Its Panel on Food Additives and Nutrient Sources added to Food (ANS) said positive trial results had been reported for Semethylselenocysteine as a source of selenium in in vitro genotoxicity assays, but many in vivo studies had turned in negative results.
It also said a lack of clinical trials was problematic and that the margin of safety submitted by the petitioners was “inadequate”.
The ANS stated: “The Panel considers that given the absence of human studies on Semethylselenocysteine, the relatively sparse database on the bioavailability of selenium from this source, and the limited data on its safety compared with other selenium compounds used in food supplements, the ULs for selenium defined by the SCF for adults and children cannot be used for judging its safety.”
It noted that an opinion given in 1999 by EFSA’s predecessor, the Scientific Committee on Food (SCF), was followed in 2000 by advice on Tolerable Upper Intake Levels (UL) for selenium, which found 850μg/day could be taken as a No-Observed-Adverse-Effect-Level (NOAEL) for clinical selenosis.
“Using an uncertainty factor of three to allow for the remaining uncertainties of the studies, the SCF derived a UL for selenium of 300μg/day,” the ANS said.
A lower amount of 250ug was determined for children aged 15-17.
The petitioners sought a level of only 200μg per day, well below these levels, but the ANS noted, “the proposed use level is equal to the UL for children between 11 and 14 years old, and is above the ULs of 60, 90, and 130μg selenium/day for children in the age ranges of 1-3, 4-6 and 7-10 years respectively as defined by the SCF.”
It concluded: “The Panel considers that given the sparsity of the experimental database on this substance, the concerns expressed by the SCF in 1999 about the way in which the body handles organic selenium compared with inorganic forms, are still applicable to Se-methylselenocysteine.”
Three companies submitted one dossier in 2005 – Eburon Organics NV, Biovitaal, Acatris. Sabinsa submitted another dossier in 2006.
The opinion means that the nutrient will not be able to be used in food supplements across the 27-member state EU from January 1, 2010.