Please refer to anzfa’s guide to applications and proposals for a more detailed explanation of the process on how to undertake

3. The Health Issue

In order to establish the regulatory response, the health issue under consideration needs to be clearly stated.

Neural tube defects (NTDs) are serious birth defects. Although the majority ( about 70%) of pregnancies affected by an NTD will result in a late stage-termination (usually after 20 weeks), infants born with an NTD will either be stillborn, or in the case of spina bifida in particular, have minor to severe health problems. Live born infants with anencephaly or encephalocoele comprise only a small proportion of those with NTDs who survive beyond one year of age.

There is convincing evidence that increased folic acid intake among women of child-bearing age from supplements and/or fortified foods can reduce the risk of NTDs.

Various education initiatives have been undertaken to encourage women of child-bearing age to increase their dietary folate intake and take folic acid supplements. Despite these campaigns, current advice for supplemental folic acid is not followed by a majority of women in the target group. Reasons for this include:

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  lack of knowledge among women about the benefits of folic acid;
  
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  knowledge not always equating to behavioural change; and
  
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  barriers to regular supplement use at the recommended dose, such as cost and access.
  

A significant issue in relation to supplementation is the fact that approximately half of all pregnancies are unplanned and the neural tube develops before a woman would know she is pregnant.

Voluntary fortification of certain foods with folic acid was first permitted in Australia in 1995 and in 1996 in New Zealand. Since that time it has resulted in modest increases in folic acid intake among women of child-bearing age. This is due primarily to the variable uptake by industry of the voluntary permissions, particularly in New Zealand.
Some States in Australia, with good quality data collection systems, have reported a fall in the NTD rate since voluntary fortification was introduced. While not all NTDs can be prevented, there are indications that the proportion of pregnancies affected by an NTD can be further reduced.
Internationally, a number of countries have reported successful mandatory folic acid fortification programs as an equitable and sustainable means of increasing the folic acid intake of women of child-bearing age and thereby reducing the incidence of NTDs.

4. Objectives

The specific objective of this Proposal is to reduce the incidence of NTDs in Australia and New Zealand through mandatory fortification of the food supply with folic acid.

The goal is to reduce the incidence of NTDs to the maximum extent possible by increasing dietary folic acid intakes in women of child-bearing age (the target population). The prime focus for achieving a reduction in this risk will be to increase the folic acid content of the food supply.
The health benefits and risks to the non-target population from increased folic acid intake are considered in making this determination.
In developing or varying a food standard, FSANZ is required by its legislation to meet three primary objectives which are set out in Section 10 of the FSANZ Act 1991. These are:

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  the protection of public health and safety;
  
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  the provision of adequate information relating to food to enable consumers to make informed choices; and
  
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  the prevention of misleading or deceptive conduct.
  

In developing and varying standards, FSANZ must also have regard to:

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  the need for standards to be based on risk analysis using the best available scientific evidence;
  
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  the promotion of consistency between domestic and international food standards;
  
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  the desirability of an efficient and internationally competitive food industry;
  
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  the promotion of fair trading in food; and
  
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  any written policy guidelines formulated by the Ministerial Council.
  

RISK ASSESSMENT of mandatory fortification

This risk assessment quantifies the NTD-related benefit that can be expected from a program of mandatory fortification of food with folic acid in Australia and New Zealand and considers other potential health benefits and risks for the population as a whole from an increase in the dietary consumption of folic acid.

To do this, a number of experts were commissioned to carry out literature reviews of benefits and risks and these are identified in the following discussion. The completed reviews were subsequently peer reviewed. A compilation of the main findings from the reviews is provided at Attachment 6 and the full text of the literature reviews is available at www.foodstandards.gov.au. An expert scientific group was also convened to obtain advice on a series of questions that arose during the initial assessment process.
To assess the impact of mandatory fortification on the target population and the population as a whole, a comprehensive dietary intake assessment has been undertaken based on the universal addition of folic acid to bread (see Attachment 7a). At Draft Assessment, a dietary intake assessment of mandatory folic acid fortification of bread-making flour was undertaken and this has been included at Attachment 7b. Comments and additional references have been considered and the risk assessment at Final Assessment has been amended, as appropriate.

Box 1: Key findings of the health benefits and risks from mandatory folic acid fortification
There is convincing evidence from a broad range of studies that increased folic acid intake reduces the risk of a pregnancy affected with a neural tube defect. Mandatory fortification at the proposed level will further reduce the incidence of NTDs in Australia and New Zealand by 4-14% and 5-15%, respectively.
At the levels of folic acid intake likely from mandatory fortification there is no evidence of an increased risk of masking the diagnosis of vitamin B₁₂ deficiency, particularly as the diagnosis of vitamin B₁₂ deficiency relies on a combination of tests at the clinical level.
Recent evidence concludes that folic acid does not reduce cardiovascular disease risk.
Recent evidence accords with FSANZ’s conclusion at Draft Assessment that there is no apparent increase in cancer risk associated with higher folic acid intakes for the population as a whole. Some studies suggest that an increase in folic acid intake may be protective of cancer, however, the evidence is not conclusive.
Recent evidence does not support an improvement in cognitive function from increased folic acid intakes.
The evidence is inconclusive for an increased risk of multiple births from increased folic acid intake.
There is no evidence of an increased risk of folate-drug interactions at the proposed levels of fortification.
Concerns about unmetabolised circulating folic acid arising from mandatory fortification overseas have been raised. No apparent adverse effects have been reported. Consequently, the health significance of this remains uncertain.