About the standard for mandatory folic acid fortification

What is the mandatory folic acid fortification standard in Australia?

All wheat flour used for making bread, with the exception of flour represented as ‘organic’, will be required to be fortified with folic acid.   The level required is between 200-300 micrograms of folic acid per 100 grams of flour.   This level of fortification will achieve an average residual level of approximately 200 micrograms folic acid per 100 g of the flour component of the final food.   Bread will contain an average level of approximately 120 micrograms of folic acid per 100 grams of bread.

All wheat flour for use in making bread represented as organic will be exempt from folic acid fortification.   Bread made from wheat flour and labelled as ‘natural’ will not be exempt from mandatory folic acid fortification.

What is the definition of bread under the Code?

Under the Code, bread is defined in Standard 2.1.1 – Cereals and Cereal Products as:

the products made by baking a yeast-leavened dough prepared from one or more cereal flours or meals and water.

This definition encompasses yeast-risen bread made from all cereal flours, not solely wheat flour.

Can I use folic acid fortified flour for products other than bread?

The use of flour fortified with folic acid in foods other than bread (e.g. pies and other bakery products) is permitted in the Code under Standard 1.3.2 – Vitamins and Minerals, providing suppliers adhere to labelling requirements.   For specific ingredient labelling requirements refer to Standard 1.2.4 - Labelling of Ingredients (also see FAQ ‘What labelling will be required under mandatory fortification?’).

What foods are likely to use folic acid fortified bread-making flour under mandatory fortification?

Only ‘wheat-flour for bread-making’ will be manditorily fortified with folic acid.   Bread made from other cereal grains (e.g. rice, corn and rye), will not be required to be fortified with folic acid provided it does not contain any wheat flour.

Foods likely to contain wheat-based bread-making flour include all plain, fancy, sweet and flat breads and bread rolls, muffins, crumpets, scones, pancakes, pikelets, crepes, yeast donuts, pizza bases and crumbed products.   It won’t be a mandatory requirement for these foods to contain folic acid; however current industry practices indicate these products may contain the same flour used to make “bread”.

For foods containing folic acid, folic acid must be declared in the ingredient list on food labels in accordance with Standard 1.2.4 – Labelling of Ingredients.

What about imported wheat flour and bread?   Will they be exempt?

No, imported wheat flour will not be exempt from mandatory folic acid fortification.

What date will industry have to comply with the standard?

FSANZ has allowed a two year transition time from gazettal of the standard to give industry time to implement requirements.   Industry must comply with mandatory folic acid fortification by 13^th September 2009.

Will there be any change to the current permissions for the addition of folic acid?

No, existing voluntary permissions for the addition of folic acid will remain in the Code, apart from the addition of folic acid to bread that contains wheat flour under Standard 1.3.2 - Vitamins and Minerals, which is now superseded by mandatory folic acid fortification.

FSANZ proposes to monitor changes in the use of voluntary fortification permissions to determine if a regulatory response is necessary in the future.   Any applications from industry for further voluntary folic acid permissions will be assessed in relation to the predicted mandatory folic acid fortification outcomes.

Will packaged flour sold in supermarkets be required to contain folic acid?

Yes, packaged wheat flour sold in supermarkets that is labelled for use in making bread will contain folic acid.   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 under Standard 1.3.2 – Vitamins and Minerals, and foods regulated by Part 2.9 - Special Purpose Foods, to fortify a range of foods.

How will mandatory folic acid fortification be enforced?

Enforcement of mandatory folic acid fortification will be the responsibility of state and territory enforcement agencies.   Contact your local enforcement officers or state/territory health department for further advice regarding this issue.

Will there be a review of the mandatory standard in the future?

Yes, the Australia and New Zealand Food Regulation Ministerial Council have agreed that a comprehensive and independent review of mandatory fortification with folic acid will be initiated two years after the implementation of the standard.   The review will consider health impacts and the effectiveness of the initiative, the actual cost effects on the food industry and the adequacy of the monitoring framework.

Labelling requirements

What labelling will be required under mandatory fortification?

For specific ingredient labelling requirements please refer to Standard 1.2.4 - Labelling of Ingredients.

Under Standard 1.2.4, suppliers are required to list folic acid in the statement of ingredients on all labelled foods containing folic acid.   This will include any food products made with folic acid fortified wheat flour.

In some situations, products are exempt from the requirement to label with an ingredient list.   These include:

• unpackaged foods;
• food made and packaged on the premises from which it is sold;
• food packaged in the presence of the purchaser; and
• foods in a small package.

Note also that under clause 4 of this Standard, where a cereal ingredient is wheat, rye, barley etc., the specific name of the cereal must be stated in the ingredient list e.g. ‘wheat flour’.

Where a nutrition claim is made regarding folic acid (folate), the label must include a declaration of folic acid (folate) in the nutrition information panel (NIP).   From a labelling perspective, the terms folic acid and folate appear to be used interchangeably for fortified foods.   For further details refer to Clause 5(1)(g) of Standard 1.2.8 –Nutrition Information Requirements.

Where a health claim is made regarding folate, the label must include a declaration of folate in the NIP.   For further details refer to Standard 1.1A.2 – Transitional Standard – Health Claims.

Will suppliers be allowed to make claims on the labels in relation to folic acid?

Yes, nutrition claims can be made on labels in relation to folic acid (folate) and health claims made in relation to folate.

Foods making nutrition claims about vitamins or minerals must be claimable foods under standard 1.3.2 – Vitamins and Minerals.   Claimable foods are defined in clause 1 of Standard 1.3.2.   The definition of ‘claimable food’ includes reference to the foods listed in the Table to clause 3 of Standard 1.3.2.   To determine what products are eligible to carry a nutrition claim about a vitamin or mineral, refer to the full details of Standard 1.3.2.

For details regarding health claims, refer to Standard 1.1A.2 – Transitional Standard - Health Claims.

FSANZ is developing a new standard to regulate nutrition, health and related claims under Proposal P293 – Nutrition, Health and Related Claims.   The conditions for making claims about the presence or absence of vitamins or minerals and any other associated health claims are being considered under this Proposal.   The new Standard may therefore impact on some of the requirements outlined above.   At this stage it is anticipated the new standard, Standard 1.2.7, will be gazetted in mid 2008.

Other questions

Australia is fortifying wheat flour for making bread with folic acid rather than fortifying bread.   Why is that?

Australian industry and enforcement agencies preferred to fortify bread with folic acid at the flour milling level rather than fortifying bread during the bread-making production stage.   Under Standard 2.1.1 - Cereals and Cereal Products, Australian manufacturers are already required to added thiamine to flour used for making bread.   Therefore mills have existing infrastructure for mandatory fortification and segregation of bread-making flour.

Where can I find a copy of the standard?

The amendments to The Australia New Zealand Food Standards Code (the Code) in relation to the mandatory folic acid standard for Australia can be located at:

http://www.foodstandards.gov.au/_srcfiles/Gazette%20Notice%20 Amendment%20No%2093%20WEB%20VERSION.pdf