---
title: "We want to sell a fertiliser or a plant biostimulant"
description: "Regulation (EU) 2019/1009 applies to EU fertilising products, those sold with CE marking. They must meet the requirements of their product function category and component material categories, pass the conformity assessment module set in Annex IV, and carry the label in Annex III. Decide first whether you use the CE route or national rules, then assign the categories and choose the module."
type: "problem"
url: "https://www.conphora.com/solutions/problem/fertiliser-product/"
markdown: "https://www.conphora.com/solutions/problem/fertiliser-product.md"
locale: "en"
language: "en"
updated: "2026-10-04"
author: "Conphora compliance team"
publisher: "Conphora"
source: "https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02019R1009-20260701"
tags: ["FPR", "chemicals-materials"]
license: "Free to quote with attribution and a link to the page"
---

# We want to sell a fertiliser or a plant biostimulant

Regulation (EU) 2019/1009 applies to EU fertilising products, those sold with CE marking. They must meet the requirements of their product function category and component material categories, pass the conformity assessment module set in Annex IV, and carry the label in Annex III. Decide first whether you use the CE route or national rules, then assign the categories and choose the module.

## Why this happens

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. [1] 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). [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]

## How to solve it

1. **Choose the CE route or national rules** The Regulation applies to EU fertilising products, which are CE marked when made available. The EU route gives free movement across Member States. Products placed on the market under national rules remain possible, so decide per product which route you take.
2. **Assign the function category** Annex I sets seven product function categories: fertiliser, liming material, soil improver, growing medium, inhibitor, plant biostimulant and fertilising product blend. The category follows from the function you claim, and the claim must be supported by the product's mode of action.
3. **Check every component material** Each component must belong to a component material category in Annex II, such as virgin substances and mixtures, plants or plant extracts, food industry by-products or micro-organisms. The categories decide which inputs are allowed and which conformity module you may use.
4. **Choose the conformity module** Annex IV sets the module per component material and function category. Internal production control, module A, is allowed for some materials only, and not for plant biostimulants or inhibitors. High-nitrogen ammonium nitrate fertilisers must use module A1. The other routes, module B with C and module D1, involve a notified body.
5. **Draw up the file, declaration and label** Draw up the technical documentation and the EU declaration of conformity, affix the CE marking, and print the Annex III label: function category designation, quantity, instructions for use, storage conditions, risk information and ingredients above 5 %. Add your name and postal address; an importer adds its own as well.

## What you need to show

- **Technical documentation and the result of the conformity assessment module** — The manufacturer, with a notified body where the module requires one (Regulation (EU) 2019/1009 Article 6(2) and Article 15; Annex IV)
- **EU declaration of conformity following the model in Annex V** — The manufacturer (Regulation (EU) 2019/1009 Article 16)
- **Label or leaflet with the Annex III information** — The manufacturer; checked by the importer (Regulation (EU) 2019/1009 Article 6(7), Article 8(4) and Annex III)

## If you do nothing

- **Only compliant products may be made available** — EU fertilising products shall only be made available on the market if they comply with the Regulation (Regulation (EU) 2019/1009 Article 5).
- **The importer must hold back non-conforming products** — Where an importer has reason to believe that an EU fertilising product is not in conformity, it must not place it on the market until it has been brought into conformity, and where it presents a risk, inform the manufacturer and the market surveillance authorities (Regulation (EU) 2019/1009 Article 8(2)).
- **Aspects outside the annexes still count** — For any aspects not covered by Annex I or II, EU fertilising products shall not present a risk to human, animal or plant health, to safety or to the environment (Regulation (EU) 2019/1009 Article 4(2)).

## Questions

### Must every fertiliser be CE marked?

No. The Regulation applies to EU fertilising products, defined as fertilising products that are CE marked when made available (Regulation (EU) 2019/1009 Articles 1(1) and 2(2)). The Regulation refers to the effects of optional harmonisation and to fertilising products placed on the market under national rules (Article 49(a)).

### Since when does the Regulation apply?

From 16 July 2022, with some articles applying earlier, from 15 July 2019 and 16 April 2020 (Regulation (EU) 2019/1009 Article 53).

### Can a plant biostimulant use internal production control?

No. Module A must not be used for a plant biostimulant in PFC 6 or an inhibitor in PFC 5 (Regulation (EU) 2019/1009 Annex IV, Part I, point 1.3). Module B followed by module C, or module D1, is available depending on the component materials (Annex IV, Part I, points 3 and 4).

### Does the Regulation replace REACH or CLP for our product?

No. It does not affect the application of other acts, including Regulation (EC) No 1907/2006 and Regulation (EC) No 1272/2008 (Regulation (EU) 2019/1009 Article 1(2)).

### How long must we keep the file?

Manufacturers keep the technical documentation and the EU declaration of conformity for 5 years after the product has been placed on the market, and give a copy of the declaration to other economic operators on request (Regulation (EU) 2019/1009 Article 6(3)).

## Regulations involved

FPR

## Sources

1. [Regulation (EU) 2019/1009 laying down rules on the making available on the market of EU fertilising products (consolidated text of 1 July 2026)](https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02019R1009-20260701) — EUR-Lex, 2026-10-04
2. [Regulation (EU) 2019/1009, document information and consolidated versions](https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=CELEX:32019R1009) — EUR-Lex, 2026-10-04