There has never been a better time to apply for an Article 13.5 or 14 health claim – in spite of the substantial investment required.
That’s the view of Naturalpha, a France-based science and nutrition consultancy, which has its HQ in Lille and a U.S. office in Massachusetts.
The company argues that thanks to the high numbers of rejected generic Article 13.1 health claims, obtaining a positive decision from the European Food Safety Authority (EFSA) via the Article 13.5 route, which is reserved for claims based on new and emerging science, or the Article 14 route, which is for disease risk reduction claims, should be easier than ever before.
In its latest “Health Claims Barometer” report, Naturalpha says that although the percentage of favorable opinions for generic Article 13.1 health claims remains low, the percentage of favorable opinions for Article 13.5 or 14 claims has almost doubled since 2009, making them an increasingly attractive option.
Naturalpha says: "Of course, the strategy for 13.5 and 14 claims requires the set‐up of a scientific program in full compliance with regulatory requirements, and so it is undoubtedly an additional investment in terms of cost and delay.
"However, this approach offers considerable advantages. On the one hand, it gives flexibility to manufacturers to protect their proprietary data and thus enjoy exclusivity. On the other hand, it allows a positioning on health topics still not covered by 13.1 health claims, such as weight management or joint health.
"Choosing the 13.5 and 14 strategy becomes less risky due to the learning process of EFSA evaluations, particularly through the analysis of the reasons for previous refusals, but also by analyzing the comments and recommendations issued by the agency.
"The organization of scientific meetings or the preparation of guidelines (such as the one on gut health and immunity recently released) by EFSA are new tools for setting up relevant research plans and optimizing the chances of success."
Certain health topics have been little covered by applications, or have received limited number of favorable opinions from EFSA, says Naturalpha. But new opportunities for innovative claims may include: weight management, joint health, fertility & reproduction, kidney health, or men's and women's health.
Eric Chappuis deputy director of consulting at Naturalpha, told Functional Ingredients: "The experience acquired from these first years of applications helps us to anticipate more easily potential critical points, and thus helps us improve claim applications admissibility. We now have a clearer vision.
"While only two Article 13.5 claims have received favorable EFSA opinions to date, this number is expected to increase in months and years to come."