Europe Should Require Foods Be Fortified With Folate

Most developing countries require flour to be fortified with folate to prevent severe birth defects. Why doesn't Europe?

“Incompatible with life.”  These are words that keep pregnant women up at night - that their baby might not be able to live.  And many women whose baby has a defect of the developing brain and spinal cord - a neural tube defect - will hear them.

The neural tube develops early in pregnancy and will (over the next eight months) develop into the central nervous system, brain and spinal cord.  At best, a problem with the neural tube means problems with these crucial systems;¹ at worst, it can mean a baby that simply does not develop a brain or a spinal cord at all.²

Neural tube defects (NTDs) are one of the most common types of birth defect, and occur in 1 in 1,000 pregnancies.  In Europe, this means neural tube defects occur in about 5,000 pregnancies a year.  And in at least half of these pregnancies, they could have been avoided if countries required foods to be fortified with folate.

Neural tube defects are about twice as common if the pregnant person has low levels in folate.  Folate is also known as vitamin B9, and the body needs it to make new cells - an especially important task in a pregnant person.

The body can’t make folate on its own, so it must be obtained from food or supplements.  Leafy greens and some nuts are particularly full of folate, but the vast majority of women (91% in the UK) don’t get enough folate from their diet to prevent neural tube defects.  Therefore, the standard recommendation is that women who intend to become pregnant should take a prenatal vitamin containing 400 micrograms of folate.

However, simply telling women to take their prenatal vitamins isn’t really enough.  The neural tube closes - and problems can develop - about four weeks after conception.  This is before many women even know they’re pregnant!  Many women simply will not know that they need to be taking folate before it’s too late to prevent a neural tube defect.

Most countries around the world therefore require folate to be included in staple products like flour, ensuring that women have a sufficient amount of folate already in their system if they become pregnant.  This strategy has been extremely effective. In Chile, introducing fortification reduced NTD rates by 55%; in Argentina, by 50%; in Costa Rica by 58%; in Canada by 49%.  Every year, thousands of parents in these countries have healthy children because their governments have required food fortification.

And yet Europe has largely chosen to pass up this clear public health win.  Of the 87 countries that currently require food fortification, only two are in Europe - Kosovo and Moldova (with the UK to join them in 2026).

(Map from the Food Fortification Initiative)

European countries seem to have two major concerns about mandating food fortification (and increasing levels of folate in most of the population):

1. Excess folate might increase B-12-deficiency-associated cognitive decline in the elderly.

2. There was some observational evidence that high levels of folate were linked to increased cancer risk.

In 2000, the European Commission Scientific Committee on Food reviewed the evidence and concluded that “although there is no conclusive evidence in humans, the Committee concludes that the risk of progression of the neurological symptoms in vitamin B12 deficient patients… cannot be excluded and should be considered the most serious adverse effect”.  As a response, many countries in Europe declined to implement fortification out of an abundance of caution.

Nor was it only experts that were concerned about adding folate to food.  In 2003, a pilot program for fortification in France failed because the public was concerned about the adverse effects of folate.  Many Europeans believe all food additives are harmful, regardless of the type of additive.

It is true that it is important to make sure to “first, do no harm” when implementing public health policy.  However, with 25 years more of data on the safety of folate, these concerns do not seem to justify European countries’ continuing decision not to fortify.

Indeed, subsequent evidence has largely repudiated the idea that folate fortification is risky.  A later re-analysis showed that the study that linked cognitive decline and folate intake was flawed; the Food and Nutrition Board at the Institute of Medicine (IOM) of the National Academies now believes that “there is no level of folate which increases the risk of progression of the neurological symptoms in vitamin B12 deficient patients”.

Furthermore, randomized control trials show no link between folate levels and increased cancer risk.  Indeed, additional folate probably has more benefits than harms and may even reduce the risk of cancer.

All of this means that in 2024, the scientific consensus on folate fortification is clear.  Major medical journals (like the Lancet and the British Medical Journal) regularly run articles about the benefits of mandatory fortification.  The European Board and College of Obstetrics and Gynaecology has urged “European governments to consider the compelling evidence to make flour fortification with folic acid mandatory”.

And yet: most of Europe doesn’t appear to have updated their views of the risks adding folate to foods.

The consequences of this have been predictable: the rate of neural tube defects in Germany is roughly double that of Chile, and mothers in Sweden are 50% more likely to lose a child to a neural tube defect than those in Canada.

It is not that fortification is too hard to implement or too expensive.  Countries like Indonesia (GDP/capita $4800) and Iran (GDP/capita $4600) have managed it, and setting up mandatory fortification in Australia cost just $2.5 million AUD ($1.66 million USD).  Fortification seems well within the capabilities of the French or Dutch or German state.

And the benefits would far outweigh the costs.  Fortifying all the flour sold in Europe would cost perhaps $45,000,000 a year.³  The average cost of medical care for a single person with spina bifida is almost a million dollars - making the program cost effective if it prevented some 60 cases of spina bifida a year.  One systematic review estimated that on average, the benefits from fortification are some 17 times the costs.

As an example, the British National Health Service will generally pay for any treatments that cost £20,000-£30,000 per additional quality-adjusted life year (QALY) lived.  When Australia implemented fortification, it cost just £5871 per QALY gained.  If fortification was a medical treatment, it would be the best purchase the NHS could make.⁴

So why are European countries still so recalcitrant to add folate to staple foods?  I find it hard to understand.  Perhaps twenty years ago, the benefits were less clear and the risks seemed more significant.  But by now, some 80 countries have implemented folate fortification, and no adverse effects of these programs has yet been found.  And every year that Europe doesn’t implement fortification, more babies die, more children suffer, and more people terminate wanted pregnancies.⁵

Europe is a wealthy continent where people (largely) live long and healthy lives.  There simply aren’t that many easy public health wins left for European countries.  But food fortification is one - and it is time that Europe caught up with the rest of the world.

1.  As in spina bifida.

2. As in anencephaly.

3. Based on the cost to fortify flour in the US in 2015, adjusted for Europe’s larger population size and inflation.

4. Though the UK will soon require some fortification, their policy is not perfect.  The UK is aiming to reduce NTD levels by 20%.  Other countries - the US, Canada, Australia - have reduced NTDs by 50% or more.  A higher fortification level could easily double the impact of the UK’s proposed policy.  And don’t just listen to me on this; here’s a BMJ feature arguing that the UK’s new fortification level will be too low.

5. About 75% of NTD pregnancies are terminated, 5% result in stillbirths or miscarriages, and 20% result in live births.