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Journal article

Annual Report of preparatory work on the toxicological studies and animal feeding studies performed under the EFSA contract OC/EFSA/GMO/2014/01, Lot 2 during the period 1/3/2017 to 27/11/2018

From

Research Group for Chemical Risk Assessment and GMO, National Food Institute, Technical University of Denmark1

National Food Institute, Technical University of Denmark2

This report describes the tasks performed in the period 1/3/2017 to 27/11/2018 under the EFSA contract OC/EFSA/GMO/2014/01, Lot 2 on toxicological studies and animal feeding studies included in applications for 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 (1995/2008), 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 six applications for GM plants submitted under Regulation (EC) No 1829/2003 for a total of three 28‐day studies on newly expressed proteins and six 90‐day studies in rodents on GM food/feed, using comprehensive checklist templates.

Language: English
Year: 2019
ISSN: 23149396 , 18314732 and 23978325
Types: Journal article
DOI: 10.2903/sp.efsa.2019.EN-1586
ORCIDs: Beltoft, Vibe Meister and Nørby, Karin Kristiane

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