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

Industry and technical issues

Information provided to Access Economics was on the basis of 100 or 200 ug folic acid /100 g flour, not on a range, and is therefore invalid. Costs will be significantly higher with a range as proposed.

Overages are not only a result of accounting for processing and storage losses. To ensure the required amount of thiamine is present in flour overages of between 25% - 1005 are needed depending on the particular mill.
Legal Liability - potential product liability
Notes comments on legal liability must be read in light of the concern about the lack of clear evidence regarding the safety, particularly long term, of folic acid fortification for those outside the target group.
Section 68 of Food Standards Australia New Zealand Act 1991 provides protection for the Commonwealth and FSANZ against being sued because of consumption of food, and states compliance with a standard is not a defence against a product liability action.
Product Liability Provisions in Part VA of the Trade Practices Act (TPA);
Under this legislation, there is a non-excludable right to bring an action for loss against the manufacturer for any injuries suffered as a result of a defect in its goods. If, as a result of eating bread, people become sick, have an increased risk of contracting a disease, the diagnosis of a disease is prevented or made more difficult, and medications are adversely affected, the manufacturer will be liable for the full loss suffered by those affected, unless it can rely on one of the statutory defences. There is a defence under the TPA in relation to product liability provisions, where the goods only have the defect because there was compliance with a mandatory standard for them (s75AK(1)(b)). For the purposes of product liability thiamine would not appear to be a mandatory standard as the manufacturer is free to exceed the minimum requirements of the standard.
With regard to the folic acid fortification range, it is unclear whether this would be viewed as a mandatory standard for the purposes of s75AA of the TPA.
Other areas of potential liability;
f there was a defence under product liability provisions in Part VA of the TPA, or legislation was passed by the Federal Government to deem mandatory fortification a Mandatory Standard for the purposes of S75AA of the TPA, this would not prevent a successful action against the manufacturer under Division 2A of Part V of the TPA or for negligence on the basis that the risk was reasonably foreseeable.
Inability to use warning statements on packaging;
Warning mechanisms can minimise liability. Bread manufacturers would need to consider placing prominent warnings on their product regarding such issues as possible relationship or effect between folic acid and cancer risks, multiple births, efficacy of anti-convulsive medication, increased rate of cognitive decline, masking of Vitamin B12 deficiency, and delay in early diagnosis of dementia. Any warning statement would have to identify the specific health issue, but such a warning would be prohibited under the current Food standard 1.1A.2, and proposed 1.2.7.
Options to address liability issues;
FSANZ must ensure that there is agreement from the Commonwealth to pass appropriate legislation to deem the Code to be a mandatory standard for the purposes of Part VA of the TPA. Agreement must also be given to amend the Code so that warning statements in relation to the risk from folic acid fortification will not be an illegal health claim.
Labelling

Fortification of all flour used for bread making will require changes to packaging of all products using bread-making flour.

Once folate is added to flour industry must by law immediately change the packaging of all products to reflect the new ingredient. Existing packaging stocks must be discarded.
Time is needed to revise packaging ready for the changeover. This exercise could well take six months and involve considerable costs in off site storage of packaging.
Fortifying organic flour limits choice and creates issues for those reaching the niche markets. Adding a synthetic vitamin to organic products and labelling them ‘natural’ or ‘organic’ does not align with what the product represents.

Consumer choice

Considers consumer choice is limited. Considers the comments that consumers can purchase non fortified flour to make their own bread are unrealistic, impractical and will produce an inferior product.

Considers there is no choice available under the preferred regulatory option as all bread will be fortified.

Natural and organic products will be affected and such claims will not be possible under mandatory fortification.
Believes findings of NZ consumer research on mandatory fortification by Hawthorne, 2005 should have been taken into consideration when making a decision, and reveals a need for an Australian study.
Retail flour which is not bread-making flour will produce an inferior loaf.
Concerned that consumers may change consumption patterns to avoid fortified products.
Ingredient labelling does not provide informed choice as it does not tell the consumer how much folic acid they are consuming.

Communication and education strategy

Considers a legally binding commitment from the governments involved is necessary for successful communication and education strategy.
The Aboriginal population have twice the rate of NTDs compared to the rest of the Australian population and would benefit from a separate, targeted programme.
Transition period

Transition period of 12 months is not adequate and requests a four year changeover period for packaging due to:

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  the large number of SKU’s affected across the food industry;
  
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  competing demands of food companies for the time from advertising agencies and print houses to make the necessary changes;
  
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  very large print runs which take time;
  
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  the extensive approval process required as part of the Trade Practices and Food Code compliance programmes, sampling and review of new packages.
  

Also to minimise costs GWF wishes to simultaneously make other changes to packaging to take account of other changes to the Code i.e. Country of Origin, Nutrition, Health and Related Claims, Mandatory Fortification with Iodine, and changes to the NRVs.