Biocidal Products: EU Countries Call for Extension of Data Protection

At their meeting on June 19, representatives of national biocidal authorities (Belgium, France, Italy, and the Netherlands) called on the EU Commission to extend data protection for biocidal products. Current protection is set to expire at the end of 2025 and affects products with outstanding applications for approval that still have incomplete data verification.

Lengthy Review Process

The original schedule for the biocidal review program for existing substances was to be completed by the end of 2024. “Existing substances” are defined as those already on the market as active ingredients in biocidal products on the reference date of May 14, 2000. Since only half of the applications had been reviewed by spring 2024, the EU extended the review program in May 2024 by another six years – until the end of 2030.

Applicants in a Bind

Applicants reacted to that decision with much chagrin. The extension would mean that the data they are required to submit by the end of 2026 (on endocrine-disrupting properties, for example) would no longer be protected from 2026 onwards. Many companies are now evaluating whether to carry out the studies required to obtain the data at all. If they withdraw their applications, the biocidal active substance in question will automatically lose its BPR authorization. Biocidal products containing this active substance would then have to be withdrawn from the EU market.

National Concerns

The four countries state these concerns in their letter to the EU. According to the authors, the disappearance of important biocidal products from the market could endanger public health and environmental protection. They also appeal for fairness. If data protection is allowed to expire before completion of the review program, companies that have invested in substance approval and thus in research and development will be penalized.

We advise you with regard to the requirements of Regulation (EU) No. 28/2012 (BPR), check the labeling and marketability of biocidal products within the EU and carry out the biocide notification in Germany with the BAuA in accordance with the Ordinance on the Notification of Biocidal Products under the Chemicals Act (ChemBiozidMeldeV).

If you have any questions, please contact us at sales@kft.de.