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.