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Scientific and technical guidance for the preparation and presentation of an application for authorisation of a health claim (revision 1)
The scientific and technical guidance of the EFSA Panel on Dietetic Products, Nutrition and Allergies for the preparation and presentation of an application for authorisation of a health claim presents a common format for the organisation of information for the preparation of a well-structured application for authorisation of health claims which fall under Article 14 (referring to children’s development and health, and to disease risk reduction claims), or 13(5) (which are based on newly developed scientific evidence and/or which include a request for the protection of proprietary data), or for the modification of an existing authorisation in accordance with Article 19 of Regulation (EC) No 1924/2006 on nutrition and health claims made on foods. This guidance outlines: the information and scientific data which must be included in the application, the hierarchy of different types of data and study designs (reflecting the relative strength of evidence which may be obtained from different types of studies) and the key issues which should be addressed in the application to substantiate the health claim.
© European Food Safety Authority, 2011
The European Commission has requested the European Food Safety Authority (EFSA) to issue an opinion on a scientific and technical guidance for applications for authorisation of health claims under Regulation (EC) No 1924/2006 on nutrition and health claims made on foods.
The Scientific Panel on Dietetic Products, Nutrition and Allergies (NDA) prepared a draft opinion which was published for public consultation. After considering all comments received, the Panel adopted its opinion on 06 July 2007. In 2011, the NDA Panel was requested by EFSA to revise the opinion with regard to the forms to be used for the submission of an application for authorisation of health claims pursuant to Article 13(5) and 14, and for the modification of an existing authorisation in accordance with Article 19 of Regulation (EC) No 1924/2006. The revision of the guidance, adopted by the NDA Panel on 13 May 2011, was of a purely administrative nature and concerned Parts 1 to 4, as well as the Appendices, of the guidance in order to simplify the presentation of an application.
This guidance applies to health claims related to the consumption of a food category, a food, or its constituents (including a nutrient or other substance, or a combination of nutrients/other substances); hereafter referred to as food/constituent.
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 (referring to children’s development and health, and to disease risk reduction claims) or 13(5) (which are based on newly developed scientific evidence and/or which include a request for the protection of proprietary data), of for modification of an existing authorisation in accordance with Article 19 of the Regulation. It is intended that the guidance will be kept under review and will be further amended and updated as appropriate in the light of experience gained from the evaluation of health claim applications.
The guidance presents a common format to assist the applicant in the preparation of a well-structured application. This format will also help the NDA Panel to deliver its scientific advice in an effective and consistent way.
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 any 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) which 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, for example to provide evidence of the mechanisms by which the food/constituent could exert the claimed effect, and of the biological plausibility of the specific claim.
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 adequately reflects the balance of all the evidence available.
In cases where any of the required data are not relevant for a particular application, reasons/justification must be given for the absence of such data in the application.
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.
Health claims, Regulation, food, substantiation, human data, comprehensive review, application, guidance