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

Vibe Meister Beltoft, Karin Kristiane Nørby*

*Corresponding author for this work

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Abstract

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.
Original languageEnglish
Article number1586E
JournalE F S A Journal
Volume16
Issue number2
Number of pages8
ISSN1831-4732
DOIs
Publication statusPublished - 2019

Keywords

  • OC/EFSA/GMO/2014/01 Lot 2
  • GMO-toxicity
  • compliance

Cite this

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title = "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",
abstract = "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.",
keywords = "OC/EFSA/GMO/2014/01 Lot 2, GMO-toxicity, compliance",
author = "Beltoft, {Vibe Meister} and N{\o}rby, {Karin Kristiane}",
year = "2019",
doi = "10.2903/sp.efsa.2019.EN-1586",
language = "English",
volume = "16",
journal = "E F S A Journal",
issn = "1831-4732",
publisher = "European Food Safety Authority (E F S A)",
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T1 - 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

AU - Beltoft, Vibe Meister

AU - Nørby, Karin Kristiane

PY - 2019

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N2 - 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.

AB - 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.

KW - OC/EFSA/GMO/2014/01 Lot 2

KW - GMO-toxicity

KW - compliance

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DO - 10.2903/sp.efsa.2019.EN-1586

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SN - 1831-4732

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