Approval of active substances
Companies have to apply for the approval of an active substance by submitting a dossier to ECHA. After the validation check has been performed by the Agency, the evaluating competent authority carries out a completeness check and an evaluation. The result is forwarded to ECHA's Biocidal Products Committee, which prepares an opinion within 270 days. This is then submitted to the European Commission for decision-making.
A similar process takes place for the renewal of the approval of an active substance, where, depending on the amount of new studies available at the renewal, a distinction is made between a full evaluation and a limited evaluation. The application to ECHA has to be submitted 550 days before the expiry date of the approval.
The provisions in the BPR will also apply to the applications submitted under the review programme of active substances under the Biocidal Products Directive. As of 1 January 2014, ECHA takes over the programme from Directorate-General Joint Research Centre (DG JRC) of the European Commission.
The BPR introduces the exclusion and substitution criteria as new elements.
Active substances meeting the exclusion criteria will not be approved. This includes:
- carcinogens, mutagens and reprotoxic substances category 1A or 1B according to the CLP Regulation
- endocrine disruptors
- persistent, bioaccumulative and toxic (PBT) substances
- very persistent and very bioaccumulative (vPvB) substances
Derogations are foreseen, in particular when the active substance might be needed on grounds of public health or of public interest when no alternatives are available.
Active substances meeting the substitution criteria will be designated as candidates for substitution during the approval procedure. The criteria are based on the intrinsic hazardous properties in combination with the use and potential exposure.
During the evaluation for national or Union authorisation of a biocidal product that contains active substances considered as candidates for substitution, a comparative assessment will be performed to estimate whether less harmful products are available for the same use.