The FPR

The Fertilising Products Regulation (FPR)

The Fertilising Products Regulation (FPR) is a key piece of legislation in the European Union aimed at harmonising the market for fertilising products across member states. Implemented in July 2022, the FPR sets out to ensure the safety, efficacy, and environmental sustainability of fertilising products while facilitating their free movement within the EU market. The regulation establishes a framework for the approval, marketing, and use of fertilisers, soil conditioners, and plant biostimulants, including those derived from seaweeds and other organic materials. EBIC was instrumental in ensuring that plant biostimulants were included in the FPR at its inception.

 

The FPR aims to achieve:

  • Market Harmonisation: By providing a unified regulatory framework, the FPR seeks to eliminate barriers to trade within the EU, ensuring that products meeting EU standards can be marketed across all member states.
  • Safety and Environmental Protection: The regulation mandates rigorous safety standards to protect human health and the environment from potential risks associated with fertilising products.
  • Innovation Support: The FPR is designed to accommodate new and innovative products while maintaining high safety and efficacy standards.

 

How does EU law recognise plant biostimulants?

The FPR applies the concept of ‘CE Marking’ for fertilising products. This means that any product which is within scope of the FPR, including biostimulants, benefits from free circulation in the EU’s internal market if it conforms with EU requirements for health, safety and environmental protection.

Plant biostimulants are regulated within the FPR under Product Function Categories (PFC) 6 for:

  • Basic quality, meaning they demonstrate a plant biostimulant effect as specified in the regulation
  • Safety requirements, meaning they comply with limits for contaminants and pathogens

And under PFC 7 for

  • Product blends.

 

Biostimulants may fall into different component material categories (CMC) as follows:

  • CMC 1 : virgin material
  • CMC 2 : plants
  • CMC 6 : food industry by-products
  • CMC 7 : microorganisms
  • CMC 8 : nutrient polymers
  • CMC 11 : industrial by-products

EBIC’s recommended changes to the FPR

While the FPR represents a significant step forward, EBIC has identified several areas where improvements are needed to enhance its effectiveness and support innovation.

Facilitating Market Access

  • Addressing National Divergences: EBIC members report that some EU member states impose additional requirements beyond those specified in the FPR, hindering market access for products that have already passed the FPR conformity assessment. There is a need for better alignment and consistent application of the FPR across all member states.
  • Expanding Component Inclusion: Many plant biostimulants, including those based on microbial organisms, phosphites, and animal by-products, are currently excluded from the FPR. EBIC advocates for a more inclusive approach that allows for the incorporation of these components into the FPR framework to reflect the evolving market needs.
  • Mandatory Harmonisation: While optional harmonisation has its place, EBIC believes that mandatory harmonisation is essential to avoid delays and ensure that plant biostimulants and other products can be marketed across the EU without being constrained by national regulations.

Protecting Human Health and the Environment

  • Contaminant Limits: The current values for contaminants in plant biostimulants appear to be workable. However, EBIC suggests ongoing reviews to ensure these values remain appropriate as new scientific data becomes available.

Reducing Unjustified Regulatory Costs

  • Positive Lists and Innovation: The reliance on positive lists for components (e.g., CMC 7, CMC 10, CMC 11) has been criticised for impeding innovation and market access. EBIC recommends adopting criteria-based CMCs, which are more adaptable and better suited to accommodate new technologies and materials.
  • REACH Registration Burdens: The FPR’s requirements for REACH registration are seen as disproportionate and administratively burdensome. EBIC calls for a reassessment of these requirements to reduce unnecessary administrative tasks and to align with existing safety and health regulations for food and feed additives.
  • Conformity Assessment Modules: The current requirements under Module D, which necessitate auditing the entire production process, are deemed excessive. EBIC proposes limiting these requirements to the specific process steps related to the manufacturing of fertilising products to enhance efficiency and reduce costs.

Enhancing Coherence

  • Transformation Processes for Protein Hydrolysates: The restriction of protein hydrolysate transformation processes to those approved for animal feed is problematic. EBIC suggests a criteria-based approach to ensure safety while allowing for greater flexibility in using protein hydrolysates in fertilising products.
  • Digital Labelling: The current proposal on digital labelling does not fully leverage the potential benefits of digitisation. EBIC supports the introduction of criteria for professional versus non-professional users to make digital labelling more practical and beneficial.

Empowering the European Commission

  • Streamlined Product Category Updates: EBIC advocates for empowering the European Commission to add new product categories without undergoing a full legislative process. This would facilitate the inclusion of innovative products and support ongoing advancements in the fertilising products sector.

The Fertilising Products Regulation is a crucial step towards a unified and safe market for fertilising products within the EU. However, for the FPR to fully realise its objectives, it is essential to address the concerns raised by EBIC and implement the recommended changes. These improvements will support innovation, reduce regulatory burdens, and ensure that the regulation remains effective in a rapidly evolving market.

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