Mandatory folic acid fortification and health outcomes 
What is mandatory folic acid fortification?
From September 2009 mandatory folic acid fortification requires Australian millers to add folic acid (a form of the B vitamin folate) to wheat flour for bread-making purposes. This means most bread (except organic) in Australia will contain added folic acid.
Why has Australia introduced mandatory folic acid fortification?
The aim of mandatory folic acid fortification is to reduce the number of neural tube defects (NTD) which are severe birth defects such as spina bifida.
In Australia, approximately 300-350 pregnancies are affected each year by NTDs. Mandatory fortification is expected to reduce the number of NTD-affected pregnancies by up to 14% (between 14 to 49 pregnancies per year). The benefits of mandatory folic acid fortification greatly exceed the costs [1] .
Is mandatory folic acid fortification safe?
Based on all available scientific evidence, adding folic acid to bread in Australia is safe for the whole population. Folic acid is added to flour in many countries, with two thirds of the worlds’ population having access to folic acid fortified flour. For over 10 years, the United States and Canada have had mandatory fortification of flour with folic acid and have found this to be an effective way of reducing NTDs.
Does folic acid cause cancer?
In developing this mandatory requirement, FSANZ assessed a reported possible link between folic acid and cancer. Based on all of the evidence, we concluded that there is no apparent risk to public health and safety, including cancer. We consulted with scientific experts both nationally and internationally who supported this conclusion. The United States National Cancer Institute has reported no significant change in cancer trends coinciding with the introduction of mandatory folic acid fortification.
However, FSANZ is continuing to monitor and assess any new evidence that might arise and has formed a group of experts to assist us with this.
What about the risk of masking vitamin B12 deficiency?
FSANZ assessed the risk that high folic acid intakes could mask the anaemia that doctors rely on to diagnosis vitamin B12 deficiency. However, there is no evidence that the level of folic acid intake from mandatory fortification will increase this risk of masking, particularly as the diagnosis of vitamin B12 deficiency now relies on a combination of different clinical tests.
Is there any evidence of health benefits from increased folate/folic acid in our food?
Folate is an essential nutrient needed by everyone for good health. It is important that everyone consumes the recommended amount of this vitamin. Currently, a small proportion of Australians have inadequate intakes. After mandatory fortification, it is expected that folate intakes will be boosted and these inadequacies addressed.
Folic acid, the form of folate used in supplements or added to food, is more easily absorbed than naturally-occurring folate. There are studies currently looking at the possible protective effects of folic acid on other types of health conditions, including cancer, stroke, mental function in the elderly, and some types of other birth defects. However, the only proven scientific evidence is that folic acid protects against NTDs.
Will mandatory folic acid fortification be monitored?
Yes, Australian health authorities will be monitoring the effectiveness of the increased levels of folic acid in the food supply and will continue to review new research on possible adverse effects. The Australian Institute of Health and Welfare has the overall coordinating role for monitoring mandatory fortification.
As part of this monitoring program, FSANZ is tracking key changes in the food supply and food consumption patterns, as well as monitoring consumer behaviour and attitudes towards foods with added vitamins and minerals.
In addition, FSANZ is monitoring and reviewing emerging scientific research on folic acid and public health and safety. Since the mandatory requirement was developed in 2007, no new evidence has emerged that changes FSANZ’s original conclusion that mandatory fortification with folic acid is safe
© Food Standards Australia New Zealand 2009
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[1] Proposal P295 – Consideration of Mandatory Fortification with Folic Acid, Final Assessment Report Attachment 11B, Cost Benefit Analysis of Fortifying the Food Supply with Folic Acid (June 2006).