Vitamin D and contribution to the normal function of the immune system: evaluation of a health claim 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 2015;13(7):4182 [9 pp.].
doi
10.2903/j.efsa.2015.4182
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 output.

Contact
Type
Opinion of the Scientific Committee/Scientific Panel
On request from
Competent Authority of France
Question Number
EFSA-Q-2008-182
Adopted
29 June 2015
Published
17 July 2015
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
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Abstract

Following an application from Specialised Nutrition Europe (formerly 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 D and its contribution to the normal function of the immune system. The Panel considers that vitamin D is sufficiently characterised. A contribution to the normal function of the immune system is a beneficial physiological effect. The Panel has previously assessed claims on vitamin D and its contribution to the normal function of the immune system with favourable outcomes. The target populations were the general population and children aged 3 to 18 years. The Panel considers that the role of vitamin D in the functioning of the immune system applies to all ages, including infants and young children (from birth to three years of age). The Panel concludes that a cause and effect relationship has been established between the dietary intake of vitamin D and contribution to the normal function of the immune system. The following wording reflects the scientific evidence: ‘Vitamin D contributes to the normal function of the immune system.’ The target population is infants and young children up to three years of age.

Summary

Following an application from Specialised Nutrition Europe (formerly 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 European Food Safety Authority (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 D and its contribution to the normal 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 general approach of the NDA Panel for the evaluation of health claim applications is outlined in the EFSA general guidance for stakeholders on the evaluation of Article 13.1, 13.5 and 14 health claims.

The food constituent that is the subject of the health claim is vitamin D, which is an essential nutrient and can be measured in foods by established methods. Vitamin D occurs naturally in foods and is authorised for addition to foods and for use in food supplements. The Panel considers that vitamin D is sufficiently characterised.

The claimed effect proposed by the applicant is that vitamin D ‘contributes to the normal function of the natural defences’. The target population proposed by the applicant is infants and young children from birth to three years of age. From the information provided, the Panel notes that the claimed effect refers to the normal function of the immune system. The Panel considers that a contribution to the normal function of the immune system is a beneficial physiological effect.

The Panel has previously assessed claims on vitamin D and its contribution to the normal function of the immune system with favourable outcomes. The target populations were the general population and children aged 3 to 18 years. The Panel considered that vitamin D plays a role in the functioning of the immune system.

The Panel considers that the role of vitamin D in the functioning of the immune system applies to all ages, including infants and young children (from birth to three years).

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

The following wording reflects the scientific evidence: ‘Vitamin D contributes to the normal function of the immune system.’

In order to bear the claim, follow-on formulae should comply with the criteria for the 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 for the 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 for the composition of these foods as laid down in Directive 2006/125/EC; and other foodstuffs intended for infants and young children should provide at least 15 % of the reference values for the nutritional labelling of foods intended for infants and young children as laid down in Directive 2006/141/EC. Such amounts can easily be consumed as part of a balanced diet. The target population is infants and young children up to three years of age. Tolerable Upper Intake Levels have been set at 25 µg/day for infants and 50 µg/day for children aged 1–10 years.

Keywords
vitamin D, infants, children, immune system, health claims
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Number of Pages
9