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REPORT     ***I
PDF 2316kWORD 419k
25 July 2017
PE 599.728v02-00 A8-0270/2017

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))

Committee on the Internal Market and Consumer Protection

Rapporteur: Ildikó Gáll-Pelcz

Rapporteurs for the opinion (*):

Elisabetta Gardini, Committee on the Environment, Public Health and Food Safety

Jan Huitema, Committee on Agriculture and Rural Development

(*) Associated committees – Rule 54 of the Rules of Procedure

DRAFT EUROPEAN PARLIAMENT LEGISLATIVE RESOLUTION
 EXPLANATORY STATEMENT
 ANNEX: LIST OF ENTITIES OR PERSONSFROM WHOM THE RAPPORTEUR HAS RECEIVED INPUT
 OPINION of the Committee on the Environment, Public Health and Food Safety
 OPINION of the Committee on Agriculture and Rural Development
 OPINION of the Committee on International Trade
 PROCEDURE – COMMITTEE RESPONSIBLE
 FINAL VOTE BY ROLL CALL IN COMMITTEE RESPONSIBLE

DRAFT EUROPEAN PARLIAMENT LEGISLATIVE RESOLUTION

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))

(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 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.  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.

Amendment    1

Proposal for a regulation

Title

 

Text proposed by the Commission

Amendment

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

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 plant nutrition products and amending Regulations (EC) No 1069/2009 and (EC) No 1107/2009

 

(This amendment from "fertilising products" to "plant nutrition products" applies throughout the text. Adopting it will necessitate corresponding changes throughout and, consequently, adopted amendments.)

Amendment    2

Proposal for a regulation

Recital 1

 

Text proposed by the Commission

Amendment

(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 Council15, 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. The scope of the harmonisation should therefore be extended in order to include recycled and organic materials.

(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 Council15, which almost exclusively covers fertilisers from mined or chemically produced, mineral 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 in 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.

_________________

_________________

15 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).

15 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).

 

(This amendment also covers a horizontal technical amendment on the term “inorganic” being changed to “mineral”; adopting it will necessitate corresponding changes of this term throughout the text and, consequently, adopted amendments.)

Amendment    3

Proposal for a regulation

Recital 2 a (new)

Text proposed by the Commission

Amendment

 

(2a)  Nutrients in food originate from the soil; healthy and nutritious soil results in healthy and nutritious crops and food. Farmers need available a wide range of fertilisers, organic and synthetic, in order to enhance their soil. When soil nutrients are missing, or depleted, plants will be nutrient deficient and may either stop growing or not contain nutritional value for human consumption.

Amendment     4

Proposal for a regulation

Recital 5 a (new)

Text proposed by the Commission

Amendment

 

(5a)  To ensure effective use of animal manure and on-farm compost, farmers should use those products which follow the spirit of "responsible agriculture", favouring local distribution channels, good agronomic and environmental practice and in compliance with the Union environmental law, such as the Nitrates Directive or the Water Framework Directive. The preferential use of fertilisers produced on-site and in neighbouring agricultural undertakings should be encouraged.

Amendment    5

Proposal for a regulation

Recital 6 a (new)

Text proposed by the Commission

Amendment

 

(6a)  A CE marked fertilising product might have more than one of the functions described in the product function categories of this Regulation. Where a claim is made in respect of only one of those functions, it should be sufficient for the product to comply with the requirements of the product function category describing that claimed function. By contrast, where a claim is made in respect of more than one of those functions, the CE marked fertilising product in question should be regarded as a combination of two or more component fertilising products, and compliance should be required for each of the component fertilising products with respect to its function. Therefore, there should be a specific product function category to cover such combinations.

Amendment    6

Proposal for a regulation

Recital 6 b (new)

Text proposed by the Commission

Amendment

 

(6b)  A manufacturer using one or more CE marked fertilising products that have already been subject to a conformity assessment, carried out 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 CE marked fertilising product should also be regarded as a combination of two or more component fertilising products, and the additional conformity requirements for the combination should be reduced to the aspects warranted by the mixing.

Amendment    7

Proposal for a regulation

Recital 8

Text proposed by the Commission

Amendment

(8)  Contaminants in CE marked fertilising products, such as cadmium, can potentially pose a risk to human and animal health and 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 CE marked 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.

(8)  Contaminants in CE marked fertilising products, if the latter are not used correctly, such as cadmium, can potentially pose a risk to human and animal health and 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 CE marked 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.

Amendment    8

Proposal for a regulation

Recital 8 a (new)

Text proposed by the Commission

Amendment

 

(8a)  Member States which already have more stringent national limit values for cadmium in fertilisers should be allowed to maintain those limit values until the rest of the Union reaches an equivalent level of ambition.

Amendment    9

Proposal for a regulation

Recital 8 b (new)

 

Text proposed by the Commission

Amendment

 

(8b)  In order to facilitate the compliance of the phosphate fertilising products with the requirements of this Regulation and to boost innovation, it is necessary to provide sufficient incentives for the development of relevant technologies, particularly decadmiation technology, and for the management of cadmium-rich hazardous waste by means of the financial resources available under Horizon 2020, LIFE programmes, the Circular Economy Finance Support Platform, through the European Investment Bank (EIB) and other financial instruments where relevant. The Commission should report annually to the European Parliament and the Council on the incentives and the Union funding provided for decadmiation.

Amendment    10

Proposal for a regulation

Recital 9

 

Text proposed by the Commission

Amendment

(9)  Products complying with all the requirements of this Regulation should be allowed to move freely on the internal market. Where one or more of the component materials in a CE marked fertilising product falls within the scope of Regulation (EC) No 1069/2009 of the European Parliament and of the Council18, but reaches a point in the manufacturing chain beyond which it no longer poses any significant risk to public or animal health (the 'end point in the manufacturing chain'), it would represent an unnecessary administrative burden to continue subjecting the product to the provisions of that Regulation. Such fertilising products should therefore be excluded from the requirements of that Regulation. Regulation (EC) No 1069/2009 should therefore be amended accordingly.

(9)  CE marked fertilising products complying with all 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 scope of Regulation (EC) No 1069/2009 of the European Parliament and of the Council, but has reached a point in the manufacturing chain beyond which it no longer poses a risk to public or animal health (the 'end point in the manufacturing chain'), it would represent an unnecessary administrative burden to continue subjecting the product to the provisions of that Regulation. Such fertilising products should therefore be excluded from the requirements of that Regulation. Regulation (EC) No 1069/2009 should therefore be amended accordingly.

_________________

_________________

18 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).

18 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).

Amendment    11

Proposal for a regulation

Recital 10

 

Text proposed by the Commission

Amendment

(10)  The end point in the manufacturing chain should be determined for each relevant component material containing animal by-products in accordance with the procedures laid down in Regulation (EC) No 1069/2009. Where a manufacturing process regulated under this Regulation starts already before that end point has been reached, the process requirements of both Regulation (EC) No 1069/2009 and this Regulation should apply cumulatively to CE marked fertilising products, which means application of the stricter requirement in case both Regulations regulate the same parameter.

(10)  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 for each relevant component material containing animal by-products in accordance with the procedures laid down in that Regulation. To take advantage of technical developments, create more opportunities for producers and businesses, and unlock the potential to make more use of nutrients from animal by-products such as animal manure, the setting of processing methods and recovery rules for animal by-products for which an end-point in the manufacturing chain has been determined should start immediately after the entry into force of this Regulation. When it concerns fertilising products containing or consisting of processed animal manure end-of-livestock-manure criteria should be defined. In order to expand or add component material categories to include more animal by-products, the power to adopt acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission. Where such an end point is reached before the CE marked 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 CE marked fertilising products, which means application of the stricter requirement in case both Regulations regulate the same parameter.

Amendment    12

Proposal for a regulation

Recital 10 a (new)

 

Text proposed by the Commission

Amendment

 

(10a)  For animal by-products already widely used in Member States for the production of fertilisers the end point should be determined without undue delay, and at the latest one year after the date of entry into force of this Regulation.

Amendment    13

Proposal for a regulation

Recital 12

Text proposed by the Commission

Amendment

(12)  Where one or more of the component materials for a CE marked fertilising product fall within the scope of Regulation (EC) No 1069/2009 and has not reached the end point in the manufacturing chain, it would be misleading to provide for the product's CE marking under this Regulation, since the making available on the market of such a product is subject to the requirements of Regulation (EC) No 1069/2009. Therefore, such products should be excluded from the scope of this Regulation.

(12)  The making available on the market of an animal by-product or a derived product for which no end point in the manufacturing chain has been defined, or for which the defined end point has not been reached at the time of making available on the market, is subject to the requirements of Regulation (EC) No 1069/2009. 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 products should therefore be excluded from the scope of this Regulation.

Amendment    14

Proposal for a regulation

Recital 13

 

Text proposed by the Commission

Amendment

(13)  For certain recovered wastes within the meaning of Directive 2008/98/EC of the European Parliament and of the Council20, 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 products does not lead to overall adverse environmental or human health impacts. For CE marked 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.

(13)  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 Council20 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 products does not lead to overall adverse environmental or human health impacts. For CE marked 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 accordingly it should be possible for products containing or consisting of such recovered waste materials to access the internal market. To ensure legal clarity, 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 of the Treaty on the Functioning of the European Union 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 CE marked fertilising products.

_________________

_________________

20 Directive 2008/98/EC of the European Parliament and of the Council on waste and repealing certain Directives (OJ L 312, 22.11.2008, p. 3).

20 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).

Amendment    15

Proposal for a regulation

Recital 13 a (new)

 

Text proposed by the Commission

Amendment

 

(13a)  Certain industry by-products, co-products or recycled products coming from specific industrial processes are currently used by manufacturers as a component of a CE marked fertilising product. For components of CE marked fertilising products, requirements related to component material categories should be laid down in this Regulation. If applicable, 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.

Amendment    16

Proposal for a regulation

Recital 14

 

Text proposed by the Commission

Amendment

(14)  Certain substances and mixtures, commonly referred to as agronomic additives, improve the nutrient release pattern of a nutrient in a fertiliser. Substances and mixtures made available on the market with the intention of them being added to CE marked fertilising products for that purpose should fulfil certain efficacy criteria at the responsibility of the manufacturer of those substances or mixtures, and should therefore as such be considered as CE marked fertilising products under this Regulation. Furthermore, CE marked fertilising products containing such substances or mixtures should be subject to certain efficacy and safety criteria. Such substances and mixtures should therefore also be regulated as component materials for CE marked fertilising products.

(14)  Certain substances and mixtures, referred to as agronomic additives, improve the nutrient release pattern of a nutrient in a fertiliser. Substances and mixtures made available on the market with the intention of them being added to CE marked fertilising products for that purpose should fulfil certain efficacy, safety and environmental criteria at the responsibility of the manufacturer of those substances or mixtures, and should therefore as such be considered as CE marked fertilising products under this Regulation. Furthermore, CE marked fertilising products containing such substances or mixtures should be subject to certain efficacy, safety and environmental criteria. Such substances and mixtures should therefore also be regulated as component materials for CE marked fertilising products.

Amendment     17

Proposal for a regulation

Recital 14 a (new)

Text proposed by the Commission

Amendment

 

(14a)  As products made up of substances and mixtures in addition to the fertilising elements are intended to be added to soil and released in to the environment, conformity criteria should apply to all materials in the product, in particular where they are small or break down into small fragments that can be dispersed throughout soil and into water systems and carried to the wider environment. Therefore biodegradability criteria and conformity testing should also be under realistic in-vivo conditions that take into consideration differential rates of decomposition under anaerobic conditions, in aquatic habitats or under water, in waterlogged conditions or in frozen soil.

Amendment    18

Proposal for a regulation

Recital 15

 

Text proposed by the Commission

Amendment

(15)  Certain substances, mixtures and micro-organisms, commonly referred to as plant biostimulants, are not as such nutrients, but nevertheless stimulate plants' nutrition processes. Where such products aim solely at improving the plants' nutrient use efficiency, tolerance to abiotic stress, or crop quality traits, they are by nature more similar to fertilising products than to most categories of plant protection products. 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 Council21 . Regulation (EC) No 1107/2009 should therefore be amended accordingly.

(15)  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, or crop quality traits, degradation of soil organic compounds, or increasing the availability of nutrients in the rhizosphere, they are by nature more similar to fertilising products than to most categories of plant protection products. Therefore, they act in addition to fertilisers, with the aim of optimizing their efficiency 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 Council21 . Regulation (EC) No 1107/2009 should therefore be amended accordingly.

_________________

_________________

21 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).

21 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).

Amendment    19

Proposal for a regulation

Recital 15 a (new)

 

Text proposed by the Commission

Amendment

 

(15a)  For micro-organisms, component material categories should be expanded or added in order to guarantee and enhance the innovative potential concerning the development and discovery of new microbial plant biostimulant products. In order to stimulate innovation and to create legal certainty for producers concerning the requirements which have to be fulfilled for the use of new micro-organisms as component materials for CE marked fertilising products, harmonized methods for the safety evaluation of new micro-organisms have to be clearly identified. The preparatory work for defining these safety evaluation methods should start immediately after the entry into force of this Regulation. The power to adopt acts in accordance with Article 290 of the Treaty should be delegated to the Commission to define, without any unnecessary delay, the requirements which producers have to comply with when demonstrating the safety of new micro-organisms in order to be used in CE marked fertilising products.

Amendment    20

Proposal for a regulation

Recital 16

 

Text proposed by the Commission

Amendment

(16)  Products with one or more functions, one of which is covered by the scope of Regulation (EC) No 1107/2009, should remain under the control tailored 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 in question. Therefore, such products should be excluded from the scope of this Regulation.

(16)  Products with one or more functions, one of which is covered by the scope of Regulation (EC) No 1107/2009, are plant protection products covered by the scope of that Regulation. Those products should remain under the control tailored for such products and provided for by that Regulation. Where such products also have the function or the action 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 in question. Therefore, such products should be excluded from the scope of this Regulation.

Amendment    21

Proposal for a regulation

Recital 17

 

Text proposed by the Commission

Amendment

(17)  This Regulation should not prevent the application of existing Union legislation relating to aspects of protection of health, safety and the environment not covered by this Regulation. This Regulation should therefore apply without prejudice to Council Directive 86/278/EEC22 , Council Directive 89/391/EEC23 , Regulation (EC) No 1907/2006 of the European Parliament and of the Council24 , Regulation (EC) No 1272/2008 of the European Parliament and of the Council25 , Commission Regulation (EC) No 1881/200626 , Council Directive 2000/29/EC27 , Regulation (EU) No 98/2013 of the European Parliament and of the Council28 , and Regulation (EU) No 1143/2014 of the European Parliament and of the Council29 .

(17)  Regardless the type of the CE marked plant nutrition product, this Regulation should not prevent the application of existing Union legislation relating to aspects of protection of health, safety and the environment not covered by this Regulation. This Regulation should therefore apply without prejudice to Council Directive 86/278/EEC22 , Council Directive 89/391/EEC23 , Regulation (EC) No 1907/2006 of the European Parliament and of the Council24 , Regulation (EC) No 1272/2008 of the European Parliament and of the Council25 , Commission Regulation (EC) No 1881/200626 , Council Directive 2000/29/EC27 , Regulation (EU) No 98/2013 of the European Parliament and of the Council28 , Regulation (EU) No 1143/2014 of the European Parliament and of the Council29 , Council Directive 91/676/EEC29a, and Directive 2000/60/EC29b

_________________

_________________

22 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).

22 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).

23 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).

23 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).

24 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) (OJ L 396, 30.12.2006, p. 1).

24 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) (OJ L 396, 30.12.2006, p. 1).

25 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 (OJ L 353, 31.12.2008, p. 1).

25 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 (OJ L 353, 31.12.2008, p. 1).

26 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).

26 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).

27 Council Directive 2000/29/EC of 8 May 2000 on protective measures against the introduction into the Community of organisms harmful to plants or plant products and against their spread within the Community (OJ L 169, 10.7.2000, p. 1).

27 Council Directive 2000/29/EC of 8 May 2000 on protective measures against the introduction into the Community of organisms harmful to plants or plant products and against their spread within the Community (OJ L 169, 10.7.2000, p. 1).

28 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).

28 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).

29 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).

29 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).

 

29a 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).

 

29b 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)

 

 

Amendment    22

Proposal for a regulation

Recital 17 a (new)

Text proposed by the Commission

Amendment

 

(17a)  The traceability of products which are vulnerable to organic pollution from certain potentially problematic sources (or perceived as such) should be ensured back to the source of the organic material. This is necessary in order to secure consumer confidence and to limit damage if local contamination occurs. As a result, businesses which use fertiliser products containing organic material from these sources may be identified. This should be compulsory for products containing material from waste or from by-products which have not undergone any processing that destroys organic pollutants, pathogens and genetic material. The aim is not only to reduce risks to health and the environment but also to reassure public opinion and cater for the concerns of farmers regarding pathogens, organic pollutants and genetic material. In order to protect land owners against pollution for which they themselves are not to blame, Member States are called upon to establish appropriate liability rules.

Amendment    23

Proposal for a regulation

Recital 17 b (new)

Text proposed by the Commission

Amendment

 

(17b)  Untreated by-products of animal production should not be subject to this Regulation.

Amendment    24

Proposal for a regulation

Recital 19a (new)

Text proposed by the Commission

Amendment

 

(19a)  In line with the circular economy, certain industry by-products or co-products from specific industrial processes are already used by manufacturers as components of CE marked fertilising products. Requirements related to such component material categories should be laid down in Annex II.

Amendment    25

Proposal for a regulation

Recital 20

 

Text proposed by the Commission

Amendment

(20)  A blend of different CE marked fertilising products, each of which has been subject to a successful assessment of conformity with the applicable requirements for that material, can itself be expected to be suitable for use as a CE marked fertilising product, subject only to certain additional requirements warranted by the blending. Therefore, in order to avoid an unnecessary administrative burden, such blends should belong to a separate category, for which the conformity assessment should be limited to the additional requirements warranted by the blending.

(20)  A combination of products from different product function categories, each of which has been subject to a successful assessment of conformity with the applicable requirements for that material, can itself be expected to be suitable for use as a CE marked fertilising product, subject only to certain additional requirements warranted by the mixing. Therefore, in order to avoid an unnecessary administrative burden, such combinations should belong to a separate category, for which the conformity assessment should be limited to the additional requirements warranted by the mixing.

 

(This amendment also covers a horizontal amendment on the term “blend” (in plural or singular) being changed to “combination” (in plural or singular); adopting it will necessitate corresponding changes of these terms throughout the text and, consequently, adopted amendments.)

Amendment    26

Proposal for a regulation

Recital 25

 

Text proposed by the Commission

Amendment

(25)  When placing a CE marked fertilising product on the market, the importer should indicate on the packaging of the fertilising product his or her name, registered trade name or registered trade mark and the postal address at which he or she can be contacted, in order to enable market surveillance.

(25)  When placing a CE marked product on the market, the importer should indicate on the packaging of the product his or her name, registered trade name or registered trade mark and the postal address at which he or she can be contacted, as well as the third-country manufacturer in order to enable market surveillance.

Amendment     27

Proposal for a regulation

Recital 31

Text proposed by the Commission

Amendment

(31)  Where harmonised standards have not been adopted, or do not with sufficient detail cover all elements of the quality and safety requirements laid down in this Regulation, uniform conditions for implementing those requirements may be needed. The Commission should therefore be empowered to adopt implementing acts setting out those conditions in common specifications. For reasons of legal certainty, it should be clarified that CE marked fertilising products must comply with such specifications even if they are considered to be in conformity with harmonised standards.

(31)  Where harmonised standards have not been adopted, or do not with sufficient detail cover all elements of the quality and safety requirements laid down in this Regulation, and where there are undue delays in the process of adopting or updating standards to reflect those requirements, interim measures may be needed to lay down uniform conditions for implementing those requirements. The Commission should therefore be empowered to adopt implementing acts setting out those conditions in common specifications. For reasons of legal certainty, it should be clarified that CE marked fertilising products must comply with such specifications even if they are considered to be in conformity with harmonised standards.

Amendment    28

Proposal for a regulation

Recital 47

 

Text proposed by the Commission

Amendment

(47)  CE-marked fertilising products should be placed on the market only if they are sufficiently effective and do not present unacceptable risks to human, animal or plant health, to safety or to the environment when properly stored and used for their intended purpose, and under conditions of use which can be reasonably foreseen, that is when such use could result from lawful and readily predictable human behaviour. Therefore, requirements for safety and quality, as well as appropriate control mechanisms, should be established. Furthermore, the intended use of CE marked fertilising products should not lead to food or feed becoming unsafe.

(47)  CE-marked 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, and under conditions of use which can be reasonably foreseen, that is when such use could result from lawful and readily predictable human behaviour. Therefore, requirements for safety and quality, as well as appropriate control mechanisms, should be established.

Amendment     29

Proposal for a regulation

Recital 49

Text proposed by the Commission

Amendment

(49)  The existing system should be supplemented by a procedure under which interested parties are informed of measures intended to be taken with regard to CE marked fertilising products presenting an unacceptable 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 fertilising products.

(49)  The existing system should be supplemented by a procedure under which all interested parties, including health and consumers stakeholders, are informed of measures intended to be taken with regard to CE marked 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 fertilising products.

Amendment    30

Proposal for a regulation

Recital 55

 

Text proposed by the Commission

Amendment

(55)  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 of the Treaty on the Functioning of the European Union should be delegated to the Commission in respect of defining larger or additional categories of CE marked fertilising products or component materials eligible for use in the production of such products. For animal by-products, component material categories should be expanded or added only to the extent an end point in the manufacturing chain has been determined in accordance with the procedures laid down in Regulation (EC) No 1069/2009, since animal by-products for which no such end point has been determined are in any event excluded from the scope of this Regulation.

(55)  Promising technical progress is being made in the field of recycling of waste, such as phosphorus recycling from sewage sludge, such as struvite, fertilising product production from animal by-products, such as biochar, and phosphorus recovery after incineration, such as ash-based products. 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 of the Treaty on the Functioning of the European Union should be delegated to the Commission in respect of the eligibility of such materials for use in production. For products derived from animal by-products, component material categories should be expanded or added only to the extent an end point in the manufacturing chain has been determined in accordance with the procedures laid down in Regulation (EC) No 1069/2009.

Amendment    31

Proposal for a regulation

Recital 55 a (new)

 

Text proposed by the Commission

Amendment

 

(55a)  A CE marked fertilising product may contain other polymers than nutrient polymers, however this should be limited to the cases where the purpose of the polymer is that of controlling the release of nutrients or increasing the water retention capacity of the CE marked fertilising product. It should be possible for innovative products containing such polymers to access the internal market. In order to minimize risks to human health, to safety or to the environment that may be posed by other polymers than nutrient polymers, the criteria for their biodegradation 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 of the Treaty on the Functioning of the European Union should be delegated to the Commission in respect of defining the criteria of the conversion of polymeric carbon to be converted into carbon dioxide (CO2) and a respective testing method for biodegradation.

Amendment    32

Proposal for a regulation

Recital 56

Text proposed by the Commission

Amendment

(56)  Furthermore, it should be possible to react immediately to new findings regarding the conditions for CE marked fertilising products to be sufficiently effective 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 of the Treaty should be delegated to the Commission to amend the requirements applicable to various categories of CE marked fertilising products.

(56)  Furthermore, it should be possible to react immediately to new findings regarding the conditions for CE marked fertilising products to be sufficiently effective and to new risk assessments regarding human, animal or plant health, safety or the environment, taking into account assessments made by or in cooperation with authorities in the Member States. For that purpose, the power to adopt acts in accordance with Article 290 of the Treaty should be delegated to the Commission to amend the requirements applicable to various categories of CE marked fertilising products.

Amendment    33

Proposal for a regulation

Recital 57

Text proposed by the Commission

Amendment

(57)  In exercising those powers, it is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level. The Commission, when preparing and drawing up delegated acts, should ensure a simultaneous, timely and appropriate transmission of relevant documents to the European Parliament and to the Council.

(57)  When adopting delegated acts provided for in 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. 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.

Amendment    34

Proposal for a regulation

Recital 59 a (new)

Text proposed by the Commission

Amendment

 

(59a)  Due to the high level of dependency on phosphate rock imports in the Union, the Commission has classified that material as a critical raw material. It is therefore necessary to monitor the impact of this Regulation on access to raw material supplies in general, on the availability of phosphate rock in particular, and, in both cases, on prices. After such evaluation, and in the case of negative impact, the Commission should take any measures that it deems to be appropriate in order to remedy those disturbances to trade.

Amendment    35

Proposal for a regulation

Article 1 – paragraph 1 – subparagraph 2 – point a

Text proposed by the Commission

Amendment

(a)  animal by-products which are subject to the requirements of Regulation (EC) No 1069/2009,

(a)  animal by-products or derived products which are made available on the market subject to the requirements of Regulation (EC) No 1069/2009,

Amendment     36

Proposal for a regulation

Article 1 – paragraph 2 – point b a (new)

Text proposed by the Commission

Amendment

 

(ba)  Directive 91/676/EEC;

Amendment    37

Proposal for a regulation

Article 1 – paragraph 2 – point b b (new)

Text proposed by the Commission

Amendment

 

(bb)  Directive 2000/60/EC;

Amendment    38

Proposal for a regulation

Article 2 – paragraph 1 – point 1

 

Text proposed by the Commission

Amendment

(1)  ‘fertilising product’ means a substance, mixture, micro-organism or any other material, applied or intended to be applied, either on its own or mixed with another material, on plants or their rhizosphere for the purpose of providing plants with nutrient or improving their nutrition efficiency;

(1)  ‘plant nutrition product’ means a substance, mixture, micro-organism or any other material, applied or intended to be applied, either on its own or mixed with another material, on fungi or their mycosphere or on plants at any growth stage, including seeds, and/or rhizosphere, for the purpose of providing plants or fungi with nutrients or of improving their physical or biological growth conditions or their general vigour, yields and quality, including by increasing the ability of the plant to take up nutrients from the phyllosphere (with the exception of plant protection products covered by Regulation (EC) No 1107/2009).

Amendment     39

Proposal for a regulation

Article 2 – paragraph 1 – point 3

Text proposed by the Commission

Amendment

(3)  ‘substance’ means a substance within the meaning of Article 3(1) of Regulation (EC) No 1907/2006;

(3)  'substance' means a chemical element and its compounds in the natural state or obtained by any manufacturing process, including any additive necessary to preserve its stability and any impurity deriving from the process used, but excluding any solvent which may be separated without affecting the stability of the substance or changing its composition.

Amendment    40

Proposal for a regulation

Article 2 – paragraph 1 – point 13

Text proposed by the Commission

Amendment

(13)  'technical specification' means a document that prescribes technical requirements to be fulfilled by a CE marked fertilising product;

(13)  'technical specification' means a document that prescribes technical requirements to be fulfilled by a CE marked fertilising product or by its production process;

Amendment    41

Proposal for a regulation

Article 3 – paragraph 1

Text proposed by the Commission

Amendment

Member States shall not impede the making available on the market of CE marked fertilising products which comply with this Regulation.

Member States shall not impede, for the aspects and risks covered by this Regulation, the making available on the market of CE marked fertilising products which comply with this Regulation.

Amendment     42

Proposal for a regulation

Article 3 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

 

This Regulation does not prevent Member States from maintaining or adopting provisions which are in compliance with the Treaties, concerning the use of CE marked fertilising products for the purpose of protecting human health and the environment, provided that those provisions do not require modification of CE marked fertilising products which are in compliance with this Regulation and do not influence the conditions for making them available on the market.

Amendment    43

Proposal for a regulation

Article 4 – paragraph 2

Text proposed by the Commission

Amendment

2.  For any aspects not covered by Annex I or II, CE marked fertilising products shall meet the requirement that their use, as specified in the use instructions, does not lead to food or feed of plant origin becoming unsafe within the meaning of Articles 14 and 15 of Regulation (EC) No 178/2002, respectively.

deleted

Amendment     44

Proposal for a regulation

Article 4 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

 

2a.  Commission shall simultaneously with the publication of this Regulation in the Official Journal of the European Union publish a guidance document giving clarity and examples to manufacturers and market surveillance authorities about how the label should look like. This guidance document shall also specify other relevant information as referred to in point (d) of paragraph 2 of Part 1 of Annex III.

Amendment    45

Proposal for a regulation

Article 6 – paragraph 3

 

Text proposed by the Commission

Amendment

3.  Manufacturers shall keep the technical documentation and the EU declaration of conformity for 10 years after the CE marked fertilising product covered by those documents has been placed on the market.

3.  Manufacturers shall keep the technical documentation and the EU declaration of conformity for five years after the CE marked fertilising product covered by those documents has been placed on the market.

 

(This is a horizontal amendment on the term for keeping all the technical documentation; adopting it will necessitate corresponding changes throughout the text and, consequently, adopted amendments)

Amendment    46

Proposal for a regulation

Article 6 – paragraph 4 – subparagraph 1

Text proposed by the Commission

Amendment

Manufacturers shall ensure that procedures are in place for CE marked fertilising products that are part of a series production to remain in conformity with this Regulation. Changes in production method or characteristics of those fertilising products and changes in the harmonised standards, common specifications referred to in Article 13 or other technical specifications by reference to which conformity of a CE marked fertilising product is declared shall be adequately taken into account.

Manufacturers shall ensure that procedures are in place for CE marked fertilising products that are part of a series production to remain in conformity with this Regulation. Changes in the characteristics of those fertilising products and changes in the harmonised standards, common specifications referred to in Article 13 or other technical specifications by reference to which conformity of a CE marked fertilising product is declared shall be adequately taken into account.

Amendment    47

Proposal for a regulation

Article 6 – paragraph 4 – subparagraph 2

 

Text proposed by the Commission

Amendment

When deemed appropriate with regard to the performance of, or the risks presented by, a CE marked fertilising product, manufacturers shall carry out sample testing of such fertilising products made available on the market, investigate, and, if necessary, keep a register of complaints, of non-conforming CE marked fertilising products and recalls of such products, and shall keep distributors informed of any such monitoring.

When deemed appropriate with regard to the performance of, or the risks presented by, a CE marked fertilising product, manufacturers shall, to protect the health and safety of consumers and the environment,  carry out sample testing of such fertilising products made available on the market, investigate, and keep a register of complaints, of non-conforming CE marked fertilising products and recalls of such products, and shall keep distributors and market surveillance authorities informed of any such monitoring.

Amendment    48

Proposal for a regulation

Article 6 – paragraph 6

 

Text proposed by the Commission

Amendment

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 CE marked fertilising product or, where the fertilising product is supplied without packaging, in a document accompanying the fertilising product. The postal address shall indicate a single point at which the manufacturer can be contacted. The contact details shall be in a language easily understood by end-users and market surveillance authorities.

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 CE marked fertilising product or, where the fertilising product is supplied without packaging, in a document accompanying the fertilising product. The postal address shall indicate a single point at which the manufacturer can be contacted. The above mentioned information shall be in a language easily understood by end-users and market surveillance authorities as determined by the Member State concerned, and shall be clear, understandable and legible.

Amendment    49

Proposal for a regulation

Article 6 – paragraph 7

 

Text proposed by the Commission

Amendment

7.  Manufacturers shall ensure that CE marked fertilising products are labelled in accordance with Annex III, or where the fertilising product is supplied without packaging, that the labelling statements are provided in a document accompanying the fertilising product and accessible for inspection purposes when the product is placed on the market. The labelling statement 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.

7.  Manufacturers shall ensure that CE marked fertilising product is labelled in accordance with Annex III,or where the package is too small for the label to contain all the information, or where the CE marked fertilising product is supplied without packaging, that the required information is provided in a document accompanying the CE marked fertilising product. The information required in accordance with Annex III 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.

Amendment    50

Proposal for a regulation

Article 6 – paragraph 10 – introductory part

Text proposed by the Commission

Amendment

10.  The manufacturer shall submit to the competent authority of the Member State of destination a report of the detonation resistance test prescribed in Annex IV for the following CE marked fertilising products:

10.  The manufacturer shall submit to the competent authority of the Member State of destination a report of the detonation resistance test prescribed in Annex IV, and guarantee that the following CE marked fertilising products are capable of passing that test:

Amendment     51

Proposal for a regulation

Article 6 – paragraph 10 – subparagraph 1 – point b

Text proposed by the Commission

Amendment

(b)  fertilising product blends, as specified in product function category 7 in Annex I, containing a fertiliser referred to in point (a).

(b)  combinations from different product function categories, as specified in product function category 7 in Annex I, containing a fertiliser referred to in point (a).

Amendment    52

Proposal for a regulation

Article 6 – paragraph 10 – subparagraph 2

 

Text proposed by the Commission

Amendment

The report shall be submitted at least five days in advance of placing those products on the market.

The report shall be submitted at least five working days in advance of placing those products on the market. List of competent authorities of Member States shall be provided by the Commission on its website.

Amendment     53

Proposal for a regulation

Article 8 – paragraph 1

Text proposed by the Commission

Amendment

1.  Importers shall place only compliant CE marked fertilising products on the market.

1.  Only compliant CE marked fertilizer can be imported into the Union and placed on the Union market.

Amendment    54

Proposal for a regulation

Article 8 – paragraph 2

 

Text proposed by the Commission

Amendment

2.  Before placing a CE marked fertilising product on the market importers shall ensure that the appropriate conformity assessment procedure referred to in Article 14 has been carried out by the manufacturer. They shall ensure that the manufacturer has drawn up the technical documentation, that the CE marked fertilising product is accompanied by the EU declaration of conformity and 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 a CE marked fertilising product is not in conformity with the applicable requirements set out in Annex I, Annex II or Annex III, he or she shall not place the fertilising product on the market until it has been brought into conformity. Furthermore, where the CE marked fertilising product presents an unacceptable 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.

2.  Before placing a CE marked fertilising product on the market importers shall ensure that the appropriate conformity assessment procedure referred to in Article 14 has been carried out by the manufacturer. They shall ensure that the manufacturer has drawn up the technical documentation, that the CE marked fertilising product is accompanied by the EU declaration of conformity and 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 a CE marked fertilising product is not in conformity with the applicable requirements of this Regulation, he or she shall not place the fertilising product on the market until it has been brought into conformity. Furthermore, where the CE marked fertilising product presents an unacceptable 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.

Amendment    55

Proposal for a regulation

Article 8 – paragraph 3

 

Text proposed by the Commission

Amendment

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 CE marked fertilising product or, where the CE marked fertilising product is supplied without packaging, in a document accompanying the fertilising product. The contact details shall be in a language easily understood by end-users and market surveillance authorities.

3.  Importers shall indicate their name, registered trade name or registered trade mark and the postal address at which they can be contacted as well as the third-country manufacturers on the packaging of the CE marked fertilising product or, where the CE marked fertilising product is supplied without packaging, in a document accompanying the fertilising product. The contact details shall be in a language easily understood by end-users and market surveillance authorities.

Amendment    56

Proposal for a regulation

Article 8 – paragraph 4

 

Text proposed by the Commission

Amendment

4.  Importers shall ensure that the CE marked fertilising product is labelled in accordance with Annex III in a language which can be easily understood by end-users, as determined by the Member State concerned.

4.  Importers shall ensure that the CE-marked fertilising product is labelled in accordance with Annex III, or where the package is too small for the label to contain all the information, or where the CE marked fertilising product is supplied without packaging, that the required information is provided in a document accompanying the CE marked fertilising product. The information required in accordance with Annex III shall be in a language which can be easily understood by end-users, as determined by the Member State concerned.

Amendment    57

Proposal for a regulation

Article 8 – paragraph 6

 

Text proposed by the Commission

Amendment

6.  When deemed appropriate with regard to the performance of or the risks presented by a CE marked fertilising product, importers shall carry out sample testing of such fertilising products made available on the market, investigate, and, if necessary, keep a register of complaints, of non-conforming CE marked fertilising products and recalls of such products, and shall keep distributors informed of any such monitoring.

6.  When deemed appropriate with regard to the performance of or the risks presented by a CE marked fertilising product, importers shall, to protect the health and safety of consumers and the environment, carry out sample testing of such fertilising products made available on the market, investigate, and keep a register of complaints, of non-conforming CE marked fertilising products and recalls of such products, and shall keep distributors informed of any such monitoring.

Amendment    58

Proposal for a regulation

Article 8 – paragraph 8

Text proposed by the Commission

Amendment

8.  Importers shall, for 10 years after the CE marked 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.

8.  Importers shall, for five years after the CE marked 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 concerned.

Amendment    59

Proposal for a regulation

Article 9 – paragraph 2 – subparagraph 1

 

Text proposed by the Commission

Amendment

Before making a CE marked fertilising product available on the market distributors shall verify that it is accompanied by the EU declaration of conformity and by the required documents, that it is labelled in accordance with Annex III in a language which can be easily understood by end-users in the Member State in which the CE marked 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.

Before making a CE marked fertilising product available on the market distributors shall verify that it is accompanied by the required documents, that it is labelled in accordance with Annex III in a language which can be easily understood by end-users in the Member State in which the CE marked 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 the package is too small for the label to contain all the information, or where the CE marked fertilising product is supplied without packaging, market distributors shall verify that the required information is provided in a document accompanying the CE marked fertilising product.

Amendment    60

Proposal for a regulation

Article 9 – paragraph 2 – subparagraph 2

Text proposed by the Commission

Amendment

Where a distributor considers or has reason to believe that a CE marked fertilising product is not in conformity with the applicable requirements set out in Annex I, Annex II or Annex III, he or she shall not make the fertilising product available on the market until it has been brought into conformity. Furthermore, where the CE marked fertilising product presents an unacceptable 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.

Where a distributor considers or has reason to believe that a CE marked fertilising product is not in conformity with the applicable requirements of this Regulation, he or she shall not make the fertilising product available on the market until it has been brought into conformity. Furthermore, where the CE marked fertilising product presents an unacceptable 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.

Amendment    61

Proposal for a regulation

Article 12 – paragraph 1

Text proposed by the Commission

Amendment

Without prejudice to the common specifications referred to in Article 13, CE marked 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.

CE marked fertilising products which are in conformity with, or have been tested 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 respective requirements set out in Annexes I, II and III covered by those standards or parts thereof.

Amendment     62

Proposal for a regulation

Article 13 – paragraph 1

Text proposed by the Commission

Amendment

The Commission may adopt implementing acts laying down common specifications, the compliance with which shall ensure conformity with the requirements set out in Annexes I, II and III covered by those specifications or parts thereof. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 41(3).

Where a requirement set out in Annexes I, II or III is not covered by harmonised standards or parts thereof, the references of which have been published in the Official Journal of the European Union, and where following a request to one or several European standardisation organisations to draft harmonised standards for that requirement the Commission observes undue delays in the adoption of that standard, the Commission may adopt implementing acts laying down common specifications for that requirement. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 41(3).

Amendment    63

Proposal for a regulation

Article 17 – paragraph 1

 

Text proposed by the Commission

Amendment

1.  The CE marking shall be affixed visibly, legibly and indelibly to the accompanying documents and, where the CE marked fertilising product is supplied in a packaged form, to the packaging.

1.  The CE marking shall be affixed visibly, legibly and indelibly to the packaging of the CE marked fertilising product or, where the CE marked fertilising product is supplied without packaging, to the documents accompanying the CE marked fertilising product.

Amendment    64

Proposal for a regulation

Article 17 – paragraph 3 – subparagraph 1

Text proposed by the Commission

Amendment

The CE marking shall be followed by the identification number of the notified body involved in the conformity assessment referred to in Annex IV, Module D1.

The CE marking shall be followed by the identification number of the notified body, where required by Annex IV.

Amendment    65

Proposal for a regulation

Article 18 – paragraph 1

 

Text proposed by the Commission

Amendment

A CE marked fertilising product that has undergone a recovery operation and complies with the requirements laid down in this Regulation shall be considered to comply with the conditions laid down in Article 6(1) of Directive 2008/98/EC and shall, therefore, be considered as having ceased to be waste.

Where a material that was waste has undergone a recovery operation and a CE marked fertilising product compliant with this Regulation contains or consists of that material, the material shall be considered to comply with the conditions laid down in Article 6(1) of Directive 2008/98/EC and shall, therefore, be considered as having ceased to be waste from the moment the EU declaration of conformity is drawn up.

Amendment     66

Proposal for a regulation

Article 30 – paragraph 2

Text proposed by the Commission

Amendment

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.

2.  The notifying authorities 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.

Amendment    67

Proposal for a regulation

Article 31 – paragraph 3

Text proposed by the Commission

Amendment

3.  Where a notified body finds that the requirements set out in Annex I, Annex II or Annex III, or corresponding harmonised standards, common specifications referred to in Article 13 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.

3.  Where a notified body finds that the requirements set out in Annex I, Annex II or Annex III, or corresponding harmonised standards, or common specifications referred to in Article 13, have not been met by a manufacturer, it shall require that manufacturer to take appropriate corrective measures and shall not issue a conformity certificate or approval decision.

Amendment    68

Proposal for a regulation

Article 31 – paragraph 4

Text proposed by the Commission

Amendment

4.  Where, in the course of the monitoring of conformity following the issue of a certificate, a notified body finds that a CE marked fertilising product no longer complies, it shall require the manufacturer to take appropriate corrective measures and shall suspend or withdraw the certificate if necessary.

4.  Where, in the course of the monitoring of conformity following the issue of a certificate or approval decision, a notified body finds that a CE marked fertilising product no longer complies, it shall require the manufacturer to take appropriate corrective measures and shall suspend or withdraw the certificate or approval decision if necessary.

Amendment    69

Proposal for a regulation

Article 31 – paragraph 5

Text proposed by the Commission

Amendment

5.  Where corrective measures are not taken or do not have the required effect, the notified body shall restrict, suspend or withdraw any certificates, as appropriate.

5.  Where corrective measures are not taken or do not have the required effect and a CE marked fertilising product thus remains non-compliant with the requirements of this Regulation, the notified body shall restrict, suspend or withdraw any certificates or approval decisions, as appropriate.

Amendment    70

Proposal for a regulation

Article 33 – paragraph 1 – point a

Text proposed by the Commission

Amendment

(a)  any refusal, restriction, suspension or withdrawal of a certificate;

(a)  any refusal, restriction, suspension or withdrawal of a certificate or approval decision;

Amendment     71

Proposal for a regulation

Article 37 – title

Text proposed by the Commission

Amendment

Procedure for dealing with CE marked fertilising products presenting a risk at national level

Procedure at national level for dealing with CE marked fertilising products presenting a risk

Amendment    72

Proposal for a regulation

Article 37 – paragraph 1 – subparagraph 1

 

Text proposed by the Commission

Amendment

Where the market surveillance authorities of one Member State have sufficient reason to believe that a CE marked fertilising product presents an unacceptable risk to human, animal or plant health, to safety or to the environment, they shall carry out an evaluation in relation to the fertilising product concerned covering the requirements laid down in this Regulation. The relevant economic operators shall cooperate as necessary with the market surveillance authorities for that purpose.

Where the market surveillance authorities of one Member State have sufficient reason to believe that a CE marked fertilising product presents a risk to human, animal or plant health, to safety or to the environment or to other aspects of public interest protection covered by this Regulation, they shall carry out an evaluation in relation to the fertilising product concerned covering all the requirements laid down in this Regulation. The relevant economic operators shall cooperate as necessary with the market surveillance authorities for that purpose.

 

(This amendment also covers a horizontal amendment on the term “unacceptable risk” (in plural or singular) being changed to “risk” (in singular); adopting it will necessitate corresponding changes of these terms throughout the text and, consequently, adopted amendments.)

Amendment     73

Proposal for a regulation

Article 37 – paragraph 1 – subparagraph 2

Text proposed by the Commission

Amendment

Where, in the course of the evaluation, the market surveillance authorities find that the CE market fertilising product does not comply with the requirements laid down in this Regulation, they shall without delay require the economic operator to take all appropriate corrective actions within a reasonable period to bring the fertilising product into compliance with those requirements, to withdraw the fertilising product from the market, to recall it, or to remove the CE marking.

Where, in the course of the evaluation, the market surveillance authorities find that the CE market fertilising product does not comply with the requirements laid down in this Regulation, they shall without delay require the economic operator to take all appropriate corrective actions to bring the fertilising product into compliance with those requirements, to withdraw the fertilising product from the market or to recall it within a reasonable period, commensurate with the nature of the risk, as they may prescribe, and to remove the CE marking.

Amendment     74

Proposal for a regulation

Article 37 – paragraph 4 – subparagraph 1

Text proposed by the Commission

Amendment

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 CE marked fertilising product being made available on their national market, to withdraw the fertilising product from that market or to recall it.

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 CE marked fertilising product being made available on their national market, to withdraw the fertilising product from that market or to recall it. Market surveillance authorities' obligations in this respect shall be without prejudice to Member States' possibility to regulate fertilising products which are not CE marked when made available on the market.

Amendment     75

Proposal for a regulation

Article 37 – paragraph 5 – point b

Text proposed by the Commission

Amendment

(b)  shortcomings in the harmonised standards referred to in Article 12 conferring a presumption of conformity.

(b)  shortcomings in the harmonised standards referred to in Article 12;

Amendment     76

Proposal for a regulation

Article 37 – paragraph 5 – point b a (new)

Text proposed by the Commission

Amendment

 

(ba)  shortcomings in the common specifications referred to in Article 13.

Amendment    77

Proposal for a regulation

Article 38 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

 

2a.  Where the national measure is considered to be justified and the non-compliance of the CE marked fertilising product is attributed to shortcomings in the common specifications referred to in point (c) of Article 37(5), the Commission shall, without delay, adopt implementing acts amending or repealing the common specification concerned. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 41(3).

Amendment    78

Proposal for a regulation

Article 39 – paragraph 1

 

Text proposed by the Commission

Amendment

1.  Where, having carried out an evaluation under Article 37(1), a Member State finds that although a CE marked fertilising product is in compliance with this Regulation it presents an unacceptable risk to human, animal or plant health, to safety or to the environment, it shall require the relevant economic operator to take all appropriate measures within a reasonable period to ensure that the fertilising product concerned, when placed on the market, no longer presents that risk, to withdraw the fertilising product from the market or to recall it.

1.  Where, having carried out an evaluation under Article 37(1), a Member State finds that although a CE marked fertilising product is in compliance with this Regulation it presents a risk to human, animal or plant health, to safety or to the environment or to other aspects of public interest protection covered by this Regulation, 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 fertilising product concerned, when made available on the market, no longer presents that risk, to withdraw the fertilising product from the market or to recall it.

Amendment    79

Proposal for a regulation

Article 40 – paragraph 1 – point c

Text proposed by the Commission

Amendment

(c)  the EU declaration of conformity does not accompany the CE marked fertilising product;

(c)  the EU declaration of conformity has not been drawn up;

Amendment    80

Proposal for a regulation

Article 42 – paragraph 1

 

Text proposed by the Commission

Amendment

1.  The Commission shall be empowered to adopt delegated acts in accordance with Article 43 to amend Annexes I to IV for the purposes of adapting them to technical progress and facilitating internal market access and free movement for CE marked fertilising products.

1.  The Commission shall be empowered to adopt delegated acts in accordance with Article 43 to amend Annexes I to IV for the purposes of adapting them to technical progress, taking into account products and materials already authorised in Member States, and in particular in the fields of fertilising product production from animal by-products and waste recovery, and for the purpose of facilitating internal market access and free movement for CE marked fertilising products:

(a)  which are likely to be subject of significant trade on the internal market, and

(a)  which have potential to be subject of significant trade on the internal market, and

(b)  for which there is scientific evidence that the they do not present an unacceptable risk to human, animal or plant health, to safety or to the environment, and that they are sufficiently effective.

(b)  for which there is scientific evidence that the they do not present a risk to human, animal or plant health, to safety or to the environment, and that they are sufficiently effective.

Amendment    81

Proposal for a regulation

Article 42 – paragraph 1 a (new)

 

Text proposed by the Commission

Amendment

 

1a.  Without undue delay after … [date of the entry into force of this Regulation], the Commission shall adopt a delegated act, in accordance with paragraph 1, to amend the component material categories set out in Annex II to add in particular animal by-products for which the end-point has been determined, struvite, biochar and ash-based products to those component material categories, as well as to lay down the requirements for the inclusion of those products in those categories. When adopting those delegated acts, the Commission shall specifically take into account technological progress in the recovery of nutrients.

Amendment    82

Proposal for a regulation

Article 42 – paragraph 2 – introductory part

 

Text proposed by the Commission

Amendment

2.  Where the Commission amends Annex II in order to add new micro-organisms to the component material category for such organisms pursuant to paragraph 1, it shall do so on the basis of the following data:

2.  Where the Commission amends Annex II in order to add new strains of micro-organisms to the component material category for such organisms, it shall do so, after verifying that all concerned strains of the additional microorganism comply with the requirements in point (b) of paragraph 1 of this Article, on the basis of the following data:

Amendment    83

Proposal for a regulation

Article 42 – paragraph 2 – point a

 

Text proposed by the Commission

Amendment

(a)  name of the micro-organism;

(a)  name of the micro-organism at strain level;

Amendment     84

Proposal for a regulation

Article 42 – paragraph 2 – point c

Text proposed by the Commission

Amendment

(c)  historical data of safe production and use of the micro-organism

(c)  scientific literature reporting about safe production and use of the micro-organism

Amendment    85

Proposal for a regulation

Article 42 – paragraph 2 – point d

Text proposed by the Commission

Amendment

(d)  taxonomic relation to micro-organism species fulfilling the requirements for a Qualified Presumption of Safety as established by the European Food Safety Agency;

(d)  taxonomic relation to micro-organism species fulfilling the requirements for a Qualified Presumption of Safety as established by the European Food Safety Authority, or reference of declared conformity to the relevant harmonised standards on safety of micro-organisms used which have been published in the Official Journal of the European Union, or conformity with the requirements for the safety evaluation of new micro-organisms as adopted by the Commission if such harmonised standards are not in place;

Amendment     86

Proposal for a regulation

Article 42 – paragraph 2 – subparagraph 1 a (new)

Text proposed by the Commission

Amendment

 

To reflect the rapid technological progress in that field, the Commission shall, by … [one year after the date of entry into force of this Regulation], adopt delegated acts in accordance with Article 43 to define criteria for the evaluation of new micro-organisms that may be used in plant nutrition products without being inscribed nominally in a positive list.

Amendment    87

Proposal for a regulation

Article 42 – paragraph 3 – subparagraph 1 a (new)

 

Text proposed by the Commission

Amendment

 

By … [six months after the date of entry into force of this Regulation], the Commission shall amend Annex II in order to insert the end-points in the manufacturing chain that have been determined in accordance with the second subparagraph of Article 5(2) of Regulation (EC) No 1069/2009, with regard to the animal by-products listed in CMC 11 of Annex II.

Amendment    88

Proposal for a regulation

Article 42 – paragraph 3 a (new)

 

Text proposed by the Commission

Amendment

 

3a.  When adopting delegated acts pursuant to paragraph 1, the Commission shall amend the component material category setting the requirement for polymers other than nutrient polymers set out in Annex II in order to reflect the latest scientific evidence and technological development, and by … [three years after the date of application of this Regulation] shall define the criteria of the conversion of polymeric carbon to be converted into carbon dioxide (CO2) and a respective testing method for biodegradation.

Amendment    89

Proposal for a regulation

Article 42 – paragraph 3 b (new)

Text proposed by the Commission

Amendment

 

3b.  When adopting delegated acts pursuant to paragraph 1, the Commission shall amend the component material category setting the criteria for other industry by-products set out in Annex II in order to reflect the present product manufacturing practices, technological development and the latest scientific evidence, and by … [one year after the date of entry into force of this Regulation] shall define the criteria for industrial by-products for their inclusion to the component material category.

Amendment    90

Proposal for a regulation

Article 42 – paragraph 4 a (new)

Text proposed by the Commission

Amendment

 

4a.  With regard to Part II of Annex I, the empowerment to adopt delegated acts in accordance with paragraphs 1 and 4 of this Article shall not cover adaptations to the contaminant limits specified therein, unless new contaminant limits are necessary as a consequence of adding new component materials under Annex II. When new contaminant limits are set, those limits shall only apply to the new component materials added.

Amendment    91

Proposal for a regulation

Article 43 – paragraph 3 a (new)

Text proposed by the Commission

Amendment

 

3a.  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.

Amendment    92

Proposal for a regulation

Article 44 – paragraph 1

Text proposed by the Commission

Amendment

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.

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. Member States shall take all measures necessary to ensure that their rules on penalties are enforced.

Amendment    93

Proposal for a regulation

Article 45 – paragraph 1 – point 1 a (new)

Regulation (EC) No 1069/2009

Article 5 – paragraph 2 – subparagraph 1 a (new)

 

Text proposed by the Commission

Amendment

 

(1a)   in paragraph 2, the following subparagraph is inserted after the first subparagraph:

 

“For derived products falling under the scope of Article 32 that are already widely used in Member States for the production of fertilisers, the Commission shall determine such an end-point by … [six months after the date of entry into force of the Fertilisers Regulation]".

Amendment    94

Proposal for a regulation

Article 46 – paragraph 1 – point 2

Regulation (EC) 1107/2009

Article 3 – point 34 – introductory part

 

Text proposed by the Commission

Amendment

(3)  "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:

“34. "plant biostimulant’ means a product containing any substance or micro-organism stimulating plant nutrition processes independently of its nutrient content, or any combination of such substances and/or micro-organisms, with the sole aim of improving one or more of the following characteristics of the plant or the plant rhizosphere:

Amendment     95

Proposal for a regulation

Article 46 – paragraph 1 – point 2

Regulation (EC) 1107/2009

Article 3 – point 34 – point c

 

Text proposed by the Commission

Amendment

(c)  crop quality traits.

(c)  crop quality.

Amendment     96

Proposal for a regulation

Article 46 – paragraph 1 – point 2

Regulation (EC) 1107/2009

Article 3 – point 34 – point c a (new)

 

Text proposed by the Commission

Amendment

 

(ca)  availability of confined nutrients in soil, rhizosphere or phyllosphere;

Amendment     97

Proposal for a regulation

Article 46 – paragraph 1 – point 2

Regulation (EC) 1107/2009

Article 3 – point 34 – point c b (new)

 

Text proposed by the Commission

Amendment

 

(cb)  degradation of organic compounds in the soil

Amendment    98

Proposal for a regulation

Article 46 – paragraph 1 – point 2

Regulation (EC) 1107/2009

Article 3 – point 34 – point c c (new)

 

Text proposed by the Commission

Amendment

 

(cc)  humification;

Amendment    99

Proposal for a regulation

Article 48 – title

Text proposed by the Commission

Amendment

Transitional provisions

Transitional provisions, review and reporting

Amendment    100

Proposal for a regulation

Article 48 – paragraph 1

Text proposed by the Commission

Amendment

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 [Publications office, please insert the date of application of this Regulation]. However, Chapter 5 shall apply mutatis mutandis to such products.

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 ... [twelve months after the date of application of this Regulation]. However, Chapter 5 shall apply mutatis mutandis to such products.

Amendment    101

Proposal for a regulation

Article 48 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

 

1a.   Member States which have already implemented a lower limit for cadmium (Cd) content in organo-mineral fertilisers and inorganic fertilisers, set out in PFC 1 (B)(3)(a) and PFC 1 (C)(I)(2)(a) of Part II of Annex I may maintain that stricter limit until the limit established according to this Regulation is equal or lower. Member States shall notify such existing national measures to the Commission by ... [six months after the date of entry into force of this Regulation].

Amendment    102

Proposal for a regulation

Article 48 – paragraph 1 b (new)

Text proposed by the Commission

Amendment

 

1b.  By … [42 months after the date of application 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 SMEs. That report shall in particular include:

 

(a)  an assessment of the functioning of the internal market for fertilising products, including the conformity assessment and market surveillance effectiveness, an analysis of the effects of partial harmonization on production, use patterns and trade flows of CE marked fertilising products and fertilising products placed on the market under national rules;

 

(b)  an assessment of application of restrictions on levels of contaminants as laid out in Annex I of this Regulation, any new relevant scientific information as regards the toxicity and carcinogenicity of contaminants if it becomes available, including the risks from uranium contamination in fertilising products;

 

(c)  an assessment of the developments in decadmiation technologies and their impact, scale and costs across the value chain, as well as related cadmium waste management; and

 

(d)  an assessment of the impacts on trade in raw material sourcing, including the availability of phosphate rock.

 

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 necessary, by a legislative proposal by … [five years after the date of application of this Regulation].

 

By ...[12 months after the entry into force of this Regulation] the Commission shall submit an evaluation of the scientific data to set the agronomic and environmental criteria to define end-of-livestock-manure criteria in order to qualify the performance of products that contain or consist of processed livestock manure;

Amendment     103

Proposal for a regulation

Article 48 – paragraph 1 c (new)

Text proposed by the Commission

Amendment

 

1c.  By … [five years after the date of entry into force of this Regulation], the Commission shall carry out a review of the conformity assessment procedure of micro-organisms

Amendment    104

Proposal for a regulation

Article 49 – paragraph 2

Text proposed by the Commission

Amendment

It shall apply from 1 January 2018.

It shall apply from … [two years after the date of entry into force of this Regulation], with the exception of Articles 19 to 35, which shall apply from … [one year after the date of entry into force of this Regulation] and Articles 13, 41, 42, 43 and 45, which shall apply from … [the date of entry into force of this Regulation].

Amendment    105

Proposal for a regulation

Annex I – part I – point 1 – point C a (new)

Text proposed by the Commission

Amendment

 

Ca.  Low carbon fertiliser

Amendment    106

Proposal for a regulation

Annex I – part I – point 5 – point A – point I a (new)

Text proposed by the Commission

Amendment

 

Ia.  Denitrification inhibitor

Amendment    107

Proposal for a regulation

Annex I – part II – point 4

Text proposed by the Commission

Amendment

4.  Where the CE marked fertilising product contains a substance for which maximum residue limits for food and feed have been established in accordance with

deleted

(a)   Council Regulation (EEC) No 315/9332 ,

 

(b)   Regulation (EC) No 396/2005 of the European Parliament and of the Council33 ,

 

(c)   Regulation (EC) No 470/2009 of the European Parliament and of the Council34 or

 

(d)   Directive 2002/32/EC of the European Parliament and of the Council35 ,

 

the use of the CE marked fertilising product as specified in the use instructions must not lead to the exceedance of those limits in food or feed.

 

__________________

 

32 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).

 

33 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).

 

34 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).

 

35 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).

 

Amendment    108

Proposal for a regulation

Annex I – part II – point 4 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

 

Ingredients submitted for approval or re-approval under Regulation (EC) No 1107/2009 but not included in Implementing Regulation (EU) No 540/2011 shall not be used in fertilising products when non-inclusion is justified by paragraph 4 of Article 1 of Regulation (EC) No 1107/2009.

Amendment    109

Proposal for a regulation

Annex I – part II – PFC 1(A) – point 1

Text proposed by the Commission

Amendment

1. An organic fertiliser shall contain

1. An organic fertiliser shall contain

-  carbon (C) and

-  organic carbon (Corg) and

-  nutrients

-  nutrients

of solely biological origin, excluding material which is fossilized or embedded in geological formations.

of solely biological origin, such as peat, including leonardite, lignite and substances obtained from those materials, but excluding other materials which are fossilized or embedded in geological formations.

Amendment    110

Proposal for a regulation

Annex I – part II – PFC 1(A) – point 2 – indent 1

Text proposed by the Commission

Amendment

-  Cadmium (Cd) 1,5 mg/kg dry matter,

-  Cadmium (Cd) 1,0 mg/kg dry matter,

Amendment    111

Proposal for a regulation

Annex I – part II – PFC 1(A) – point 2 – indent 5

Text proposed by the Commission

Amendment

-  Lead (Pb) 120 mg/kg dry matter, and

-  Lead (Pb) 20 mg/kg dry matter, and

Amendment    112

Proposal for a regulation

Annex I – part II – PFC 1(A) – point 2 – indent 6

Text proposed by the Commission

Amendment

-  Biuret (C2H5N3O2) 12 g/kg dry matter.

-  Biuret (C2H5N3O2) under detection limit.

Amendment    113

Proposal for a regulation

Annex I – part II – PFC 1(A) – point 3

 

Text proposed by the Commission

3.  Salmonella spp. shall be absent in a 25 g sample of the CE marked fertilising product.

Amendment

3.  Pathogens must not be present in the organic fertiliser in a concentration of more than the respective limits outlined in the table below:

Micro-organism to be tested

Sampling plans

Limit

 

n

c

m

M

Salmonella spp

5

0

0

Absence in 25g or 25ml

Escherichia coli or Enterococcaceae

5

5

0

1000 in 1g or 1ml

where n = number of samples to be tested

c = number of samples where the number of bacteria expressed in CFU may be 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

Parasites Ascaris spp. and Toxocara spp. in all stages of their development must not be present in 100g or 100ml of the organic fertiliser.

Amendment    114

Proposal for a regulation

Annex I – part II – PFC 1(A) (I) – point1 a (new)

Text proposed by the Commission

Amendment

 

1a.  The CE marked fertilising product shall contain at least one of the following declared nutrients: nitrogen (N), phosphorus pentoxide (P2O5) or potassium oxide (K2O).

Amendment    115

Proposal for a regulation

Annex I – part II – PFC 1 (A) (I) – point 2 a (new)

Text proposed by the Commission

Amendment

 

2a.  Where the CE marked fertilising product contains more than one nutrient the product shall contain the primary declared nutrients in the minimum quantities stated below: □

 

2,5 % by mass of total nitrogen (N), or 2 % by mass of total phosphorus pentoxide (P2O5), or2 % by mass of total potassium oxide (K2O), and

 

6,5 % by mass of total sum of nutrients.

Amendment    116

Proposal for a regulation

Annex I – part II – PFC 1(A) (II) – point 1 a (new)

Text proposed by the Commission

Amendment

 

1a.  The CE marked fertilising product shall contain at least one of the following declared nutrients: nitrogen (N), phosphorus pentoxide (P2O5) or potassium oxide (K2O).

Amendment    117

Proposal for a regulation

Annex I – part II – PFC 1(A)(II) – point 2 – introductory part

Text proposed by the Commission

Amendment

2.  The CE marked fertilising product shall contain at least one of the following declared nutrients in the minimum quantities stated:

2.  The CE marked fertilising product shall contain at least one of the following declared primary nutrients in the minimum quantities stated:

Amendment    118

Proposal for a regulation

Annex I – part II – PFC 1(A) (II) – point 2 – indent 1

Text proposed by the Commission

Amendment

-  2% by mass of total nitrogen (N),

-  1% by mass of total nitrogen (N), and/or

Amendment    119

Proposal for a regulation

Annex I – part II – PFC 1 (A) (II) – point 2 – indent 2

Text proposed by the Commission

Amendment

–  1% by mass of total phosphorus pentoxide (P2O5), or

–  2 % by mass of total phosphorus pentoxide (P2O5), or

Amendment    120

Proposal for a regulation

Annex I – part II – PFC 1 (A) (II) – point 2 – indent 3

Text proposed by the Commission

Amendment

–  2% by mass of total potassium oxide (K2O).

–  1 % (one percent) by mass of total potassium oxide (K2O) and

Amendment    121

Proposal for a regulation

Annex I – part II – PFC 1 (A) (II) – point 2 – indent 3 a (new)

Text proposed by the Commission

Amendment

 

  6,5 % by mass of total sum of nutrients.

Amendment    122

Proposal for a regulation

Annex I – part II – PFC 1 (A) (II) – point 2 a (new)

Text proposed by the Commission

Amendment

 

2a.  Where the CE marked fertilising product contains more than one nutrient the product shall contain the primary declared nutrients in the minimum quantities stated below: □

 

2 % by mass of total nitrogen (N), or 1 % by mass of total phosphorus pentoxide (P2O5), or2 % by mass of total potassium oxide (K2O), and

 

5 % by mass of total sum of primary nutrients.

Amendment    123

Proposal for a regulation

Annex I – part II – PFC 1(B) – point 1

Text proposed by the Commission

Amendment

1.  An organo-mineral fertiliser shall be a co-formulation of

1.  An organo-mineral fertiliser shall be a co-formulation of

–  one or more inorganic fertilisers, as specified in PFC 1(C) below, and

–  one or more mineral fertilisers, as specified in PFC 1(C) below, and

–  a material containing organic carbon (C) and

–  one or more materials containing organic carbon (Corg) and

–  nutrients of solely biological origin, excluding material which is fossilized or embedded in geological formations.

–  nutrients of solely biological origin, such as peat, including leonardite, lignite and substances obtained from those materials, but excluding other materials which are fossilized or embedded in geological formations.

Amendment    124

Proposal for a regulation

Annex I – part II – PFC 1(B) – point 3 – point a – point 2 – indent 3

Text proposed by the Commission

Amendment

-  As of [Publications office, please insert the date occurring twelve years after the date of application of this Regulation]: 20 mg/kg phosphorus pentoxide (P2O5),

-  As of ... [nine years after the date of application of this Regulation]: 20 mg/kg phosphorus pentoxide (P2O5),

Amendment    125

Proposal for a regulation

Annex I – part II – PFC 1(B) – point 3 – point e

Text proposed by the Commission

Amendment

(e)  Lead (Pb) 120 mg/kg dry matter.

(e)  Lead (Pb) 20 mg/kg dry matter.

Amendment    126

Proposal for a regulation

Annex I – part II – PFC 1(B) – point 4

 

Text proposed by the Commission

4.  Salmonella spp. shall be absent in a 25 g sample of the CE marked fertilising product.

Amendment

4.  Pathogens must not be present in the organo-mineral fertiliser in a concentration of more than the respective limits outlined in the table below:

Micro-organism to be tested

Sampling plans

Limit

 

n

c

m

M

Salmonella spp

5

0

0

Absence in 25g or 25ml

Escherichia coli or Enterococcaceae

5

5

0

1000 in 1g or 1ml

where n = number of samples to be tested

c = number of samples where the number of bacteria expressed in CFU may be 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

Parasites Ascaris spp. and Toxocara spp. in all stages of their development must not be present in 100g or 100ml of the organo-mineral fertiliser.

Amendment    127

Proposal for a regulation

Annex I – part II – PFC 1(B)(I) – point 2 – indent 2

Text proposed by the Commission

Amendment

-  2 % by mass of total phosphorus pentoxide (P2O5), or

-  1 % by mass of Phosphorus pentoxide (P2O5) soluble in neutral ammonium citrate and water, or

Amendment    128

Proposal for a regulation

Annex I – part II – PFC 1 (B) (I) – point 2 a (new)

Text proposed by the Commission

Amendment

 

2a.  Where the CE marked fertilising product contains more than one nutrient the product shall contain the primary declared nutrients in the minimum quantities stated below:

 

2,5 % by mass of total nitrogen (N), out of which 1% by mass of the CE marked fertilising product shall be organic nitrogen (N), or2 % by mass of total phosphorus pentoxide (P2O5), or 2 % by mass of total potassium oxide (K2O), and

 

6,5 % by mass of total sum of primary nutrients.

Amendment    129

Proposal for a regulation

Annex I – part II – PFC 1(B)(I) – point 4

Text proposed by the Commission

Amendment

4.  In the CE marked fertilising product, each unit shall contain the organic matter and the nutrients in their declared content.

4.  In the CE marked fertilising product, each unit shall contain organic carbon and all the nutrients in their declared content. A unit refers to one of the component pieces of product such as granules, pellets, etc.

Amendment    130

Proposal for a regulation

Annex I – part II – PFC 1(B)(II) – point 2 a (new)

Text proposed by the Commission

Amendment

 

2a.  Where the product contains more than one nutrient, the following minimum quantities shall be present:

 

  1 % by mass of total nitrogen (N), or

 

  1 % by mass of total phosphorus pentoxide (P2O5), or

 

  1 % by mass of total potassium oxide (K2O),

 

and where the sum of the nutrients is minimum 4 %.

Amendment    131

Proposal for a regulation

Annex I – part II – PFC 1(B) (II) – point 3

Text proposed by the Commission

Amendment

3.  Organic carbon (C) shall be present in the CE marked fertilising product by at least 3 % by mass.

3.  Organic carbon (C) shall be present in the CE marked fertilising product by at least 1 % by mass.

Amendment    132

Proposal for a regulation

Annex I – part II – PFC 1(C) – point 1

Text proposed by the Commission

Amendment

1. An inorganic fertiliser shall be a fertiliser other than an organic or organo-mineral fertiliser.

1. A mineral fertiliser shall be a fertiliser containing nutrients in a mineral form, or processed into a mineral form from animal or plant origin. Organic carbon (Corg) in the CE marked fertilising product shall not exceed 1 % by mass. That excludes carbon which comes from coatings complying with the requirements of CMC 9 and 10 and agronomic additives complying with the requirements of PFC 5 and CMC 8.

Amendment    133

Proposal for a regulation

Annex I – part II – PFC 1(C) - point 1 a (new)

Text proposed by the Commission

Amendment

 

1a. Phosphorus fertilisers have to fulfil at least one of the following minimum solubility levels to be plant-available, otherwise they cannot be declared as phosphorus fertiliser:

 

  Water solubility: minimum level 40% of total P, or

 

  Solubility in neutral ammonium citrate: minimum level 75 % of total P, or

 

  Solubility in formic acid (only for soft rock phosphate): minimum level 55 % of total P.

Amendment    134

Proposal for a regulation

Annex I – part II – PFC 1(C) - point 1 b (new)

Text proposed by the Commission

Amendment

 

1b. The total declarable nitrogen content is given by the sum of ammoniacal N, nitric N, ureic N, N from methylene-urea, N from isobutylidene diurea, N from crotonylidene diurea. The declarable phosphorus content is given by the phosphatic P form. New forms can be added after a scientific examination in accordance with Article 42(1).

Amendment    135

Proposal for a regulation

Annex I – part II – PFC 1 (C) (I) – point 1

Text proposed by the Commission

Amendment

1.  An inorganic macronutrient fertiliser shall be aimed at providing plants with one or more of the following macronutrients: nitrogen (N), phosphorus (P), potassium (K), magnesium (Mg), calcium (Ca), sulphur (S) or sodium (Na).

1.  An mineral macronutrient fertiliser shall be aimed at providing plants with one or more of the following macronutrients:

 

(a)  Primary: nitrogen (N), phosphorus (P), and potassium (K).

 

(b)  Secondary: magnesium (Mg), calcium (Ca), sulphur (S) or sodium (Na).

 

 

Amendment    136

Proposal for a regulation

Annex I – part II – PFC 1(C) I – point 2 – point a – point 2 – indent 3

Text proposed by the Commission

Amendment

-  As of [Publications office, please insert the date occurring twelve years after the date of application of this Regulation]: 20 mg/kg phosphorus pentoxide (P2O5),

-  As of ... [nine years after the date of application of this Regulation]: 20 mg/kg phosphorus pentoxide (P2O5),

Amendment    137

Proposal for a regulation

Annex I – part II – PFC 1(C)(I) – point 2 – point e

Text proposed by the Commission

Amendment

(e)  Lead (Pb) 150 mg/kg dry matter,

(e)  Lead (Pb) 20 mg/kg dry matter,

Amendment    138

Proposal for a regulation

Annex I – part II- PFC 1 (C) (I) – point 2 – point f

Text proposed by the Commission

Amendment

(f)  Arsenic (As) 60 mg/kg dry matter,

(f)  Arsenic (As) 20 mg/kg dry matter,

Amendment    139

Proposal for a regulation

Annex I – part II – PFC 1(C) (I)(a)(i) – point 1

Text proposed by the Commission

Amendment

1.  A straight solid inorganic macronutrient fertiliser shall have a declared content of not more than one nutrient.

1.  A straight solid mineral macronutrient fertiliser shall have a declared content of:

 

(a)  not more than one primary nutrient (nitrogen (N), phosphorus (P), and potassium (K)), or

Amendment    140

Proposal for a regulation

Annex I – part II – PFC 1(C) (I)(a)(i) – point 1 – point b (new)

Text proposed by the Commission

Amendment

 

(b)  not more than one secondary nutrient (Magnesium (Mg), Calcium (Ca), sulphur ( S) and sodium (Na).

Amendment    141

Proposal for a regulation

Annex I – part II – PFC 1(C) (I)(a)(i) – point 1 a (new)

Text proposed by the Commission

Amendment

 

1a.  A straight solid mineral macronutrient fertiliser with a declared content of not more than one primary nutrient, can contain one or more secondary nutrients.

Amendment    142

Proposal for a regulation

Annex I – part II – PFC 1(C) (I)(a)(i) – point 2 – introductory part

Text proposed by the Commission

Amendment

2.  The CE marked fertilising product shall contain one of the following declared nutrients in the minimum quantity stated:

2.  The CE marked fertilising product shall contain primary and/or secondary declared nutrients in the minimum quantity stated:

Amendment    143

Proposal for a regulation

Annex I – part 2 – PFC 1 (C) (I) (a) (i) – point 2 – indent 2

Text proposed by the Commission

Amendment

–  12% by mass of total phosphorus pentoxide (P2O5),

–  12 % by mass of phosphorus pentoxide (P2O5) soluble in neutral ammonium citrate and water,

Amendment    144

Proposal for a regulation

Annex I – part 2 – PFC 1 (C) (I) (a) (i) – point 2 – indent 7

Text proposed by the Commission

Amendment

–  1% by mass of total sodium oxide (Na2O).

–  3 % by mass of total sodium oxide (Na2O),

Amendment    145

Proposal for a regulation

Annex I – part II – PFC 1(C) (I)(a)(ii) – point 1

Text proposed by the Commission

Amendment

1.  A compound solid inorganic macronutrient fertiliser shall have a declared content of more than one nutrient.

1.  A compound solid mineral macronutrient fertiliser shall have a declared content of more than one primary and/or secondary nutrient.

Amendment    146

Proposal for a regulation

Annex I – part II – PFC 1(C) (I)(a)(ii) – point 2 – introductory part

Text proposed by the Commission

Amendment

2.  The CE marked fertilising product shall contain more than one of the following declared nutrients in the minimum quantities stated:

2.  The CE marked fertilising product shall contain more than one of the primary and/or secondary declared nutrients in the minimum quantities stated:

Amendment    147

Proposal for a regulation

Annex I – part II – PFC 1(C) (I)(a)(ii) – point 2 – indent 2

Text proposed by the Commission

Amendment

–  3% by mass of total phosphorus pentoxide (P2O5),

–  5 % by mass of total phosphorus pentoxide (P2O5) soluble in neutral ammonium citrate and water,

Amendment    148

Proposal for a regulation

Annex I – part II – PFC 1(C) (I)(a)(ii) – point 2 – indent 3

Text proposed by the Commission

Amendment

–  3% by mass of total potassium oxide (K2O),

–  5 % by mass of total potassium oxide (K2O),

Amendment    149

Proposal for a regulation

Annex I – part II – PFC 1(C) (I)(a)(ii) – point 2 – indent 4

Text proposed by the Commission

Amendment

–  1,5% by mass of total magnesium oxide (MgO),

–  2 % by mass of total magnesium oxide (MgO),

Amendment    150

Proposal for a regulation

Annex I – part II – PFC 1(C) (I)(a)(ii) – point 2 – indent 5

Text proposed by the Commission

Amendment

–  1,5% by mass of total calcium oxide (CaO),

–  2 % by mass of total calcium oxide (CaO),

Amendment    151

Proposal for a regulation

Annex I – part II – PFC 1(C) (I)(a)(ii) – point 2 – indent 6

Text proposed by the Commission

Amendment

–  1,5% by mass of total sulphur trioxide (SO3), or

–  5 % by mass of total sulphur trioxide (SO3),

Amendment    152

Proposal for a regulation

Annex I – part II – PFC 1(C) (I)(a)(ii) – point 2 – indent 7

Text proposed by the Commission

Amendment

–  1% by mass of total sodium oxide (Na2O).

–  3 % by mass of total sodium oxide (Na2O).

Amendment    153

Proposal for a regulation

Annex I – part II – PFC 1(C)(I)(a)(i-ii)(A) – point 5 – indent 1

Text proposed by the Commission

Amendment

-  following five thermal cycles as described under Heading 4.2 in Module A1 in Annex IV,

-  following five thermal cycles as described under Heading 4.2 in Module A1 in Annex IV, for testing before placing on the market,

Amendment    154

Proposal for a regulation

Annex I – part II – PFC 1(C) (I)(b)(i) – point 1

Text proposed by the Commission

Amendment

1.  A straight liquid inorganic macronutrient fertiliser shall have a declared content of not more than one nutrient.

1.  A straight liquid mineral macronutrient fertiliser shall have a declared content of:

 

(a)  not more than one primary nutrient

Amendment    155

Proposal for a regulation

Annex I – part II – PFC 1(C) (I)(b)(i) – point 1 – point b (new)

Text proposed by the Commission

Amendment

 

(b)  not more than one secondary nutrient.

Amendment    156

Proposal for a regulation

Annex I – part II – PFC 1(C) (I)(b)(i) – point 1 a (new)

Text proposed by the Commission

Amendment

 

1a.  straight liquid mineral macronutrient fertiliser with a declared content of not more than one primary nutrient, can contain one or more secondary nutrient.

Amendment    157

Proposal for a regulation

Annex I – part II – PFC 1(C) (I)(b)(i) – point 2 – introductory part

Text proposed by the Commission

Amendment

2.  The CE marked fertilising product shall contain one of the following declared nutrients in the minimum quantity stated:

2.  The CE marked fertilising product shall contain one of the primary and/or secondary declared nutrients in the minimum quantity stated:

Amendment    158

Proposal for a regulation

Annex I – part II – PFC 1(C) (I) (b) (i) – point 2 – indent 2

Text proposed by the Commission

Amendment

–  5% by mass of total phosphorus pentoxide (P2O5),

–  5 % by mass of total phosphorus pentoxide (P2O5) soluble in neutral ammonium citrate and water,

Amendment    159

Proposal for a regulation

Annex I – part II – PFC 1(C) (I) (b) (i) – point 2 – indent 6

Text proposed by the Commission

Amendment

–  5% by mass of total sulphur trioxide (SO3), or

–  5 % by mass of total sulphur trioxide (SO3),

Amendment    160

Proposal for a regulation

Annex I – part II – PFC 1(C) (I) (b) (i) – point 2 – indent 7

Text proposed by the Commission

Amendment

–  1% by mass of total sodium oxide (Na2O).

–  from 0,5 % to 5 % by mass of total sodium oxide (Na2O).

Amendment    161

Proposal for a regulation

Annex I – part II – PFC 1(C) (I)(b)(ii) – point 1

Text proposed by the Commission

Amendment

1.  A compound liquid inorganic macronutrient fertiliser shall have a declared content of more than one nutrient.

1.  A compound liquid mineral macronutrient fertiliser shall have a declared content of more than one primary and/or secondary nutrient.

Amendment    162

Proposal for a regulation

Annex I – part II – PFC 1(C) (I)(b)(ii) – point 2 – introductory part

Text proposed by the Commission

Amendment

2.  The CE marked fertilising product shall contain more than one of the following declared nutrients in the minimum quantities stated:

2.  The CE marked fertilising product shall contain more than one of the primary and/or secondary declared nutrients in the minimum quantities stated:

Amendment    163

Proposal for a regulation

Annex I – part II – PFC 1(C)(I)(b)(ii) – point 2 – indent 1

Text proposed by the Commission

Amendment

-  1,5% by mass of total nitrogen (N),

-  3 % by mass of total nitrogen (N), or

Amendment    164

Proposal for a regulation

Annex I – part II – PFC 1(C) (I) (b) (ii) – point 2 – indent 2

Text proposed by the Commission

Amendment

–  1,5% by mass of total phosphorus pentoxide (P2O5),

–  1,5 % by mass of total phosphorus pentoxide (P2O5) soluble in neutral ammonium citrate and water,

Amendment    165

Proposal for a regulation

Annex I – part II – PFC 1(C) (I) (b) (ii) – point 2 – indent 3

Text proposed by the Commission

Amendment

–  1,5% by mass of total potassium oxide (K2O),

–  3 % by mass of total potassium oxide (K2O), or

Amendment    166

Proposal for a regulation

Annex I – part II – PFC 1(C) (I) (b) (ii) – point 2 – indent 4

Text proposed by the Commission

Amendment

–  0,75% by mass of total magnesium oxide (MgO),

–  1,5 % by mass of total magnesium oxide (MgO), or

Amendment    167

Proposal for a regulation

Annex I – part II – PFC 1(C) (I) (b) (ii) – point 2 – indent 5

Text proposed by the Commission

Amendment

–  0,75% by mass of total calcium oxide (CaO),

–  1,5 % by mass of total calcium oxide (CaO), or

Amendment    168

Proposal for a regulation

Annex I – part II – PFC 1(C) (I) (b) (ii) – point 2 – indent 6

Text proposed by the Commission

Amendment

–  0,75% by mass of total sulphur trioxide (SO3), or

–  1,5 % by mass of total sulphur trioxide (SO3), or

Amendment    169

Proposal for a regulation

Annex I – part II – PFC 1 (C) (II) – point 1

Text proposed by the Commission

Amendment

1.  An inorganic micronutrient fertiliser shall be an inorganic fertiliser other than a macronutrient fertiliser aimed at providing one or more of the following nutrients: boron (B), cobalt (Co), copper (Cu), iron (Fe), manganese (Mn), molybdenum (Mo) or zinc (Zn).

1.  An inorganic micronutrient fertiliser shall be an inorganic fertiliser other than a macronutrient fertiliser aimed at providing one or more of the following nutrients: boron (B), cobalt (Co), copper (Cu), iron (Fe), manganese (Mn), molybdenum (Mo), selenium (Se), silicon (Si) or zinc (Zn).

Amendment    170

Proposal for a regulation

Annex I – part II – PFC 1(C) a (new)

Text proposed by the Commission

Amendment

 

PFC1(C) a: LOW CARBON FERTILISER

 

1.  A CE marked fertilising product shall be termed low carbon fertilizer if it contains more than 1 % organic carbon (Corg) and up to 15 % organic carbon (Corg).

 

2.  Carbon present in calcium cyanamide and in urea and its condensation and association products will not be included in organic carbon for the purpose of that definition.

 

3.  The specifications of solid/liquid, straight/compound, macronutrient/micronutrient fertilisers of PFC1(C) will apply for the purpose of this category.

 

4.  Products sold under PFC1(C)a shall comply with contaminant levels as specified in Annex I defined for organic or organo-mineral fertilisers in any case where PFC1(C) does not contain any limit values for those contaminants.

Amendment    171

Proposal for a regulation

Annex I – part II – PFC 2 – point 1

Text proposed by the Commission

Amendment

1.  A liming material shall be a CE marked fertilising product aimed at correcting soil acidity, and containing oxides, hydroxides, carbonates or silicates of the nutrients calcium (Ca) or magnesium (Mg).

1.  A liming material shall be a CE marked fertilising product aimed at correcting soil acidity, and containing oxides, hydroxides, carbonates or/and silicates of the nutrients calcium (Ca) or magnesium (Mg).

Amendment    172

Proposal for a regulation

Annex I – part II – PFC 2 – point 2 – indent 1

Text proposed by the Commission

Amendment

-  Cadmium (Cd) 3 mg/kg dry matter,

-  Cadmium (Cd) 1 mg/kg dry matter,

Amendment    173

Proposal for a regulation

Annex I – part II – PFC 2 – point 2 – indent 5

Text proposed by the Commission

Amendment

-  Lead (Pb) 200 mg/kg dry matter, and

-  Lead (Pb) 20 mg/kg dry matter, and

Amendment    174

Proposal for a regulation

Annex I – part II – PFC 2 – point 2 – indent 6

Text proposed by the Commission

Amendment

-  Arsenic (As) 120 mg/kg dry matter.

-  Arsenic (As) 20 mg/kg dry matter.

Amendment    175

Proposal for a regulation

Annex I – part II – PFC 3

Text proposed by the Commission

Amendment

A soil improver shall be a CE marked fertilising product aimed at being added to the soil for the purpose of maintaining, improving or protecting the physical or chemical properties, the structure or the biological activity of soil.

A soil improver shall be a material, including mulch, added to soil in situ primarily to maintain or improve its physical properties, and which may improve its chemical and/or biological properties or activity.

Amendment    176

Proposal for a regulation

Annex I – part II – PFC 3 – point 1a (new)

Text proposed by the Commission

Amendment

 

1a. The CE marked fertilising product shall contain 15 % or more material of biological origin.

Amendment    177

Proposal for a regulation

Annex I – part II – PFC 3(A) – point 1

Text proposed by the Commission

Amendment

1.  An organic soil improver shall consist exclusively of material of solely biological origin, excluding material which is fossilized or embedded in geological formations.

1.  An organic soil improver shall consist exclusively of material of solely biological origin, including peat, leonardite, lignite and humic substances obtained from them, but excluding other materials which are fossilized or embedded in geological formations.

Amendment    178

Proposal for a regulation

Annex I – part II – PFC 3(A) – point 2 – indent 1

Text proposed by the Commission

Amendment

-  Cadmium (Cd) 3 mg/kg dry matter,

-  Cadmium (Cd) 1,5 mg/kg dry matter,

Amendment    179

Proposal for a regulation

Annex I – part II – PFC 3(A) – point 2 – indent 2

Text proposed by the Commission

Amendment

-  Hexavalent chromium (Cr VI) 2 mg/kg dry matter,

-  Hexavalent chromium (Cr VI) 1 mg/kg dry matter,

Amendment    180

Proposal for a regulation

Annex I – part II – PFC 3(A) – point 2 – indent 5

Text proposed by the Commission

Amendment

-  Lead (Pb) 120 mg/kg dry matter.

-  Lead (Pb) 20 mg/kg dry matter.

Amendment    181

Proposal for a regulation

Annex I – part II – PFC 3(A) – point 3 – point a

 

Text proposed by the Commission

(a)  Salmonella spp. shall be absent in a 25 g sample of the CE marked fertilising product.

Amendment

(a)  Pathogens must not be present in the organic soil improver in a concentration of more than the respective limits outlined in the table below:

Micro-organism to be tested

Sampling plans

Limit

 

n

c

m

M

Salmonella spp

5

0

0

Absence in 25g or 25ml

Escherichia coli or Enterococcaceae

5

5

0

1000 in 1g or 1ml

where n = number of samples to be tested

c = number of samples where the number of bacteria expressed in CFU may be 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

Parasites Ascaris spp. and Toxocara spp. in all stages of their development must not be present in 100g or 100ml of the organic soil improver.

Amendment    182

Proposal for a regulation

Annex I – part II – PFC 3(B) – point 1

Text proposed by the Commission

Amendment

1.  An inorganic soil improver shall be a soil improver other than an organic soil improver.

1.  An inorganic soil improver shall be a soil improver other than an organic soil improver, and shall include mulch films. A biodegradable mulch film shall be a biodegradable polymer film complying in particular with the requirements of points 2a and 3 of CMC 10 in Annex II and intended to be placed on the soil in situ to protect its structure, suppress weed growth, reduce soil moisture loss, or prevent erosion.

Amendment    183

Proposal for a regulation

Annex I – part II – PFC 3(B) – point 2 – indent 5

Text proposed by the Commission

Amendment

-  Lead (Pb) 150 mg/kg dry matter.

-  Lead (Pb) 20 mg/kg dry matter.

Amendment    184

Proposal for a regulation

Annex I – part II – PFC 4 – point 1

Text proposed by the Commission

Amendment

1.  A growing medium shall be a material other than soil intended for use as a substrate for root development.

1.  A growing medium shall be a material other than soil in situ in which plants and mushrooms are grown.

Amendment    185

Proposal for a regulation

Annex I – part II – PFC 4 – point 2 – indent 1

Text proposed by the Commission

Amendment

-  Cadmium (Cd) 3 mg/kg dry matter,

-  Cadmium (Cd) 1,5 mg/kg dry matter,

Amendment    186

Proposal for a regulation

Annex I – part II – PFC 4 – point 2 – indent 5

Text proposed by the Commission

Amendment

-  Lead (Pb) 150 mg/kg dry matter.

-  Lead (Pb) 20 mg/kg dry matter.

Amendment    187

Proposal for a regulation

Annex I – part II – PFC 4 – point 3

 

Text proposed by the Commission

3.  Salmonella spp. shall be absent in a 25 g sample of the CE marked fertilising product.

Amendment

3.  Pathogens must not be present in the growing medium in a concentration of more than the respective limits outlined in the table below:

Micro-organism to be tested

Sampling plans

Limit

 

n

c

m

M

Salmonella spp

5

0

0

Absence in 25g or 25ml

Escherichia coli or Enterococcaceae

5

5

0

1000 in 1g or 1ml

where n = number of samples to be tested

c = number of samples where the number of bacteria expressed in CFU may be 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

Parasites Ascaris spp. and Toxocara spp. in all stages of their development must not be present in 100g or 100ml of the growing medium.

Amendment    188

Proposal for a regulation

Annex I – part II – PFC 5 – point 1

Text proposed by the Commission

Amendment

An agronomic additive shall be a CE marked fertilising product intended to be added to a product providing plants with nutrient, with the intention to improve that product's nutrient release patterns.

An agronomic additive shall be a CE marked fertilising product, intended to be added to a product, which has a proven effect on the transformation or plant-availability of different forms of mineral or mineralized nutrients, or both, or which is to be added to the soil with the intention to improve that nutrient uptake by plants or to reduce nutrient losses.

Amendment    189

Proposal for a regulation

Annex I – part II – PFC 5(A) – point 2 – introductory part

Text proposed by the Commission

Amendment

Each substance shall have been registered pursuant to Regulation (EC) No 1907/2006,36 in a dossier containing

Each substance shall have been registered pursuant to Regulation (EC) No 1907/2006,36 unless explicitly covered by one of the registration obligation exemptions provided for in Article 6 of that Regulation or in Annex IV or Annex V thereto.

__________________

__________________

36 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 Article 2(7)(d)(i) of Regulation (EC) No 1907/2006, as a substance registered in a dossier containing the information here indicated, and if information is available to the fertilising product manufacturer within the meaning of Article 2(7)(d)(ii) of Regulation (EC) No 1907/2006.

36 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 Article 2(7)(d)(i) of Regulation (EC) No 1907/2006, as a substance registered in a dossier containing the information here indicated, and if information is available to the fertilising product manufacturer within the meaning of Article 2(7)(d)(ii) of Regulation (EC) No 1907/2006.

Amendment    190

Proposal for a regulation

Annex I – part II – PFC 5(A) – point 2 – point a

Text proposed by the Commission

Amendment

(a)  the information provided for by Annex VI, VII and VIII of Regulation (EC) No 1907/2006, and

deleted

Amendment    191

Proposal for a regulation

Annex I – part II – PFC 5(A) – point 2 – point b

Text proposed by the Commission

Amendment

(b)  a chemical safety report pursuant to Article 14 of Regulation (EC) No 1907/2006 covering the use as fertilising product,

deleted

Amendment    192

Proposal for a regulation

Annex I – part II – PFC 5(A) – point 2 – subparagraph 2

Text proposed by the Commission

Amendment

unless explicitly covered by one of the registration obligation exemptions provided for by Annex IV to that Regulation or by points 6, 7, 8, or 9 of Annex V to that Regulation.

deleted

Amendment    193

Proposal for a regulation

Annex I – part II – PFC 5(A)(I a) (new)

Text proposed by the Commission

Amendment

 

PFC 5(A)(Ia): Denitrification inhibitor

 

1.  A denitrification inhibitor shall be an inhibitor that reduces 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)(I). It shall contribute to increase the availability of nitrate to the plant and to reduce N2O emissions.

 

2.  The effectiveness of this method can be assessed by measuring nitrous oxide emissions in gas samples collected in a suitable measuring device and measuring the amount of N2O of that sample in a gas chromatograph. The assessment shall also record the water content of the soil.

Amendment    194

Proposal for a regulation

Annex I – part II – PFC 5(B) – point 2 – introductory part

Text proposed by the Commission

Amendment

2. The substance shall have been registered pursuant to Regulation (EC) No 1907/2006,37 in a dossier containing

2. The substance shall have been registered pursuant to Regulation (EC) No 1907/2006,37 unless explicitly covered by one of the registration obligation exemptions provided for in Article 6 of that Regulation or in Annex IV or Annex V thereto.

__________________

__________________

37 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 Article 2(7)(d)(i) of Regulation (EC) No 1907/2006, as a substance registered in a dossier containing the information here indicated, and if information is available to the fertilising product manufacturer within the meaning of Article 2(7)(d)(ii) of Regulation (EC) No 1907/2006.

37 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 Article 2(7)(d)(i) of Regulation (EC) No 1907/2006, as a substance registered in a dossier containing the information here indicated, and if information is available to the fertilising product manufacturer within the meaning of Article 2(7)(d)(ii) of Regulation (EC) No 1907/2006.

Amendment    195

Proposal for a regulation

Annex I – part II – PFC 5(B) – point 2 – point a

Text proposed by the Commission

Amendment

(a)  the information provided for by Annex VI, VII and VIII of Regulation (EC) No 1907/2006, and

deleted

Amendment    196

Proposal for a regulation

Annex I – part II – PFC 5(B) – point 2 – point b

Text proposed by the Commission

Amendment

(b)  a chemical safety report pursuant to Article 14 of Regulation (EC) No 1907/2006 covering the use as fertilising product,

deleted

Amendment    197

Proposal for a regulation

Annex I – part II – PFC 5(B) – point 2 – subparagraph 2

Text proposed by the Commission

Amendment

unless explicitly covered by one of the registration obligation exemptions provided for by Annex IV to that Regulation or by points 6, 7, 8, or 9 of Annex V to that Regulation.

deleted

Amendment    198

Proposal for a regulation

Annex I – part II – PFC 5(C) – point 2 – introductory part

Text proposed by the Commission

Amendment

2. The substance shall have been registered pursuant to Regulation (EC) No 1907/2006,38 in a dossier containing

2. The substance shall have been registered pursuant to Regulation (EC) No 1907/2006,38 unless explicitly covered by one of the registration obligation exemptions provided for in Article 6 of that Regulation or in Annex IV or Annex V thereto.

__________________

__________________

38 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 Article 2(7)(d)(i) of Regulation (EC) No 1907/2006, as a substance registered in a dossier containing the information here indicated, and if information is available to the fertilising product manufacturer within the meaning of Article 2(7)(d)(ii) of Regulation (EC) No 1907/2006.

38 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 Article 2(7)(d)(i) of Regulation (EC) No 1907/2006, as a substance registered in a dossier containing the information here indicated, and if information is available to the fertilising product manufacturer within the meaning of Article 2(7)(d)(ii) of Regulation (EC) No 1907/2006.

Amendment    199

Proposal for a regulation

Annex I – part II – PFC 5(C) – point 2 – point a

Text proposed by the Commission

Amendment

(a)  the information provided for by Annex VI, VII and VIII of Regulation (EC) No 1907/2006, and

deleted

Amendment    200

Proposal for a regulation

Annex I – part II – PFC 5(C) – point 2 – point b

Text proposed by the Commission

Amendment

(b)  a chemical safety report pursuant to Article 14 of Regulation (EC) No 1907/2006 covering the use as fertilising product,

deleted

Amendment    201

Proposal for a regulation

Annex I – part II – PFC 5(C) – point 2 – subparagraph 2

Text proposed by the Commission

Amendment

unless explicitly covered by one of the registration obligation exemptions provided for by Annex IV to that Regulation or by points 6, 7, 8, or 9 of Annex V to that Regulation.

deleted

Amendment    202

Proposal for a regulation

Annex I – part II – PFC 6 – point 1 – introductory part

Text proposed by the Commission

Amendment

1.  A plant biostimulant shall be a CE marked fertilising 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:

1.  A plant biostimulant shall be a CE marked fertilising 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 and the plant rhizophere or phyllosphere:

Amendment    203

Proposal for a regulation

Annex I – part II – PFC 6 – point 1 – point c a (new)

Text proposed by the Commission

Amendment

 

(ca)  availability of confined nutrients in the soil and rhizosphere.

Amendment    204

Proposal for a regulation

Annex I – part II – PFC 6 – point 1 – point c b (new)

Text proposed by the Commission

Amendment

 

(cb)  humification

Amendment    205

Proposal for a regulation

Annex I – part II – PFC 6 – point 1 – point c c (new)

Text proposed by the Commission

Amendment

 

(cc)  degradation of organic compounds in the soil, or

Amendment    206

Proposal for a regulation

Annex I – part II – PFC 6 – point 2 – indent 1

Text proposed by the Commission

Amendment

-  Cadmium (Cd) 3 mg/kg dry matter,

-  Cadmium (Cd) 1,5 mg/kg dry matter,

Amendment    207

Proposal for a regulation

Annex I – part II – PFC 6 – point 3

Text proposed by the Commission

Amendment

3.  The plant biostimulant shall have the effects that are claimed on the label for the crops specified thereon.

3.  The plant biostimulant shall have the effects that are claimed on the label for the plant specified thereon. Where the plant biostimulant contains one or more ingredients that have been approved under Regulation (EC) No 1107/2009, the information provided during conformity assessment will provide compelling empirical evidence of the biostimulant effect, taking into account relevant parameters, e.g. relative concentrations of components, application rate, timing, plant growth stage, target crop, etc.

Amendment    208

Proposal for a regulation

Annex I – part II – PFC 6(A) – point 1

Text proposed by the Commission

Amendment

1.  A microbial plant biostimulant shall consist solely of a micro-organism or a consortium of micro-organisms referred to in Component Material Category 7 of Annex II.

1.  A microbial plant biostimulant shall consist:

 

(a)  of a micro-organism or a consortium of microorganisms referred to in Component Material Category 7 of Annex II;

 

(b)  of microorganisms or a consortium of microorganisms different from those provided under point (a). They can be used as component material categories as long as they comply with the requirements set out in the Component Material Category 7 of Annex II.

Amendment    209

Proposal for a regulation

Annex I – part II – PFC 6 (A) – point 3

 

Text proposed by the Commission

3.  Salmonella spp. shall be absent in a 25 g or 25 ml sample of the CE marked fertilising product.

 

Amendment

3.  Pathogens must not be present in the microbial plant biostimulant in a concentration of more than the respective limits outlined in the table below:

Micro-organisms/their toxins, metabolites

Sampling plans

Limit

 

n

c

 

Salmonella spp

5

0

Absence in 25g or 25 ml

Escherichia coli

5

0

Absence in 1g or 1ml

Listeria monocytogenes

5

0

Absence in 25g or 25 ml

Vibrio spp

5

0

Absence in 25g or 25 ml

Shigella spp

5

0

Absence in 25g or 25 ml

Staphylococcus aureus

5

0

Absence in 25g or 25 ml

Enterococcaceae

5

2

10 CFU/g

Anaerobic plate count unless the microbial biostimulant is an aerobic bacterium

5

2

105 CFU/g or ml

Yeast and mould count unless the microbial biostimulant is a fungus

5

2

1000 CFU/g or ml

where  n= number of units comprising the sample; c= number of sample units giving values over the defined limit.

Amendment    210

Proposal for a regulation

Annex I – part II – PFC 6 (A) – point 4

Text proposed by the Commission

Amendment

4.  Escherichia coli shall be absent in a 1 g or 1 ml sample of the CE marked fertilising product.

deleted

Amendment    211

Proposal for a regulation

Annex I – part II – PFC 6 (A) – point 5

Text proposed by the Commission

Amendment

5.  Enterococcaceae must not be present in the CE marked fertilising product by more than 10 CFU/g fresh mass.

deleted

Amendment    212

Proposal for a regulation

Annex I – part II – PFC 6 (A) – point 6

Text proposed by the Commission

Amendment

6.  Listeria monocytogenes shall be absent in a 25 g or 25 ml sample of the CE marked fertilising product.

deleted

Amendment    213

Proposal for a regulation

Annex I – part II – PFC 6 (A) – point 7

Text proposed by the Commission

Amendment

7.  Vibrio spp shall be absent in a 25 g or 25 ml sample of the CE marked fertilising product.

deleted

Amendment    214

Proposal for a regulation

Annex I – part II – PFC 6 (A) – point 8

Text proposed by the Commission

Amendment

8.  Shigella spp shall be absent in a 25 g or 25 ml sample of the CE marked fertilising product.

deleted

Amendment    215

Proposal for a regulation

Annex I – part II – PFC 6 (A) – point 9

Text proposed by the Commission

Amendment

9.  Staphylococcus aureus shall be absent in a 1 g or 1 ml sample of the CE marked fertilising product.

deleted

Amendment    216

Proposal for a regulation

Annex I – part II – PFC 6 (A) – point 10

Text proposed by the Commission

Amendment

10.  Aerobic plate count shall not exceed 105 CFU/g or ml sample of the CE marked fertilising product, unless the microbial biostimulant is an aerobic bacterium.

deleted

Amendment    217

Proposal for a regulation

Annex I – part II – PFC 6(A) – point 12 – subparagraph 2

Text proposed by the Commission

Amendment

the plant biostimulant shall have a pH superior or equal to 4.

deleted

Amendment    218

Proposal for a regulation

Annex I – part II – PFC 6(A) – point 13

Text proposed by the Commission

Amendment

13.  The shelf-life of the microbial plant biostimulant shall be at least 6 months under the storage conditions specified on the label.

deleted

Amendment    219

Proposal for a regulation

Annex I – part II – PFC 7 – point 3 – introductory part

Text proposed by the Commission

Amendment

3.  The blending shall not change the nature of each component fertilising product

3.  The blending shall not change the function of each component fertilising product

Amendment    220

Proposal for a regulation

Annex II – part I – CMC 11 a (new)

Text proposed by the Commission

Amendment

 

CMC 11a: Other industry by-products

Amendment    221

Proposal for a regulation

Annex II – part II – CMC 1 – point 1 – introductory part

Text proposed by the Commission

Amendment

1.  A CE marked fertilising product may contain substances and mixtures, other than39

1.  A CE marked fertilising product may contain substances and mixtures, including technical additives, other than39

__________________

__________________

39 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 11 on animal by-products, CMCs 9 and 10 on polymers, and CMC 8 on agronomic additives.

39 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 11 on animal by-products, CMCs 9 and 10 on polymers, and CMC 8 on agronomic additives.

Amendment    222

Proposal for a regulation

Annex II – part II – CMC 1 – point 1 – point b

Text proposed by the Commission

Amendment

(b)  by-products within the meaning of Directive 2008/98/EC,

(b)  by-products within the meaning of Directive 2008/98/EC, except by-products registered pursuant to Regulation (EC) No 1907/2006 other than those covered by one of the registration obligation exemptions provided for by point 5 of Annex V to that Regulation,

Amendment    223

Proposal for a regulation

Annex II – part II – CMC 1 - point 1 – point e

Text proposed by the Commission

Amendment

(e)  polymers, or

(e)  polymers with the exception of those used in growing media not in contact with the soil, or

Amendment    224

Proposal for a regulation

Annex II – part II – CMC 1 – point 2 – subparagraph 1 – introductory part

Text proposed by the Commission

Amendment

All the substances incorporated into the CE marked fertilising product, in their own or in a mixture, shall have been registered pursuant to Regulation (EC) No 1907/2006, in a dossier containing

Unless explicitly covered by one of the registration obligation exemptions provided for in Article 6 of Regulation (EC) No 1907/2006 or by Annexes IV or V to that Regulation, all the substances incorporated into the CE marked fertilising product, in their own or in a mixture, shall have been registered pursuant to Regulation (EC) No 1907/2006, in a dossier containing

Amendment    225

Proposal for a regulation

Annex II – part II – CMC 1 – point 2 – subparagraph 1 – point a

Text proposed by the Commission

Amendment

(a)  the information provided for by Annex VI, VII and VIII of Regulation (EC) No 1907/2006, and

deleted

Amendment    226

Proposal for a regulation

Annex II – part II – CMC 1 – point 2 – subparagraph 1 – point b

Text proposed by the Commission

Amendment

(b)  a chemical safety report pursuant to Article 14 of Regulation (EC) No 1907/2006 covering the use as fertilising product,

deleted

Amendment    227

Proposal for a regulation

Annex II – part II – CMC 1 – point 2 – subparagraph 2

Text proposed by the Commission

Amendment

unless explicitly covered by one of the registration obligation exemptions provided for by Annex IV to that Regulation or by points 6, 7, 8, or 9 of Annex V to that Regulation.

deleted

Amendment    228

Proposal for a regulation

Annex II – part II – CMC 2 – point 1

Text proposed by the Commission

Amendment

1.  A CE marked fertilising product may contain plants, plant parts or plant extracts having undergone no other processing than cutting, grinding, centrifugation, pressing, drying, freezedrying or extraction with water.

1.  A CE marked fertilising product may contain plants, plant parts or plant extracts having undergone no other processing than cutting, grinding, centrifugation, sieving, milling, pressing, drying, freeze-drying, buffering, extrusion, radiation, frost-treatment, sanitation by using heat, extraction with water or any other preparation/processing that does not render the final substance subject to registration under Regulation (EC) No. 1907/2006.

Amendment    229

Proposal for a regulation

Annex II – part II – CMC 2 – point 2

Text proposed by the Commission

Amendment

2.  For the purpose of paragraph 1, plants are understood to include algae and exclude blue-green algae.

2.  For the purpose of paragraph 1, plants are understood to include algae except for blue-green algae that produce cyanotoxins classified as hazardous in accordance with Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures.

Amendment    230

Proposal for a regulation

Annex II – part II – CMC 3 – point 1

Text proposed by the Commission

Amendment

1.  A CE marked fertilising product may contain compost obtained through aerobic composting of exclusively one or more of the following input materials:

1.  A CE marked plant nutrition product may contain compost, a liquid or non-liquid microbial or non-microbial extract made out of compost, obtained through aerobic composting, and the possible ensuing multiplication of the naturally occurring microbials of exclusively one or more of the following input materials:

Amendment    231

Proposal for a regulation

Annex II – part II – CMC 3 – point 1 – point b

Text proposed by the Commission

Amendment

(b)  Animal by-products of categories 2 and 3 according to Regulation (EC) No 1069/2009;

(b)  Products derived from animal by-products referred to in Article 32 of Regulation (EC) No 1069/2009 for which the end point in the manufacturing chain has been reached in accordance with Article 5of that Regulation;

Amendment    232

Proposal for a regulation

Annex II – part II – CMC 3 – point 1 – point c – introductory part

 

Text proposed by the Commission

Amendment

(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

(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, except

Amendment    233

Proposal for a regulation

Annex II – part II – CMC 3 – point 1 – point c – indent 2

Text proposed by the Commission

Amendment

–  sewage sludge, industrial sludge or dredging sludge, and

–  sewage sludge, industrial sludge (apart for non-consumable food residues, fodder and plantations linked to agrofuels) or dredging sludge, and

Amendment    234

Proposal for a regulation

Annex II – part II – CMC 3 – point 1 – point d – point 1 – indent 1

Text proposed by the Commission

Amendment

–  the additive is registered pursuant to Regulation (EC) No 1907/200640, in a dossier containing

–  the additive is registered pursuant to Regulation (EC) No 1907/200640, unless explicitly covered by one of the registration obligation exemptions provided for in Article 6 of that Regulation or in Annex IV or Annex V thereto.

__________________

__________________

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 Article 2(7)(d)(i) of Regulation (EC) No 1907/2006, as a substance registered in a dossier containing the information here indicated, and if information is available to the fertilising product manufacturer within the meaning of Article 2(7)(d)(ii) 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 Article 2(7)(d)(i) of Regulation (EC) No 1907/2006, as a substance registered in a dossier containing the information here indicated, and if information is available to the fertilising product manufacturer within the meaning of Article 2(7)(d)(ii) of Regulation (EC) No 1907/2006.

Amendment    235

Proposal for a regulation

Annex II – part II – CMC 3 – point 1 – point d – point 1 – indent 2

Text proposed by the Commission

Amendment

  the information provided for by Annex VI, VII and VIII of Regulation (EC) No 1907/2006, and

deleted

Amendment    236

Proposal for a regulation

Annex II – part II – CMC 3 – point 1 – point d – point 1 – indent 3

Text proposed by the Commission

Amendment

  a chemical safety report pursuant to Article 14 of Regulation (EC) No 1907/2006 covering the use as fertilising product,

deleted

Amendment    237

Proposal for a regulation

Annex II – part II – CMC 3 – point 1 – point d – point 2

Text proposed by the Commission

Amendment

unless explicitly covered by one of the registration obligation exemptions provided for by Annex IV to that Regulation or by points 6, 7, 8, or 9 of Annex V to that Regulation, and

deleted

– the total concentration of all additives does not exceed 5 % of the total input material weight; or

 

Amendment    238

Proposal for a regulation

Annex II – part II – CMC 3 – point 1 – point e a (new)

Text proposed by the Commission

Amendment

 

(ea)  Unprocessed and mechanically processed residues from food production industries, except from industries using animal by-products according to Regulation (EC) No 1069/2009.

Amendment    239

Proposal for a regulation

Annex II – part II – CMC 3 – point 1 – point e b (new)

Text proposed by the Commission

Amendment

 

(eb)  Materials that conform to CMC 2, CMC 3, CMC 4, CMC 5, CMC 6 and CMC 11.

Amendment    240

Proposal for a regulation

Annex II – part II – CMC 3 – point 2 – indent 1

Text proposed by the Commission

Amendment

–  which only processes input materials referred to in paragraph 1 above, and

–  in which production lines for the processing of input materials referred to in paragraph 1 above are clearly separated from production lines for the processing of input materials other than referred to in paragraph 1, and

Amendment    241

Proposal for a regulation

Annex II – part II – CMC 3 – point 6 – point a – indent 2

Text proposed by the Commission

Amendment

-  Criterion: maximum 25 mmol O2/kg organic matter/h; or

-  Criterion: maximum 50 mmol O2/kg organic matter/h; or

Amendment    242

Proposal for a regulation

Annex II – part II – CMC 4 – title

Text proposed by the Commission

Amendment

CMC 4: Energy crop digestate

CMC 4: Energy crop digestate and plant-based bio-waste

Amendment    243

Proposal for a regulation

Annex II – part II – CMC 4 – point 1 – point b – point 1 – introductory part

Text proposed by the Commission

Amendment

–  the additive is registered pursuant to Regulation (EC) No 1907/200643, in a dossier containing

–  the additive is registered pursuant to Regulation (EC) No 1907/200643, unless explicitly covered by one of the registration obligation exemptions provided for in Article 6 of that Regulation or in Annex IV or Annex V thereto.

__________________

__________________

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 Article 2(7)(d)(i) of Regulation (EC) No 1907/2006, as a substance registered in a dossier containing the information here indicated, and if information is available to the fertilising product manufacturer within the meaning of Article 2(7)(d)(ii) of Regulation (EC) No 1907/2006.

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 Article 2(7)(d)(i) of Regulation (EC) No 1907/2006, as a substance registered in a dossier containing the information here indicated, and if information is available to the fertilising product manufacturer within the meaning of Article 2(7)(d)(ii) of Regulation (EC) No 1907/2006.

Amendment    244

Proposal for a regulation

Annex II – part II – CMC 4 – point 1 – point b – point 1 – indent 1

Text proposed by the Commission

Amendment

  the information provided for by Annex VI, VII and VIII of Regulation (EC) No 1907/2006, and

deleted

Amendment    245

Proposal for a regulation

Annex II – part II – CMC 4 – point 1 – point b – point 1 – indent 2

Text proposed by the Commission

Amendment

  a chemical safety report pursuant to Article 14 of Regulation (EC) No 1907/2006 covering the use as fertilising product,

deleted

Amendment    246

Proposal for a regulation

Annex II – part II – CMC 4 – point 1 – point b – point 2

Text proposed by the Commission

Amendment

unless explicitly covered by one of the registration obligation exemptions provided for by Annex IV to that Regulation or by points 6, 7, 8, or 9 of Annex V to that Regulation, and

deleted

  the total concentration of all additives does not exceed 5 % of the total input material weight; or

 

Amendment    247

Proposal for a regulation

Annex II – part II – CMC 4 – point 1 – point c

Text proposed by the Commission

Amendment

(c)  Any material referred to in points (a)-(b) that has previously been digested.

(c)  Any material referred to in points (a)-(b) that has previously been digested without any traces of aflatoxins.

Amendment    248

Proposal for a regulation

Annex II – part II – CMC 4 – point 2 – indent 1

Text proposed by the Commission

Amendment

–  which only processes input materials referred to in paragraph 1 above, and

–  in which production lines for the processing of input materials referred to in point 1 above are clearly separated from production lines for the processing of input materials other than referred to in point 1, and

Amendment    249

Proposal for a regulation

Annex II – part II – CMC 4 – point 3 – point b

Text proposed by the Commission

Amendment

(b)  Thermophilic anaerobic digestion at 55°C with a treatment process including a pasteurisation step (70°C – 1h);

(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 142/20111a;

 

_________________

 

1a 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 054 26.2.2011, p. 1).

Amendment    250

Proposal for a regulation

Annex II – part II – CMC 4 – point 3 – point d

Text proposed by the Commission

Amendment

(d)  Mesophilic anaerobic digestion at 37-40°C with a treatment process including a pasteurisation step (70°C – 1h); or

(d)  Mesophilic anaerobic digestion at 37-40°C with a treatment process including pasteurisation as desribed in point 1 of section 1 of Chapter I of Annex V to Regulation (EU) No 142/2011; or

Amendment    251

Proposal for a regulation

Annex II – part II – CMC 5 – point 1 – point c – indent 2

Text proposed by the Commission

Amendment

–  sewage sludge, industrial sludge or dredging sludge,

–  sewage sludge, industrial sludge other than those specified in point (ea) or dredging sludge, and

Amendment    252

Proposal for a regulation

Annex II – part II – CMC 5 – point 1 – point d – point 1 – introductory part

Text proposed by the Commission

Amendment

–  the additive is registered pursuant to Regulation (EC) No 1907/200644, in a dossier containing

–  the additive is registered pursuant to Regulation (EC) No 1907/200644, unless explicitly covered by one of the registration obligation exemptions provided for in Article 6 of that Regulation or in Annex IV or Annex V thereto.

__________________

__________________

44 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 Article 2(7)(d)(i) of Regulation (EC) No 1907/2006, as a substance registered in a dossier containing the information here indicated, and if information is available to the fertilising product manufacturer within the meaning of Article 2(7)(d)(ii) of Regulation (EC) No 1907/2006.

44 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 Article 2(7)(d)(i) of Regulation (EC) No 1907/2006, as a substance registered in a dossier containing the information here indicated, and if information is available to the fertilising product manufacturer within the meaning of Article 2(7)(d)(ii) of Regulation (EC) No 1907/2006.

Amendment    253

Proposal for a regulation

Annex II – part II – CMC 5 – point 1 – point d – point 1 – indent 1

Text proposed by the Commission

Amendment

  the information provided for by Annex VI, VII and VIII of Regulation (EC) No 1907/2006, and

deleted

Amendment    254

Proposal for a regulation

Annex II – part II – CMC 5 – point 1 – point d – point 1 – indent 2

Text proposed by the Commission

Amendment

  a chemical safety report pursuant to Article 14 of Regulation (EC) No 1907/2006 covering the use as fertilising product,

deleted

unless it is covered by the registration obligation exemption provided for by Annex IV to that Regulation or by points 6, 7, 8, or 9 of Annex V to that Regulation, and

 

  the total concentration of all additives does not exceed 5 % of the total input material weight; or

 

Amendment    255

Proposal for a regulation

Annex II – part II – CMC 5 – point 1 – point e – introductory part

Text proposed by the Commission

Amendment

(e)  Any material listed in points (a)-(d) that

(e)  Any material without aflatoxins listed in points (a)-(d) that

Amendment    256

Proposal for a regulation

Annex II – part II – CMC 5 – point 1 – point e a (new)

Text proposed by the Commission

Amendment

 

(ea)  Unprocessed and mechanically processed residues from food production industries, except from industries using animal by-products in accordance with Regulation (EC) No 1069/2009.

Amendment    257

Proposal for a regulation

Annex II – part II – CMC 5 – point 1 – point e b (new)

Text proposed by the Commission

Amendment

 

(eb)  Materials that conform to CMC 2, CMC 3, CMC 4, CMC5 , CMC 6 and CMC 11.

Amendment    258

Proposal for a regulation

Annex II – part II – CMC 5 – point 2 – indent 1

Text proposed by the Commission

Amendment

–  which only processes input materials referred to in paragraph 1 above, and

–  in which production lines for the processing of input materials referred to in point 1 above are clearly separated from production lines for the processing of input materials other than referred to in point 1, and

Amendment    259

Proposal for a regulation

Annex II – part II – CMC 5 – point 3 – point a

Text proposed by the Commission

Amendment

(a)  Thermophilic anaerobic digestion at 55°C during at least 24h and a hydraulic retention time of at least 20 days;

(a)  Thermophilic anaerobic digestion at 55°C during at least 24h and a hydraulic retention time of at least 20 days, followed by an analysis to verify that the digestion process successfully destroyed the pathogens;

Amendment    260

Proposal for a regulation

Annex II – part II – CMC 5 – point 3 – point b

Text proposed by the Commission

Amendment

(b)  Thermophilic anaerobic digestion at 55°C with a treatment process including a pasteurisation step (70°C – 1h);

(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;

Amendment    261

Proposal for a regulation

Annex II – part II – CMC 5 – point 3 – point d

Text proposed by the Commission

Amendment

(d)  Mesophilic anaerobic digestion at 37-40°C with a treatment process including a pasteurisation step (70°C – 1h); or

(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

Amendment    262

Proposal for a regulation

Annex II – part II – CMC 6 – point 1 – point c a (new)

Text proposed by the Commission

Amendment

 

(ca)  olive pomace, i.e. a viscous by-product of olive milling obtained by treating the wet pomace with organic solvents in two (2-phase pomace) or three phases (3-phase pomace).

Amendment    263

Proposal for a regulation

Annex II – part II – CMC 6 – point 1 – point c b (new)

Text proposed by the Commission

Amendment

 

(cb)  by-products of the feed industry which are listed in the catalogue of individual feed materials in Regulation (EU) No 68/2013,

Amendment    264

Proposal for a regulation

Annex II – part II – CMC 6 – point 1 – point c c (new)

Text proposed by the Commission

Amendment

 

(cc)  any other material or substance that has been approved for incorporation in food or animal feed.

Amendment    265

Proposal for a regulation

Annex II – part II – CMC 6 – point 2 – introductory part

Text proposed by the Commission

Amendment

The substance shall have been registered pursuant to Regulation (EC) No 1907/200647, in a dossier containing

The substance shall have been registered pursuant to Regulation (EC) No 1907/200647, unless explicitly covered by one of the registration obligation exemptions provided for in Article 6 of that Regulation or in Annex IV or Annex V thereto.

__________________

__________________

47 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 Article 2(7)(d)(i) of Regulation (EC) No 1907/2006, as a substance registered in a dossier containing the information here indicated, and if information is available to the fertilising product manufacturer within the meaning of Article 2(7)(d)(ii) of Regulation (EC) No 1907/2006.

47 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 Article 2(7)(d)(i) of Regulation (EC) No 1907/2006, as a substance registered in a dossier containing the information here indicated, and if information is available to the fertilising product manufacturer within the meaning of Article 2(7)(d)(ii) of Regulation (EC) No 1907/2006.

Amendment    266

Proposal for a regulation

Annex II – part II – CMC 6 – point 2 – point a

Text proposed by the Commission

Amendment

(a)  the information provided for by Annex VI, VII and VIII of Regulation (EC) No 1907/2006, and

deleted

Amendment    267

Proposal for a regulation

Annex II – part II – CMC 6 – point 2 – point b

Text proposed by the Commission

Amendment

(b)  a chemical safety report pursuant to Article 14 of Regulation (EC) No 1907/2006 covering the use as fertilising product,

deleted

Amendment    268

Proposal for a regulation

Annex II – part II – CMC 6 – point 2 – subparagraph 2

Text proposed by the Commission

Amendment

unless explicitly covered by one of the registration obligation exemptions provided for by Annex IV to that Regulation or by points 6, 7, 8, or 9 of Annex V to that Regulation.

deleted

Amendment    269

Proposal for a regulation

Annex II – part II – CMC 6 – point 2 – subparagraph 2 a (new)

Text proposed by the Commission

Amendment

 

All substances shall contain aflatoxins under the detection limit.

Amendment    270

Proposal for a regulation

Annex II – part II – CMC 7 – point 1 – indent 1

Text proposed by the Commission

Amendment

  have undergone no other processing than drying or freeze-drying and

deleted

Amendment    271

Proposal for a regulation

Annex II – part II – CMC 8 – point 1

Text proposed by the Commission

Amendment

1.  A CE marked fertilising product may contain a substance or a mixture intended to improve the fertilising product's nutrient release patterns, only if that substance's or mixture's compliance with the requirements of this Regulation for a product in PFC 5 of Annex I has been demonstrated in accordance with the conformity assessment procedure applicable to such an agronomic additive.

1.  A CE marked fertilising product may contain a substance or a mixture (including technological additives, for example: anti-caking agents, defoaming agents, anti-dust agents, dyes and rheological agents) intended to improve the fertilising product's nutrient release patterns, only if that substance's or mixture's compliance with the requirements of this Regulation for a product in PFC 5 of Annex I has been demonstrated in accordance with the conformity assessment procedure applicable to such an agronomic additive.

Amendment    272

Proposal for a regulation

Annex II – part II – CMC 8 – point 3 a (new)

Text proposed by the Commission

Amendment

 

3a.  A CE marked fertilising product may contain a compliant denitrification inhibitor as referred to in PFC 5(A)(Ia) of Annex I, only if it contains nitrogen in some form.

Amendment    273

Proposal for a regulation

Annex II – part II – CMC 8 – point 4

Text proposed by the Commission

Amendment

4.  A CE marked fertilising product may contain a compliant urease inhibitor, as referred to in PFC 5(A)(II) of Annex I, only if at least 50% of the total nitrogen (N) content of the fertilising product consists of the nitrogen (N) form urea (CH4N2O).

4.  A CE marked fertilising product may contain a compliant urease inhibitor, as referred to in PFC 5(A)(II) of Annex I, only if at least 50% of the total nitrogen (N) content of the fertilising product consists of the nitrogen (N) form ammonium (NH4+) or ammonium (NH4+) and urea (CH4N2O).

Amendment    274

Proposal for a regulation

Annex II – part II – CMC 9 – point 3

Text proposed by the Commission

Amendment

3.  The polymers shall not contain formaldehyde.

3.  The polymers shall contain a maximum of 600 ppm free formaldehyde.

Amendment    275

Proposal for a regulation

Annex II – part II – CMC 10 – point 1

Text proposed by the Commission

Amendment

1.  A CE marked fertilising product may contain other polymers than nutrient polymers only in cases where the purpose of the polymer is that of

1.  A CE marked fertilising product may contain other polymers than nutrient polymers only in cases where the purpose of the polymer is that of

(a)   controlling 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'), or

(a)   controlling 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'), or

(b)   increasing the water retention capacity of the CE marked fertilising product.

(b)   increasing the water retention capacity of the CE marked fertilising product, or

 

(ba)  improving the soil as a biodegradable mulch film, which complies in particular with the requirements of points 2a and 3 of CMC 10, or

 

(bb)  binding components of the fertilising product, without any contact with the soil, or

 

(bc)  improving the stability of the CE marked fertilising products, or

 

(bd)  improving water penetration into soil.

Amendment    276

Proposal for a regulation

Annex II – part II – CMC 10 – point 2

Text proposed by the Commission

Amendment

2.  As of [Publications office, please insert the date occurring three years after the date of application of this Regulation], the following criterion shall be complied with: The polymer shall be capable of undergoing physical, biological decomposition, such that most of it ultimately decomposes into carbon dioxide (CO2), biomass and water. It shall have at least 90 % of the organic carbon converted into CO2 in maximum 24 months, in a biodegradability test as specified points (a)-(c) below.

2.  As of ... [five years after the date of application of this Regulation], the following criterion shall be complied with: The polymer shall be capable of undergoing physical, biological decomposition, such that most of it ultimately decomposes into carbon dioxide (CO2), biomass and water. It shall have at least 90 % of the organic carbon converted into CO2 in maximum 48 months after the end of the claimed functionality period of the fertilising product indicated on the label, and as compared to an appropriate standard in the biodegradation test. The biodegradability criteria, and the development of an appropriate testing method for biodegradation shall be evaluated in the light of the latest scientific evidence and set in delegated acts adopted pursuant to Article 42 of this Regulation.

(a)  The test shall be conducted at 25°C ± 2°C.

 

(b)  The test shall be conducted in accordance with a method for determining the ultimate aerobic biodegradability of plastic materials in soils by measuring oxygen demand or the amount of carbon dioxide evolved.

 

(c)  A micro-crystalline cellulose powder with the same dimension as the test material shall be used as a reference material in the test.

 

(d)  Prior to the test, the test material shall not be subject to conditions or procedures designed to accelerate the degradation of the film, such as exposure to heat or light.

 

Amendment    277

Proposal for a regulation

Annex II – part II – CMC 10 – point 2 a (new)

Text proposed by the Commission

Amendment

 

2a.  The biodegradable mulch films referred to in PFC 3 (B), shall comply with the following criterion:

 

The polymer shall be capable of undergoing physical, biological decomposition, such that it ultimately decomposes into carbon dioxide (CO2), biomass and water and it shall have at least 90 %, absolute or relative to the reference material, of the organic carbon converted into CO2 in a maximum of 24 months, in a biodegradability test in accordance with Union standards for biodegradation of polymers in soil.

Amendment    278

Proposal for a regulation

Annex II – part II – CMC 10 – point 3 a (new)

Text proposed by the Commission

Amendment

 

3a.  As the product is intended to be added to soil and released in to the environment, these criteria shall apply to all materials in the product.

Amendment    279

Proposal for a regulation

Annex II – part II – CMC 10 – point 3 b (new)

Text proposed by the Commission

Amendment

 

3b.  A CE marked product containing polymers other than nutrient polymers shall be exempted from the requirements set out in points 1, 2 and 3 under the condition that the polymers are solely used as binding material for the fertilising product and they are not in contact with the soil.

Amendment    280

Proposal for a regulation

Annex II – part II – CMC 11

 

Text proposed by the Commission

A CE marked fertilising product may contain animal by-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, which are listed in the table below and as specified therein:

 

Amendment

Subject to the adoption by the Commission of the delegated acts pursuant to Article 42, a CE marked fertilising product may contain animal by-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, which are listed in the table below and as specified therein

 

Derived product

Processing standards to reach the end point in the manufacturing chain

1

Meat meal

Determined in accordance with the second subparagraph of Article 5(2) of Regulation (EC) No 1069/2009

2

Bone meal

Determined in accordance with the second subparagraph of Article 5(2) of Regulation (EC) No 1069/2009

3

Meat-and-bone meal

Determined in accordance with the second subparagraph of Article 5(2) of Regulation (EC) No 1069/2009

4

Blood of animals

Determined in accordance with the second subparagraph of Article 5(2) of Regulation (EC) No 1069/2009

5

Hydrolysed proteins of Category III – according to Regulation 1069/2009

Determined in accordance with the second subparagraph of Article 5(2) of Regulation (EC) No 1069/2009

6

Processed manure

Determined in accordance with the second subparagraph of Article 5(2) of Regulation (EC) No 1069/2009

7

Compost (1)

Determined in accordance with the second subparagraph of Article 5(2) of Regulation (EC) No 1069/2009

8

Biogas digestion residues(1)

Determined in accordance with the second subparagraph of Article 5(2) of Regulation (EC) No 1069/2009

9

Feather meal

Determined in accordance with the second subparagraph of Article 5(2) of Regulation (EC) No 1069/2009

10

Hides and skins

Determined in accordance with the second subparagraph of Article 5(2) of Regulation (EC) No 1069/2009

11

Hoofs and horns

Determined in accordance with the second subparagraph of Article 5(2) of Regulation (EC) No 1069/2009

12

Guano of bats

Determined in accordance with the second subparagraph of Article 5(2) of Regulation (EC) No 1069/2009

13

Wool and hair

Determined in accordance with the second subparagraph of Article 5(2) of Regulation (EC) No 1069/2009

14

Feather and downs

Determined in accordance with the second subparagraph of Article 5(2) of Regulation (EC) No 1069/2009

15

Pig bristles

Determined in accordance with the second subparagraph of Article 5(2) of Regulation (EC) No 1069/2009

16

Glycerine and other products of Category 2 and 3 materials derived from the biodiesel and renewable fuels production

Determined in accordance with the second subparagraph of Article 5(2) of Regulation (EC) No 1069/2009

17

Petfood and dog chews that have been refused for commercial reasons or technical failures

Determined in accordance with the second subparagraph of Article 5(2) of Regulation (EC) No 1069/2009

(1) derived from Category 2 and 3 materials other than Meat-and-bone meal and Processed animal protein

Amendment    281

Proposal for a regulation

Annex II – part II – CMC 11 a (new)

Text proposed by the Commission

Amendment

 

CMC 11a: Other industry by-products

 

1.  A CE marked fertilising product may contain other industry by-products such as ammonium sulfate from caprolactam production, sulfuric acid from refining natural gas and oils as well as other materials coming from specific industrial processes, which are excluded from CMC 1 and are listed in the table below, under the conditions specified therein:

 

2.  From … [one year after the date of entry into force of this Regulation], the criteria for industrial by-products that have been used in compliance with Regulation 2003/2003 as components of EC fertilising products, for their inclusion to the component material category shall be established in the light of the latest scientific evidence and set in delegated acts adopted pursuant to Article 42 of this Regulation.

Amendment    282

Proposal for a regulation

Annex III – part 1 – point 2 – point e

Text proposed by the Commission

Amendment

(e)  A description of all components above 5% by product weight in descending order of magnitude by dry weight, including an indication of the relevant component material categories ('CMC') as referred to in Annex II.

(e)  A description of all components above 1% by product weight in descending order of magnitude by dry weight, including an indication of the relevant component material categories ('CMC') as referred to in Annex II and including the content as percentage by the dry matter;

Amendment    283

Proposal for a regulation

Annex III – part 1 – point 2 – point e a (new)

Text proposed by the Commission

Amendment

 

(ea)  In the case of any product containing material originating from organic wastes or by-products, which has not been through a process which has destroyed all organic materials, the label shall specify which wastes and by-products have been used and a batch number or production time series number. That number shall refer to the traceability data held by the producer and which identifies the individual sources (farms, factories, etc.) of each organic waste/by-product used in the batch/time series. The Commission shall publish, after a public consultation and by … [two years after the date of entry into force of this Regulation], specifications for the implementation of this provision, which will enter into force by … [three years after the publication of the specifications]. In order to minimise the administrative burden for operators and for market surveillance authorities, the Commission specifications shall take into account both the requirements of paragraphs 5 to 7 of Article 6 and Article 11 and existing traceability systems (e.g. for animal by-products or industry systems) as well as Union waste classification codes.

Amendment    284

Proposal for a regulation

Annex III – part 1 – point 2 a (new)

Text proposed by the Commission

Amendment

 

2a.  Short instructions for intended use, including intended application rate and timing, intended target plants and storage shall be made available by the manufacturers.

Amendment    285

Proposal for a regulation

Annex III – part 1 – point 7 a (new)

Text proposed by the Commission

Amendment

 

7a.  No product can make claims related to another PFC without meeting the full requirements of that additional PFC, nor are any direct or implied claims of plant protection effects allowed.

Amendment    286

Proposal for a regulation

Annex III – part 2 – PFC 1 – point 2 – point b

Text proposed by the Commission

Amendment

(b)  The nitrification inhibitor content shall be expressed as a percentage by mass of the total nitrogen (N) present as ammonium nitrogen (NH4+) and urea nitrogen (CH4N2O).

(b)  The nitrification inhibitor content shall be expressed as a percentage by mass of the total nitrogen (N) present as ammonium nitrogen (NH4+) or ammonium nitrogen (NH4+) and urea nitrogen (CH4N2O).

Amendment    287

Proposal for a regulation

Annex III – part 2 – PFC 1(A) – point 1 – point a

Text proposed by the Commission

Amendment

(a)  the declared nutrients nitrogen (N), phosphorus (P) or potassium (K), by their chemical symbols in the order N-P-K;

(a)  the declared nutrients nitrogen (N), phosphorus (P) or potassium (K), by their chemical symbols in the order N-P-K; the declared nitrogen content is given by the sum of ammoniacal N, nitric N, ureic N, N from urea formaldehyde, N from isobutylidene diurea, N from crotonylidene diurea and N from cyanamide.

 

Phosphorus fertilisers must fulfil the following minimum solubility levels to be plant-available, otherwise they cannot be declared as phosphorus fertilisers:

 

  water solubility: minimum level 25 % of total P,

 

  solubility in neutral ammonium citrate: minimum level 30 % of total P,

 

  solubility in formic acid (only for soft rock phosphate): minimum level 35 % of total P.

Amendment    288

Proposal for a regulation

Annex III – part 2 – PFC1 (A) – point 1 – point b

Text proposed by the Commission

Amendment

(b)  the declared nutrients magnesium (Mg), calcium (Ca), sulphur (S) or sodium (Na), by their chemical symbols in the order Mg-Ca-S-Na;

(b)  the declared nutrients calcium (Ca), magnesium (Mg), sodium (Na) or sulphur (S) by their chemical symbols in the order Ca- Mg - Na - S;

 

(This amendment applies throughout the text. Adopting it will necessitate corresponding changes throughout.)

Amendment    289

Proposal for a regulation

Annex III – part 2 – PFC 1(A) – point 1 – point c

 

Text proposed by the Commission

Amendment

(c)  numbers indicating the total content of the declared nutrients nitrogen (N), phosphorus (P) or potassium (K), followed by numbers in brackets indicating the total content of magnesium (Mg), calcium (Ca), sulphur (S) or sodium (Na),

(c)  numbers indicating the average content of the declared nutrients nitrogen (N), phosphorus (P) or potassium (K), followed by numbers in brackets indicating the total content of magnesium (Mg), calcium (Ca), sulphur (S) or sodium (Na),

Amendment    290

Proposal for a regulation

Annex III – part 2 – PFC 1(A) – point 1 – point d – indent 6

Text proposed by the Commission

Amendment

  Organic carbon (C); and

  Organic carbon (C) and C/N ratio;

Amendment    291

Proposal for a regulation

Annex III – part 2 – PFC 1(A) – point 1 – point d – indent 7 a (new)

Text proposed by the Commission

Amendment

 

  In a form such as powder or pellets.

Amendment    292

Proposal for a regulation

Annex III – part 2 – PFC 1(B) – point 1 – point d – indent 2

Text proposed by the Commission

Amendment

  Total Phosphorus pentoxide (P2O5).

  Phosphorus pentoxide (P2O5) soluble in neutral ammonium citrate and water.

Amendment    293

Proposal for a regulation

Annex III – part 2 – PFC 1(B) – point 1 – point d – indent 2 – subindent 3

Text proposed by the Commission

Amendment

  where soft ground phosphate is present, phosphorous pentoxide (P2O5) soluble in formic acid

  Phosphorus pentoxide (P2O5) only soluble in mineral acids

Amendment    294

Proposal for a regulation

Annex III – part 2 – PFC 1(B) – point 1 a (new)

Text proposed by the Commission

Amendment

 

1a.  The total declared nitrogen content is given by the sum of ammoniacal N, nitric N, ureic N, N from methylene-urea, N from isobutylidene diurea, N from crotonylidene diurea and N from cyanamide.

Amendment    295

Proposal for a regulation

Annex III – part 2 – PFC1 (C) (I) – point 1 – point d – indent 2

Text proposed by the Commission

Amendment

  Total Phosphorus pentoxide (P2O5);

  Phosphorus pentoxide (P2O5) soluble in neutral ammonium citrate and water

Amendment    296

Proposal for a regulation

Annex III – part 2 – PFC1 (C) (I) – point 1 – point d – indent 2 – indent 3

Text proposed by the Commission

Amendment

–  Where soft ground phosphate is present, phosphorous pentoxide (P2O5) soluble in formic acid;

–  Phosphorus pentoxide (P2O5) only soluble in mineral acids;

Amendment    297

Proposal for a regulation

Annex III – part 2 – PFC1 (C) (I) – point 1 – point d – indent 4 – indent 1 a (new)

Text proposed by the Commission

Amendment

 

  in a form such as powder or pellets;

Amendment    298

Proposal for a regulation

Annex III – part 2 – PFC 1(C)(I) – point 1 – point d a (new)

Text proposed by the Commission

Amendment

 

(da)  pH

Amendment    299

Proposal for a regulation

Annex III – part 2 – PFC 1(C)(I) – point 1 a (new)

Text proposed by the Commission

Amendment

 

1a.  Fertilising products that contain less than 5ppm of cadmium, arsenic, lead, chromium VI and mercury, respectively, shall be eligible to use a visible “Green Label” in their packaging and label. The Commission shall be empowered to adopt delegated acts in accordance with Article 43, supplementing this Regulation to set the technical standards of such labels.

Amendment    300

Proposal for a regulation

Annex III – part 2 – PFC 1(C)(I)(a) – point 3 – point c

Text proposed by the Commission

Amendment

(c)  powder, where at least 90% of the product can pass through a sieve with a mesh of 10 mm, or

(c)  powder, where at least 90 % of the product can pass through a sieve with a mesh of 1 mm, or

Amendment    301

Proposal for a regulation

Annex III – part 2 – PFC 1(C)(I)(a) – point 4 a (new)

Text proposed by the Commission

Amendment

 

4a.  For CE marked products referred to in point (bb) of point 1 of CMC 10 of Annex II where polymers are solely used as binding material, the following marking shall be present: “The fertilising product is not intended to be in contact with the soil.”

Amendment    302

Proposal for a regulation

Annex III – part 2 – PFC 1(C) (II) – point 1

Text proposed by the Commission

Amendment

1.  The declared micronutrients in the CE marked fertilising product 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 name(s) of their counter-ion(s),

1.  The declared micronutrients in the CE marked fertilising product 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), selenium (Se), silicon (Si) and zinc (Zn), followed by the name(s) of their counter-ion(s),

Amendment    303

Proposal for a regulation

Annex III – part 2 – PFC 1(C) a (new)

Text proposed by the Commission

Amendment

 

PFC 1(C) a: Low carbon fertiliser

 

1.  The following information elements relating to macronutrients shall be present:

 

(a)  the declared nutrients nitrogen (N), phosphorus (P) or potassium (K), by their chemical symbols in the order N-P-K;

 

(b)  the declared nutrients magnesium (Mg), calcium (Ca), sulphur (S) or sodium (Na), by their chemical symbols in the order Mg-Ca-S-Na;

 

(c)  numbers indicating the total content of the declared nutrients nitrogen (N), phosphorus (P) or potassium (K), followed by numbers in brackets indicating the total content of magnesium (Mg), calcium (Ca), sulphur (S) or sodium (Na);

 

(d)  the content of the following declared nutrients, in the following order and as a percentage of the fertiliser by mass:

 

  Total Nitrogen (N)

 

  minimum amount of organic nitrogen (N), followed by a description of the origin of the organic matter used;

 

  Nitrogen (N) in the form of nitric nitrogen;

 

  Nitrogen (N) in the form of ammoniacal nitrogen;

 

  Nitrogen (N) in the form of urea nitrogen;

 

  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;

 

  Total potassium oxide (K2O);

 

  Water soluble potassium oxide (K2O);

 

  magnesium oxide (MgO), calcium oxide (CaO), sulphur trioxide (SO3) and sodium oxide (Na2O), 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, the total content and 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.  The following other elements shall be indicated as a percentage by mass of the CE marked fertilising product:

 

  Organic carbon (C) content; and

 

  Dry matter content.

 

3.  Where one or more of the micronutrients boron (B), cobalt (Co), copper (Cu), iron (Fe), manganese (Mn), molybdenum (Mo) and zinc (Zn), are present in the minimum content indicated as a percentage by mass in the table below, they

 

  shall be declared if they are intentionally added to the CE marked fertilising product, and

 

  may be declared in other cases:

 

Micronutrient

Percentage by mass

 

Boron (B)

0,01

 

Cobalt (Co)

0,002

 

Copper (Cu)

0,002

 

Manganese (Mn)

0,01

 

Molybdenum (Mo)

0,001

 

Zinc

0,002

 

They shall be declared after the information on macronutrients. The following information elements shall be present:

 

(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 name(s) of their counter-ion(s);

 

(b)  The total micronutrient content expressed as a percentage of the fertiliser by mass

 

  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, the total content and the content soluble in water; and

 

  in other cases, as the total content;

 

(c)  Where the declared micronutrient(s) are chelated by chelating agent(s), 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 a percentage of the CE marked fertilising product by mass;

 

(d)  Where the CE marked fertilising product contains micronutrient(s) complexed by complexing agent(s):

 

  the following qualifier after the name and the chemical identifier of the micronutrient: ‘complexed by …', and the amount of complexed micronutrient as a percentage of the CE marked fertilising product by mass; and

 

  the name of the complexing agent or its abbreviation.

 

(e)  The following statement: ‘To be used only where there is a recognised need. Do not exceed the appropriate rate’.

Amendment    304

Proposal for a regulation

Annex III – part 2 – PFC 3 – point 1 – indent 3

Text proposed by the Commission

Amendment

  Total nitrogen (N) content;

deleted

Amendment    305

Proposal for a regulation

Annex III – part 2 – PFC 3 – point 1 – indent 4

Text proposed by the Commission

Amendment

  Total phosphorus pentoxide (P2O5) content;

deleted

Amendment    306

Proposal for a regulation

Annex III – part 2 – PFC 3 – point 1 – indent 5

Text proposed by the Commission

Amendment

  Total potassium oxide (K2O) content;

deleted

Amendment    307

Proposal for a regulation

Annex III – part 2 – PFC 6 – point e

Text proposed by the Commission

Amendment

(e)  dose, timing (plant development stage) and frequency of application;

(e)  dose, timing (plant development stage), placement and frequency of application (in line with the empirical evidence justifying the biostimulant claim(s));

Amendment    308

Proposal for a regulation

Annex III – part 2 – PFC 6 – point f a (new)

Text proposed by the Commission

Amendment

 

(fa)  statement that the product is not a plant protection product;

Amendment    309

Proposal for a regulation

Annex III – part 3 –PFC 1(A)

Text proposed by the Commission

Amendment

 

Permissible tolerance for the declared nutrient content and other declared parameter

 

Permissible tolerance for the declared nutrient content and other declared parameter

Organic carbon (C)

± 20 % relative deviation of the declared value up to a maximum of 2,0 percentage point in absolute terms

Organic carbon (C)

± 15 % relative deviation of the declared value up to a maximum of 2,0 percentage point in absolute terms

Dry matter content

± 5,0 percentage point in absolute terms

Dry matter content

± 5,0 percentage point 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

Total nitrogen (N)

± 15 % relative deviation of the declared value up to a maximum of 1,0 percentage point in absolute terms

Organic nitrogen (N)

± 50 % relative deviation of the declared value up to a maximum of 1,0 percentage point in absolute terms

Organic nitrogen (N)

± 15 % 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 phosphorus pentoxide (P2O5)

± 15 % 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 potassium oxide (K2O)

± 15 % relative deviation of the declared value up to a maximum of 1,0 percentage point in absolute terms

Total and water-soluble magnesium oxide, calcium oxide, sulphur trioxide or sodium oxide

± 25% of the declared content of those nutrients up to a maximum of 1,5 percentage points in absolute terms.

Total and water-soluble magnesium oxide, calcium oxide, sulphur trioxide or sodium oxide

± 25% of the declared content of those nutrients up to a maximum of 1,5 percentage points in absolute terms.

Total copper (Cu)

± 50 % relative deviation of the declared value up to a maximum of 2,5 percentage points in absolute terms

Total copper (Cu)

± 50 % relative deviation of the declared value up to a maximum of 2,5 percentage points in absolute terms

Total zinc (Zn)

± 50 % relative deviation of the declared value up to a maximum of 2,0 percentage points in absolute terms

Total zinc (Zn)

± 50 % relative deviation of the declared value up to a maximum of 2,0 percentage points in absolute terms

Quantity

- 5 % relative deviation of the declared value

Quantity

- 5 % relative deviation of the declared value

 

 

Declared forms of nitrogen, phosphorus and potassium

Binaries: maximum tolerance, in absolute terms, of 1,1 N and 0,5 organic N, 1,1 P2O5, 1,1 K2O and 1,5 for the sum of two nutrients.

 

 

 

Ternaries: maximum tolerance, in absolute terms, of 1,1 N and 0,5 organic N, 1,1 P2O5, 1,1 K2O and 1,9 for the sum of three nutrients.

 

 

 

± 10 % of the total declared content of each nutrient up to a maximum of 2 percentage points in absolute terms.

Amendment    310

Proposal for a regulation

Annex III – part 3 – PFC 1(B) – table 1

 

Text proposed by the Commission

Permissible tolerance for the declared content of forms of inorganic macronutrient

N

P2O5

K2O

MgO

CaO

SO3

Na2O

± 25 % of the declared content of the nutrient forms present up to a maximum of 2 percentage point in absolute terms

± 25 % of the declared content of those nutrients up to a maximum of 1,5 percentage points in absolute terms.

± 25 % of the declared content up to a maximum of 0,9 percentage points in absolute terms

Amendment

Permissible tolerance for the declared content of forms of inorganic macronutrient

N

P2O5

K2O

MgO

CaO

SO3

Na2O

± 25 % of the declared content of the nutrient forms present up to a maximum of 2 percentage point in absolute terms for each nutrient separately and for the sum of nutrients

-50 % and +100 % of the declared content of those nutrients up to a maximum of -2 and +4 percentage points in absolute terms.

± 25 % of the declared content up to a maximum of 0.9 percentage points in absolute terms

P2O5 tolerances refer to phosphorus pentoxide (P2O5) soluble in neutral ammonium citrate and water.

 

 

Amendment    311

Proposal for a regulation

Annex III – part 3 –PFC 1(B)

 

Text proposed by the Commission

Amendment

Organic carbon: ± 20 % relative deviation of the declared value up to a maximum of 2,0 percentage point in absolute terms

Organic carbon: ± 15 % relative deviation of the declared value up to a maximum of 2,0 percentage point in absolute terms

Organic nitrogen: ± 50 % relative deviation of the declared value up to a maximum of 1,0 percentage point in absolute terms

Organic nitrogen: ± 15 % relative deviation of the declared value up to a maximum of 1,0 percentage point in absolute terms

Total copper (Cu) ± 50 % relative deviation of the declared value up to a maximum of 2,5 percentage points in absolute terms

Total copper (Cu) ± 15 % relative deviation of the declared value up to a maximum of 2,5 percentage points in absolute terms

Total zinc (Zn) ± 50 % relative deviation of the declared value up to a maximum of 2,0 percentage points in absolute terms

Total zinc (Zn) ± 15 % relative deviation of the declared value up to a maximum of 2,0 percentage points in absolute terms

Amendment    312

Proposal for a regulation

Annex III – part 3 - PFC 1(C)(I)

 

Text proposed by the Commission

Permissible tolerance for the declared content of forms of inorganic macronutrient

N

P2O5

K2O

MgO

CaO

SO3

Na2O

± 25 % of the declared content of the nutrient forms present up to a maximum of 2 percentage point in absolute terms

± 25 % of the declared content of those nutrients up to a maximum of 1,5 percentage points in absolute terms.

± 25 % of the declared content up to a maximum of 0,9 percentage points in absolute terms

Granulometry: ± 10 % relative deviation applicable to the declared percentage of material passing a specific sieve

Quantity: ± 5 % relative deviation of the declared value

Amendment

Permissible tolerance for the declared content of forms of inorganic macronutrient

N

P2O5

K2O

MgO

CaO

SO3

Na2O

± 25 % of the declared content of the nutrient forms present up to a maximum of 2 percentage point in absolute terms for each nutrient separately and for the sum of nutrients

-50 % and +100 % of the declared content of those nutrients up to a maximum of -2 and +4 percentage points in absolute terms.

-50 % and +100 % of the declared content up to a maximum of -2 and +4 percentage points in absolute terms

The above tolerance values apply also for the N-forms and for the solubilities.

Granulometry: ± 20 % relative deviation applicable to the declared percentage of material passing a specific sieve

Quantity: ± 3 % relative deviation of the declared value

Amendment    313

Proposal for a regulation

Annex III – part 3 – PFC 3

Forms of the declared nutrient and other declared quality criteria

Permissible tolerances for the declared parameter

pH

± 0,7 at the time of manufacture

 

± 1,0 at any time in the distribution chain

Organic carbon (C)

± 10% relative deviation of the declared value up to a maximum of 1,0 percentage points 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

± 10% relative deviation of the declared value

Quantity

- 5% relative deviation of the declared value at the time of manufacture

 

- 25% relative deviation of the declared value at any time in the distribution chain

Carbon (C) org /Nitrogen (N) org

± 20% relative deviation of the declared value up to a maximum of 2,0 percentage points in absolute terms

Granulometry

± 10 % relative deviation applicable to the declared percentage of material passing a specific sieve.

Amendment

Forms of the declared nutrient and other declared quality criteria

Permissible tolerances for the declared parameter

pH

± 0,7 at the time of manufacture

 

± 0,9 at any time in the distribution chain

Organic carbon (C)

± 10% relative deviation of the declared value up to a maximum of 1,0 percentage points 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

± 10% relative deviation of the declared value

Quantity

- 5% relative deviation of the declared value at the time of manufacture

 

- 15% relative deviation of the declared value at any time in the distribution chain

Carbon (C) org /Nitrogen (N) org

± 20% relative deviation of the declared value up to a maximum of 2,0 percentage points in absolute terms

Granulometry

± 10 % relative deviation applicable to the declared percentage of material passing a specific sieve.

Amendment    314

Proposal for a regulation

Annex III – part 3 – PFC 4

Forms of the declared nutrient and other declared quality criteria

Permissible tolerances for the declared parameter

Electric conductivity

± 50% relative deviation at the time of manufacture

 

± 75% relative deviation at any time in the distribution chain

pH

± 0,7 at the time of manufacture

 

± 1,0 at any time in the distribution chain

Quantity by volume (litres or m³)

- 5% relative deviation at the time of manufacture

 

- 25% relative deviation at any time in the distribution chain

Quantity (volume) determination of materials with particle size greater than 60 mm

- 5% relative deviation at the time of manufacture

 

- 25% relative deviation at any time in the distribution chain

Quantity (volume) determination of pre-shaped GM

- 5% relative deviation at the time of manufacture

 

- 25% relative deviation at any time in the distribution chain

Water-soluble nitrogen (N)

± 50% relative deviation at the time of manufacture

 

± 75% relative deviation at any time in the distribution chain

Water-soluble phosphorus pentoxide (P2O5)

± 50% relative deviation at the time of manufacture

 

± 75% relative deviation at any time in the distribution chain

Water-soluble potassium oxide (K2O)

± 50% relative deviation at the time of manufacture

 

± 75% relative deviation at any time in the distribution chain

Amendment

Forms of the declared nutrient and other declared quality criteria

Permissible tolerances for the declared parameter

Electric conductivity

± 50% relative deviation at the time of manufacture

 

± 60% relative deviation at any time in the distribution chain

pH

± 0,7 at the time of manufacture

 

± 0,9 at any time in the distribution chain

Quantity by volume (litres or m³)

- 5% relative deviation at the time of manufacture

 

- 15% relative deviation at any time in the distribution chain

Quantity (volume) determination of materials with particle size greater than 60 mm

- 5% relative deviation at the time of manufacture

 

- 15% relative deviation at any time in the distribution chain

Quantity (volume) determination of pre-shaped GM

- 5% relative deviation at the time of manufacture

 

- 15% relative deviation at any time in the distribution chain

Water-soluble nitrogen (N)

± 50% relative deviation at the time of manufacture

 

± 60% relative deviation at any time in the distribution chain

Water-soluble phosphorus pentoxide (P2O5)

± 50% relative deviation at the time of manufacture

 

± 60% relative deviation at any time in the distribution chain

Water-soluble potassium oxide (K2O)

± 50% relative deviation at the time of manufacture

 

± 60% relative deviation at any time in the distribution chain

Amendment    315

Proposal for a regulation

Annex IV – part 1 – point 1 – point 1 – point b

Text proposed by the Commission

Amendment

(b)  energy crop digestates as specified in CMC 4,

(b)  energy crop digestates and plant-based bio-waste as specified in CMC 4,

Amendment    316

Proposal for a regulation

Annex IV – part 1 – point 1 – point 1 – point f a (new)

Text proposed by the Commission

Amendment

 

(fa)  non-processed or mechanically processed plants, plant parts or plant extracts as specified in CMC 2.

Amendment    317

Proposal for a regulation

Annex IV – part 1 – point 1 – point 3 – point b a (new)

Text proposed by the Commission

Amendment

 

(ba)  a denitrification inhibitor as specified in PFC 5(A)(Ia),

Amendment    318

Proposal for a regulation

Annex IV – part 1 – point 3 – point 2 – point a a (new)

Text proposed by the Commission

Amendment

 

(aa)  a denitrification inhibitor as specified in PFC (A)(Ia),

Amendment    319

Proposal for a regulation

Annex IV – part 2 – module A – point 2.2 – point b

Text proposed by the Commission

Amendment

(b)  conceptual design and manufacturing drawings and schemes,

deleted

Amendment    320

Proposal for a regulation

Annex IV – part 2 – module A – point 2.2 – point c

Text proposed by the Commission

Amendment

(c)  descriptions and explanations necessary for the understanding of those drawings and schemes and the use of the CE marked fertilising product,

deleted

Amendment    321

Proposal for a regulation

Annex IV – part 2 – module A1 – point 4 – paragraph 1

Text proposed by the Commission

Amendment

The cycles and test referred to under Headings 4.1-4.3 below shall be carried out on a representative sample of the product at least every 3 months on behalf of the manufacturer, in order to verify conformity with

The cycles and test referred to under Headings 4.1-4.3 below shall be carried out on a representative sample of the product at least every six months in the case of continuous operation of the plant or every year for the periodic production on behalf of the manufacturer, in order to verify conformity with

Amendment    322

Proposal for a regulation

Annex IV – part 2 – module A1 – point 4.3.5 a (new)

Text proposed by the Commission

Amendment

 

4.3.5a.  The manufacturer shall keep the test reports together with the technical documentation.

Amendment    323

Proposal for a regulation

Annex IV – part 2 – module B – point 3.2 – point c – indent 6

Text proposed by the Commission

Amendment

–  test reports, and

–  test reports, including studies on agronomic efficiency, and

Amendment    324

Proposal for a regulation

Annex IV – part 2 – module D1 – point 2 – point b

Text proposed by the Commission

Amendment

(b)  conceptual design and manufacturing drawings and schemes, including a written description and a diagram of the production process, where each treatment, storage vessel and area is clearly identified,

(b)  a written description and a diagram of the production process;

(1)

  OJ C 389, 21.10.2016, p. 80


EXPLANATORY STATEMENT

Introduction

On 17th of March 2016 the European Commission adopted a proposal for a draft Regulation laying down rules on the making available on the market of CE marked fertilising products.

Currently, the legislative framework regarding the conditions for making fertilisers available on the internal market, Regulation (EC) No 2003/2003 of the European Parliament and of the Council, almost exclusively covers fertilisers from mined or chemically produced inorganic materials. The draft proposal will replace this legislation and will encompass a greater range of fertilising products, opening up the Single Market for free circulation of fertilising products from organic or secondary raw materials. Therefore, the proposal aligns the rules on fertilising products with the New Legislative Framework for product legislation and its sole legal base is Article 114 of TFEU.

The proposal by the Commission aims to help EU industry become more sustainable and competitive, foster sustainable economic growth and generate new jobs. The proposed Regulation seeks to harmonise EU rules for products derived from waste organic materials and by-products.

Preparation of the proposal

The proposal is based on extensive consultations with stakeholders and an impact assessment. The evaluation of the existing Fertilisers Regulation carried out in 2010 concluded that the Fertilisers Regulation could be more effective in promoting innovative fertilisers, and that reforms would also be needed to strengthening the internal market. It also showed that neither economic operators, nor national authorities considered that mutual recognition was sufficient for ensuring free movement of organic fertilisers, since fertilisers are products for which strict rules are needed to ensure product quality, protection of the environment and health.

All interested stakeholders were consulted during the preparation phase, including as part of the public consultation on Circular economy published in May 2015. Stakeholders were also invited to give feedback to the Roadmap for the revision of the Fertilisers Regulation published in October 2015.

The proposal is supported by an impact assessment, which showed that the reform would lead to administrative simplification and ensure flexibility needed on the market, while at the same time ensuring protection of health and environment.

General comments

The Rapporteur welcomes the proposal of the ’Fertilising Products Regulation’ as part of the Circular Economy Package. The proposal modernises the conformity assessment and market surveillance in line with ‘the new legislative framework’ for product legislation, covers a wider range of fertilising products (including those manufactured from secondary raw materials), and set limits for the presence of heavy metals and contaminants in fertilising products in order to protect public interests.

1. Optional harmonisation

The initiative aims at reaching a critical mass through internal market for such products. Mutual recognition of non-harmonised fertilisers has proven extremely difficult in the past, whereas product harmonisation legislation has been an effective way of securing internal market access for inorganic fertilisers. It is therefore concluded that product harmonisation legislation for fertilisers from organic or secondary raw materials does not go beyond what is necessary for providing the regulatory certainty required to incentivise large scale investment in the circular economy.

The regulatory technique chosen in this proposal leaves economic operators a maximum of flexibility to put new products in the internal market without compromising on safety and quality. Furthermore, it leaves Member States free to allow non-harmonised fertilisers to the national market, without depriving those economic operators seeking cross-border trade for larger markets of the possibility to opt for the benefits of the harmonised regulatory framework.

The Rapporteur believes that existing barriers to free movement of innovative fertilisers, in the form of diverging, national regulatory frameworks, cannot be successfully removed through Member States’ unilateral actions. EU actions could encourage free movement of such organic fertilisers in the internal market by establishing harmonised and ambitious quality, safety and environmental criteria. Besides, a European regulatory framework will raise Member States’ attention to the economic and environmental potential of innovative fertilisers, put organic fertilisers on an equal footing with mineral-based fertilisers and incentivise innovation.

The Rapporteur highlights that companies opting for the harmonised route would benefit from facilitated access to the entire internal market. The administrative costs would also decrease, as there would be less need to register individual products according to diverging national rules. Producers not subject to third party certification procedures would be less affected compared to those supporting the costs of third party certification (e.g. SMEs). Those costs would be mitigated by the reduction of the frequency of controls according to the volume of production and the reduction of the number of external samplings after the recognition year. In this sense optional harmonisation would facilitate the smooth transition to the new regulatory framework leaving producers the choice to market product either for the local or for the EU markets.

2. New requirements and range of the Regulation

One aim of the Regulation is to improve safety standards of fertilising products as well lower limits for heavy metals, especially cadmium, for each product function category (PFC). This might improve food and consumer safety, along with soil protection. In accordance with new safety standards, maximum limits for impurities, such as organic or microbial contaminants, are defined. Furthermore, a new minimum nutrient content for each individual PFC is set, to ensure quality of CE-marked fertilising products.

The limits of cadmium allowed in phosphate fertilisers raise a lot of debate in relation to the right balance between public interest objectives and proportionate means to achieve them, as well as to the scientific base and availability of necessary technologies to date. At Committee level, the Committee for Environment, Public Health and Food Safety of the Parliament has been granted exclusive competence to set the allowed cadmium limits in Annex I of the proposal.

3. Clear distinction between fertilizers

The current definition of fertilizing products incorporated in the proposal may cause confusion to the farmers, as it includes various kinds of products, with different functions and characteristics. Therefore, there should be a very clear distinction between fertilizers (products that provide nutrients for the growth of the plants) and other types of products (soil improvers, growing medium, agronomic additives or biostimulants), which have different functions, such as stimulating certain functions of plants, have effects on the soil, etc.

4. Reduction of administrative burden

The proposal sets a number of requirements for economic operators in order to achieve the Single Market that safeguards relevant public interests, such as safety, protection of public health and environment, etc. However, these objectives should be met with least burdensome measures so that innovation and job creation in the sector is not hurdled. Therefore, the Rapporteur considers it important to adjust the proposal so that obligations of economic operators are proportionate to the objectives of this Regulation without going beyond what is necessary.

5. Labelling

The Rapporteur finds it important that labelling must be clear and comprehensive, and it should include all the information on the available nutrients and their solubility’s. This is essential for farmers in order to assess properly the agronomic efficacy of the products and to choose the most appropriate product for the needs of their crops and the conditions and characteristics of soil and climate. It also improves efficiency and it is favourable for the environment.

Conclusions

The Rapporteur believes that this proposal will lead to simplification and reduction of the administrative burden for producers of fertilising products seeking access to more than one national territory on the internal market, since such access will no longer depend on mutual recognition. At the same time, it will avoid banning or restricting market access for producers that do not aim at compliance with EU-level rules, by keeping open the possibility to access national markets subject to any national rules, or opt for mutual recognition in the cross-border activities.

The Rapporteur also finds that the new approach taken by the Commission could lead to a variety of unprecedented rules for the fertiliser sector. In addition, there are number of inconsistencies, uncertainties and missing definitions in the proposal, which are needed to be clarified. From this perspective, an entry into force of the new Regulation on 1 January 2018 seems to be overambitious.

In the review clause the Commission is requested to report in 2023 about the functioning of the internal market to assess the impacts of the partial harmonization, to verify whether this Regulation contributes to the foreseen administrative simplification and to assess the restrictions on levels of contaminants as laid out in Annex I. The foreseen date of the report respectively depends on any changes that might be introduced to the application timeline foreseen in Article 49.


ANNEX: LIST OF ENTITIES OR PERSONSFROM WHOM THE RAPPORTEUR HAS RECEIVED INPUT

The following list is drawn up on a purely voluntary basis under the exclusive responsibility of the rapporteur. The rapporteur has received input from the following entities or persons in the preparation of the draft report:

Entity and/or person

Fertilizers Europe

European Biostimulant Industry Council (EBIC)

European Consortium of the Organic-Based Fertilizer Industry (ECOFI)

Alliance Européenne des Engrais Phosphatés

 

The European Sustainable Phosphorus Platform

 

 

The European Sustainable Phosphorus Platform

 

 

The European Sustainable Phosphorus Platform

 

The European Sustainable Phosphorus Platform

 

 

Copa - Cogeca

 

 

Chemicals Legislation European Enforcement Network (CLEEN)

Fertisac

Phosagro

Stockholm University Baltic Sea Centre (Baltic Eye project)

GRODAN

SOBAC

 

Veolia

SUEZ Group

Office Chérifien des Phosphates (OCP)

BAYER


OPINION of the Committee on the Environment, Public Health and Food Safety (2.6.2017)

for the Committee on the Internal Market and Consumer Protection

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))

Rapporteur: Elisabetta Gardini

(*) Associated committee – Rule 54 of the Rules of Procedure

SHORT JUSTIFICATION

Context

Fertilising products are used to feed plants and improve plant growth, mainly in agriculture. They can be grouped into two broad groups: fertilisers, which provide nutrients to plants, and other products, whose primary objective is to promote plant growth through other means. As the world population keeps increasing, fertilisers deliver key benefits thanks in particular to increased crop yields. However, some challenges in terms of the environment, public health and food safety are associated with fertiliser use.

According to Commission estimates, the fertilising products sector has an annual turnover ranging from €20 to €25 billion and accounts for about 100 000 jobs; SMEs represent 90% of companies. An in house study published in 2015 also highlighted that in most EU Member States, fertilisers account for about 10% of farmers' costs, although the figure can be as high as 20% in Ireland and as low as 3.6% in Malta.

Current legal framework

The 2003 Fertilisers Regulation (Regulation (EC) No 2003/2003) defines different types of fertilisers, which have been approved as 'EC fertilisers' and can circulate freely on the EU market. Although the current regulation covers various types of fertilisers, current 'EC fertilisers' are essentially conventional and mineral fertilisers sourced from primary raw materials, some of which require energy and CO2-intensive production processes. In addition, the Regulation does not include limits to the content of heavy metals and other contaminants, such as pathogens and physical impurities.

In March 2016, the Commission put forward a legislative proposal on fertilising products, as part of the Circular Economy package. The proposal covers a wider range of fertilising products (including those manufactured from secondary raw materials), and also sets limits on heavy metals and contaminants present in fertilising products.

Position of the rapporteur

The rapporteur welcomes the proposal put forward by the Commission as it will allow all fertilisers to access the internal market and put into practice the principles of the Circular Economy. The rapporteur also considers that covering all types of fertilising products - and not only the mineral ones - in EU legislation is an extremely positive step forward. It will contribute to creating a more complete internal market and it will help and strengthen SMEs’ investments in the Circular Economy.

However, it is also of crucial importance, to set realistic and achievable targets, to ensure that the limits and requirements can be complied with. Priority should be given to the protection of human and animal health and of the environment, but this should be balanced with the socio-economic impacts these measures might have. In addition, it is important to safeguard food security and ensure that the food supply can still meet the demands of a constantly growing population. The new rules should have a strong scientific basis and be based on robust risk assessments, rather than only on the precautionary principle, which would lead to unjustified restrictions and unfairly ban some products from the internal market. Unless there is robust scientific data concluding that there are risks posed to the environment or human and animal health, technically unrealistic requirements should not be set. This approach has been adopted by the rapporteur on the proposal and in particular on the issue of contaminants.

Among contaminants, the issue of cadmium (Cd) is of particular importance. Cadmium, present mostly in mineral phosphate fertilisers, raises particular concerns as it can accumulate in soils, transfer to foodstuffs and potentially lead to adverse effects on health, soil biodiversity and groundwater quality - without bringing any benefit to plants. Cadmium content in phosphate fertilisers depends on the phosphate rock used, as it is present in the rock and is not released, even after the production process. Cadmium content in phosphate rocks varies from under 10 mg Cd/kg phosphorus (P2O5) to 200 mg/kg, depending on where it is mined. The Commission proposal introduces a gradual reduction of the maximum level of metal impurity from 60 mg Cd/kg P2O5 to 40 mg Cd/kg after three years, and to 20 mg Cd/kg after 12 years. These would be the most restrictive limits in the world: Japan, Australia, California and New Zealand have higher Cd limits - whereas currently there are no limits in the EU.

Fertiliser products in the EU are produced using a wide variety of long-established methods, many of which are fully in line with the Circular Economy principles. It is therefore important to ensure that these production methods can be maintained and that rules that run counter to them are not established.

In addition, the rapporteur is committed to ensuring the harmonisation between the rules applicable to different fertiliser categories to ensure that high quality products and many more choices are available to the farmers.

Some fertilisers, defined as "dual use” products, are made of the same chemical compounds as crop protection products. In the Commission proposal, there is no reference to these products and this should be corrected to ensure a clear distinction between the two categories, which have different characteristics.

The Commission also proposes to exclude organic organo-mineral fertilisers and biostimulants made from animal by-products (ABPs) from the scope of the Regulation. In addition, the only ABPs that could be commercialised as CE marked are those that have reached the so-called "end-point" to avoid the fraudulent use of ABPs as animal feed. However, ABPs that have not reached the end-point have to comply with very strict requirements and therefore it should also be possible for these ABPs to be commercialised at EU level.

In addition to these issues, several terms and definitions should be improved in order to better reflect technological progress and in particular in relation to innovative products, such as biostimulants.

There is also a need to ensure that clearer information is provided to farmers and consumers. This should be done by specifying the nutrients available in a given mineral fertiliser and by improving the general labelling requirements specified in Annex III. This would allow farmers and consumers to optimise the use of the fertilisers, and thus reduce the environmental impact of these products.

AMENDMENTS

The Committee on the Environment, Public Health and Food Safety calls on the Committee on the Internal Market and Consumer Protection, as the committee responsible, to take into account the following amendments:

Amendment    1

Proposal for a regulation

Title 1

Text proposed by the Commission

Amendment

Proposal for a

Proposal for a

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

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

laying down rules on the making available on the market of CE marked fertilising products and amending Regulations (EC) No 1069/2009, (EC) No 1107/2009 and Directive 91/676/EEC

(Text with EEA relevance)

(Text with EEA relevance)

Justification

It is essential to make a link between the trade in fertilisers and their use, in other words between this regulation and the nitrates directive. If trading and use are kept totally separate, this regulation risks not achieving its objective, because in that case it would be possible for Member States or regions, using the rules on the use of fertilisers, to prevent certain fertilisers, such as compost from organic waste, being used in practice.

Amendment    2

Proposal for a regulation

Recital 1

Text proposed by the Commission

Amendment

(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 Council15, 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. The scope of the harmonisation should therefore be extended in order to include recycled and organic materials.

(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 Council15, 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 contribute to the circular economy and allow a more resource-efficient overall use of nutrients, while lowering Union dependency on nutrients from third countries. The scope of the harmonisation should therefore be extended in order to include recycled and organic materials.

__________________

__________________

15 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).

15 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).

Amendment    3

Proposal for a regulation

Recital 1 a (new)

Text proposed by the Commission

Amendment

 

(1a)  This Regulation should foster the goals of the circular economy, provided it ensures at the same time that farmers have a secure supply of highly efficient fertilisers. The Commission should present the European Parliament and the Council with a report that takes stock of the application of this Regulation by ... [OJ please insert the date: five years after its entry into force].

Amendment    4

Proposal for a regulation

Recital 8

Text proposed by the Commission

Amendment

(8)  Contaminants in CE marked fertilising products, such as cadmium, can potentially pose a risk to human and animal health and 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 CE marked 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.

(8)  Contaminants in CE marked fertilising products, such as cadmium, pose a risk to human and animal health and the environment as they accumulate in the environment and enter the food chain. Several Member States already impose contaminant levels for cadmium due to the risk cadmium poses to human and animal health and to the environment. Their content should therefore be limited in such products. Furthermore, impurities in CE marked 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.

Amendment    5

Proposal for a regulation

Recital 8 a (new)

Text proposed by the Commission

Amendment

 

(8a)  Member States which already have more stringent national limit values for cadmium in fertilisers should be allowed to maintain those limit values until the rest of the Union reaches an equivalent level of ambition.

Amendment    6

Proposal for a regulation

Recital 8 b (new)

Text proposed by the Commission

Amendment

 

(8b)  A cadmium content labelling requirement for CE marked fertilising products, to show the actual cadmium (Cd) content in mg/kg phosphorus pentoxide (P205), should be introduced throughout the Union. That requirement could take the form of a clearly visible colour-coded label on the product so that users can immediately tell whether they are using a product with higher or lower cadmium content. It should be possible to introduce special indications for fertilising products with an actual cadmium content equal to or lower than 20 mg/kg phosphorus pentoxide (P205).

Amendment    7

Proposal for a regulation

Recital 10 a (new)

Text proposed by the Commission

Amendment

 

(10a)  In order to take advantage of technical progress concerning the potential use of animal by-products, the relevant component material category should be further expanded without undue delay by including more animal by-products. That expanded component material category could help create more opportunities and legal certainty for producers and businesses by unlocking the potential to make better use of nutrients from animal by-products such as animal manure. Consequently, the power to adopt delegated acts in accordance with Article 290 of the Treaty on the Functioning of the European Union should be delegated to the Commission in respect of the addition, without undue delay, of certain animal by-products to specific component material categories.

Amendment    8

Proposal for a regulation

Recital 10 b (new)

Text proposed by the Commission

Amendment

 

(10b)  For animal by-products already widely used in Member States for the production of fertilisers, such as processed animal manure, the end point should be determined without undue delay, and at the latest by ... [OJ please insert the date: six months after the date of entry into force of this Regulation].

Amendment    9

Proposal for a regulation

Recital 13

Text proposed by the Commission

Amendment

(13)  For certain recovered wastes within the meaning of Directive 2008/98/EC of the European Parliament and of the Council20, 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 products does not lead to overall adverse environmental or human health impacts. For CE marked 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.

(13)  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 Council20, 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 products does not lead to overall adverse environmental or human health impacts. For CE marked 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. In order to take advantage of the technical developments and to further incentivise innovation in the recovery of valuable waste streams, the Commission should be empowered to adopt delegated acts in accordance with Article 290 of the Treaty on the Functioning of the European Union (TFEU) to add or expand the relevant component material categories, so as to include more recovered waste eligible for use in the production of CE-marked fertilising products, such as struvite, biochar and ash-based products. The proper assessment and setting of processing requirements should start immediately after the entry into force of this Regulation.

__________________

__________________

20 Directive 2008/98/EC of the European Parliament and of the Council on waste and repealing certain Directives (OJ L 312, 22.11.2008, p. 3).

20 Directive 2008/98/EC of the European Parliament and of the Council on waste and repealing certain Directives (OJ L 312, 22.11.2008, p. 3).

Amendment    10

Proposal for a regulation

Recital 15

Text proposed by the Commission

Amendment

(15)  Certain substances, mixtures and micro-organisms, commonly referred to as plant biostimulants, are not as such nutrients, but nevertheless stimulate plants' nutrition processes. Where such products aim solely at improving the plants' nutrient use efficiency, tolerance to abiotic stress, or crop quality traits, they are by nature more similar to fertilising products than to most categories of plant protection products. 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 Council21 Regulation (EC) No 1107/2009 should therefore be amended accordingly.

(15)  Certain substances, micro-organisms and mixtures thereof, commonly referred to as plant biostimulants, are not necessarily nutrients, but nevertheless stimulate plants' general vigour and nutrition processes. Where such products aim solely at improving the plants' nutrient use efficiency, nutrient availability tolerance to abiotic stress, plant quality traits, degradation of soil organic matter, or at increasing the availability of confined nutrients in the soil or the rhizosphere, or yield, they are by nature more similar to fertilising products than to most categories of plant protection products. 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 Council21. Regulation (EC) No 1107/2009 should therefore be amended accordingly.

_________________

_________________

21 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).

21 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).

Amendment    11

Proposal for a regulation

Recital 17

Text proposed by the Commission

Amendment

(17)  This Regulation should not prevent the application of existing Union legislation relating to aspects of protection of health, safety and the environment not covered by this Regulation. This Regulation should therefore apply without prejudice to Council Directive 86/278/EEC22 , Council Directive 89/391/EEC23 , Regulation (EC) No 1907/2006 of the European Parliament and of the Council24 , Regulation (EC) No 1272/2008 of the European Parliament and of the Council25 , Commission Regulation (EC) No 1881/200626 , Council Directive 2000/29/EC27 , Regulation (EU) No 98/2013 of the European Parliament and of the Council28 , and Regulation (EU) No 1143/2014 of the European Parliament and of the Council29 .

(17)  This Regulation should not prevent the application of existing Union legislation relating to aspects of protection of health, safety and the environment not covered by this Regulation. This Regulation should therefore apply without prejudice to Council Directive 86/278/EEC22 , Council Directive 91/676/EEC22a , Council Directive 2000/60/EC 22b , Council Directive 89/391/EEC23 , Regulation (EC) No 1907/2006 of the European Parliament and of the Council24 , Regulation (EC) No 1272/2008 of the European Parliament and of the Council25 , Commission Regulation (EC) No 1881/200626 , Council Directive 2000/29/EC27 , Regulation (EU) No 98/2013 of the European Parliament and of the Council28 , and Regulation (EU) No 1143/2014 of the European Parliament and of the Council29 and Council Regulation (EC) No 834/2007 29a .

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22 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).

22 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).

 

22a 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).

 

22b 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).

23 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).

23 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).

24 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) (OJ L 396, 30.12.2006, p. 1).

24 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) (OJ L 396, 30.12.2006, p. 1).

25 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 (OJ L 353, 31.12.2008, p. 1).

25 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 (OJ L 353, 31.12.2008, p. 1).

26 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).

26 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).

27 Council Directive 2000/29/EC of 8 May 2000 on protective measures against the introduction into the Community of organisms harmful to plants or plant products and against their spread within the Community (OJ L 169, 10.7.2000, p. 1).

27 Council Directive 2000/29/EC of 8 May 2000 on protective measures against the introduction into the Community of organisms harmful to plants or plant products and against their spread within the Community (OJ L 169, 10.7.2000, p. 1).

28 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).

28 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).

29 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).

29 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).

 

29a Council Regulation (EC) No 834/2007 of 28 June 2007 on organic production and labelling of organic products (OJ L 189, 20.7.2007, p. 1) .

Justification

The scope of the fertilising regulation is solely to guarantee the functioning of the internal market and to partially harmonise the conditions for placing in the market of CE marked fertilising products that can be traded in the internal market. The Nitrate Directive, the Water Framework Directive (200/60/EC) and the Council Regulation (EC) on organic production and labelling of organic products (No 834/2007) should fall outside the scope of placing in the market of the fertilising regulation.

Amendment    12

Proposal for a regulation

Recital 55

Text proposed by the Commission

Amendment

(55)  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 of the Treaty on the Functioning of the European Union should be delegated to the Commission in respect of defining larger or additional categories of CE marked fertilising products or component materials eligible for use in the production of such products. For animal by-products, component material categories should be expanded or added only to the extent an end point in the manufacturing chain has been determined in accordance with the procedures laid down in Regulation (EC) No 1069/2009, since animal by-products for which no such end point has been determined are in any event excluded from the scope of this Regulation.

(55)  Promising technical progress is being made in the field of recycling of waste, such as phosphorus recycling from sewage sludge, in particular struvite, fertilising product production from animal by-products, such as biochar and phosphorus recovery after incineration, in particular from ash-based products, and considering that such products are already authorised in several Member States under national law. It should be possible for products containing or consisting of such materials to access the internal market without undue 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 larger or additional categories of CE marked fertilising products or component materials eligible for use in the production of such products. In particular, a delegated act adding struvite, biochar and ash-based products to the categories of component materials should be adopted without undue delay after the entry into force of this Regulation. For animal by-products, component material categories should be expanded or added only to the extent an end point in the manufacturing chain has been determined in accordance with the procedures laid down in Regulation (EC) No 1069/2009.

Amendment    13

Proposal for a regulation

Recital 56

Text proposed by the Commission

Amendment

(56)  Furthermore, it should be possible to react immediately to new findings regarding the conditions for CE marked fertilising products to be sufficiently effective 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 of the Treaty should be delegated to the Commission to amend the requirements applicable to various categories of CE marked fertilising products.

(56)  Furthermore, it should be possible to react immediately to new findings regarding the conditions for CE marked fertilising products to be sufficiently effective and to new risk assessments regarding human, animal or plant health, safety or the environment, taking into account assessments made by or in cooperation with authorities in the Member States. For that purpose, the power to adopt acts in accordance with Article 290 of the Treaty should be delegated to the Commission to amend the requirements applicable to various categories of CE marked fertilising products.

Amendment    14

Proposal for a regulation

Recital 59 a (new)

Text proposed by the Commission

Amendment

 

(59a)  Provisions should be adopted to permit the continued use of products placed on the market in the context of mutual recognition under Regulation EC No 764/2008 of the European Parliament and of the Council1a.

 

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1a Regulation (EC) No 764/2008 of the European Parliament and of the Council of 9 July 2008 laying down procedures relating to the application of certain national technical rules to products lawfully marketed in another Member State and repealing Decision No 3052/95/EC (OJ L 218, 13.8.2008, p. 21).

Amendment    15

Proposal for a regulation

Article 1 – paragraph 2 – point b a (new)

Text proposed by the Commission

Amendment

 

(ba)  Directive 91/676/EEC;

Justification

The scope of the fertilising regulation is solely to guarantee the functioning of the internal market and to partially harmonise the conditions for placing in the market of CE marked fertilising products that can be traded in the internal market. Whereas the scope of the nitrates directive is the protection of water from agricultural pollution through certain restrictions of use of nutrients harmonised at EU level in already polluted areas. Amending the restriction on use in polluted areas included in the nitrates directive should fall outside of the scope of placing in the market of the fertilising regulation.

Amendment    16

Proposal for a regulation

Article 1 – paragraph 2 – point b b (new)

Text proposed by the Commission

Amendment

 

(bb)  Directive 2000/60/EC;

Justification

The scope of the fertilising regulation is solely to guarantee the functioning of the internal market and to partially harmonise the conditions for placing in the market of CE marked fertilising products that can be traded in the internal market. The water framework directive on good quality water in Europe (2000/60/EC) should fall outside of the scope of placing in the market of the fertilising regulation.

Amendment    17

Proposal for a regulation

Article 1 – paragraph 2 – point h a (new)

Text proposed by the Commission

Amendment

 

(ha)  Regulation (EC) No 834/2007.

Justification

Important to recognize organic agriculture and its particularities in the scope of fertiliser regulation.

Amendment    18

Proposal for a regulation

Article 2 – paragraph 1 – point 1

Text proposed by the Commission

Amendment

(1)  ‘fertilising product’ means a substance, mixture, micro-organism or any other material, applied or intended to be applied, either on its own or mixed with another material, on plants or their rhizosphere for the purpose of providing plants with nutrient or improving their nutrition efficiency;

(1)  'fertilising product' means a substance, mixture, micro-organism or any other material applied or intended to be applied, either on its own or mixed with another material, on fungi or their mycosphere or on plants at any growth stage, including seeds, and/or rhizosphere, for the purpose of providing plants or fungi with nutrients or of improving their physical or biological growth conditions or their general vigour, yields and quality by enhancing their nutrition efficiency, including by increasing the ability of the plant to take up nutrients from the phyllosphere (with the exception of plant protection products covered by Regulation (EC) No 1107/2009).

Amendment    19

Proposal for a regulation

Article 3 – paragraph 1

Text proposed by the Commission

Amendment

Member States shall not impede the making available on the market of CE marked fertilising products which comply with this Regulation.

Member States shall not impede the making available on the market of CE marked fertilising products which comply with this Regulation for reasons of composition, labelling or other provisions of this Regulation. Concerning the use of CE marked fertilising products, Member States may maintain or adopt national provisions for the purpose of protecting human health and the environment. However, those provisions shall not require modification of CE marked fertilising products which are in compliance with this Regulation. Also, those provisions shall not influence the conditions for making them available on the market.

Amendment    20

Proposal for a regulation

Article 4 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

 

2a.  The Commission shall simultaneously with the publication of this Regulation in the Official Journal of the European Union publish a guidance document giving clarity and examples to manufacturers and market surveillance authorities about the appearance of the label. This guidance document shall also specify other relevant information as referred to in point d of paragraph 2 of part I of Annex III.

Justification

In order to provide a clear information to the farmers and to avoid incorrect fertiliser applications with negative consequences for the environment, concrete requirements and visual aspects of labels for mineral fertilisers should be provided by the European Commission in a guidance document.

Amendment    21

Proposal for a regulation

Article 6 – paragraph 9

Text proposed by the Commission

Amendment

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 CE marked 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 CE marked fertilising products which they have placed on the market.

9.  Manufacturers shall, further to a 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 CE marked 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 CE marked fertilising products which they have placed on the market.

Amendment    22

Proposal for a regulation

Article 6 – paragraph 10 – subparagraph 1 – point a

Text proposed by the Commission

Amendment

(a)  straight or compound solid inorganic macronutrient ammonium nitrate fertilisers of high nitrogen content, as specified in product function category 1(C)(I)(a)(i-ii)(A) in Annex I;

(a)  straight or compound solid mineral macronutrient ammonium nitrate fertilisers of high nitrogen content, as specified in product function category 1(C)(I)(a)(i-ii)(A) in Annex I;

 

(This amendment from "inorganic fertiliser" to "mineral fertiliser" applies throughout the text. Adopting it will necessitate corresponding changes throughout.)

Amendment    23

Proposal for a regulation

Article 7 – paragraph 2 – point b

Text proposed by the Commission

Amendment

(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 a CE marked fertilising product;

(b)  further to a request from a competent national authority, provide that authority with all the information and documentation necessary to demonstrate the conformity of a CE marked fertilising product;

Amendment    24

Proposal for a regulation

Article 9 – paragraph 5

Text proposed by the Commission

Amendment

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 CE marked fertilising product. They shall cooperate with that authority, at its request, on any action taken to eliminate the risks posed by CE marked fertilising products which they have made available on the market.

5.  Distributors shall, further to a 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 CE marked fertilising product. They shall cooperate with that authority, at its request, on any action taken to eliminate the risks posed by CE marked fertilising products which they have made available on the market.

Amendment    25

Proposal for a regulation

Article 18 – paragraph 1

Text proposed by the Commission

Amendment

(1)  A CE marked fertilising product that has undergone a recovery operation and complies with the requirements laid down in this Regulation shall be considered to comply with the conditions laid down in Article 6(1) of Directive 2008/98/EC and shall, therefore, be considered as having ceased to be waste.

(1)  Where a material that was waste has undergone a recovery operation in accordance with this Regulation and a compliant CE marked fertilising product contains or consists of that material, the material shall be considered to comply with the conditions laid down in Article 6(1) of Directive 2008/98/EC and shall, therefore, be considered as having ceased to be waste from the moment the Union declaration of conformity is drawn up.

Amendment    26

Proposal for a regulation

Article 23 – paragraph 3 – subparagraph 2

Text proposed by the Commission

Amendment

A body belonging to a business association or professional federation representing undertakings involved in the design, manufacturing, provision, or use of CE marked fertilising products which it assesses, may, on condition that its independence and the absence of any conflict of interest are demonstrated, be considered such a body.

A body belonging to a business association or professional federation representing undertakings involved in the design, manufacturing, provision, or use of CE marked fertilising products which it assesses, may not be considered such a body.

Amendment    27

Proposal for a regulation

Article 23 – paragraph 8 – subparagraph 1

Text proposed by the Commission

Amendment

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 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. Appropriate protection shall be ensured for employees who report breaches committed within conformity assessment bodies against, at a minimum, retaliation, discrimination or any other type of unfair treatment.

Amendment    28

Proposal for a regulation

Article 33 – paragraph 2

Text proposed by the Commission

Amendment

2.  Notified bodies shall provide the other bodies notified under this Regulation carrying out similar conformity assessment activities covering the same CE marked fertilising products with relevant information on issues relating to negative and, on request, positive conformity assessment results.

2.  Without prejudice to existing Union rules on data protection and confidentiality of business information and the protection of tests and studies submitted for conformity assessment, notified bodies shall provide the other bodies notified under this Regulation carrying out similar conformity assessment activities covering the same CE marked fertilising products with relevant information on issues relating to negative and, on request, positive conformity assessment results.

Justification

Without this addition, Article 33 (2) implies that Notified Bodies may share applicants’ data among themselves without restriction, which could impair data protection.

Amendment    29

Proposal for a regulation

Article 42 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

1.  The Commission shall be empowered to adopt delegated acts in accordance with Article 43 to amend Annexes I to IV for the purposes of adapting them to technical progress and facilitating internal market access and free movement for CE marked fertilising products.

1.  The Commission shall be empowered to adopt delegated acts in accordance with Article 43 to amend Annexes I to IV for the purposes of adapting them to technical progress, in particular as regards the production of fertilisers from animal by-products and waste recovery products or which are used by manufacturers as by-products from or co-products of other industrial and/or agricultural processes, as well as recycled products, taking into account products and materials that have already been authorised in Member States, and for the facilitation of internal market access and free movement for CE marked fertilising products:

Amendment    30

Proposal for a regulation

Article 42 – paragraph 1 – point a

Text proposed by the Commission

Amendment

(a)  which are likely to be subject of significant trade on the internal market, and

(a)  which have potential to be subject of significant trade on the internal market, and

Amendment    31

Proposal for a regulation

Article 42 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

 

1a.  Without undue delay after the entry into force of this Regulation, the Commission shall adopt a delegated act, in accordance with paragraph 1, to amend the component material categories set out in Annex II to add in particular animal by-products, struvite, biochar and ash-based products to those component material categories, as well as to lay down the requirements for the inclusion of those products in those categories. The Commission shall specifically take into account technological progress in the recovery of nutrients.

Amendment    32

Proposal for a regulation

Article 42 – paragraph 1 b (new)

Text proposed by the Commission

Amendment

 

1b.  By [OJ please insert the date: six months after the date of publication of this Regulation], the Commission shall adopt a delegated act in accordance with paragraph 1 to amend Annex II in order to insert the end-points in the manufacturing chain that have been determined in accordance with the second subparagraph of Article 5(2) of Regulation (EC) No 1069/2009, with regard to the animal by-products listed in CMC11 of this Regulation.

Amendment    33

Proposal for a regulation

Article 42 – paragraph 2 – point a

Text proposed by the Commission

Amendment

(a)   name of the micro-organism;

(a)   name of the micro-organism, to the strain level;

Justification

Different strains of the same species may have extremely different properties.

Amendment    34

Proposal for a regulation

Article 42 – paragraph 2 – point d

Text proposed by the Commission

Amendment

(d)  taxonomic relation to micro-organism species fulfilling the requirements for a Qualified Presumption of Safety as established by the European Food Safety Agency;

(d)  taxonomic relation to micro-organism species fulfilling the requirements for a Qualified Presumption of Safety as established by the European Food Safety Authority;

Amendment    35

Proposal for a regulation

Article 42 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

 

2a.  The Commission shall be empowered to adopt delegated acts in accordance with Article 43 with regard to setting out requirements for the safety evaluation of new micro-organisms for the purpose of paragraph 2. The first of those delegated acts shall be presented to the European Parliament and to the Council no later than ... [OJ please insert the date: one year after the entry into force of this Regulation].

Justification

There is much innovation and development possible for the use of micro-organisms in fertilising products. Therefore it is important to ensure that this Regulation, as much as possible, enables development and innovation in this field. Facilitating the inclusion of more micro-organisms in this Regulation is one important step in this regard.

Amendment    36

Proposal for a regulation

Article 42 – paragraph 4 a (new)

Text proposed by the Commission

Amendment

 

4a.  With regard to Part II of Annex I, the empowerment to adopt delegated acts in accordance with paragraphs 1 and 4 excludes adaptations to the contaminant limits specified therein, unless new contaminant limits are necessary as a consequence of adding new component materials under Annex II. When new contaminant limits are set, those limits shall only apply to the new component materials added.

Amendment    37

Proposal for a regulation

Article 42 – paragraph 4 b (new)

Text proposed by the Commission

Amendment

 

4b.  The Commission shall review Part II of Annex I by ... [OJ please insert the date: ten years after the entry into force of this Regulation] or in case there is any new relevant scientific information available as regards the toxicity and carcinogenicity of relevant contaminants or any new technological progress and innovation in the field of production and use of fertilising products.

Justification

Requirements related to contaminant of product function categories shall be exempted from the powers delegated to the European Commission and reviewed via the ordinary legislative procedure given that one of the objectives of the new regulation is to address environmental concerns arising from contamination by EC-fertilisers of soil, inland waters, sea waters and ultimately food, thus making it a primary concern for human health.

Amendment    38

Proposal for a regulation

Article 45 – paragraph 1 – point 1 a (new)

Regulation (EC) No 1069/2009

Article 5 – paragraph 2 – point 1 a (new)

 

Text proposed by the Commission

Amendment

 

(1a)   in paragraph 2, the following subparagraph is added after the first subparagraph:

 

“For derived products falling under the scope of Article 32 that are already widely used in Member States for the production of fertilisers, the Commission shall determine such an end-point by [Publications office, please insert the date occurring six months after the date of publication of the Fertilisers Regulation]".

Amendment    39

Proposal for a regulation

Article 46 – paragraph 1 – point 2

Regulation (EC) 1107/2009

Article 3 – point 34 – introductory part

 

Text proposed by the Commission

Amendment

(3)  "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:

(3)  "34."plant biostimulant" means a product containing any substance or micro-organism stimulating plant nutrition processes independently of its nutrient content, or any combination of such substances and/or micro-organisms, with the sole aim of improving one or more of the following characteristics of the plant or the plant rhizosphere:

Amendment    40

Proposal for a regulation

Article 46 – paragraph 1 – point 2

Regulation (EC) 1107/2009

Article 3 – point 34 – point c a (new)

 

Text proposed by the Commission

Amendment

 

(ca)  degradation of organic matter in the soil;

Amendment    41

Proposal for a regulation

Article 46 – paragraph 1 – point 2

Regulation (EC) 1107/2009

Article 3 – point 34 – point c b (new)

 

Text proposed by the Commission

Amendment

 

(cb)  increase the availability of nutrients confined in the soil or the rhizosphere.

Amendment    42

Proposal for a regulation

Article 46 a (new)

Directive 91/676/EEC

Article 2 – point g

 

Text proposed by the Commission

Amendment

 

Article 46a

 

Amendment of Directive 91/676/EEC

 

In Directive 91/676/EEC point (g) of Article 2 is replaced by the following:

 

"(g) 'livestock manure': means waste products excreted by livestock or a mixture of litter and waste products excreted by livestock, even in processed form, unless these products have undergone a processing in accordance with Regulation (EC) No 1069/2009 and have reached a nitrate fertiliser replacement value of at least 90%."

Justification

It is important to provide a link between this regulation and the Nitrates Directive.

Amendment    43

Proposal for a regulation

Article 46 b (new)

Regulation (EC) No 1907/2006

Annex V – point 12

 

Text proposed by the Commission

Amendment

 

Article 46b

 

Amendment to Regulation (EC) No 1907/2006

 

Point 12 in Annex V is replaced by the following:

 

"12. Compost, biogas and digestate"

Justification

In order to support innovation and development in the circular economy regulatory certainty is essential. The following suggested amendment consolidate the wide spread implementation practice of Regulation (EC) No 1907/2006 (REACH) that digestates are not subject to registration under that Regulation.

Amendment    44

Proposal for a regulation

Article 48 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

 

1a.   Member States which have already implemented a lower limit for cadmium (Cd) content in organo-mineral fertilisers and inorganic fertilisers, set out in PFC 1 (B)(3)(a) and PFC 1 (C)(I)(2)(a) of Part II of Annex I may maintain that stricter limit until the limit established according to this Regulation is equal or lower. Member States shall notify such existing national measures to the Commission by ... [[OJ please insert the date: six months after the date of entry into force of this Regulation].

Amendment    45

Proposal for a regulation

Article 49 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

 

2a.   By way of derogation from paragraph 2 of this Article, Articles 42 and 45 shall apply from ... [OJ please insert the date: the date of entry into force of the Regulation].

Amendment    46

Proposal for a regulation

Annex I – part I – point 5 – point A – point I a (new)

Text proposed by the Commission

Amendment

 

Ia.  Denitrification inhibitor

Justification

It is necessary to add the denitrification inhibitor in the “Agronomic additive category”. Denitrification inhibitors are fundamental substances which aim to prevent atmospheric pollution by reducing the formation of dinitrogen from products such as livestock manure and bio-digestate.

Amendment    47

Proposal for a regulation

Annex I – part II – PFC 1(A) – paragraph 1

Text proposed by the Commission

Amendment

An organic fertiliser shall contain

An organic fertiliser shall contain

-  carbon (C) and

-  organic carbon (Corg) and

-  nutrients

-  nutrients

of solely biological origin, excluding material which is fossilized or embedded in geological formations.

of solely biological origin, such as peat, including leonardite, lignite and substances obtained from those materials, but excluding other materials which are fossilized or embedded in geological formations.

Amendment    48

Proposal for a regulation

Annex I – part II – PFC 1(A) – paragraph 2 – indent 1

Text proposed by the Commission

Amendment

-  Cadmium (Cd) 1,5 mg/kg dry matter,

-  Cadmium (Cd) 1.0 mg/kg dry mater

Justification

Given the fact that one of the intentions of the current regulation is to reduce the usage of organo-mineral and inorganic fertilisers and increase the usage of organic fertilisers in the EU market, it is of utmost importance that we aim to reduce as much as possible the accumulation in EU arable soil of carcinogenic substances like Cadmium. Cadmium is, since 2014 on the Candidate List given its known carcinogenic classification as C1A (known carcinogen in humans) under the REACH Regulation.

Amendment    49

Proposal for a regulation

Annex I – part II – PFC 1(A) – paragraph 2 – indent 5

Text proposed by the Commission

Amendment

-  Lead (Pb) 120 mg/kg dry matter, and

-  Lead (Pb) 20 mg/kg dry matter, and

Justification

The French Food Security Agency (ANSES) has concluded in a 2016 report that levels for Lead found in baby and child food are of extreme risk and non-acceptable and should immediately be lowered. Similarly, the European Commission’s study of the Joint Research Centre and the Institute for Reference Materials and Measurements in which the total lead in baby food in Europe was determined, Lead was found as very problematic substance for babies’ intake. Given the fact that presence of lead in fertilisers easily contaminates crops for human consumption, as it was confirmed by EFSA’s study on Lead dietary exposure in the European population, maximum limits for this toxic contaminant in contaminants should drastically be lowered for all fertilisers, including organic ones

Amendment    50

Proposal for a regulation

Annex I – part II – PFC 1(A) – paragraph 2 – indent 6

Text proposed by the Commission

Amendment

-  Biuret (C2H5N3O2) 12 g/kg dry matter.

-  Biuret (C2H5N3O2) under detection limit.

Justification

It is necessary to fix a low limit for biuret (chemical complex present in urea) in order to avoid fraudulent uses of urea that, thanks to its low price, could be used as substitute for organic matter.

Amendment    51

Proposal for a regulation

Annex I – part II – PFC 1(A) – paragraph 3

 

Text proposed by the Commission

3.  Salmonella spp. shall be absent in a 25 g sample of the CE marked fertilising product.

Amendment

3.  Pathogens must not be present in the organic fertiliser in a concentration of more than the respective limits outlined in the table below:

Micro-organism to be tested

Sampling plans

Limit

 

n

c

m

M

Salmonella spp

5

0

0

Absence in 25g or 25ml

Escherichia coli or Enterococcaceae

5

5

0

1000 in 1g or 1ml

where n = number of samples to be tested

c = number of samples where the number of bacteria expressed in CFU may be 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

Parasites Ascaris spp. and Toxocara spp. in all stages of their development must not be present in 100g or 100ml of the organic fertiliser.

Amendment    52

Proposal for a regulation

Annex I – part II – PFC 1(A) (I) – paragraph 1 a (new)

Text proposed by the Commission