Ninety-one Article 13.1 health claims eligible for further assessment might know the direction of their fates next year if the European Food Safety Authority (EFSA) finalizes its re-evaluations by the end of 2012 as planned, according to EAS has said. Stefanie Geiser, EAS regulatory affairs manager, said that with EFSA having confirmed its deadline of December 31, 2012 for finalization of its evaluation work on Article 13.1 health claims eligible for further assessment, a final European Commission decision followed by a further six-month transition could see these claims finally permitted or banned toward the end of 2013.

Article 13.1 claims deemed eligible for further assessment are those that EFSA at first judged of insufficient characterization/evidence and for which Member States had submitted further data. They include a wide range of health claims for probiotics as well as a few other substances, for example, related to vitamin K2 and vascular health, prunes and bowel function, lutein and eye health, soy isoflavones and menopause/bone health, alpha-cyclodextrin and glucose homeostasis, polyphenols from olive and lipid metabolism and lactotripeptides/peptides and the cardiovascular system.

“For now the European Commission has proposed a first ‘Union list’ of 222 permitted Article 13.1 health claims, which is currently under scrutiny with the European Parliament,” said Ms. Geiser. “While the end of the transition period for the first list of rejected Article 13.1 claims could be towards end 2012, the transition period for those of the 91 claims that would not be positively re-assessed by EFSA could possibly end around one year later. There is also an additional set of more than 2000 claims that the European Commission has put on hold and for which the length of the transition period is still unknown. This includes many claims for botanicals and some other ingredients for which the European Commission and Member States still need to discuss details related to methodology of assessment, conditions of use and/or scope.”