Comparative assessment for products containing a candidate for substitution
The objective of this provision in the BPR 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 candidates 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.
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 (BPC) 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.
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 on alternatives.
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.
Authorisation of products containing a candidate for substitution
In accordance with Article 23(1) of the BPR, the receiving competent authority or, in the case of an evaluation of an application for a Union Authorisation (UA), the evaluating Competent Authority (eCA), shall perform a comparative assessment as part of the evaluation of an application for authorisation or for renewal of authorisation of a BP containing an active substance that is a candidate for substitution (CFS) in accordance with Article 10(1) of that Regulation. This also applies to the applications for product authorisation referred to in Article 91 of the BPR.
The product will only be authorised if there are no better alternatives.
As required by Article 24 of the BPR, the Commission has drawn up Technical Guidance Notes (TGN) to facilitate the implementation of Chapter VII and, in particular, Article 23(3) Further detailed information about the practical approach for the implementation of the new concept of Comparative Assessment is described in the following CA-documents CA-May15-Doc.4.3.a - Final - TNG on comparative assessment and CA-March14-Doc.5.4 Final- comparative_assmt_consolidated_version.doc which are available on the CIRCABC Public.