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

Modified Option 2

Does not support mandatory fortification as proposed because it removes consumer choice, is involuntary mass medication with no control group, and does not provide sufficient folic acid for optimum NTD prevention, therefore folic acid supplements are still required.

Alternative proposal to include:

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  exemption for organic flours;
  
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  exemption for non-wheat flours such as rye, rice, spelt;
  
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  fortification at the bakery stage rather than at the milling stage;
  
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  education to the target group to increase dietary folate from natural sources and folic acid supplements;
  
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  change to dietary supplement regulations to allow higher levels of folic acid in dietary supplements from the current 300 ug maximum;
  
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  clear labelling of fortified products including information on the risk of a vitamin B12 deficiency; and
  
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  an awareness campaign to educate primary healthcare practitioners about the risks of vitamin B12 deficiency, particularly in the elderly.
  

The reasons for the exemptions and fortification changes are to preserve consumer choice, and provide alternatives for those who wish to avoid fortified foods.

C38	Grey Power Marlborough Inc, New Zealand Mr Dennis Paget	Supports Option 1 Consider the proposal should be delayed until such time as a confident decision is arrived at and a programme can be undertaken with no doubt to its efficacy and safety. Health Risks Expresses concern over potential detrimental effect of the proposal on the elderly population. Raises the following questions: is the Government aware of the possible detriment to health and still going ahead with the proposal? is there commercial gain being made by some unannounced party? has adequate research been undertaken in NZ to determine effects on the elderly? will there be publicly funded screening of the elderly to determine B12 status? International experience They note UK has revoked their decision to proceed through a doubt that it will be safe.
C39	International Federation for Spina Bifida and Hydrocephalus Ms Pia Wurzer/Mr Pierre Mertens	Supports Option 2 Strongly supports mandatory flour fortification with folic acid. International Federation policy provided which includes support for fortification of staple food with folic acid to reduce the incidence of NTDs, promotion of the health benefits of folic acid and further research into the prevention of NTDs.
C40	International Federation for Spina Bifida and Hydrocephalus Mr Lieven Bauwens	Supports Option 2 Strongly supports mandatory folic acid fortification for the following reasons: based on scientific research, mandatory fortification of staple foods is the only non-discriminatory prevention measure to prevent neural tube defects;. reaches all women of childbearing age before they become pregnant, providing maximum protection against NTDs for all children, especially as many pregnancies are unplanned; reduces the number of associated terminations, which they oppose; has been shown to be safe; latest research shows no increase in twinning and no delayed diagnosis of vitamin B12 deficiency; considers there is growing evidence for folic acids role in preventing other congenital anomalies including cleft lip/palate, heart defects, stroke, Alzheimer’s, Down syndrome and some forms of cancer; does not rely only on public education programs and public awareness about folic acid, therefore everyone benefits regardless of social class or income; and international experience has shown a significant decrease in the prevalence of NTDs, for example USA and Canada. Attached the International Federation for Spina Bifida and Hydrocephalus Policy Statement on this issue.`
C41	Judith Maher, consumer representative for the Consumers’ Health Forum of Australia and member of the Breast Cancer Network of Australia	Supports Option – 2 No further comments made.
C42	National Council on Folic Acid, USA Ms Adriane Griffen	Supports Option 2 Applauds the DAR P295. Considers mandatory fortification to the proposed levels is proven, safe, extremely feasible, inexpensive and long over-due. Notes since introduction in US in 998 NTDs have decreased by 26%. Notes more than 50 countries where folic acid fortification of flour is mandatory.
C43	New Zealand Organisation for Rare Disorders John Forman	Supports option 2 Strongly supports immediately fortifying food supply with folate. Health risks Believes evidence of benefit is very strong and any risk of harm is minimal to negligible. Considers the proposal to be a significant public health initiative. Argues there is a moral duty and possibly a legal duty on both governments to implement folate fortification through FSANZ to protect the community. Compares folate fortification with other important public health initiatives such as pasteurisation of milk to demonstrate that failure to implement this proposal would be negligent.
C44	Open Forum for Health Information, New Zealand Ms Patricia Holborow	Supports Option 1 Data Concerned there is not enough information to indicate safety, whether prevention of NTDs will be achieved, and whether the proposed approach is sufficiently cost effective to counteract the possible effects of excess for the general population. Considers two actions are needed before the proposal goes ahead: research into the effects of excess folate including original research and the research currently available; economic comparison of NTDs and side effects of excess folate. Consider a decision delayed is better than a wrong decision.
C45	Soil & Health Association of New Zealand Mr Steffan Browning	Supports Option 1 Believes mandatory fortification with folic acid is contrary to the FSANZ Act 1991 in particular Objectives 1 (a) and (b) and Objectives 2 (a), (c), (d). Health risks Believes a healthy diet negates the need for fortification. Considers adequate science has not been met by FSANZ and NZFSA nor does it appear to be impartial or precautionary. Conscious of links between environmental toxins (e.g. dioxin) and NTD and stresses other causal effects on NTD occurrence must be taken into account when or before considering a dietary solution. It is known that high doses of folic acid can have adverse effects. Questions why unhealthy individuals appear not to have been considered when mentioning potential adverse effects. Supplements No comprehensive promotion and education strategies to increase folate intakes have taken place in New Zealand thus no appropriate study base exists on which to use or discount that option in the initial assessment (Option 4). Consumer choice Mandatory fortification will reduce choice for those wanting to avoid additives therefore considers it is in opposition to the FSANZ Act. Real informed choice will allow a consumer to have fortified or non-fortified items. An exemption for organic foods would allow consumer choice. Impact on industry Small businesses will have difficulty in equipping facilities to implement fortification and this would be a barrier to fair trade as promoted in FSANZ Act. Organic processing standards forbid the addition of synthetic vitamins. Mandatory fortification has repercussions for organic producers, the addition of synthetic vitamins would be contrary to consumer expectations and have significant implications on trade in organic produce. An exemption for organic products will give both countries greater trade options. International experience Critical of FSANZ’s Publication: Mandatory Folic Acid Fortification in that it shows a bias towards a mandatory fortification outcome in referring to the US & Canada.
C46	Spina Bifida Association, Washington DC Ms Cindy Brownstein	Supports Option – 2 Strongly supports mandatory fortification of flour with folic acid. Believes that the costs to millers of adding folic acid to flour are small compared with the enormous public health benefit. Described their association’s recent involvement in working with corn producers to ensure that corn meal entering the US was fortified with folic acid.
C47	Spina Bifida Foundation of Victoria Mr Peter Hudson	Supports Option 2 States that the burden of disease is significant for many of those with spina bifida and their families. Acknowledges that mandatory fortification at the proposed level will not achieve the maximum possible reduction of NTDs. Education Community education will be critical to ensure that women who could become pregnant are aware of the recommendation to take folic acid supplements daily, particularly women who are younger, less educated and of lower socio-economic status. Recurrent government funding will be necessary to implement the education and key stakeholders such as the spina bifida organisations are well placed to form partnerships with government to assist in providing the education. Monitoring Very important that recurrent funding is made available to monitor the outcomes of mandatory fortification such as the incidence of NTDs and other birth defects, blood levels of folate and the incidence of stroke, heart disease and various cancers as well as new developments on the health affects of folic acid. For monitoring to be effective it must be consistent, systematic, robust and sustained.
C48	Spina Bifida Group of NSW Ms Anita Fisher	Supports option 2 Considers mandatory fortification is the only way to ensure equal access to folic acid regardless of education or financial situation. NTD incidence Estimated that about 5000 people in Australia have spina bifida and each year about 315 pregnancies are affected by a NTD. Considers research clearly shows that the correct dosage of folate can prevent up to 70% of cases of NTDs. Suggests the current prevention methods have not been as successful as possible and need to be reconsidered. Refers to a recent meeting of medical specialists from NSW spina bifida clinics who noted the increased prevalence in spina bifida over the past year. Health risks Considers fortification with folate is safe. Believes mandatory fortification will ensure the majority of women in Australia will have access to folic acid as part of their daily diet. International experience Fortifying flour is consistent with international experience and research to reduce the incidence of NTD. Voluntary fortification Refers to FSANZ Folate Fortification Consultation Initial Assessment Report October 2004 as highlighting how education and voluntary fortification programs have not been as successful as possible. Supplements Concerned supplements are of limited use as many women are reluctant to take supplements if they are not intending to get pregnant. Notes at least 40% of pregnancies are unplanned, so mandatory fortification offers some protection against this. Notes supplement use is highest amongst well educated women & those who have the financial means;..
C49	Spina Bifida Hydrocephalus Queensland Mr Bill Shead	Supports Option 2 Health benefits Notes that whilst mandatory fortification will not prevent spina bifida completely in Australia or NZ it will reduce the incidence. This is especially the case when women do not supplement their diet with folic acid. International experience Considers the experience of sixty or so other nations who have introduced mandatory fortification attests to both the value of mandatory fortification and the lack of any negative consequences of it.
	Industry
	Food Manufacturers
I1	Allied Mills Australia Pty Ltd. Mr J. Di Leo	Modified Option 1 Considers that mandatory folate fortification in Australia is premature. Considers insufficient study has been carried out to warrant fortification for all Australians. Food Vehicle Questions the choice of flour as the food vehicle rather than a supplement to increase folate intake in the target group. Health Risks Considers the following uncertainties have not been addressed: the long term effect on the community (non-target groups); women with gluten intolerance; and evidence from prominent dietitians and nutritionists. Impact on industry Should folate be mandated across Australia, Allied Mills would comply with mandatory fortification, but must have the following provisos: compensation from the Government for additional costs incurred ( $650,000 capital costs and $40,000 ongoing costs for equipment, testing and labelling, to be given prior to the programme); Allied Mills cannot be held responsible for accurate levels of folate addition as flour is released daily from bins in the mills, but laboratory test results may not be available for several weeks; Allied Mills must have Government indemnity for all incidences that may arise from any adverse effects of flour folate fortification on consumers (including all future health concerns/future litigation); and the mandatory fortification and testing of flour must be industry wide. Supplements / Education Preferred strategy is for education in the school system and folate supplements supplied free of charge, funded by the Government, directly to the target audience.
I2	Axiome Pty Ltd Mr David Bill	Preferred option not stated. Form of folate for fortification Refers to an application submitted in July 2005 to amend the FSANZ Code to approve L-Methylfolate, calcium as a permitted form of the vitamin, Folate. Notes this is now on the FSANZ work plan but has not commenced. Notes there is currently only one permitted form of folate, folic acid, approved for fortification of food. This is considered a pro-vitamin rather than a vitamin as it needs reduction before it can function as a coenzyme. In comparison, L-Methylfolate is the predominant natural form in foods and the essential form that occurs and is stored in the body. It does not mask B12 deficiency. This would provide an alternative form of folate for fortification. Therefore, proposes that FSANZ prioritise and expedite the assessment of application A566 as is permitted under sections 24 and 36 of the FSANZ Act 1991.
I3	Fonterra Co-Operative Group Ltd. Ms Sonia Chandra	Supports a modified Option 1 Opposes the mandatory fortification approach being implemented. Preferred Option Extension of permissions for voluntary fortification first alongside a comprehensive education and communication programme. Mandatory fortification should then be investigated as a final option only. View aligns with Dairy Australia and the general industry position. Ministerial Council Policy Guidelines Considers the preferred option contradicts the Specific Order Policy Principals, specifically that the assessment of the most effective public health strategy, and demonstrated population health need taking into account both the severity and prevalence, have not been taken into account. Data Considers justification for mandatory fortification is based on outdated and insufficient data. Considers there is insufficient evidence to proceed with this proposed choice. Notes 2006 news poll data from the Australian Food and Grocery Council (AFGC) indicated women of childbearing age consume on average only 11 slices of bread a week i.e. meeting only one day’s folic acid requirement per week. Health Risks Considers FSANZ has not conducted appropriate evaluation and surveillance of the current voluntary scheme, or investigated uncertainties due to limited evidence, or given detailed consideration to practical implementation. Considers these gaps could lead to health risk. Notes the uncertainty around chronic exposure to increased folic acid beginning in childhood. Considers research into a safe dose has not occurred. Acknowledged FSANZ have recognised the potential risks but have not addressed these satisfactorily. Monitoring Considers the cost and responsibility for monitoring and enforcing compulsory folate addition is inadequately acknowledged. A funding and responsibility plan is needed. Considers the problem of a validated testing method and means of measuring levels of folic acid have been overlooked. Consumer choice Considers the proposal restricts consumer choice. Considers NZ and Australian consumers may respond negatively to mandatory fortification for the benefit of a certain segment of the population. Transition period Fonterra supports an 18 month phase in time to cope with the changes. International experience Notes UK has delayed the development of their mandatory fortification with folic acid due to emerging evidence. The Scientific Advisory Committee have requested more time for safety research on benefits and risks. Voluntary fortification Believes extension of this option combined with education and promotion is the most effective strategy. This would encourage industry to create a wider range of products, raise awareness of the health issues and advertise the benefits of the nutrient. Considers voluntary fortification plus a health promotion campaign has not been adequately trialled and evaluated. Food vehicles Considers it likely that using several vehicles would have a greater impact than fortification of a single food. Only 120 food vehicles are currently approved. Dairy products are not included which is considered inconsistent with Std. 1.3.2. Considers dairy products are also a staple food for the target group and recommends dairy foods be given the opportunity to add folic acid if desired. Notes folate containing milk powder and folate enriched milk are available. Communication and education Refers to FSANZ stating voluntary fortification was not very successful. Considers the approval process and approved health message are very limiting and promotional initiatives inadequate. Consumer research suggests using more positive folate messages and more flexible wording through a variety of communication mediums. Considers marketing of fortified foods is very difficult as the prescribed health claim is a very negative message on a product. Broader health claims would make folate fortification more attractive to industry. The lengthy application process on a case by case basis needs review. Considers the following is needed alongside voluntary fortification: increased communications and education; freeing up of the wording on the health claims; and simplifying the application process.
I4	George Weston Foods Ltd (GWF) Ms Fiona Fleming	Supports a modified Option 1 Supports extension of voluntary permissions as proposed in the Initial Assessment. Does not believe that mandatory fortification of bread-making flour will address the reasons noted in the Draft Assessment for women not following advice to increase supplemental folic acid. Believes voluntary fortification as part of a national education campaign will increase the folic acid intake of women more effectively than the proposed mandatory fortification programme due to restricted bread consumption of the target group.