EU Extends Approval of 4,5-Dichloro-2-Octyl-2H-Isothiazol-3-One and Disapproves d-Allethrin

On 6 March 2023 the Official Journal of the EU published two implementing decisions modifying the list of allowed or banned active substances in biocides under the Biocidal Products Regulation (EU) No. 528/2012. The texts will enter into force on 26 March 2023.

3E Review

Postponement of Expiry Date of an Active Substance

4,5-Dichloro-2-octyl-2H-isothiazol-3-one is currently approved for use in biocidal products of product-type 8 (i.e., wood preservatives) until 30 June 2023. A renewal request is still being considered. To give the Norwegian evaluating authority enough time and allow the applicant to submit all necessary information, as well as allow the European Chemicals Agency (ECHA) to submit its opinion, Commission Implementing Decision (EU) 2023/471 postpones the expiry date to 31 December 2025.

Disapproval of One Active Substance

D-Allethrin is currently included in the EU Biocides Review Program (Commission Delegated Regulation (EU) No. 1062/2014) for eventual use in biocides of product-type 18. Commission Implementing Decision (EU) 2023/470 disapproves d-Allethrin for use in biocidal products of product-type 18 (i.e., insecticides, acaricides, and products to control other arthropods) based on ECHAs opinion issued on 12 October 2021, in which the authority found discrepancy between the proposed reference specification and the composition of the material that was used for testing to generate the toxicological data. In addition, some unacceptable risk for the environment and the population was identified.

3E Analysis

Producers, importers, and distributors of active substances and ready-to-use biocidal products are informed that they can continue marketing biocides containing 4,5-Dichloro-2-octyl-2H-isothiazol-3-one until 31 December 2025. The approval may or may not be renewed again depending on the outcome of the current evaluation by the competent national authorities and ECHA.

As of 26 March 2023, the use of d-Allethrin in biocidal products of product-type 18 is prohibited.