In the assessment of the technical equivalence an active substance is compared to one already approved substance (reference active substance) to determine if both are equivalent.
ECHA is responsible for this assessment and it is done in two tiers. The tier I is based on the assessment of analytical data. If it fails, a tier II assessment is performed based on the hazard profile using physico-chemical and (eco)toxicological data.
The technical equivalence of an active substance needs to be assessed when:
- The source of an active substance is different from the source of the already approved reference substance (technical material from a new or different manufacturer).
- The source of an active substance is the same as a reference one but there was a change in the manufacturing process (new or different method applied, or starting materials changed), or in the manufacturing location.
Companies have to submit an application to ECHA which, based on the assessment of technical equivalence, will take a decision within 90 days.