Companies can apply for the approval or the inclusion in Annex I of an active substance by submitting a dossier to ECHA.
New active substances
Companies have to apply for approval of an active substance by submitting a dossier to ECHA. After the validation check has been performed by ECHA, the evaluating competent authority carries out a completeness check and an evaluation within one year.
The result of the evaluation is forwarded to ECHA's Biocidal Products Committee, which prepares an opinion within 270 days. The opinion serves as a basis for the decision-making by the European Commission and the Member States. The approval of an active substance is granted for a defined number of years, not exceeding ten years.
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 BPR introduces exclusion and substitution criteria as new elements.
Exclusion criteria
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 may be needed on the grounds of public health or of public interest when no alternatives are available.
Substitution criteria
Active substances meeting the substitution criteria will undergo a public consultation and may 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 containing 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.
Existing active substances
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 review programme is a Commission work programme for reviewing all existing biocidal active substances. The programme was set up under the Biocidal Products Directive and continues under the Biocidal Products Regulation.
Substances which were on the market before 14 May 2000 and are evaluated under the review programme are referred to as existing active substances.