EU withdraws provisional approval for MAI’s novaluron

Date:04-13-2012

The European Commission has decided to withdraw provisional approval for Makhteshim Agan’s insecticide novaluron based on a letter of 29 February 2012 the company informed the UK of its intention not to support the evaluation any further and not to submit further data.

Makhteshim Agan submitted their application to UK for the inclusion of novaluron in Annex I to the Plant Protection Products Directive on 29 March 2001. Later, the Commission confirmed that the dossier can satisfy the data and information requirements of Annex II and Annex III to Directive 91/414/EEC, was considered "complete". So, Member States where thereby given the possibility to grant provisional authorisations, for plant protection products containing novaluron for an initial period of three years. EU also granted extension to provisional approval for this active ingredient for further date submission.

Since the additional information requested by the European Food Safety Authority (EFSA) had not been submitted, the dossier can no longer be considered to be complete. Existing provisional authorisations should, consequently, be withdrawn and no new authorisations granted. Member States grant any period of grace for products containing novaluron should expire at the latest one year after the withdrawal of the respective authorisation. Otherwise, authorisations for plant protection products containing novaluron are to be withdrawn by 3 October 2012.