EFSA Provides Final Guidance to Applicants on Health Claims 

26/07/07 Following public consultation, the European Food Safety Authority (EFSA) has published its final guidance to applicants on the submission of health claims for authorisation.

The purpose of this guidance is to assist applicants in preparing and presenting their applications for authorisation of health claims which fall under Article 14 of the Regulation, i.e. reduction of disease risk claims and claims referring to children’s development and health. This guidance will be updated at a later stage to cover applications for authorisation of the health claims which fall under Article 18 of the Regulation, i.e. applications for inclusion of health claims in the Community list of permitted claims provided for in Article 13 which are based on newly developed scientific evidence and/or which include a request for the protection of proprietary data. It is intended that the guidance will be kept under review and will be amended and updated as appropriate in the light of experience gained from evaluation of health claim applications.

During the consultation of the draft document useful comments were received from stakeholders and Member States and all of them were considered by the NDA Panel. The guidance will help companies who want to submit health claims for authorisation. It addresses what they need to include in their application, in particular concerning the scientific data and evidence required to support claims.

In accordance with the requirements of the Regulation, the application must contain:

(a) information on the characteristics of the food/constituent for which a health claim is made. Where applicable, this information should contain aspects considered pertinent to the claim, such as the composition, physical and chemical characteristics, manufacturing process, stability, and bioavailability.

(b) a proposal for the wording of the health claim, including, as appropriate, the specific conditions of use.  The following should be specified, with a rationale: the target population for the intended health claim; where appropriate, a statement addressed to persons who should avoid using the food/constituent for which the health claim is made; the quantity of the food/constituent and pattern of consumption required to obtain the claimed effect, and whether this quantity could reasonably be consumed as part of a balanced diet; a warning for a food/constituent that is likely to present a health risk if consumed to excess; any other restrictions of use; directions for preparation and/or use.

The application must also contain all pertinent scientific data (published and unpublished, data in favour and not in favour) identified that form the basis for substantiation of the health claim. Data from studies in humans addressing the relationship between the consumption of the food/constituent and the claimed effect will be required for substantiation of a health claim; because of the scientific uncertainties in extrapolating non-human data to humans, data from studies in animals or model systems may be included only as supporting evidence, e.g. to explain the mechanism underlying the claimed effect of the food/constituent.

A comprehensive review of the data from human studies addressing the specific relationship between the food/constituent and the claimed effect is required. This review, and the identification of data considered pertinent to the claim, should be performed in a systematic and transparent manner in order to demonstrate that the application reflects adequately the balance of all the evidence available.

In cases where any of the required data does not apply for a particular application, reasons/justification must be given for the absence of such data in the application.

Guidance is provided for the presentation of summaries of the data from intervention studies and non-interventional studies in humans according to a hierarchy of study designs, reflecting the relative strength of evidence that may be obtained from different types of studies.  Instructions are provided for presenting summaries of data from individual studies in humans so as to highlight the relevant aspects related to the design, results and quality of the studies.

As specified in the Regulation, health claims should be substantiated by taking into account the totality of the available scientific data and by weighing the evidence, subject to the specific conditions of use. In particular, the evidence should demonstrate the extent to which:

(a) the claimed effect of the food/constituent is relevant for human health,

(b) a cause and effect relationship is established between the consumption of the food/constituent and the claimed effect in humans (such as: the strength, consistency, specificity, dose-response, and biological plausibility of the relationship),

(c) the quantity of the food/constituent and pattern of consumption required to obtain the claimed effect could reasonably be achieved as part of a balanced diet,

(d) the specific study group(s) in which the evidence was obtained is representative of the target population for which the claim is intended.

EFSA has given the opportunity to Member States and stakeholders to comment on the draft guidance document on disease risk reduction claims and claims for children. A technical meeting with experts of the Stakeholder Consultative Platform2 was held on 11 June in Parma, discussions with experts from Members States took place and in addition the draft Guidance Document was placed on the EFSA website for public consultation.

Comments received during the consultation covered issues such as the type and level of evidence needed for substantiation of the claim; information on the characteristics of the product such as its composition and the manufacturing process; and consumer understanding of claims. The consultation led to text changes resulting in a clearer, simpler and more user-friendly document. Examples have also been added to assist the applicants. Following questions raised during the consultation, clarifications have been made for instance regarding the type of information required for a claim concerning an ingredient or a food and the type of human studies to be considered.

The issue of consumer understanding was perceived as one of the key topics. In the event of a favourable opinion, the NDA Panel will evaluate the wording of the health claim proposed by the applicant. In doing so, the Panel will seek to ensure that it reflects the scientific evidence and is understandable in terms of its relevance for human health. Where required, the Panel may recommend changes based on their scientific assessment. The Panel will ensure that claims that are considered from a scientific point of view to be vague, confusing or misleading will not receive a favourable opinion.

EFSA expects now to receive the first applications as regards disease reduction claims and claims referring to children’s development and health (article 14 of the Regulation. Following a completeness check and the formal acceptance of the validated dossiers the Panel will assess the health claim and provide a scientific opinion within 5 months.