertiliser

1.  A solid organo-mineral fertiliser shall be in solid form.

2.  A solid organo-mineral fertiliser shall contain at least one of the following declared primary nutrients: nitrogen (N), phosphorus pentoxide (P2O5) or potassium oxide (K2O).

Where a solid organo-mineral fertiliser contains only one declared primary nutrient, that nutrient content shall be at least the following:

(a)  2,5 % by mass of total nitrogen (N), out of which 1 % by mass shall be organic nitrogen (Norg),

(b)  2 % by mass of total phosphorus pentoxide (P2O5), or

(c)  2 % by mass of total potassium oxide (K2O).

Where a solid organo-mineral fertilisercontains more than one declared primary nutrient, those nutrient contents shall be at least the following:

(a)  2 % by mass of total nitrogen (N), out of which 0,5 % by mass shall be organic nitrogen (Norg),

(b)  2 % by mass of total phosphorus pentoxide (P2O5), or

(c)  2 % by mass of total potassium oxide (K2O).

The sum of those nutrient contents shall be at least 8 % by mass.

3.  Organic carbon (Corg) content in a solid organo-mineral fertiliser shall be at least 7,5 % by mass.

4.  In a solid organo-mineral fertiliser, each physical unit shall contain ▌ organic ▌ carbon (Corg) and all the nutrients in their declared content. A physical unit refers to one of the component pieces of a product, such as granules or pellets.

PFC 1(B)(II): Liquid organo-mineral fertiliser

1.  A liquid organo-mineral fertiliser shall be in liquid form.

2.  A liquid organo-mineral fertiliser shall contain at least one of the following declared primary nutrients ▌: nitrogen (N), phosphorus pentoxide (P2O5) or ▌ potassium oxide (K2O).

Where a liquid organo-mineral fertiliser contains only one declared primary nutrient, that nutrient content shall be at least the following:

(a)  2 % by mass of total nitrogen (N), out of which 0,5 % by mass shall be organic nitrogen (N org),

(b)  2 % by mass of total phosphorus pentoxide (P2O5), or

(c)  2 % by mass of total potassium oxide (K2O).

Where a liquid organo-mineral fertiliser contains more than one declared primary nutrient, those nutrient contents shall be at least the following:

(a)  2 % by mass of total nitrogen (N), out of which 0,5 % by mass shall be organic nitrogen (Norg),

(b)  2 % by mass of total phosphorus pentoxide (P2O5), or

(c)  2 % by mass of total potassium oxide (K2O)-

The sum of those nutrient contents shall be at least 6 % by mass.

3.  Organic carbon (Corg) content in a liquid organo-mineral fertiliser shall be at least 3 % by mass.

PFC 1(C): Inorganic fertiliser

1.  An inorganic fertiliser shall be a fertiliser containing or releasing nutrients in a mineral form, other than an organic or organo-mineral fertiliser.

2.  In addition to the requirements of either PFC 1(C)(I) or PFC 1(C)(II), an inorganic fertiliser which contains more than 1 % by mass of organic carbon (Corg), other than organic carbon (Corg) from:

—  chelating or complexing agents referred to in point 3 of component material category (CMC) 1 in Part II of Annex II,

—  nitrification inhibitors, denitrification inhibitors or urease inhibitors referred to in point 4 of CMC 1 in Part II of Annex II,

—  coating agents referred to in point 1(a) of CMC 9 in Part II of Annex II,

—  urea (CH4N2O), or

—  calcium cyanamide (CaCN2)

shall meet the requirement that pathogens in an inorganic fertiliser must not exceed the limits set out in the following table:

Micro-organisms

to be tested

Sampling

plans

Limit

n

c

m

M

Salmonella spp.

5

0

0

Absence in

25 g or 25 ml

Escherichia coli

or

Enterococcaceae

5

5

0

1 000 in

1 g or 1 ml

Where:

n = number of samples to be tested,

c = number of samples where the number of bacteria expressed in CFU is between m and M,

m = threshold value for the number of bacteria expressed in CFU that is considered satisfactory,

M = maximum value of the number of bacteria expressed in CFU.

PFC 1(C)(I): Inorganic macronutrient fertiliser

1.  An inorganic macronutrient fertiliser shall be aimed at providing plants or mushrooms with one or more of the following macronutrients:

(a)  primary macronutrients: nitrogen (N), phosphorus (P) or potassium (K),

(b)  secondary macronutrients: calcium (Ca), magnesium (Mg), ▌ sodium (Na) or sulphur (S).

2.  Contaminants in an inorganic macronutrient fertiliser must not exceed the following limit values:

(a)  cadmium (Cd):

(i)  where an inorganic macronutrient fertiliser has a total phosphorus (P) content of less than 5 % phosphorus pentoxide (P2O5)-equivalent by mass: 3 mg/kg dry matter, or

(ii)  where an inorganic macronutrient fertiliser has a total phosphorus (P) content of 5 % phosphorus pentoxide (P2O5)-equivalent or more by mass ('phosphate fertiliser'): 60 mg/kg phosphorus pentoxide (P2O5);

(b)  hexavalent chromium (Cr VI): 2 mg/kg dry matter,

(c)  mercury (Hg): 1 mg/kg dry matter,

(d)  nickel (Ni): 100 mg/kg dry matter,

(e)  lead (Pb): 120 mg/kg dry matter,

(f)  arsenic (As): 40 mg/kg dry matter,

(g)  biuret (C2H5N3O2): 12 g/kg dry matter, ▌

(h)  perchlorate (ClO4-): 50 mg/kg dry matter.

3.  The copper (Cu) content in an inorganic macronutrient fertiliser must not exceed 600 mg/kg dry matter, and the zinc (Zn) content in an inorganic macronutrient fertiliser must not exceed 1 500 mg/kg dry matter. However, these limit values shall not apply where copper (Cu) or zinc (Zn) has been intentionally added to an inorganic macronutrient fertiliser for the purpose of correcting a soil micronutrient deficiency and is declared in accordance with Annex III.

PFC 1(C)(I)(a ): Solid inorganic macronutrient fertiliser

A solid ▌ inorganic macronutrient fertiliser shall be in solid form.

PFC 1(C)(I)(a)(i): Straight solid inorganic macronutrient fertiliser

1.  A straight solid inorganic macronutrient fertiliser shall have a declared content of:

(a)  only one macronutrient (nitrogen (N), phosphorus (P), potassium (K), calcium (Ca), magnesium (Mg), sodium (Na), sulphur (S)), or

(b)  only one primary macronutrient (nitrogen (N), phosphorus (P), potassium (K)) and one or more secondary macronutrients (calcium (Ca), magnesium (Mg), sodium (Na), sulphur (S)).

2.  Where a straight solid inorganic macronutrient fertiliser contains only one declared macronutrient (nitrogen (N), phosphorus (P), potassium (K), calcium (Ca), magnesium (Mg), sodium (Na), sulphur (S)), that macronutrient content shall be at least the following:

(a)   10 % by mass of total nitrogen (N),

(b)   12 % by mass of total phosphorus pentoxide (P2O5),

(c)   6 % by mass of total potassium oxide (K2O),

(d)   5 % by mass of total magnesium oxide (MgO),

(e)   12 % by mass of total calcium oxide (CaO),

(f)   10 % by mass of total sulphur trioxide (SO3), or

(g)   1 % by mass of total sodium oxide (Na2O).

However, the total sodium oxide (Na2O) content shall not exceed 40 % by mass.

Where a straight solid inorganic macronutrient fertiliser contains only one declared primary macronutrient (nitrogen (N), phosphorus (P), potassium (K)) and one or more declared secondary macronutrients (calcium (Ca), magnesium (Mg), sodium (Na), sulphur (S)):

(a)  that primary macronutrient content shall be at least the following:

(i)  3 % by mass of total nitrogen (N),

(ii)  3 % by mass of total phosphorus pentoxide (P2O5), or

(iii)  3 % by mass of total potassium oxide (K2O);

(b)  that or those secondary macronutrient contents shall be at least the following:

(i)  1,5 % by mass of total magnesium oxide (MgO),

(ii)  1,5 % by mass of total calcium oxide (CaO),

(iii)  1,5 % by mass of total sulphur trioxide (SO3), or

(iv)  1 % by mass of total sodium oxide (Na2O).

However, the total sodium oxide (Na2O) content shall not exceed 40 % by mass.

The sum of all declared primary and secondary macronutrient contents shall be at least 18 % by mass.

PFC 1(C)(I)(a)(ii): Compound solid inorganic macronutrient fertiliser

1.  A compound solid inorganic macronutrient fertiliser shall have a declared content of:

(a)  more than one primary macronutrient (nitrogen (N), phosphorus (P), potassium (K)), or

(b)  more than one secondary macronutrient (calcium (Ca), magnesium (Mg), sodium (Na), sulphur (S)) and no primary macronutrient (nitrogen (N), phosphorus (P), potassium (K)).

2.  A compound solid inorganic macronutrient fertiliser shall contain more than one of the following declared macronutrients in at least the following contents:

(a)   3 % by mass of total nitrogen (N),

(b)   3 % by mass of total phosphorus pentoxide (P2O5),

(c)   3 % by mass of total potassium oxide (K2O),

(d)   1,5 % by mass of total magnesium oxide (MgO),

(e)   1,5 % by mass of total calcium oxide (CaO),

(f)   1,5 % by mass of total sulphur trioxide (SO3), or

(g)   1 % by mass of total sodium oxide (Na2O).

However, the total sodium oxide (Na2O) content shall not exceed 40 % by mass.

The sum of all declared macronutrient contents shall be at least 18 % by mass.

PFC 1(C)(I)(a)(i‑ii)(A): Straight or compound solid inorganic macronutrient ammonium nitrate fertiliser of high nitrogen content

1.  A straight or compound solid inorganic macronutrient ammonium nitrate fertiliser of high nitrogen content shall be ammonium nitrate (NH4NO3)-based and contain 28 % or more by mass of nitrogen (N) as a result of ammonium nitrate (NH4NO3).

2.  Any matter other than ammonium nitrate (NH4NO3) shall be inert towards ammonium nitrate (NH4NO3).

3.  A straight or compound solid inorganic macronutrient ammonium nitrate fertiliser of high nitrogen content shall be made available to the end-user only in packaged form. The package shall be closed in such a way or by such a device that, when it is opened, the fastening, the fastening seal or the package itself is irreparably damaged. Valve sacks may be used.

4.  The oil retention of a straight or compound solid inorganic macronutrient ammonium nitrate fertiliser of high nitrogen content, following two thermal cycles as described under point 4.1 in Module A1 in Part II of Annex IV, must not exceed 4 % by mass.

5.  The detonation resistance of a straight or compound solid inorganic macronutrient ammonium nitrate fertiliser of high nitrogen content shall be such, that:

–   following five thermal cycles as described under point 4.3 in Module A1 in Part II of Annex IV,

–   in two detonation resistance tests as described under point 4.4 in Module A1 in Part II of Annex IV,

one or more of the supporting lead cylinders is crushed by less than 5 %.

6.  The % by mass of combustible material measured as carbon (C) must not exceed:

–   0,2 % for a straight or compound solid inorganic macronutrient ammonium nitrate fertiliser of high nitrogen content having a nitrogen (N) content of at least 31,5 % by mass, and

–   0,4 % for a straight or compound solid inorganic macronutrient ammonium nitrate fertiliser of high nitrogen content having a nitrogen (N) content of at least 28 % but less than 31,5 % by mass.

7.  A solution of 10 g of a straight or compound solid inorganic macronutrient ammonium nitrate fertiliser of high nitrogen content in 100 ml of water must have a pH of at least 4,5.

8.  Not more than 5 % by mass shall pass through a 1 mm mesh sieve, and not more than 3 % by mass shall pass through a 0,5 mm mesh sieve.

9.  The copper (Cu) content shall not be higher than 10 mg/kg, and the chlorine (Cl) content shall not be higher than 200 mg/kg.

PFC 1(C)(I)(b): Liquid inorganic macronutrient fertiliser

A liquid inorganic macronutrient fertiliser shall be in liquid form.

PFC 1(C)(I)(b)(i): Straight liquid inorganic macronutrient fertiliser

1.  A straight liquid inorganic macronutrient fertiliser shall have a declared content of:

(a)  only one macronutrient (nitrogen (N), phosphorus (P), potassium (K), calcium (Ca), magnesium (Mg), sodium (Na), sulphur (S)), or

(b)  only one primary macronutrient (nitrogen (N), phosphorus (P), potassium (K)) and one or more secondary macronutrients (calcium (Ca), magnesium (Mg), sodium (Na), sulphur (S)).

2.  Where a straight liquid inorganic macronutrient fertiliser contains only one declared macronutrient (nitrogen (N), phosphorus (P), potassium (K), calcium (Ca), magnesium (Mg), sodium (Na), sulphur (S)), that macronutrient content shall be at least the following:

(a)   5 % by mass of total nitrogen (N),

(b)   5 % by mass of total phosphorus pentoxide (P2O5),

(c)   3 % by mass of total potassium oxide (K2O),

(d)   2 % by mass of total magnesium oxide (MgO),

(e)   6 % by mass of total calcium oxide (CaO),

(f)   5 % by mass of total sulphur trioxide (SO3), or

(g)   1 % by mass of total sodium oxide (Na2O).

However, the total sodium oxide (Na2O) content shall not exceed 40 % by mass.

Where a straight liquid inorganic macronutrient fertiliser contains only one declared primary macronutrient (nitrogen (N), phosphorus (P), potassium (K)), and one or more declared secondary macronutrients (calcium (Ca), magnesium (Mg), sodium (Na),sulphur (S)):

(a)  that primary macronutrient content shall be at least the following :

(i)  1,5 % by mass of total nitrogen (N),

(ii)  1,5 % by mass of total phosphorus pentoxide (P2O5), or

(iii)  1,5 % by mass of total potassium oxide (K2O); and

(b)  that or those secondary macronutrient contents shall be at least the following:

(i)  0,75 % by mass of total magnesium oxide (MgO),

(ii)  0,75 % by mass of total calcium oxide (CaO),

(iii)  0,75 % by mass of total sulphur trioxide (SO3), or

(iv)  0,5 % by mass of total sodium oxide (Na2O).

However, the total sodium oxide (Na2O) content shall not exceed 20 % by mass.

The sum of all declared primary and secondary macronutrient contents shall be at least 7 % by mass.

PFC 1(C)(I)(b)(ii): Compound liquid inorganic macronutrient fertiliser

1.  A compound liquid inorganic macronutrient fertiliser shall have a declared content of:

(a)  more than one primary macronutrient (nitrogen (N), phosphorus (P), potassium (K)), or

(b)  more than one secondary macronutrient (calcium (Ca), magnesium (Mg), sodium (Na), sulphur (S)), and no primary macronutrient (nitrogen (N), phosphorus (P), potassium (K)).

2.  A compound liquid inorganic macronutrient fertiliser shall contain more than one of the following declared nutrients in at least the following contents:

(a)   1,5 % by mass of total nitrogen (N),

(b)   1,5 % by mass of total phosphorus pentoxide (P2O5),

(c)   1,5 % by mass of total potassium oxide (K2O),

(d)   0,75 % by mass of total magnesium oxide (MgO),

(e)   0,75 % by mass of total calcium oxide (CaO),

(f)   0,75 % by mass of total sulphur trioxide (SO3), or

(g)   0,5 % by mass of total sodium oxide (Na2O).

However, the total sodium oxide (Na2O) content shall not exceed 20 % by mass.

The sum of all declared nutrient contents shall be at least 7 % by mass.

PFC 1(C)(II): Inorganic micronutrient fertiliser

1.  An inorganic micronutrient fertiliser shall be an inorganic fertiliser other than an inorganic macronutrient fertiliser aimed at providing plants or mushrooms with one or more of the following micronutrients: boron (B), cobalt (Co), copper (Cu), iron (Fe), manganese (Mn), molybdenum (Mo) or zinc (Zn).

2.  Inorganic micronutrient fertilisers shall be made available to the end-user only in packaged form.

3.  Contaminants in an inorganic micronutrient fertiliser must not exceed the following limit values:

Contaminant

Limit values of contaminants expressed in mg,

in relation to the total micronutrient content expressed in kg

(mg/kg of total micronutrient content, which means boron (B),

cobalt (Co), copper (Cu), iron (Fe), manganese (Mn),

molybdenum (Mo) and zinc (Zn))

Arsenic (As)

1 000

Cadmium (Cd)

200

Lead (Pb)

600

Mercury (Hg)

100

Nickel (Ni)

2 000

PFC 1(C)(II)(a): Straight inorganic micronutrient fertiliser

1.  A straight inorganic micronutrient fertiliser shall have a declared content of not more than one micronutrient.

2.  A straight inorganic micronutrient fertiliser shall belong to one of the typologies, and shall comply with the corresponding description and minimum micronutrient content requirements in the following table:

Typology

Description

Minimum micronutrient content

Micronutrient salt fertiliser

A chemically obtained straight solid inorganic micronutrient fertiliser containing a mineral ion salt ▌ as its essential ingredient

10 % by mass of micronutrient salt fertiliser shall consist of a water-soluble micronutrient

Micronutrient oxide or hydroxide fertiliser

A chemically obtained straight solid inorganic micronutrient fertiliser containing oxide or hydroxide as its essential ingredient

10 % by mass of a micronutrient oxide or hydroxide fertiliser shall consist of a micronutrient

Micronutrient-based fertiliser

A straight inorganic micronutrient fertiliser combining a micronutrient salt fertiliser with one or more other micronutrient salt fertilisers and/or with a single micronutrient chelate

5 % by mass of a micronutrient-based fertiliser shall consist of a micronutrient

Micronutrient solution fertiliser

An aqueous solution of different forms of a straight inorganic micronutrient fertiliser

2 % by mass of a micronutrient solution fertiliser shall consist of a water-soluble micronutrient

Micronutrient suspension fertiliser

A suspension of different forms of a straight inorganic micronutrient fertiliser

2 % by mass of a micronutrient suspension fertiliser shall consist of a micronutrient

Micronutrient chelate fertiliser

A water-soluble straight inorganic micronutrient fertiliser in which the declared micronutrient is chemically combined with chelating agent(s) fulfilling the requirements of CMC 1 in Part II of Annex II

—  5 % by mass of a micronutrient chelate fertiliser shall consist of a water-soluble micronutrient, and

—  at least 80 % of the water-soluble micronutrient shall be chelated by a chelating agent fulfilling the requirements of CMC 1 in Part II of Annex II

UVCB1 iron chelates

A water-soluble straight inorganic micronutrient fertiliser in which the declared iron is chemically combined with chelating agent(s) fulfilling the requirements of CMC 1 in Part II of Annex II

—  5 % by mass of UVCB iron chelates shall consist of water-soluble iron, and

—  at least 80 % of the water-soluble iron shall be chelated and at least 50 % of the water soluble iron shall be chelated by a chelating agent fulfilling the requirements of CMC 1 in Part II of Annex II

Micronutrient complex fertiliser

A water-soluble straight inorganic micronutrient fertiliser in which the declared micronutrient is chemically combined with complexing agent(s) fulfilling the requirements of CMC 1 in Part II of Annex II

—  5 % by mass of a micronutrient complex fertiliser shall consist of a water-soluble micronutrient, and

—  at least 80 % of the water-soluble micronutrient shall be complexed by a complexing agent fulfilling the requirements of CMC 1 in Part II of Annex II

1 UVCB: Substance of unknown or variable composition, complex reaction products or biological materials.

PFC 1(C)(II)(b): Compound inorganic micronutrient fertiliser

1.  A compound inorganic micronutrient fertiliser shall have a declared content of more than one micronutrient.

2.  The sum of all declared micronutrient contents in a compound inorganic micronutrient fertiliser shall be at least:

(a)  2 % by mass for fertilisers in liquid form;

(b)  5 % by mass for ▌ fertilisers in solid form.

PFC 2: Liming material

1.  A liming material shall be an EU fertilising product the function of which is to correct soil acidity.

A liming material shall contain oxides, hydroxides, carbonates or silicates of the nutrients calcium (Ca) or magnesium (Mg).

2.  Contaminants in a liming material must not exceed the following limit values:

(a)   cadmium (Cd): 2 mg/kg dry matter,

(b)   hexavalent chromium (Cr VI): 2 mg/kg dry matter,

(c)   mercury (Hg): 1 mg/kg dry matter,

(d)   nickel (Ni): 90 mg/kg dry matter,

(e)  lead (Pb): 120 mg/kg dry matter, ▌

(f)  arsenic (As): 40 mg/kg dry matter.

3.  The copper (Cu) content in a liming material must not exceed 300 mg/kg dry matter, and the zinc (Zn) content in a liming material must not exceed  800 mg/kg dry matter.

4.  The following parameters determined on the basis of the mass of a liming material shall be met:

(a)   minimum neutralising value: 15 (equivalent CaO) or 9 (equivalent HO-),

(b)   minimum reactivity: 10 % (hydrochloric acid test) or 50 % after 6 months (incubation test), and

(c)  minimum grain size: at least 70 % < 1 mm, except for burnt limes, granulated liming material and chalk (at least 70 % of the liming material shall pass through a 1 mm sieve).

PFC 3: Soil improver

A soil improver shall be an EU fertilising product the function of which is to maintain, improve or protect the physical or chemical properties, the structure or the biological activity of the soil to which it is added.

PFC 3(A): Organic soil improver

1.  An organic soil improver shall consist ▌of material 95 % of which is of solely biological origin.

An organic soil improver may contain peat, leonardite and lignite, but no other material which is fossilized or embedded in geological formations.

2.  Contaminants in an organic soil improver must not exceed the following limit values:

(a)   cadmium (Cd): 2 mg/kg dry matter,

(b)   hexavalent chromium (Cr VI): 2 mg/kg dry matter,

(c)   mercury (Hg): 1 mg/kg dry matter,

(d)   nickel (Ni): 50 mg/kg dry matter, ▌

(e)   lead (Pb): 120 mg/kg dry matter, and

(f)  inorganic arsenic (As): 40 mg/kg dry matter.

3.  The copper (Cu) content in an organic soil improver must not exceed 300 mg/kg dry matter, and the zinc (Zn) content in an organic soil improver must not exceed 800 mg/kg dry matter.

4.  Pathogens in an organic soil improver must not exceed the limits set out in the following table:

Micro-organisms to be tested

Sampling plans

Limit

n

c

m

M

Salmonella spp.

5

0

0

Absence in 25 g or 25 ml

Escherichia coli or Enterococcaceae

5

5

0

1 000 in 1 g or 1 ml

Where:

n = number of samples to be tested,

c = number of samples where the number of bacteria expressed in CFU is between m and M,

m = threshold value for the number of bacteria expressed in CFU that is considered satisfactory,

M = maximum value of the number of bacteria expressed in CFU.

5.  An organic soil improver shall contain 20 % or more dry matter.

6.  Organic carbon (Corg) content in an organic soil improver shall be at least 7,5 % by mass.

PFC 3(B): Inorganic soil improver

1.  An inorganic soil improver shall be a soil improver other than an organic soil improver.

2.  Contaminants in an inorganic soil improver must not exceed the following limit values:

(a)   cadmium (Cd): 1,5 mg/kg dry matter,

(b)   hexavalent chromium (Cr VI): 2 mg/kg dry matter,

(c)   mercury (Hg): 1 mg/kg dry matter,

(d)   nickel (Ni): 100 mg/kg dry matter, ▌

(e)  lead (Pb): 120 mg/kg dry matter,

(f)  inorganic arsenic (As): 40 mg/kg dry matter.

3.  The copper (Cu) content in an inorganic soil improver must not exceed 300 mg/kg dry matter, and the zinc (Zn) content in an inorganic soil improver must not exceed 800 mg/kg dry matter.

PFC 4: Growing medium

1.  A growing medium shall be an EU fertilising product other than soil in situ, the function of which is for plants or mushrooms to grow in.

For the purpose of this point, plants include algae.

2.  Contaminants in a growing medium must not exceed the following limit values:

(a)   cadmium (Cd): 1,5 mg/kg dry matter,

(b)   hexavalent chromium (Cr VI): 2 mg/kg dry matter,

(c)   mercury (Hg): 1 mg/kg dry matter,

(d)   nickel (Ni): 50 mg/kg dry matter, ▌

(e)   lead (Pb) 120 mg/kg dry matter, and

(f)  inorganic arsenic (As): 40 mg/kg dry matter.

3.  The copper (Cu) content in a growing medium must not exceed 200 mg/kg dry matter, and the zinc (Zn) content in a growing medium must not exceed 500 mg/kg dry matter.

4.  Pathogens in a growing medium must not exceed the limits set out in the following table:

Micro-organisms to be tested

Sampling plans

Limit

n

c

m

M

Salmonella spp.

5

0

0

Absence in 25 g or 25 ml

Escherichia coli or Enterococcaceae

5

5

0

1 000 in 1 g or 1 ml

Where:

n = number of samples to be tested,

c = number of samples where the number of bacteria expressed in CFU is between m and M,

m = threshold value for the number of bacteria expressed in CFU that is considered satisfactory,

M = maximum value of the number of bacteria expressed in CFU.

PFC 5 ▌: Inhibitor

An inhibitor shall be an EU fertilising product the function of which is to improve the nutrient release patterns of a product providing plants with nutrients by delaying or stopping the activity of specific groups of micro-organisms or enzymes.

PFC 5(A) ▌: Nitrification inhibitor

1.  A nitrification inhibitor shall inhibit the biological oxidation of ammoniacal nitrogen (NH3-N) to nitrite nitrogen (NO2-), thus slowing the formation of nitrate nitrogen (NO3-).

2.  The ammoniacal nitrogen (NH3-N) oxidation rate shall be measured by:

(a)  ammoniacal nitrogen (NH3-N) disappearance, or

(b)  the sum of nitrite nitrogen (NO2-) and nitrate nitrogen (NO3-) production with respect to time.

Compared to a control sample where the nitrification inhibitor has not been added, a soil sample containing the nitrification inhibitor ▌ shall show a 20 % reduction in ammoniacal nitrogen (NH3-N) oxidation rate based on an analysis carried out 14 days after application at the 95% confidence level.

PFC 5(B): Denitrification inhibitor

1.  A denitrification inhibitor shall inhibit the formation of nitrous oxide (N2O) by slowing down or blocking the conversion of nitrate (NO3-) to dinitrogen (N2) without influencing the nitrification process as described in PFC 5(A).

2.  Compared to a control sample where the denitrification inhibitor has not been added, an in vitro test containing the denitrification inhibitor shall show a 20 % reduction in rate of the release of nitrous oxide (N2O) based on an analysis carried out 14 days after application at the 95 % confidence level.

PFC 5(C): Urease inhibitor

1.  A urease inhibitor shall inhibit hydrolytic action on urea (CH4N2O) by the urease enzyme, primarily targeted to reduce ammonia volatilisation.

2.  Compared to a control sample where the urease inhibitor has not been added, an in-vitro test containing the urease inhibitor shall show a 20 % reduction in the rate of hydrolysis of urea (CH4N2O) based on an analysis carried out 14 days after application at the 95 % confidence level.

PFC 6: Plant biostimulant

1.  A plant biostimulant shall be an EU fertilising product the function of which is to stimulate plant nutrition processes independently of the product's nutrient content with the sole aim of improving one or more of the following characteristics of the plant or the plant rhizosphere:

(a)  nutrient use efficiency,

(b)  tolerance to abiotic stress,

(c)  ▌ quality traits, or

(d)  availability of confined nutrients in the soil or rhizosphere.

2.  Contaminants in a plant biostimulant must not exceed the following limit values:

(a)   cadmium (Cd): 1,5 mg/kg dry matter,

(b)   hexavalent chromium (Cr VI): 2 mg/kg dry matter, ▌

(c)   lead (Pb): 120 mg/kg dry matter,

(d)  mercury (Hg): 1 mg/kg dry matter,

(e)  nickel (Ni): 50 mg/kg dry matter, and

(f)  inorganic arsenic (As): 40 mg/kg dry matter.

3.  The copper (Cu) content in a plant biostimulant must not exceed 600 mg/kg dry matter, and the zinc (Zn) content in a plant biostimulant must not exceed 1 500 mg/kg dry matter.

4.  The plant biostimulant shall have the effects that are claimed on the label for the plants specified thereon.

PFC 6(A): Microbial plant biostimulant

1.  A microbial plant biostimulant shall consist ▌ of a micro-organism or a consortium of micro-organisms referred to in CMC 7 in Part II of Annex II.

2.  Pathogens in a microbial plant biostimulant must not exceed the limits set out in the following table:

Micro-organisms/their toxins, metabolites

Sampling plans

Limit

n

c

Salmonella spp.

5

0

Absence in 25 g or 25 ml

Escherichia coli

5

0

Absence in 1 g or 1 ml

Listeria monocytogenes

5

0

Absence in 25 g or 25 ml

Vibrio spp.

5

0

Absence in 25 g or 25 ml

Shigella spp.

5

0

Absence in 25 g or 25 ml

Staphylococcus aureus

5

0

Absence in 25 g or 25 ml

Enterococcaceae

5

2

10 CFU/g

Anaerobic plate count unless the microbial plant biostimulant is an aerobic bacterium

5

2

105 CFU/g or ml

Yeast and mould count unless the microbial plant biostimulant is a fungus

5

2

1 000 CFU/g or ml

▌Where:

n = number of units comprising the sample,

c = number of sample units giving values over the defined limit.

3.  When the microbial plant biostimulant is in liquid form, the plant biostimulant shall have a pH optimal for contained micro-organisms and for plants.

PFC 6(B): Non-microbial plant biostimulant

1.  A non-microbial plant biostimulant shall be a plant biostimulant other than a microbial plant biostimulant.

2.  Pathogens in a non-microbial plant biostimulant must not exceed the limits set out in the following table:

Micro-organisms

to be tested

Sampling

plans

Limit

n

c

m

M

Salmonella spp.

5

0

0

Absence in

25 g or 25 ml

Escherichia coli

or

Enterococcaceae

5

5

0

1 000 in

1 g or 1 ml

Where:

n = number of samples to be tested,

c = number of samples where the number of bacteria expressed in CFU is between m and M,

m = threshold value for the number of bacteria expressed in CFU that is considered satisfactory,

M = maximum value of the number of bacteria expressed in CFU.

PFC 7: Fertilising product blend

1.  A fertilising product blend shall be an EU fertilising product composed of two or more EU fertilising products of PFC 1 to PFC 6 for which the compliance with the requirements of this Regulation of each component EU fertilising product in the blend has been demonstrated in accordance with the conformity assessment procedure applicable to that component EU fertilising product.

2.  The blending shall not change the nature of each component EU fertilising product and shall not have an adverse effect on human, animal or plant health, on safety, or on the environment, under reasonably foreseeable conditions of storage or use of the fertilising product blend.

3.  The manufacturer of the blend shall assess the conformity of the blend with the requirements set out in points 1 and 2 of this PFC, ensure the blend's compliance with the labelling requirements laid down in Annex III, and assume responsibility pursuant to Article 16(4) of this Regulation for the compliance of the blend with the requirements of this Regulation by:

(a)   drawing up an EU declaration of conformity for the fertilising product blend in accordance with Article 6(2) of this Regulation, and

(b)   being in possession of the EU declaration of conformity of each of the component EU fertilising products.

4.  Economic operators making fertilising product blends available on the market shall respect the following provisions of this Regulation with regard to the EU declaration of conformity of each component EU fertilising product as well as of the blend:

(a)   Article 6(3) (manufacturers' obligation to keep the EU declaration of conformity);

(b)   point (a) of Article 7(2) (authorised representatives' obligation to keep the EU declaration of conformity);

(c)   Article 8(8) (importers' obligation to keep a copy of the EU declaration of conformity at the disposal of the market surveillance authorities).

ANNEX II

Component Material Categories (CMCs)

An EU fertilising product shall consist solely of component materials complying with the requirements for one or more of the CMCs listed in this Annex.

The component materials, and the input materials used to produce them, shall not contain any of the substances for which maximum limit values are indicated in Annex I in such quantities as to jeopardise the EU fertilising product's compliance with the applicable requirements of that Annex.

Part I

Designation of CMCs

CMC 1: Virgin material substances and mixtures

CMC 2: Plants, plant parts or plant extracts

CMC 3: Compost

CMC 4: Fresh crop digestate

CMC 5: Digestate other than fresh crop digestate

CMC 6: Food industry by-products

CMC 7: Micro-organisms

CMC 8: Nutrient polymers

CMC 9: Polymers other than nutrient polymers

CMC 10: Derived products within the meaning of Regulation (EC) No 1069/2009

CMC 11: By-products within the meaning of Directive 2008/98/EC

Part II

Requirements related to CMCs

This Part defines the component materials of which EU fertilising products shall solely consist.

CMC 1: Virgin material substances and mixtures

1.  An EU fertilising product may contain substances and mixtures, except(38):

(a)  waste within the meaning of Directive 2008/98/EC,

(b)  substances or mixtures which have ceased to be waste in one or more Member States by virtue of the national measures transposing Article 6 of Directive 2008/98/EC,

(c)  substances formed from precursors which have ceased to be waste in one or more Member States by virtue of the national measures transposing Article 6 of Directive 2008/98/EC, or mixtures containing such substances,

(d)  by-products within the meaning of Directive 2008/98/EC,

(e)  animal by-products or derived products within the meaning of Regulation (EC) No 1069/2009,

(f)  polymers ▌,

(g)  compost, or

(h)  digestate.

2.  All substances incorporated into the EU fertilising product, on their own or in a mixture, shall have been registered pursuant to Regulation (EC) No 1907/2006(39), with a dossier containing:

(a)  the information provided for by Annexes VI, VII and VIII to Regulation (EC) No 1907/2006, and

(b)  a chemical safety report pursuant to Article 14 of Regulation (EC) No 1907/2006 covering the use as a fertilising product,

unless explicitly covered by one of the registration obligation exemptions provided for by Annex IV to Regulation (EC) No 1907/2006 or by points 6, 7, 8, or 9 of Annex V to that Regulation.

3.  Where the substance or one of the substances in the mixture is intended to enhance the long term availability to plants of micronutrients in the EU fertilising product, that substance shall be either a chelating agent or a complexing agent, and the following rules shall apply:

(a)  The chelating agent shall be an organic substance consisting in a molecule which:

(i)  has two or more sites that donate electron pairs to a central transition metal cation (zinc (Zn), copper (Cu), iron (Fe), manganese (Mn), magnesium (Mg), calcium (Ca) or cobalt (Co)), and

(ii)  is large enough to form a five- or six- membered cyclic structure.

The EU fertilising product shall remain stable in standard Hoagland solution at pH 7 and 8 for at least 3 days.

(b)  The complexing agent shall be an organic substance forming a flat or steric structure with one di- or tri- valent transition metal cation (zinc (Zn), copper (Cu), iron (Fe), manganese (Mn) or cobalt (Co)).

The EU fertilising product shall remain stable in water solution at pH 6 and 7 for at least 1 day.

4.  Where the substance or one of the substances in the mixture is intended to improve the EU fertilising product's nutrient release patterns by delaying or stopping the activity of specific groups of micro-organisms or enzymes, that substance shall be an a nitrification inhibitor, a denitrification inhibitor or a urease inhibitor, and the following rules shall apply:

(a)  The nitrification inhibitor shall inhibit the biological oxidation of ammoniacal nitrogen (NH3-N) to nitrite nitrogen (NO2-), thus slowing the formation of nitrate nitrogen (NO3-).

The ammoniacal nitrogen (NH3-N) oxidation rate shall be measured either by:

(i)  ammoniacal nitrogen (NH3-N) disappearance, or

(ii)  the sum of nitrite nitrogen (NO2-) and nitrate nitrogen (NO3-) production with respect to time.

Compared to a control sample where the nitrification inhibitor has not been added, a soil sample containing the nitrification inhibitor shall show a 20 % reduction in ammoniacal nitrogen (NH3-N) oxidation rate based on an analysis carried out 14 days after application at the 95 % confidence level.

At least 50 % of the total nitrogen (N) content of the EU fertilising product shall consist of the nitrogen (N) forms ammonium (NH4+) and urea (CH4N2O).

(b)  The denitrification inhibitor shall inhibit the formation of nitrous oxide (N2O) by slowing down or blocking the conversion of nitrate (NO3)- to dinitrogen (N2) without influencing the nitrification process as described in PFC 5(A).

Compared to a control sample where the denitrification inhibitor has not been added, an in vitro test containing the denitrification inhibitor shall show a 20 % reduction in rate of the release of nitrous oxide (N2O) based on an analysis carried out 14 days after application at the 95 % confidence level.

(c)  The urease inhibitor shall inhibit hydrolytic action on urea (CH4N2O) by the urease enzyme, primarily targeted to reduce ammonia volatilisation. Compared to a control sample where the urease inhibitor has not been added, an in-vitro test containing the urease inhibitor shall show a 20 % reduction in the rate of hydrolysis of urea (CH4N2O) based on an analysis carried out 14 days after application at the 95 % confidence level.

At least 50 % of the total nitrogen (N) content of the EU fertilising product shall consist of the nitrogen (N) form urea (CH4N2O).

CMC 2: Plants, plant parts or plant extracts

An EU fertilising product may contain plants, plant parts or plant extracts having undergone no other processing than cutting, grinding, milling, sieving, sifting, centrifugation, pressing, drying, frost treatment, freeze-drying or extraction with water or supercritical CO2 extraction.

For the purpose of this point, plants include mushrooms and algae and exclude blue-green algae (cyanobacteria).

CMC 3: Compost

1.  An EU fertilising product may contain compost obtained through aerobic composting of exclusively one or more of the following input materials:

(a)  bio-waste within the meaning of Directive 2008/98/EC resulting from separate bio-waste collection at source;

(b)  derived products referred to in Article 32 of Regulation (EC) No 1069/2009 for which the end point in the manufacturing chain has been determined in accordance with the third subparagraph of Article 5(2) of that Regulation;

(c)  living or dead organisms or parts thereof, which are unprocessed or processed only by manual, mechanical or gravitational means, by dissolution in water, by flotation, by extraction with water, by steam distillation or by heating solely to remove water, or which are extracted from air by any means, except:

—   the organic fraction of mixed municipal household waste separated through mechanical, physicochemical, biological and/or manual treatment,

—   sewage sludge, industrial sludge or dredging sludge, and

—   animal by-products or derived products falling within the scope of ▌ Regulation (EC) No 1069/2009 for which no end point in the manufacturing chain has been determined in accordance with the third subparagraph of Article 5(2) of that Regulation;

(d)  composting additives which are necessary to improve the process performance or the environmental performance of the composting process provided that:

(i)   the additive is registered pursuant to Regulation (EC) No 1907/2006(40), with a dossier containing:

–  the information provided for by Annexes VI, VII and VIII to Regulation (EC) No 1907/2006, and

–  a chemical safety report pursuant to Article 14 of Regulation (EC) No 1907/2006 covering the use as a fertilising product,

unless explicitly covered by one of the registration obligation exemptions provided for by Annex IV to Regulation (EC) No 1907/2006 or by point 6, 7, 8 or 9 of Annex V to that Regulation, and

(ii)   the total concentration of all additives does not exceed 5 % of the total input material weight; or

(e)  any material listed in points (a), (b) or (c) which:

(i)   has previously been composted or digested, and

(ii)   contains no more than 6 mg/kg dry matter of PAH16(41).

2.  The composting shall take place in a plant:

(a)  in which production lines for the processing of input materials referred to in point 1 are clearly separated from production lines for the processing of input materials other than those referred to in point 1, and

(b)   where physical contacts between input and output materials are avoided, including during storage.

3.  The aerobic composting shall consist of controlled decomposition of biodegradable materials, which is predominantly aerobic and which allows the development of temperatures suitable for thermophilic bacteria as a result of biologically produced heat. All parts of each batch shall be either regularly and thoroughly moved and turned or subject to forced ventilation in order to ensure the correct sanitation and homogeneity of the material. During the composting process, all parts of each batch shall have one of the following temperature-time profiles:

–  70°C or more for at least 3 days,

–   65°C or more for at least 5 days,

–   60°C or more for at least 7 days, or

–   55°C or more for at least 14 days.

4.  The compost shall contain:

(a)  no more than 6 mg/kg dry matter of PAH16(42);

(b)  no more than 3 g/kg dry matter of macroscopic impurities above 2 mm in any of the following forms: glass, metal or plastics; and

(c)  no more than 5 g/kg dry matter of the sum of the macroscopic impurities referred to in point (b).

▌From … [seven years after the date of entry into force of this Regulation], the presence of plastics above 2 mm within the maximum limit value referred to in point (b) shall be no more than 2,5 g/kg dry matter ▌. By … [ten years after the date of entry into force of this Regulation] the limit-value of 2,5 g/kg dry matter for plastics above 2 mm shall be re-assessed in order to take into account the progress made with regards to separate collection of bio-waste.

5.  The compost shall meet at least one of the following stability criteria:

(a)  Oxygen uptake rate:

—   Definition: an indicator of the extent to which biodegradable organic matter is being broken down within a specified time period. The method is not suitable for material with a content of particle sizes > 10 mm that exceeds 20 %,

—   Criterion: maximum 25 mmol O2/kg organic matter/h; or

(b)  Self heating factor:

—   Definition: the maximum temperature reached by a compost in standardised conditions as an indicator of the state of its aerobic biological activity,

—   Criterion: minimum Rottegrad III.

CMC 4: Fresh crop digestate

1.  An EU fertilising product may contain digestate obtained through anaerobic digestion of exclusively one or more of the following input materials:

(a)  plants or plant parts grown for the production of biogas. For the purpose of this point, plants include algae and exclude blue-green algae (cyanobacteria);

(b)  digestion additives which are needed to improve the process performance or the environmental performance of the digestion process provided that:

(i)   the additive is registered pursuant to Regulation (EC) No 1907/2006(43), with a dossier containing:

–  the information provided for by Annexes VI, VII and VIII to Regulation (EC) No 1907/2006, and

–  a chemical safety report pursuant to Article 14 of Regulation (EC) No 1907/2006 covering the use as a fertilising product,

unless explicitly covered by one of the registration obligation exemptions provided for by Annex IV to Regulation (EC) No 1907/2006 or by point 6, 7, 8 or 9 of Annex V to that Regulation, and

(ii)   the total concentration of all additives does not exceed 5 % of the total input material weight; or

(c)  any material referred to in point (a) ▌ that has previously been digested.

2.  The anaerobic digestion shall take place in a plant:

(a)  in which production lines for the processing of input materials referred to in point 1 are clearly separated from production lines for the processing of input materials other than those referred to in point 1, and

(b)   where physical contacts between input and output materials are avoided, including during storage.

3.  The anaerobic digestion shall consist of controlled decomposition of biodegradable materials, which is predominantly anaerobic and at temperatures suitable for mesophilic or thermophilic bacteria. All parts of each batch shall be regularly and thoroughly moved and turned in order to ensure the correct sanitation and homogeneity of the material. During the digestion process, all parts of each batch shall have one of the following temperature-time profiles:

(a)  thermophilic anaerobic digestion at 55°C for at least 24 hours followed by a hydraulic retention time of at least 20 days;

(b)  thermophilic anaerobic digestion at 55°C with a treatment process including pasteurisation as described in point 1 of Section 1 of Chapter I of Annex V to Commission Regulation (EU) No 142/2011(44);

(c)  thermophilic anaerobic digestion at 55°C followed by composting in:

–  70°C or more for at least 3 days,

–  65°C or more for at least 5 days,

–  60°C or more for at least 7 days, or

–  55°C or more for at least 14 days;

(d)  mesophilic anaerobic digestion at 37-40°C with a treatment process including ▌ pasteurisation as described in point 1 of Section 1 of Chapter I of Annex V to Regulation (EU) No 142/2011; or

(e)  mesophilic anaerobic digestion at 37-40°C followed by composting in:

–  70°C or more for at least 3 days,

–  65°C or more for at least 5 days,

–  60°C or more for at least 7 days, or

–  55°C or more for at least 14 days.

4.  Both the solid and the liquid part of the digestate shall meet at least one of the following stability criteria:

(a)  Oxygen uptake rate:

–  Definition: an indicator of the extent to which biodegradable organic matter is being broken down within a specified time period. The method is not suitable for material with a content of particle sizes > 10 mm that exceeds 20 %;

–  Criterion: maximum 25 mmol O2/kg organic matter/h; or

(b)  Residual biogas potential:

–  Definition: an indicator of the gas released from a digestate in a 28 day period and measured against the volatile solids contained within the sample. The test is run in triplicate, and the average result is used to demonstrate compliance with the criterion. The volatile solids are those solids in a sample of material that are lost on ignition of the dry solids at 550°C.

–  Criterion: maximum 0,25 l biogas/g volatile solids.

CMC 5: digestate other than fresh crop digestate

1.  An EU fertilising product may contain digestate obtained through anaerobic digestion of exclusively one or more of the following input materials:

(a)  bio-waste within the meaning of Directive 2008/98/EC resulting from separate bio-waste collection at source;

(b)  derived products referred to in Article 32 of Regulation (EC) No 1069/2009 for which the end point in the manufacturing chain has been determined in accordance with the third subparagraph of Article 5(2) of that Regulation;

(c)  living or dead organisms or parts thereof which are unprocessed or processed only by manual, mechanical or gravitational means, by dissolution in water, by flotation, by extraction with water, by steam distillation or by heating solely to remove water, or which are extracted from air by any means, except:

(i)  the organic fraction of mixed municipal household waste separated through mechanical, physicochemical, biological and/or manual treatment,

(ii)  sewage sludge, industrial sludge or dredging sludge,

(iii)  animal by-products or derived products falling within the scope of ▌ Regulation (EC) No 1069/2009 for which no end point in the manufacturing chain has been determined in accordance with the third subparagraph of Article 5(2) of that Regulation;

(d)  digestion additives which are necessary to improve the process performance or the environmental performance of the digestion process provided that:

(i)  the additive is registered pursuant to Regulation (EC) No 1907/2006(45), with a dossier containing:

—  the information provided for by Annexes VI, VII and VIII to Regulation (EC) No 1907/2006, and

—  a chemical safety report pursuant to Article 14 of Regulation (EC) No 1907/2006 covering the use as a fertilising product,

unless explicitly covered by one of the registration obligation exemptions provided for by Annex IV to Regulation (EC) No 1907/2006 or by point 6, 7, 8 or 9 of Annex V to that Regulation, and

(ii)  the total concentration of all additives does not exceed 5 % of the total input material weight; or

(e)  any material listed in points (a), (b) or (c) which:

(i)  has previously been composted or digested, and

(ii)  contains no more than 6 mg/kg dry matter of PAH16(46).

2.  The anaerobic digestion shall take place in a plant:

(a)  in which production lines for the processing of input materials referred to in point 1 are clearly separated from production lines for the processing of input materials other than those referred to in point 1, and

(b)  where physical contacts between input and output materials are avoided, including during storage.

3.  The anaerobic digestion shall consist of controlled decomposition of biodegradable materials, which is predominantly anaerobic and at temperatures suitable for mesophilic or thermophilic bacteria. All parts of each batch shall be regularly and thoroughly moved and turned in order to ensure the correct sanitation and homogeneity of the material. During the digestion process, all parts of each batch shall have one of the following temperature-time profiles:

(a)  thermophilic anaerobic digestion at 55°C for at least 24 hours followed by a hydraulic retention time of at least 20 days;

(b)  thermophilic anaerobic digestion at 55°C with a treatment process including ▌ pasteurisation as described in point 1 of Section 1 of Chapter I of Annex V to Regulation (EU) No 142/2011;

(c)  thermophilic anaerobic digestion at 55°C followed by composting in:

–  70°C or more for at least 3 days,

–  65°C or more for at least 5 days,

–  60°C or more for at least 7 days, or

–  55°C or more for at least 14 days;

(d)  mesophilic anaerobic digestion at 37-40°C with a treatment process including ▌ pasteurisation as described in point 1 of Section 1 of Chapter I of Annex V to Regulation (EU) No 142/2011; or

(e)  mesophilic anaerobic digestion at 37-40°C followed by composting in:

–  70°C or more for at least 3 days,

–  65°C or more for at least 5 days,

–  60°C or more for at least 7 days, or

–  55°C or more for at least 14 days.

4.  Neither the solid nor the liquid part of the digestate shall contain more than 6 mg/kg dry matter of PAH16(47).

5.  The digestate shall contain:

(a)  no more than 3 g/kg dry matter of macroscopic impurities above 2 mm in any of the following forms: glass, metal or plastics; and

(b)  no more than 5 g/kg dry matter of the sum of the macroscopic impurities referred to in point (a).

From… [seven years after the date of entry into force of this Regulation], the presence of plastics above 2 mm within the maximum limit value referred to in point (a) shall be no more than 2,5 g/kg dry matter ▌. By … [ten years after the date of entry into force of this Regulation] the limit-value of 2,5 g/kg dry matter for plastics above 2 mm shall be re-assessed in order to take into account the progress made with regards to separate collection of bio-waste.

6.  Both the solid and the liquid part of the digestate shall meet at least one of the following stability criteria:

(a)  Oxygen uptake rate:

–  Definition: an indicator of the extent to which biodegradable organic matter is being broken down within a specified time period. The method is not suitable for material with a content of particle sizes > 10 mm that exceeds 20 %.

–  Criterion: maximum 25 mmol O2/kg organic matter/h; or

(b)  Residual biogas potential:

–  Definition: an indicator of the gas released from a digestate in a 28 day period and measured against the volatile solids contained within the sample. The test is run in triplicate, and the average result is used to demonstrate compliance with the criterion. The volatile solids are those solids in a sample of material that are lost on ignition of the dry solids at 550°C.

–  Criterion: maximum 0,25 l biogas/g volatile solids.

CMC 6: Food industry by-products

1.  An EU fertilising product may contain component material consisting of one of the following substances:

(a)  food industry factory lime, i.e. a material from the food processing industry obtained by carbonation of organic matter, using exclusively burnt lime from natural sources;

(b)  molasses, i.e. a viscous by-product of the refining of sugarcane or sugar beets into sugar;

(c)  vinasse, i.e. a viscous by-product of the fermentation process of molasses into ethanol, ascorbic acid or other products;

(d)  distillers grains, i.e. by-products resulting from the production of alcoholic beverages;

(e)  plants, plant parts or plant extracts having undergone only heat treatment or heat treatment in addition to processing methods referred to in CMC 2; or

(f)  lime from drinking water production, i.e. residue which is released by production of drinking water from groundwater or surface water and consists, mainly, of calcium carbonate.

2.  All substances incorporated into the EU fertilising product, on their own or in a mixture, shall have been registered pursuant to Regulation (EC) No 1907/2006(48), with a dossier containing:

(a)  the information provided for by Annexes VI, VII and VIII to Regulation (EC) No 1907/2006, and

(b)  a chemical safety report pursuant to Article 14 of Regulation (EC) No 1907/2006 covering the use as a fertilising product,

unless explicitly covered by one of the registration obligation exemptions provided for by Annex IV to Regulation (EC) No 1907/2006 or by point 6, 7, 8, or 9 of Annex V to that Regulation.

CMC 7: Micro-organisms

An EU fertilising product belonging to PFC 6(A) may contain micro-organisms, including dead or empty-cell micro-organisms and non-harmful residual elements of the media on which they were produced, which:

–  have undergone no other processing than drying or freeze-drying; and

–  are listed in the following table:

Azotobacter spp.

Mycorrhizal fungi

Rhizobium spp.

Azospirillum spp.

CMC 8: Nutrient polymers

1.  An EU fertilising product may contain polymers exclusively made up of monomer substances complying with the criteria set out in points 1 and 2 of CMC 1, where the purpose of the polymerisation is to control the release of nutrients from one or more of the monomer substances.

2.  At least 60 % of the polymers shall be soluble in a phosphate buffer solution with a pH of 7,5 at 100 ºC.

3.  The final degradation products shall be only ammonia (NH3), water and carbon dioxide(CO2).

4.  The polymers shall not contain more than 600 ppm of free formaldehyde.

CMC 9: Polymers other than nutrient polymers

1.  An EU fertilising product may contain polymers other than nutrient polymers only in cases where the purpose of the polymer is:

(a)  to control the water penetration into nutrient particles and thus the release of nutrients (in which case the polymer is commonly referred to as a 'coating agent'),

(b)  to increase the water retention capacity or wettability of the EU fertilising product, or

(c)  to bind material in an EU fertilising product belonging to PFC 4.

2.  From … [seven years after the date of entry into force of this Regulation], the polymers referred to in point 1(a) and (b) shall comply with the biodegradability criteria established by delegated acts referred to in Article 42(6). In the absence of such criteria, an EU fertilising product placed on the market after that date shall not contain such polymers.

3.  For the polymers referred to in point  1(a) and (b), neither the polymer, nor its degradation by-products, shall show any overall adverse effect on animal or plant health, or on the environment, under reasonably foreseeable conditions of use in the EU fertilising product. The polymer shall pass a plant growth acute toxicity test, an earthworm acute toxicity test and a nitrification inhibition test with soil micro-organisms as follows:

(a)  In the plant growth acute toxicity test, the germination rate and the plant biomass of the tested plant species grown on the soil exposed to the test material shall be more than 90 % of the germination rate and the plant biomass of the same plant species grown on corresponding blank soil not exposed to the test material.

▌The results shall ▌ be considered to be valid only if in the controls (i.e. blank soil):

–  the seedling emergence is at least 70 %;

–  the seedlings do not exhibit visible phytotoxic effects (e.g. chlorosis, necrosis, wilting, leaf and stem deformations) and the plants exhibit only normal variation in growth and morphology for that particular species;

–  the mean survival of emerged control seedlings is at least 90 % for the duration of the study; and

–  environmental conditions for a particular species are identical and growing media contain the same amount of soil matrix, support media, or substrate from the same source.

(b)  In the earthworm acute toxicity test, the observed mortality and the biomass of surviving earthworms in a soil exposed to the test material shall not differ by more than 10 % compared to those from the corresponding blank soil not exposed to the test material. The results shall be considered to be valid, if:

–  the percent mortality observed in the control (i.e. blank soil) is less than 10 %, and

–  the average loss of biomass (mean weight) of the worms in the blank soil does not exceed 20 %.

(c)  In the nitrification inhibition test with soil micro-organisms, the nitrite formation in soil exposed to the test material shall be more than 90 % of those from the corresponding blank soil not exposed to the test material. The results shall be considered to be valid, if the variation between replicate control samples (blank soil) and test samples is less than 20 %.

CMC 10: derived products within the meaning of Regulation (EC) No 1069/2009

An EU fertilising product may contain derived products within the meaning of Regulation (EC) No 1069/2009 having reached the end point in the manufacturing chain as determined in accordance with that Regulation, and which are listed in the following table and as specified therein(49):

CMC 11: By-products within the meaning of Directive 2008/98/EC

1.  An EU fertilising product may contain by-products within the meaning of Directive 2008/98/EC, except(50):

(a)  animal by-products or derived products within the meaning of Regulation (EC) No 1069/2009,

(b)  polymers,

(c)  compost, or

(d)  digestate.

2.  The by-products shall have been registered pursuant to Regulation (EC) No 1907/2006, with a dossier containing:

(a)  the information provided for by Annexes VI, VII and VIII to Regulation (EC) No 1907/2006, and

(b)  a chemical safety report pursuant to Article 14 of Regulation (EC) No 1907/2006 covering the use as a fertilising product,

unless explicitly covered by one of the registration obligation exemptions provided for by Annex IV to Regulation (EC) No 1907/2006 or by point 6, 7, 8 or 9 of Annex V to that Regulation.

3.  From … [three years after the date of entry into force of this Regulation], the by-products shall comply with the criteria established by delegated act referred to in Article 42(7). An EU fertilising product placed on the market after that date shall not contain by-products referred to in point 1 which do not comply with such criteria.

ANNEX III

Labelling requirements

This Annex sets out the labelling requirements for EU fertilising products. The requirements laid down in Part II and Part III of this Annex for a given PFC, as specified in Annex I, apply to EU fertilising products in all subcategories of that PFC.

Part I

General labelling requirements

1.  The following information shall be provided:

(a)  for EU fertilising products in PFC 1 to PFC 6, the designation as indicated in Part I of Annex I of the PFC corresponding to the product's claimed function;

(b)  for EU fertilising products in PFC 7, the designations as indicated in Part I of Annex I of all the PFCs corresponding to the claimed functions of the component EU fertilising products;

(c)  the quantity of the EU fertilising product, indicated by mass or volume;

(d)  instructions for intended use, including application rates, timing and frequency, and target plants or mushrooms;

(e)  recommended storage conditions;

(f)  for products containing a polymer belonging to CMC 9 in Part II of Annex II, the time period following use during which the nutrient release is being controlled or the water retention capacity is being increased (the 'functionality period'), which shall not be longer than the period between two applications in accordance with the use instructions referred to in point (d);

(g)  any relevant information on measures recommended to manage risks to human, animal or plant health, to safety or to the environment; and

(h)  a list of all ingredients above 5 % by product weight in descending order of magnitude by dry weight, including the designations of the relevant CMCs as referred to in Part I of Annex II to this Regulation; where the ingredient is a substance or a mixture, it shall be identified as specified in Article 18 of Regulation (EC) No 1272/2008.

2.  Where the EU fertilising product has functions described in two or more of the PFCs laid down in Annex I, only those functions for which the EU fertilising product ▌ has ▌ been subject to a successful conformity assessment in accordance with this Regulation may be claimed by using the corresponding PFC designations as indicated in Part I of Annex I.

3.  Where the EU fertilising product contains a substance for which maximum residue limits for food and feed have been established in accordance with Regulation (EEC) No 315/93, Regulation (EC) No 396/2005, Regulation (EC) No 470/2009 or Directive 2002/32/EC, the instructions referred to in point 1(d) shall ensure that the intended use of the EU fertilising product does not lead to the exceedance of those limits in food or feed.

4.  Where the EU fertilising product contains derived products within the meaning of Regulation (EC) No 1069/2009 other than manure, the following instruction shall be provided on the label: "Farmed animals shall not be fed, either directly or by grazing, with herbage from land to which the product has been applied unless the cutting or grazing takes place after the expiry of a waiting period of at least 21 days.".

5.  Where the EU fertilising product contains ricin, the following instruction shall be provided on the label: "Hazardous to animals in case of ingestion".

6.  Where the EU fertilising product contains unprocessed or processed cocoa shells, the following instruction shall be provided on the label: "Toxic to dogs and cats".

7.  Where the EU fertilising product contains a polymer with the purpose of binding material in the product, as referred to in point 1(c) of CMC 9 in Part II of Annex II, the user shall be instructed not to use the product in contact with soil, and in collaboration with the manufacturer, make sure of a sound disposal of the products after end of use.

8.  Information other than the information required under points 1 to 6:

(a)  shall not mislead the user, for example by attributing to the product properties that it does not possess, or by suggesting that the product possesses unique characteristics which similar products also have;

(b)  shall relate to verifiable factors; ▌

(c)  shall not make claims such as 'sustainable' or 'environmentally friendly' unless such claims refer to legislation, or clearly identified guidelines, standards or schemes, with which the EU fertilising product complies; and

(d)  shall not make claims by means of statements or visual representations that the EU fertilising product prevents or treats plant diseases or protects plants against harmful organisms.

9.  The phrase 'poor in chloride' or similar may only be used if the chloride (Cl-) content is below 30 g/kg of dry matter.

10.  Where the nutrient content information requirements in this Annex are expressed in oxidised form, the nutrient content may be expressed in elemental form instead or in addition to the oxidised form in accordance with the following conversion factors:

phosphorus (P) = phosphorus pentoxide (P2O5) × 0,436;

potassium (K) = potassium oxide (K2O) × 0,830;

calcium (Ca) = calcium oxide (CaO) × 0,715;

magnesium (Mg) = magnesium oxide (MgO) × 0,603;

sodium (Na) = sodium oxide (Na2O) × 0,742;

sulphur (S) = sulphur trioxide (SO3) × 0,400.

11.  Where the information requirements in this Annex refer to organic carbon (Corg), the information may refer to organic matter instead of or in addition to organic carbon (Corg), in accordance with the following conversion factor:

organic carbon (Corg) = organic matter × 0,56.

Part II

Product-specific labelling requirements

PFC 1: Fertiliser

1.  The content of nutrients may be declared only where they are present in the EU fertilising product in the minimum quantity specified in Annex I for the relevant PFC.

2.  If nitrogen (N) or phosphorus (P) are not declared nutrients, the content of nitrogen (N) or phosphorus pentoxide (P2O5) shall nevertheless be indicated if above 0,5 % by mass. That indication shall be separate from the nutrient declaration.

3.  The following rules apply to fertilisers containing ▌ inhibitors, as specified in ▌ CMC 1 in Part II of Annex II:

(a)  the label shall state the words “nitrification inhibitor”, "denitrification inhibitor" or "urease inhibitor" , as relevant ▌;

(b)  the nitrification inhibitor content shall be expressed as a % by mass of the total nitrogen (N) present as ammonium nitrogen (NH4+) and urea nitrogen (CH4N2O);

(c)  the denitrification inhibitor content shall be expressed as a % by mass of the nitrate (NO3-) present;

(d)  the urease inhibitor content shall be expressed as a % by mass of the total nitrogen (N) present as urea nitrogen (CH4N2O).▌

4.  The term "mineral fertiliser" may be used only if the fertiliser belongs to PFC 1(C) and fulfils the following additional conditions:

(a)  the mineral fertiliser must not contain more than 1 % by mass of organic carbon (Corg), other than organic carbon from:

(i)  chelating or complexing agents referred to in point 3 of CMC 1 in Part II of Annex II,

(ii)  nitrification inhibitors, denitrification inhibitors or urease inhibitors referred to in point 4 of CMC 1 in Part II of Annex II,

(iii)  coating agents referred to in point 1(a) of CMC 9 in Part II of Annex II,

(iv)  urea (CH4N2O), or

(v)  calcium cyanamide (CaCN2);

(b)  where phosphorus (P) is a declared nutrient, the declared phosphorus content shall consist only of phosphorus in the phosphatic form, and the mineral fertiliser shall fulfil at least one of the following solubility criteria:

(i)  water solubility: minimum level 40 % of total phosphorus (P),

(ii)  solubility in neutral ammonium citrate: minimum level 75 % of total phosphorus (P), or

(iii)  solubility in formic acid (only for soft rock phosphate): minimum level 55 % of total phosphorus (P);

(c)  where nitrogen (N) is a declared nutrient, the declared nitrogen content shall consist only of the sum of nitric nitrogen, ammoniacal nitrogen, ureic nitrogen, and nitrogen from methylene-urea, from isobutylidenediurea, and from crotonylidenediurea.

PFC 1(A): Organic fertiliser

The following information shall be provided:

(a)  the declared primary nutrients nitrogen (N), phosphorus (P) or potassium (K), by their chemical symbols in the order N-P-K;

(b)  the declared secondary nutrients calcium (Ca), magnesium (Mg), sodium (Na), or sulphur (S) ▌ by their chemical symbols in the order Ca-Mg-Na-S;

(c)  numbers indicating the ▌ content of the declared nutrients total nitrogen (N), total phosphorus in the form of phosphorus pentoxide (P2O5) or total potassium in the form of potassium oxide (K2O), followed by numbers in brackets indicating the total content of calcium oxide (CaO), magnesium oxide (MgO), sodium oxide (Na2O) or sulphur trioxide (SO3);

(d)  the content of the following declared nutrients and other parameters, in the following order and as % by mass:

(i)  nitrogen (N):

–  total nitrogen (N);

–  minimum amount of organic nitrogen (Norg), followed by a description of the origin of the organic matter used;

–  nitrogen ▌ in the form of ammoniacal nitrogen;

(ii)  total phosphorus pentoxide (P2O5);

(iii)  total potassium oxide (K2O);

(iv)  calcium oxide (CaO), magnesium oxide (MgO), sodium oxide (Na2O) and sulphur trioxide (SO3) ▌, expressed:

–  where those nutrients are totally soluble in water, only as the content soluble in water;

–  where the soluble content of those nutrients is at least a quarter of the total content of those nutrients, as the total content and as the content soluble in water;

–  in other cases, as the total content;

(v)  organic carbon (Corg);

(vi)  dry matter;

(e)  the ratio of organic carbon to total nitrogen (Corg/N);

(f)  production date;

(g)  the form of the physical unit of the product, such as powder or pellets, if applicable.

PFC 1(B): Organo-mineral fertiliser

1.  The following information ▌ shall be provided:

(a)  the declared primary nutrients nitrogen (N), phosphorus (P) or potassium (K), by their chemical symbols in the order N-P-K;

(b)  where applicable, the declared secondary nutrients calcium (Ca), magnesium (Mg), ▌ sodium (Na) or sulphur (S) by their chemical symbols in the order Ca-Mg-Na-S;

(c)  numbers indicating the ▌ content of the declared nutrients total nitrogen (N), total phosphorus in the form of phosphorus pentoxide (P2O5) or total potassium in the form of potassium oxide (K2O), followed by numbers in brackets indicating the total content of calcium oxide (CaO), magnesium oxide (MgO), sodium oxide (Na2O) or sulphur trioxide (SO3);

(d)  the content of the following declared nutrients and other parameters, in the following order and as % by mass:

(i)  nitrogen (N):

—  total nitrogen (N);

—  minimum amount of organic nitrogen (Norg), followed by a description of the origin of the organic matter used;

—  nitrogen ▌ in the form of nitric nitrogen;

—  nitrogen ▌ in the form of ammoniacal nitrogen;

—  nitrogen ▌ in the form of urea nitrogen;

(ii)  phosphorus pentoxide (P2O5):

—  total phosphorus pentoxide (P2O5);

—  water-soluble phosphorus pentoxide (P2O5);

—  phosphorus pentoxide (P2O5) soluble in neutral ammonium citrate;

—  where soft ground phosphate is present, phosphorus pentoxide (P2O5) soluble in formic acid;

(iii)  potassium oxide (K2O):

—  total potassium oxide (K2O);

—  water soluble potassium oxide (K2O);

(iv)  calcium oxide (CaO), magnesium oxide (MgO), sodium oxide (Na2O) and sulphur trioxide (SO3) ▌, expressed:

—  where those nutrients are totally soluble in water, only as the content soluble in water;

—  where the soluble content of those nutrients is at least a quarter of the total content of those nutrients, as the total content and as the content soluble in water;

—  in other cases, as the total content; ▌

(v)  organic carbon (Corg);

(vi)  dry matter,

(e)  where urea (CH4N2O) is present, information about the possible air quality impacts of the release of ammonia from the fertiliser use, and an invitation to users to apply appropriate remediation measures.

2.   Where one or more of the micronutrients boron (B), cobalt (Co), ▌ iron (Fe), manganese (Mn) and molybdenum (Mo) ▌ are present in the minimum content indicated as % by mass in the following table, they:

–  shall be declared if they are intentionally added to an organo-mineral fertiliser, and

–  may be declared in other cases:

Micronutrient

Content of micronutrient (% by mass)

Solid organo-mineral fertiliser

Liquid organo-mineral fertiliser

Intended for use on crops or grassland

Intended for horticultural use

Boron (B)

0,01

0,01

0,01

Cobalt (Co)

0,002

n.a.

0,002

Iron (Fe)

0,5

0,02

0,02

Manganese (Mn)

0,1

0,01

0,01

Molybdenum (Mo)

0,001

0,001

0,001

3.  Where one or both of the micronutrients copper (Cu) and zinc (Zn) are present, without being intentionally added, in the minimum content indicated as % by mass in the following table, they may be declared:

Micronutrient

Content of micronutrient (% by mass)

Solid organo-mineral fertiliser

Liquid organo-mineral fertiliser

Intended for use on crops or grassland

Intended for horticultural use

Copper (Cu)

0,01

0,002

0,002

Zinc (Zn)

0,01

0,002

0,002

4.  Where copper (Cu) or zinc (Zn) is intentionally added to the organo-mineral fertiliser, the total content of copper (Cu) or zinc (Zn) shall be declared.

5.  The micronutrients referred to in points 2, 3 and 4 shall be declared after the information on macronutrients. The following information shall be provided:

(a)  indication of the names and chemical symbols of the declared micronutrients, listed in the following order: boron (B), cobalt (Co), copper (Cu), iron (Fe), manganese (Mn), molybdenum (Mo) and zinc (Zn), followed by the names of their counter-ions;

(b)  the total micronutrient content expressed as % by mass:

–  where those micronutrients are totally soluble in water, only as the content soluble in water;

–  where the soluble content of those micronutrients is at least a quarter of the total content of those micronutrients, as the total content and as the content soluble in water;

–  in other cases, as the total content;

(c)  where the declared micronutrients are chelated by chelating agents, the following qualifier after the name and the chemical identifier of the micronutrient:

–  ‘chelated by … (name of the chelating agent or its abbreviation)’, and the amount of chelated micronutrient as % by mass;

(d)  where the organo-mineral fertiliser contains micronutrients complexed by complexing agents ▌ the following qualifier after the name and the chemical identifier of the micronutrient:

–  ‘complexed by … (name of the complexing agent or its abbreviation)’, and the amount of complexed micronutrient as % by mass; ▌

(e)  where micronutrients are intentionally added, the following statement: ‘To be used only where there is a recognised need. Do not exceed the application rate’.

6.  Where an organo-mineral fertiliser has a cadmium (Cd) content equal to or lower than 20 mg/kg phosphorus pentoxide (P2O5), the statement “Low cadmium (Cd) content" or similar, or a visual representation to that effect, may be added.

PFC 1(C): Inorganic fertiliser

PFC 1(C)(I): Inorganic macronutrient fertiliser

1.  The following information shall be provided:

(a)  where applicable, the declared primary nutrients nitrogen (N), phosphorus (P) or potassium (K), by their chemical symbols in the order N-P-K;

(b)  where applicable, the declared secondary nutrients calcium (Ca), magnesium (Mg), ▌ sodium (Na) or sulphur (S) by their chemical symbols in the order Ca-Mg-Na-S;

(c)  numbers indicating the ▌ content of the declared nutrients total nitrogen (N), total phosphorus in the form of phosphorus pentoxide (P2O5) or total potassium in the form of potassium oxide (K2O), followed by numbers in brackets indicating the total content of calcium oxide (CaO), magnesium oxide (MgO), sodium oxide (Na2O) or sulphur trioxide (SO3);

(d)  the content of the following declared nutrients, in the following order and as % by mass:

(i)  nitrogen (N):

—  total nitrogen (N);

–  nitrogen ▌ in the form of nitric nitrogen;

–  nitrogen ▌ in the form of ammoniacal nitrogen;

–  nitrogen ▌ in the form of urea nitrogen;

–  nitrogen ▌ from urea formaldehyde, isobutylidenediurea, crotonylidenediurea;

–  nitrogen ▌ from cyanamide nitrogen;

(ii)  phosphorus pentoxide (P2O5):

—  total phosphorus pentoxide (P2O5);

–  water-soluble phosphorus pentoxide (P2O5);

–  phosphorus pentoxide (P2O5) soluble in neutral ammonium citrate;

–  where soft ground phosphate is present, phosphorus pentoxide (P2O5) soluble in formic acid;

(iii)  water soluble potassium oxide (K2O);

(iv)  calcium oxide (CaO), magnesium oxide (MgO), sodium oxide (Na2O) and sulphur trioxide (SO3) ▌, expressed:

–  where those nutrients are totally soluble in water, only as the content soluble in water;

–  where the soluble content of those nutrients is at least a quarter of the total content of those nutrients, as the total content and as the content soluble in water;

–  in other cases, as the total content,

(e)  where urea (CH4N2O) is present, information about the possible air quality impacts of the release of ammonia from the fertiliser use, and an invitation to users to apply appropriate remediation measures.

2.  Where an inorganic macronutrient fertiliser has a cadmium (Cd) content equal to or lower than 20 mg/kg phosphorous pentoxide (P2O5), the statement “Low cadmium (Cd) content" or similar, or a visual representation to that effect, may be added.

PFC 1(C)(I)(a): Solid inorganic macronutrient fertiliser

1.  A solid inorganic macronutrient fertiliser may be labelled ▌'complex' only if each physical unit contains all the declared nutrients in their declared content ▌.

2.  The granulometry of a solid inorganic macronutrient fertiliser shall be indicated, expressed as % by mass of the product passing through a determined sieve.

3.  The form of the physical unit of the product shall be indicated with one of the following mentions:

(a)  granules,

(b)  pellets,

(c)  powder, where at least 90 % by mass of the product can pass through a sieve with a mesh of 1 mm, or

(d)  prills.

4.  For coated solid inorganic macronutrient fertilisers, the name of the coating agents and the percentage of fertiliser coated by each coating agent shall be indicated and followed by:

(a)  for polymer coated solid inorganic macronutrient fertilisers, the following marking: ‘The rate of nutrient releases can vary according to the temperature of the substrate. An adjustment of fertilisation may be necessary”; and

(b)  for sulphur (S) coated solid inorganic macronutrient fertilisers and sulphur (S)/polymer coated solid inorganic macronutrient fertilisers, the following marking: ‘The rate of nutrient release can vary according to the temperature of the substrate and the biological activity. An adjustment of fertilisation may be necessary”.

5.  Where one or more of the micronutrients boron (B), cobalt (Co), ▌ iron (Fe), manganese (Mn) and molybdenum (Mo) ▌ are present in the minimum content indicated in the following table as % by mass, they:

–  shall be declared if they are intentionally added to the solid inorganic macronutrient fertiliser, and

–  may be declared in other cases:

Micronutrient

Content of micronutrients (% by mass)

Intended for use on crops or grassland

Intended for horticultural use

Boron (B)

0,01

0,01

Cobalt (Co)

0,002

n.a.

Iron (Fe)

0,5

0,02

Manganese (Mn)

0,1

0,01

Molybdenum (Mo)

0,001

0,001

6.  Where one or both of the micronutrients copper (Cu) and zinc (Zn) are present, without being intentionally added, in the minimum content indicated as % by mass in the following table, they may be declared:

Micronutrient

Content of micronutrients (% by mass)

Intended for use on crops or grassland

Intended for horticultural use

Copper (Cu)

0,01

0,002

Zinc (Zn)

0,01

0,002

7.  Where copper (Cu) or zinc (Zn) is intentionally added to the solid inorganic macronutrient fertiliser the total content of copper (Cu) or zinc (Zn) shall be declared.

8.  The micronutrients referred to in points 5, 6 and 7 shall be declared after the information on macronutrients. The following information shall be provided:

(a)  indication of the names and chemical symbols of the declared micronutrients, listed in the following order: boron (B), cobalt (Co), copper (Cu), iron (Fe), manganese (Mn), molybdenum (Mo) and zinc (Zn), followed by the names of their counter-ions;

(b)  the total micronutrient content expressed as % by mass:

–  where those micronutrients are totally soluble in water, only as the content soluble in water;

–  where the soluble content of those micronutrients is at least a quarter of the total content of those micronutrients, as the total content and as the content soluble in water;

–  in other cases, as the total content;

(c)  where the declared micronutrients are chelated by chelating agents, the following qualifier after the name and the chemical identifier of the micronutrient:

–  ‘chelated by…( name of the chelating agent or its abbreviation)’, and the amount of chelated micronutrient as % by mass;

(d)  where the solid inorganic macronutrient fertiliser contains micronutrients complexed by complexing agents ▌ the following qualifier after the name and the chemical identifier of the micronutrient: ▌

–  ‘complexed by …( name of the complexing agent or its abbreviation)’, and the amount of complexed micronutrient as % by mass;

(e)  where micronutrients are intentionally added, the following statement: ‘To be used only where there is a recognised need. Do not exceed the application rate’.

PFC 1(C)(I)(b): Liquid inorganic macronutrient fertiliser

1.  The label shall indicate whether the liquid inorganic macronutrient fertiliser is in suspension or in solution. ▌

2.  The nutrient content may be indicated as % by mass or volume.

3.  Where one or more of the micronutrients boron (B), cobalt (Co), ▌ iron (Fe), manganese (Mn) and molybdenum (Mo) ▌ are present in the minimum content indicated in the following table as % by mass, they:

–  shall be declared if they are intentionally added to the liquid inorganic macronutrient fertiliser, and

–  may be declared in other cases:

Micronutrient

Content of micronutrient (% by mass)

Boron (B)

0,01

Cobalt (Co)

0,002

Iron (Fe)

0,02

Manganese (Mn)

0,01

Molybdenum (Mo)

0,001

4.  Where one or both of the micronutrients copper (Cu) and zinc (Zn) are present, without being intentionally added, by at least 0,002 % by mass, they may be declared.

5.  Where copper (Cu) or zinc (Zn) is intentionally added to the liquid inorganic macronutrient fertiliser the total content of copper (Cu) or zinc (Zn) shall be declared.

6.  The micronutrients referred to in points 3, 4 and 5 shall be declared after the information on macronutrients. The following information shall be provided:

(a)  indication of the names and chemical symbols of the declared micronutrients, listed in the following order: boron (B), cobalt (Co), copper (Cu), iron (Fe), manganese (Mn), molybdenum (Mo) and zinc (Zn), followed by the names of their counter-ions;

(b)  the total micronutrient content expressed as % by mass or volume:

–  where those micronutrients are totally soluble in water, only as the content soluble in water;

–  where the soluble content of those micronutrients is at least a quarter of the total content of those micronutrients, as the total content and as the content soluble in water;

–  in other cases, as the total content;

(c)  where the declared micronutrients are chelated by chelating agents, the following qualifier after the name and the chemical identifier of the micronutrient:

–  ‘chelated by…( name of the chelating agent or its abbreviation)’, and the amount of chelated micronutrient as % by mass;

(d)  where the liquid inorganic macronutrient fertiliser contains micronutrients complexed by complexing agents the following qualifier after the name and the chemical identifier of the micronutrient:

–  ‘complexed by …( name of the complexing agent or its abbreviation)’, and the amount of complexed micronutrient as % by mass;

(e)  where micronutrients are intentionally added, the following statement: ‘To be used only where there is a recognised need. Do not exceed the application rate’.

PFC 1(C)(II): Inorganic micronutrient fertiliser

1.  The declared micronutrients in the inorganic micronutrient fertiliser shall be listed by their names and chemical symbols in the following order: boron (B), cobalt (Co), copper (Cu), iron (Fe), manganese (Mn), molybdenum (Mo) and zinc (Zn), followed by the names of their counter-ions,

2.  Where the declared micronutrients are chelated by chelating agents, and each chelating agent can be identified and quantified and chelates at least 1% water-soluble micronutrient, the following qualifier shall be added after the name and the chemical identifier of the micronutrient:

–  ‘chelated by…(name of the chelating agent or its abbreviation)’, and the amount of chelated micronutrient as % by mass.

3.  Where the declared micronutrients are complexed by complexing agents, the following qualifier shall be added after the name and the chemical identifier of the micronutrient:

–  ‘complexed by …(name of the complexing agent or its abbreviation)’, and the amount of complexed micronutrient as % by mass.

4.  The following statement shall appear: ‘To be used only where there is a recognised need. Do not exceed the application rate’.

PFC 1(C)(II)(a): Straight inorganic micronutrient fertiliser

1.  The label shall indicate the relevant typology, as referred to in the table under PFC 1(C)(II)(a) in Part II of Annex I.

2.  The total micronutrient content shall be expressed as % by mass:

–  where the micronutrient is totally soluble in water, only as the content soluble in water;

–  where the soluble content of the micronutrient is at least a quarter of the total content of that micronutrient, as the total content and as the content soluble in water;

–  in other cases, as the total content.

PFC 1(C)(II)(b): Compound inorganic micronutrient fertiliser

1.  Micronutrients may be declared only if they are present in the minimum content indicated in the following table as % by mass:

Micronutrient

Content of micronutrient (% by mass)

Non-chelated, non-complexed

Chelated or complexed

Boron (B)

0,2

n.a.

Cobalt (Co)

0,02

0,02

Copper (Cu)

0,5

0,1

Iron (Fe)

2

0,3

Manganese (Mn)

0,5

0,1

Molybdenum (Mo)

0,02

n.a.

Zinc (Zn)

0,5

0,1

2.  If the compound inorganic micronutrient fertiliser is in suspension or in solution, the label shall indicate "in suspension" or "in solution", as relevant.

3.  The total micronutrient content shall be expressed as % by mass:

–  where the micronutrients are totally soluble in water, only as the content soluble in water;

–  where the soluble content of the micronutrients is at least half of the total content of those micronutrients, as the total content and as the content soluble in water;

–  in other cases, as the total content.

PFC 2: Liming material

The following parameters shall be declared in the following order:

–  neutralising value;

–  granulometry, expressed as % by mass of product passing through a ▌ sieve of 1,0 mm;

–  total calcium oxide (CaO), expressed as % by mass ▌;

–  total magnesium oxide (MgO), expressed as % by mass ▌;

–  reactivity and method of determination of reactivity, except for oxide and hydroxide limes.

PFC 3: Soil improver

1.  The dry matter content expressed as % by mass shall be declared.

2.  The following nutrients expressed as % by mass shall be declared, if exceeding 0,5 % by mass: nitrogen (N), phosphorus pentoxide (P2O5) and potassium oxide (K2O).

PFC 3(A) Organic soil improver

The following parameters shall be declared:

–  pH;

–  electrical conductivity, given as mS/m;

–  organic carbon (Corg) content, expressed as % by mass;

–  minimum amount of organic nitrogen (Norg), expressed as % by mass, followed by a description of the origin of the organic matter used;

–  the ratio of organic carbon to total nitrogen (Corg/N).

PFC 4: Growing medium

The following parameters shall be declared in the following order:

–  electrical conductivity given as mS/m, except for mineral wool;

–  pH;

–  quantity:

—   for mineral wool, expressed as number of pieces and the three dimensions length, height, and width;

—   for other pre-shaped growing media, expressed as size in at least two dimensions;

—   for other growing media, expressed as total volume;

—   except for pre-shaped growing media, quantity expressed as volume of materials with a particle size greater than 60 mm, when present;

–  nitrogen (N) extractable by CaCl2/DTPA (calcium chloride/ diethylenetriaminepentaacetic acid; 'CAT-soluble'), if above 150 mg/l;

–  phosphorus pentoxide (P2O5) extractable by CaCl2/DTPA (calcium chloride/ diethylenetriaminepentaacetic acid; 'CAT-soluble'), if above 20 mg/l;

–  potassium oxide (K2O) extractable by CaCl2/DTPA (calcium chloride/ diethylenetriaminepentaacetic acid; 'CAT-soluble'), if above 150 mg/l;

–  production date.

PFC 5: Inhibitor

All ingredients shall be declared by product weight or volume in descending order of magnitude.

PFC 6: Plant biostimulant

The following information shall be provided:

(a)  physical form;

(b)  production and expiry date;

(c)  application method(s);

(d)  effect claimed for each target plant; and

(e)  any relevant instructions related to the efficacy of the product, including soil management practices, chemical fertilisation, incompatibility with plant protection products, recommended spraying nozzles size, sprayer pressure and other anti-drift measures.

PFC 6(A): Microbial plant biostimulant

All intentionally added micro-organisms shall be indicated. Where the micro-organism has several strains, the intentionally added strains shall be indicated. Their concentration shall be expressed as the number of active units per volume or weight, or in any other manner that is relevant to the micro-organism, e.g. colony forming units per gram (cfu/g).

The label shall contain the following phrase: 'Micro-organisms may have the potential to provoke sensitising reactions'.

PFC 7: Fertilising product blend

All the labelling requirements applicable to all component EU fertilising products apply to the fertilising product blend, and shall be expressed in relation to the final fertilising product blend.

Where the fertilising product blend contains one or more plant biostimulants belonging to PFC 6, the concentration of each plant biostimulant in the blend shall be indicated in g/kg or g/l at 20°C.

Part III

Tolerance rules

1.  The declared nutrient content or physico-chemical characteristics of an EU fertilising product may deviate from the actual value only in accordance with the tolerances established in this Part for the relevant PFC. The tolerances are intended to allow for deviations in manufacture, in the distribution chain, and during sampling and analysis.

2.  The tolerances allowed in respect of the declared parameters indicated in this Part are negative and positive values ▌.

3.  By derogation from point 1, the actual content of a component, in an EU fertilising product, for which a minimum or a maximum content is specified in Annex I or Annex II may never be lower than the minimum content or exceed the maximum content.

PFC 1: Fertiliser

The following tolerance rules apply to fertilisers containing nitrification inhibitors, denitrification inhibitors or urease inhibitors, as specified in CMC 1 in Part II of Annex II:

Inhibitors

Permissible tolerance for the declared content of inhibitors

Concentration below or equal to 2 %

± 20 % of the declared value

Concentration of more than 2 %

± 0,3 percentage points in absolute terms

PFC 1(A): Organic fertiliser

Forms of the declared nutrient and other declared parameters

Permissible tolerance for the declared nutrient content and other declared parameters

Organic carbon (Corg)

± 20 % relative deviation of the declared value up to a maximum of 2,0 percentage points in absolute terms

Dry matter content

± 5,0 percentage points in absolute terms

Total nitrogen (N)

± 50 % relative deviation of the declared value up to a maximum of 1,0 percentage point in absolute terms

Organic nitrogen (Norg)

± 50 % relative deviation of the declared value up to a maximum of 1,0 percentage point in absolute terms

Total phosphorus pentoxide (P2O5)

± 50 % relative deviation of the declared value up to a maximum of 1,0 percentage point in absolute terms

Total potassium oxide (K2O)

± 50 % relative deviation of the declared value up to a maximum of 1,0 percentage point in absolute terms

Total and water-soluble magnesium oxide (MgO), calcium oxide (CaO), sulphur trioxide(SO3) or sodium oxide (Na2O)

± 25 % of the declared content of those nutrients up to a maximum of 1,5 percentage points in absolute terms.

Organic carbon (Corg)/total nitrogen (N)

± 20 % relative deviation of the declared value up to a maximum of 2,0 percentage points in absolute terms

Quantity

± 1,5 % relative deviation of the declared value

PFC 1(B): Organo-mineral fertiliser

Forms of the declared nutrient and other declared parameters

Permissible tolerance for the declared macronutrient content and other declared parameters

Organic carbon (Corg)

± 20 % relative deviation of the declared value up to a maximum of 2,0 percentage points in absolute terms

Dry matter content

± 5,0 percentage points in absolute terms

Declared forms of inorganic nitrogen (N)

± 25 % relative deviation of the declared value up to a maximum of 2,0 percentage points in absolute terms

Organic nitrogen (Norg)

± 50 % relative deviation of the declared value up to a maximum of 1,0 percentage point in absolute terms

Declared forms of phosphorus pentoxide (P2O5)

± 25 % relative deviation of the declared value up to a maximum of 1,5 percentage points in absolute terms

Declared forms of potassium oxide (K2O)

± 25 % relative deviation of the declared value up to a maximum of 1,5 percentage points in absolute terms

Total and water-soluble magnesium oxide (MgO), calcium oxide (CaO), sulphur trioxide (SO3)

± 25 % of the declared content of those nutrients up to a maximum of 1,0 percentage point in absolute terms.

Total and water-soluble sodium oxide (Na2O)

± 25 % of the declared content up to a maximum of 0,9 percentage point in absolute terms

Quantity

± 1,5 % relative deviation of the declared value

Micronutrient ▌

Permissible tolerance for the declared content of forms of micronutrient

Concentration below or equal to 2 %

± 20 % of the declared value

Concentration of more than 2 % and below or equal to 10 %

± 20 % of the declared value up to a maximum of 1,0 percentage point in absolute terms

Concentration of more than 10 %

± 1,0 percentage point in absolute terms

PFC 1(C): Inorganic fertiliser

Forms of the declared nutrient and other declared parameters

Permissible tolerance for the declared macronutrient content and other declared parameters

Declared forms of nitrogen (N)

± 20 % relative deviation of the declared value up to a maximum of 1,5 percentage points in absolute terms

Declared forms of phosphorus pentoxide (P2O5)

± 20 % relative deviation of the declared value up to a maximum of 1,5 percentage points in absolute terms

Declared forms of potassium oxide (K2O)

± 20 % relative deviation of the declared value up to a maximum of 1,5 percentage points in absolute terms

Declared forms of nitrogen (N), phosphorus pentoxide (P2O5) or potassium oxide (K2O) in binary fertilisers

± 1,5 percentage points in absolute terms

Declared forms of nitrogen (N), phosphorus pentoxide (P2O5) or potassium oxide (K2O) in tertiary fertilisers

± 1,9 percentage points in absolute terms

Total and water-soluble magnesium oxide (MgO), calcium oxide (CaO), sulphur trioxide (SO3)

± 25 % of the declared content of those nutrients up to a maximum of 1,0 percentage point in absolute terms.

Total and water soluble sodium oxide (Na2O)

—  25 % of the declared content up to a maximum of 0,9 percentage point in absolute terms

+ 50 % of the declared content up to a maximum of 1,8 percentage points in absolute terms

Granulometry

± 10 % relative deviation of the declared percentage of material passing a specific sieve

Quantity

± 1 % relative deviation of the declared value

Micronutrient ▌

Permissible tolerance for the declared content of forms of micronutrient

Concentration below or equal to 2 %

± 20 % of the declared value

Concentration of more than 2 % and below or equal to 10 %

± 20 % of the declared value up to a maximum of 1,0 percentage point in absolute terms

Concentration of more than 10 %

± 1,0 percentage point in absolute terms

Quantity: ± 5 % relative deviation of the declared value

PFC 2: Liming material

Forms of the declared nutrient and other declared parameters

Permissible tolerances for the declared parameter

Neutralising value

± 3

Granulometry

± 10 % relative deviation of the declared percentage of material passing a specific sieve.

Total calcium oxide (CaO)

± 3,0 percentage points in absolute terms

Total magnesium oxide (MgO)

Concentration below 8 %

Concentration between 8 to 16 %

Concentration above or equal to 16 %

± 1,0 percentage point in absolute terms

± 2,0 percentage points in absolute terms

± 3,0 percentage points in absolute terms

Reactivities (hydrochloric acid test and incubation test)

± 5,0 percentage points in absolute terms

Quantity

± 1 % relative deviation of the declared value

PFC 3: Soil improver

Forms of the declared nutrient and other declared parameters

Permissible tolerances for the declared parameter

pH

± 1,0 of the declared value

Organic carbon (Corg)

± 10 % relative deviation of the declared value up to a maximum of 1,0 percentage point in absolute terms

Organic nitrogen (Norg)

± 50 % relative deviation of the declared value up to a maximum of 1,0 percentage point in absolute terms

Total nitrogen (N)

± 20 % relative deviation up to a maximum of 1,0 percentage point in absolute terms

Total phosphorus pentoxide (P2O5)

± 20 % relative deviation up to a maximum of 1,0 percentage point in absolute terms

Total potassium oxide (K2O)

± 20 % relative deviation up to a maximum of 1,0 percentage point in absolute terms

Dry matter content

± 10 % relative deviation of the declared value

Quantity

± 5 % relative deviation of the declared value ▌

Electrical conductivity

± 75 % relative deviation of the declared value

PFC 4: Growing medium

Forms for the declared nutrient and other declared parameters

Permissible tolerances for the declared parameter

Electrical conductivity

± 75 % relative deviation of the declared value

pH

± 1,0 of the declared value

Quantity by volume (litres or m³)

± % relative deviation of the declared value

Quantity (volume) determination of materials with particle size greater than 60 mm

± % relative deviation of the declared value

Quantity (volume) determination of pre-shaped growing medium

± % relative deviation ▌of ▌the declared value

Nitrogen (N) extractable by CaCl2/DTPA (calcium chloride/ diethylenetriaminepentaacetic acid; 'CAT-soluble')

± 75 % relative deviation of the declared value

Phosphorus pentoxide (P2O5) extractable by CaCl2/DTPA (calcium chloride/ diethylenetriaminepentaacetic acid; 'CAT-soluble')

± 75 % relative deviation of the declared value

Potassium oxide (K2O) extractable by CaCl2/DTPA (calcium chloride/ diethylenetriaminepentaacetic acid; 'CAT-soluble')

± 75 % relative deviation of the declared value

PFC 5: Inhibitor

Inhibiting compound

Permissible tolerance for the declared content of inhibiting compound

Concentration below or equal to 2 %

± 20 % of the declared value

Concentration of more than 2 %

± 0,3 percentage point in absolute terms

Quantity: ± 5 % relative deviation of the declared value

PFC 6(A): Microbial plant biostimulant

The actual concentration(s) of micro-organisms may deviate by no more than 15 % from the declared value(s).

PFC 7: Fertilising product blend

Where the fertilising product blend contains one or more plant biostimulants belonging to PFC 6, the following tolerances shall apply for the declared concentration of each plant biostimulant:

Declared concentration in g/kg or g/l at 20°C

Permissible tolerance

Up to 25

± 15 % relative deviation ▌

More than 25 up to 100

± 10 % relative deviation

More than 100 up to 250

± 6 % relative deviation

More than 250 up to 500

± 5 % relative deviation

More than 500

± 25 g/kg or ± 25 g/l

ANNEX IV

Conformity assessment procedures

Part I

Applicability of conformity assessment procedures

This Part sets out the applicability of conformity assessment procedure modules, as specified in Part II of this Annex, to EU fertilising products depending on their CMCs as specified in Annex II , and their PFCs as specified in Annex I .

1.  Applicability of Internal production control (Module A)

1.1  Module A may be used for an EU fertilising product composed solely of one or more of the following component materials:

(a)  virgin material substances or mixtures as specified in CMC 1 in Part II of Annex II, except a nitrification inhibitor, a denitrification inhibitor or a urease inhibitor,

(b)  fresh crop digestates as specified in CMC 4 in Part II of Annex II,

(c)  food industry by-products as specified in CMC 6 in Part II of Annex II,

(d)  micro-organisms as specified in CMC 7 in Part II of Annex II,

(e)  nutrient polymers as specified in CMC 8 in Part II of Annex II,

(f)  by-products within the meaning of Directive 2008/98/EC as specified in CMC 11 in Part II of Annex II.

1.2.  Module A may also be used for a fertilising product blend as specified in PFC 7.

1.3.  By derogation from points 1.1 and 1.2, Module A must not be used for:

(a)  a straight or compound solid inorganic macronutrient ammonium nitrate fertiliser of high nitrogen content, as specified in PFC 1(C)(I)(a)(i-ii)(A), or a fertilising product blend as specified in PFC 7 containing 28 % or more by mass of nitrogen (N) from an EU fertilising product belonging to PFC 1(C)(I)(a)(i-ii)(A),

(b)  an inhibitor as specified in PFC 5, or

(c)  a plant biostimulant as specified in PFC 6.

2.  Applicability of Internal production control plus supervised product testing (Module A1)

Module A1 shall be used for a straight or compound solid inorganic macronutrient ammonium nitrate fertiliser of high nitrogen content, as specified in PFC 1(C)(I)(a)(i‑ii)(A), and for a fertilising product blend as specified in PFC 7 containing 28 % or more by mass of nitrogen (N) from an EU fertilising product belonging to PFC 1(C)(I)(a)(i-ii)(A).

3.  Applicability of EU-type examination (Module B) followed by Conformity to type based on internal production control (Module C)

3.1.  Module B followed by Module C may be used for an EU fertilising product composed solely of one or more of the following component materials:

(a)  nitrification inhibitor, denitrification inhibitor or urease inhibitor as specified in CMC 1 in Part II of Annex II,

(b)  plants, plant parts or plant extracts as specified in CMC 2 in Part II of Annex II,

(c)  polymers other than nutrient polymers as specified in CMC 9 in Part II of Annex II,

(d)  certain derived -products within the meaning of Regulation (EC) No 1069/2009 as specified in CMC 10 in Part II of Annex II, ▌

(e)  CMCs referred to in point 1.1 ▌of this Part.

3.2.  Module B followed by Module C may also be used for:

(a)  an inhibitor as specified in PFC 5 ▌,

(b)  a plant biostimulant as specified in PFC 6, and

(c)  a fertilising product blend as specified in PFC 7.

3.3.  By derogation from points 3.1 and 3.2, Module B followed by Module C must not be used for a straight or compound solid inorganic macronutrient ammonium nitrate fertiliser of high nitrogen content, as specified in PFC 1(C)(I)(a)(i-ii)(A), or a fertilising product blend as specified in PFC 7 containing 28 % or more by mass of nitrogen (N) from an EU fertilising product belonging to PFC 1(C)(I)(a)(i-ii)(A).

4.  Applicability of Quality assurance of the production process (Module D1)

4.1.  Module D1 may be used for any EU fertilising product.

4.2.  By derogation from point 4.1, Module D1 must not be used for a straight or compound solid inorganic macronutrient ammonium nitrate fertiliser of high nitrogen content, as specified in PFC 1(C)(I)(a)(i-ii)(A), or a fertilising product blend as specified in PFC 7 containing 28 % or more by mass of nitrogen (N) from an EU fertilising product belonging to PFC 1(C)(I)(a)(i-ii)(A).

Part II

Description of conformity assessment procedures

Module A – Internal production control

1.  Description of the module

Internal production control is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down under points 2, 3 and 4, and ensures and declares on his or her sole responsibility that the EU fertilising products concerned satisfy the requirements of this Regulation that apply to them.

2.  Technical documentation

2.1  The manufacturer shall establish the technical documentation. The documentation shall make it possible to assess the EU fertilising product's conformity with the relevant requirements, and shall include an adequate analysis and assessment of the risk(s).

2.2  The technical documentation shall specify the applicable requirements and cover, as far as relevant for the assessment, the design, manufacture and intended use of the EU fertilising product. The technical documentation shall contain, where applicable, at least the following elements:

(a)  a general description of the EU fertilising product, the PFC corresponding to the claimed function of the EU fertilising product and description of the intended use,

(b)  a list of component materials used, the CMCs as referred to in Annex II to which they belong and information about their origin or manufacturing process,

(c)  the EU declarations of conformity for the component EU fertilising products of the fertilising product blend,

(d)   drawings, schemes, descriptions and explanations necessary for the understanding of the manufacturing process of the EU fertilising product,

(e)  a specimen of the label or the leaflet, or both, referred to in Article 6(7)containing the information required in accordance with Annex III,

(f)  a list of the harmonised standards referred to in Article 13, common specifications referred to in Article 14 and/or other relevant technical specifications applied. In the event of partly applied harmonised standards or common specifications, the technical documentation shall specify the parts which have been applied,

(g)  results of ▌ calculations made, including the calculations to demonstrate conformity with point 5 of Part II of Annex I, examinations carried out, etc., ▌

(h)  test reports,

(i)  where the EU fertilising product contains or consists of by-products within the meaning of Directive 2008/98/EC, technical and administrative evidence that the by-products comply with the criteria established by delegated act referred to in Article 42(7) of this Regulation, and with the national measures transposing Article 5(1) of Directive 2008/98/EC and, where applicable, implementing acts referred to in Article 5(2) or national measures adopted under Article 5(3) of that Directive,

(j)  where the EU fertilising product contains total chromium (Cr) above 200 mg/kg,information about the maximum quantity and exact source of total chromium (Cr).

3.  Manufacturing

▌ The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure compliance of the manufactured EU fertilising products with the technical documentation referred to under point 2 and with the requirements of this Regulation that apply to them.

4.  CE marking and EU declaration of conformity

4.1.  The manufacturer shall affix the CE marking to each individual packaging of the EU fertilising product that satisfies the applicable requirements of this Regulation, or, where it is supplied without packaging, in a document accompanying the EU fertilising product.

4.2.  The manufacturer shall draw up a written EU declaration of conformity for an EU fertilising product or type and keep it together with the technical documentation at the disposal of the national authorities for 5 years after the EU fertilising product has been placed on the market. The EU declaration of conformity shall identify the EU fertilising product or type for which it has been drawn up.

4.3.  A copy of the EU declaration of conformity shall be made available to the relevant authorities upon request.

5.  Authorised representative

The manufacturer's obligations set out under point 4 may be fulfilled by his or her authorised representative, on his or her behalf and under his or her responsibility, provided that they are specified in the mandate.

Module A1 – Internal production control plus supervised product testing

1.  Description of the module

▌ Internal production control plus supervised product testing is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down under points 2, 3, 4, and 5, and ensures and declares on his or her sole responsibility that the EU fertilising products concerned satisfy the requirements of this Regulation that apply to them.

2.  Technical documentation

2.1.  The manufacturer shall establish the technical documentation. The documentation shall make it possible to assess the EU fertilising product's conformity with the relevant requirements, and shall include an adequate analysis and assessment of the risk(s).

2.2.  The technical documentation shall specify the applicable requirements and cover, as far as relevant for the assessment, the design, manufacture and intended use of the EU fertilising product. The technical documentation shall contain, where applicable, at least the following elements:

(a)  a general description of the EU fertilising product, the PFC corresponding to the claimed function of the EU fertilising product and description of the intended use,

(b)  a list of component materials used, the CMCs as referred to in Annex II to which they belong and information about their origin or manufacturing process,

(c)  the EU declarations of conformity for the component EU fertilising products of the fertilising product blend,

(d)  drawings, schemes, descriptions and explanations necessary for the understanding of the manufacturing process of the EU fertilising product,

(e)  a specimen of the label or the leaflet, or both, referred to in Article 6(7) containing the information required in accordance with Annex III,

(f)  the names and addresses of the sites, and of the operators of the sites, at which the product and its principal components were manufactured,

(g)  a list of the harmonised standards referred to in Article 13, common specifications referred to in Article 14 and/or other relevant technical specifications applied. In the event of partly applied harmonised standards or common specifications, the technical documentation shall specify the parts which have been applied,

(h)  results of ▌ calculations made, including the calculations to demonstrate conformity with point 5 of Part II of Annex I, examinations carried out, etc., ▌

(i)  test reports, including the reports from product checks for oil retention and detonation resistance, referred to in point 4 and

(j)  where the EU fertilising product contains or consists of by-products within the meaning of Directive 2008/98/EC, technical and administrative evidence that the by-products comply with the criteria established by delegated acts referred to in Article 42(7) of this Regulation, and with the national measures transposing Article 5(1) of Directive 2008/98/EC and, where applicable, implementing acts referred to in Article 5(2) or national measures adopted under Article 5(3) of that Directive.

3.  Manufacturing

The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure compliance of the manufactured EU fertilising products with the technical documentation referred to in point 2 and with the requirements of this Regulation that apply to them.

4.  Product checks for oil retention and detonation resistance

▌ The thermal cycles and tests referred to in points 4.1 to 4.4 shall be carried out on a representative sample of the EU fertilising product ▌ every 3 months on behalf of the manufacturer, in order to verify conformity with:

(a)  the oil retention requirement referred to in point 4 under PFC 1(C)(I)(a)(iii)(A) in Annex I, and

(b)  the detonation resistance requirement referred to in point 5 under PFC 1(C)(I)(a)(i-ii)(A) in Annex I.

The thermal cycles and tests shall be carried out under the responsibility of a notified body chosen by the manufacturer.

4.1.  Thermal cycles prior to a test for compliance with the oil retention requirement referred to in point 4 under PFC 1(C)(I)(a)(i‑ii)(A) in Annex I

4.1.1.  Principle and definition

In a closed suitable laboratory flask, heat the sample from ambient temperature to 50°C and maintain at this temperature for a period of two hours (phase at 50°C). Thereupon cool the sample until a temperature of 25°C is achieved and maintain at that temperature for two hours (phase at 25°C). The combination of the successive phases at 50°C and 25°C forms one thermal cycle. After being subjected to two thermal cycles, the test sample is held at a temperature of 20 (±3)°C for the determination of the oil retention value.

4.1.2.  Apparatus

Normal laboratory apparatus, in particular:

(a)  water baths or ovens thermostated at 25 ± 1 °C and 50 ± 1 °C respectively,

(b)  suitable laboratory flasks with an individual capacity of 150 ml.

4.1.3.  Procedure

4.1.3.1.  Put each test sample of 70  5 g into a suitable laboratory flask which is then closed.

4.1.3.2.  After attaining the temperature of 50 °C and maintain that temperature for two hours, change the temperature of the flask to the 25 °C bath or oven and proceed as described in 4.1.1.

4.1.3.3.  If using a water bath maintain the water of each bath at constant temperature and keep in motion by rapid stirring. Ensure the water level comes above the level of the sample. Protect the stopper from condensation by a foam rubber cap.

4.2.  Oil retention test referred to in point 4 under PFC 1(C)(I)(a)(i-ii)(A) in Annex I

4.2.1.  Description

The oil retention of an EU fertilising product shall be the quantity of oil retained by the EU fertilising product determined under the operating conditions specified and expressed as a % by mass.

The test shall be carried out on a representative sample of the EU fertilising product. Before being tested, the whole mass of the sample shall be thermally cycled two times in accordance with point 4.1.

The method is applicable to both prilled and granular fertilisers which do not contain oil soluble materials.

4.2.2.  Principle

Total immersion of the test sample in gas oil for a specified period, followed by the draining away of surplus oil under specified conditions. Measurement of the increase in mass of the test portion.

4.2.3.  Reagents

Gas oil with the following characteristics:

(a)  viscosity max.: 5 mPas at 40 °C;

(b)  density: 0,8 g/ml to 0,85 g/ml at 20 °C;

(c)  sulphur content: ≤ 1,0 % (m/m);

(d)  ash: ≤ 0,1 % (m/m).

4.2.4.  Apparatus

Ordinary laboratory apparatus, and:

(a)  balance, capable of weighing to the nearest 0,01 g;

(b)  beakers, of capacity 500 ml;

(c)  funnel, of plastic materials, preferably with a cylindrical wall at the upper end, diameter approximately 200 mm;

(d)  test sieve, aperture 0,5 mm, fitting into the funnel;

Note: The size of the funnel and sieve is such as to ensure that only a few granules lie one above another and the oil is able to drain easily.

(e)  filter paper, rapid filtering grade, creped, soft, mass 150 g/m2;

(f)  absorbent tissue (laboratory grade).

4.2.5.  Procedure

4.2.5.1.  Two individual determinations are carried out in quick succession on separate portions of the same test sample.

4.2.5.2.  Remove particles smaller than 0,5 mm using the test sieve. Weigh to the nearest 0,01 g approximately 50 g of the sample into the beaker. Add sufficient gas oil to cover the prills or granules completely and stir carefully to ensure that the surfaces of all the prills or granules are fully wetted. Cover the beaker with a watch glass and leave to stand for one hour at 25 (± 2) °C.

4.2.5.3.  Filter the entire contents of the beaker through the funnel containing the test sieve. Allow the portion retained by the sieve to remain there for one hour so that most of the excess oil can drain away.

4.2.5.4.  Lay two sheets of filter paper (about 500 mm x 500 mm) on top of each other on a smooth surface; fold the four edges of both filter papers upwards to a width of about 40 mm to prevent the prills or granules from rolling away. Place two layers of absorbent tissue in the centre of the filter papers. Pour the entire contents of the sieve over the absorbent tissues and spread the prills or granules evenly with a soft, flat brush. After two minutes lift one side of the tissues to transfer the prills or granules to the filter papers beneath and spread them evenly over these with the brush. Lay another sheet of filter paper, similarly with its edges turned upward, on the sample and roll the prills or granules between the filter papers with circular movements while exerting a little pressure. Pause after every eight circular movements to lift the opposite corners of the filter papers and return to the centre the prills or granules that have rolled to the periphery. Keep to the following procedure: make four complete circular movements, first clockwise and then anticlockwise. Then roll the prills or granules back to the centre as described above. This procedure is to be carried out three times (24 circular movements, corners lifted twice). Carefully insert a new sheet of filter paper between the bottom sheet and the one above it and allow the prills or granules to roll onto the new sheet by lifting the edges of the upper sheet. Cover the prills or granules with a new sheet of filter paper and repeat the same procedure as described above. Immediately after rolling, pour the prills or granules into a tared dish and reweigh to the nearest 0,01 g to determine the mass of the quantity of gas oil retained.

4.2.5.5.  Repeating the rolling procedure and reweighing

If the quantity of gas oil retained in the portion is found to be greater than 2,00 g, place the portion on a fresh set of filter papers and repeat the rolling procedure, lifting the corners in accordance with point 4.2.5.4. (two times eight circular movements, lifting once). Then reweigh the portion.

4.2.5.6.  Two oil retention tests per sample are to be carried out.

4.2.6.  Test report

4.2.6.1.  Expression of the results

4.2.6.1.1.  Method of calculation and formula

The oil retention, from each determination (point 4.2.5.1) expressed as a % by mass of the sieved test portion, is given by the equation:

Oil retention =

20190327-P8_TA-PROV(2019)0306_EN-p0000002.png

 100

where:

m1 is the mass, in grams, of the sieved test portion (point 4.2.5.2) ,

m2 is the mass, in grams, of the test portion according to points 4.2.5.4. and 4.2.5.5. respectively as the result of the last weighing.

4.2.6.1.2.  Take as the result the arithmetic mean of the two individual determinations.

4.2.6.2.  The test report shall form part of the technical documentation.

4.3.  Thermal cycles prior to the detonation resistance test referred to in point 5 under PFC 1(C)(I)(a)(i‑ii)(A) in Annex I

4.3.1.  Principle and definition

In a tight box heat the sample from ambient temperature to 50°C and maintain at this temperature for a period of one hour (phase at 50°C). Thereupon cool the sample until a temperature of 25°C is achieved and maintain at that temperature for one hour (phase at 25°C). The combination of the successive phases at 50°C and 25°C forms one thermal cycle. After being subjected to the required number of thermal cycles, the test sample is held at a temperature of 20 ±3°C pending the execution of the detonation resistance test.

4.3.2.  Apparatus

Method 1

(a)  A water bath, thermostated in a temperature range of 20 to 51°C with a minimum heating and cooling rate of 10°C/h, or two water baths, one thermostated at a temperature of 20°C, the other at 51°C. The water in the bath(s) is continuously stirred; the volume of the bath shall be large enough to guarantee ample circulation of the water.

(b)  A stainless steel box, watertight all around and provided with a temperature recording device in the centre. The outside width of the box is 45 ± 2 mm and the wall thickness is 1,5 mm (see Figure 1 as an example). The height and length of the box can be chosen to suit the dimensions of the water bath, e.g. length 600 mm, height 400 mm.

Method 2

(a)  Suitable oven, thermostated in a temperature range of 20 °C to 51 °C with a minimum heating and cooling rate of 10 °C/h.

(b)  Suitable airtight plastics boxes or bags provided with a suitable temperature recording device in the centre of the sample or a stainless steel box as described in point (b) of method 1 of point 4.3.2. Once filled, the outside thickness of the box or bag shall be maximum 45 mm.

4.3.3.  Procedure

▌ Place a quantity of fertilisers sufficient for the detonation resistance test into the boxes or bags and close them. Place the stainless steel boxes in the water bath (method 1) or the boxes or bags in the oven (method 2). Heat the water or oven to 51°C and measure the temperature in the centre of the fertiliser. One hour after the temperature at the centre has reached 50°C start cooling. One hour after the temperature at the centre has reached 25°C ▌ start heating for the second cycle. In the case of two water baths or ovens, transfer the boxes or bags to the other bath or oven after each heating/cooling period.

Figure 1

20190327-P8_TA-PROV(2019)0306_EN-p0000003.png

A: O-ring

B: Cover

C: Bolt

D: Box

4.4.  Detonation resistance test referred to in point 5 under PFC 1(C)(I)(a)(i‑ii)(A) in Annex I

4.4.1.  Description

4.4.1.1  The test shall be carried out on a representative sample of the EU fertilising product. Before being tested for resistance to detonation, the whole mass of the sample is to be thermally cycled five times in accordance with point 4.3.

4.4.1.2.  The EU fertilising product shall be subjected to the detonation resistance test in a horizontal steel tube under the following conditions (the details of the materials are in point 4.4.3):

(a)  seamless steel tube:

(i)   Tube length: 1 000 mm at least,

(ii)   Nominal external diameter: 114 mm at least,

(iii)   Nominal wall thickness: 5 mm at least,

(b)  booster: the type and mass of the booster chosen shall be such as to maximise the detonation pressure applied to the sample in order to determine its susceptibility to the transmission of detonation,

(c)  temperature of the sample: 15 °C to 25 °C,

(d)  witness lead cylinders for detecting detonation: 50 mm diameter and 100 mm height,

(e)  placed at 150 mm intervals and supporting the tube horizontally.

NOTE: The test is to be carried out twice. The test is deemed conclusive if in both tests one or more of the supporting lead cylinders is crushed by less than 5 %.

4.4.2.  Principle

The test sample is confined in a steel tube and subjected to detonation shock from an explosive booster charge. Propagation of the detonation is determined from the degree of crushing of lead cylinders on which the tube rests horizontally during the test.

4.4.3.  Materials

(a)  Plastic explosive containing 83 % to 86 % penthrite

–  density: 1 500 kg/m3 to 1 600 kg/m3

–  detonation velocity: 7 300 m/s to 7 700 m/s

–  mass: (500 ± 1) g;

or any other plastic explosive with similar detonation characteristics.

(b)  Seven lengths of flexible detonating cord with non-metallic sleeve

–  filling mass: 11 g/m to 13 g/m

–  length of each cord: (400 ± 2) mm.

(c)  Compressed pellet of secondary explosive, recessed to receive detonator

–  explosive: hexogen/wax 95/5 ▌ or similar secondary explosive, with or without added graphite

–  density: 1 500 kg/m3 to 1 600 kg/m3

–  diameter: 19 mm to 21 mm

–  height: 19 mm to 23 mm

–  mass of the compressed pellet: maximum 10 g

–  central recess to receive detonator: maximal diameter 7,0 to 7,3 mm, depth about 12 mm. In case of detonators with large diameters, the diameter of the recess shall be slightly larger (e.g. 0,5 mm) than the diameter of the detonator.

(d)  Seamless steel tube as specified in ISO 65 – 1981 – Heavy Series, with nominal dimensions DN 100 (4'')

–  outside diameter: 113,1 mm to 115,0 mm

–  wall thickness: 5,0 mm to 6,5 mm

–  length: 1 005 ± 2 mm.

(e)  Bottom plate

–  material: steel of good weldable quality

–  dimensions: 160 mm × 160 mm

–  thickness: 5 mm to 6 mm.

(f)  Six lead cylinders

–  diameter: 50 ± 1 mm

–  height: 100 mm to 101 mm

–  materials: soft lead, at least 99,5 % purity.

(g)  Steel block

–  length: at least 1 000 mm

–  width: at least 150 mm

–  height: at least 150 mm (alternatively a stack of several beams can be used to achieve this height)

–  Mass: at least 300 kg if there is no firm base for the steel block.

(h)  Plastic or cardboard cylinder for booster charge

–  wall thickness: 1,5 mm to 2,5 mm

–  diameter: 92 mm to 96 mm

–  height: 64 mm to 67 mm.

(i)  Detonator (electric or non-electric) with initiation force 8 to 10

(j)  Wooden or plastic disc

–  diameter: 92 mm to 96 mm. Diameter to be matched to the internal diameter of the plastic or cardboard cylinder (point (h))

–  thickness: 20 mm.

(k)  Wooden or plastic rod of same dimensions as detonator (point (i))

(l)  Small split pins (maximum length 20 mm)

(m)  Split pins (length about 20 mm)

4.4.4.  Procedure

4.4.4.1.  Preparation of booster charge for insertion into steel tube

4.4.4.1.  Depending on the availability of equipment, the explosive can be initiated in the booster charge either

–  by seven-point simultaneous initiation as referred to in point 4.4.4.1.1. , or

–  by central initiation by a compressed pellet as referred to in point 4.4.4.1.2..

4.4.4.1.1.  Seven‑point simultaneous initiation

The booster charge prepared for use is shown in Figure 2.

4.4.4.1.1.1.  Drill holes in the wooden or plastic disc (point (j) under point 4.4.3.) parallel to the axis of the disc through the centre and through six points symmetrically distributed around a concentric circle 55 mm in diameter. The diameter of the holes shall be 6 mm to 7 mm (see Section A‑B in Figure 2), depending on the diameter of the detonating cord used (point(b) under point 4.4.3.).

4.4.4.1.1.2.  Cut seven lengths of flexible detonating cord (point (b) under point 4.4.3.) each 400 mm long, avoiding any loss of explosive at each end by making a clean cut and immediately sealing the end with adhesive. Push each of the seven lengths through each of the seven holes in the wooden or plastic disc (point (j) under point 4.4.3.) until their ends project a few centimetres on the other side of the disc. Then insert a small ▌split pin (point (l) under point 4.4.3.) transversally into the textile sleeve of each length of cord 5 mm to 6 mm from the end and apply adhesive around the outside of the lengths of cord in a band 2 cm wide adjacent to the pin. Finally, pull the long piece of each cord to bring the pin into contact with the wooden or plastic disc.

4.4.4.1.1.3.  Shape the plastic explosive (point (a) under point 4.4.3.) to form a cylinder 92 mm to 96 mm in diameter, depending on the diameter of the cylinder (point (h) under point 4.4.3.). Stand this cylinder upright on a level surface and insert the shaped explosive. Then insert the wooden or plastic disc(51) carrying the seven lengths of detonating cord into the top of the cylinder and press it down onto the explosive. Adjust the height of the cylinder (64 mm to 67 mm) so that its top edge does not extend beyond the level of the wood or plastic. Finally, fix the cylinder to the wooden or plastic disc for instance with staples or small nails, around its entire circumference.

4.4.4.1.1.4.  Group the free ends of the seven lengths of detonating cord around the circumference of the wooden or plastic rod (point (k) under point 4.4.3.) so that their ends are all level in a plane perpendicular to the rod. Secure them in a bundle around the rod by means of adhesive tape(52).

4.4.4.1.2.  Central initiation by a compressed pellet

The booster charge prepared for use is shown in Figure 3.

4.4.4.1.2.1.  Preparing a compressed pellet

Taking the necessary safety precautions, place maximum 10 g of a secondary explosive (point (c) under point 4.4.3.) in a mould with an inside diameter of 19 mm to 21 mm and compress to the correct shape and density (the ratio of diameter: height should be roughly 1:1). In the centre of the bottom of the mould there is a peg, 12 mm in height and 7,0 mm to 7,3 mm in diameter (depending on the diameter of the detonator used), which forms a cylindrical recess in the compressed cartridge for subsequent insertion of the detonator.

4.4.4.1.2.2.  Preparing the booster charge

Place the explosive (point (a) under point 4.4.3.) into the cylinder (point (h) under point 4.4.3.) standing upright on a level surface, then press it down with a wooden or plastic die to give the explosive a cylindrical shape with a central recess. Insert the compressed pellet into this recess. Cover the cylindrically shaped explosive containing the compressed pellet with a wooden or plastic disc (point (j) under point 4.4.3.) having a central hole 7,0 mm to 7,3 mm in diameter for insertion of a detonator. Fix the wooden or plastic disc and the cylinder together with a cross of adhesive tape. Ensure that the hole drilled in the disc and the recess in the compressed pellet are coaxial by inserting the wooden or plastic rod (point (k) under point 4.4.3.).

4.4.4.2.  Preparing steel tubes for the detonation tests

At one end of the steel tube (point (d) under point 4.4.3.), drill two diametrically opposed holes 4 mm in diameter perpendicularly through the side wall at a distance of 4 mm from the edge. Butt weld the bottom plate (point (e) under point 4.4.3.) to the opposite end of the tube, completely filling the right angle between the bottom plate and the wall of the tube with weld metal around the entire circumference of the tube.

4.4.4.3.  Filling and charging the steel tube

See Figures 2 and 3.

4.4.4.3.1.  The test sample, the steel tube and the booster charge shall be conditioned to temperatures of (20  5)°C. About 20 kg of the test sample should be available for two detonation resistance tests.

4.4.4.3.2.1  Place the tube upright with its square bottom plate resting on a firm, flat surface, preferably concrete. Fill the tube to about one‑third of its height with the test sample and drop it 10 cm vertically onto the flat surface five times to compact the prills or granules as densely as possible in the tube. To accelerate compaction, vibrate the tube by striking the side wall with a 750 g to 1 000 g hammer between drops for a total of 10 times.

4.4.4.3.2.2.  Repeat this charging method with another portion of the test sample. Finally, a further addition shall be made such that, after compaction by raising and dropping the tube 10 times and a total of 20 intermittent hammer blows, the charge fills the tube to a distance of 70 mm from its orifice.

4.4.4.3.2.3  The filling height of the sample shall be adjusted in the steel tube so that the booster charge (referred to in point 4.4.4.1.1. or 4.4.4.1.2.) to be inserted later will be in close contact with the sample over its entire surface.

4.4.4.3.3.  Insert the booster charge into the tube so that it is in contact with the sample; the top surface of the wooden or plastic disc shall be 6 mm below the end of the tube. Ensure essential close contact between explosive and test sample by taking out the booster charge and adding or removing small quantities of sample. As shown in Figures 2 and 3, split pins should be inserted through the holes near the open end of the tube and their legs opened flat against the tube.

4.4.4.4.  Positioning of the steel tube and lead cylinders (see Figure 4)

4.4.4.4.1.  Number the bases of the lead cylinders (point (f) under point 4.4.3.) 1, 2, 3, 4, 5 and 6. Make six marks 150 mm apart along a line on a steel block (point 4.4.3.(g)) lying on a horizontal base, with each mark at least 75 mm from any edge of the block. Place a lead cylinder upright on each of these marks, with the base of each cylinder centred on its mark (see Figure 4).

4.4.4.4.2.  Lay the steel tube prepared according to point 4.4.4.3 horizontally on the lead cylinders so that the axis of the tube is parallel to the centre line of the lead cylinders and the welded end of the tube extends 50 mm beyond lead cylinder No 6. To prevent the tube from rolling, insert small wooden or plastic wedges between the tops of the lead cylinders and the tube wall (one on each side) or place a cross of wood between the tube and the steel block or stack of beams. (see Figure 4)

Note: Make sure that the tube is in contact with all six lead cylinders; a slight curvature of the tube surface can be compensated for by rotating the tube about its longitudinal axis; if any of the lead cylinders is too tall, tap the cylinder in question carefully with a hammer until it is the required height.

4.4.4.5.  Preparation for detonation

4.4.4.5.1.  Set up the apparatus as described in point 4.4.4.4. in a bunker or suitably prepared underground site or suitable location. Ensure that the temperature of the steel tube is kept at (20  5)°C before detonation.

Note: ▌ Detonation can cause steel fragments to be projected with high kinetic energy, therefore, firing shall be carried out at a suitable distance from dwellings or thoroughfares.

4.4.4.5.2.  If the booster charge with seven‑point initiation is used, ensure that the detonation cords are stretched out as described in the footnote to point 4.4.4.1.1.4. and arranged as horizontally as possible.

4.4.4.5.3.  Finally, remove the wooden or plastic rod and replace with the detonator. Do not carry out firing until the danger zone has been evacuated and the test personnel have taken cover.

4.4.4.5.4.  Detonate the explosive.

4.4.4.6.1.  Allow sufficient time for the fumes (gaseous and sometimes toxic decomposition products such as nitrous gases) to disperse, then collect the lead cylinders and measure their heights with a Vernier caliper.

4.4.4.6.2.  Record for each of the marked lead cylinders, the degree of crushing expressed as a percentage of the original height of 100 mm. If the cylinders are crushed obliquely, record the highest and the lowest values and calculate the average.

4.4.4.7.  Detonation velocity measurement can also be performed.

4.4.4.8.  Two detonation tests per sample are to be carried out.

4.4.5.  Test report

Values for the following parameters are to be given in the test report for each of the detonation resistance tests:

–  the values actually measured for the outside diameter of the steel tube and for the wall thickness,

–  the Brinell hardness of the steel tube,

–  the temperature of the tube and the sample shortly before firing,

–  the packing density (kg/m3) of the sample in the steel tube,

–  the height of each lead cylinder after firing, specifying the corresponding cylinder number,

–  method of initiation employed for the booster charge.

4.4.6.  Evaluation of test results

If, in each firing, the crushing of at least one lead cylinder is less than 5 %, the test shall be considered conclusive and it shall be considered that the sample presented is resistant to detonation.

4.4.7.  The test report shall form part of the technical documentation.

Figure 2

20190327-P8_TA-PROV(2019)0306_EN-p0000004.png

Booster charge with seven-point initiation

1: Steel tube

2: Wooden or plastic disc with seven holes

3: Plastic or cardboard cylinder

4: Detonating cords

5: Plastic explosive

6: Test sample

7: 4 mm hole drilled to receive split pin

8: Split pin

9: Wooden or plastic rod surrounded by 4

10: Adhesive tape for securing 4 around 9

Figure 3

20190327-P8_TA-PROV(2019)0306_EN-p0000005.png

1: Steel tube

2: Wooden of plastic disc

3: Plastic or cardboard cylinder

4: Wooden of plastic rod

5: Plastic explosive

6: Compressed pellet

7: Test sample

8: 4 mm hole drilled to receive split pin

9: Split pin

10: Wooden or plastic die for 5

Figure 4

20190327-P8_TA-PROV(2019)0306_EN-p0000006.png

Numbers in circles:

1: Steel tube

2: Lead cylinders

3: Steel block or stack of beams

4: Bottom plate

5: Booster charge

Numbers in squares:

Lead cylinders 1 to 6

5.  CE marking and EU declaration of conformity

5.1.  The manufacturer shall affix the CE marking and, under the responsibility of the notified body referred to in point 4, the latter's identification number to each individual packaging of the EU fertilising product that satisfies the applicable requirements of this Regulation or, where it is supplied without packaging, in a document accompanying the EU fertilising product.

5.2.  The manufacturer shall draw up a written EU declaration of conformity for an EU fertilising product type and keep it together with the technical documentation at the disposal of the national authorities for 5 years after the EU fertilising product has been placed on the market. The EU declaration of conformity shall identify the EU fertilising product type for which it has been drawn up.

5.3.  A copy of the EU declaration of conformity shall be made available to the relevant authorities upon request.

6.  Notified bodies' information and operational obligations

6.1.  Each notified body shall, without undue delay, inform its notifying authority and other bodies notified under this Regulation carrying out similar conformity assessment activities covering the same EU fertilising products of the following:

(a)  any case where the manufacturer has not complied with the 3-month period for performing the tests required under point 4;

(b)  any test results which demonstrate non-conformity with the detonation resistance requirement referred to in point 5 under PFC 1(C)(I)(a)(i-ii)(A) in Annex I.

6.2.  In the case referred to in point  6.1.(b) the notified body shall request the manufacturer to take the necessary measures in accordance with Article 6(8).

7.  Authorised representative

The manufacturer's obligations set out in points 4.4.7. and 5 may be fulfilled by his or her authorised representative, on his or her behalf and under his or her responsibility, provided that they are specified in the mandate.

Module B – EU-type examination

1.  Description of the module

1.1.   EU-type examination is the part of a conformity assessment procedure in which a notified body examines the technical design of an EU fertilising product and verifies and attests that the technical design of the EU fertilising product meets the requirements of this Regulation.

1.2.  Assessment of the adequacy of the technical design of the EU fertilising product is carried out through examination of the technical documentation and supporting evidence ▌, plus examination of samples, representative of the production envisaged ▌.

2.  Technical documentation

2.1.   The manufacturer shall establish the technical documentation. The ▌ documentation shall make it possible to assess the EU fertilising product's conformity with the relevant requirements ▌ and shall include an adequate analysis and assessment of the risk(s).

2.2.  The technical documentation shall specify the applicable requirements and cover, as far as relevant for the assessment, the design, manufacture and intended use of the EU fertilising product. The technical documentation shall contain, where applicable, at least the following elements:

(a)   a general description of the EU fertilising product, the PFC corresponding to the claimed function of the EU fertilising product and description of the intended use,

(b)  a list of component materials used, the CMCs as referred to in Annex II to which they belong and information about their origin or manufacturing process,

(c)  the EU declarations of conformity for the component EU fertilising products of the fertilising product blend,

(d)  drawings, schemes, descriptions and explanations necessary for the understanding of the manufacturing process of the EU fertilising product,

(e)  a specimen of the label or the leaflet, or both, referred to in Article 6(7) containing the information required in accordance with Annex III,

(f)   a list of the harmonised standards referred to in Article 13, common specifications referred to in Article 14 and/or other relevant technical specifications applied. In the event of partly applied harmonised standards or common specifications, the technical documentation shall specify the parts which have been applied,

(g)   results of ▌ calculations made, including the calculations to demonstrate conformity with point 5 of Part II of Annex I, examinations carried out, etc.,

(h)   test reports,

(i)   where the EU fertilising product contains or consists of derived products within the meaning of Regulation (EC) No 1069/2009, the commercial documents or health certificates required pursuant to that Regulation, and evidence that the derived products have reached the end point in the manufacturing chain within the meaning of that Regulation,

(j)  where the EU fertilising product contains or consists of by-products within the meaning of Directive 2008/98/EC, technical and administrative evidence that the by-products comply with the criteria established by delegated act referred to in Article 42(7) of this Regulation, and with the national measures transposing Article 5(1) of Directive 2008/98/EC and, where applicable, implementing acts referred to in Article 5(2) or national measures adopted under Article 5(3) of that Directive, and

(k)  where the EU fertilising product contains total chromium (Cr) above 200 mg/kg,information about the maximum quantity and exact source of total chromium (Cr).

3.  Application for EU-type examination

3.1.  The manufacturer shall lodge an application for EU-type examination with a single notified body of his or her choice.

3.2.  The application shall include:

(a)  the name and address of the manufacturer and, if the application is lodged by the authorised representative, his or her name and address as well,

(b)  a written declaration that the same application has not been lodged with any other notified body,

(c)  the technical documentation referred to in point 2, ▌

(d)  the samples representative of the production envisaged. The notified body may request further samples if needed for carrying out the test programme,

(e)  the supporting evidence for the adequacy of the technical design solution. This supporting evidence shall mention any documents that have been used, in particular where the relevant harmonised standards or common specifications have not been applied in full. The supporting evidence shall include, where necessary, the results of tests carried out in accordance with other relevant technical specifications by the appropriate laboratory of the manufacturer, or by another testing laboratory on his or her behalf and under his or her responsibility.

4.  Assessment of the adequacy of the technical design

▌The notified body shall:

(a)  examine the technical documentation and supporting evidence to assess the adequacy of the technical design of the EU fertilising product;

(b)  verify that the sample(s) have been manufactured in conformity with the technical documentation, and identify the elements which have been designed in accordance with the applicable provisions of the relevant harmonised standards ▌or common specifications, as well as the elements which have been designed in accordance with other relevant technical specifications;

(c)  carry out appropriate examinations and tests on the sample(s), or have them carried out, to check whether, where the manufacturer has chosen to apply the solutions in the relevant harmonised standards or common specifications, these have been applied correctly;

(d)  carry out appropriate examinations and tests on the sample(s), or have them carried out, to check whether, where the solutions in the relevant harmonised standards or common specifications▌ have not been applied, or where relevant harmonised standards or common specifications do not exist, the solutions adopted by the manufacturer meet the corresponding ▌ requirements of this Regulation;

(e)  agree with the manufacturer on a location where the examinations and tests will be carried out.

5.  Evaluation report

The notified body shall draw up an evaluation report that records the activities undertaken in accordance with point 4 and their outcomes. Without prejudice to its obligations vis-à-vis the notifying authority, the notified body shall release the content of that report, in full or in part, only with the agreement of the manufacturer.

6.  EU-type examination certificate

6.1.  Where the type meets the requirements of this Regulation that apply to the EU fertilising product concerned, the notified body shall issue an EU-type examination certificate to the manufacturer. The certificate shall contain the name and address of the manufacturer, the conclusions of the examination, the conditions (if any) for its validity and the necessary data for identification of the approved type. The EU-type examination certificate may have one or more annexes attached.

6.2.  The EU-type examination certificate and its annexes shall contain all relevant information to allow the conformity of manufactured EU fertilising products with the examined type to be evaluated ▌.

6.3.  Where the type does not satisfy the requirements of this Regulation, the notified body shall refuse to issue an EU-type examination certificate and shall inform the applicant accordingly, giving detailed reasons for its refusal.

7.  Changes which may affect the conformity of the EU fertilising product

7.1.  The notified body shall keep itself apprised of any changes in the generally acknowledged state of the art which indicate that the approved type may no longer comply with the requirements of this Regulation and shall determine whether such changes require further investigation. If so, the notified body shall inform the manufacturer accordingly.

7.2.  The manufacturer shall inform the notified body that holds the technical documentation relating to the EU-type examination certificate of all modifications to the approved type that may affect the conformity of the EU fertilising product with the requirements of this Regulation or the conditions for validity of the EU-type examination certificate. Such modifications shall require additional approval in the form of an addition to the original EU-type examination certificate.

8.  Notified bodies' information obligation

8.1.  Each notified body shall inform its notifying authority concerning the EU-type examination certificates and/or any additions thereto which it has issued or withdrawn, and shall, periodically or upon request, make available to its notifying authority the list of EU-type examination certificates and/or any additions thereto refused, suspended or otherwise restricted.

8.2.  Each notified body shall inform the other notified bodies concerning the EU-type examination certificates and/or any additions thereto which it has refused, withdrawn, suspended or otherwise restricted, and, upon request, concerning the EU-type examination certificates and/or additions thereto which it has issued.

8.3.  The Commission, the Member States and the other notified bodies may, on request, obtain a copy of the EU-type examination certificates and/or additions thereto. On request, the Commission and the Member States may obtain a copy of the technical documentation and the results of the examinations carried out by the notified body.

9.  Availability of the EU-type examination certificate

9.1.  The notified body shall keep a copy of the EU-type examination certificate, its annexes and additions, as well as the technical file including the documentation submitted by the manufacturer, until the expiry of the validity of the EU-type examination certificate.

9.2.  The manufacturer shall keep a copy of the EU-type examination certificate, its annexes and additions together with the technical documentation at the disposal of the national authorities for 5 years after the EU fertilising product has been placed on the market.

10.  Authorised representative

The manufacturer's authorised representative may lodge the application referred to in point 3 and fulfil the obligations set out in points 7 and 9.2., provided that they are specified in the mandate.

Module C – Conformity to type based on internal production control

1.  Description of the module

▌Conformity to type based on internal production control is the part of a conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2 and 3, and ensures and declares on his or her sole responsibility that the EU fertilising products concerned are in conformity with the type described in the EU-type examination certificate and satisfy the requirements of this Regulation that apply to them.

2.  Manufacturing

▌The manufacturer shall take all measures necessary so that the manufacturing process and its monitoring ensure conformity of the manufactured EU fertilising products with the approved type described in the EU-type examination certificate and with the requirements of this Regulation that apply to them.

3.  CE marking and EU declaration of conformity

3.1  The manufacturer shall affix the CE marking to each individual packaging of the EU fertilising product that is in conformity with the type described in the EU-type examination certificate and satisfies the applicable requirements of this Regulation or, where it is supplied without packaging, in a document accompanying the EU fertilising product.

3.2  The manufacturer shall draw up a written EU declaration of conformity for an EU fertilising product type and keep it together with the technical documentation at the disposal of the national authorities for 5 years after the EU fertilising product has been placed on the market. The EU declaration of conformity shall identify the EU fertilising product type for which it has been drawn up.

3.3.  A copy of the EU declaration of conformity shall be made available to the relevant authorities upon request.

4.  Authorised representative

The manufacturer's obligations set out in point 3 may be fulfilled by his or her authorised representative, on his or her behalf and under his or her responsibility, provided that they are specified in the mandate.

Module D1 - Quality assurance of the production process

1.  Description of the module

▌Quality assurance of the production process is the conformity assessment procedure whereby the manufacturer fulfils the obligations laid down in points 2, 4, and 7, and ensures and declares on his or her sole responsibility that the EU fertilising products concerned satisfy the requirements of this Regulation that apply to them.

2.  Technical documentation

2.1.  The manufacturer ▌ shall establish the technical documentation. The documentation shall make it possible to assess the EU fertilising product's conformity with the relevant requirements, and shall include an adequate analysis and assessment of the risk(s).

2.2.  The technical documentation shall specify the applicable requirements and cover, as far as relevant for the assessment, the design, manufacture and intended use of the EU fertilising product. The technical documentation shall contain, where applicable, at least the following elements:

(a)  a general description of the EU fertilising product, the PFC corresponding to the claimed function of the EU fertilising product and description of the intended use,

(b)  a list of component materials used, the CMCs as referred to in Annex II, to which they belong and information about their origin or manufacturing process,

(c)  the EU declarations of conformity for the component EU fertilising products of the fertilising product blend,

(d)  drawings, schemes, descriptions and explanations necessary for the understanding of the manufacturing process of the EU fertilising product, and, in relation to compost belonging to CMC 3 or digestate belonging to CMC 5, as defined in Annex II, a written description and a diagram of the production process, where each treatment, storage vessel and area is clearly identified,

(e)  a specimen of the label or the leaflet, or both, referred to in Article 6(7) containing the information required in accordance with Annex III,

(f)  a list of the harmonised standards referred to in Article 13, common specifications referred to in Article 14 and/or other relevant technical specifications applied. In the event of partly applied harmonised standards or common specifications, the technical documentation shall specify the parts which have been applied,

(g)  results of ▌ calculations made, including the calculations to demonstrate conformity with point 5 of Part II of Annex I, examinations carried out, etc.,

(h)  test reports,

(i)  where the EU fertilising product contains or consists of derived products within the meaning of Regulation (EC) No 1069/2009, the commercial documents or health certificates required pursuant to that Regulation, and evidence that the derived products have reached the end point in the manufacturing chain within the meaning of that Regulation,

(j)  where the EU fertilising product contains or consists of by-products within the meaning of Directive 2008/98/EC, technical and administrative evidence that the by-products comply with the criteria established by delegated act referred to in Article 42(7) of this Regulation, and with the national measures transposing Article 5(1) of Directive 2008/98/EC and, where applicable, implementing acts referred to in Article 5(2) or national measures adopted under Article 5(3)of that Directive, and

(k)  where the EU fertilising product contains total chromium (Cr) above 200 mg/kg, information about the maximum quantity and exact source of total chromium (Cr).

3.  Availability of technical documentation

▌The manufacturer shall keep the technical documentation at the disposal of the relevant national authorities for 5 years after the EU fertilising product has been placed on the market.

4.  Manufacturing

The manufacturer shall operate an approved quality system for production, final product inspection and testing of the EU fertilising products concerned as specified in point 5, and shall be subject to surveillance as specified in point 6.

5.  Quality system

5.1.  The manufacturer shall implement a quality system which shall ensure compliance of the EU fertilising products with the requirements of this Regulation that apply to them.

5.1.1.  The quality system shall cover the quality objectives and the organisational structure with responsibilities and powers of the management with regard to product quality.

5.1.1.1.  For compost belonging to CMC 3 and digestate belonging to CMC 5, as defined in Annex II, senior management of the manufacturer's organisation shall:

(a)  ensure that sufficient resources (people, infrastructure, equipment) are available to create and implement the quality system;

(b)  appoint a member of the organisation’s management who shall be responsible for:

–  ensuring that quality management processes are established, approved, implemented and maintained;

–  reporting to senior management of the manufacturer on the performance of the quality management and any need for improvement;

–  ensuring the promotion of awareness of customer needs and legal requirements throughout the manufacturer's organisation, and for making the personnel aware of the relevance and importance of the quality management requirements to meet the legal requirements of this Regulation;

–  ensuring that each person whose duties affect the product quality is sufficiently trained and instructed; and

–  ensuring the classification of the quality management documents mentioned under point 5.1.4.;

(c)  conduct an internal audit every year, or sooner than scheduled if triggered by any significant change that may affect the quality of the EU fertilising product; and

(d)  ensure that appropriate communication processes are established within and outside the organisation and that communication take place regarding the effectiveness of the quality management.

5.1.2.  The quality system shall cover the manufacturing, quality control and quality assurance techniques, processes and systematic actions.

5.1.2.1.  For compost belonging to CMC 3 and digestate belonging to CMC 5, as defined in Annex II, the quality system shall ensure compliance with the composting and digestion process criteria specified in that Annex.

5.1.3.  The quality system shall cover the examinations and tests to be carried out before, during and after manufacture with a specified frequency.

5.1.3.1.  For compost belonging to CMC 3 and digestate belonging to CMC 5, as defined in Annex II, the examinations and tests shall comprise the following elements:

(a)  The following information shall be recorded for each batch of input materials:

(i)  date of delivery;

(ii)  amount by weight (or estimation based on the volume and density);

(iii)  identity of the input material supplier;

(iv)  input material type;

(v)  identification of each batch and delivery location on site. A unique identification code shall be assigned throughout the production process for quality management purposes; and

(vi)  in case of refusal, the reasons for the rejection of the batch and where it was sent.

(b)  Qualified staff shall carry out a visual inspection of each consignment of input materials and verify compatibility with the specifications of input materials laid down in CMC 3 and CMC 5 in Annex II.

(c)  The manufacturer shall refuse any consignment of any given input material where visual inspection raises any suspicion of:

–  the presence of hazardous or damageable substances for the composting or digestion process or for the quality of the final EU fertilising product, or

–  incompatibility with the specifications laid down in CMC 3 and CMC 5 in Annex II, in particular by presence of plastics leading to excedence of the limit value for macroscopic impurities.

(d)  The staff shall be trained on:

–  potential hazardous properties that may be associated with input materials, and

–  features that allow hazardous properties and the presence of plastics to be recognised.

(e)  Samples shall be taken on output materials, to verify that they comply with the component material specifications for compost and digestate laid down in CMC 3 and CMC 5 in Annex II, and that the properties of the output material do not jeopardise the EU fertilising product's compliance with the relevant requirements in Annex I.

(f)  The output material samples shall be taken on a regular basis with at least the following frequency:

Annual input

(tonnes)

Samples / year

≤ 3 000

1

3 001 – 10 000

2

10 001 – 20 000

3

20 001 – 40 000

4

40 001 – 60 000

5

60 001 – 80 000

6

80 001 – 100 000

7

100 001 – 120 000

8

120 001 – 140 000

9

140 001 – 160 000

10

160 001 – 180 000

11

> 180 000

12

(g)  If any tested output material sample fails one or more of the applicable limits specified in the relevant sections of Annexes I and II, the person responsible for quality management referred to in point 5.1.1.1(b) shall:

(i)  clearly identify the non-conforming output materials and their storage place,

(ii)  analyse the reasons of the non-conformity and take any necessary action to avoid its repetition,

(iii)  record in the quality records referred to in point 5.1.4. if reprocessing takes place, or if the output material is eliminated.

5.1.4.  The quality system shall cover the manufacturer’s ▌ quality records, such as inspection reports and test data, calibration data, qualification reports on the personnel concerned, etc.,

5.1.4.1.  For compost belonging to CMC 3 and digestate belonging to CMC 5, as defined in Annex II, the quality records shall demonstrate effective control of input materials, production, storage and compliance of input- and output materials with the relevant requirements of this Regulation. Each document shall be legible and available at its relevant place(s) of use, and any obsolete version shall be promptly removed from all places where it is used, or at least identified as obsolete. The quality management documentation shall at least contain the following information:

(a)  a title,

(b)  a version number,

(c)  a date of issue,

(d)  the name of the person who issued it,

(e)  records about the effective control of input materials,

(f)  records about the effective control of the production process,

(g)  records about the effective control of the output materials,

(h)  records of non-conformities,

(i)  reports on all accidents and incidents that occur to the site, their known or suspected causes and actions taken,

(j)  records of the complaints expressed by third parties and how they have been addressed,

(k)  a record of the date, type and topic of training followed by the persons responsible for the quality of the product,

(l)  results of internal audit and actions taken, and

(m)  results of external audit review and actions taken.

5.1.5  The quality system shall cover the means of monitoring the achievement of the required product quality and the effective operation of the quality system ▌.

5.1.5.1.  For compost belonging to CMC 3 and digestate belonging to CMC 5, as defined in Annex II, the manufacturer shall establish an annual internal audit program in order to verify the compliance of the quality system with the following components:

(a)  a procedure that defines the responsibilities and requirements for planning and conducting internal audits, establishing records and reporting results shall be established and documented. A report identifying the non-conformities to the quality scheme shall be prepared and all corrective actions shall be reported. The records of the internal audit shall be annexed to the quality management documentation;

(b)  priority shall be given to non-conformities identified by external audits;

(c)  each auditor shall not audit his or her own work;

(d)  the management responsible for the area audited shall ensure that the necessary corrective actions are taken without undue delay;

(e)  internal audit realised in the frame of another quality management system can be taken into account provided that it is completed by an audit of the requirements to this quality system.

5.1.6.  All the elements, requirements and provisions adopted by the manufacturer shall be documented in a systematic and orderly manner in the form of written policies, procedures and instructions. The quality system documentation shall permit a consistent interpretation of the quality programmes, plans, manuals and records. It shall, in particular, contain an adequate description of all the quality management elements set out in points 5.1.1. to 5.1.5.

5.2.  The manufacturer shall lodge an application for assessment of his or her quality system with the ▌ notified body of his or her choice, for the EU fertilising products concerned. The application shall include:

—  the name and address of the manufacturer and, if the application is lodged by the authorised representative, his or her name and address as well,

—  a written declaration that the same application has not been lodged with any other notified body,

—  all relevant information for the EU fertilising product category envisaged,

—  the documentation concerning the quality system containing all the elements set out in point 5.1,

—  the technical documentation referred to in point 2.

5.3.1.  The notified body shall assess the quality system to determine whether it satisfies the requirements referred to in point 5.1.

5.3.2.  It shall presume conformity with those requirements in respect of the elements of the quality system that comply with the corresponding specifications of the relevant harmonised standard.

5.3.3.  In addition to experience in quality management systems, the auditing team shall have at least one member with experience of evaluation in the relevant product field and product technology concerned, and knowledge of the applicable requirements of this Regulation. The audit shall include an assessment visit to the manufacturer's premises. The auditing team shall review the technical documentation referred to in point 2 in order to verify the manufacturer's ability to identify the relevant requirements of this Regulation and to carry out the necessary examinations with a view to ensuring compliance of the EU fertilising product with those requirements.

5.3.4.  The decision shall be notified to the manufacturer. The notification shall contain the conclusions of the audit and the reasoned assessment decision.

5.4.  The manufacturer shall undertake to fulfil the obligations arising out of the quality system as approved and to maintain it so that it remains adequate and efficient.

5.5.1.  The manufacturer shall keep the notified body that has approved the quality system informed of any intended change to the quality system.

5.5.2.  The notified body shall evaluate any proposed changes and decide whether the modified quality system will continue to satisfy the requirements referred to in point 5.1 or whether reassessment is necessary.

5.5.3.  It shall notify the manufacturer of its decision. The notification shall contain the conclusions of the examination and the reasoned assessment decision.

6.  Surveillance under the responsibility of the notified body

6.1.  The purpose of surveillance is to make sure that the manufacturer duly fulfils the obligations arising out of the approved quality system.

6.2.  The manufacturer shall, for assessment purposes, allow the notified body access to the manufacture, inspection, testing and storage sites and shall provide it with all necessary information, in particular:

—  the quality system documentation,

—  the technical documentation referred to in point 2,

—  the quality records, such as inspection reports and test data, calibration data, qualification reports on the personnel concerned.

6.3.1.  The notified body shall carry out periodic audits to make sure that the manufacturer maintains and applies the quality system and shall provide the manufacturer with an audit report.

6.3.2.  For compost belonging to CMC 3 and digestate belonging to CMC 5, as defined in Annex II, the notified body shall take and analyse output material samples during each audit, and the audits shall be carried out with the following frequency:

(a)  during the notified body's first year of surveillance of the plant in question: the same frequency as the sampling frequency indicated in the table included in point  5.1.3.1(f); and

(b)  during the following years of surveillance: half the sampling frequency indicated in the table included in point 5.1.3.1(f).

6.4  In addition, the notified body may pay unexpected visits to the manufacturer. During such visits the notified body may, if necessary, carry out product tests, or have them carried out, in order to verify that the quality system is functioning correctly. The notified body shall provide the manufacturer with a visit report and, if tests have been carried out, with a test report.

7.  CE marking and EU declaration of conformity

7.1.  The manufacturer shall affix the CE marking and, under the responsibility of the notified body referred to in point 5.2, the latter's identification number to each individual packaging of the EU fertilising product that satisfies the applicable requirements of this Regulation or, where it is supplied without packaging, in a document accompanying the EU fertilising product.

7.2.  The manufacturer shall draw up a written EU declaration of conformity for an EU fertilising product or type and keep it, together with the technical documentation at the disposal of the national authorities for 5 years after the EU fertilising product has been placed on the market. The EU declaration of conformity shall identify the EU fertilising product or type for which it has been drawn up.

7.3.  A copy of the EU declaration of conformity shall be made available to the relevant authorities upon request.

8.  Availability of quality system documentation

The manufacturer shall, for 5 years after the EU fertilising product has been placed on the market, keep at the disposal of the national authorities:

—  the documentation referred to in point 5.1.6.,

—  the information on the changes referred to in points 5.5.1 and 5.5.2, as approved,

—  the decisions and reports of the notified body referred to in points  5.5.3, 6.3.1 and 6.4.

9.  Notified bodies' information obligation

9.1.  Each notified body shall inform its notifying authority of quality system approvals issued or withdrawn, and shall, periodically or upon request, make available to its notifying authority the list of quality system approvals refused, suspended or otherwise restricted.

9.2.  Each notified body shall inform the other notified bodies of quality system approvals which it has refused, withdrawn, suspended or otherwise restricted, and, upon request, of quality system approvals which it has issued.

10.  Authorised representative

The manufacturer's obligations set out in points 3, 5.2, 5.5.1, 7 and 8 may be fulfilled by his or her authorised representative, on his or her behalf and under his or her responsibility, provided that they are specified in the mandate.

ANNEX V

EU Declaration of conformity (No XXX)(53)

1.  EU fertilising product (product-, batch-, or type- number):

2.  Name and address of the manufacturer and, where applicable, its authorised representative:

3.  This EU declaration of conformity is issued under the sole responsibility of the manufacturer.

4.  Object of the declaration (identification of the EU fertilising product allowing traceability; it may, where necessary for the identification of the EU fertilising product, include an image):

5.  The object of the declaration described above is in conformity with ▌:

—  Regulation (EU) …/…(54)(55),

—  other Union harmonisation legislation where applicable:

6.  References to the relevant harmonised standards or to the common specifications used or references to the other technical specifications in relation to which conformity is declared:

7.  Where applicable, the notified body ... (name, number) performed … (description of intervention) and issued the certificate or approval decision … (number):

8.  Where applicable, annexed to this EU declaration of conformity are the EU declarations of conformity for the component EU fertilising products of the fertilising product blend.

9.  Additional information:

Signed for and on behalf of:

(place and date of issue):

(name, function) (signature):

(1) OJ C 389, 21.10.2016, p. 80.
(2) This position replaces the amendments adopted on 24 October 2017 (Texts adopted, P8_TA(2017)0392).
(3)OJ C 389, 21.10.2016, p.80.
(4) Position of the European Parliament of 27 March 2019.
(5)Regulation (EC) No 2003/2003 of the European Parliament and of the Council of 13 October 2003 relating to fertilisers (OJ L 304, 21.11.2003, p. 1).
(6)Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products and repealing Regulation (EEC) No 339/93 (OJ L 218, 13.8.2008, p. 30).
(7)Decision No 768/2008/EC of the European Parliament and of the Council of 9 July 2008 on a common framework for the marketing of products, and repealing Council Decision 93/465/EEC (OJ L 218, 13.8.2008, p. 82).
(8)Regulation (EC) No 1069/2009 of the European Parliament and of the Council of 21 October 2009 laying down health rules as regards animal by-products and derived products not intended for human consumption and repealing Regulation (EC) No 1774/2002 (Animal by-products Regulation) (OJ L 300, 14.11.2009, p. 1)
(9)Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (OJ L 31, 1.2.2002, p. 1).
(10)Directive 2008/98/EC of the European Parliament and of the Council of 19 November 2008 on waste and repealing certain Directives (OJ L 312, 22.11.2008, p. 3).
(11)Regulation (EC) No 1107/2009 of the European Parliament and of the Council of 21 October 2009 concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC and 91/414/EEC (OJ L 309, 24.11.2009, p. 1).
(12)Council Directive 86/278/EEC of 12 June 1986 on the protection of the environment, and in particular of the soil, when sewage sludge is used in agriculture (OJ L 181, 4.7.1986, p. 6).
(13)Council Directive 89/391/EEC of 12 June 1989 on the introduction of measures to encourage improvements in the safety and health of workers at work (OJ L 183, 29.6.1989, p. 1).
(14)Council Directive 91/676/EEC of 12 December 1991 concerning the protection of waters against pollution caused by nitrates from agricultural sources (OJ L 375, 31.12.1991, p. 1).
(15)Directive 2000/60/EC of the European Parliament and of the Council of 23 October 2000 establishing a framework for Community action in the field of water policy (OJ L 327, 22.12.2000, p. 1).
(16)Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC (OJ L 106, 17.4.2001, p. 1).
(17) Regulation (EC) No 852/2004 of the European Parliament and of the Council of 29 April 2004 on the hygiene of foodstuffs (OJ L 139, 30.4.2004, p.1).
(18)Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules (OJ L 165, 30.4.2004, p. 1).
(19)Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 396, 30.12.2006, p. 1).
(20)Commission Regulation (EC) No 1881/2006 of 19 December 2006 setting maximum levels for certain contaminants in foodstuffs (OJ L 364, 20.12.2006, p. 5).
(21)Council Regulation (EC) No 834/2007 of 28 June 2007 on organic production and labelling of organic products and repealing Regulation (EEC) No 2092/91 (OJ L 189, 20.7.2007, p. 1).
(22)Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, p. 1).
(23)Regulation (EU) No 98/2013 of the European Parliament and of the Council of 15 January 2013 on the marketing and use of explosives precursors (OJ L 39, 9.2.2013, p. 1).
(24)Regulation (EU) No 1143/2014 of the European Parliament and of the Council of 22 October 2014 on the prevention and management of the introduction and spread of invasive alien species (OJ L 317, 4.11.2014, p. 35).
(25)Regulation (EU) 2016/2031 of the European Parliament of the Council of 26 October 2016 on protective measures against pests of plants, amending Regulations (EU) No 228/2013, (EU) No 652/2014 and (EU) No 1143/2014 of the European Parliament and of the Council and repealing Council Directives 69/464/EEC, 74/647/EEC, 93/85/EEC, 98/57/EC, 2000/29/EC, 2006/91/EC and 2007/33/EC (OJ L 317, 23.11.2016, p 4).
(26)Directive (EU) 2016/2284 of the European Parliament and of the Council of 14 December 2016 on the reduction of national emissions of certain atmospheric pollutants, amending Directive 2003/35/EC and repealing Directive 2001/81/EC (OJ L 344, 17.12.2016, p. 1).
(27) Regulation (EU) 2017/625 of the European Parliament and of the Council of 15 March 2017 on official controls and other official activities performed to ensure the application of food and feed law, rules on animal health and welfare, plant health and plant protection products, amending Regulations (EC) No 999/2001, (EC) No 396/2005, (EC) No 1069/2009, (EC) No 1107/2009, (EU) No 1151/2012, (EU) No 652/2014, (EU) 2016/429 and (EU) 2016/2031 of the European Parliament and of the Council, Council Regulations (EC) No 1/2005 and (EC) No 1099/2009 and Council Directives 98/58/EC, 1999/74/EC, 2007/43/EC, 2008/119/EC and 2008/120/EC, and repealing Regulations (EC) No 854/2004 and (EC) No 882/2004 of the European Parliament and of the Council, Council Directives 89/608/EEC, 89/662/EEC, 90/425/EEC, 91/496/EEC, 96/23/EC, 96/93/EC and 97/78/EC and Council Decision 92/438/EEC (Official Controls Regulation) (OJ L 95, 7.4.2017, p. 1).
(28)Regulation (EU) No 1025/2012 of the European Parliament and of the Council of 25 October 2012 on European standardisation, amending Council Directives 89/686/EEC and 93/15/EEC and Directives 94/9/EC, 94/25/EC, 95/16/EC, 97/23/EC, 98/34/EC, 2004/22/EC, 2007/23/EC, 2009/23/EC and 2009/105/EC of the European Parliament and of the Council and repealing Council Decision 87/95/EEC and Decision No 1673/2006/EC of the European Parliament and of the Council (OJ L 316, 14.11.2012, p. 12).
(29) OJ L 123, 12.5.2016, p. 1.
(30)Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission’s exercise of implementing powers (OJ L 55, 28.2.2011, p. 13)
(31)+ OJ; please insert the date of entry into force of Regulation in PE-CONS 76/2'018 (COD 2016/0084)
(32)+ OJ; please insert the date of entry into force of Regulation in PE-CONS 76/2018 (COD 2016/0084)
(33)+ OJ; please insert the date of entry into force of Regulation in PE-CONS 76/2'018 (COD 2016/0084)
(34)Council Regulation (EEC) No 315/93 of 8 February 1993 laying down Community procedures for contaminants in food (OJ L 37, 13.2.1993, p. 1).
(35)Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC (OJ L 70, 16.3.2005, p. 1).
(36)Regulation (EC) No 470/2009 of the European Parliament and of the Council of 6 May 2009 laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin, repealing Council Regulation (EEC) No 2377/90 and amending Directive 2001/82/EC of the European Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and of the Council (OJ L 152, 16.6.2009, p. 11).
(37)Directive 2002/32/EC of the European Parliament and of the Council of 7 May 2002 on undesirable substances in animal feed (OJ L 140, 30.5.2002, p. 10).
(38)The exclusion of a material from CMC 1 does not prevent it from being an eligible component material by virtue of another CMC stipulating different requirements. See, for instance, CMC 3 on compost, CMCs 4 and 5 on digestate, CMCs 8 and 9 on polymers, CMC 10 on derived products within the meaning of Regulation (EC) No 1069/2009 or CMC 11 on by-products within the meaning of Directive 2008/98/EC.
(39) In the case of a substance recovered in the European Union, this condition is fulfilled if the substance is the same, within the meaning of point (d)(i) of Article 2(7) of Regulation (EC) No 1907/2006, as a substance registered with a dossier containing the information here indicated, and if information is available to the fertilising product manufacturer within the meaning of point (d)(ii) of Article 2(7) of Regulation (EC) No 1907/2006.
(40)In the case of an additive recovered in the European Union, this condition is fulfilled if the additive is the same, within the meaning of point (d)(i) of Article 2(7)of Regulation (EC) No 1907/2006, as a substance registered with a dossier containing the information here indicated, and if information is available to the fertilising product manufacturer within the meaning of point (d)(ii) of Article 2(7) of Regulation (EC) No 1907/2006.
(41)Sum of naphthalene, acenaphthylene, acenaphthene, fluorene, phenanthrene, anthracene, fluoranthene, pyrene, benzo[a]anthracene, chrysene, benzo[b]fluoranthene, benzo[k]fluoranthene, benzo[a]pyrene, indeno[1,2,3-cd]pyrene, dibenzo[a,h]anthracene and benzo[ghi]perylene.
(42)Sum of naphthalene, acenaphthylene, acenaphthene, fluorene, phenanthrene, anthracene, fluoranthene, pyrene, benzo[a]anthracene, chrysene, benzo[b]fluoranthene, benzo[k]fluoranthene, benzo[a]pyrene, indeno[1,2,3-cd]pyrene, dibenzo[a,h]anthracene and benzo[ghi]perylene.
(43)In the case of an additive recovered in the European Union, this condition is fulfilled if the additive is the same, within the meaning of point (d)(i) of Article 2(7) of Regulation (EC) No 1907/2006, as a substance registered with a dossier containing the information here indicated, and if information is available to the fertilising product manufacturer within the meaning of point (d)(ii) of Article 2(7) of Regulation (EC) No 1907/2006.
(44)Commission Regulation (EU) No 142/2011 of 25 February 2011 implementing Regulation (EC) No 1069/2009 of the European Parliament and of the Council laying down health rules as regards animal by-products and derived products not intended for human consumption and implementing Council Directive 97/78/EC as regards certain samples and items exempt from veterinary checks at the border under that Directive (OJ L 54, 26.2.2011, p. 1).
(45)In the case of an additive recovered in the European Union, this condition is fulfilled if the additive is the same, within the meaning of point (d)(i) of Article 2(7) of Regulation (EC) No 1907/2006, as a substance registered with a dossier containing the information here indicated, and if information is available to the fertilising product manufacturer within the meaning of point (d)(ii) of Article 2(7) of Regulation (EC) No 1907/2006.
(46)Sum of naphthalene, acenaphthylene, acenaphthene, fluorene, phenanthrene, anthracene, fluoranthene, pyrene, benzo[a]anthracene, chrysene, benzo[b]fluoranthene, benzo[k]fluoranthene, benzo[a]pyrene, indeno[1,2,3-cd]pyrene, dibenzo[a,h]anthracene and benzo[ghi]perylene.
(47)Sum of naphthalene, acenaphthylene, acenaphthene, fluorene, phenanthrene, anthracene, fluoranthene, pyrene, benzo[a]anthracene, chrysene, benzo[b]fluoranthene, benzo[k]fluoranthene, benzo[a]pyrene, indeno[1,2,3-cd]pyrene, dibenzo[a,h]anthracene and benzo[ghi]perylene
(48)In the case of a substance recovered in the European Union, this condition is fulfilled if the substance is the same, within the meaning of point (d)(i) of Article 2(7) of Regulation (EC) No 1907/2006, as a substance registered with a dossier containing the information here indicated, and if information is available to the fertilising product manufacturer within the meaning of point (d)(ii) of Article 2(7) of Regulation (EC) No 1907/2006.
(49) The table will be established by delegated acts referred to in Article 42(5).
(50) The exclusion of a material from CMC 11 does not prevent it from being an eligible component material by virtue of another CMC stipulating different requirements. See, for instance, CMC 3 on compost, CMCs 4 and 5 on digestate, CMCs 8 and 9 on polymers or CMC 10 on derived products within the meaning of Regulation (EC) No 1069/2009.
(51)The diameter of the disc must always correspond to the inside diameter of the cylinder.
(52)NB: When the six peripheral lengths of cord are taut after assembly, the central cord must remain slightly slack.
(53)It is optional for the manufacturer to assign a number to the EU declaration of conformity.
(54) Regulation (EU) …/… of the European parliament and the Council of…laying down rules on the making available on the market of EU fertilising products and amending Regulations (EC) No 1069/2009 and (EC) No 1107/2009 and repealing Regulation (EC) No 2003/2003 (OJ L…)
(55)* OJ : please insert the number of this Regulation PE-CONS 76/2018 – 2016/0084 (COD) and complete the footnote.


Protection of workers from the risks related to exposure to carcinogens or mutagens at work ***I
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Resolution
Consolidated text
European Parliament legislative resolution of 27 March 2019 on the proposal for a directive of the European Parliament and of the Council amending Directive 2004/37/EC on the protection of workers from the risks related to exposure to carcinogens or mutagens at work (COM(2018)0171 – C8-0130/2018 – 2018/0081(COD))
P8_TA-PROV(2019)0307A8-0382/2018

(Ordinary legislative procedure: first reading)

The European Parliament,

–  having regard to the Commission proposal to Parliament and the Council (COM(2018)0171),

–  having regard to Article 294(2) and Articles 153(2)(b) and 153(1)(a) of the Treaty on the Functioning of the European Union, pursuant to which the Commission submitted the proposal to Parliament (C8-0130/2018),

–  having regard to Article 294(3) of the Treaty on the Functioning of the European Union,

–  having regard to the opinion of the European Economic and Social Committee of 19 September 2018(1),

–  after consulting the Committee of the Regions,

–  having regard to the provisional agreement approved by the committee responsible under Rule 69f(4) of its Rules of Procedure and the undertaking given by the Council representative by letter of 18 February 2019 to approve Parliament’s position, in accordance with Article 294(4) of the Treaty on the Functioning of the European Union,

–  having regard to Rule 59 of its Rules of Procedure,

–  having regard to the report of the Committee on Employment and Social Affairs and the opinion of the Committee on Legal Affairs (A8-0382/2018),

1.  Adopts its position at first reading hereinafter set out;

2.  Calls on the Commission to refer the matter to Parliament again if it replaces, substantially amends or intends to substantially amend its proposal;

3.  Instructs its President to forward its position to the Council, the Commission and the national parliaments.

Position of the European Parliament adopted at first reading on 27 March 2019 with a view to the adoption of Directive (EU) 2019/… of the European Parliament and of the Council amending Directive 2004/37/EC on the protection of workers from the risks related to exposure to carcinogens or mutagens at work

P8_TC1-COD(2018)0081


(Text with EEA relevance)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on the Functioning of the European Union, and in particular point (b) of Article 153(2), in conjunction with point (a) of Article 153(1) thereof,

Having regard to the proposal from the European Commission,

After transmission of the draft legislative act to the national parliaments,

Having regard to the opinion of the European Economic and Social Committee(2),

After consulting the Committee of the Regions,

Acting in accordance with the ordinary legislative procedure(3),

Whereas:

(1)  Delivering on the European Pillar of Social Rights(4), proclaimed by the European Parliament, the Council and the Commission at the Social Summit for Fair Jobs and Growth in Gothenburg on 17 November 2017, is a shared political commitment and responsibility. Principle 10 of the European Pillar of Social Rights provides that workers have the right to a healthy, safe and well-adapted work environment. The right of workers to a high level of protection of their health and safety at work and to a working environment adapted to their professional needs also includes ▌protection from carcinogens and mutagens at the workplace, irrespective of the duration of the employment or of the exposure.

(2)  This Directive respects fundamental rights and observes the principles recognised in the Charter of Fundamental Rights of the European Union, in particular the right to life and the right to fair and just working conditions provided for, respectively, in Articles 2 and 31 thereof.

(3)  Directive 2004/37/EC of the European Parliament and of the Council(5) aims to protect workers against risks to their health and safety from exposure to carcinogens or mutagens at the workplace. A consistent level of protection from the risks related to carcinogens and mutagens is provided for in that Directive ▌ by a framework of general principles to enable Member States to ensure the consistent application of minimum requirements. The aim of those minimum requirements is to protect workers at Union level and to contribute to reducing differences in the levels of protection of workers across the Union and to ensuring a level playing field. Binding occupational exposure limit values are important components of the general arrangements for the protection of workers established by Directive 2004/37/EC. Those limit values need to be evidence-based, proportionate and measurable and should be established on the basis of available information, including up-to-date scientific and technical data, the economic feasibility of implementation and compliance, a thorough assessment of the socioeconomic impact and the availability of exposure measurement protocols and techniques at the workplace. More stringent binding occupational exposure limit values can be set by Member States in close cooperation with the social partners. In addition, Directive 2004/37/EC does not prevent Member States from applying additional measures, such as a biological limit value.

(4)  Directive 2004/37/EC aims to cover substances or mixtures which meet the criteria for classification as a category 1A or 1B carcinogen or mutagen set out in Annex I to Regulation (EC) No 1272/2008 of the European Parliament and of the Council(6) as well as substances, mixtures or processes referred to in Annex I to Directive 2004/37/EC. The substances which meet the criteria for classification as a category 1A or 1B carcinogen or mutagen set out in Annex I to Regulation (EC) No 1272/2008 are those with a harmonised classification or classified in accordance with Article 4 or 36 of that Regulation and notified to the European Chemicals Agency (ECHA) pursuant to Article 40 of that Regulation. Those substances are listed in the public Classification and Labelling Inventory maintained by ECHA. For any new addition to the list of substances, mixtures and processes referred to in Annex I to Directive 2004/37/EC in accordance with point (a)(ii) of Article 2 of that Directive, robust scientific evidence of the carcinogenicity of the relevant substance needs to be demonstrated, based on available valid scientific sources such as the Committee for Risk Assessment (RAC) of ECHA, the International Agency for Research on Cancer (IARC) and national bodies, paying particular attention to peer-reviewed published literature on that substance.

(5)  Occupational exposure limit values are part of the risk-management measures under Directive 2004/37/EC. Those limit values should be revised regularly in accordance with the precautionary principle and the principle of the protection of workers, and in light of sound available scientific and technical data concerning carcinogens and mutagens. Consideration should also be given to improving measurement techniques, risk-management measures and other relevant factors. Compliance with those limit values is without prejudice to other employers’ obligations ▌pursuant to that Directive, in particular the reduction of the use of carcinogens and mutagens at the workplace, the prevention or reduction of workers’ exposure to carcinogens or mutagens and the measures which should be implemented to that effect. Those measures should include, in so far as is technically possible, the replacement of the carcinogen or mutagen with a substance, mixture or process which is not dangerous or is less dangerous to workers’ health, the use of a closed system and other measures aiming to reduce the level of workers’ exposure ▌.

(6)  Hazardous drugs, including cytotoxic drugs primarily used for cancer treatment, could have genotoxic, carcinogenic or mutagenic properties. It is therefore important to protect workers who are exposed to such drugs through work involving: the preparation, administration or disposal of hazardous drugs, including cytotoxic drugs; services related to cleaning, transport, laundry or waste disposal of hazardous drugs or of materials contaminated by such drugs; or personal care for patients treated with hazardous drugs. Hazardous drugs, including cytotoxic drugs, are subject to Union measures providing for minimum requirements for the protection of health and safety of workers, in particular those provided for in Council Directive 98/24/EC(7). Hazardous drugs that contain substances that are also carcinogens or mutagens are subject to Directive 2004/37/EC. The Commission should assess the most appropriate instrument for ensuring the occupational safety of workers exposed to hazardous drugs, including cytotoxic drugs. In doing so, access to the best available treatments for patients should not be jeopardised.

(7)  For most carcinogens and mutagens, it is not scientifically possible to identify levels below which exposure would not lead to adverse effects. While setting the limit values at the workplace in relation to carcinogens and mutagens pursuant to this Directive ▌ does not completely eliminate risks to the health and safety of workers arising from exposure at work (residual risk), it nonetheless contributes to a significant reduction in the risks arising from such exposure in the stepwise and goal-setting approach pursuant to Directive 2004/37/EC. For other carcinogens and mutagens, it is scientifically possible to identify levels below which exposure is not expected to lead to adverse effects.

(8)  Maximum levels for workers’ exposure to some carcinogens or mutagens are established by values which, pursuant to Directive 2004/37/EC, are not to be exceeded.

(9)  This Directive strengthens the protection of workers’ health and safety at their workplace. The Commission should review Directive 2004/37/EC on a regular basis and make legislative proposals, if appropriate. New limit values should be set out in that Directive ▌ in the light of available information, including new scientific and technical data and evidence-based best practices, techniques and protocols for exposure-level measurement at the workplace. That information should, if possible, include data on residual risks to the health of workers, recommendations of the Scientific Committee on Occupational Exposure Limits (SCOEL) and opinions of RAC, as well as opinions of the Advisory Committee on Safety and Health at Work (ACSH) and monographs of the IARC. Transparency of information is a tool for prevention in this context and should be ensured. Information related to residual risk ▌ is valuable for any future work to limit risks from occupational exposure to carcinogens and mutagens, and should be made publicly available at Union level. This Directive follows the specific recommendations of SCOEL, RAC and the ACSH, the importance of which has been highlighted in previous amendments to Directive 2004/37/EC.

(10)  It is also necessary, in light of scientific data, to consider ▌the absorption pathways of carcinogens and mutagens other than inhalation, including the possibility of uptake through the skin, and, in such cases, assign a skin notation for relevant substances in order to ensure the best possible level of protection. The amendments to Annex III to Directive 2004/37/EC provided for in this Directive constitute a further step in a longer-term process initiated to update that Directive ▌.

(11)  The assessment of health effects of carcinogens subject to this Directive was based on the relevant scientific expertise from ▌SCOEL and ▌ RAC.

(12)  SCOEL, the activities of which are regulated by Commission Decision 2014/113/EU(8), assists the Commission in particular in identifying, evaluating and analysing in detail the latest available scientific data and in proposing occupational exposure limit values for the protection of workers from chemical risks, which are to be set at Union level pursuant to Directives 98/24/ECand ▌ 2004/37/EC.

(13)  In accordance with Regulation (EC) No 1907/2006 of the European Parliament and of the Council(9) RAC prepares opinions of ECHA concerning the risks of chemical substances to human health and the environment. In the context of this Directive, RAC prepared its opinion as requested in accordance with point (c) of Article 77(3) of that Regulation ▌.

(14)  The 2018-2019 campaign “Healthy Workplaces Manage Dangerous Substances” is a good example of how the European Agency for Safety and Health at Work (EU-OSHA) can support the implementation of occupational safety and health legislation at Union level. It is desirable that EU-OSHA work closely with Member States to provide tailored information and examples of good practices to workers in contact with certain substances, highlighting policy developments and the legislative framework already in place.

(15)  Cadmium and many of its inorganic compounds meet the criteria for classification as carcinogenic (category 1B) in accordance with Regulation (EC) No 1272/2008 and are therefore carcinogens within the meaning of Directive 2004/37/EC. It is therefore appropriate, on the basis of available information, including scientific and technical data, to establish ▌ a limit value for cadmium and its inorganic compounds in that Directive ▌. In addition, cadmium, cadmium nitrate, cadmium hydroxide and cadmium carbonate have been identified as substances of very high concern pursuant to point (a) of Article 57 of Regulation (EC) No 1907/2006 and are included in the candidate list referred to in Article 59(1) of that Regulation ▌.

(16)  With regard to cadmium, it is foreseeable that it will be difficult to comply with a limit value of 0,001 mg/m3 ▌in the short term. It is therefore appropriate to introduce a transitional period of eight years, during which the limit value 0,004 mg/m3 (inhalable fraction) should apply. With a view to protecting legitimate expectations and in order to avoid potential disruptions of existing practices in Member States that implement, on the date of the entry into force of this Directive, a biomonitoring system with a biological limit value not exceeding 0,002 mg Cd/g creatinine in urine, the limit value of 0,004 mg/m3 should, in those Member States, be measured as respirable fraction during the transitional period, in light of the SCOEL and ACSH opinions on cadmium and its inorganic compounds.

(17)  On the basis of available valid scientific sources such as those provided by SCOEL, RAC and relevant national bodies, the Commission should, no later than three years after the date of entry into force of this Directive, assess the option of amending Directive 2004/37/EC by adding provisions on a combination of an airborne occupational exposure limit and a biological limit value for cadmium and its inorganic compounds.

(18)  Setting a biological limit value for cadmium and its inorganic compounds would protect workers against their systemic toxicity, which mainly affects the kidneys and bones. Biological monitoring can thus contribute to the protection of workers at the workplace, but only as a means of complementing the monitoring of the concentration of cadmium and its inorganic compounds in the air and therefore within the breathing zone of workers. The Commission should issue practical guidelines for biological monitoring.

(19)  Beryllium and most inorganic beryllium compounds meet the criteria for classification as carcinogenic (category 1B) in accordance with Regulation (EC) No 1272/2008 and are therefore carcinogens within the meaning of Directive 2004/37/EC. In addition to having carcinogenic properties, beryllium is known to provoke chronic beryllium disease (CBD) and beryllium sensitisation (BeS). It is therefore appropriate, on the basis of the available information, including scientific and technical data, to establish a limit value for beryllium and inorganic beryllium compounds in that Directive and to assign a notation for skin and respiratory sensitisation.

(20)  With regard to beryllium, it is foreseeable that it will be difficult to comply with a limit value of 0,0002 mg/m3 in the short term. It is therefore appropriate to introduce a transitional period of seven years, during which the limit value of 0,0006 mg/m3 should apply.

(21)  Arsenic acid and its salts, as well as most inorganic arsenic compounds, meet the criteria for classification as carcinogenic (category 1A) in accordance with Regulation (EC) No 1272/2008 and are therefore carcinogens within the meaning of Directive 2004/37/EC. It is therefore appropriate, on the basis of the available information, including scientific and technical data, ▌to establish a limit value for arsenic acid and its salts, as well as inorganic arsenic compounds in that Directive. In addition, arsenic acid, diarsenic pentaoxide and diarsenic trioxide are identified as substances of very high concern ▌ pursuant to point (a) of Article 57 of Regulation (EC) No 1907/2006 and are included in Annex XIV to that Regulation, requiring authorisation before they can be used.

(22)  With regard to arsenic acid, it is foreseeable that the copper smelting sector will have difficulties in complying with a limit value of 0,01 mg/m3. A transitional period of four years should therefore be introduced.

(23)  Formaldehyde meets the criteria for classification as carcinogenic (category 1B) in accordance with Regulation (EC) No 1272/2008 and is therefore a carcinogen within the meaning of Directive 2004/37/EC. Formaldehyde is a local acting genotoxic carcinogen ▌ and there is sufficient scientific evidence of its carcinogenicity in humans. Formaldehyde is also a contact allergen for the skin (skin sensitiser). It is therefore appropriate, on the basis of the available information, including scientific and technical data, to establish a long- and short-term limit value for formaldehyde in that Directive and to assign a notation for skin sensitisation. In addition, at the request of the Commission, ECHA is also gathering existing information to assess the potential exposure to formaldehyde and formaldehyde releasers at the workplace, including industrial and professional uses .

(24)  Formaldehyde fixatives are routinely used in the healthcare sector across the Union because of their convenience of handling, high degree of accuracy and extreme adaptability. In some Member States, it is foreseeable that the healthcare sector will have difficulties in complying, in the short term, with a limit value of 0,37 mg/m3 or 0,3 ppm. It is therefore appropriate to introduce for that sector a transitional period of five years, during which the limit value of 0,62 mg/m3 or 0,5 ppm should apply. The healthcare sector should, however, minimise exposure to formaldehyde and is encouraged to respect the limit value of 0,37 mg/m3 or 0,3 ppm during the transitional period where possible.

(25)  In some Member States, formaldehyde is routinely used for the purposes of embalming deceased persons as part of their cultural or religious practices. It is foreseeable that the funeral sector will have difficulties in complying, in the short term, with the limit value of 0,37 mg/m3 or 0,3 ppm. It is therefore appropriate to introduce for that sector a transitional period of five years, during which the limit value of 0,62 mg/m3 or 0,5 ppm should apply.

(26)  The notations for sensitisation set in this Directive for beryllium and formaldehyde are introduced to improve clarity. When setting such notations during the update of Directive 2004/37/EC, consistency should be ensured with the relevant Union law. This may include adding sensitisation notations for substances for which there is already a specific entry in Annex III to that Directive, where relevant.

(27)  4,4'-Methylene-bis(2-chloroaniline) (MOCA) meets the criteria for classification as carcinogenic (category 1B) in accordance with Regulation (EC) No 1272/2008 and is therefore a carcinogen within the meaning of Directive 2004/37/EC. Its carcinogenicity, together with its manifest genotoxic characteristics, has made it possible to classify that substance as carcinogenic to humans. The possibility of a significant uptake through the skin was identified for MOCA. It is therefore appropriate to establish a limit value for MOCA and to assign a skin notation to it. In addition, it was identified as a substance of very high concern ▌pursuant to point (a) of Article 57 of Regulation (EC) No 1907/2006 and included in Annex XIV to that Regulation, requiring authorisation before it can be placed on the market or used. It is possible, on the basis of available information, including scientific and technical data, to set a limit value for MOCA.

(28)  The Commission has consulted the ACSH. It has also carried out a two-stage consultation of management and labour at Union level in accordance with Article 154 of the Treaty on the Functioning of the European Union. The ACSH has adopted opinions for ▌substances covered by this Directive and proposed a binding occupational exposure limit value for each of them, supporting the relevant notations for some of them ▌.

(29)  The limit values established in this Directive are to be kept under regular scrutiny and review to ensure consistency with Regulation (EC) No 1907/2006, in particular to take account of the interaction between limit values established in Directive 2004/37/EC and derived no-effect levels for hazardous chemicals under that Regulation in order to protect workers effectively.

(30)  Since the objective of this Directive, namely to protect workers against risks to their health and safety, including the prevention of such risks, arising or likely to arise from exposure to carcinogens or mutagens at work, cannot be sufficiently achieved by the Member States, but can rather, by reason of its scale and effects, be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality, as set out in that Article, this Directive does not go beyond what is necessary in order to achieve that objective.

(31)  In implementing this Directive, Member States should avoid imposing administrative, financial and legal constraints in a way which would hold back the creation and development of small and medium-sized undertakings. In this regard, Member States and relevant bodies at Union and national level are encouraged to provide incentives, guidance and advice to micro, small and medium-size enterprises to comply with the terms of this Directive. In this context social partner agreements, guidance and other joint action identifying and developing best practice are most welcome.

(32)  Given that this Directive concerns the protection of the health and safety of workers at their workplace, it should be transposed within two years of the date of its entry into force.

(33)  Directive 2004/37/EC should therefore be amended accordingly,

HAVE ADOPTED THIS DIRECTIVE:

Article 1

Directive 2004/37/EC is amended as follows:

(1)  in Article 18a, the following subparagraphs are added:"

"No later than … [three years after the date of entry into force of this Directive] the Commission shall assess the option of amending this Directive to add provisions on a combination of an airborne occupational exposure limit and a biological limit value for cadmium and its inorganic compounds.

No later than 30 June 2020 the Commission shall, taking into account the latest developments in scientific knowledge, and after appropriate consultation with relevant stakeholders, in particular health practitioners and health professionals, assess the option of amending this Directive in order to include hazardous drugs, including cytotoxic drugs, or to propose a more appropriate instrument for the purpose of ensuring the occupational safety of workers exposed to such drugs. On that basis, the Commission shall present, if appropriate, and after consulting management and labour, a legislative proposal.".

"

(2)  Annex III is amended in accordance with the Annex to this Directive.

Article 2

1.  Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by ... [two years after the date of entry into force of this Directive]. They shall immediately inform the Commission thereof.

When Member States adopt those measures, they shall contain a reference to this Directive or shall be accompanied by such a reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States.

2.  Member States shall communicate to the Commission the text of the measures of national law which they adopt in the field covered by this Directive.

Article 3

This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

Article 4

This Directive is addressed to the Member States.

Done at …,

For the European Parliament For the Council

The President The President

ANNEX

In point A of Annex III to Directive 2004/37/EC, the following rows are added:

"

Name of agent

EC No (1)

CAS No (2)

Limit values

Notation

Transitional measures

8 hours (3)

Short-term (4)

mg/m3 (5)

ppm (6)

f/ml (7)

mg/m3 (5)

ppm (6)

f/ml (7)

Cadmium and its inorganic compounds

0,001 (11)

 

Limit value 0,004 mg/m3 (12) until … [eight years after the date of entry into force of this Directive].

Beryllium and inorganic beryllium compounds

0,0002 (11)

dermal and respiratory sensitisation (13)

Limit value 0,0006 mg/m3 until … [seven years after the date of entry into force of this Directive].

Arsenic acid and its salts, as well as inorganic arsenic compounds

0,01 (11)

For the copper smelting sector, the limit value shall come into force on … [four years after the date of entry into force of this Directive].

Formaldehyde

200-001-8

50-00-0

0,37

0,3

0,74

0,6

dermal sensitisation

(14)

Limit value of 0,62 mg/m3 or 0,5 ppm (3) for the health care, funeral and embalming sectors until … [five years after the date of entry into force of this Directive].

4,4'-Methylene-bis(2-chloroaniline)

202-918-9

101-14-4

0,01

skin (10)

 

__________________________

(11)   Inhalable fraction.

(12)   Inhalable fraction. Respirable fraction in those Member States that implement, on the date of the entry into force of this Directive, a biomonitoring system with a biological limit value not exceeding 0,002 mg Cd/g creatinine in urine.

(13)  The substance can cause sensitisation of the skin and of the respiratory tract.

(14)  The substance can cause sensitisation of the skin.

".

___________________

(1) OJ C 440, 6.12.2018, p. 145.
(2)OJ C 440, 6.12.2018, p. 145.
(3)Position of the European Parliament of 27 March 2019.
(4)OJ C 428, 13.12.2017, p. 10.
(5)Directive 2004/37/EC of the European Parliament and of the Council of 29 April 2004 on the protection of workers from the risks related to exposure to carcinogens or mutagens at work (Sixth individual Directive within the meaning of Article 16(1) of Council Directive 89/391/EEC) (OJ L 158, 30.4.2004, p. 50).
(6)Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, p. 1).
(7)Council Directive 98/24/EC of 7 April 1998 on the protection of the health and safety of workers from the risks related to chemical agents at work (fourteenth individual Directive within the meaning of Article 16(1) of Directive 89/391/EEC) (OJ L 131, 5.5.1998, p. 11).
(8)Commission Decision 2014/113/EU of 3 March 2014 on setting up a Scientific Committee on Occupational Exposure Limits for Chemical Agents and repealing Decision 95/320/EC (OJ L 62, 4.3.2014, p. 18).
(9)Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 396, 30.12.2006, p. 1).


Common rules for certain types of combined transport of goods between Member States ***I
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European Parliament legislative resolution of 27 March 2019 on the proposal for a directive of the European Parliament and of the Council amending Directive 92/106/EEC on the establishment of common rules for certain types of combined transport of goods between Member States (COM(2017)0648 – C8-0391/2017 – 2017/0290(COD))
P8_TA(2019)0308A8-0259/2018

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Disclosure of income tax information by certain undertakings and branches ***I
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European Parliament legislative resolution of 27 March 2019 on the proposal for a directive of the European Parliament and of the Council amending Directive 2013/34/EU as regards disclosure of income tax information by certain undertakings and branches (COM(2016)0198 – C8-0146/2016 – 2016/0107(COD))
P8_TA(2019)0309A8-0227/2017

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Common provisions on the European Regional Development Fund, the European Social Fund Plus, the Cohesion Fund, and the European Maritime and Fisheries Fund and financial rules for those ***I
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European Parliament legislative resolution of 27 March 2019 on the proposal for a regulation of the European Parliament and of the Council laying down common provisions on the European Regional Development Fund, the European Social Fund Plus, the Cohesion Fund, and the European Maritime and Fisheries Fund and financial rules for those and for the Asylum and Migration Fund, the Internal Security Fund and the Border Management and Visa Instrument (COM(2018)0375 – C8-0230/2018 – 2018/0196(COD))
P8_TA(2019)0310A8-0043/2019

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Asylum, Migration and Integration Fund
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European Parliament resolution of 27 March 2019 on the Commission delegated regulation of 14 December 2018 amending Annex II to Regulation (EU) No 516/2014 of the European Parliament and of the Council establishing the Asylum, Migration and Integration Fund (C(2018)08466 – 2018/2996(DEA))
P8_TA-PROV(2019)0311B8-0214/2019

The European Parliament,

–  having regard to the Commission delegated regulation (C(2018)08466),

–  having regard to Article 290 of the Treaty on the Functioning of the European Union,

–  having regard to Regulation (EU) No 516/2014 of the European Parliament and of the Council of 16 April 2014 establishing the Asylum, Migration and Integration Fund, amending Council Decision 2008/381/EC and repealing Decisions No 573/2007/EC and No 575/2007/EC of the European Parliament and of the Council and Council Decision 2007/435/EC(1), and in particular Articles 16(2) and 26(5) thereof,

–  having regard to the motion for a resolution by the Committee on Civil Liberties, Justice and Home Affairs,

–  having regard to Rule 105(3) of its Rules of Procedure,

A.  whereas Article 1 of the Commission delegated regulation proposes that Annex II of Regulation (EU) No 516/2014 be amended to include a specific action related to ‘the establishment, development and operation of adequate reception and accommodation and detention facilities, and respective services, for applicants for international protection or third-country nationals who are present in a Member State and do not or no longer fulfil the conditions for entry and/or stay’;

B.  whereas the Commission delegated regulation proposes that a concept of ‘controlled centres’ be included in that new specific action, and thus that funding be provided to Member States for the establishment, development and operation of such ‘controlled centres’;

C.  whereas the concept of ‘controlled centres’ is a controversial concept of questionable legality which does not exist under Union law and has not been approved by the co-legislators;

D.  whereas Parliament takes the view that such a concept should not be funded unless and until it is properly defined in an appropriate legislative instrument – adopted by the co-legislators – detailing the legal basis, nature, purpose and objective of such a concept;

1.  Objects to the Commission delegated regulation;

2.  Instructs its President to forward this resolution to the Commission and to notify it that the delegated regulation cannot enter into force;

3.  Instructs its President to forward this resolution to the Council and to the governments and parliaments of the Member States.

(1) OJ L 150, 20.5.2014, p. 168.


Instrument for financial support for external borders and visa
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European Parliament resolution of 27 March 2019 on the Commission delegated regulation of 14 December 2018 amending Annex II to Regulation (EU) No 515/2014 of the European Parliament and of the Council establishing as part of the Internal Security Fund, the instrument for financial support for external borders and visa (C(2018)08465 – 2018/2994(DEA))
P8_TA-PROV(2019)0312B8-0215/2019

The European Parliament,

–  having regard to the Commission delegated regulation (C(2018)08465),

–  having regard to Article 290 of the Treaty on the Functioning of the European Union,

–  having regard to Regulation (EU) No 515/2014 of the European Parliament and of the Council of 16 April 2014 establishing as part of the Internal Security Fund, the instrument for financial support for external borders and visa and repealing Decision No 574/2007/EC (1), and in particular Articles 7(2) and 17(5) thereof,

–  having regard to the motion for a resolution by the Committee on Civil Liberties, Justice and Home Affairs,

–  having regard to Rule 105(3) of its Rules of Procedure,

A.  whereas Article 1 of the Commission delegated regulation proposes that Annex II of Regulation (EU) No 515/2014 be amended to include a specific action related to ‘[the] establishment, development and operation including the provision of services such as identification, [...] registration and first reception, of hotspot areas’;

B.  whereas the Commission delegated regulation proposes that a concept of ‘controlled centres’ be included in that new specific action, and thus that funding be provided to Member States for the provision of services in such ‘controlled centres’;

C.  whereas the concept of ‘controlled centres’ is a controversial concept of questionable legality which does not exist under Union law and has not been approved by the co-legislators;

D.  whereas Parliament takes the view that such a concept should not be funded unless and until it is properly defined in an appropriate legislative instrument – adopted by the co-legislators – detailing the legal basis, nature, purpose and objective of such a concept;

1.  Objects to the Commission delegated regulation;

2.  Instructs its President to forward this resolution to the Commission and to notify it that the delegated regulation cannot enter into force;

3.  Instructs its President to forward this resolution to the Council and to the governments and parliaments of the Member States.

(1) OJ L 150, 20.5.2014, p. 143.


Genetically modified soybean MON 87751 (MON-87751-7)
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European Parliament resolution of 27 March 2019 on the draft Commission implementing decision authorising the placing on the market of products containing, consisting of or produced from genetically modified soybean MON 87751 (MON-87751-7), pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (D060916/01 – 2019/2603(RSP))
P8_TA-PROV(2019)0313B8-0216/2019

The European Parliament,

–  having regard to the draft Commission implementing decision authorising the placing on the market of products containing, consisting of or produced from genetically modified soybean MON 87751 (MON-87751-7), pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (D060916/01),

–  having regard to Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed(1), and in particular Articles 7(3) and 19(3) thereof,

–  having regard to the vote of the Standing Committee on the Food Chain and Animal Health referred to in Article 35 of Regulation (EC) No 1829/2003, on 7 March 2019, at which no opinion was delivered,

–  having regard to Articles 11 and 13 of Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission’s exercise of implementing powers(2),

–  having regard to the opinion adopted by the European Food Safety Authority (EFSA) on 20 June 2018 and published on 2 August 2018(3),

–  having regard to the proposal for a regulation of the European Parliament and of the Council amending Regulation (EU) No 182/2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission’s exercise of implementing powers (COM(2017)0085, COD(2017)0035),

–  having regard to its previous resolutions objecting to the authorisation of genetically modified organisms(4),

–  having regard to the motion for a resolution of the Committee on the Environment, Public Health and Food Safety,

–  having regard to Rule 106(2) and (3) of its Rules of Procedure,

A.  whereas on 26 September 2014, Monsanto Europe S.A./N.V. submitted on behalf of Monsanto company, United States, an application, in accordance with Articles 5 and 17 of Regulation (EC) No 1829/2003, for the placing on the market of foods, food ingredients and feed containing, consisting of or produced from genetically modified (GM) soybean MON 87751 (‘the application’) to the national competent authority of the Netherlands, and whereas the application also covered the placing on the market of products containing or consisting of GM soybean MON 87751 for uses other than food and feed, with the exception of cultivation;

B.  whereas, on 20 June 2018, EFSA adopted a favourable opinion in relation to the authorisation(5);

C.  whereas GM soybean MON 87751 was developed to confer resistance against certain lepidopteran pests and expresses the Bt proteins Cry1A.105 and Cry2Ab2 for this purpose;

Bt toxins

D.  whereas studies show that Bt toxins may have adjuvant properties which reinforce the allergenic properties of other foodstuffs; whereas soybeans themselves produce many plant allergens, and there is a specific risk that the Bt protein can enhance the immune system response to these compounds at the consumption stage;

E.  whereas a member of the EFSA Panel on Genetically Modified Organisms (EFSA GMO Panel) previously stated that while unintended effects have never been identified in any application where Bt proteins are expressed, they could ‘not be observed by the toxicological studies that are currently recommended and performed for the safety assessment of GM plants at EFSA because they do not include the appropriate tests for this purpose’(6);

F.  whereas in relation to the current authorisation, the EFSA GMO Panel itself recognises that there is limited knowledge and experimental evidence available on the potential of the newly expressed proteins to act as adjuvants(7);

G.  whereas studies stress the need for further research and long-term studies on the adjuvant properties of Bt toxins; whereas, while questions remain in relation to the role of Bt toxins and their adjuvant properties, GM plants containing them should not be authorised for import for food and feed uses;

Toxicity and 90-day feeding studies

H.  whereas two 28-day repeated dose toxicity studies with mice were performed, one with the Cry1a.105 protein and one with the Cry2Ab2 protein;

I.  whereas those toxicity studies were conducted with the isolated proteins, i.e. not with the proteins in combination, which were derived from bacteria and therefore not identical to those produced in the plant; whereas that means that the studies did not emulate exposure under practical conditions;

J.  whereas the two toxicity studies did not fully comply with the relevant OECD requirements in that coagulation examinations were based on a relatively low number of samples and functional observational battery and locomotor activity tests were not performed; whereas it is essential that all such requirements are fulfilled in the authorisation procedure;

K.  whereas multiple statistically significant differences between the control and test group were identified in the 90-day feeding study which, according to comments from a Member State competent authority, should have been examined further(8);

L.  whereas the 90-day feeding study with rats contained the following weaknesses: the study did not use two different dosages of test material as required by Commission Implementing Regulation (EU) 503/2013(9) and none of the test materials were analysed for possible contamination with other genetically modified organisms (GMOs);

M.  whereas, while EFSA identifies soymilk as being the main contributor in human diets with the highest chronic exposure(10), toasted defatted soybean meal was used as the test material in the feeding study; whereas expression levels of the Bt proteins in the soybean meal were not measured, meaning that it is not possible to link the outcome of the study with specific Bt toxin levels;

Member State competent authority comments

N.  whereas Member State authorities submitted many critical comments during the three-month consultation period(11), inter alia that many questions regarding the safety and possible toxicity of GM soybeans remain unresolved, that the combinatory effects of both proteins have not been analysed, that further information should be considered before the risk assessment can be finalised, that the environmental monitoring plan does not meet the objectives set out in Annex VII to Directive 2001/18/EC of the European Parliament and of the Council(12) and that it should be amended before consent is given, and that there is no reason to presume that consumption of Cry proteins is safe and does not represent a danger to humans, animals or the environment;

O.  whereas the Union is party to the UN Convention on Biological Diversity, which places on its parties the responsibility to ensure that activities within their jurisdictions do not cause damage to the environment of other States(13); whereas the decision on whether or not to authorise the GM soybean is within the Union’s jurisdiction;

P.  whereas, in line with a request from one Member State, existing data on the impact of the cultivation of GM soybean MON 87751 on producing and exporting countries should be considered in the application; whereas the same Member State recommends a study to assess how imports of certain products influence crop choices in Europe and therefore the biodiversity resulting from such agrosystem choices(14);

Q.  whereas the competent authorities of several Member States have criticised the lack of robustness of the post-market monitoring plan;

Lack of democratic legitimacy

R.  whereas the vote on 7 March 2019 of the Standing Committee on the Food Chain and Animal Health referred to in Article 35 of Regulation (EC) No 1829/2003 delivered no opinion, meaning that there was not a qualified majority in favour of authorisation;

S.  whereas on several occasions(15) the Commission has deplored the fact that, since the entry into force of Regulation (EC) No 1829/2003, it has adopted authorisation decisions without the support of the Standing Committee on the Food Chain and Animal Health and that the return of the dossier to the Commission for a final decision, which is very much the exception for the procedure as a whole, has become the norm for decision-making on GM food and feed authorisations; whereas that practice has also been deplored by President Juncker as undemocratic(16);

T.  whereas, on 28 October 2015, Parliament rejected at first reading(17) the legislative proposal of 22 April 2015 amending Regulation (EC) No 1829/2003 and called on the Commission to withdraw it and submit a new one;

U.  whereas recital 14 of Regulation (EU) No 182/2011 states that the Commission should, as far as possible, act in such a way as to avoid going against any predominant position which might emerge within the appeal committee against the appropriateness of an implementing act, especially on sensitive issues such as consumer health, food safety and the environment;

V.  whereas Regulation (EC) No 1829/2003 states that GM food or feed must not have adverse effects on human health, animal health or the environment and that the Commission must take into account any relevant provisions of Union law and other legitimate factors relevant to the matter under consideration when drafting its decision to renew the authorisation;

1.  Considers that the draft Commission implementing decision exceeds the implementing powers provided for in Regulation (EC) No 1829/2003;

2.  Considers that the draft Commission implementing decision is not consistent with Union law, in that it is not compatible with the aim of Regulation (EC) No 1829/2003, which is, in accordance with the general principles laid down in Regulation (EC) No 178/2002 of the European Parliament and of the Council(18), to provide the basis for ensuring a high level of protection of human life and health, animal health and welfare, and environmental and consumer interests in relation to GM food and feed, while ensuring the effective functioning of the internal market;

3.  Calls on the Commission to withdraw its draft implementing decision;

4.  Reiterates its commitment to advancing work on the Commission proposal amending Regulation (EU) No 182/2011; calls on the Council to move forward with its work in relation to that Commission proposal as a matter of urgency;

5.  Calls on the Commission to suspend any implementing decision regarding applications for authorisation of GMOs until the authorisation procedure has been revised in such a way as to address the shortcomings of the current procedure which has proven inadequate;

6.  Calls on the Commission to withdraw proposals for GMO authorisations if no opinion is delivered by the Standing Committee on the Food Chain and Animal Health, whether for cultivation or for food and feed uses;

7.  Instructs its President to forward this resolution to the Council and the Commission, and to the governments and parliaments of the Member States.

(1) OJ L 268, 18.10.2003, p. 1.
(2) OJ L 55, 28.2.2011, p. 13.
(3) EFSA GMO Panel (EFSA Panel on genetically Modified Organisms), 2018. Scientific opinion on the assessment of genetically modified soybean MON 87751 for food and feed uses under Regulation (EC) No 1829/2003 (application EFSA-GMO-NL-2014–121). EFSA Journal 2018; 16(8):5346, 32 pp. doi: 10.2903/j.efsa.2018.5346.
(4)–––––––––––––––––––––––—————–––——— - Resolution of 16 January 2014 on the proposal for a Council decision concerning the placing on the market for cultivation, in accordance with Directive 2001/18/EC of the European Parliament and of the Council, of a maize product (Zea mays L., line 1507) genetically modified for resistance to certain lepidopteran pests (OJ C 482, 23.12.2016, p. 110).Resolution of 16 December 2015 on Commission Implementing Decision (EU) 2015/2279 of 4 December 2015 authorising the placing on the market of products containing, consisting of, or produced from genetically modified maize NK603 × T25 (OJ C 399, 24.11.2017, p. 71).Resolution of 3 February 2016 on the draft Commission implementing decision authorising the placing on the market of products containing, consisting of, or produced from genetically modified soybean MON 87705 × MON 89788 (OJ C 35, 31.1.2018, p. 19).Resolution of 3 February 2016 on the draft Commission implementing decision authorising the placing on the market of products containing, consisting of, or produced from genetically modified soybean MON 87708 × MON 89788 (OJ C 35, 31.1.2018, p. 17).Resolution of 3 February 2016 on the draft Commission implementing decision authorising the placing on the market of products containing, consisting of, or produced from genetically modified soybean FG72 (MST-FGØ72-2) (OJ C 35, 31.1.2018, p. 15).Resolution of 8 June 2016 on the draft Commission implementing decision authorising the placing on the market of products containing, consisting of, or produced from genetically modified maize Bt11 × MIR162 × MIR604 × GA21, and genetically modified maizes combining two or three of those events (OJ C 86, 6.3.2018, p. 108).Resolution of 8 June 2016 on the draft Commission implementing decision as regards the placing on the market of a genetically modified carnation (Dianthus caryophyllus L., line SHD-27531-4) (OJ C 86, 6.3.2018, p. 111).Resolution of 6 October 2016 on the draft Commission implementing decision renewing the authorisation for the placing on the market for cultivation of genetically modified maize MON 810 seeds (OJ C 215, 19.6.2018, p. 76).Resolution of 6 October 2016 on the draft Commission implementing decision authorising the placing on the market of genetically modified maize MON 810 products (OJ C 215, 19.6.2018, p. 80).Resolution of 6 October 2016 on the draft Commission implementing decision concerning the placing on the market for cultivation of genetically modified maize Bt11 seeds (OJ C 215, 19.6.2018, p. 70).Resolution of 6 October 2016 on the draft Commission implementing decision concerning the placing on the market for cultivation of genetically modified maize 1507 seeds (OJ C 215, 19.6.2018, p. 73).Resolution of 6 October 2016 on the draft Commission implementing decision authorising the placing on the market of products containing, consisting of, or produced from genetically modified cotton 281-24-236 × 3006-210-23 × MON 88913 (OJ C 215, 19.6.2018, p. 83).Resolution of 5 April 2017 on the draft Commission implementing decision authorising the placing on the market of products containing, consisting of, or produced from genetically modified maize Bt11 × 59122 × MIR604 × 1507 × GA21, and genetically modified maizes combining two, three or four of the events Bt11, 59122, MIR604, 1507 and GA21 pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council on genetically modified food and feed (OJ C 298, 23.8.2018, p. 34).Resolution of 17 May 2017 on the draft Commission implementing decision authorising the placing on the market of products containing, consisting of, or produced from genetically modified maize DAS-40278-9, pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council on genetically modified food and feed (OJ C 307, 30.8.2018, p. 71).Resolution of 17 May 2017 on the draft Commission implementing decision authorising the placing on the market of products containing, consisting of, or produced from genetically modified cotton GHB119 (BCS-GHØØ5-8) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (OJ C 307, 30.8.2018, p. 67).Resolution of 13 September 2017 on the draft Commission implementing decision authorising the placing on the market of products containing, consisting of, or produced from genetically modified soybean DAS-68416-4, pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council on genetically modified food and feed (OJ C 337, 20.9.2018, p. 54).Resolution of 4 October 2017 on the draft Commission implementing decision authorising the placing on the market of products containing, consisting of, or produced from genetically modified soybean FG72 × A5547-127 pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council on genetically modified food and feed (OJ C 346, 27.9.2018, p. 55).Resolution of 4 October 2017 on the draft Commission implementing decision authorising the placing on the market of products containing, consisting of, or produced from genetically modified soybean DAS-44406-6, pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council on genetically modified food and feed (OJ C 346, 27.9.2018, p. 60).Resolution of 24 October 2017 on the draft Commission implementing decision renewing the authorisation for the placing on the market of products containing, consisting of, or produced from genetically modified maize 1507 (DAS-Ø15Ø7-1) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council on genetically modified food and feed (OJ C 346, 27.9.2018, p. 122).Resolution of 24 October 2017 on the draft Commission implementing decision authorising the placing on the market of products containing, consisting of, or produced from genetically modified soybean 305423 × 40-3-2 (DP-3Ø5423-1 × MON-Ø4Ø32-6) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council on genetically modified food and feed (OJ C 346, 27.9.2018, p. 127).Resolution of 24 October 2017 on the draft Commission implementing decision authorising the placing on the market of products containing, consisting of, or produced from genetically modified oilseed rapes MON 88302 × Ms8 × Rf3 (MON-883Ø2-9 × ACSBNØØ5-8 × ACS-BNØØ3-6), MON 88302 × Ms8 (MON-883Ø2-9 × ACSBNØØ5-8) and MON 88302 × Rf3 (MON-883Ø2-9 × ACS-BNØØ3-6) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council on genetically modified food and feed (OJ C 346, 27.9.2018, p. 133).Resolution of 1 March 2018 on the draft Commission implementing decision renewing the authorisation for the placing on the market of products containing, consisting of, or produced from genetically modified maize 59122 (DAS-59122-7) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council on genetically modified food and feed (Texts adopted, P8_TA(2018)0051).Resolution of 1 March 2018 on the draft Commission implementing decision authorising the placing on the market of products containing, consisting of, or produced from genetically modified maize MON 87427 × MON 89034 × NK603 (MON-87427-7 × MON-89Ø34-3 × MON-ØØ6Ø3-6) and genetically modified maize combining two of the events MON 87427, MON 89034 and NK603, and repealing Decision 2010/420/EU (Texts adopted, P8_TA(2018)0052).Resolution of 3 May 2018 on the draft Commission implementing decision renewing the authorisation for the placing on the market of food and feed produced from genetically modified sugar beet H7-1 (KM-ØØØH71-4) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council on genetically modified food and feed (Texts adopted, P8_TA(2018)0197).Resolution of 30 May 2018 on the draft Commission implementing decision renewing the authorisation for the placing on the market of products containing, consisting of, or produced from genetically modified maize GA21 (MON-ØØØ21-9) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council on genetically modified food and feed (Texts adopted, P8_TA(2018)0221).Resolution of 30 May 2018 on the draft Commission implementing decision authorising the placing on the market of products containing, consisting of, or produced from genetically modified maize 1507 × 59122 × MON 810 × NK603, and genetically modified maize combining two or three of the single events 1507, 59122, MON 810 and NK603, and repealing Decisions 2009/815/EC, 2010/428/EU and 2010/432/EU pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council on genetically modified food and feed (Texts adopted, P8_TA(2018)0222).Resolution of 24 October 2018 on the draft Commission implementing decision renewing the authorisation for the placing on the market of products containing, consisting of or produced from genetically modified maize NK603 × MON 810 (MON-ØØ6Ø3-6 × MON-ØØ81Ø-6) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (Texts adopted, P8_TA(2018)0416).Resolution of 24 October 2018 on the draft Commission implementing decision authorising the placing on the market of products containing, consisting of or produced from genetically modified maize MON 87427 × MON 89034 × 1507 × MON 88017 × 59122, and genetically modified maize combining two, three or four of the single events MON 87427, MON 89034, 1507, MON 88017 and 59122 and repealing Decision 2011/366/EU (Texts adopted, P8_TA(2018)0417).– Resolution of 31 January 2019 on the draft Commission implementing decision amending Implementing Decision 2013/327/EU as regards the renewal of the authorisation to place on the market feed containing or consisting of genetically modified oilseed rapes Ms8, Rf3 and Ms8 × Rf3 pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (Texts adopted, P8_TA(2019)0057).Resolution of 31 January 2019 on the draft Commission implementing decision authorising the placing on the market of products containing, consisting of or produced from genetically modified maize 5307 (SYN-Ø53Ø7-1), pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council on genetically modified food and feed (Texts adopted, P8_TA(2019)0058).Resolution of 31 January 2019 on the draft Commission implementing decision authorising the placing on the market of products containing, consisting of or produced from genetically modified maize MON 87403 (MON-874Ø3-1), pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (Texts adopted, P8_TA(2019)0059).Resolution of 31 January 2019 on the draft Commission implementing decision authorising the placing on the market of products containing, consisting of or produced from genetically modified cotton GHB614 × LLCotton25 × MON 15985 pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (Texts adopted, P8_TA(2019)0060).European Parliament resolution of 13 March 2019 on the draft Commission implementing decision authorising the placing on the market of products containing, consisting of or produced from genetically modified maize 4114 (DP-ØØ4114-3), pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (Texts adopted, P8_TA(2019)0196).European Parliament resolution of 13 March 2019 on the draft Commission implementing decision authorising the placing on the market of products containing, consisting of or produced from genetically modified maize MON 87411 (MON-87411-9), pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (Texts adopted, P8_TA(2019)0197).European Parliament resolution of 13 March 2019 on the draft Commission implementing decision authorising the placing on the market of products containing, consisting of or produced from genetically modified maize Bt11 × MIR162 × 1507 × GA21 and sub-combinations Bt11 × MIR162 × 1507, MIR162 × 1507 × GA21 and MIR162 × 1507 pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (Texts adopted, P8_TA-(2019)0198).
(5) https://www.efsa.europa.eu/en/efsajournal/pub/5346
(6) https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2018.5309 p34
(7) EFSA response to Member States comments, p109, Annex G: http://registerofquestions.efsa.europa.eu/roqFrontend/questionLoader?question=EFSA-Q-2014-00719
(8) Annex G, Member States comments, pp. 27-33, http://registerofquestions.efsa.europa.eu/roqFrontend/questionLoader?question=EFSA-Q-2014-00719
(9) Commission Implementing Regulation (EU) No 503/2013 of 3 April 2013 on applications for authorisation of genetically modified food and feed in accordance with Regulation (EC) No 1829/2003 of the European Parliament and of the Council and amending Commission Regulations (EC) No 641/2004 and (EC) No 1981/2006 (OJ L 157, 8.6.2013, p. 1).
(10) EFSA opinion, p. 22, https://www.efsa.europa.eu/en/efsajournal/pub/5346
(11) Annex G, Member State comments, http://registerofquestions.efsa.europa.eu/roqFrontend/questionLoader?question=EFSA-Q-2014-00719
(12) Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC (OJ L 106 17.4.2001, p. 1).
(13) United Nations Convention on Biological Diversity, 1992, Article 3, https://www.cbd.int/convention/articles/default.shtml?a=cbd-03
(14) Annex G, Member States comments, pp. 67-68, http://registerofquestions.efsa.europa.eu/roqFrontend/questionLoader?question=EFSA-Q-2014-00719
(15) See, for example, the explanatory memorandum of its legislative proposal presented on 22 April 2015 amending Regulation (EC) No 1829/2003 as regards the possibility for the Member States to restrict or prohibit the use of genetically modified food and feed on their territory and in the explanatory memorandum of the legislative proposal presented on 14 February 2017 amending Regulation (EU) No 182/2011.
(16) For example. in the Opening Statement at the European Parliament plenary session included in the political guidelines for the next European Commission (Strasbourg, 15 July 2014) or in the State of the Union Address 2016 (Strasbourg, 14 September 2016).
(17) OJ C 355, 20.10.2017, p. 165.
(18) Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters on food safety (OJ L 31, 1.2.2002, p. 1.).


Genetically modified maize 1507 × NK603 (DAS-Ø15Ø7-1 × MON-ØØ6Ø3-6)
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European Parliament resolution of 27 March 2019 on the draft Commission implementing decision renewing the authorisation for the placing on the market of products containing, consisting of or produced from genetically modified maize 1507 × NK603 (DAS-Ø15Ø7-1 × MON-ØØ6Ø3-6) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (D060917/01 – 2019/2604(RSP))
P8_TA-PROV(2019)0314B8-0217/2019

The European Parliament,

–  having regard to the draft Commission implementing decision renewing the authorisation for the placing on the market of products containing, consisting of or produced from genetically modified maize 1507 × NK603 (DAS-Ø15Ø7-1 × MON-ØØ6Ø3-6) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (D060917/01),

–  having regard to Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed(1), and in particular Articles 11(3) and 23(3) thereof,

–  having regard to the vote of the Standing Committee on the Food Chain and Animal Health referred to in Article 35 of Regulation (EC) No 1829/2003, on 7 March 2019, at which no opinion was delivered,

–  having regard to Articles 11 and 13 of Regulation (EU) No 182/2011 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission’s exercise of implementing powers(2),

–  having regard to the opinion adopted by the European Food Safety Authority (EFSA) on 20 June 2018 and published on 25 July 2018(3),

–  having regard to the proposal for a regulation of the European Parliament and of the Council amending Regulation (EU) No 182/2011 laying down the rules and general principles concerning mechanisms for control by Member States of the Commission’s exercise of implementing powers (COM(2017)0085, COD(2017)0035),

–  having regard to its previous resolutions objecting to the authorisation of genetically modified organisms(4),

–  having regard to the motion for a resolution of the Committee on the Environment, Public Health and Food Safety,

–  having regard to Rule 106(2) and (3) of its Rules of Procedure,

A.  whereas Commission Decision 2007/703/EC(5) authorised the placing on the market of food and feed containing, consisting of, or produced from genetically modified (GM) maize 1507 × NK603; whereas the scope of that authorisation also covers the placing on the market of products, other than food and feed, containing or consisting of GM maize 1507 × NK603 for the same uses as any other maize with the exception of cultivation;

B.  whereas, on 20 October 2016, Pioneer Overseas Corporation, on behalf of Pioneer Hi-Bred International, Inc., and Dow AgroSciences Europe, on behalf of Dow AgroSciences LLC, jointly submitted to the Commission an application, in accordance with Articles 11 and 23 of Regulation (EC) No 1829/2003, for the renewal of that authorisation;

C.  whereas, on 25 July 2018, EFSA issued a favourable opinion in accordance with Articles 6 and 18 of Regulation (EC) No 1829/2003;

D.  whereas the EFSA opinion stated that the applicants’ literature search had retrieved 120 publications, out of which, after having applied eligibility and inclusion criteria that had been defined a priori by the applicants, only one publication, an opinion by the EFSA Panel on Genetically Modified Organisms (EFSA GMO Panel), was considered as relevant by the applicants;

E.  whereas EFSA, despite the fact that it considered that the applicants’ future literature searches could be improved, did not perform a systematic literature search on its own, but simply assessed the literature search carried out by the applicants, and on that basis concluded that no new publication had been identified which would raise a safety concern;

F.  whereas, likewise, for the other items assessed, such as bioinformatic data, post-market monitoring, as well as the overall assessment, EFSA simply relies on information given by the applicants, and as a consequence takes over the applicants’ assessment;

G.  whereas EFSA adopted its opinion on the assumption that the DNA sequence of the two events in GM maize NK603 x MON 810 is identical to the sequence of the originally assessed events; whereas this hypothesis does not seem to have been based on any data or evidence provided by the applicants but rather purely on a statement provided by them;

H.  whereas EFSA acknowledges that the annual post-market environmental monitoring reports proposed by the applicants consist mainly of general surveillance of imported GM plant material; whereas EFSA considers that further discussion with applicants and risk managers is needed on the practical implementation of the post-market environmental monitoring reports, e.g. regarding actual data gathered on exposure and/or adverse effects as implemented in existing monitoring systems;

I.  whereas the GM maize 1507 × NK603 expresses the cry1F gene, which confers protection against certain lepidopteran pests, the pat gene, which confers tolerance to glufosinate-ammonium based herbicides, and the cp4 epsps gene, which confers tolerance to glyphosate-based herbicides;

J.  whereas GM Bt plants express the insecticidal toxin in every cell throughout their life, including in the parts eaten by humans and animals; whereas animal feeding experiments show that GM Bt plants may have toxic effects(6); whereas it has been shown that the Bt toxin in GM plants differs significantly from that of the naturally occurring Bt toxin(7); whereas there are concerns regarding a possible evolution of resistance to Cry proteins in lepidopteran target pests, which may lead to altered pest control practices in the countries where it is cultivated;

K.  whereas glufosinate is classified as toxic to reproduction and thus falls under the exclusion criteria set out in Regulation (EC) No 1107/2009 of the European Parliament and of the Council(8); whereas the approval of glufosinate expired on 31 July 2018(9);

L.  whereas questions remain concerning the carcinogenicity of glyphosate; whereas EFSA concluded in November 2015 that glyphosate was unlikely to be carcinogenic and the European Chemicals Agency (ECHA) concluded in March 2017 that no classification was warranted; whereas, on the contrary, in 2015 the World Health Organisation’s International Agency for Research on Cancer classified glyphosate as a probable carcinogen for humans(10);

M.  whereas application of the complementary herbicides, in this case glyphosate and glufosinate, is part of regular agricultural practice in the cultivation of herbicide-resistant plants and it can therefore be expected that residues from spraying will be present in the harvest and are inevitable constituents;

N.  whereas it has to be expected that the GM maize will be exposed to both higher and repeated doses of glyphosate and glufosinate, which will not only lead to a higher burden of residues in the harvest, but may also influence the composition of the GM maize plant and its agronomic characteristics;

O.  whereas information on residue levels of herbicides and their metabolites is essential for a thorough risk assessment of herbicide-tolerant GM plants; whereas residues from spraying with herbicides are considered outside the remit of the EFSA GMO Panel; whereas the impacts of spraying the GM maize with herbicides have not been assessed, nor has the cumulative effect of spraying with both glyphosate and glufosinate;

P.  whereas the Union is party to the UN Convention on Biological Diversity, which places on its parties the responsibility to ensure that activities within their jurisdiction do not cause damage to the environment of other States(11); whereas the decision on whether or not to authorise the GM maize is within the Union’s jurisdiction;

Q.  whereas comments submitted by Member States during the three-month consultation period refer to, inter alia: non-compliance with EFSA’s guidelines as regards the post-market environmental monitoring reports, several deficiencies in those reports, including the fact that the occurrence of teosinte as a wild relative of maize in Europe had been ignored and that information regarding the fate of Bt toxins in the environment is missing; concerns regarding the reliability of data to confirm the risk assessment conclusion; an insufficient proposed monitoring plan; an inadequate literature search, leading to the omission of important studies, and an improper declaration of identified literature as being irrelevant; and the failure to provide any data to demonstrate the sequence identity of a current maize variety containing the stacked event 1507 x NK603, with the originally assessed event(12);

R.  whereas the vote on 7 March 2019 of the Standing Committee on the Food Chain and Animal Health referred to in Article 35 of Regulation (EC) No 1829/2003 delivered no opinion, meaning that there was no qualified majority in favour of authorisation;

S.  whereas on several occasions(13) the Commission has deplored the fact that, since the entry into force of Regulation (EC) No 1829/2003, it has adopted authorisation decisions without the support of the Standing Committee on the Food Chain and Animal Health, and that the return of the dossier to the Commission for a final decision, which is very much the exception for the procedure as a whole, has become the norm for decision-making on GM food and feed authorisations; whereas that practice has also been deplored by President Juncker as being undemocratic(14);

T.  whereas, on 28 October 2015, Parliament rejected at first reading(15) the legislative proposal of 22 April 2015 amending Regulation (EC) No 1829/2003 and called on the Commission to withdraw it and submit a new one;

U.  whereas recital 14 of Regulation (EU) No 182/2011 states that the Commission should, as far as possible, act in such a way as to avoid going against any predominant position which might emerge within the appeal committee against the appropriateness of an implementing act, especially on sensitive issues such as consumer health, food safety and the environment;

V.  whereas Regulation (EC) No 1829/2003 states that GM food or feed must not have adverse effects on human health, animal health or the environment and that the Commission shall take into account any relevant provisions of Union law and other legitimate factors relevant to the matter under consideration when drafting its decision renewing the authorisation;

1.  Considers that the draft Commission implementing decision exceeds the implementing powers provided for in Regulation (EC) No 1829/2003;

2.  Considers that the draft Commission implementing decision is not consistent with Union law, in that it is not compatible with the aim of Regulation (EC) No 1829/2003, which is, in accordance with the general principles laid down in Regulation (EC) No 178/2002 of the European Parliament and of the Council(16), to provide the basis for ensuring a high level of protection of human life and health, animal health and welfare, and environmental and consumer interests, in relation to GM food and feed, while ensuring the effective functioning of the internal market;

3.  Calls on the Commission to withdraw its draft implementing decision;

4.  Reiterates its commitment to advancing work on the Commission proposal amending Regulation (EU) No 182/2011; calls on the Council to move forward with its work in relation to that Commission proposal as a matter of urgency;

5.  Calls on the Commission to suspend any implementing decision regarding applications for authorisation of genetically modified organisms (GMOs) until the authorisation procedure has been revised in such a way as to address the shortcomings of the current procedure, which has proven inadequate;

6.  Calls on the Commission to withdraw proposals for GMO authorisations if no opinion is delivered by the Standing Committee on the Food Chain and Animal Health, whether for cultivation or for food and feed uses;

7.  Calls on the Commission to uphold its commitments under the UN Convention on Biological Diversity, and in particular not to authorise the import of any GM plant for food or feed uses which has been made tolerant to a herbicide which is not authorised for use in the Union;

8.  Calls on the Commission not to authorise any herbicide-tolerant GM plants without full assessment of the residues from spraying with complementary herbicides and their commercial formulations as applied in the countries of cultivation;

9.  Instructs its President to forward this resolution to the Council and the Commission, and to the governments and parliaments of the Member States.