ENSSER Comments on the EFSA Draft Guidance on the Risk Assessment of Food and Feed from Genetically Modified Animals

 30 Sep 2011 – The current “Draft Guidance on the risk assessment of food and feed from genetically modified animals including animal health and welfare aspects published by EFSA on August 10, 2011 is based on risk assessment concepts that do not take into account generally accepted features of risk assessment as undertaking problem formulation, setting limits of concerns and performing uncertainty analysis. These features are going to be integrated into the risk assessment schemes of the USA since several years, have been recognised as elements of risk assessment by the WHO and have been considered by EFSA in the Guidance on the environmental risk assessment of genetically modified plants. ENSSER is of the opinion that any updated EFSA Guidance on risk assessment should not be adopted if it fails to elaborate on these issues.

The appropriate elaboration of these normative features of risk assessment are of specific importance because the requested “proof of safety” as required by in the GM animal guidance cannot never be established in absolute terms but only within certain limits of concerns Such limits of concerns need to be set before the conductof concrete risk assessments in a stakeholder-based process. It is not appropriate to let the applicants suggest and EFSA decide about these normative elements of risk assessment as for example foreseen in the recent EFSA “Guidance on the submission of applications for authorisation of genetically modified food and feed and genetically modified plants for food or feed uses under Regulation (EC) No 1829/2003”.


ENSSER recommends stalling the work on the draft GM animal guidance until the obvious confusion about appropriate concepts for conducting GMO risk assessment consistent with the spirit and letters of EU GMO regulation has been resolved. Many years after the adoption of the current regulatory framework it is finally necessary to discuss the crucial normative and technical issues through a comprehensive stakeholder debate. ENSSER underlines that this is also one outcome of the EFSA Consultative Workshop hold in March 2011.