The Regulation (EU) 2019/1009 entered into application on the 16th of July 2022 to repeal and replace the former Regulation (EC) 2003/2003. A consolidated version of the FPR was published in March 2023 to include several amendments.
The regulation covers 7 Product Function Categories (PFCs) designated as follows
- PFC 1: Fertiliser:
- A: Organic fertiliser
- B: Organo-mineral fertiliser
- C: Inorganic fertiliser
- PFC 2: Liming material
- PFC 3: Soil improver
- PFC 4: Growing medium
- PFC 5: Inhibitor
- PFC 6: Plant biostimulant
- PFC 7: Fertilising product blend
An EU fertilising product shall only consist of component materials complying with the requirements for one or more of the 15 Component Material Categories (CMCs) as follows:
- CMC 1: Virgin material substances and mixtures
- CMC 2: Plants, plant parts or plant extracts
- CMC 3: Compost
- CMC 4: Fresh crop digestate
- CMC 5: Digestate other than fresh crop digestate
- CMC 6: Food industry by-products
- CMC 7: Micro-organisms
- CMC 8: Nutrient Polymers
- CMC 9: Polymers other than nutrient polymers
- CMC 10: Derived products within the meaning of Regulation (EC) No 1069/2009
- CMC 11: By-products within the meaning of Directive 2008/98/EC5
- CMC 12: Precipitated phosphate salts and derivates (struvite)
- CMC 13: Thermal oxidation materials and derivates (ashes)
- CMC 14: Pyrolysis and gasification materials (biochar)
- CMC 15: High purity materials
Notified bodies are responsible for assessing the conformity of fertilising products according to the conformity assessment procedure described in Modules B+C and Module D1. The NANDO database lists all the notified bodies. Currently, 14 notified bodies have been approved. It is possible to submit an application to any notified body, whatever the location of the manufacturer of the fertilising product.
Body type | Name | Country |
NB 2806 | CerTrust Kft. | Hungary |
NB 2973 | Eurofins Certification | France |
NB 2947 | Inspectorate Estonia AS | Estonia |
NB 2949 | Instytut Nadzoru Technicznego Sp. z o.o. | Poland |
NB 2972 | Jednostka Certyfikujaca Wyroby Siec Badawcza Lukasiewicz Instytut Nowych Syntez Chemicznych | Poland |
NB 2929 | Kiwa VERIN B.V. | Netherlands |
NB 0163 | LABORATORIO OFICIAL JOSE MARIA DE MADARIAGA | Spain |
NB 1326 | LIMITED LIABILITY COMPANY LATVIAN CERTIFICATION CENTRE (LATSERT) | Latvia |
NB 1434 | POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A. | Poland |
NB 2982 | SERVICIO DE CERTIFICACIÓN CAAE, S.L (UNIPERSONAL) | Spain |
NB 2832 | Stichting Global Network Group TIC trading as EMCI Register and EFCI Register | Netherlands |
NB 1749 | TNO Defense, Security and Safety | Netherlands |
NB 0906 | TUV AUSTRIA HELLAS LTD | Greece |
NB 2979 | Österreichische Agentur für Gesundheit und Ernährungssicherheit GmbH | Austria |
In February 2020, the European Commission notified CEN with a Standardization Request to develop European Standards (EN) and Technical Specifications (TS). From February to April 2022, CEN published 82 Technical Specifications via three Technical Committees (TCs) to provide analytical methods to be used by producers to verify the compliance of their products with the FPR:
- CEN/ TC 223 ‘Soil improvers and growing media’
- CEN/TC 260 ‘Fertilisers and liming material’
- CEN/TC 455 ‘Plant biostimulants’
The ENs which will follow-up on these TS are expected to be published in 2024/2025 after validation through interlaboratory tests.
The regulation obligation under REACH
One of the main concerns related to the FPR is the registration obligation under REACH to all ingredients contained in fertiliser products, where these fall under the following CMCs:
- CMC 1 (Virgin material substances and mixtures);
- CMC 3 (for composting additives only);
- CMC 4 and 5 (for digestion additives only);
- CMC 6 (Food industry by-products);
- CMC 8 (Nutrient Polymers);
- CMC 9 (Polymers other than nutrient polymers);
- CMC 10 (Derived products within the meaning of Regulation (EC) No 1069/2009);
- CMC 11 (By-products within the meaning of Directive 2008/98/EC);
- CMC 12 (Precipitated phosphate salts and derivates);
- CMC 13 (Thermal oxidation materials and derivates);
- CMC 14 (Pyrolysis and gasification materials); and
- CMC 15 (High purity materials).
This means that to comply with the FPR, all relevant components of fertilising products must be registered under EU REACH, even if they are manufactured or imported in volumes of less than 1 metric ton per calendar year. Furthermore, some of the exemptions from registration provided by Annex V of REACH are not applicable under the FPR.
In addition, to ensure that the “safety of the intended use” can be demonstrated in a manner comparable to that of other regulatory regimes for products intended for use on arable soil or crops, additional information is required for Annex VII (1 – 10 tons per annum) REACH registrations for most of the CMCs. Specifically, for in scope registrations at 1 – 10 tpa, REACH Annex VIII (10 – 100 tpa) information requirements are applicable.
To ensure that relevant fertilising products comply with the FPR, manufacturers should
- Verify the compliance of all ingredients used in your fertilising products (including all co-formulants) with the CMCs listed in Regulation (EU) 2019/1009. If a given ingredient complies with CMC 1, 3, 4, 5, 6, 8, 9, 10, 11, 12, 13, 14 and 15, REACH registration may be required.
- Assess the relevant ingredients to determine whether or not co-formulants are sourced from REACH registered supply chains.
- For any substances which are not sourced from REACH registered supply chains, consider whether any of the available exemptions under REACH are applicable. Remember – the Fertilising Product Regulation disapplies some of the existing REACH registration exemptions.
- For substances that are already REACH registered, confirm with your supplier that the registration meets the information requirements of the Fertilising Product Regulation.
- For substances which require registration under REACH in order to comply with Regulation (EU) 2019/1009, prepare a compliance strategy.
Our dedicated team will be pleased to help you with the verification of compliance of your fertilizing products with the FPR as well as the required steps to place them on the EU market.
Article contributor
Caroline PIGEAT – Regulatory Manager – Plant Nutrition