National safeguard clauses (Art. 23/ RL 2001/18) – The role of EFSA & National Biosafety Committees

Abstract

Since 2003, EFSA has been requested by the European Commission, under Article 29(1) and in accordance with Article 22(2) and 22(5)(c) of Regulation (EC) No 178/2002, to assess the information submitted by Member States (MS) concerning the invoke of Article 16 of Directive (EEC) 90/220 or Article 23 of Directive (EC) No 2001/18 (‘safeguard clauses’). The MS were Luxemburg for Bt176 maize; Germany for Bt176 and temporarily (in 2007) MON810 maize; Austria for Bt176, MON810 and T25maize; France forMs1xRf1, and Topas 19/2 oilseed rape, and MON810 maize; Hungary for MON810 maize, and Greece for Topas 19/2 oilseed rape and MON810 maize. The level of scientific information provided in the various safeguard clauses is very heterogeneous. In all cases the GMO Panel concluded, that, with respect to the specific questions raised, and on the basis of current scientific knowledge, there is no reason to believe that the continued placing on the market of Bt176, T25 & MON810 maize, and Ms1xRf1 & Topas 19/2 oilseed rape is likely to cause any adverse effects for human and animal health or the environment under the conditions of their respecttive consents (EFSA, 2004a,b, 2005, 2006a,b, 2008a,b). There is a discussion whether EFSA should request the opinion of the established Scientific Biosafety Committee of the applying EU Member State in order to clarify the scientific basis of future safeguard applications. With one exception (ZKBS, 2007), the author is not aware that such a national Biosafety Committee has published a scientific statement in relation to their specific Member State action. Another point of discussionmight be on the novelty or additional scientific knowledge to base the safeguard clause on. In the safeguard clause issued in 2006 by Austria on GT73 oilseed rape for import, the argumentation had already been assessed (and dismissed) by theMS Authority (e. g. TheNetherlands) under Directive 2001/18/ECwho initially issued the consent. Despite that fact, in 2008, the same document was sent to EFSA again to justify a safeguard clause. A formal standardisation of the information required in support of a safeguard clause (e. g. novelty, additional scientific information, opinion of the national Biosafety Committee etc.) would be a way forward to streamline the regulatory requirement that the Member State shall immediately supply its review of the environmental risk assessment.