The European Chemicals agency, ECHA, has published a further guidance document regarding biocides, “Guidance on applications for technical equivalence“.
This Guidance document informs potential applicants about their obligations resulting from the provisions of Article 54 of the Biocidal Products Regulation, when they need to apply for an assessment of technical equivalence and on the procedural steps in making that application. The guidance also informs potential applicants about the assessment process conducted by the Agency and the approach used for assessing the technical equivalence of the alternative source of an active substance versus its reference source.
Technical equivalence is defined in the BPR in Article 3(1)(w): “technical equivalence means similarity, as regards the chemical composition and hazard profile, of a substance….. Therefore, the need to conduct appropriate analytical measurements on the biocidal product, or active ingredient contained therein is of prime importance, alongside establishing the risk from the product.
The document is comprehensive and provides very good guidance to applicants. Similarities to the approaches used previously with REACH are apparent, which is helpful to applicants who have previously registered substances under REACH as well as for consistency of approach for Agency staff.
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