A measure on requirements to be fulfilled by companies when submitting applications for the authorisation of new GMOs for food/feed uses was today adopted by the European Commission. The key objectives of this Regulation are: to reinforce and improve the authorisation process of GM food and feed and to clarify the requirements for submitting a request. These new requirements aim to ensure a more transparent process and improve consumer confidence. Endorsed in a meeting of the Standing Committee on the Food Chain and Animal Health (SCFCAH) on 25 February 2013, the Regulation was subject to an extensive consultation with Member States and interested parties. The risk assessment strategy outlined in the Regulation is based on the European Food Safety Authority's (EFSA) guidance and international standards. The Regulation clarifies inter alia, the protocols to be used by applicants when performing studies, requests to review additional available studies as soon as they become available, and specifies quality assurance requirements of the studies performed on GMOs. It also includes the obligation for companies to submit 90-day feeding studies on rodents for single GMO events, for which a protocol has been developed by EFSA based on the OECD protocol for chemicals. This draft Regulation foresees a transitional period of 6 months for companies to comply. The new rules will apply 20 days following publication in the Official Journal of the EU.
Zitiert nach: http://europa.eu/rapid/press-release_MEX-13-0403_en.htm