Technical equivalence assessments are required for alternative sources under both the Plant Protection Products Regulation (EC) No 1107/2009 and the Biocidal Products Regulation (EU) No 528/2012.
Technical equivalence is used to determine the similarity with regards to chemical composition and hazard profile of substances. The substances can be produced from a different source to the reference source or following a change in the manufacturing location or process compared to the substance included in the initial risk assessment.
A supplier wishing to market a new source of active substance in the EU must first establish the technical equivalence of the active substance, to demonstrate that the level of hazard posed for health and the environment is comparable versus the reference source. If the new source has the same or less harmful effects (taking into consideration impurities) compared to the reference source, then the new source can be considered (eco)toxicologically equivalent to the reference source. The procedures for the assessment of the equivalence of technical materials of substances regulated under plant protection and biocides are set out in a guidance document, SANCO/10597/2003. A two-tiered approach is used in order to assess the equivalence of different sources of technical materials. Tier I involves the evaluation of analytical data (technical specification with supporting five batch analysis and validation data). If equivalence can be established based on this data, then the Tier II assessment is not necessary. If equivalence cannot be established on the basis of the Tier I data, then further mammalian toxicity/ecotoxicity consideration is necessary according to the Tier II requirements following a systematic approach.
We have many years experience of managing technical equivalence applications, from the generation of the initial ‘five-batch analysis’ report based on representative batches, to successfully establishing technical equivalence at EU level. We provide the following services to our clients:
- Study monitoring of the generation and validation of the five batch analysis report, including selection of batches, screening for impurities and generation of the five batch analysis report with supporting validation data
- Preparation of the technical equivalence dossier application and submission to the selected EU Member State(s)
- Responding to queries raised by the authorities during the technical equivalence assessment, liaison with the client and generation of additional higher tier data (e.g. Ames test, QSAR analysis) where necessary
If you require assistance with a technical equivalence application, please send an email to info@kerona.ie or contact the team on +353 1 849 5284.