For the first time since 2011, EFSA has refreshed the scientific and technical guidance for the preparation and presentation of a health claim application. Although there seem 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 The guidance mainly foresees changes in the presentation of published and unpublished data intended to substantiate the claimed effect.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 more logical layout.
In more detail, while no major updates are foreseen for part 1 including the administrative and technical data, the information to be provided within the food characterisation part will now depend on whether vitamins or minerals or other constituents are the subjects of the claim application. For the latter, the requested information remains the same as before, while for vitamins and minerals, the chemical form is sufficient.
EFSA included a new part 3 outlining requirements for the characterization of the claimed effect in more detail than before. In addition, more explicit details on what should be done to identify pertinent scientific data are requested. For all ingredients other than vitamins and minerals, conducting a comprehensive review of published scientific data according to another EFSA guidance on the application of systematic review methodology is required (EFSA Journal 2010;8(6):1637). This review should include authorship, objectives, eligibility criteria, search strategy, and a list of studies that have been identified. In contrast to previous applications, EFSA requested not only a list of studies not considered pertinent but also the reason(s) for exclusion from the application. A list of unpublished pertinent studies and other supporting data including the procedure to identify these publications should also be provided in this part 4. However, in part 5 (previously: part 3), the applicant is now encouraged to give an overview of the pertinent scientific data. With regards to the characteristics of the relationship between the intake of the ingredient or food and the claimed effect, no major changes are foreseen. An overview and summary of supportive evidence including bioavailability (formerly in chapter 2, food characterisation) and mode of action data shall now be described in this chapter as well. The last chapter includes the annexes such as glossary and appreciations and reprints of references.
In an appendix to the updated guidance, EFSA outlined information to be presented in a full study report on human efficacy studies. In essence, EFSA adapted the International Conference on Harmonisation (ICH) E3 guideline, a format that is usually applied to the reporting of outcomes of clinical trials.
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. Indeed, quite a number of documents have been published in the meantime, including guidance on the reporting of statistical results or the various guidances on the scientific requirement for health claims. Yet, none of these guidances solves 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.