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Codex recommendations on the scientific basis of health claims

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Abstract

Background

Within the framework of Codex Alimentarius, attempts are being made at international level to establish guidelines for use of nutrition and health claims. An important issue that has to be addressed is the process of scientific substantiating of claims on foods.

Objective

To provide an insight into the current step procedure of the proposed draft recommendations on the scientific basis of health claims. These Codex recommendations are intended to facilitate governments’ own evaluation of health claims made by the industry.

Methods

Review of comments of governments, observers and non-governmental organizations (NGOs) and relevant references to the proposed draft recommendations of the last sessions of the Codex Committee on Nutrition and Food for Special Dietary Uses (CCNFSDU). A literature search was performed using the PubMed database.

Results/Conclusions

Several proposed draft recommendations on the scientific substantiation of health claims have been considered and amended by the CCNFSDU in recent years but the work is not yet complete. The current work draws on the work of FUFOSE and PASSCLAIM and also on that of WHO and FDA. Given the important role of Codex in food safety, the draft recommendations emphasize circumstances where additional evaluation of safety or nutritional safety needs to be considered. High quality human intervention studies are the prime evidence needed to substantiate claims but there is recognition that, in some cases, only observational studies may be available. Animal and in vitro studies will also be evaluated as part of the totality of the evidence. It has been suggested that the recommendations should include re-evaluation of claims after a certain time period, or if new evidence calls into question the scientific validity underpinning the claims. Setting out a common approach for the substantiation of health claims is an important step in the use of health claims around the world. There is a need to reflect emerging as well as consensus science. The substantiating evidence should be proportionate to the claim. Further progress in the elaboration of this relevant Codex text is needed to reach consensus.

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Fig. 1

Notes

  1. The following language was suggested: “Convincing evidence – There are consistent associations between the diet, food or food constituent and the health effect, with little or no evidence to the contrary. There should be a substantial number of human studies of acceptable quality, preferably including both observational and experimental studies and preferably conducted in different population groups. Any intake response relationships should be supportive of a causal relationship and the relationship should be biologically plausible. Supporting evidence sources should be consistent with the findings of human evidence” [7].

  2. In the USA “unqualified” health claims (also referred to as “authorized health claims”) must be supported by significant scientific agreement among qualified experts that the claim is supported by the totality of publicly available scientific evidence for a substance/disease relationship. In comparison, “qualified” health claims are supported by scientific evidence, but do not meet the significant scientific agreement standard. As a result, to ensure that they are not false or misleading to consumers, they must be accompanied by a disclaimer or other qualifying language to accurately communicate the level of scientific evidence supporting the claim. Both unqualified and qualified health claims may be used on conventional foods and on dietary supplements [20].

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Acknowledgments

This article was commissioned by the Functional Foods Task Force of the European branch of the International Life Sciences Institute (ILSI Europe). Industry members of this task force are Ajinomoto Europe, Barilla G. & F. Fratelli, Bayer CropScience BioScience, Beverage Partners Worldwide, Cadbury, Coca-Cola Europe, Colloïdes Naturels International, CSM, Danisco, Danone, Dow Europe, DSM, FieslandCampina, Frutarom, International Nutrition Company—INC, Kellogg Europe, Kraft Foods, La Morella Nuts, Mars, Martek Biosciences Corporation, McNeil Nutritionals, Monsanto, Naturex, Nestlé, PepsiCo International, Procter & Gamble, Raisio Group, Red Bull, Raffinerie Tirlemontoise—ORAFTI, Südzucker/BENEO Group, Syral, Tate & Lyle, Ülker Bisküvi, Unilever, Soremartec Italia—Ferrero Group, Valio, Wild Flavors, Wimm-Bill-Dann Foods, Wrigley and Yakult Europe. For further information about ILSI Europe, please email info@ilsieurope.be or call +32-2-7710014. The opinions expressed herein are those of the authors and do not necessarily represent the views of ILSI Europe.

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The author declares no conflict of interest.

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  1. Federal Institute for Risk Assessment (BfR), Thielallee 88-92, 14198, Berlin, Germany

    Rolf Grossklaus

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Grossklaus, R. Codex recommendations on the scientific basis of health claims. Eur J Nutr 48 (Suppl 1), 15–22 (2009). https://doi.org/10.1007/s00394-009-0077-z

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