Scientific Opinion on the substantiation of a health claim related to increasing maternal folate status by supplemental folate intake and reduced risk of neural tube defects 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):3328 [9 pp.].
doi
10.2903/j.efsa.2013.3328
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 the United Kingdom following an application by Rank Nutrition Ltd
Question Number
EFSA-Q-2013-00265
Adopted
10 July 2013
Published
26 July 2013
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
Download Article (235.39 KB)
Abstract

Following an application from Rank Nutrition Ltd, submitted for authorisation of a health claim pursuant to Article 14 of Regulation (EC) No 1924/2006 via the Competent Authority of the United Kingdom, 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 increasing maternal folate status by supplemental folate intake and reduced risk of neural tube defects. The Panel considers that the food constituent, supplemental folate, which is the subject of the claim, is sufficiently characterised. Increasing maternal folate status by supplemental folate intake is a beneficial physiological effect in the context of reducing the risk of neural tube defects. In weighing the evidence, the Panel took into account that the association between low maternal folate intakes and an increased risk of neural tube defects is well established, and that a recent systematic review showed an effect of maternal folic acid intakes on the risk of neural tube defects. The Panel concludes that a cause and effect relationship has been established between increasing maternal folate status by supplemental folate intake and a reduced risk of neural tube defects.

Summary

Following an application from Rank Nutrition Ltd, submitted for authorisation of a health claim pursuant to Article 14 of Regulation (EC) No 1924/2006 via the Competent Authority of the United Kingdom, 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 increasing maternal folate status by supplemental folate intake and reduced risk of neural tube defects (NTD).

The scope of the application was proposed to fall under a health claim referring to disease risk reduction.

The food constituent that is the subject of the health claim is folic acid. Folic acid is used as synthetic folate in food supplements and in food fortification because of its stability, and becomes biologically active after reduction. Folate is the generic name for this B-vitamin and different forms of folate are authorised for addition to foods (Annex II of Regulation (EC) No 1925/2006 and Annex II of Directive 2002/46/EC). This evaluation applies to all forms of folate authorised for addition to foods (Annex II of the Regulation (EC) No 1925/2006 and Annex II of Directive 2002/46/EC).

The Panel considers that the food constituent, supplemental folate, which is the subject of the health claim, is sufficiently characterised.

The claimed effect proposed by the applicant is “protective effect of folic acid against neural tube defects in the foetus, through beneficially raising maternal red blood cell folate”. The target population proposed by the applicant is women of child-bearing age. The Panel considers that increasing maternal folate status by supplemental folate intake is a beneficial physiological effect in the context of reducing the risk of NTD.

In weighing the evidence, the Panel took into account that the association between low maternal folate intakes and an increased risk of NTD is well established, and that a recent systematic review showed an effect of maternal folic acid intakes on the risk of NTD.

The Panel concludes that a cause and effect relationship has been established between increasing maternal folate status by supplemental folate intake and a reduced risk of NTD.

The Panel considers that the following wording reflects the scientific evidence: “Supplemental folate intake increases maternal folate status. Increasing maternal folate status contributes to the reduction of the risk of NTD.”

The Panel considers that in order to obtain the claimed effect 400 μg supplemental folate should be consumed daily for at least one month before and up to three months after conception. The target population is women of child-bearing age.

Keywords
Folate, neural tube defects, NTD, health claims
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Number of Pages
9