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REACH24H’s Fluroxypyr Application Passes through Technical Equivalence Assessment under EU PPP Regulation Featured

On 11 Aug 2017, the UK competent authority, Chemical Regulation Directorate, ?Health and Safety Executive (HSE) concluded that a new source of fluroxypyr origin from China is technical equivalent to the current reference specification for the active substance under Regulation (EC) 1107/2009 (the EU Plant Protection Product Regulation). The application for the technical equivalence (TE) assessment was submitted by REACH24H, a leading regulatory consulting company in China, on behalf of a Chinese pesticide manufacturer.

In Europe, the approval of active substance normally requires 2 to 4 years. However by demonstrating that the alternative source of active ingredient has the same or less harmful effects (taking into consideration of impurities) when compared to the reference source, the technical equivalence assessment enables the entry of generic technical product into the EU market in a costless and efficient way.

During the equivalence assessment between the reference source and the new source, a two-tiered approach will be utilized. Tier I will evaluate chemistry data, including manufacturing process and technical specification with supporting five batch analysis on representative batches and validation data. If the equivalence cannot be concluded at this stage, the assessment will proceed to Tier II, which involves further consideration on mammalian toxicity and eco-toxicity profiles.

The time duration the equivalence assessment would vary from 8 to 12 months, depending on the policy of the Rapporteur Member State (RMS) selected, technical skills, number of pending dossier and workload of the authority, etc. In this submission, REACH24H produces the?fastest?record of only 7 months with a Tier II assessment and thus become the first Asian consulting company who achieves technical equivalent assessment in EU.

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