Scientific Opinion on the substantiation of a health claim related to thiamin and maintenance of normal neurological development and function pursuant to Article 14 of Regulation (EC) No 1924/2006

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Article
EFSA Journal 2011;9(2):1980 [8 pp.].
doi
10.2903/j.efsa.2011.1980
EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA)
Panel Members
Carlo Agostoni, Jean-Louis Bresson, Susan Fairweather-Tait, Albert Flynn, Ines Golly, Hannu Korhonen, Pagona Lagiou, Martinus Løvik, Rosangela Marchelli, Ambroise Martin, Bevan Moseley, Monika Neuhäuser-Berthold, Hildegard Przyrembel, Seppo Salminen, Yolanda Sanz, Sean (J.J.) Strain, Stephan Strobel, Inge Tetens, Daniel Tomé, Hendrik van Loveren and Hans Verhagen.
Acknowledgement

The Panel wishes to thank the members of the Working Group on Claims for the preparatory work on this scientific opinion: Carlo Agostoni, Jean-Louis Bresson, Susan Fairweather-Tait, Albert Flynn, Ines Golly, Marina Heinonen, Hannu Korhonen, Martinus Løvik, Ambroise Martin, Hildegard Przyrembel, Seppo Salminen, Yolanda Sanz, Sean (J.J.) Strain, Inge Tetens, Hendrik van Loveren and Hans Verhagen.

Contact
Type
Opinion of the Scientific Committee/Scientific Panel
On Request From
the Competent Authority of Germany following an application by HiPP GmbH
Question Number
EFSA-Q-2009-00455
Adopted
28 January 2011
Published
10 February 2011
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
Article (182.52 KB)182.52 KB
Abstract

Following an application from HiPP GmbH submitted pursuant to Article 14 of Regulation (EC) No 1924/2006 via the Competent Authority of Germany, the Panel on Dietetic Products, Nutrition and Allergies was asked to deliver an opinion on the scientific substantiation of a health claim related to thiamin and maintenance of normal neurological development and function. Thiamin is a well recognised nutrient and is measurable in foods by established methods. Thiamin is considered to be sufficiently characterised. Maintenance of normal neurological development and function is considered to be a beneficial physiological effect. It is well recognised that the clinical signs of thiamin deficiency include mental changes, such as apathy, decrease in short-term memory, confusion and irritability as well as polyneuritis and paralysis of the peripheral nerves. All essential nutrients, including vitamins and minerals, are required for normal development of infants and children. The Panel concludes that a cause and effect relationship has been established between the dietary intake of thiamin and maintenance of normal neurological development and function. The following wording reflects the scientific evidence: “Thiamin contributes to the maintenance of normal neurological development and function.” The target population is infants and children up to 3 years.

Summary

Following an application from HiPP GmbH submitted pursuant to Article 14 of Regulation (EC) No 1924/2006 via the Competent Authority of Germany, the Panel on Dietetic Products, Nutrition and Allergies was asked to deliver an opinion on the scientific substantiation of a health claim related to thiamin and maintenance of normal neurological development and function.

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

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

The claimed effect is “thiamin in the diet is necessary for the normal development and function of the neurological system”. The proposed target population for the health claim is children from birth to three years. The Panel considers that maintenance of normal neurological development and function is a beneficial physiological effect.

The applicant identified two human intervention studies, seven observational studies, three reviews and one medical position paper on the composition of infant formulae, four opinions of authoritative/scientific bodies and five textbook chapters as pertinent to the claim.

It is well recognised that the clinical signs of thiamin deficiency include mental changes, such as apathy, decrease in short-term memory, confusion and irritability as well as polyneuritis and paralysis of the peripheral nerves. Manifestations are seen in the autonomic, the sensory and the motor systems.

The Panel notes that all essential nutrients, including vitamins and minerals, are required for normal development of infants and children.

The Panel also notes that the role of thiamin in normal neurological function is not specific to any population group.

The Panel concludes that a cause and effect relationship has been established between the dietary intake of thiamin and maintenance of normal neurological development and function.

The Panel considers that the following wording reflects the scientific evidence: “Thiamin contributes to the maintenance of normal neurological development and function.”

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 3 years.

Keywords
Thiamin, infants, children, neurological function, development, health claims.
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Number of Pages
8