Biocides

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 also UK.

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
• Mutual recognitions in parallel
• Mutual recognitions in sequence
• Renewals of authorizations
• Administrative changes
• Minor and major changes

Moreover, we can act as Only Representative (OR) or the equivalent in EU and support at any stage of the registration process.

We look forward to hearing from you.

———————————-

All biocidal products require an authorisation before they can be placed on the market, and the active substances contained in that biocidal product must be previously approved. There are, however, certain exceptions to this principle. For example, biocidal products containing active substances in the Review Programme can be made available on the market and used (subject to national laws) pending the final decision on the approval of the active substance (and up to 3 years after). Products containing new active substances that are still under assessment may also be allowed on the market where a provisional authorisation is granted. Disinfectants, preservatives, pesticides (e.g. insecticides and rodenticides) and antifouling paints are examples of biocidal products.

How Cantul Can help ?

• Product authorisation preparation and submission
• Article 89 Transition period requirements ( Member state Notification or Registration)
• CLP compliance, label reviews, PCN notifications
• Active substance approval preparation and submission
• Article 95 submissions