The Biocidal Products Regulation (BPR, Regulation (EU) 528/2012) provides a regulatory framework for biocidal products placed on the European Union market. The BPR entered in force in September 2013 and replaced the Biocidal Products Directive (Directive 98/8/EC).
The biocidal products are divided into 22 biocidal product-types which are grouped in four main groups:
- Main group 1: Disinfectants
- Main group 2: Preservatives
- Main group 3: Pest Control
- Main group 4: Other biocidal products
Biocidal products must be authorised before they can be placed on the European market, and the active substances contained in that biocidal product need to be previously approved. A Review Programme of all existing active substances has been initiated under the Biocidal Products Directive and it continues under the BPR. Biocidal products containing active substances in the Review Programme can be placed on the market and used (subject to national regulations) until the final decision (and up to 3 years after) on the approval of the active substance is made.
Manufacturers or importers are responsible for registration of biocidal products if they plan to sell their products within the European Union.
At wca we can provide the following Biocides registration services:
- Support with application for biocidal product authorisation under Regulation 528/2012
- Review of existing data, data gap analysis and design of testing strategies
- Commissioning of relevant testing and study monitoring
- Preparation of dossier in IUCLID 6
- Development and refinement of human health and environmental hazard assessments
- Assessment of endocrine disrupting properties
- Assistance with submission of complete registration dossiers
- Classification and labelling in accordance with Directive 1999/45/EC and Regulation (EC) No 1272/2008
- Post-submission support
Please contact us for further information on our services.