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Regulation (EU) 2019/1009 of the European Parliament and of the Council of 5 June 2019 laying down rules on the making available on the market of EU fertilising products and amending Regulations (EC) No 1069/2009 and (EC) No 1107/2009 and repealing Regulation (EC) No 2003/2003 (Text with EEA relevance)

Regulation (EU) 2019/1009 of the European Parliament and of the Council of 5 June 2019 laying down rules on the making available on the market of EU fertilising products and amending Regulations (EC) No 1069/2009 and (EC) No 1107/2009 and repealing Regulation (EC) No 2003/2003 (Text with EEA relevance)

CHAPTER I GENERAL PROVISIONS

Article 1 Scope

1.

This Regulation applies to EU fertilising products.

This Regulation does not apply to:

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

  2. plant protection products covered by the scope of Regulation (EC) No 1107/2009.

2.

This Regulation does not affect the application of the following legal acts:

  1. Directive 86/278/EEC;

  2. Directive 89/391/EEC;

  3. Directive 91/676/EEC;

  4. Directive 2000/60/EC;

  5. Directive 2001/18/EC;

  6. Regulation (EC) No 852/2004;

  7. Regulation (EC) No 882/2004;

  8. Regulation (EC) No 1881/2006;

  9. Regulation (EC) No 1907/2006;

  10. Regulation (EC) No 834/2007;

  11. Regulation (EC) No 1272/2008;

  12. Regulation (EU) No 98/2013;

  13. Regulation (EU) No 1143/2014;

  14. Regulation (EU) 2016/2031;

  15. Directive (EU) 2016/2284;

  16. Regulation (EU) 2017/625.

Article 2 Definitions

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

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

  2. ‘EU fertilising product’ means a fertilising product which is CE marked when made available on the market;

  3. ‘substance’ means a substance as defined in point 1 of Article 3 of Regulation (EC) No 1907/2006;

  4. ‘mixture’ means a mixture as defined in point 2 of Article 3 of Regulation (EC) No 1907/2006;

  5. ‘micro-organism’ means a micro-organism as defined in point 15 of Article 3 of Regulation (EC) No 1107/2009;

  6. ‘liquid form’ means a suspension or a solution, where a suspension is a two-phase dispersion in which solid particles are maintained in suspension in the liquid phase, and a solution is a liquid that is free of solid particles, or a gel and includes pastes;

  7. ‘solid form’ means form characterised by structural rigidity and resistance to changes of shape or volume and in which the atoms are tightly bound to each other, either in a regular geometric lattice (crystalline solids) or in an irregular manner (an amorphous solid);

  8. ‘% by mass’ means a percentage of the mass of the entire EU fertilising product in the form in which it is made available on the market;

  9. ‘making available on the market’ means any supply of an EU fertilising product for distribution or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge;

  10. ‘placing on the market’ means the first making available of an EU fertilising product on the Union market;

  11. ‘manufacturer’ means any natural or legal person who manufactures an EU fertilising product or has an EU fertilising product designed or manufactured, and markets that EU fertilising product under his or her name or trademark;

  12. ‘authorised representative’ means any natural or legal person established within the Union who has received a written mandate from a manufacturer to act on his or her behalf in relation to specified tasks;

  13. ‘importer’ means any natural or legal person established within the Union who places an EU fertilising product from a third country on the Union market;

  14. ‘distributor’ means any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes an EU fertilising product available on the market;

  15. ‘economic operators’ means the manufacturer, the authorised representative, the importer and the distributor;

  16. ‘technical specification’ means a document that prescribes technical requirements to be fulfilled by an EU fertilising product, by its production process or by the methods for its sampling and analysis;

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

  18. ‘accreditation’ means accreditation as defined in point 10 of Article 2 of Regulation (EC) No 765/2008;

  19. ‘national accreditation body’ means national accreditation body as defined in point 11 of Article 2 of Regulation (EC) No 765/2008;

  20. ‘conformity assessment’ means the process demonstrating whether the requirements of this Regulation relating to an EU fertilising product have been fulfilled;

  21. ‘conformity assessment body’ means a body that performs conformity assessment activities including testing, certification and inspection;

  22. ‘recall’ means any measure aimed at achieving the return of an EU fertilising product that has already been made available to the end-user;

  23. ‘withdrawal’ means any measure aimed at preventing an EU fertilising product in the supply chain from being made available on the market;

  24. ‘Union harmonisation legislation’ means any Union legislation harmonising the conditions for the marketing of products;

  25. ‘CE marking’ means a marking by which the manufacturer indicates that the EU fertilising product is in conformity with the applicable requirements set out in Union harmonisation legislation providing for its affixing.

Article 3 Free movement

1.

Member States shall not impede, for reasons relating to composition, labelling or other aspects covered by this Regulation, the making available on the market of EU fertilising products which comply with this Regulation.

2.

By way of derogation from paragraph 1 of this Article, a Member State which, on 14 July 2019 benefits from a derogation from Article 5 of Regulation (EC) No 2003/2003 in relation to cadmium content in fertilisers granted in accordance with Article 114(4) TFEU may continue to apply the national limit values for cadmium content in fertilisers which are applicable in that Member State on 14 July 2019 to EU fertilising products until such time as harmonised limit values for cadmium content in phosphate fertilisers which are equal to or lower than the limit values applicable in the Member State concerned on 14 July 2019 are applicable at Union level.

3.

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

Article 4 Product requirements

1.

An EU fertilising product shall:

  1. meet the requirements set out in Annex I for the relevant product function category;

  2. meet the requirements set out in Annex II for the relevant component material category or categories; and

  3. be labelled in accordance with the labelling requirements set out in Annex III.

2.

For any aspects not covered by Annex I or II, EU fertilising products shall not present a risk to human, animal or plant health, to safety or to the environment.

3.

By 16 July 2020, the Commission shall publish a guidance document for manufacturers and market surveillance authorities with clear information and examples concerning the visual appearance of the label referred to in Annex III.

Article 5 Making available on the market

CHAPTER II OBLIGATIONS OF ECONOMIC OPERATORS

Article 6 Obligations of manufacturers

Article 7 Authorised representative

Article 8 Obligations of importers

Article 9 Obligations of distributors

Article 10 Cases in which obligations of manufacturers apply to importers and distributors

Article 11 Packaging and repackaging by importers and distributors

Article 12 Identification of economic operators

CHAPTER III CONFORMITY OF EU FERTILISING PRODUCTS

Article 13 Presumption of conformity

Article 14 Common specifications

Article 15 Conformity assessment procedures

Article 16 EU declaration of conformity

Article 17 General principles of CE marking

Article 18 Rules and conditions for affixing the CE marking

Article 19 End-of-waste status

CHAPTER IV NOTIFICATION OF CONFORMITY ASSESSMENT BODIES

Article 20 Notification

Article 21 Notifying authorities

Article 22 Requirements relating to notifying authorities

Article 23 Information obligation on notifying authorities

Article 24 Requirements relating to notified bodies

Article 25 Presumption of conformity of notified bodies

Article 26 Subsidiaries of and subcontracting by notified bodies

Article 27 Application for notification

Article 28 Notification procedure

Article 29 Identification numbers and lists of notified bodies

Article 30 Changes to notifications

Article 31 Challenge of the competence of notified bodies

Article 32 Operational obligations of notified bodies

Article 33 Appeal against decisions of notified bodies

Article 34 Information obligation on notified bodies

Article 35 Exchange of experience

Article 36 Coordination of notified bodies

CHAPTER V UNION MARKET SURVEILLANCE, CONTROL OF EU FERTILISING PRODUCTS ENTERING THE UNION MARKET AND UNION SAFEGUARD PROCEDURE

Article 37 Union market surveillance and control of EU fertilising products entering the Union market

Article 38 Procedure at national level for dealing with EU fertilising products presenting a risk

Article 39 Union safeguard procedure

Article 40 Compliant EU fertilising products which present a risk

Article 41 Formal non-compliance

CHAPTER VI DELEGATED POWERS AND COMMITTEE PROCEDURE

Article 42 Amendments of Annexes

Article 43 Separate delegated acts for separate component material categories

Article 44 Exercise of the delegation

Article 45 Committee procedure

CHAPTER VII AMENDMENTS

Article 46 Amendments to Regulation (EC) No 1069/2009

Article 47 Amendments to Regulation (EC) No 1107/2009

CHAPTER VIII TRANSITIONAL AND FINAL PROVISIONS

Article 48 Penalties

Article 49 Report

Article 50 Biodegradability review

Article 51 Repeal of Regulation (EC) No 2003/2003

Article 52 Transitional provisions

Article 53 Entry into force and application

ANNEX I

ANNEX II

ANNEX III

ANNEX IV

ANNEX V