Gaining Technical Equivalence for your sources of pesticide active substances
According to the European Commission guidance document on the assessment of equivalence of technical materials (SANCO/10597/2003 – rev. 10.1), the assessment follows a tiered approach involving:
- Covers the identity of the active substance and associated analytical methods used.
- Requires submission of 5-batch data on the chemical composition of the active substance technical material.
- Requires submission of validation data for the analytical methods used to generate the 5-batch data.
- The 5-batch data is used to propose a technical specification for the new active substance source.
- A comparison of the technical specifications of the new source and the reference source is performed to determine equivalence.
- Equivalence of the new source is established if: (i) it has a minimum purity not lower than the reference source, (ii) it contains no new impurities, (iii) the limits for (eco)toxicologically relevant impurities certified in the reference source are not exceeded, and (iv) the limits for non-relevant impurities certified in the reference source are not in exceedance of well-defined threshold values.
If equivalence cannot be established based upon the chemical comparison, then the assessment moves on to:
- Addresses the (eco)toxicological properties of the new source of the active substance technical material.
- The assessment establishes if the new source presents an unacceptable hazard increase compared to the reference source due to: (i) any new impurities, (ii) increased levels of (eco)toxicologically relevant impurities, or (iii) increased levels of non-relevant impurities which exceed the acceptable limits.
- If sufficient evidence can be provided to demonstrate that the new source presents no unacceptable increased hazards to health or the environment then equivalence can be concluded.
Enviresearch has expertise and experience in the preparation of technical equivalence dossiers in accordance with SANCO/10597/2003 – rev. 10.1.
Our services include:
- Review of 5-batch data for deriving technical specifications.
- Review of method validation data to ensure regulatory compliance. Performing (Q)SAR analysis for prediction of (eco)toxicological properties of impurities.
- Study monitoring of 5-batch (Tier I) and bacterial reverse mutation studies (Tier II).
- Preparation of technical equivalence reports according the European Commission evaluation report template.