Texts adopted - CE marked fertilising products ***I

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Document selected : A8-0270/2017
Texts tabled : A8-0270/2017		Debates : PV 23/10/2017 - 17 CRE 23/10/2017 - 17 PV 27/03/2019 - 16 CRE 27/03/2019 - 16		Votes : PV 24/10/2017 - 5.7 CRE 24/10/2017 - 5.7 Explanations of votes PV 27/03/2019 - 18.7		Texts adopted : P8_TA(2017)0392 P8_TA(2019)0306

Texts adopted

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Tuesday, 24 October 2017 - Strasbourg

CE marked fertilising products ***I

P8_TA(2017)0392

A8-0270/2017

Amendments adopted by the European Parliament on 24 October 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))(1)

(Ordinary legislative procedure: first reading)

Text proposed by the Commission

Amendment

Amendment 1
Proposal for a regulation
Title

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. If agreed by the co-legislators, corresponding changes will apply throughout the text, including those parts reflected in the amendments below.)

Amendment 2
Proposal for a regulation
Recital 1

(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 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.

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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”. If agreed by the co-legislators, corresponding changes will apply throughout the text, including those parts reflected in the amendments below.)

Amendment 3
Proposal for a regulation
Recital 2 a (new)

(2a) Nutrients in food originate from the soil; healthy and nutritious soil results in healthy and nutritious crops and food. Farmers need a wide range of fertilisers, organic and synthetic to be available, 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)

(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)

(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)

(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

(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)

(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)

(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 395
Proposal for a regulation
Recital 8 c (new)

(8c) As from [date of application of this Regulation] the Commission should establish a mechanism further facilitating access to finance for research and innovation into decadmiation technologies and their implementation in the production process in the Union for all phosphate fertilisers, and into possible cadmium removal solutions that are economically viable on an industrial scale and allow the treatment of the waste generated.

Amendment 10
Proposal for a regulation
Recital 9

(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 Council18, 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.

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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

(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)

(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

(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

(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.

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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)

(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

(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)

(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

(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 optimising 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.

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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)

(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 micro-organisms as component materials for CE marked fertilising products, harmonized methods for the safety evaluation of 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 micro-organisms in order to be used in CE marked fertilising products.

Amendment 20
Proposal for a regulation
Recital 16

(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

(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

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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).

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).

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).

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).

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)

(17a) The traceability of products which are vulnerable to organic pollution from certain potentially problematic sources (or perceived as such) back to the source of the organic material should be ensured. This is necessary in order to secure consumer confidence and to limit damage if local contamination occurs. As a result, businesses which use fertilising 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)

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

Amendment 24
Proposal for a regulation
Recital 19 a (new)

(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

(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). If agreed by the co-legislators, corresponding changes will apply throughout the text, including those parts reflected in the amendments below.)

Amendment 26
Proposal for a regulation
Recital 25

(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

(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

(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. Furthermore, the intended use of CE marked fertilising products should not lead to food or feed becoming unsafe.

Amendment 29
Proposal for a regulation
Recital 49

(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

(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)

(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 minimise 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

(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

(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)

(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

(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)

(ba) Directive 91/676/EEC;

Amendment 37
Proposal for a regulation
Article 1 – paragraph 2 – point b b (new)

(bb) Directive 2000/60/EC;

Amendment 38
Proposal for a regulation
Article 2 – paragraph 1 – point 1

(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 (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

(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

(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

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)

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 provided that they do not influence the conditions for making them available on the market.

Amendment 44
Proposal for a regulation
Article 4 – paragraph 2 a (new)

2a. Commission shall simultaneously with the publication of this Regulation in the Official Journal of the European Union publish a guidance document giving clear information 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

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. If agreed by the co-legislators, corresponding changes will apply throughout the text, including those parts reflected in the amendments below.)

Amendment 46
Proposal for a regulation
Article 6 – paragraph 4 – subparagraph 1

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

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

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. Such 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

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

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

(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

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. The list of the competent authorities of Member States shall be provided by the Commission on its website.

Amendment 53
Proposal for a regulation
Article 8 – paragraph 1

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

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

Amendment 54
Proposal for a regulation
Article 8 – paragraph 2

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

(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

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

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). If agreed by the co-legislators, corresponding changes will apply throughout the text, including those parts reflected in the amendments below.)

Amendment 73
Proposal for a regulation
Article 37 – paragraph 1 – subparagraph 2

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

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

(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)

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

Amendment 77
Proposal for a regulation
Article 38 – paragraph 2 a (new)

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 (ba) 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

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

Amendment 80
Proposal for a regulation
Article 42 – paragraph 1

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 the 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)

1a. Without undue delay after … [date of the entry into force of this Regulation], the Commission shall adopt delegated acts, 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 345
Proposal for a regulation
Article 42 – paragraph 1 b (new)

1b. The Commission shall be empowered to adopt delegated acts in accordance with Article 43 to extend the date of entry into force of the 20mg/kg limit referred to in Annex I, part II, PFC1(B), point 3, point (a), point 2 and Annex I, part II, PFC1(C)I, point 2, point (a), point 2, if, based on a thorough impact assessment, it has evidence to consider that the introduction of a stricter limit would seriously jeopardise the supply of fertilising products to the Union.

Amendment 82
Proposal for a regulation
Article 42 – paragraph 2 – introductory part

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

(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

Amendment 85
Proposal for a regulation
Article 42 – paragraph 2 – point d

(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 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)

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 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)

By … [six months after the date of entry into force of this Regulation], the Commission shall adopt delegated acts in accordance with Article 43 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 CMC 11 of Annex II.

Amendment 88
Proposal for a regulation
Article 42 – paragraph 3 a (new)

3a. When adopting delegated acts referred to in paragraph 1, the Commission shall amend the component material category setting the requirement for polymers other than nutrient polymers 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)

3b. When adopting delegated acts referred to in paragraph 1, the Commission shall amend the component material category setting the criteria for other industry by-products 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 91
Proposal for a regulation
Article 43 – paragraph 3 a (new)

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

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.

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)

(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) No 1107/2009
Article 3 – point 34 – introductory part

(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) No 1107/2009
Article 3 – point 34 – point c

Amendment 96
Proposal for a regulation
Article 46 – paragraph 1 – point 2
Regulation (EC) No 1107/2009
Article 3 – point 34 – point c a (new)

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

Amendment 97
Proposal for a regulation
Article 46 – paragraph 1 – point 2
Regulation (EC) No 1107/2009
Article 3 – point 34 – point c b (new)

(cb) degradation of organic compounds in the soil;

Amendment 98
Proposal for a regulation
Article 46 – paragraph 1 – point 2
Regulation (EC) No 1107/2009
Article 3 – point 34 – point c c (new)

(cc) humification;

Amendment 99
Proposal for a regulation
Article 48 – title

Transitional provisions

Transitional provisions, reporting and review

Amendment 100
Proposal for a regulation
Article 48 – paragraph 1

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)

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)

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)

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

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)

Ca. Low carbon fertiliser

Amendment 106
Proposal for a regulation
Annex I – part I – point 5 – point A – point I a (new)

Ia. Denitrification inhibitor

Amendment 107
Proposal for a regulation
Annex I – part II – point 4

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 ,

(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 a (new)

4a. 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

1. An organic fertiliser shall contain

— carbon (C) and

— organic carbon (Corg) and

— 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

— Cadmium (Cd) 1,5 mg/kg dry matter,

— Cadmium (Cd) 1,0 mg/kg dry matter,

Amendment 112
Proposal for a regulation
Annex I – part II – PFC 1(A) – point 2 – indent 6

— 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) – point 1 a (new)

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)

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)

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

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

— 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

– 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

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

– 1 % 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)

– 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)

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

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 343
Proposal for a regulation
Annex I – part II – PFC1(B) – point 3 – point a – point 2 – indents 2 and 3

– As of [Publications office, please insert the date occurring three years after the date of application of this Regulation]: 40 mg/kg phosphorus pentoxide (P2O5), and

– As of [Publications office, please insert the date occurring six years after the date of application of this Regulation]: 40 mg/kg phosphorus pentoxide (P2O5), and

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

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

— 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)

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

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)

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

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

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)

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)

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

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 344
Proposal for a regulation
Annex I – part II – PFC 1(C)(I) – point 2 – point a – point 2 – indents 2 and 3

– As of [Publications office, please insert the date occurring three years after the date of application of this Regulation]: 40 mg/kg phosphorus pentoxide (P2O5), and

– As of [six years after the date of application of this Regulation]: 40 mg/kg phosphorus pentoxide (P2O5), and

– 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 [sixteen years after the date of application of this Regulation]: 20 mg/kg phosphorus pentoxide (P2O5),

Amendment 139
Proposal for a regulation
Annex I – part II – PFC 1(C)(I)(a)(i) – point 1

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)

(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)

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

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

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

– 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

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

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

– 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

– 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

– 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

– 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

– 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

– 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

— 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

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)

(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)

1a. A 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

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 158
Proposal for a regulation
Annex I – part II – PFC 1(C)(I)(b)(i) – point 2 – indent 2

– 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

– 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

– 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

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

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

— 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

– 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

– 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

– 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

– 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

– 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

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).

Amendment 170
Proposal for a regulation
Annex I – part II – PFC 1(C) a (new)

PFC 1(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 PFC 1(C)a shall comply with contaminant levels as specified in Annex I defined for organic or organo-mineral fertilisers in any case where PFC 1(C) does not contain any limit values for those contaminants.

Amendment 171
Proposal for a regulation
Annex I – part II – PFC 2 – point 1

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 398
Proposal for a regulation
Annex I – part II – PFC 2 – point 3

3. The following parameters determined on dry matter shall be met:

– Minimum neutralising value: 15 (equivalent CaO) or 9 (equivalent HO-), and

– Minimum reactivity: 10% or 50% after 6 months (incubation test).

– Minimum reactivity: 10% or 50% after 6 months (incubation test), and

– Minimum grain size: 70 % < 1 mm, except for burnt limes, granulated liming material and chalk (=70 % of the grain size shall pass through a 1 mm sieve)

Amendment 175
Proposal for a regulation
Annex I – part II – PFC 3 – point 1

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 1 a (new)

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

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 179
Proposal for a regulation
Annex I – part II – PFC 3(A) – point 2 – indent 2

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

— Hexavalent chromium (Cr VI) 1 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

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 184
Proposal for a regulation
Annex I – part II – PFC 4 – point 1

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 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

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 193
Proposal for a regulation
Annex I – part II – PFC 5(A)(I a) (new)

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 202
Proposal for a regulation
Annex I – part II – PFC 6 – point 1 – introductory part

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:

Amendment 203
Proposal for a regulation
Annex I – part II – PFC 6 – point 1 – point c a (new)

(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)

(cb) humification,

Amendment 205
Proposal for a regulation
Annex I – part II – PFC 6 – point 1 – point c c (new)

(cc) degradation of organic compounds in the soil.

Amendment 206
Proposal for a regulation
Annex I – part II – PFC 6 – point 2 – indent 1

— Cadmium (Cd) 3 mg/kg dry matter,

— Cadmium (Cd) 1,5 mg/kg dry matter,

Amendment 208
Proposal for a regulation
Annex I – part II – PFC 6(A) – point 1

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) of this point. 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

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

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

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

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

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

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

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

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

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

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)

CMC 11a: Other industry by-products

Amendment 221
Proposal for a regulation
Annex II – part II – CMC 1 – point 1 – introductory part

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.

Amendment 222
Proposal for a regulation
Annex II – part II – CMC 1 – point 1 – point b

(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

(e) polymers, or

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

Amendment 228
Proposal for a regulation
Annex II – part II – CMC 2 – point 1

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

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 – introductory part

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

(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 5 of that Regulation;

Amendment 232
Proposal for a regulation
Annex II – part II – CMC 3 – point 1 – point c – introductory part

(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

Amendment 233
Proposal for a regulation
Annex II – part II – CMC 3 – point 1 – point c – indent 2

– 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 238
Proposal for a regulation
Annex II – part II – CMC 3 – point 1 – point e a (new)

(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)

(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

– 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 241
Proposal for a regulation
Annex II – part II – CMC 3 – point 6 – point a – indent 2

— 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

CMC 4: Energy crop digestate

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

Amendment 247
Proposal for a regulation
Annex II – part II – CMC 4 – point 1 – point c

Amendment 248
Proposal for a regulation
Annex II – part II – CMC 4 – point 2 – indent 1

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

Amendment 249
Proposal for a regulation
Annex II – part II – CMC 4 – point 3 – point b

(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 54, 26.2.2011, p. 1).

Amendment 250
Proposal for a regulation
Annex II – part II – CMC 4 – point 3 – point d

(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 251
Proposal for a regulation
Annex II – part II – CMC 5 – point 1 – point c – indent 2

– sewage sludge, industrial sludge or dredging sludge,

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

Amendment 255
Proposal for a regulation
Annex II – part II – CMC 5 – point 1 – point e – introductory part

(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)

(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)

(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

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

Amendment 259
Proposal for a regulation
Annex II – part II – CMC 5 – point 3 – point a

(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

(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

(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)

(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)

(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)

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

Amendment 269
Proposal for a regulation
Annex II – part II – CMC 6 – point 2 – subparagraph 2 a (new)

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

– 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

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)

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

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).

Amendment 274
Proposal for a regulation
Annex II – part II – CMC 9 – point 3

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

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

(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

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 laid down in delegated acts referred to in 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)

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)

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)

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 (EC) 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)

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 (EC) No 2003/2003 as components of CE marked fertilising products, for their inclusion to the component material category shall be established in the light of the latest scientific evidence and laid down in delegated acts referred to in Article 42 of this Regulation.

Amendment 282
Proposal for a regulation
Annex III – part 1 – point 2 – point e

(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)

(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)

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)

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

(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

(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

(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. If agreed by the co-legislators, corresponding changes will apply throughout the text, including those parts reflected in the amendments below.)

Amendment 289
Proposal for a regulation
Annex III – part 2 – PFC 1(A) – point 1 – point c

(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

– 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)

– 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

– 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

– 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)

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 – PFC 1(C)(I) – point 1 – point d – indent 2

– Total Phosphorus pentoxide (P2O5);

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

Amendment 296
Proposal for a regulation
Annex III – part 2 – PFC 1(C)(I) – point 1 – point d – indent 2 – subindent 3

– 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 – PFC 1(C)(I) – point 1 – point d – indent 4 – subindent 1 a (new)

– 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)

(da) pH

Amendment 299
Proposal for a regulation
Annex III – part 2 – PFC 1(C)(I) – point 1 a (new)

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

Amendment 301
Proposal for a regulation
Annex III – part 2 – PFC 1(C)(I)(a) – point 4 a (new)

4a. For CE marked fertilising 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

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)

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;

(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 399
Proposal for a regulation
Annex III – part 2 – PFC 2 – indent 2

— Granulometry, expressed a percentage of product passing through a determined sieve;

— Granulometry, expressed as the percentage of product passing through the sieves of 1,0 mm and 3,15 mm;

Amendment 304
Proposal for a regulation
Annex III – part 2 – PFC 3 – point 1 – indent 3

– Total nitrogen (N) content;

deleted

Amendment 305
Proposal for a regulation
Annex III – part 2 – PFC 3 – point 1 – indent 4

– Total phosphorus pentoxide (P2O5) content;

deleted

Amendment 306
Proposal for a regulation
Annex III – part 2 – PFC 3 – point 1 – indent 5

– Total potassium oxide (K2O) content;

deleted

Amendment 307
Proposal for a regulation
Annex III – part 2 – PFC 6 – point e

(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)

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

Amendment 309
Proposal for a regulation
Annex III – part 3 –PFC 1(A)

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)

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

Text proposed by the Commission
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

Text proposed by the Commission
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

(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)

(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)

(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)

(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

(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

(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

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)

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

– 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

(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)	The matter was referred back for interinstitutional negotiations to the committee responsible, pursuant to Rule 59(4), fourth subparagraph (A8-0270/2017).

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