Scientific data linking folate and NTD reduction is very strong, winning qualified health claims from the likes of the US Food and Drug Administration (FDA) and prompting mandatory fortification of foodstuffs in about 75 countries, especially in Africa and the Americas.
But there has been somewhat of a void in Europe with no official claim from the European Food Safety Authority (EFSA) – until now.
While this article 14 opinion relates purely to supplementation at 400 micrograms a day for women of child-bearing age or women in their first trimester of pregnancy, its effect could be broader.
The submission was made by consultancy Rank Nutrition on behalf of UK charity Shine, the Council for Responsible Nutrition (CRN), the Health Food Manufacturers’ Association (HFMA) and the Proprietary Association of Great Britain (PAGB). It was based in advice from the UK Department of Health (DoH).
Ingrid Atteryd, chair of new group which Food Supplements Europe (FSE), said, "...we congratulate all involved in this great achievement for the food supplement sector. EFSA’s endorsement of folic acid supplements as contributing to reducing the risks of neural tube defects is recognition of the importance of this supplement for public health."
Fortification versus supplementation
Leading vitamins and minerals supplier DSM said the opinion was a long time coming, was a fair reflection of the state of science in the area, and could provoke further change in international folic acid policy.
“Since current fortification programmes cover only a part of the world and major regions like Europe, Russia, China, India and others have no measures in place, an improvement in the intake of folic acid in Europe and on a worldwide basis would have a significant public health impact,” said Manfred Eggersdorfer, senior vice president in nutrition science and advocacy at the Swiss operation of the Dutch ingredients giant.
NTDS are estimated to afflict about 300,000 births per year globally, with studies showing adequate folate intake can reduce that incidence by about 70-75% - facts that have driven so many governments to mandatory fortification.
Of the supplemental focus of the opinion, Eggersdorfer said, “Supplements are most effective only in the case of those who take active measures in planning for pregnancy, in the case of everyone else fortification benefits.”
The UK DoH advises women who could become pregnant to take 400 micrograms of supplemental folic acid prior to conception, and then for the first 12 weeks of pregnancy.
HFMA said the claim, once passed into law, "will mean that information can be included on the packs of food supplements, and in other commercial communications, which will maximise the message to consumers."
Shine CEO Jackie Bland added she was confident, "this will help us all in more robustly addressing what is a serious public health issue, currently affecting 1 in 1,000 pregnancies in the UK and up to 12 in 1,000 pregnancies in other parts of Europe."
At last year’s ESPEN Congress on Nutrition and Metabolism in Barcelona, Rima Obeid from the University of Saarland, Germany, backed mandatory fortification of folic acid.
“Folic acid lowers neural tube defects by up to 70%, depending on the baseline risk,” said Obeid. “From this perspective folic acid fortification can meet the requirements of pregnant people, and also aid genetic polymorphisms, and it can improve folate status in elderly people.”
But some governments have baulked at the idea due to over-consumption concerns.
Although it can be modified by the European Commission after EU member state discussion, EFSA’s Panel on Dietetic Products, Nutrition and Allergies (NDA) approved wording that stated: “Supplemental folate intake increases maternal folate status. Increasing maternal folate status contributes to the reduction of the risk of NTD.”
Other vitamin and mineral winners
EFSA’s NDA panel also turned in positive article 14 opinions relating to under-3s for three claims submitted way back in 2008 by the European Dietetic Food Industry Association (IDACE):
IDACE’s Roger Clarke told us his group, which has about another 30 mostly vitamin-related submissions in the system that are yet to be assessed, “was very happy with the positive opinions which were fully in line with the conditions of use we proposed.”
Eggersdorfer said the vitamin A opinion was, “very useful”.
“Vitamin A fortification for infants up to three years as covered by the health claim with 15 % of the reference level can help to improve health and the immune system, in Europe, and elsewhere. In many parts of the world, maize and wheat flour are fortified with vitamin A. So this health claim will support to communicate and advocate the role of vitamin A.”