Answer given by Mr Dalli on behalf of the Commission
In its opinion of March 2010(1) the European Food Safety Authority (EFSA) concluded that steviol glycosides covered by the proposed specifications are not carcinogenic, genotoxic or associated with any reproductive/developmental toxicity. The in vitro genotoxicity referred to was considered by EFSA and EFSA considered that this study does not raise concern as this effect was not confirmed in vivo.
Taking into account the opinion of EFSA, the Commission submitted to the Standing Committee of the Food Chain and Animal Health a draft Commission Regulation to include steviol glycosides in Annex II to Regulation (EC) 1333/2008(2) and a draft Commission Regulation laying down specifications for all the food additives listed in Annexes II and III to Regulation (EC) 1333/2008 including specifications for steviol glycosides.
The specifications for steviol glycosides are based on the advice of EFSA who referred to the specifications proposed by the Joint FAO/WHO Expert Committee on Food Additives (JECFA)(3). These specifications are internationally recognised, and are known by the producers of steviol glycosides, by the food producers and by the Member States control authorities.
According to Article 14 of Regulation (EC) 1333/2008 the specifications of food additives shall be adopted when the food additive is included in the lists in the annexes for the first time. The measure authorising the use of steviol glycosides at appropriate maximum use levels and the measure on specifications are to be adopted according to the regulatory procedure with scrutiny. Both texts were therefore presented together at the Standing Committee on 4 July 2011 where they received a favourable vote by the Member States. Due to imperative requirements of the adoption procedure, including translations, a certain lapse of time in the adoption of both measures may occur.
It is in the interest of consumer safety that the proposed conditions of use are adopted as soon as possible in order to avoid that products, containing steviol glycosides at levels that are not safe, are maintained on the market.