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EU agrees new ED assessment deadlines for ai renewals

EU member states have approved timetables for applicants to submit additional data on endocrine disrupting properties of agrochemical active ingredients as part of their applications to renew EU approvals.

 

EU member states have approved timetables for applicants to submit additional data on endocrine disrupting properties of agrochemical active ingredients as part of their applications to renew EU approvals. The European Commission outlined planned amendments to Regulation 844/2012 in September, as part of the implementation of new criteria for identifying endocrine disruptors (EDs). The deadlines will apply from November 10th, the same implementation date as the new ED criteria. The changes cover renewal applications that have not yet reached the stage of a vote by the EU Standing Committee on Plants, Animals, Food and Feed on a draft decision on renewal.

The Commission notes that existing information in these applications may not be enough for the new assessment of ED properties to be concluded. The amendments allow the European Food Safety Authority (EFSA) to request additional information in these cases. Furthermore, for applications that have completed the assessment and reached the stage of a decision being drafted, the changes give the Commission the right to decide that more information is needed. In both cases, applicants will have between three and 30 months to submit additional data, depending on the type of information requested. Within this period, applicants will also be able to apply for a derogation from a possible ED ban. Such derogations are allowed if no alternative crop protection solutions are available.

If, based on existing information in a renewal application, the EFSA concludes that the ai meets ED criteria, applicants will be able to apply for a derogation. Once they have been informed of the EFSA’s conclusion, they will have three months to submit their application and supporting data.

For information submissions and for derogation applications, the rapporteur member state for the ai will have 90 days to evaluate the data and the EFSA will have 120 days from receipt of the rapporteur’s report to reach its conclusion.

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