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

Vibe Meister Beltoft*, Karin Kristiane Nørby, Camilla Thyregod

*Corresponding author for this work

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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.
Original languageEnglish
Article number1857E
Book seriesEFSA Supporting Publications
Issue number5
Number of pages9
Publication statusPublished - 2020

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