Aprobación de sustancias activas
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 which are candidates for substitution
The objective of this provision is to identify substances of particular concern to public health or the environment and to ensure that these substances are phased-out and replaced by more suitable alternatives over time.
The criteria are based on the intrinsic hazardous properties in combination with the use. An active substance will be considered as a candidate for substitution if any of the following criteria are met:
- It meets at least one of the exclusion criteria.
- It is classified as a respiratory sensitiser.
- Its toxicological reference values are significantly lower than those of the majority of approved active substances for the same product-type and use.
- It meets two of the criteria to be considered as PBT.
- It causes concerns for human or animal health and for the environment even with very restrictive risk management measures.
- It contains a significant proportion of non-active isomers or impurities.
If during the approval process of an active substance, the evaluating competent authority identifies an active substance as a potential candidate for substitution, this will be listed in the conclusions of its evaluation. In such cases, ECHA will initiate a public consultation.
Active substances which are candidates for substitution will not be approved for more than seven years, even in the case of renewal. If the active substance meets one or more exclusion criteria, it will only be approved for five years.
When an active substance is identified as a candidate for substitution, products containing that active substance will have to be subject to a comparative assessment at the time of authorisation and will only be authorised if there are no better alternatives.
Since harmonised classification is a key element in the exclusion criteria and therefore for the assessment of whether an active substance is a candidate for substitution, the ECHA secretariat will aim to ensure cooperation between the Biocidal Products Committee and the Risk Assessment Committee (RAC).
Similarly, the PBT properties of an active substance also need to be assessed when deciding whether an active substance is a candidate for substitution. Therefore, the ECHA secretariat will also aim to ensure cooperation among the BPC and the ECHA PBT expert group.