For existing biocidal products, national dossiers must be submitted at the latest by the date of Annex I inclusion of the respective active substances, corresponding to approximately two years after publication of decision.
The first and most important steps in dossier preparation are:
- Definition of the appropriate dossier strategy: Is the frame formulation concept applicable? Should independent dossiers be submitted in different Member States or should mutual recognition be applied for?
- Identification of data gaps and read across options between data on products of similar composition
- Identification of substances of concern and definition of necessary regulatory activities
- Selection of the Reference Member State (if the mutual recognition concept is chosen)
- Clarification of possible critical issues with the (Reference) Member State in a pre-submission meeting.
Once the above points have been clarified, the next steps are:
- Planning and monitoring of studies
- Dossier preparation, including exposure and risk assessments
- Dossier submission to the (Reference) Member State and follow-up (i.e. timely and competent response to questions raised by the authorities).
SCC can cover all above points. Likewise, we can assist you in specific questions, e.g. in the preparation of exposure and risk assessments.
