Answer given by Mr Dalli on behalf of the Commission
1. The Commission is aware of the study ‘Glyphosate-Based Herbicides Produce Teratogenic Effects on Vertebrates by Impairing Retinoic Acid Signaling’ from Paganelli et al, which has been made available to Member States at the Standing Committee of Food Chain and Animal Health (SCoFCAH) on 28 September 2010. In addition, the Commission has asked Germany, the rapporteur Member State when glyphosate was first approved as active substance by Commission Directive 2001/99/EC(1), to examine its relevance in the framework of the evaluation of pesticides. That examination is essential as it must be verified whether the laboratory conditions under which the study has been performed are sufficiently representative for the exposure that may be expected from a normal and correct use of the substance as a pesticide.
As for any substance, the approval may be reconsidered in the light of adverse evidence revealed by experience. Depending on the seriousness and urgency of the matter, the Commission may propose to impose additional conditions, to reduce the existing uses, or, in the worst case, to completely ban the substance. If necessary, it may also consider reviewing the existing maximum residue levels (MRLs).
Once Germany will have provided its views on the study, the Commission will decide on how to proceed further and examine whether the current conditions of use and risk mitigation measures set by the Member States remain sufficient as to maintain the high level of protection of the citizen and the environment that is sought in the European Union. In any case, a programme for re-examination of active substances included in Annex I of Directive 91/414/EC as amended among others by Directive 2001/99/EC, for which the approval period is near to expire, is currently under discussion and this programme includes glyphosate.
2. The findings of the study are relevant for the scientific assessment of glyphosate and of glyphosate tolerant GMOs. The new policy as regards GMO cultivation, proposed by the Commission last July, does not alter the existing risk assessment procedure for EU authorisations which is considered appropriate to address the type of issues raised by the study. The new policy aims at allowing Member States to restrict or prohibit cultivation in their territory on grounds other than those based on risk to health or environment.
3. Concerning the pending application for the cultivation of NK603, the next step would be the submission of a draft decision to the SCoFCAH, which is the first step of the comitology procedure. Considering the fact that it would be the first herbicide-tolerant GMO for cultivation used in the EU, the Commission is analysing the need to include specific requirements in particular for post-market monitoring in the draft decision before proceeding further. In addition, the Commission will consider the actions taken as regards Part 1 of the question when considering the authorisation for cultivation of the GMO NK603.
Commission Directive 2001/99/EC of 20 November 2001 amending Annex I to Council Directive 91/414/EEC concerning the placing of plant protection products on the market to include glyphosate and thifensulfuron-methyl as active substances, OJ L 304, 21.11.2001.