Helsinki -- The European Chemicals Agency (ECHA) has published a new Guidance on applications for technical equivalence. The document is now available in the Guidance section of the ECHA website.
This guidance document is intended to inform potential applicants about how and when they need to apply for an assessment of technical equivalence of an active substance and on the procedural steps in making such an application under Article 54 of the Biocidal Products Regulation (Regulation (EU) No 528/2012, (BPR)).
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.
Unlike under the Biocidal Products Directive 98/8/EC (BPD), where technical equivalence was assessed by the Member State competent authority, the assessment of technical equivalence under the BPR will be performed by ECHA for approved active substances. Where considered relevant, the guidance is harmonised with the assessment of technical equivalence for plant protection products under Regulation (EC) No. 1107/2009.