Regulation (EU) 2019/1009 of the European Parliament and of the CouncilShow full title

Article 6 U.K. 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.

4. Manufacturers shall ensure that procedures are in place for EU fertilising products that are part of a series production to remain in conformity with this Regulation. Changes in the production process or in the characteristics of those EU fertilising products and changes in the harmonised standards, common specifications referred to in Article 14 or other technical specifications by reference to which conformity of an EU fertilising product is declared or by application of which its conformity is verified shall be adequately taken into account.

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.

5. Manufacturers shall ensure that the packaging of the EU fertilising products which they have placed on the market bears a type number, batch number or other element allowing their identification or, where the EU fertilising products are supplied without packaging, that the required information is provided in a document accompanying each fertilising product.

6. Manufacturers shall indicate their name, registered trade name or registered trade mark and the postal address at which they can be contacted on the packaging of the EU fertilising product or, where the EU fertilising product is supplied without packaging, in a document accompanying the EU fertilising product. The postal address shall indicate a single point at which the manufacturer can be contacted. Such information shall be in a language easily understood by end-users and market surveillance authorities and shall be clear, understandable and legible.

7. Manufacturers shall ensure that EU fertilising products are accompanied by the information required under Annex III. Where an EU fertilising product is supplied in a package, the information shall appear on a label which is affixed to that package. Where the package is too small to contain all the information, the information that cannot be provided on the label shall be provided in a separate leaflet accompanying that package. Such a leaflet shall be regarded as part of the label. Where the EU fertilising product is supplied without packaging, all the information shall be provided in a leaflet. The label and the leaflet shall be accessible for inspection purposes when the EU fertilising product is made available on the market. The information shall be in a language which can be easily understood by end-users, as determined by the Member State concerned, and shall be clear, understandable and intelligible.

8. Manufacturers who consider or have reason to believe that an EU fertilising product which they have placed on the market is not in conformity with this Regulation shall immediately take the corrective measures necessary to bring that EU fertilising product into conformity, to withdraw it or to recall it, as appropriate. Furthermore, where manufacturers consider or have reason to believe that an EU fertilising product which they have placed on the market presents a risk to human, animal or plant health, to safety or to the environment, they shall immediately inform the competent national authorities of the Member States in which they made the EU fertilising product available on the market to that effect, giving details, in particular, of any non-compliance and of any corrective measures taken.

9. Manufacturers shall, further to a reasoned request from a competent national authority, provide it with all the information and documentation, in paper or electronic form, necessary to demonstrate the conformity of the EU fertilising product with this Regulation, in a language which can be easily understood by that authority. They shall cooperate with that authority, at its request, on any action taken to eliminate the risks posed by an EU fertilising product which they have placed on the market.