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Regulatory Affairs International

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Biocides consulting

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

For a complete list of services offered by Di Renzo Regulatory Affairs