Approval of active substances
Active substances need to be approved before an authorisation for a biocidal product containing them can be granted.
The active substances are first assessed by an evaluating Member State competent authority and the results of these evaluations are forwarded to ECHA's Biocidal Products Committee, which prepares an opinion within 270 days. The opinion serves as the basis for the decision on approval which is adopted by the European Commission. The approval of an active substance is granted for a defined number of years, not exceeding 10 years and is renewable.
The BPR introduces formal exclusion and substitution criteria which apply to the evaluation of active substances.
In principle, active substances meeting the exclusion criteria will not be approved .
- carcinogens, mutagens and reprotoxic substances categories 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. In this case, approval of an active substance is granted for a maximum of five years (also for active substances where the assessment report was submitted before 1 September 2013, as per the transitional provisions).
Active substances potentially 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. In this case, approval of an active substance is granted for a maximum of seven years (for active substances where the assessment report was submitted before 1 September 2013, the approval period can be a maximum of 10 years, as per the transitional provisions).
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. This will assess whether alternative products or methods are available for the same use which present a lower risk, as well as whether the chemical diversity of the active substances is adequate.