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.