Go to content

4. Assessments

The described assessment in the EU-BPR Evaluation Manual can be used for both the approval procedure for the active substances as well as for the authorisation procedure for products based on approved substances. NL specific approaches that should be taken into account in the assessment for active substances and products for the Dutch market are described in the NL-BPR Evaluation manual. So, the NL procedure for evaluation of a substance or product, described in the NL part, is reverted to where no EU procedure has been laid down or where a specific assessment is necessary.

An EU Evaluation Manual for the Authorisation of Biocidal Products (EU EMPA CA-May13-Doc.6.2.d) has been developed for this purpose and was intended for experts working on the dossier evaluation of biocidal products under Directive 98/8/EC at the Competent Authorities of their EU Member State. Although this EU Evaluation Manual for the Authorisation of Biocidal Products has been written for product authorisation under the European Biocidal Products Directive (98/8/EG), the information in this manual may also be useful as background information because the different aspects of a risk evaluation are elaborated in more detail and can be used as guidance for specific aspects of biocide dossier evaluation under the BPR 528/2012.

Biocidal products based on micro-organisms

The technical advice on the hazard and exposure assessment and the risk characterisation and the evaluation of the active substances and biocidal products in accordance with Annex II, Title 2 and Annex III, Title 2 of the BPR for micro-organisms for all aspects as physical chemical, efficacy, human toxicology, and environment are listed in the ‘Guidance on the Biocidal Products Regulation Volume V, Guidance on Active Micro-organisms and Biocidal Products‘” for which 2.1 (March 2017) is the current version. The guidance is published on ECHA’s website under BPR regulation. No specific approaches for product authorisation are obligated by the Ctgb.

The TL Evaluation Manual describes the methods necessary to be used in the assessment. In general for all aspects the same methods as already available in the EU-part, and in the NL part of the BPR Evaluation Manual are used. However, for some aspects available methods will not be immediately included in the assessment, because in some cases there is a transitional period.

Index