We dedicate this month’s issue to regulatory affairs. Additionally, if you want to know more about probiotics and health claims, please register for our a&r first webinar of 2017.


EFSA guidance – update on the format for health claim applications

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 The guidance mainly foresees changes in the presentation of published and unpublished data intended to substantiate the claimed effect.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 A list of unpublished pertinent studies and other supporting data including the procedure to identify these publications should also be provided in this part 4.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.

Update on scientific guidances expected

An update on the not yet revised scientific guidance documents was pronounced by EFSA in order to include lessons learnt from previous evaluations as well as further updates in the relevant fields. The first revision for the guidance on the scientific requirements for claims related to antioxidants, oxidative damage and cardiovascular health is expected by the end of 2017, followed by the successive revision of the remaining scientific guidances, which is expected to be finalized by the beginning of 2020.

4 caffeine Claims still on hold

There are still four caffeine claims on hold, although a qualified majority voted in favour of these claims. Nevertheless, the EU Parliament rejected the claims due to concerns from one Member State regarding the consumption of energy drinks high in sugar by adolescents and the link to the health claims on caffeine. As a result, the Commission asked Member States to provide information on caffeine claims on energy drinks in the respective markets.

The four pending claims are related to increased endurance performance and capacity, increased alertness, and improved concentration.

Natural Mineral Water and the use of nutrition and health claims

In 2016, the European Court of Justice (ECJ) provided a preliminary rule stating the health claim regulation (1924/2006) and the directive on natural mineral water (2009/54/EC) should work in parallel. Only in case of conflicts, the specific indications and/or claims in the Directive on mineral water will prevail. The EU Commission now drafted a Working Document on the use of nutrition and health claims to the mineral water directive on natural mineral water.

New article 14 Health Claims opinions by EFSA (Nov-Feb) for children under 3 years of age

  • Nutrimune® (pasteurized cow’s skim milk fermented with Lactobacillus paracasei CBA L74) and immune defence against pathogens in the gastrointestinal and upper respiratory tracts


  • Vitamin C and protection of DNA, proteins and lipids from oxidative damage


a&r comments: From November 2016 to January 2017, only two article 14 health claims were published. For Nutriume, the panel considers the evidence provided as insufficient to establish a cause and effect relationship for several reasons. The criteria used to diagnose common cold and the reporting of the process were inconsistent, the results have not been replicated, and the mode of action was not considered plausible. For vitamin C, the Panel considered that its role in the claimed effect applies to all ages, and that a cause and effect relationship has been established between the dietary intake of vitamin C and protection of DNA, proteins and lipids from oxidative damage.

a&r has the pleasure to invite you to the first webinar of 2017.

Topic: Are there attractive claims on probiotics beyond EFSA?

Probiotics failed to receive health claim approval from EFSA, so what are the possibilities to make attractive claims without a product specific EFSA health claim? In our webinar „Are there attractive health claims on probiotics beyond EFSA“, we will present the basic background of the European Health Claim Regulation, the current situation of probiotics, together with its particular challenges. Finally we will present options for claims on probiotics within the EFSA framework as well as alternatives.

Date: 6th of April 2017

Time: 15:00 – 15:45 UTC/GMT +1  (30 min talk and 15 min Q&A)

Irene Wohlfahrt
Irene WohlfahrtSenior Consultant
Dr. Inês Rocha
Dr. Inês RochaScientific Consultant

At analyze & realize, we are experts in the field of natural health products, having provided our services for more than 20 years. We offer a unique combination of expertise in natural health products through our scientific, regulatory, and strategic innovation consulting and our clinical research organization with its own clinical trial center in Berlin, Germany. Thanks to our close interaction with the natural product market as well as our extensive network, we are always at the forefront of the latest information and innovation trends. With its international team of 35 employees, a&r is a leading European one-stop-shop ready to guide and support your needs in natural health product innovation.

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