Authorisation of biocidal products

Biocidal products may only be placed on the market or used in the EU if they have been authorised in accordance with the Biocidal Products Regulation (Regulation (EU) No. 528/2012). Various procedures with different requirements and costs may apply, depending on the product itself, its active substances, its intended uses, and the countries in which it is to be marketed.

If a product is only to be placed on the market in a single member state, a national authorisation in that country is sufficient. If the product is to be placed on the market in additional member states, mutual recognition of the national authorisation can be applied for. If the product is to be placed on the market throughout the European Union, there is also the alternative of submitting an application for a Union authorisation. In addition, it is possible to apply for simplified authorisation, which involves significantly lower data requirements, for products that have a low risk potential in accordance with a number of criteria set out in the Biocidal Products Regulation.

Notwithstanding the above authorisation procedures, certain biocidal products (depending on the active substances they contain) are subject to national transitional provisions in accordance with Article 89 of the Biocidal Products Regulation, which in most cases involve biocidal product notifications according to national procedures.

Which of the above-mentioned procedures are applicable and most suitable varies greatly from product to product. DLAC GmbH offers you comprehensive advice and support throughout all steps of the biocidal product authorisation process – from selecting the type of application and preparing the application to supporting you through the regulatory evaluation process, right up to the decision and beyond.

 

Our consultation and support services

• Advice on elements of the Biocidal Products Regulationand use of intelligent strategies
• Impact analysis
• Preparation of technical dossiers in IULCID, submission of applications for product authorisation to the competent authority(ies) and management of the case in the Register for Biocidal Products (R4BP)
• 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