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

This Regulation does not apply to:

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

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

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

(a) Directive 86/278/EEC;

(b) Directive 89/391/EEC;

(c) Directive 91/676/EEC;

(d) Directive 2000/60/EC;

(e) Directive 2001/18/EC;

(f) Regulation (EC) No 852/2004;

(g) Regulation (EC) No 882/2004;

(h) Regulation (EC) No 1881/2006;

(i) Regulation (EC) No 1907/2006;

(j) Regulation (EC) No 834/2007;

(k) Regulation (EC) No 1272/2008;

(l) Regulation (EU) No 98/2013;

(m) Regulation (EU) No 1143/2014;

(n) Regulation (EU) 2016/2031;

(o) Directive (EU) 2016/2284;

(p) Regulation (EU) 2017/625.

Article 2

Definitions

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Article 3

Free movement

Article 4

Product requirements

An EU fertilising product shall:

(a) meet the requirements set out in Annex I for the relevant product function category;

(b) meet the requirements set out in Annex II for the relevant component material category or categories; and

(c) be labelled in accordance with the labelling requirements set out in Annex III.

Article 5

Making available on the market

EU fertilising products shall only be made available on the market if they comply with this Regulation.

CHAPTER II

OBLIGATIONS OF ECONOMIC OPERATORS

Article 6

Obligations of manufacturers

Where compliance of an EU fertilising product with the applicable requirements laid down in this Regulation has been demonstrated by that conformity assessment procedure, manufacturers shall draw up an EU declaration of conformity and affix the CE marking.

On request, manufacturers shall make a copy of the EU declaration of conformity available to other economic operators.

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

Article 7

Authorised representative

The obligations laid down in Article 6(1) and the obligation to draw up technical documentation referred to in Article 6(2) shall not form part of the authorised representative’s mandate.

An authorised representative shall perform the tasks specified in the mandate received from the manufacturer. The mandate shall allow the authorised representative to do at least the following:

(a) keep the EU declaration of conformity and the technical documentation at the disposal of national market surveillance authorities for 5 years after the EU fertilising product covered by those documents has been placed on the market;

(b) further to a reasoned request from a competent national authority, provide that authority with all the information and documentation necessary to demonstrate the conformity of an EU fertilising product;

(c) cooperate with the competent national authorities, at their request, on any action taken to eliminate the risks posed by EU fertilising products covered by the authorised representative’s mandate.

Article 8

Obligations of importers

Where an importer considers or has reason to believe that an EU fertilising product is not in conformity with this Regulation, the importer shall not place the EU fertilising product on the market until it has been brought into conformity. Furthermore, where the EU fertilising product presents a risk to human, animal or plant health, to safety or to the environment, the importer shall inform the manufacturer and the market surveillance authorities to that effect.

On request, importers shall make a copy of the EU declaration of conformity available to other economic operators.

Article 9

Obligations of distributors

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

Article 10

Cases in which obligations of manufacturers apply to importers and distributors

An importer or distributor shall be considered a manufacturer for the purposes of this Regulation, and shall be subject to the obligations of the manufacturer under Article 6, where that importer or distributor places an EU fertilising product on the market under his or her name or trademark or modifies an EU fertilising product already placed on the market in such a way that compliance with this Regulation may be affected.

Article 11

Packaging and repackaging by importers and distributors

Where an importer or distributor packages or repackages an EU fertilising product and is not considered a manufacturer pursuant to Article 10, that importer or distributor shall:

(a) ensure that the packaging bears his or her name, registered trade name or registered trade mark and postal address preceded by the words ‘packaged by’ or ‘repackaged by’; and

(b) keep a specimen of the original information referred to in Article 6(7) or Article 8(4) at the disposal of the market surveillance authorities for 5 years after having made the EU fertilising product available on the market.

Article 12

Identification of economic operators

Economic operators shall, on request, identify the following to the market surveillance authorities:

(a) any economic operator who has supplied them with an EU fertilising product;

(b) any economic operator to whom they have supplied an EU fertilising product.

CHAPTER III

CONFORMITY OF EU FERTILISING PRODUCTS

Article 13

Presumption of conformity

Article 14

Common specifications

The Commission may adopt implementing acts laying down common specifications for the requirements set out in Annex I, II or III or tests referred to in Article 13(2) where:

(a) those requirements or tests are not covered by harmonised standards or parts thereof, the references of which have been published in the Official Journal of the European Union;

(b) the Commission observes undue delays in the adoption of requested harmonised standards; or

(c) the Commission has decided in accordance with the procedure referred to in Article 11(5) of Regulation (EU) No 1025/2012 to maintain with restriction or to withdraw the references to the harmonised standards or parts thereof by which those requirements or tests are covered.

Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 45(3).

Article 15

Conformity assessment procedures

Article 16

EU declaration of conformity

Article 17

General principles of CE marking

The CE marking shall be subject to the general principles set out in Article 30 of Regulation (EC) No 765/2008.

Article 18

Rules and conditions for affixing the CE marking

The identification number of the notified body shall be affixed by the body itself or, under its instructions, by the manufacturer or his or her authorised representative.

Article 19

End-of-waste status

This Regulation lays down criteria in accordance with which material that constitutes waste, as defined in Directive 2008/98/EC, can cease to be waste, if it is contained in a compliant EU fertilising product. In such cases, the recovery operation under this Regulation shall be performed before the material ceases to be waste, and the material shall be considered to comply with the conditions laid down in Article 6 of that Directive and therefore to have ceased to be waste from the moment that the EU declaration of conformity was drawn up.

CHAPTER IV

NOTIFICATION OF CONFORMITY ASSESSMENT BODIES

Article 20

Notification

Member States shall notify the Commission and the other Member States of bodies authorised to carry out third-party conformity assessment tasks under this Regulation.

Article 21

Notifying authorities

Article 22

Requirements relating to notifying authorities

Article 23

Information obligation on notifying authorities

Member States shall inform the Commission of their procedures for the assessment and notification of conformity assessment bodies and the monitoring of notified bodies, and of any changes thereto.

The Commission shall make that information publicly available.

Article 24

Requirements relating to notified bodies

A conformity assessment body, its top level management and the personnel responsible for carrying out the conformity assessment tasks shall not be directly involved in the design, manufacture, marketing or use of fertilising products or represent the parties engaged in those activities. They shall not engage in any activity that may conflict with their independence of judgement or integrity in relation to conformity assessment activities for which they are notified. This shall in particular apply to consultancy services.

Conformity assessment bodies shall ensure that the activities of their subsidiaries or subcontractors do not affect the confidentiality, objectivity or impartiality of their conformity assessment activities.

At all times and for each conformity assessment procedure and each kind or category of EU fertilising products in relation to which it has been notified, a conformity assessment body shall have at its disposal the necessary:

(a) personnel with technical knowledge and sufficient and appropriate experience to perform the conformity assessment tasks;

(b) descriptions of procedures in accordance with which conformity assessment is carried out, ensuring the transparency and the ability of reproduction of those procedures. It shall have appropriate policies and procedures in place that distinguish between tasks it carries out as a notified body and other activities;

(c) procedures for the performance of activities which take due account of the size of an undertaking, the sector in which it operates, its structure, the degree of complexity of the product technology in question and the mass or serial nature of the production process.

A conformity assessment body shall have the means necessary to perform the technical and administrative tasks connected with the conformity assessment activities in an appropriate manner and shall have access to all necessary equipment or facilities.

The personnel responsible for carrying out the conformity assessment tasks shall have the following:

(a) sound technical and vocational training covering all the conformity assessment activities in relation to which the conformity assessment body has been notified;

(b) satisfactory knowledge of the requirements of the assessments they carry out and adequate authority to carry out those assessments;

(c) appropriate knowledge and understanding of the requirements set out in Annexes I, II and III, of the applicable harmonised standards referred to in Article 13 and common specifications referred to in Article 14 and of the relevant provisions of Union harmonisation legislation and of national legislation;

(d) the ability to draw up certificates, records and reports demonstrating that assessments have been carried out.

The remuneration of the top level management and personnel responsible for carrying out the conformity assessment tasks of a conformity assessment body shall not depend on the number of assessments carried out or on the results of those assessments.

Article 25

Presumption of conformity of notified bodies

Where a conformity assessment body demonstrates its conformity with the criteria laid down in the relevant harmonised standards or parts thereof the references of which have been published in the Official Journal of the European Union it shall be presumed to comply with the requirements set out in Article 24 in so far as the applicable harmonised standards cover those requirements.

Article 26

Subsidiaries of and subcontracting by notified bodies

Article 27

Application for notification

Article 28

Notification procedure

Only such a body shall be considered a notified body for the purposes of this Regulation.

Article 29

Identification numbers and lists of notified bodies

It shall assign a single such number even where the body is notified under several Union acts.

The Commission shall ensure that the list is kept up to date.

Article 30

Changes to notifications

Article 31

Challenge of the competence of notified bodies

That implementing act shall be adopted in accordance with the advisory procedure referred to in Article 45(2).

Article 32

Operational obligations of notified bodies

In so doing they shall nevertheless respect the degree of rigour and the level of protection required for the compliance of the EU fertilising product with this Regulation.

Article 33

Appeal against decisions of notified bodies

Member States shall ensure that an appeal procedure against decisions of the notified bodies is available.

Article 34

Information obligation on notified bodies

Notified bodies shall inform the notifying authority of the following:

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

(b) any circumstances, affecting the scope of or conditions for notification;

(c) any request for information which they have received from market surveillance authorities regarding conformity assessment activities;

(d) on request, conformity assessment activities performed within the scope of their notification and any other activity performed, including cross-border activities and subcontracting.

Article 35