EU Moves Ahead with Approval of DBNPA BIT and Formic Acid for Biocidal Products to Improve Safety and Standards

The European Commission has announced plans to approve three active substances - 2,2-Dibromo-2-cyanoacetamide (DBNPA), 1,2-Benzisothiazol-3(2H)-one (BIT) and formic acid - for specific uses in biocidal products. These proposals, detailed in WTO notifications G/TBT/N/EU/1099, G/TBT/N/EU/1100 and G/TBT/N/EU/1101 of 2 December 2024, aim to harmonise the EU market for biocidal products while ensuring the protection of human health and the environment.

DBNPA Approval for Product Type 6

The EU intends to approve DBNPA (CAS No 10222-01-2) as an active substance for use in product type 6 biocidal products, which are in-can preservatives. DBNPA is recognised for its rapid antimicrobial action, making it effective in preserving products susceptible to microbial contamination. However, due to its endocrine disrupting properties, it meets the exclusion criteria set out in Article 5(1) of the Biocidal Products Regulation (BPR; Regulation (EU) No 528/2012). Nevertheless, a derogation under Article 5(2)(c) of the BPR allows for its approval for specific uses where there are no suitable alternatives and the benefits outweigh the risks.

BIT Approval for Product Types 6 and 13

Similarly, the EU is proposing the approval of BIT (CAS No 2634-33-5) for use in product types 6 and 13. Product type 13 refers to metalworking fluid preservatives. BIT is widely used for its efficacy against bacteria and fungi, making it valuable in the preservation of various products. Its approval is intended to provide manufacturers with an effective means of ensuring product longevity and safety.

Formic Acid Approval for Product Type 6

The EU is also planning to approve formic acid (CAS No 64-18-6) for use in product-type 6 biocidal products. Formic acid is known for its effectiveness in controlling microbial growth and is widely used in industrial applications.

Stakeholder Involvement and Implementation Date

These approvals are part of the EU's ongoing efforts to regulate biocidal products under the Biocidal Products Regulation, which aims to improve the functioning of the biocidal products market while ensuring a high level of protection for human health and the environment. Stakeholders are invited to comment on these proposals within 60 days from the date of notification. The proposed date of adoption for the approvals is February 2025, with entry into force 20 days after publication in the Official Journal of the EU.

These developments underline the EU's commitment to maintaining high standards for biocidal products, balancing the need for effective preservation solutions with the need to protect public health and the environment.