EFSA has refreshed the scientific and technical guidance for the preparation and presentation of a health claim application and provided the second revision last month. Although there seems to be no substantial changes in contents, the structure of future claim applications will change to a significant degree. The guidance mainly foresees changes in the presentation of published and unpublished data intended to substantiate the claimed effect. Indeed, the updated guidance provides a better-structured format by providing a more coherent and logical layout.

When used in conjunction with the general scientific guidance on health claim applications published in 2016, EFSA expects the updated guidance’s application format to make the evaluation process of health claims more efficient, provided that applicants adhere to it (Valeriu Curtui, Head of EFSA’s Nutrition Unit).

The updated guidance, however, still does not solve the problem that there is no opportunity for dialogue with EFSA, e.g.. in the form of a pre-assessment meeting providing scientific advice and protocol assistance to the applicants. Indeed, this is an established standard in the process of obtaining market authorisation for drugs.

More information will be available in our February News Digest Edition.

Source: http://onlinelibrary.wiley.com/doi/10.2903/j.efsa.2017.4680/full