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References

Attachment 1

Draft variation to the Australia New Zealand Food Standards Code

To commence: on gazettal
[1] Standard 1.1A.2 of the Australia New Zealand Food Standards Code is varied by omitting from the Table to subclause 3(e), all of the entries under the heading, Bread, substituting –
Bread
To commence: 15 months from gazettal
[2] Standard 1.3.2 of the Australia New Zealand Food Standards Code is varied by –
[2.1] omitting the Purpose, substituting –
This Standard regulates the addition of vitamins and minerals to foods, and the claims which can be made about the vitamin and mineral content of foods. Standards contained elsewhere in this Code also regulate claims and the addition of vitamins and minerals to specific foods, such as, the addition of thiamin to flour for making bread (Australia only) and the addition of folic acid to bread in Standard 2.1.1, the addition of vitamin D to table edible oil spreads and margarine in Standard 2.4.2, the addition of vitamins to formulated caffeinated beverages in Standard 2.6.4, the addition of vitamins and minerals to special purpose foods standardised in Part 2.9 and the addition of iodine to certain salt products in Standard 2.10.2.
[2.2] omitting from the Table to clause 3, under the headings Cereal and cereal products, Bread, the entry for folic acid.
[3] Standard 2.1.1 of the Australia New Zealand Food Standards Code is varied by –
[3.1] omitting the Purpose, substituting –
This Standard defines a number of products composed of cereals, qualifies the use of the term ‘bread’, and requires the addition of thiamin to flour for making bread (Australia only) and the addition of folic acid to bread.
[3.2] inserting after clause 5 –
6 Mandatory addition of folic acid to bread
(1) Subclause 1(2) of Standard 1.1.1 does not apply to this clause.
(2) Bread must contain no less than 0.8 mg/kg and no more than 1.8 mg/kg of folic acid.
Editorial note:
The maximum limit for folic acid given in subclause 6(2) ensures the addition of folic acid to bread in Australia and New Zealand is in controlled amounts to provide for a safe population intake of dietary folic acid. Subclause 6(2) will be reviewed when sufficient monitoring data are available to assess the impact of this mandatory requirement.
Between gazettal and commencement of clause 6, manufacturers may take up the voluntary permission to add folic acid to bread contained in Standard 1.3.2, in preparation for the commencement of the mandatory requirement in subclause 6(2).

Attachment 2

Summary of Submissions from the Draft Assessment Report

Executive Summary

Background

In July 2006 FSANZ received 148 submissions in response to the Draft Assessment Report of Proposal P295 – Consideration of Mandatory Fortification with Folic Acid. There were two options proposed at Draft Assessment to increase the folic acid intake among women of childbearing age to reduce the incidence of neural tube defects (NTDs) in Australia and New Zealand, namely:

Option 1 – Maintaining the status quo;

Option 2 – Mandatory folic acid fortification of all bread-making flour;

KEY ISSUES IDENTIFIED FROM SUBMISSIONS

1. Regulatory options

Reasons for and against each of the regulatory options included:

1.1 Maintaining the status quo

Support
Those in favour of maintaining the status quo expressed concern about a range of issues, including:

• 
  the health risks from increased folic acid are not fully known;
  
• 
  folic acid supplements will still be required;
  
• 
  consumer choice is reduced;
  
• 
  the proposal uses a population-wide approach for the benefit of a small sub-group of the population; and
  
• 
  the impact on organic breads as the addition of synthetic substances is not permitted.
  

The low prevalence of NTDs and the reduction in NTD rates were also noted, as was the perception that the implementation of mandatory fortification was a foregone conclusion.

Opposed
Those against maintaining the status quo noted the limited effectiveness of voluntary fortification, supplementation and health promotion. Some considered the preferred approach was a long overdue public health measure. It was acknowledged the current uptake of voluntary fortification by industry food is low and uptake of folic acid supplements is inadequate especially by those in lower socio-economic groups and Indigenous women.

It was noted that not all women respond to educational messages and the status quo disadvantages women who have unplanned pregnancies. Some individuals and health professionals who had direct experience with NTDs acknowledged the trauma associated with terminating an NTD affected pregnancy.

1.2 Mandatory folate fortification

Support
Those in support of mandatory folic acid fortification recognised its capacity to reach a broad spectrum of the population, particularly disadvantaged population groups who may not respond to education and supplement promotion. The proposed approach was recognised as a safe and effective public health intervention that can reduce the incidence of NTDs, improve serum folate and lower homocysteine. Its success internationally in reducing NTDs was recognised. The potential for mandatory folic acid fortification to positively influence other health outcomes was mentioned frequently, although few references were provided apart from those included in the Draft Assessment Report. The limitations of voluntary fortification were acknowledged, particularly its susceptibility to market forces. The lack of widespread folic acid supplement use among the target group was also acknowledged, despite health promotion.
Against
A significant number of submissions were opposed to the mandatory fortification proposal but did not specify their preference for a regulatory option. Many submitters opposed the preferred mandatory approach because:

• 
  the effectiveness in reducing NTDs based on the proposed fortification level was not considered sufficient justification for population wide consumption of folic acid;
  
• 
  it did not provide sufficient consumer choice;
  
• 
  it resulted in ‘mass medication’ of the population;
  
• 
  the possible health risks and future health risks are unknown, especially for children and the elderly;
  
• 
  there are technical difficulties and significant cost implications for industry fortifying the proposed food vehicle to the required level; and
  
• 
  there is a need for further research and consideration before mandatory fortification is presented as the final option.
  

Alternative approaches (presented below as a separate issue) were suggested by a number of submitters, particularly industry and one jurisdiction. Many favoured extension of voluntary permissions (as this approach allows for consumer choice) combined with enhanced education, and increasing the level of folic acid permitted in foods (in keeping with the recently revised Nutrient Reference Values).

Many submitters stressed the need for a national monitoring and surveillance system to be in place prior to implementation.
Some submitters considered the proposed approach did not align with the Ministerial Council Policy Guidelines.
The assessment examining the effectiveness of current voluntary permissions was considered inadequate, given the limited data. The recent UK and Irish Food Standards Agency reports were noted as not being considered.