EFSA Set to Finalize Article 13.1 Reevaluations by End of Year, Says EAS

March 21, 2012

Such claims include ones that EFSA at first judged as having insufficient supportive evidence and had requested submitters to provide more information.

The European Food Safety Authority (EFSA; Parma, Italy) has confirmed that by December 31, 2012, it intends to finish re-evaluating 91 Article 13.1 health claims for which it had requested additional data.

Such claims include ones that EFSA at first judged as having insufficient supportive evidence and had requested submitters to provide more information. These include health claims for probiotics, as well as others, such as 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 cardiovascular health.

“While the end of the transition period for the first list of rejected Article 13.1 claims could be towards the end of 2012, the transition period for those of the 91 claims [to be] reassessed by EFSA could possibly end around one year later,” said Stefanie Geiser, regulatory affairs manager for regulatory consultant EAS (Brussels), in a press statement. The European Commission has already proposed a first “Union List” of 222 permitted Article 13.1 health claims, which is currently being reviewed by the European Parliament.

“There is also an additional set of over 2,000 claims that the European Commission has put on hold and for which the length of the transition period is still unknown,” she added. “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 [and] conditions of use and/or scope.”