Overview of fortification

·                What is fortification?

·                What is mandatory folic acid fortification?

Fortification is the intentional addition of vitamins and minerals to food at levels higher than those found in the original food.  

Voluntary fortification allows food manufacturers to choose what vitamins and minerals they want to add to food, providing they are permitted in the Australia New Zealand Food Standards Code (the Code).   For example many breakfast cereals are fortified with a range of vitamins and minerals.

Mandatory fortification of food is where food manufacturers are required to add a vitamin or mineral.   These are added in response to a significant public health need, for example, manufacturers are required to add vitamin D to margarine and thiamin to flour for making bread in Australia.

·                Why do we need mandatory fortification with folic acid?

For more than ten years, Australia and New Zealand have introduced a number of initiatives to increase the folic acid intake of women planning to or who may become pregnant to reduce the risk of their children developing neural tube defects .   These have included health claims on food labels, education programs, voluntary folic acid fortification of foods - such as breakfast cereals and bread - and encouraging women to take folic acid supplements.   Despite these initiatives, most women of child-bearing age are still not consuming enough folic acid.   Food Standards Australia New Zealand (FSANZ) is introducing mandatory fortification of wheat flour for making bread to provide additional protection against neural tube defects .

The decision to fortify bread with folic acid was guided by overseas experience in the United States and Canada where the introduction of mandatory fortification of bread with folic acid has reduced the incidence of neural tube defects.   Mandatory fortification is one initiative in neural tube reduction and other initiatives will continue to be important.   These include continuing our existing voluntary fortification measures and encouraging women planning to or who may become pregnant to take supplements.

·                  How effective is mandatory fortification in increasing folic acid intakes and reducing neural tube defects in the Australian population?

Mandatory folic acid fortification in Australia is expected to increase folic acid intakes in the target population (women aged 16-44 years) by an average of 100 micrograms per day.   This increase is expected to reduce the number of pregnancies affected by neural tube defects each year by an estimated 14-49 out of 300-350 pregnancies.

Overview of folic acid and neural tube defects

·                What is folic acid and why is it important?

·                Is folic acid different to folate?

Folate is a B group vitamin we all need for healthy growth and development, especially of our nervous systems.   This vitamin is known as  folate when occurring naturally in food, such a green leafy vegetables.  Folic acidis the ‘man made’ form used in supplements or added to food.   Folic acid is more readily absorbed than naturally-occurring folate.

Folic acid is important to the healthy development of babies in early pregnancy.   A baby’s growth is the most rapid in the first weeks of life – often before a woman is aware she is pregnant.   The neural tube closes and fuses very early in pregnancy; if it doesn’t close, the result is a neural tube defect such as spina bifida.   Folic acid taken at recommended levels for at least one month before and three months after conception can prevent the occurrence of most neural tube defects.

To reduce the risk of neural tube defects, women planning to or who may become pregnant should consume at least 400 micrograms of folic acid every day.   Women who have a family history of neural tube defects should also ask their GP for advice about their individual needs.

·                What are neural tube defects?

Neural tube defects are severe birth defects that are associated with considerable morbidity and mortality as well as hardships for carers and families.   Two forms of neural tube defects are spina bifida and anencephaly.   Spina bifida is a condition in which the spinal cord is exposed.   A majority of babies born with spina bifida grow to adulthood with varying degrees of disability, including problems with bowel and bladder control, and paralysis.   In anencephaly, infants die shortly after birth because most or all of the brain is absent.

Key messages regarding intake of folic acid – benefits and risks

·                How much folic acid do I need?

·                Will I still need to take a folic acid supplement?

·                What are good sources of folic acid?

To reduce the risk of neural tube defects, women planning to or who may become pregnant should consume at least 400 micrograms of folic acid every day.   Women who have a family history of neural tube defects should also ask their GP for advice about their individual needs.

It is difficult to ensure women will get enough folic acid from their diet to reduce the risks of neural tube defects in pregnancy.   The best way to guarantee women get enough folic acid is to take a folic acid supplement of at least 400 micrograms every day, in addition to eating foods that have added folic acid (fortified) and are naturally rich in folate.

Folic acid supplements are available in Australia over the counter from pharmacies and through your doctor at varying doses.   Look for supplements that contain at least 400 micrograms of folic acid; these will generally be supplements containing only folic acid or special pregnancy supplements.   Multi-vitamin supplements generally contain less.

The foods that might be fortified with folic acid include breakfast cereals, yeast extracts and fruit juices.   Check the ingredient list to see whether folic acid has been added (sometimes listed as folate).   Mandatory fortification of bread in Australia will provide an additional source of folic acid.   Bread will contain an average of 120 micrograms of folic acid per 100 grams (approximately 3 slices).

·                Are there any health risks from mandatory folic acid fortification?

Based on the best scientific evidence, there is no apparent risk to public health and safety either from the amounts of folic acid already obtained from foods voluntarily fortified by the food industry, or from the estimated increase in folic acid intakes as the result of mandatory fortification.   We investigated: masking the diagnosis of vitamin B12 deficiency; cancer; twinning; cognitive function; and miscarriage.

However, as there remains some uncertainty in the scientific literature on the potential health risks of folic acid, we have taken a conservative approach to mandatory folic acid fortification.   We are proposing an upper limit on the amount of folic acid mandated in wheat flour for bread-making and will be establishing a monitoring framework to investigate the health impacts of mandatory folic acid fortification.   There will be a comprehensive and independent review of mandatory folic acid fortification, which will be initiated two years after the implementation of the standard.

Food vehicle

·                Under mandatory fortification, what foods will folic acid be added to?

Folic acid will be added to wheat flour for making bread.  

Food products that are made with wheat bread-making flour can be expected to contain folic acid under mandatory fortification.   Foods assumed to contain wheat-based bread-making flour are: all plain, fancy, sweet and flat breads and bread rolls, muffins, crumpets, scones, pancakes, pikelets, crepes, yeast donuts, pizza bases and crumbed products.   Check the ingredient list to see whether folic acid has been added (sometimes listed as folate).

Organic bread will not be required to contain folic acid.

·                Why was bread chosen for fortification?

Bread was chosen as the appropriate food vehicle for fortification as it is consumed by a large proportion of women of child-bearing age across different socio-economic sub-groups and is technically feasible to fortify.

·                Do other countries fortify bread with folic acid?

Yes.   The United States, Canada, Indonesia and South Africa require bread to be fortified with folic acid.   The United Kingdom and Ireland have recently agreed that mandatory bread fortification should be introduced.

·                Will any bread be exempt from mandatory fortification?

·                What if I don’t want to consume bread that is fortified with folic acid?

Organic bread will not be required to contain folic acid.   This will provide some choice for consumers who do not wish to buy bread with added folic acid.   Bread made from other cereal grains such as rice, corn and rye, provided they do not contain any wheat flour, do not have to contain folic acid.   However, manufacturers may add folic acid if they wish.

Check the ingredient list to see whether folic acid has been added (sometimes listed as folate).

·                Will packaged flour sold in supermarkets contain folic acid?

Packaged wheat flour sold in supermarkets in Australia that is labelled for use in making bread will contain folic acid under mandatory fortification.   Other types of packaged flour (i.e. other cereal flours and wheat flour not labelled for use in making bread) will not be required to contain folic acid.   However, manufacturers may use voluntary permissions in the Australia New Zealand Food Standards Code to fortify a range of foods, which includes all cereal flours.   Check the ingredient list to see whether folic acid has been added (sometimes listed as folate).

·                What about imported wheat flour?   Will it be exempt?

Imported wheat flour for making bread sold in Australia will be required to be fortified with folic acid.   However, the amount of wheat flour imported into Australia is small.

Consumer issues

·                How will I know which food products contain folic acid?

The Australia New Zealand Food Standards Code requires manufacturers to list folic acid in the ingredient list on the labels of folic acid-fortified foods.

Bread that is packaged at the point of sale; bread made and packaged on the premises from which it is sold; and unpackaged bread is not required to provide ingredient information.   Consumer information about the presence of folic acid and other ingredients may in some instances be available from the food outlet; however it is not a requirement.

·                How much bread will I need to eat to consume the required amount of folic acid?

·                How will I consume enough folic acid if I don’t eat bread?

·                Is it true that mandatory folic acid fortification will not provide women with the recommended 400 µg of folic acid a day?

It is important to realise that women planning to or who may become pregnant should not rely on bread alone to obtain their required amount of folic acid.   Women should consume a variety of foods that are fortified with folic acid (fruit juice, bread, breakfast cereal) and take a folic acid supplement of at least 400 µg.   Refer to the ingredients list to determine whether a food product is fortified with folic acid (sometimes listed as folate).

Mandatory and/or voluntary folic acid fortification alone may not provide women with the recommended 400 µg folic acid a day.   Mandatory fortification is being implemented as a means of providing additional protection against NTDs to women of child-bearing age.  

·                Will fortification increase the price of bread?

The cost to consumers of mandatory folic acid fortification is likely to be small; probably less than 1% of the price of a loaf of bread.

·                What is the proposed date of implementation?

The mandatory Standard allows industry two years to implement folic acid fortification from gazettal.   Manufacturers must comply with mandatory folic acid fortification by 13 September 2009.