Answer given by Mr Dalli on behalf of the Commission
The extension of the expiry dates for the inclusion in Annex I to Directive 91/414/EEC(1) applies to all 31 active substances covered by Directive 2010/77/EU(2), which includes glyphosate. There were no technical or other relevant reasons for a differentiated procedure for glyphosate.
The conclusions of the evaluation carried out by Germany as Rapporteur Member State (RMS) on the new studies mentioned in the Honourable Member's Question E‑7874/101, were shared by other Member States' experts. The Honourable Member is invited to refer also to the reply to Question P‑10522/10(3). Therefore, in accordance with the precautionary principle, there was no reason to reconsider the inclusion of glyphosate.
Applications for renewal of the inclusions concerned have been submitted for all the 31 substances within the applicable legal deadlines.
Directive 2010/77/EU and Regulation (EU) No 1141/2010(4) laying down the procedure for the renewal of the inclusion of the 31 active substances, among which glyphosate, were based on an in-depth examination and consideration of all consequences related to the new legislative framework of the regulation No 1107/2009(5) placing of plant protection products on the market. The renewals provided for in Directive 2010/77/EU were taken for a period necessary to enable the applicants to prepare their applications and to enable the Commission to evaluate and decide upon such applications with a view to new detailed rules for such renewals. These new rules have been laid down in Regulation (EU) No 1141/2010, which rules anticipate the application of the new legislative framework, i.e. Regulation (EC) No 1107/2009 on placing of plant protection products on the market.
The new expiry dates for these substances thus allow for their evaluation against the criteria of Regulation (EC) No 1107/2009, which will be applicable in the phase of the assessments leading to the decision either to renew the inclusion (in the new terminology: ‘approval’) or not to approve each of these substances. In particular, as laid down in its Article 14, ‘the approval of an active substance shall be renewed where it is established that the approval criteria provided for in Article 4 are satisfied’. Therefore, all criteria for approval of an active substance laid down in Article 4 of Regulation (EC) No 1107/2009 will be applicable to these substances.
The Commission is aware of the study of Hardell and Eriksson mentioned by the Honourable Member. The study was evaluated by the RMS in 2000 and the conclusions of that evaluation were included in an addendum to the assessment report on glyphosate. The conclusions of the experts were that the data did not sufficiently support the hypothesis in terms of the methodology applied. Finally, all substances are assessed on the basis of defined data requirements and scientifically sound methodologies, which subsequently permit to identify any hazardous property and risk behaviour of the substances.