Transition period

Certain biocidal products are subject to national transitional provisions pursuant to Article 89 of the Biocidal Products Regulation (Regulation (EU) No. 528/2012), which allow for provisional placing on the market of a Member State in accordance with nationally established rules. Whether a product falls under the national transitional provisions depends on its active substances and their approval status in accordance with the Review Regulation (Regulation (EU) No. 1062/2014). The transitional provisions are generally applicable as long as a biocidal product contains at least one active substance that has not yet been approved in accordance with the Review Regulation for at least one of the relevant product types.

The requirements for placing biocidal products on the market under the transitional provisions show some similarities, but also significant differences between the individual Member States. The requirements often include notification obligations for biocidal products, which, however, vary considerably from country to country with regard to the required data, fees and assessment periods. In Germany, for example, biocidal products must be notified to the Federal Institute for Occupational Safety and Health (Bundesanstalt für Arbeitsschutz und Arbeitsmedizin, BAuA) under the transitional provisions of the Biocide Law Implementation Ordinance (Biozidrechts-Durchführungsverordnung, ChemBiozidDV).

DLAC GmbH offers comprehensive advice and support regarding notification requirements for biocidal products under transitional provisions – from selecting the relevant application type to preparing the application and accompanying the official assessment process, right up to the decision and beyond.

 

Our consultation and support services

• Advice on elements of the national transitional provisions for biocidal products
• Impact analysis
• Preparation of applications for biocidal product notifications under transitional law
• Literature research and acquisition of relevant data
• Toxicological and ecotoxicological assessment of biocidal products
• Assistance with necessary studies – from selection and design of studies to laboratory search and commissioning
• Communication with the authorities