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Three guidance documents for the EU BPR regulation will be released soon
On September 1, 2013, the European Chemicals Agency (ECHA) will officially publish three guidance documents of the Biocidal Regulation (BPR) on data requirements, technical equivalence assessment and suppliers of active substances to guide applicants on how to respond to biocidal regulations
.
The information requirements guidance document will clarify the information
required to be included in the dossier submitted when applying for approval of an active substance or authorization of a biocidal product in accordance with the Biocidal Regulation.
The technical equivalence guidance document will clarify the obligations
of potential applicants when conducting technical equivalence assessments under section 54 of the Biocides Regulation.
This provision describes the circumstances under which an applicant is required to apply for a technical equivalence assessment and the corresponding procedures
.
The Active Substance Supplier Guidance Document sets out the obligations
of active substance suppliers under Article 95 of the Biocides Regulation (transition period for the authorization of active substance files).
The guidelines will also indicate the procedures for the approval of active substance dossier and the regulatory outcome
of dossier submission.
(Xiaohua)