EU Regulation Ensures that Biostimulants Are Safe and Effective


What laws regulate plant biostimulants in Europe?


P lant biostimulants are a new category of crop inputs. Different European countries have used different names for them in national rules (where they exist), and those rules have been quite variable from one country to another. To respond to growing farmer interest in having access to these new tools for improving nutrient use efficiency, helping plants tolerate abiotic stress (i.e. difficult growing conditions like extreme temperatures and drought or water logging, among others), and enhancing crop quality, European lawmakers included plant biostimulants in the new EU Fertilising Products Regulation (FPR) that went into force in July 2019.

In total, the FPR counts 7 different “Product Function Categories (PFCs)”, with plant biostimulants being PFC 6. They may also be found in PFC 7 blends.

The FPR provides a common definition of plant biostimulants and offers access to a Single European Market. Starting in July 2022 when the first CE - marked EU Fertilising Products can be placed on the market. This European regulation will co-exist alongside national laws but has promoted alignment on definitions and approaches to placing products on national markets


What are the safety requirements for plant biostimulants under the EU Fertilising Products Regulation?


Part of the EU’s Circular Economy package, the FPR promotes greater recycling and re-use of materials related to plant nutrition and soil fertility. In this context, the regulation sets high standards for product safety requirements, such as limits on heavy metal contaminants and pathogens, to ensure high levels of protection for people, animals, and the environment. Different types of component materials are subject to additional requirements and restrictions to reflect their nature and risk profile. For example, although there is no list of toxicology and ecotoxicology data points in the new regulation itself, these questions are addressed by REACH registration for the substances covered by Europe’s chemical legislation, which the FPR refers to for relevant component materials. Materials derived from animal by-products must have reached an endpoint relative to the Animal By-Products Regulation. Micro-organisms currently have to be inscribed on an approved list (CMC 7). The initial text of the FPR includes 11 Component Material Categories (CMCs), but work is already underway to add additional CMCs.

A full list of the safety requirements can be found in Annex I (for product - level requirements) and Annex II (for component - level requirements) of the FPR.


How does the EU Fertilising Products Regulation ensure product effectiveness?


The Fertilising Products Regulation (FPR) specifies that plant biostimulants should have the effect claimed on their labels. The justification for these claims (as well as compliance with the safety requirements) is verified by an independent body during the conformity assessment process. Manufacturers (or importers, distributors or other economic actors placing a product on the market) must submit a dossier of technical information and test results to a conformity assessment body when seeking the rate to use the CE - Mark on their plant biostimulants and to place them on the EU Single Market.

Harmonised European standards are currently under development by Technical Committee 455 of the European Committee for Standardization (CEN) to explain how to justify biostimulant claims. European standards are developed in a multi-stakeholder context, with national government authorities, industry, consumers, environmental groups, researchers and other relevant stakeholders able to participate either through National Standardisation Bodies or through European groups like ANEC (the consumer voice in standardisation) or ECOS (the only environmental organisation worldwide specialised in standardisation)