The European Union Approves Formic Acid for Biocidal Products: Conditions and Implications

November 3, 2023

Approval of Formic Acid

Formic acid, also known as methanoic acid, is a chemical compound with the IUPAC name methanoic acid. Its identification numbers include EC number: 200-579-1 and CAS number: 64-18-6. The approval of formic acid for TP 2, 3, 4, and 5 as an active substance is effective from November 1, 2024, and remains in effect until October 31, 2034.

Conditions and Considerations

The authorization of biocidal products containing formic acid is subject to several conditions aimed at ensuring the safety of users and the environment. These conditions include:

  1. Risk Assessment of the Biocidal Product: The risk assessment of the product gives particular attention to the evaluation of efficacy, hazard, exposure, and risk characterization for users and the environment related to all uses covered by an authorization request. This is especially required for uses not considered during the approval of the active substance at the European Union level.

  1. User Categories: The product assessment must pay particular attention to different user categories, including professional or industrial users, non-professional users, and the risk of potential secondary exposure for the general public and children.

  1. Analysis of Residues in Contact with Food or Animal Feed: For biocidal products that may result in the presence and transfer of residues from treated surfaces to food or animal feed, a food risk assessment is required to determine if the concentration of residues found on the treated surface is below maximum residue levels (MRLs) and thus whether exposure to residues poses an acceptable risk. This assessment must comply with relevant regulations such as Regulation (EC) No. 470/2009, Regulation (EC) No. 396/2005, Regulation (EU) No 528/2012 (Biocidal Products Regulation), Document CA-March17-Doc.7.6.c-final, or more recent guidance like the Draft ARTFood Guidance. If the risk is unacceptable, appropriate risk reduction measures must be implemented to ensure that MRLs are not exceeded.

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