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Policy Making

Safeguard and emergency measures

As provided for in Directive 2001/18/EC (Article 23), where a Member State, as a result of new or additional scientific evidence made available since the date of the authorisation, has detailed grounds for considering that an authorised GMO constitutes a risk to human health or the environment, it may provisionally restrict or prohibit the sale and use of this GMO on its territory. The Member State immediately informs the Commission and the other Member States and supplies its review of the environmental risk assessment and the new or additional scientific evidence on which its decision is based. The Commission then submits this evidence to EFSA asking for its opinion. On the basis of the opinion of EFSA, the Commission prepares a proposal on whether the Member State should repeal, maintain or amend its measure. This proposal is submitted for voting to the Member States under the Comitology procedure.

Where it is evident that GMOs authorised for cultivation under Regulation (EC) 1829/2003, or notified under the Regulation for re-authorisation of their cultivation, are likely to constitute a serious risk to human health, animal health or the environment, measures are taken under the emergency procedures of Regulation (EC) No 178/2002 (Article 34 of Regulation (EC) No 1829/2003 in conjunction with Articles 53 and 54 of Regulation (EC) No 178/2002). In this case the Commission also presents a proposal under the Comitology procedure with a view to the extension, amendment or abrogation of the national measure.