The claim – which will come into effect 18th November – states that supplemental folic acid intake increases maternal folate status. With a second sentence stating: “Low maternal folate status is a risk factor in the development of neural tube defects in the developing foetus.”
Submitted by Rank Nutrition, charity Shine, The Proprietary Association of Great Britain (PAGB), The Health Food Manufacturers’ Association (HFMA) and The Council for Responsible Nutrition (CRN), the claim can only be used for food supplements which provide at least 400 micrograms (μg) of folic acid per daily portion, with the target audience being women of “child-bearing age”.
This daily intake should be sustained for at least a month before and up to three months after conception.
Neural tube defects are caused by the incomplete development of the brain, spinal cord and/or their protective coverings and occur when the foetus’ spine fails to close properly.
Folic acid (vitamin B9) – the synthetic form of folate found naturally in green leafy vegetables, pulses and some fruits – plays a role in cell growth. A pregnant woman requires more folate for this function and therefore it may not be possible for them to get enough from the diet alone.
The condition forms in the first 28 days of pregnancy, before many women know they are pregnant. It is usually diagnosed at the 20-week scan and often results in late terminations, the charity said.
Shine says each day in the UK an average of at least two babies conceived will develop (NTDs) such as spina bifida and the fatal condition anencephaly.
Worldwide, at least 300,000 newborns are affected by an NTD every year.
Shine, a spina bifida charity, said the new claim would empower women to make fully informed choices and help battle existing misconceptions, for the first time enabling manufacturers to explain what folic acid actually does. Previously supplement firms could only claim on pack that folic acid "supports maternal tissue growth".
Martine Austin, health campaigns officer for Shine, said: “Too many of the women that I speak to see it as something optional that they can take when they’re pregnant ‘because it’s good for the baby’, rather than something that’s essential prior to conception to help prevent some very serious consequences.”
There has been talk of upping folate intakes through the mandatory fortification of flour-containing products like bread since the publication of a Medical Research Council trial in 1991 that suggested folic acid (vitamin B9) may help reduce the risk of neural tube defects by up to 72%. The UK's Department of Health (DoH) is currently awaiting the results of the National Diet and Nutrition Survey, due in the first quarter of 2015, as well as research commissioned on new ways to encourage women to increase their intake.
Professor David Richardson, scientific adviser for CRNUK, told us although this health claim may “transform” communication around folic acid, for flour fortification “significant scientific, technical, legal and consumer-understanding issues” remained since this could apply to the whole population not just the target population of pregnant women.
Graham Keen, executive director for the trade association HFMA, said he expected a strong industry take-up of the claim, and added that the turnaround of the dossier – submitted by Rank Nutrition consultant and HFMA scientific adviser Dr Michele Sadler in May 2013 – had been relatively fast.
What does this mean for the fortification debate?
The DoH is currently engaging with industry stakeholders including CRNUK and HFMA to assess the impact of the proposal for mandatory fortification of bread flour – something already done in the US, Canada and Australia.
A DoH spokesperson told us the claim approval reinforced its advice on folic supplementation prior to and after conception.
"With a decision as important as the mandatory fortification of food, it is vital that we take the latest evidence into account. We believe we need information on the blood folate status of the population, which will be available in 2015, to inform our final decision.”
CRNUK's Richardson said there were complex issues for the state to consider including whether fortification of all flour-containing products - including those high in energy, salt, sugar and fat – would be appropriate and whether the measure would sufficiently account for all of the target population considering avoidance of certain products due to food allergy, intolerance or preferences.
He also called for more up-to-date information on levels for voluntary fortification, particularly considering the new authorised health claim, and greater attention on the intimate metabolic relationship between folic acid and vitamin B12 for other neurological conditions.
HFMA said it supported the principle of folate fortification of certain foods, but added that the supplemental 400 µg was required in addition to ensuring good dietary intake levels,“not as an alternative”.
“We have made the point in our discussions with the Department of Health that great care should be taken about suggesting to at-risk groups that their folic acid needs might be met by consumption of fortified foods alone, with a potential short-fall resulting,” Keen told
NutraIngredients.
Folic and folate
The claim joins another for folate which states that the nutrient “contributes to maternal tissue growth during pregnancy”, however this claim does not mention the risk factor for neural tube defects, as well as a health claim for its “role in the process of cell division”.
Richardson said the current UK reference nutrient intake value of 200 µg per day was the lowest recommendation for adults compared to other EU member states and international organisations. For example, for DACH (Germany, Austria and Switzerland) the reference value was 300 µg per day folate equivalents, while the USA, Canada, Australia and New Zealand recommended 400 µg a day. In its recent population reference intake, EFSA recommended 330 µg a day.