Ninety-One Health Claims Submitted to EFSA On Track to be Assessed by Next Year

EAS Regulatory Affairs Manager Stefanie Geiser said that with EFSA having confirmed its deadline of 31 December 2012 for finalisation 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 towards the end of 2013.

Feb 28 2012 --- 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) finalises its re-evaluations by the end of 2012 as planned, EAS has said.

EAS Regulatory Affairs Manager Stefanie Geiser said that with EFSA having confirmed its deadline of 31 December 2012 for finalisation 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 towards the end of 2013.

Article 13.1 claims deemed eligible for further assessment are those that EFSA at first judged of insufficient characterisation/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.

To address the implications of this and the many other challenges companies are facing EAS is holding a workshop on 22 March in Brussels to help companies survive the EU’s Nutrition and Health Claims Regulation and successfully market products with claims across the EU.

“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 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 ninety-one claims that would not be positively re-assessed by EFSA could possibly end around one year later. There is also an additional set of over two thousand 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.”

“With so many aspects of the claims regulation still being implemented and under discussion it is difficult for companies to get the concrete advice they need to be able to understand which claims are at which stage and timeline in the process,” she continued. ”Following the huge demand for our first claims workshop this year, we are now holding a second claims workshop on 22 March 2012 to address precisely these issues.”

At the workshop Geiser and EAS Senior Adviser on International Food and Health Law and Scientific Affairs Patrick Coppens will give insight into claims ‘on hold’ in the process, which will be able to benefit from a longer transition period. They will also highlight latest claims regulation interpretation issues and how these will affect current market practice, practical advice on the do's and don'ts for developing an EFSA dossier, and case studies with national label examples providing an insight what changes will be required for certain claims within specific timelines.

They will present the latest developments around the Article 13.1 Union list, providing practical examples of permitted claims, and the latest news on the ongoing scrutiny procedure in the European Parliament.

“Our aim is to help companies correctly interpret the legislation and plan business strategies around the predicted outcomes,” Geiser said.