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 1/3/2016 to 28/2/2017

Abstract

This report describes the tasks performed in the period 1/3/2016 to 28/2/2017 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.

On methodical support for risk-oriented surveillance over consumer products safety on the unified economic territory of the eurasian economic union

“…These bases are prepared by such organizations as European Food Safety Authority or EFSA, Food and Veterinary Office or FVO, and others. For example, EFSA provides a methodological base for assessing products risks by systematic publishing of relevant Guidances for Risk Assessment which can be used by all parties who are interested in assessing products safety, such as manufacturers, distributors, authorities responsible for assessing conformity, and control and surveillance authorities [14][15][16]. It is fixed in legislation that all concerned partied are to be obligatory informed about hazardous products 2 .…”