In more detail
On 16 July 2022, Regulation (EU) 2019/1009 (hereinafter referred to as "Regulation"), which lays down provisions on placing fertiliser products on the of EU market, entered into force. This Regulation repealed Regulation (EC) 2003/2003, and represents a major change in the regulation of fertiliser products within the European Union. It is particularly relevant to producers and importers intending to place these products on the European market.
Updates on scope
The new Regulation extends the scope of the harmonisation provided for in repealed Regulation (EC) 2003/2003 to include recycled and organic materials. In this sense, it includes products intended to improve the nutritional efficiency of plants, thus facilitating free circulation in the internal market.
Significantly, harmonised standards continue to be optional under the new Regulation for all products, except for those that provide nutrients to plants and that are placed on the market with the CE marking. In addition, the Regulation does not apply to products that do not bear the CE marking when placed on the market. This allows manufacturers and distributors of fertiliser products to choose whether they want to follow the procedure of the European Regulation or the one provided for in the national regulation for placing products on the market.
Furthermore, as each product has different functions, they have been divided into adapted functional categories with different safety and quality requirements. Likewise, the component materials of fertilisers have been classified according to their degree of hazardousness and variability, with different processing requirements and control mechanisms for each case. The aim is to limit the content of contaminants in products, with particular emphasis on cadmium, although Member States that have (or will adopt) national provisions limiting cadmium content are allowed to maintain them as long as they are justified and have been communicated to the Commission. Derogations from the cadmium content limits provided for in the repealed Regulation (EC) 2003/2003 also continue to be allowed.
The Regulation excludes biostimulants for plant protection products from the scope of Regulation (EC) 1107/2009. An exception has been made for dual-use products, in which case the regulation on plant protection products applies. Fertiliser products that do not have a plant protection function are subject to Regulation (EC) 1907/2006, concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals.
Manufacturing, distribution and supply chain Economic Operators
Manufacturers are responsible for the conformity assessment of fertiliser products and must draw up declarations of conformity and affix the CE marking. They are also obliged to keep the technical documentation and the declaration of conformity for five years after the fertiliser has been placed on the European market. Manufacturers must also indicate their name, registered trade name, and contact address on the product packaging or in an accompanying document. This information must be clear and in a language easily understandable by consumers and monitoring authorities.
Manufacturers may appoint an authorised representative in writing to carry out specific tasks, including the following:
- Retain the product's declaration of conformity and technical documentation;
- Provide information and documentation to national authorities to demonstrate the conformity of a product;
- Cooperate with national authorities to eliminate product risks.
It is up to the importer to verify that products from third countries placed on the EU market comply with the Regulation. Importers must also ensure that conformity assessment procedures have been carried out and that the marking and documentation provided by the manufacturer can be inspected by the competent national authorities. In addition, importers must also indicate on the packaging their name, registered trade name and the postal address at which they can be contacted.
Distributors must act with due diligence to ensure that their actions concerning the product do not adversely affect conformity with the requirements of the Regulation.
It should be noted that any economic operator who either places a fertiliser product on the market under his own name or modifies a fertiliser product in such a way as to jeopardise its compliance with the requirements of the Regulation, shall be considered to be the manufacturer with all the obligations that these carries.
A presumption of conformity is established for fertiliser products conforming to standards or parts of harmonised standards published in the Official Journal of the European Union.
For other fertiliser products, Annex IV of the Regulation sets out modules of conformity assessment procedures depending on the level of risk and safety required. The choice of conformity assessment procedure by the manufacturer must allow a more stringent procedure to be followed than is strictly necessary for the product in order to facilitate administrative formalities without endangering product conformity. The documentation used in the framework of these processes must be drawn up in the official language of the Member State in which the competent notified body is established.
In this regard, Member States must designate a notifying authority to carry out the assessment and notification procedures for the conformity assessment bodies as well as for the monitoring of notified bodies. The notifying authority may delegate conformity assessment or surveillance responsibilities to a non-public body, provided that it is a legal person and meets the requirements of the Regulation.
The Regulation introduces more extensive labelling requirements than the repealed legislation. Nonetheless, as extensive information on labels makes it difficult for interested people to read them and complicated to manage for economic agents, there is a current Proposal for a Regulation amending Regulation (EU) 2019/1009 (hereinafter referred to as the Proposal), in order to improve the readability of labels, as well as to make it easier for economic operators to manage them. This new Proposal introduces the possibility to digitalize labels with particular requirements pursuing the general objectives the Regulation: a higher protection of human health and of the environment and the proper functioning of the internal market.
The Proposal foresees that different economic operators can choose between using a digital or a physical label. In case a digital label is chosen for EU fertiliser products supplied to end-users in a package, it must be ensured that the physical label also contains minimum information such as information on the protection of human health and the environment, among others. In contrast, where products are supplied in bulk, labelling elements have to be provided in a leaflet or on a digital label. Requirements are also established for digital labelling, with the need to include all labelling elements: information enabling the manufacturer of the products to be identified and contacted, the CE marking and references to the corresponding notified bodies. Finally, it is foreseen that access to digital labels must be easy and free of charge, and they have to be available for five years after the EU fertiliser product has been placed on the market.
For more details, you can consult the full text of the Regulation by clicking on this link.