Folic Acid - NZFSA Response: Key Issues

Key Issues

NZFSA response

Disparity in the figures submitters have supplied in the number of NTD affected pregnancies prevented.

FSANZ used the Wald model to estimate the number of NTD affected pregnancies that could be prevented by mandatory fortification of bread with folic acid at a concentration of 135mcg/100g (the mid-point of the mandated range). For New Zealand this is expected to result in between 4-14 NTD affected pregnancies prevented per year.

Ref: FSANZ (2006) Final Assessment Report, Proposal P295 Consideration of Mandatory Fortification with Folic Acid.

Mandatory fortification is unlikely to be effective.

At the level proposed, mandatory fortification of bread with folic acid is expected to provide benefit with regard to reduction in the number of NTD affected pregnancies in New Zealand. This is evidenced by the reduction in rates of NTD affected pregnancies in countries where folic acid fortification has been mandated such as Canada, the USA and Chile. The extent of the reduction appears to depend on the prevailing background rate of NTD affected pregnancies prior to fortification.

Ref: FSANZ (2006) Final Assessment Report, Proposal P295 Consideration of Mandatory Fortification with Folic Acid.

No new evidence provided to support a delay.

There is public concern over links between folic acid and adverse health impacts

Cancer – colon and prostate

Vitamin B12.

The possibility of adverse effects not confirmed.

FSANZ undertook a thorough assessment of all available evidence of both the benefits and risks associated with increasing folic acid intake during the development of the mandatory fortification with folic acid standard. As part of its commitment to on-going monitoring of the Standard, FSANZ continues to evaluate all new evidence as it comes to light. At this time there is no new evidence on risks associated with mandatory fortification at the level proposed to support a delay.

FSANZ has provided NZFSA with an up to date “Summary of emerging evidence on health outcomes” associated with mandatory folic acid fortification. This document is attached.

There is no evidence of harm/adverse health effects at the levels proposed.

At this time there is no new evidence associated with mandatory folic acid fortification at the level proposed to indicate that there is a risk to public health and safety.

Long term health effects on men, children/non target groups is not known.

As part of its commitment to on-going monitoring of the Standard, FSANZ will continue to evaluate all new evidence as it comes to light. Long term health effects will be captured as part of this monitoring.

Low quality of data for New Zealand NTD affected pregnancies (terminations not included).

Number of NTD affected pregnancies overall is declining (or is masked by high number of terminations).

Reduction in New Zealand could be because scans showing NTD affected pregnancies can end in pregnancy termination.

The data inadequacy issues around the number of NTD affected pregnancies are acknowledged in the FSANZ reports.

Complete New Zealand NTD affected pregnancies data (terminations, still births and live births) are only available for 1998 to 2003. These annual totals show a downward trend in NTD affected pregnancies rate per 10,000 births (17.4 to 11.2). Termination of pregnancy data for NTD affected pregnancies is available for 2004-8 and appears stable over the period (28-29 annually)

It is not widely understood that the fortification of bread is a method of replacing the vitamin B9 [folate] stripped out of flour by the milling and baking process.

Review milling process with less nutrients being extracted.

It is true that the milling process removes some nutrients - restoration is not the objective of this mandatory fortification regime. The level of folic acid being mandated for addition is much higher than for the purpose of restoration. The objective is to reduce the risk of an NTD affected pregnancy.

There are health benefits from mandatory fortification.

The totality of evidence to date, except in relation to reducing the risk of NTD affected pregnancies, does not support the mandatory addition of folic acid to food for any other health benefit.

Ref: FSANZ (2007) First Review Report, Proposal P295, Consideration of Mandatory Fortification with Folic Acid.

New Zealand population is folate deficient.

A proportion of New Zealand adults have inadequate intakes of folate as reported by the Ministry of Health’s 1997 National Nutrition Survey but the proportion is small (less than 1 in 10).

The aim of mandatory fortification is to top up other sources of folate intake.

Agreed.

Consideration should be given to reports of scientific meetings and unpublished data.

FSANZ and NZFSA have only considered published data available in peer reviewed journals.

Some sectors of population exceed upper daily intake.

This is probable but the level of mandatory fortification has been set to minimise this. Additionally the upper level of intake has a five fold safety margin built in.

Ref: National Health and Medical Research Council of Australia and New Zealand Ministry of Health (2006) Nutrient Reference Values for Australia and New Zealand Including Recommended Dietary Intakes.

If half of all women planning pregnancy took folic acid supplements at the correct time the reduction in the incidence of NTD affected pregnancies would be equivalent to that achieved by mandatory fortification.

This issue is covered in the FSANZ assessments regarding the relative merits of mandatory fortification versus supplementation. Evidence indicates this approach has not been successful on its own and that the uptake, and therefore effect, is very limited.

Some people may be allergic to folic acid.

Rare health events may occur with any food. If the Standard comes into force, folic acid will be required to be declared in the ingredients list of packaged bread and will be made available upon request where bread is not required to be labelled. Those with allergens will be able to avoid such breads.

Women will not receive optimal level of folic acid from fortification.

Folate status in Canada increased but not to optimal level.

Prevention of NTD affected pregnancies in US stabilised at 20%.

Mandatory fortification is only one part of the approach to reduce NTD affected pregnancies. The objective is to reduce the risk of an NTD affected pregnancy not to meet the entire pre and during pregnancy requirements exclusively through this single fortified food.

Folic acid and folate are essentially same nutrient.

Folic acid is the synthetic version of folate.

The evidence for reducing the risk of NTD affected pregnancies is related to folic acid intake (rather than folate).

The standards for voluntary fortification and for mandatory fortification are different.

Voluntary only sets a maximum claimable level. Mandatory sets a range to be present in the final product.

Agreed.

Folate intakes were not considered in the dietary modelling, should they have been?

Dietary modelling only considered folic acid intake because there is no evidence to link folate intake to a reduction in NTD affected pregnancies (ie all the evidence on NTD affected pregnancy reductions relates to folic acid intake).

With status quo there would be a need to restrict sale of high level folic acid tablets.

The Ministry of Health is currently considering the provision of a lower level folic acid tablet.

Increasing the base level of folic acid may affect safe levels for people getting folic acid from other sources as well.

This issue was taken into account in the FSANZ dietary modelling.

Level of folic acid being added may have even greater benefit than modelled

Wald model equation flawed.

This is possible. Further investigation of this is being undertaken in association with FSANZ. However, FSANZ is not aware of, nor has any documentation of, any errors that were made in the NTD affected pregnancy estimates in the Final Assessment Report.

Key Issues

NZFSA response

Any decision must not have an effect on our current volume of bread sales.

Reduced bread sales due to consumer concerns of adverse effects.

Any reduction in bread sales will have on-going implications for staffing levels in bakeries.

The potential impact on bread sales from mandatory fortification with folic acid is not known. An impact could result from consumer resistance to paying slightly more for fortified bread if such costs are passed on by the bread maker. An impact on bread sales could also result if consumer concerns expressed in some submissions are carried through to purchase decisions.

Industry would pass costs onto consumers.

Noted. The potential extent of costs and the level to which these might be passed on to consumers was explored in the cost benefit analyses undertaken during the standard’s development process.

Cost of monitoring unknown.

The cost of monitoring varies depending on whether a government funded survey is undertaken or an industry ‘due diligence’ and specific approach is adopted. The user guide canvasses different means for demonstrating compliance – refer to the following link on the NZFSA website

http://www.nzfsa.govt.nz/processed-food-retail-sale/bakery-products/mandatory-user-guide/page-06.htm

There has been a two year lead time to prepare implementation.

Two years is more than is usually provided as a transitional period for amendments to the Code. The two year period was set to mitigate some of the industry cost and ensure there was adequate time to prepare for the Standard’s commencement.

Cost information provided by the industry cannot be trusted. Further information on costs could be obtained from other countries.

NZFSA believes that New Zealand is the only country that is mandating the fortification of bread, hence the lack of information on costs. Other countries (including Australia) are fortifying flour. The costs are therefore not comparable.

Industry has not had major objections to the costs associated with mandatory fortification and is not using this to request an end to mandatory fortification.

Noted.

Industry would save $10 million from application and compliance requirements if flour was fortified and not bread.

NZFSA and FSANZ met with both the New Zealand Flour Millers and the New Zealand bread manufacturers during the development of the mandatory folic acid fortification standard. The New Zealand Flour Millers made it very clear that the cost of providing the infrastructure to add folic acid to flour would effectively put them out of business. Thus the New Zealand government supported the option to add folic acid to bread during the bread making process.

Segal review didn’t endorse mandatory fortification as most cost effective option.

Noted.

Bread product brand is built on no additives, no preservatives, no emulsifiers but cost of being organic is too high.

The circumstances are the same for all brands of bread (other than organic) with mandatory fortification.

Wasted packaging is contrary to the principles of the packaging accord.

The two year transitional period was designed to take this into account.

Anticipated costs appear high compared to US.

Costs are not directly comparable because in the US, flour is fortified.

It is cheap to fortify.

The costs involved not just fortification but also include packaging changes, monitoring and verification.

Key Issues

NZFSA response

Uncertainty about ability of bakers to ensure each loaf of bread produced in plants throughout New Zealand will be able to meet upper and lower level of standard.

This is acknowledged and NZFSA worked with industry during the development of the standard to ensure that industry would be able to meet the proposed levels noting that a range is provided to allow for variation between loaves.

Ability of industry to meet the level required by the folic acid standard.

NZFSA consulted with industry during the development of the standard to ensure that industry would be able to meet the proposed levels. Indications at the time were that the proposed levels were achievable.

Subsequent to the standard being gazetted, industry has indicated that further testing of folic acid levels in fortified bread has shown that it is more difficult than first thought to achieve these levels for every slice and loaf of bread. However it is not expected that each slice will have the same level of folic acid. It is expected that over a number of slices the level of folic acid will meet the level required by the Standard.

What systems are in place for measuring folic acid distribution in bread?

NZFSA conducts auditing, verification and compliance surveys on standards as appropriate. Industry is generally given time to accommodate and comply with a new standard before any such NZFSA activity is undertaken.

Folic acid is water soluble so should not present a significant difficulty with uneven distribution being surprising.

For technical reasons, the vast majority of folic acid will be added as a dry ingredient in pre-mixes.

Industry was quoted in the Final Assessment Report as saying that mandatory fortification would not present a burden to industry – what has changed.

Industry opposition is not solely on cost grounds.

New Zealand bakers have additional opportunities to add folic acid at milling or bread making stage.

Agree - provided the bread meets the required level of fortification, the Standard does not does not restrict where in the processing chain the fortificant might be added.

Australian wheat and flour is imported into New Zealand which will be fortified.

Australian wheat is already imported into New Zealand. This will not be fortified. Where flour is imported for use in bread production, manufacturers will have to accommodate this and ensure they continue to meet the New Zealand Standard.

Adding iodised salt doesn’t appear to be an issue for bread manufacturers.

Agree - industry has not raised any concerns regarding the addition of iodised salt to bread.

If bakers cannot ensure even distribution of folic acid how can they meet the requirements to make health claims for omega 3 and other additives

Bakers already add other additives successfully.

The addition of other beneficial food additives generally does not require a range to be met and in the main there are no levels for these additives in the Code.

Mandatory fortification is for therapeutic benefit and the level in bread would make it a therapeutic product.

Folic acid is a permitted vitamin in food. The addition of vitamins and minerals to the food supply is not generally considered to be for a therapeutic purpose.

Difficulty for ‘craft’ bakers to get correct level.

Acknowledged. NZFSA is working with the baking industry to assist with implementation.

Testing methods still questionable.

Industry is working with laboratories and progress is continuing to be made with testing methods.

The industry has already done the work to meet the required range.

Noted.

Key Issues

NZFSA response

Option 1 is the most effective means in achieving public health goals.

Mandatory fortification is only one part of the overall public health approach that includes a range of health promotion strategies and folic acid supplementation.

Delaying decision will only mean more babies will be born with NTD affected pregnancies.

If the mandatory fortification regime is successful, delaying the decision will impact on the reduction of NTD affected pregnancies.

The issues have been thoroughly analysed, there is no new information.

FSANZ processes were robust. On the available evidence, including overseas experience with mandatory fortification, the proposed level of fortification does not pose a risk to public health and safety. The level was set to minimise any potential health risks that might emerge in the future particularly for the non-target population.

The targeted population will have to eat 11 slices of bread to obtain sufficient levels to prevent NTD affected pregnancies.

Fortification is only one part of an overall public health approach to reduce NTD affected pregnancies.

Fortification was never intended to be the sole source of folic acid for the target population (women aged between 16-44 years).

The level of fortification set in the Standard is 135 micrograms of folic acid for every 100 grams of bread. This is equivalent to about 2-3 slices of bread per day which in itself will deliver a clear health benefit.

The 11 slices of bread is equivalent to taking 400 micrograms of folic acid. 400 micrograms was chosen to illustrate the point that the most reliable evidence for the prevention of NTD affected pregnancies suggests 400 micrograms is the optimum level of folic acid and could reduce NTD affected pregnancies by 70%.

Is bread the most suitable vehicle?

The FSANZ development process thoroughly canvassed a full range of food vehicles for mandatory folic acid fortification. Based on the criteria of wide consumption by women of child bearing age as well as technical feasibility; milk and milk products and bread and bread products were considered the most suitable food vehicles for mandatory fortification. However, due to the high consumption of milk by young children relative to adults, bread was considered to be more suitable.

Not introducing the Standard will put the health services under severe financial strain – implications for other services.

Not introducing the Standard would potentially mean that health services would not see the financial benefits of the expected reduction in the number of NTD affected pregnancies.

The costs associated with NTD affected pregnancies were assessed by FSANZ.

Status quo could bring a false sense of security for women preparing for pregnancy and they may not take additional folic acid.

Mandatory fortification is only one part of an approach to reduce the risk of an NTD affected pregnancy. Other initiatives that are currently in place will remain - for example, the Ministry of Health website states the following:

Daily folate requirements increase substantially for pregnant and breastfeeding women and therefore they are recommended to consume around 600 and 500 mcg of folate each day, respectively.

http://www.moh.govt.nz/moh.nsf/pagesmh/3184#folate3

The Ministry of Health website also addresses the question will women planning a pregnancy still need to take a folic acid supplement with mandatory folic acid fortification?

Women planning a pregnancy will still need to take a daily dose of folic acid after September 2009 when bread is mandatorily fortified. This dose will either be a low dose of at least 400 mcg day, or a high dose of 5 mg day of folic acid, depending on the perceived risk of having a NTD affected pregnancy. The supplements would need to be taken for at least a month before conception and 12 weeks after conception. The Ministry of Health is working with PHARMAC to secure a subsidised 400 mcg tablet.
http://www.moh.govt.nz/moh.nsf/pagesmh/3184#women

Blunt instrument to target such a small proportion of the population.

Fortification of bread was chosen to reach those women for whom pregnancies are unplanned. Other initiatives such as education programmes and voluntary fortification have not been demonstrated to be effective on their own.

Status quo reaches all regardless of ethnicity, and socio-economic status (Maori are disproportionately represented in NTD affected pregnancies).

This was a key factor during the development of the Standard and the decision to adopt it.

84% of consumers are against mandatory fortification.

This is consistent with submissions received if those representing the interests of industry, public health and science are not counted as consumers.

Consumer opposition is driven by misinformation

Misinformation driven by public relations campaign.

Submissions against mandatory fortification have used the same terms as used in the media and quoted by industry.

Key Issues

NZFSA response

Concern with process of decision making not being through government.

The statutory process for giving lawful effect to food standards is set out in Part 2A of the Food Act 1981. It provides for the Minister to issue the food standard, subject to a number of procedural requirements relating to notification and consultation. This mechanism allows for flexibility but has checks and balances associated with it. Food standards have the additional check of being a deemed regulation, which means they must be tabled in Parliament and are subject to the scrutiny of the Regulations Review Committee.

Concerns about meeting legal requirements for decision making.

NZFSA is of the view that all relevant procedural requirements set out in the Food Act are being followed in the current process. NZFSA also considers that administrative law principles are being followed.

Years of work undone in three weeks.

The Minister has not yet made a decision as to which of the three options will be implemented.

Indemnity for bakers and bakery owners if there is ever any litigation resulting from complications attributed to manufacture of folic acid.

The Public Finance Act 1989 provides for the Minister of Finance to offer an indemnity “if it appears to the Minister to be necessary or expedient in the public interest to do so”.

Possible breaches of the Human Rights Act relating to mass medication and other rights.

NZFSA is of the view that folic acid is a nutrient that has a health benefit. It is not a medication. NZFSA does not agree that there is a potential breach of rights.

Key Issues

NZFSA response

We do not want anything put into our bread.

NZFSA acknowledges that consumers are concerned about what goes into their bread. It should be noted that folic acid is a vitamin.

We do not want anything put in our bread - the ‘natural’ debate.

Organic bread will be exempt from mandatory fortification with folic acid, providing consumers the option to purchase unfortified bread as well. There are currently certification criteria for organic products but none for food products called ‘natural’.

Having to buy organic bread is not a choice – it is too expensive for most New Zealanders. People do not have time to make their own bread.

Bakers should be able to provide choice.

In the debate over whether consumers should have choice (ie voluntary fortification) versus the benefits of achieving public health goals with mandatory fortification, the benefits to public health as a result of mandatory fortification were assessed as outweighing the limitation of consumer choice.

We will make our own bread.

Noted. The Standard provides for bread to be fortified as opposed to flour. This initiative allows consumers to make their own, unfortified bread.

Key Issues

NZFSA response

Standard development process is potentially undermined by a decision to not go ahead with the Standard.

The power to give lawful effect to the food standard is given to the Minister under the Food Act 1981.

We should be able to set our own food standards not like the current arrangement that sees this ability dominated by Australia.

Since New Zealand joined the trans-Tasman food standards system there have been two reviews of the impact of joining. Both reviews have identified substantial benefits from the joint system.

New Zealand has the ability to set its own standards in relation to matters that are outside the scope of the Food Treaty or that relates to matters that are an exception to it (a process that is provided for in the Treaty).

Consider the issue of alignment between Australia and New Zealand is of no relevance in a domestic based bakery especially given very little bread exchanged between the countries.

New Zealand and Australia share a joint food standards system. It is important to minimise the differences between the two countries to the extent possible.

Key Issues

NZFSA response

Baking Industry is promising to do some work around increasing the variety of breads available with folic acid if the Standard is not implemented next month. Industry meeting planned for 25 August 2009.

Noted.

The uptake of voluntary fortification of bread in New Zealand has been low.

Noted.

Education programmes should be introduced.

The evidence suggests this needs to be combined with fortification and supplementation to be effective.

NZFSA notes that no matter which option is supported, submitters indicated they supported education programmes.

Education programmes do not work.

The evidence suggests education programmes need to be combined with fortification and supplementation to be effective.

Target population should be advised to take folic acid tablets.

The target population are and will continue to be advised (via web and health professionals) to take folic acid tablets but this can never be 100% effective because evidence has shown that 50% of pregnancies are unplanned.

Advising target population to take folic acid tablets alone has been shown not to work as 50% of pregnancies are unplanned.

The evidence suggests supplementation needs to be combined with fortification and education.

Target group should be encouraged to eat foods known to be high in folate.

The target population is encouraged to consume foods high in natural folates in conjunction with taking a folic acid supplement and consuming folic acid fortified foods.

Ref: Ministry of Health (2008) Food and Nutrition Guidelines for Healthy Pregnant and Breastfeeding Women.

Should have food labelling in relation to what’s fortified and what’s not.

The food label must list all ingredients in the product. These can be found in the ingredients list and sometimes also in the Nutrition Information Panel (NIP).

NZFSA should provide enhanced education

on folic acid.

Both the Ministry of Health and NZFSA provide information on their websites.

Key Issues

NZFSA response

Concern that the issue of cancer was not addressed in the consultation document. The public health and science community was critical of NZFSA and the Minister for not defending the standard or rebutting the claims of cancer. Industry and consumers were critical that cancer concerns were not discussed in the document and were not listed as a disadvantage to the status quo option.

The FSANZ Final Assessment Report and First Review Report were referenced in the discussion document. These reports thoroughly canvassed potential risks. NZFSA has not disputed the FSANZ assessments. It should be noted that FSANZ and NZFSA continue to monitor the science.

FSANZ has provided NZFSA with an up to date summary of emerging evidence on health outcomes. This document is attached.