Conformity Assessment

Conformity Assessment

Conformity assessment is a crucial process used to ensure that products meet specific regulatory standards and requirements before they are placed on the market.

The conformity of a plant biostimulant is assessed by a Notified Body (NB) before it is placed on EU internal markets. Manufacturers must demonstrate that all legislative requirements outlined in the EU Fertilising Products Regulation (FPR) have been met.

Conformity assessment includes testing, inspection and certification, following the procedure outlined in the FPR. Biostimulants must undergo a conformity assessment to ensure they meet safety, efficacy, and environmental standards.

This makes the FPR very different from other EU legislation, such as plant protection product legislation, which is contingent to product authorisation in an EU member state.

How does the FPR set out requirements for biostimulants?

The EU Fertilising Products Regulation (FPR) establishes the requirements for biostimulants, setting out standards for their safety and performance. Under this framework, biostimulants are assessed based on their intended use and the claims made about their benefits. The assessment ensures that products meet the necessary criteria for placing them on the EU market.

The FPR defines various categories and components for biostimulants. These include:

• Active Substances: The specific substances or microorganisms that have a beneficial effect on plants.
• Claims and Efficacy: The claims made about the product’s effectiveness, which must be substantiated by scientific evidence.
• Safety Standards: Ensuring that biostimulants do not pose risks to human health, animals, or the environment.

How does conformity assessment work?

The conformity assessment for biostimulants involves several key steps:

• Documentation and Testing: Manufacturers must provide comprehensive documentation and evidence demonstrating that their biostimulants meet the required standards. This includes performance data, safety information, and details about the product’s composition.
• Evaluation by Notified Bodies: Notified bodies, which are designated organisations authorised to assess conformity, review the submitted documentation and perform evaluations. They ensure that biostimulants comply with EU regulations before granting CE mark certification. Companies may submit their dossiers to any NB, even one outside the main target market. National authorisation is not required for a product that is CE marked.
• Market Surveillance: Post-market surveillance activities help ensure that products continue to meet the required standards throughout their lifecycle. This involves monitoring and checking products already on the market to detect any potential issues or non-compliance.

Why is conformity assessment important?

In the context of the European Union’s Single Market, conformity assessment helps verify that products, including biostimulants, comply with EU legislation and safety standards. This process plays a vital role in facilitating trade, protecting consumers, and ensuring a level playing field for businesses.

For more detailed information on conformity assessment in the EU, visit the European Commission’s Single Market webpage.

Challenges and recommendations

While the conformity assessment process is essential for ensuring product safety and compliance, there are several challenges and areas for improvement.

Some EU member states may impose additional national requirements, leading to inconsistencies in the application of the FPR. There is a need for greater alignment and consistency to ensure that products meeting EU standards are accepted across all member states.

The current regulatory framework may not fully encompass emerging biostimulant technologies. EBIC recommends expanding the list of approved components and adopting a criteria-based approach to facilitate the inclusion of new and innovative products.

The conformity assessment process can be complex and administratively burdensome. Streamlining procedures and reducing unnecessary requirements can help make the process more efficient and accessible for manufacturers.