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EU to adjust dossier submission for ai renewals

The European Commission is to amend rules on submitting supplementary dossiers for the second group of active ingredients going through the programme to renew EU approvals. Such dossiers contain the new data required for renewals, and comprise a summary of studies and a more detailed complete version. Dossiers for the renewals of 29 ais had to be submitted in 2012 ( Agrow No 622, p 12). After the rapporteur member state completes the assessment, the original rules required the applicant to submit the summary, updated to include the additional data requested by the rapporteur, to the European Food Safety Authority (EFSA). However, the Commission wants applicants to submit summary and complete dossiers to enable the EFSA to finalise its conclusion. Its proposals were voted through by the EU regulatory committee in March.



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