We want to sell a fertiliser or a plant biostimulant

Regulation (EU) 2019/1009 sets the rules for EU fertilising products. A fertilising product is a substance, mixture, micro-organism or other material applied to plants or their rhizosphere, or to mushrooms or their mycosphere, to provide them with nutrients or improve their nutrition efficiency (Article 2(1)). An EU fertilising product is one that is CE marked when made available on the market (Article 2(2)), and the Regulation applies to those products (Article 1(1)). It applies from 16 July 2022, with earlier dates for some articles (Article 53).^[1]

The CE route is a choice. Member States may not impede, for reasons covered by the Regulation, the making available of EU fertilising products that comply with it (Article 3(1)). The Commission's report on the application of the Regulation, due by 16 July 2026, has to analyse the effects of optional harmonisation on EU fertilising products and on fertilising products placed on the market under national rules (Article 49(a)). Products without CE marking are outside the Regulation's scope (Articles 1(1) and 2(2)); as Article 49(a) assumes, national rules then govern them. The consolidated versions and amendments are listed on the act's EUR-Lex page, which also lists a Commission proposal of 8 July 2025 to simplify certain requirements of this Regulation, the CLP Regulation and the Cosmetics Regulation (COM(2025) 531).^[1][2]

The product requirements are built from two classifications. An EU fertilising product must meet the requirements of Annex I for its product function category, those of Annex II for its component material categories, and be labelled under Annex III (Article 4(1)). Annex I designates seven categories, from fertiliser and liming material to soil improver, growing medium, inhibitor, plant biostimulant and fertilising product blend, and the claimed function must be supported by the product's mode of action (Annex I, Parts I and II). For aspects not covered by the annexes, the product must not present a risk to human, animal or plant health, safety or the environment (Article 4(2)).^[1]

The duties are spread over the supply chain. The manufacturer draws up the technical documentation, carries out the conformity assessment procedure in Annex IV, draws up an EU declaration of conformity and affixes the CE marking (Article 6(2)), keeps the documents for 5 years (Article 6(3)), and puts its name and postal address on the packaging or an accompanying document (Article 6(6)). Annex IV sets which module applies: module A only for certain component materials, and never for plant biostimulants, inhibitors or high-nitrogen ammonium nitrate fertilisers (Annex IV, Part I, point 1.3). Importers check the procedure, the documentation and the label, and add their own name and postal address (Article 8(2) to (4)). The declaration follows the model in Annex V and is translated into the languages the Member State requires (Article 16(2)).^[1]