The Biocidal Product Regulation (EU) No. 528/2012 sets the framework for the making available and use of biocidal products in the European Union. The European Chemicals Agency (ECHA) is the central EU agency responsible for the regulation of biocides.
We guide you through the regulatory process in all of the European Union member states and the associated countries.
We support you through general consulting and in:
- Conducting Data Gap Analyses (DGA)
- Monitoring of tests
- Calculating risk assessments
- Preparing dossiers in the required International Uniform ChemicaL Information Database (IUCLID)
- Preparing summaries of the product characteristics (SPC Editor)
- Providing technical translations
- Reviewing classifications according to Regulation (EC) No. 1272/2008 on the classification, labelling and packaging of substances and mixtures (CLP Regulation)
- Guiding you through the authorization process during the transitional period according to national schemes until EU approval of active substances
- Carrying out submissions and dossier follow-up on the ECHAs online Register for Biocidal Products (R4BP 3)
- Creating and submitting poison center notifications (PCN)
We assist you with all application types for the authorization of biocidal products and biocidal product families, including:
- Applications for national authorizations
- Applications for simplified procedure
- Mutual recognitions in parallel
- Mutual recognitions in sequence
- Renewals of authorizations
- Administrative changes
- Minor and major changes
We look forward to hearing from you.
