The Biocidal Products Regulation 528/2012 (EC) concerns market access and use of biocidal products in the European Union. The regulation covers a very diverse group of products including disinfectants, preservatives, pest control, anti-fouling and embalming products.
There are, however, certain restrictions and obligations, including:
- Hazard-based exclusion criteria and substitution criteria for active substances and products; an increased focus on the presence of nanomaterials in products
- Regulation of articles treated with biocidal products
- The requirement to submit data (or demonstrate access to data) for all biocide active substances
The approval of biocidal products either as an authorization or a registration is the responsibility of each EU Member State. Member States have different administrative and, on occasion, regulatory requirements. These requirements are not expected to become fully harmonized, even with the removal of interim procedures that were put in place as transitional measures by member states. National requirements and their constant change represent a challenge for companies wishing to place their biocide products on the market.
TSG can help
- Our multidisciplinary team of scientists and registration specialists has years of proven experience gaining approvals for biocidal active substances and product authorizations or registrations for biocidal products across the EU
- We work with both major chemical companies and small suppliers, targeting services to each company’s specific needs
- We have wide-ranging expertise from working in industry, government organizations, and research facilities
- We believe that proactive project management is essential to ensure that our clients’ needs are identified and met in a timely manner
- We have a comprehensive pan-European infrastructure to meet those challenges presented by differing requirements across the European Union with offices in France, Spain, Germany, UK, Slovenia, Slovakia, and Poland, offering focused, local registration support
- We can provide support for non-EU European countries including Switzerland, and Norway.