Legal act: 
Regulation (EU) 2019/1009

Consolidated act:
16/03/2023

Regulation (EU) 2019/1009

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.

 

Definitions

% 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.

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.

Placing on the market’ means the first making available of an EU fertilising product on the Union market.

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.

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.

Withdrawal means any measure aimed at preventing an EU fertilising product in the supply chain from being made available on the market.

 

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

1. When placing EU fertilising products on the market, manufacturers shall ensure that they have been designed and manufactured in accordance with the requirements set out in Annexes I and II.
2. Before placing EU fertilising products on the market, manufacturers shall draw up the technical documentation and carry out the relevant conformity assessment procedure referred to in Article 15, or have it carried out. 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.
3. Manufacturers shall keep the technical documentation and the EU declaration of conformity for 5 years after the EU fertilising product covered by those documents has been placed on the market. On request, manufacturers shall make a copy of the EU declaration of conformity available to other economic operators.

 

Article 16 - EU declaration of conformity

1. The EU declaration of conformity shall state that the fulfilment of the requirements laid down in this Regulation has been demonstrated.
2. The EU declaration of conformity shall have the model structure set out in Annex V, shall contain the elements specified in the relevant modules set out in Annex IV and shall be continuously updated. It shall be translated into the language or languages required by the Member State in which the EU fertilising product is placed or made available on the market.
3. Where an EU fertilising product is subject to more than one Union act requiring an EU declaration of conformity, a single EU declaration of conformity shall be drawn up in respect of all such Union acts. That declaration shall state the Union acts concerned and their publication references. It may be a dossier made up of relevant individual EU declarations of conformity.
4. By drawing up the EU declaration of conformity, the manufacturer shall assume responsibility for the compliance of the EU fertilising product with the requirements laid down in this Regulation.

 

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

1. The CE marking shall be affixed visibly, legibly and indelibly to the packaging of the EU fertilising product or, where the EU fertilising product is supplied without packaging, to a document accompanying the EU fertilising product.
2. The CE marking shall be affixed before the EU fertilising product is placed on the market.
3. The CE marking shall be followed by the identification number of the notified body, where required under Annex IV. 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.
4. Member States shall build upon existing mechanisms to ensure correct application of the regime governing the CE marking and shall take appropriate action in the event of improper use of that marking.

For more informations, see ANNEX IV - Conformity assessment procedures, Part II (L 170/88).

 

Regulation (EC) No 2003/2003

Scope

This Regulation shall apply to products which are placed on the market as fertilisers designated ‘EC fertiliser’.

 

Definitions

Placing on the market means the supply of fertiliser, whether in return for payment or free of charge, or storage for the purpose of supply. Importation of a fertiliser into the customs territory of the European Community shall be deemed to constitute placing on the market.

Manufacturer means the natural or legal person responsible for placing a fertiliser on the market; in particular a producer, an importer, a packager working for its own account, or any person changing the characteristics of a fertiliser, shall be deemed to be a manufacturer. However, a distributor who does not change the characteristics of the fertiliser shall not be deemed to be a manufacturer.

 

CHAPTER II - Placing on the market

Article 5 - Free circulation

1. Without prejudice to Article 15 and other Community legislation, Member States shall not, on grounds of composition, identification, labelling or packaging, and other provisions contained in this Regulation, prohibit, restrict or hinder the placing on the market of fertilisers marked ‘EC fertiliser’ which comply with the provisions of this Regulation.
2. Fertilisers that are marked ‘EC fertiliser’ in accordance with this Regulation shall circulate freely within the Community.

 

Article 9 - Markings

1. Without prejudice to other Community rules, the packages, labels and accompanying documents, referred to in Article 7 shall bear the following markings:
   1. Compulsory identification
      • The words ‘EC FERTILISER’ in capital letters;
      • Where it exists, the designation of the type of fertiliser as set out in Annex 1;
      • For blended fertilisers, the marking ‘blend’ after the designation of the type;
      • The additional markings specified in Article 19, 21 or 23;
      • Nutrients shall be indicated both in words and by the appropriate chemical symbols, e.g. nitrogen (N), phosphorus (P), phosphorus pentoxide (P2O5), potassium (K), potassium oxide (K2O), calcium (Ca), calcium oxide (CaO), magnesium (Mg), magnesium oxide (MgO), sodium (Na), sodium oxide (Na2O), sulphur (S), sulphur trioxide (SO3), boron (B), copper (Cu), cobalt (Co), iron (Fe), manganese (Mn), molybdenum (Mo), zinc (Zn);
      • If the fertiliser contains micro-nutrients of which all or part are chemically linked with an organic molecule, the name of the micro-nutrient shall be followed by one of the following qualifiers:
        1. ‘chelated by . . .’ (name of chelating agent or its abbreviation as set out in section E.3.1 of Annex I);
        2. ‘complexed by . . .’ (name of complexing agent as set out in section E.3.2 of Annex I);
      • Micro-nutrients contained in the fertiliser, listed in the alphabetical order of their chemical symbols: B, Co, Cu, Fe, Mn, Mo, Zn;
      • For products listed in sections E.1 and E.2 of Annex I, the specific directions for use;
      • Quantities of fluid fertilisers, expressed by mass. The expression of quantities of fluid fertilisers by volume or in terms of mass versus volume (kilograms per hectolitre or grams per litre) shall be optional;
      • Net or gross mass and, optionally, volume for fluid fertilisers. If the gross mass is given, the tare mass must be indicated beside it;
      • The name or trade name and the address of the manufacturer.
   2. Optional identification
      • As listed in Annex I;
      • The directions for the storage and handling, and for fertilisers not listed in Annex I, sections E.1 and E.2, the specific directions for the use of the fertiliser;
      • Indications of the dose rates and conditions of use suitable for the soil and crop conditions under which the fertiliser is used;
      • The mark of the manufacturer and the trade description of the product.

The indications referred to in (b) must not conflict with those referred to in (a) and must be clearly separated from them.

2. All the markings referred to in paragraph 1 must be clearly separated from any other information on the packages, labels and accompanying documents.
3. Fluid fertilisers may be placed on the market only if the manufacturer provides suitable additional instructions covering, in particular, storage temperature and prevention of accidents during storage.
4. Detailed rules for the application of this Article shall be adopted under the procedure referred to in Article 32(2).