The European Union’s Fertilising Products Regulation (FPR) – (EU) 2019/1009 regulates the manufacturing and importing of fertilizing products within the EU. This regulation aims to ensure safety, quality, and environmental sustainability of these products. Understanding and complying with the FPR is essential for businesses in this sector.
The FPR defines a “fertilising product” as any substance, mixture, or micro-organism intended for application on plants to provide nutrients or improve their nutritional efficiency. Through the FPR, a CE marked fertiliser (EU fertiliser) product has access to free movement across the EU member states. All EU fertilising products must meet specific requirements outlined in the FPR’s annexes. These requirements cover aspects like composition, labelling, and safety.
FPR – Product Function Categories (PFCs)
In fertilising products regulation, product function categories (PFCs) focus on the intended roles of fertilising products. By categorizing fertilising products based on their function, the regulation ensures that each product delivers on its promises, while adhering to safety and environmental standards. There are seven PFC categories which are described in Annex I of the regulation:
- Fertiliser
- Liming material
- Soil improver
- Growing medium
- Inhibitor
- Plant biostimulant
- Fertilising product blend
There are also specific subcategories under the categories. For example, in PFC1 there are subcategories for inorganic and organic fertilisers, liquid and solid fertilisers, and macronutrient and micronutrient fertilisers. Each category has its own requirements in respect to nutrient content, nutrient type, contaminants and labelling. Sometimes there are several options for the product function category choice and any of them can be selected as long as the product complies with the requirements of specific PFC.
Component Material Categories (CMCs)
In fertiliser product regulation (FPR), component material categories (CMCs) play a crucial role. In particular, they categorize the various materials used in fertilising products, ensuring that each component adheres to specified safety and quality benchmarks. Whether it’s the primary nutrients or secondary additives, the categorization provided by CMCs ensures a structured and comprehensive approach to product assessment. Currently there are 15 CMC categories which are described in Annex II of the regulation. The categories cover virgin material substances and mixtures (CMC 1) as well as plant based or other processed biological materials (CMC 2-6), and waste derived materials (CMC 12-15):
- 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/EC
- CMC 12: Precipitated phosphate salts and derivates
- CMC 13: Thermal oxidation materials and derivates
- CMC 14: Pyrolysis and gasification materials
- CMC 15: Recovered high purity materials
Fertilising Product Conformity Assessment Procedures
At the heart of the FPR regulation lies a pivotal focus on the procedures of conformity assessment. These procedures evaluate whether a product aligns with the stipulated standards, ensuring that manufacturers and distributors maintain the highest levels of compliance.
Conformity assessment procedures are divided to four modules which have specific requirements. The module applicability is depending on the CMC and PFC categories of the product. The compliance assessment in different modules can be an internal product control (Module A), EU-type examination (Module B), conformity by type based on internal process control (Module C), or it can be a quality assurance of the production process (Module D).
All in all, the product must comply with all the requirements specified in fertiliser product regulation and specifically in the selected PFC category, and raw material CMC categories. In addition, there are requirements for the labelling, documentation, testing and quality system. The manufacturer must prepare a written EU declaration of conformity for an EU fertilising product.
How We Can Assist
Ecobio offers its expertise in the requirements of the EU fertilizer product regulation and chemical legislation. Close cooperation ensures compliance and getting the products on the market.
Ecobio´s services for fertiliser industry:
- Legislation surveys
- Assistance in conformity assessments and audits
- REACH registrations
- Safety data sheets
- Labelling
- Compliance documents
- Fertilisers made from recycled materials
For further enquiries, please email Anne Kallioinen at anne.kallioinen@ecobio.fi
