Annual Report of preparatory activities for the evaluation of toxicity studies supporting the GM food/feed safety assessment, performed during the period 28/11/2018 to 5/12/2019
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Disclaimer: The present document has been produced and adopted by the bodies identified above as author(s). This task has been carried out exclusively by the author(s) in the context of a contract between the European Food Safety Authority and the author(s), awarded following a tender procedure. The present document is published complying with the transparency principle to which the Authority is subject. It may not be considered as an output adopted by the Authority. The European Food Safety Authority reserves its rights, view and position as regards the issues addressed and the conclusions reached in the present document, without prejudice to the rights of the authors.
Abstract
This report describes the tasks performed in the period 28/11/2018 to 5/12/2019under the EFSA contract OC/EFSA/GMO/2018/02, Lot 2 on toxicological studies and animal feeding studies included in applicationsfor market authorisation of genetically modified feed/plants under Regulation (EC) No 1829/2003. The tasks cover the check for study adherence to relevant EFSA guidance documents and to OECD Test Guideline no 407 (2008), OECD Test Guideline no 408 (1998) and OECD Principles on Good Laboratory Practice.During the period covered by this report, preparatory work has been performed on five applications for GM plantssubmitted under Regulation (EC) No 1829/2003 for a total of two 28‐day studies on newly expressed proteins and six 90‐day studies in rodents on GM food/feed, using comprehensive checklist templates.