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

Key issues

Will mandatory fortification of bread with folic acid result in other health benefits?

No other health benefits, apart from a reduced risk of NTDs, have been conclusively associated with an increase in folic acid intake.

Whilst a reduced risk of cardiovascular disease was previously reported as a potential health benefit, a review of current evidence (much of it published early in 2006) does not support this association.

Are there any possible health risks from mandatory fortification with folic acid?

The expected average increase in folic acid intake arising from mandatory folic fortification is unlikely to pose any increased risk of masking the diagnosis of vitamin B₁₂ deficiency in older people or in the zinc status of the population. The available evidence also suggests that folic acid is unlikely to interfere with anti-epileptic, antifolate or some anti-inflammatory drugs at folic acid intakes below one milligram per day.

A small proportion of young children (7% of 2-3 year olds in Australia) are expected to exceed the Upper Level of Intake (UL) for folic acid based on the proposed level of fortification. Whilst this is undesirable, it is unlikely to pose a health risk as there is a considerable margin of safety inherent in setting the UL. No comparable data on folic acid intakes among children under five years are available for New Zealand.
In addition to the potential health risks described above, there remains some uncertainty about other potential adverse health effects (e.g. cancer incidence and an increase in multiple births) from increased folic acid. As a result of these uncertainties a risk management approach has been adopted consisting of:

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  the requirement to ensure the level of folic acid in the final food meets a specified range, rather than placing the requirement on the folic acid content of the flour;
  

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  a conservative approach to the level of fortification;
  

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  the inclusion of an upper limit in the standard; and
  

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  identifying the need to monitor potential health risks.
  

These elements together limit the intake in non-target populations, provide greater predictability regarding folic acid consumption and establish a mechanism to inform a review of the standard which is proposed within five years of implementation.

Does mandatory fortification allow for consumer choice?

Under mandatory fortification nearly all breads will be fortified. This will include bread and bread rolls, sweet buns, fruit bread, English style muffins, some flat breads and bread crumbs. Breads which fall outside the definition of ‘bread’ in the Australia New Zealand Food Standards Code², will not be required to be fortified with folic acid.

Some unfortified products such as unleavened flat breads, hot plate products such as crumpets and pikelets, pizza bases, and retail flours will provide consumers with other options.
Consumers will be informed about the addition of folic acid to bread through labelling that requires all ingredients of a product to be identified in the ingredient list.

How will industry implement mandatory folic acid fortification?

Mandatory fortification will require all bread to contain folic acid within a prescribed range of 80-180 micrograms (µg) of folic acid per 100 g of bread. Bread manufacturers will need to decide the most suitable and cost effective methods of fortifying for their particular bread production process. Folic acid could be added through the use of flour fortified with folic acid, dry ingredients such as a bread improver³ fortified with folic acid, a complete bread premix which has been fortified with folic acid, or a folic acid vitamin premix which is added to the dough.

FSANZ will prepare an implementation guide, education materials, and, if required, workshops to assist industry. Industry will have 15 months from when the new standard is gazetted to comply with the mandatory fortification requirements.

How will mandatory fortification be monitored?

Responsibility for establishing and funding a monitoring system extends beyond FSANZ’s responsibility under the Food Standards Australia New Zealand Act 1991. FSANZ will, however, routinely monitor some elements of the system such as:

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  tracking changes in voluntarily fortified foods;
  
  
  
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  updating the folic acid composition of foods in the food composition databases;
  
  
  
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  tracking labelling changes on fortified foods;
  
  
  
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  tracking changes in food consumption patterns for different demographic groups in key food categories that are likely to be fortified; and
  
  
  

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  researching consumers’ attitudes and behaviour towards fortified foods.
  

Monitoring other elements of the impact of mandatory folic acid fortification, particularly the main outcome measure of a change in the national rate of NTDs, will require involvement of health and regulatory agencies at a Commonwealth, State and Territory level in Australia and the New Zealand Government. Other outcome measures, such as cancer incidence, are already routinely collected and reported and will contribute to baseline data for the monitoring system.

Further information about the elements of and responsibilities for establishing a monitoring system are provided in Section 18 of this report and at Attachment 12.

What other strategies are planned to support mandatory fortification?

FSANZ recognises that mandatory fortification is one strategy in NTD prevention, and that other strategies will continue to be important including the existing voluntary fortification of other foods, the promotion of supplement use and education for women of child-bearing age.

FSANZ will talk with relevant industry members and government agencies to ensure that recommendations about supplement use take account of expected increases in dietary folic acid intake among women of child-bearing age.
FSANZ has prepared a communication and education strategy for mandatory folic acid fortification that aims to increase awareness among all target audiences of the proposed standard for mandatory folic acid fortification and its implementation. To implement the strategy, FSANZ will seek opportunities to collaborate with organisations to provide information and education about the proposed standard to consumers, industry, health professionals and other key stakeholders.
FSANZ has begun to collaborate with a range of organisations as optimal reduction in the incidence of NTDs depends on these strategies being collaborative and sustained.