REPORT 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

Text proposed by the Commission

Amendment

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

Text proposed by the Commission

Amendment

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

Text proposed by the Commission

Amendment

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

Text proposed by the Commission

Amendment

(6b)  A manufacturer using one or more CE marked fertilising products that have already been subject to a conformity assessment, carried out by that manufacturer or another manufacturer, might wish to rely on that conformity assessment. For the purpose of reducing the administrative burden to a minimum, the resulting CE marked fertilising product should also be regarded as a combination of two or more component fertilising products, and the additional conformity requirements for the combination should be reduced to the aspects warranted by the mixing.

Text proposed by the Commission

Amendment

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

(8)  Contaminants in CE marked fertilising products, if the latter are not used correctly, such as cadmium, can potentially pose a risk to human and animal health and the environment as they accumulate in the environment and enter the food chain. Their content should therefore be limited in such products. Furthermore, impurities in CE marked fertilising products derived from bio-waste, in particular polymers but also metal and glass, should be either prevented or limited to the extent technically feasible by detection of such impurities in separately collected bio-waste before processing.

Text proposed by the Commission

Amendment

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

Text proposed by the Commission

Amendment

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

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

Text proposed by the Commission

Amendment

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

Text proposed by the Commission

Amendment

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

Text proposed by the Commission

Amendment

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

Text proposed by the Commission

Amendment

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

Text proposed by the Commission

Amendment

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

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

Text proposed by the Commission

Amendment

(49)  The existing system should be supplemented by a procedure under which interested parties are informed of measures intended to be taken with regard to CE marked fertilising products presenting an unacceptable risk to human, animal or plant health, to safety or to the environment. It should also allow market surveillance authorities, in cooperation with the relevant economic operators, to act at an early stage in respect of such fertilising products.

(49)  The existing system should be supplemented by a procedure under which all interested parties, including health and consumers stakeholders, are informed of measures intended to be taken with regard to CE marked fertilising products presenting a risk to human, animal or plant health, to safety or to the environment. It should also allow market surveillance authorities, in cooperation with the relevant economic operators, to act at an early stage in respect of such fertilising products.

Text proposed by the Commission

Amendment

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

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

Text proposed by the Commission

Amendment

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

(57)  When adopting delegated acts provided for in this Regulation, it is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making. In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States' experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts.

Text proposed by the Commission

Amendment

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

Text proposed by the Commission

Amendment

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

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

Text proposed by the Commission

Amendment

(ba)  Directive 91/676/EEC;

Text proposed by the Commission

Amendment

(bb)  Directive 2000/60/EC;

Text proposed by the Commission

Amendment

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

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

Text proposed by the Commission

Amendment

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

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

Text proposed by the Commission

Amendment

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

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

Text proposed by the Commission

Amendment

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

Text proposed by the Commission

Amendment

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

deleted

Text proposed by the Commission

Amendment

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

Text proposed by the Commission

Amendment

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

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

Text proposed by the Commission

Amendment

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

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

Text proposed by the Commission

Amendment

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

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

Text proposed by the Commission

Amendment

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

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

Text proposed by the Commission

Amendment

8.  Importers shall, for 10 years after the CE marked fertilising product has been placed on the market, keep a copy of the EU declaration of conformity at the disposal of the market surveillance authorities and ensure that the technical documentation can be made available to those authorities, upon request.

8.  Importers shall, for five years after the CE marked fertilising product has been placed on the market, keep a copy of the EU declaration of conformity at the disposal of the market surveillance authorities and ensure that the technical documentation can be made available to those authorities, upon request. On request, importers shall make a copy of the EU declaration of conformity available to other economic operators concerned.

Text proposed by the Commission

Amendment

Where a distributor considers or has reason to believe that a CE marked fertilising product is not in conformity with the applicable requirements set out in Annex I, Annex II or Annex III, he or she shall not make the fertilising product available on the market until it has been brought into conformity. Furthermore, where the CE marked fertilising product presents an unacceptable risk to human, animal or plant health, to safety or to the environment, the distributor shall inform the manufacturer or the importer to that effect as well as the market surveillance authorities.

Where a distributor considers or has reason to believe that a CE marked fertilising product is not in conformity with the applicable requirements of this Regulation, he or she shall not make the fertilising product available on the market until it has been brought into conformity. Furthermore, where the CE marked fertilising product presents an unacceptable risk to human, animal or plant health, to safety or to the environment, the distributor shall inform the manufacturer or the importer to that effect as well as the market surveillance authorities.

Text proposed by the Commission

Amendment

Without prejudice to the common specifications referred to in Article 13, CE marked fertilising products which are in conformity with harmonised standards or parts thereof the references of which have been published in the Official Journal of the European Union shall be presumed to be in conformity with the requirements set out in Annexes I, II and III covered by those standards or parts thereof.

CE marked fertilising products which are in conformity with, or have been tested in conformity with harmonised standards or parts thereof the references of which have been published in the Official Journal of the European Union shall be presumed to be in conformity with the respective requirements set out in Annexes I, II and III covered by those standards or parts thereof.

Text proposed by the Commission

Amendment

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

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

Text proposed by the Commission

Amendment

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

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

Text proposed by the Commission

Amendment

2.  The notifying Member State shall provide the Commission, on request, with all information relating to the basis for the notification or the maintenance of the competence of the notified body concerned.

2.  The notifying authorities shall provide the Commission, on request, with all information relating to the basis for the notification or the maintenance of the competence of the notified body concerned.

Text proposed by the Commission

Amendment

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

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

Text proposed by the Commission

Amendment

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

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

Text proposed by the Commission

Amendment

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

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

Text proposed by the Commission

Amendment

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

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

Text proposed by the Commission

Amendment

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

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

Text proposed by the Commission

Amendment

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

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

Text proposed by the Commission

Amendment

Where the relevant economic operator does not take adequate corrective action within the period referred to in the second subparagraph of paragraph 1, the market surveillance authorities shall take all appropriate provisional measures to prohibit or restrict the CE marked fertilising product being made available on their national market, to withdraw the fertilising product from that market or to recall it.

Where the relevant economic operator does not take adequate corrective action within the period referred to in the second subparagraph of paragraph 1, the market surveillance authorities shall take all appropriate provisional measures to prohibit or restrict the CE marked fertilising product being made available on their national market, to withdraw the fertilising product from that market or to recall it. Market surveillance authorities' obligations in this respect shall be without prejudice to Member States' possibility to regulate fertilising products which are not CE marked when made available on the market.

Text proposed by the Commission

Amendment

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

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

Text proposed by the Commission

Amendment

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

Text proposed by the Commission

Amendment

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

Text proposed by the Commission

Amendment

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

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

Text proposed by the Commission

Amendment

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

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

Text proposed by the Commission

Amendment

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

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

Text proposed by the Commission

Amendment

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

Text proposed by the Commission

Amendment

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

Text proposed by the Commission

Amendment

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

Text proposed by the Commission

Amendment

3a.  Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making.

Text proposed by the Commission

Amendment

Member States shall lay down rules on penalties applicable to infringements of this Regulation and shall take all measures necessary to ensure that they are implemented. The penalties provided for shall be effective, proportionate and dissuasive. Member States shall, without delay, notify the Commission of those rules and of those measures and shall notify it, without delay, of any subsequent amendment affecting them.

Member States shall lay down rules on penalties applicable to infringements of this Regulation and shall take all measures necessary to ensure that they are implemented. The penalties provided for shall be effective, proportionate and dissuasive. Member States shall, without delay, notify the Commission of those rules and of those measures and shall notify it, without delay, of any subsequent amendment affecting them. Member States shall take all measures necessary to ensure that their rules on penalties are enforced.

Text proposed by the Commission

Amendment

Transitional provisions

Transitional provisions, review and reporting

Text proposed by the Commission

Amendment

Member States shall not impede the making available on the market of products which were placed on the market as fertilisers designated "EC fertiliser" in conformity with Regulation (EC) No 2003/2003 before [Publications office, please insert the date of application of this Regulation]. However, Chapter 5 shall apply mutatis mutandis to such products.

Member States shall not impede the making available on the market of products which were placed on the market as fertilisers designated "EC fertiliser" in conformity with Regulation (EC) No 2003/2003 before ... [twelve months after the date of application of this Regulation]. However, Chapter 5 shall apply mutatis mutandis to such products.

Text proposed by the Commission

Amendment

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

Text proposed by the Commission

Amendment

1b.  By … [42 months after the date of application of this Regulation], the Commission shall submit to the European Parliament and to the Council a report assessing the application of this Regulation and its overall impact as to the attainment of its objectives, including the impact on SMEs. That report shall in particular include:

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

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

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

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

The report shall take due account of technological progress and innovation as well as standardisation processes affecting production and use of fertilising products. It shall be accompanied, if necessary, by a legislative proposal by … [five years after the date of application of this Regulation].

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

Text proposed by the Commission

Amendment

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

Text proposed by the Commission

Amendment

It shall apply from 1 January 2018.

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

Text proposed by the Commission

Amendment

Ca.  Low carbon fertiliser

Text proposed by the Commission

Amendment

Ia.  Denitrification inhibitor

Text proposed by the Commission

Amendment

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

deleted

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

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

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

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

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

__________________

³² Council Regulation (EEC) No 315/93 of 8 February 1993 laying down Community procedures for contaminants in food (OJ L 37, 13.2.1993, p. 1).

³³ Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC (OJ L 70, 16.3.2005, p. 1).

³⁴ Regulation (EC) No 470/2009 of the European Parliament and of the Council of 6 May 2009 laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin, repealing Council Regulation (EEC) No 2377/90 and amending Directive 2001/82/EC of the European Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and of the Council (OJ L 152, 16.6.2009, p. 11).

³⁵ Directive 2002/32/EC of the European Parliament and of the Council of 7 May 2002 on undesirable substances in animal feed (OJ L 140, 30.5.2002, p. 10).

Text proposed by the Commission

Amendment

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

Text proposed by the Commission

Amendment

1. An organic fertiliser shall contain

1. An organic fertiliser shall contain

-  carbon (C) and

-  organic carbon (Corg) and

-  nutrients

-  nutrients

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

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

Text proposed by the Commission

Amendment

-  Cadmium (Cd) 1,5 mg/kg dry matter,

-  Cadmium (Cd) 1,0 mg/kg dry matter,

Text proposed by the Commission

Amendment

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

-  Lead (Pb) 20 mg/kg dry matter, and

Text proposed by the Commission

Amendment

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

-  Biuret (C₂H₅N3O₂) under detection limit.

Text proposed by the Commission

Amendment

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

Text proposed by the Commission

Amendment

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

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

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

Text proposed by the Commission

Amendment

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

Text proposed by the Commission

Amendment

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

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

Text proposed by the Commission

Amendment

-  2% by mass of total nitrogen (N),

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

Text proposed by the Commission

Amendment

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

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

Text proposed by the Commission

Amendment

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

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

Text proposed by the Commission

Amendment

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

Text proposed by the Commission

Amendment

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

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

5 % by mass of total sum of primary nutrients.

Text proposed by the Commission

Amendment

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

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

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

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

–  a material containing organic carbon (C) and

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

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

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

Text proposed by the Commission

Amendment

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

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

Text proposed by the Commission

Amendment

(e)  Lead (Pb) 120 mg/kg dry matter.

(e)  Lead (Pb) 20 mg/kg dry matter.

Text proposed by the Commission

Amendment

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

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

Text proposed by the Commission

Amendment

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

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

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

Text proposed by the Commission

Amendment

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

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

Text proposed by the Commission

Amendment

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

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

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

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

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

Text proposed by the Commission

Amendment

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

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

Text proposed by the Commission

Amendment

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

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

Text proposed by the Commission

Amendment

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

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

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

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

Text proposed by the Commission

Amendment

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

Text proposed by the Commission

Amendment

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

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

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

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

Text proposed by the Commission

Amendment

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

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

Text proposed by the Commission

Amendment

(e)  Lead (Pb) 150 mg/kg dry matter,

(e)  Lead (Pb) 20 mg/kg dry matter,

Text proposed by the Commission

Amendment

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

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

Text proposed by the Commission

Amendment

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

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

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

Text proposed by the Commission

Amendment

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

Text proposed by the Commission

Amendment

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

Text proposed by the Commission

Amendment

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

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

Text proposed by the Commission

Amendment

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

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

Text proposed by the Commission

Amendment

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

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

Text proposed by the Commission

Amendment

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

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

Text proposed by the Commission

Amendment

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

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

Text proposed by the Commission

Amendment

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

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

Text proposed by the Commission

Amendment

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

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

Text proposed by the Commission

Amendment

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

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

Text proposed by the Commission

Amendment

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

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

Text proposed by the Commission

Amendment

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

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

Text proposed by the Commission

Amendment

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

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

Text proposed by the Commission

Amendment

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

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

Text proposed by the Commission

Amendment

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

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

(a)  not more than one primary nutrient

Text proposed by the Commission

Amendment

(b)  not more than one secondary nutrient.

Text proposed by the Commission

Amendment

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

Text proposed by the Commission

Amendment

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

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

Text proposed by the Commission

Amendment

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

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

Text proposed by the Commission

Amendment

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

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

Text proposed by the Commission

Amendment

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

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

Text proposed by the Commission

Amendment

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

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

Text proposed by the Commission

Amendment

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

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

Text proposed by the Commission

Amendment

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

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

Text proposed by the Commission

Amendment

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

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

Text proposed by the Commission

Amendment

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

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

Text proposed by the Commission

Amendment

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

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

Text proposed by the Commission

Amendment

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

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

Text proposed by the Commission

Amendment

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

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

Text proposed by the Commission

Amendment

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

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

Text proposed by the Commission

Amendment

PFC1(C) a: LOW CARBON FERTILISER

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

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

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

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

Text proposed by the Commission

Amendment

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

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

Text proposed by the Commission

Amendment

-  Cadmium (Cd) 3 mg/kg dry matter,

-  Cadmium (Cd) 1 mg/kg dry matter,

Text proposed by the Commission

Amendment

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

-  Lead (Pb) 20 mg/kg dry matter, and

Text proposed by the Commission

Amendment

-  Arsenic (As) 120 mg/kg dry matter.

-  Arsenic (As) 20 mg/kg dry matter.

Text proposed by the Commission

Amendment

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

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

Text proposed by the Commission

Amendment

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

Text proposed by the Commission

Amendment

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

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

Text proposed by the Commission

Amendment

-  Cadmium (Cd) 3 mg/kg dry matter,

-  Cadmium (Cd) 1,5 mg/kg dry matter,

Text proposed by the Commission

Amendment

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

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

Text proposed by the Commission

Amendment

-  Lead (Pb) 120 mg/kg dry matter.

-  Lead (Pb) 20 mg/kg dry matter.

Text proposed by the Commission

Amendment

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

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

Text proposed by the Commission

Amendment

-  Lead (Pb) 150 mg/kg dry matter.

-  Lead (Pb) 20 mg/kg dry matter.

Text proposed by the Commission

Amendment

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

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

Text proposed by the Commission

Amendment

-  Cadmium (Cd) 3 mg/kg dry matter,

-  Cadmium (Cd) 1,5 mg/kg dry matter,

Text proposed by the Commission

Amendment

-  Lead (Pb) 150 mg/kg dry matter.

-  Lead (Pb) 20 mg/kg dry matter.

Text proposed by the Commission

Amendment

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

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

Text proposed by the Commission

Amendment

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

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

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³⁶ In the case of an additive recovered in the European Union, this condition is fulfilled if the additive is the same, within the meaning of Article 2(7)(d)(i) of Regulation (EC) No 1907/2006, as a substance registered in a dossier containing the information here indicated, and if information is available to the fertilising product manufacturer within the meaning of Article 2(7)(d)(ii) of Regulation (EC) No 1907/2006.

³⁶ In the case of an additive recovered in the European Union, this condition is fulfilled if the additive is the same, within the meaning of Article 2(7)(d)(i) of Regulation (EC) No 1907/2006, as a substance registered in a dossier containing the information here indicated, and if information is available to the fertilising product manufacturer within the meaning of Article 2(7)(d)(ii) of Regulation (EC) No 1907/2006.

Text proposed by the Commission

Amendment

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

deleted

Text proposed by the Commission

Amendment

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

deleted

Text proposed by the Commission

Amendment

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

deleted

Text proposed by the Commission

Amendment

PFC 5(A)(Ia): Denitrification inhibitor

1.  A denitrification inhibitor shall be an inhibitor that reduces the formation of nitrous oxide (N₂O) by slowing down or blocking the conversion of nitrate (NO₃-) to dinitrogen (N₂) without influencing the nitrification process as described in PFC 5(A)(I). It shall contribute to increase the availability of nitrate to the plant and to reduce N₂O emissions.

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

Text proposed by the Commission

Amendment

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

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

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³⁷ In the case of an additive recovered in the European Union, this condition is fulfilled if the additive is the same, within the meaning of Article 2(7)(d)(i) of Regulation (EC) No 1907/2006, as a substance registered in a dossier containing the information here indicated, and if information is available to the fertilising product manufacturer within the meaning of Article 2(7)(d)(ii) of Regulation (EC) No 1907/2006.

³⁷ In the case of an additive recovered in the European Union, this condition is fulfilled if the additive is the same, within the meaning of Article 2(7)(d)(i) of Regulation (EC) No 1907/2006, as a substance registered in a dossier containing the information here indicated, and if information is available to the fertilising product manufacturer within the meaning of Article 2(7)(d)(ii) of Regulation (EC) No 1907/2006.

Text proposed by the Commission

Amendment

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

deleted

Text proposed by the Commission

Amendment

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

deleted

Text proposed by the Commission

Amendment

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

deleted

Text proposed by the Commission

Amendment

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

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

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³⁸ In the case of an additive recovered in the European Union, this condition is fulfilled if the additive is the same, within the meaning of Article 2(7)(d)(i) of Regulation (EC) No 1907/2006, as a substance registered in a dossier containing the information here indicated, and if information is available to the fertilising product manufacturer within the meaning of Article 2(7)(d)(ii) of Regulation (EC) No 1907/2006.

³⁸ In the case of an additive recovered in the European Union, this condition is fulfilled if the additive is the same, within the meaning of Article 2(7)(d)(i) of Regulation (EC) No 1907/2006, as a substance registered in a dossier containing the information here indicated, and if information is available to the fertilising product manufacturer within the meaning of Article 2(7)(d)(ii) of Regulation (EC) No 1907/2006.

Text proposed by the Commission

Amendment

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

deleted

Text proposed by the Commission

Amendment

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

deleted

Text proposed by the Commission

Amendment

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

deleted

Text proposed by the Commission

Amendment

1.  A plant biostimulant shall be a CE marked fertilising product stimulating plant nutrition processes independently of the product's nutrient content with the sole aim of improving one or more of the following characteristics of the plant:

1.  A plant biostimulant shall be a CE marked fertilising product stimulating plant nutrition processes independently of the product's nutrient content with the sole aim of improving one or more of the following characteristics of the plant and the plant rhizophere or phyllosphere:

Text proposed by the Commission

Amendment

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

Text proposed by the Commission

Amendment

(cb)  humification

Text proposed by the Commission

Amendment

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

Text proposed by the Commission

Amendment

-  Cadmium (Cd) 3 mg/kg dry matter,

-  Cadmium (Cd) 1,5 mg/kg dry matter,

Text proposed by the Commission

Amendment

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

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

Text proposed by the Commission

Amendment

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

1.  A microbial plant biostimulant shall consist:

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

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

Text proposed by the Commission

Amendment

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

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Text proposed by the Commission

Amendment

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

deleted

Text proposed by the Commission

Amendment

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

deleted

Text proposed by the Commission

Amendment

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

deleted

Text proposed by the Commission

Amendment

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

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Text proposed by the Commission

Amendment

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

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Text proposed by the Commission

Amendment

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

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Text proposed by the Commission

Amendment

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

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Text proposed by the Commission

Amendment

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

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Text proposed by the Commission

Amendment

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

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

Text proposed by the Commission

Amendment

CMC 11a: Other industry by-products

Text proposed by the Commission

Amendment

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

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

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³⁹ The exclusion of a material from CMC 1 does not prevent it from being an eligible component material by virtue of another CMC stipulating different requirements. See, for instance, CMC 11 on animal by-products, CMCs 9 and 10 on polymers, and CMC 8 on agronomic additives.

³⁹ The exclusion of a material from CMC 1 does not prevent it from being an eligible component material by virtue of another CMC stipulating different requirements. See, for instance, CMC 11 on animal by-products, CMCs 9 and 10 on polymers, and CMC 8 on agronomic additives.

Text proposed by the Commission

Amendment

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

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

Text proposed by the Commission

Amendment

(e)  polymers, or

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

Text proposed by the Commission

Amendment

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

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

Text proposed by the Commission

Amendment

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

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Text proposed by the Commission

Amendment

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

deleted

Text proposed by the Commission

Amendment

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

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Text proposed by the Commission

Amendment

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

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

Text proposed by the Commission

Amendment

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

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

Text proposed by the Commission

Amendment

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

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

Text proposed by the Commission

Amendment

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

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

Text proposed by the Commission

Amendment

–  sewage sludge, industrial sludge or dredging sludge, and

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

Text proposed by the Commission

Amendment

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

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

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⁴⁰ In the case of an additive recovered in the European Union, this condition is fulfilled if the additive is the same, within the meaning of Article 2(7)(d)(i) of Regulation (EC) No 1907/2006, as a substance registered in a dossier containing the information here indicated, and if information is available to the fertilising product manufacturer within the meaning of Article 2(7)(d)(ii) of Regulation (EC) No 1907/2006.

⁴⁰ In the case of an additive recovered in the European Union, this condition is fulfilled if the additive is the same, within the meaning of Article 2(7)(d)(i) of Regulation (EC) No 1907/2006, as a substance registered in a dossier containing the information here indicated, and if information is available to the fertilising product manufacturer within the meaning of Article 2(7)(d)(ii) of Regulation (EC) No 1907/2006.

Text proposed by the Commission

Amendment

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

deleted

Text proposed by the Commission

Amendment

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

deleted

Text proposed by the Commission

Amendment

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

deleted

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

Text proposed by the Commission

Amendment

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

Text proposed by the Commission

Amendment

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

Text proposed by the Commission

Amendment