How does the approval process work for Biocides?
Active Substance Approval
All (both existing and new) active substances (the active ingredient in a biocidal product) must be reviewed at EU level under Regulation (EU) No 528/2012 (formerly European Directive 98/8/EC) for a given product-type (PT). The EU approval process of an active substance requires application for approval and the submission of a technical and scientific dossier by the substance manufacturer to the evaluating Competent Authority (CA) or Rapporteur Member State (RMS) for that active substance. The RMS evaluates and prepares a draft Competent Authority Report (CAR) of the submitted data that also contains a proposal on the decision to approve or non-approve the active substance.
The draft CAR is subjected to detailed peer review by experts from the other Member States through the Biocidal Products Committee (BPC) and its technical Working Groups at the European Chemicals Agency (ECHA). The BPC Opinion containing its conclusions on the proposal to approve or non-approve the substance are transferred to the European Commission (DG Health and Food Safety) that proposes a Commission Implementing Regulation on the approval or non-approval of the substance. The Commission Implementing Regulation on the approval or non-approval of an active substance must be accepted and voted on by the Standing Committee for Biocidal Products (SCBP). The SCBP is a Committee that helps the Commission implement the EU legislation on biocides and its members are experts nominated by the Member States. Substances are either voted on to the list of approved substances for a period of 5, 7 or 10 years or are non-approved.
- Where an active substance is approved, the biocidal product containing the approved substance must then be authorised in each Member State in accordance with the Biocidal Products Regulation.
- Where an active substance is non-approved, the biocidal product containing the non-approved substances shall no longer be made available on the market for the relevant product-types.
ECHA maintain a list of all approved and non-approved biocide active substances.
Active substances may be reviewed at any time in light of new available scientific or technical information. In any case a systematic renewal of approved substances after their initial approval period of 5, 7 or 10-years is undertaken. Application for the renewal of the active substance approval is carried out and the RMS renewal evaluation is again peer reviewed. Following renewal of approval of an active substance, each plant protection product containing that active substance must also be reviewed and re-authorised or not.
Following EU approval of the active substance biocidal products containing the active substance must be authorised in each Member State. Data to defend the biocidal product(s) must be fully examined and a decision on product authorisation undertaken. Both the data requirements for biocidal product authorisation and the criteria (Annex VI of the BPR - Uniform Principles) by which the product is evaluated are harmonised at the European level. The authorisation of products can be carried out via different processes:
The EU legislation framework has always encouraged mutual recognition and Regulation (EC) No 528/2012 requires greater cooperation among Member State countries across the European Union. Where a biocidal product is authorised in one Member State, an applicant may seek mutual recognition of the authorisation in another Member State.
Applications for product authorisation, authorisation by mutual recognition, Union authorisation and simplified authorisation must be submitted via ECHA using the Register for Biocidal Products (R4BP).