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Parliamentary question - P-010522/2010(ASW)Parliamentary question

Answer given by Mr Dalli on behalf of the Commission

Directive 91/414/EEC provides that at the expiry of the approval period of an active substance, renewal shall be granted for the period necessary to complete a review where an application has been made for such renewal in sufficient time and in any case not less than two years before the inclusion period is due to lapse. The Commission has received requests regarding renewal of inclusions for substances for which the inclusion period is going to expire in 2011 and 2012, among them glyphosate. Therefore, in order to permit the definition and completion of the renewal programme, it has been necessary to postpone the inclusion expiration dates with Directive 2010/77/EU for all substances concerned.

Complementary to that decision, the Commission has adopted a Regulation (EU) No 1141/2010 laying down the procedure for the renewal of the inclusion of these active substances, among which glyphosate[1]. According to the procedure set in that regulation, a renewal dossier on glyphosate will have to be submitted by 31 May 2012 to permit the re-evaluation of the substance which will be performed in the light of the new criteria laid down in Regulation (EC) No 1107/2009 which will be applicable as from 14 June 2011.

With respect to the question on the recent scientific data reported in the previous Question E‑7874/10, the matter has been brought to the attention of the Standing Committee on the Food Chain and Animal Health on 29 September 2010 and the Commission invited Germany, the Rapporteur Member State which evaluated glyphosate prior to its EU wide approval in 2001, to provide its views on the above studies, the validity of their methodology and their relevance.

The German authorities came to the conclusion that such studies had been performed under highly artificial conditions, extremely different from agricultural circumstances and that it is hardly possible to predict adverse effect on mammals on that basis. They point out there is a comprehensive and reliable toxicological database for glyphosate and the findings of these studies do not put into question the current EU risk assessment for the substance. That conclusion, reported in the Standing Committee meetings on 28 October 2010 and 23 November 2010, is shared by the other Member States. As a consequence, the Commission does not consider there is currently a solid basis to ban or impose additional restrictions on the use of glyphosate in the EU.

OJ C 279 E, 23/09/2011