Conformity assessment procedures - EU fertilizing products
Conformity Assessment
Regulation (EU) No. 2019/1009 of the European Parliament and of the Council (consolidated version in HTML format dated November 20, 2024) laying down rules for the placing on the market of fertilizing products (consolidated version in PDF format dated July 3, 2024) applies to seven categories of fertilizing products:
1. fertilizers (organic, inorganic, organo-mineral),
2. soil
liming materials, 3
. soil amendments, 4. growing media,
5. inhibitors,
6. plant biostimulants,
7. blends of fertilizing products.
Regulation (EU) No. 2019/1009 of the European Parliament and of the Council does not apply to:
- by-products of animal origin or other products subject to the requirements of Regulation (EC) No. 1069/2009 when placed on the market,
- or plant protection products falling within the scope of Regulation (EC) No. 1107/2009
Definition of a fertilizer product:
“fertilizer product” means a substance, mixture, microorganism, or any other material that is used or intended for use on plants or their rhizosphere or on fungi or their mycosphere, or is intended to form a rhizosphere or mycosphere, either alone, or in combination with other materials, for the purpose of supplying nutrients to those plants or fungi or improving their nutrient
use efficiency. Regulation (EU) No. 2019/1009 of the European Parliament and of the Council applies only to the design, manufacture, and placing on the market of EU fertilizer products, but does not cover their use or method of application. Regulation (EU) 2019/1009 of the European Parliament and of the Council sets limits for hazardous contaminants in fertilizers.
Placing on the marketEU
fertilizing products placed on the market must comply with Regulation (EU) 2019/1009 of the European Parliament and of the Council.
products that comply with harmonized standards are presumed to comply with the requirements set out in Annexes I, II, and III to which those standards or parts thereof apply. Harmonized standards for Regulation (EU) No. 2019/1009 of the European Parliament and of the Council have already been published in EUR-LEX : (EU)2024/2387 (hEN 10. 9. 2024).
· Requirements for EU fertilizing products:
- they must meet the requirements set out in Annex I for the relevant product function category;
- they must meet the requirements set out in Annex II for the relevant category or categories of constituent materials;
- they must be labeled in accordance with the labeling requirements set out in Annex III.
EU fertilizing products must not pose a risk to human, animal, or plant health, safety, or the environment.
Conformity assessment procedures for EU
fertilizing products The applicable conformity assessment procedure is set out in Annex IV to Regulation (EU) No. 2019/1009 of the European Parliament and of the Council.The following modules
may be used for the conformity assessment of EU fertilizing products, applying the rules set out in this Annex IV:
- MODULE A – INTERNAL PRODUCTION CONTROL
- MODULE A1 – INTERNAL PRODUCTION CONTROL PLUS PRODUCT TESTING UNDER SUPERVISION
- MODULE B – EU TYPE EXAMINATION
- MODULE C – CONFORMITY TO TYPE BASED ON INTERNAL PRODUCTION CONTROL
- MODULE D1:
EU
- QUALITY ASSURANCE OF THE MANUFACTURING PROCESS
Declaration of Conformity
The EU Declaration of Conformity confirms that the product meets the requirements of Regulation (EU) No. 2019/1009 of the European Parliament and of the Council.
A model EU Declaration of Conformity is set out in Annex V to Regulation (EU) No. 2019/1009 of the European Parliament and of the Council. The EU Declaration of Conformity must contain the elements specified in the relevant modules listed in Annex IV and must be kept up to date. If Annex IV requires the identification number of the notified body to be indicated, it must be placed after the CE marking. CE
Marking
The general principles of the CE marking are set out in Regulation (EC) No 765/2008 of the European Parliament and of the Council. The rules and conditions for affixing the CE marking are set out in Article 18 of Regulation (EU) No 2019/1009 of the European Parliament and of the Council.
Labeling of EU Fertilizing Products The requirements for the labeling of EU fertilizing products are set out in Annex III to Regulation (EU) No 2019/1009 of the European Parliament and of the Council.
|
2021/C 119/01 |
Commission Communication on the appearance of the label on EU fertilizing products in accordance with Annex III to Regulation (EU) 2019/1009 of the European Parliament and of the Council (EU) 2019/1009 |
Technical documentation
Manufacturers
Manufacturers must keep the technical documentation and the declaration of conformity for EU fertilizing products for a period of five years from the date the product was placed on the EU market to which these documents relate.
Importers
: For a period of five years from the date the EU fertilizer product is placed on the market, importers shall keep a copy of the EU declaration of conformity for the purposes of market surveillance authorities and ensure that the technical documentation can be made available to these authorities upon request.
: The obligations of distributors are set out in Articles 9 and 10 of Regulation (EU) 2019/1009 of the European Parliament and of the Council.
In the case of repackaging and packaging, importers and distributors must comply with the requirements set out in Regulation (EU) 2019/1009 of the European Parliament and of the Council.
https://eur-lex.europa.eu/legal-content/CS/TXT/PDF/?uri=CELEX:02019R1009-20241117&qid=1738570134252
Control authority in the Czech Republic: Central Institute for Supervision and Testing in Agriculture (ÚKZÚS)
Control authority in Slovakia: Central Institute for Supervision and Testing in Agriculture (ÚKSÚP
) Public Register of Fertilizers
