The European Commission has officially approved the use of formic acid as an active substance in biocidal products for product-types 2, 3, 4, and 5. This decision, detailed in Commission Implementing Regulation (EU) 2023/2643, marks a significant development in the regulation of biocides within the EU.
Background of the Approval
Formic acid, known chemically as methanoic acid, has undergone thorough evaluation for its use in specific biocidal product types:
- Product-type 2: Disinfectants and algaecides not intended for direct application to humans or animals.
- Product-type 3: Veterinary hygiene.
- Product-type 4: Food and feed area.
- Product-type 5: Drinking water.
The assessment, spearheaded by Belgium as the rapporteur Member State, involved rigorous evaluation by competent authorities and discussions within the European Chemicals Agency (ECHA). The Biocidal Products Committee, after considering these assessments, recommended approval, recognizing the efficacy of formic acid in these applications while emphasising adherence to safety and usage conditions.
Key Conditions for Authorisation
The Commission's approval comes with specific conditions to ensure the safe use of formic acid in these biocidal products. These conditions focus on detailed product assessments, particularly concerning exposures, risks, and efficacy linked to uses not covered in the Union-level risk assessment. Moreover, the regulation pays special attention to:
- Professional and non-professional users.
- Secondary exposure of the general public and children.
- Potential residues in food or feed, necessitating the assessment of maximum residue levels (MRLs) and appropriate risk mitigation measures.
Implications for Stakeholders
With the approval effective from November 1, 2024, stakeholders in the biocides sector, including manufacturers and users, must align with the new regulation. This involves adapting to the specific conditions set out for each product type, especially concerning safety assessments and compliance with established MRLs. This proactive approach will help ensure that the integration of formic acid into biocidal products is both effective and safe, meeting the high standards of consumer and environmental safety expected in the EU.
Moving Forward
As the regulation becomes binding and directly applicable in all Member States, it is incumbent upon relevant parties to take necessary preparatory measures. These measures include adjusting product formulations, updating safety data sheets, and ensuring that all stakeholders are informed about the new requirements and conditions for the use of formic acid in biocidal products.
For more detailed information on the regulation and its implications, stakeholders are encouraged to review the full text of Commission Implementing Regulation (EU) 2023/2643, available at the EU's official journal.
This is a significant step in the ongoing efforts to regulate and ensure the safe use of biocidal products in the European Union. The approval of formic acid for specific product types underlines the EU's commitment to public health and environmental safety, while also fostering innovation in the biocides sector.
