Biocides are currently regulated at an EU level by EC Regulation no. 528/2012, with procedures, requirements and arrangements for obtaining marketing authorizations.
The European Agency for which the competent authorities of individual countries refer, the ECHA, is also publishing a number of guidelines for the entire registration procedure of biocides, from preparation of the dossier requirements to post-marketing requirements. However, as with other types of products, individual European states may have special requests for granting authorizations.
In non-EU countries the regulation of biocides can differ greatly from the European situation.
The existence of a large network that binds DR International with regulatory experts in the field allows our consulting firm to assist companies in the registration of biocides in many European and certain non-EU countries.
Among the services that DR International is able to offer, are:
- Check if the active ingredients of a formulation are present in the list of those approved in Europe
- Prior assessment, preparation and submission of a dossier for the authorization of a biocide in accordance with the relevant European legislation and authorization process