Assessment of equivalence of active substances or additive
The purpose of technical equivalence is to determine the similarity with regards to the chemical composition and hazard profile, of substances produced from a source different to the reference source or from the reference source but following a change to the manufacturing process and/or manufacturing location compared to the substance of the reference source in respect of which the initial risk assessment was carried out.
The technical equivalence of an active substance needs to be assessed in the context of biocidal product authorisation when there has been a change in regard to the source of the active substance. Relevant companies' obligations are described in Commission Delegated Regulation (EU) No 837/2013 amending Annex III to Regulation (EU) No 528/2012.
Companies may request the assessment of the Technical Equivalence of their active substance once the decision on the approval of the active substance has been adopted. Applications for TE –assessments must be made to ECHA.
Please refer to the ECHA website for more information on technical equivalence:
- General information
- Practical guide on BPR – Technical equivalence
- Recommendations for applicants on information requirements for technical equivalence Tier II
- BSM application instructions: Technical equivalence and chemical similarity
- Instructions for submission
Timeline Technical equivalence
Submission to ECHA => payment to ECHA within 30 days
Within 90 days after receipt of application ECHA makes a decision and informs applicant and member states (stop-the-clock of max. 180 in case additional data are needed)