Scientific Opinion on the substantiation of a health claim related to vitamin A and contribution to normal development and function of the immune system pursuant to Article 14 of Regulation (EC) No 1924/2006

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Article
Panel on Dietetic Products, Nutrition and Allergies
EFSA Journal
EFSA Journal 2013;11(7):3334 [11 pp.].
doi
10.2903/j.efsa.2013.3334
Panel members at the time of adoption
Carlo Agostoni, Roberto Berni Canani, Susan Fairweather-Tait, Marina Heinonen, Hannu Korhonen, Sébastien La Vieille, Rosangela Marchelli, Ambroise Martin, Androniki Naska, Monika Neuhäuser-Berthold, Grażyna Nowicka, Yolanda Sanz, Alfonso Siani, Anders Sjödin, Martin Stern, Sean (J.J.) Strain, Inge Tetens, Daniel Tomé, Dominique Turck and Hans Verhagen
Acknowledgements

The Panel wishes to thank the members of the Working Group on Claims: Carlo Agostoni, Jean-Louis Bresson, Susan Fairweather-Tait, Marina Heinonen, Ambroise Martin, Hildegard Przyrembel, Yolanda Sanz, Alfonso Siani, Anders Sjödin, Sean (J.J.) Strain, Inge Tetens, Hendrik Van Loveren, Hans Verhagen and Peter Willatts for the preparatory work on this scientific opinion.

Contact
Type
Opinion of the Scientific Committee/Scientific Panel
On request from
Competent Authority of France following an application by IDACE
Question Number
EFSA-Q-2008-160
Adopted
10 July 2013
Published
26 July 2013
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
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Abstract

Following an application from IDACE, submitted pursuant to Article 14 of Regulation (EC) No 1924/2006 via the Competent Authority of France, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to vitamin A and contribution to normal development and function of the immune system. The food constituent, vitamin A, which is the subject of the health claim, is sufficiently characterised. Contribution to normal development and function of the immune system is a beneficial physiological effect for infants and young children. A claim on vitamin A and normal function of the immune system in the general population has already been assessed with a favourable outcome. The Panel notes that the role of vitamin A in the normal function of the immune system also applies to the developing immune system of infants and young children (from birth to three years). The Panel concludes that a cause and effect relationship has been established between dietary intake of vitamin A and contribution to normal development and function of the immune system. The following wording reflects the scientific evidence: “Vitamin A contributes to the normal function of the immune system”. The target population is infants and children up to three years.

Summary

Following an application from IDACE, submitted for authorisation of a health claim pursuant to Article 14 of Regulation (EC) No 1924/2006 via the Competent Authority of France, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to vitamin A and contribution to normal development and function of the immune system.

The scope of the application was proposed to fall under a health claim referring to children’s development and health.

The food constituent that is the subject of the health claim is vitamin A, which is a well recognised nutrient and is measurable in foods by established methods. The Panel considers that vitamin A is sufficiently characterised.

The claimed effect proposed by the applicant is “necessary for the development and functioning of multiple aspects of the immune system”. The target population proposed by the applicant is “infants (from birth onwards) and young children (until three years of age)”. The Panel considers that contribution to normal development and function of the immune system is a beneficial physiological effect for infants and young children.

A claim on vitamin A and normal function of the immune system in the general population has already been assessed by the Panel with a favourable outcome. The conclusion from the Panel was based on the well-established role of vitamin A in regulating the proliferation of immune cells, on deficiency symptoms which included impaired phagocytic activity of macrophages and impaired antibody-mediated immunity in children, and on the effect of vitamin A supplementation on the incidence of infections in malnourished children.

The Panel notes that the role of vitamin A in the normal function of the immune system also applies to the developing immune system of infants and young children (from birth to three years).

The Panel concludes that a cause and effect relationship has been established between dietary intake of vitamin A and contribution to normal development and function of the immune system.

The following wording reflects the scientific evidence: “Vitamin A contributes to the normal function of the immune system”.

The Panel considers that, in order to bear the claim, follow-on formulae should comply with the criteria of composition of follow-on formulae as laid down in Directive 2006/141/EC; nutritionally complete foods for special medical purposes intended for use by infants and nutritionally complete foods for special medical purposes other than those intended for use by infants should comply with the criteria of composition of these foods as laid down in Directive 1999/21/EC; processed cereal-based foods for infants and young children should comply with the criteria of composition of these foods as laid down in Directive 2006/125/EC; other foodstuffs intended for infants and young children should provide at least 15 % of the reference values for nutrition labelling for foods intended for infants and young children as laid down in Directive 2006/125/EC. Such amounts can be easily consumed as part of a balanced diet. The target population is infants and children up to three years. A Tolerable Upper Intake Level for pre-formed vitamin A (retinol and retinyl esters) has been established for children, and has been set at 800 μg RE/day for children of 1-3 years of age.

Keywords
Vitamin A, infants, children, immune system, health claims
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Number of Pages
11