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Proposal P295 – Mandatory Fortification with Folic Acid – Issues Paper

18 April 2007

Dear Sir/Madam

Thank you for the opportunity to comment on this issues paper. The following sets out the comments of the New Zealand Food Safety Authority (NZFSA), Ministry of Health (MoH), Ministry of Economic Development (MED), Ministry of Consumer Affairs (MCA) and the Commerce Commission. For ease of reading comments have been listed under the chapter headings.

Options for addressing NTDs (Chapter 2)

The Review Report must clearly state that the New Zealand MoH recommendation for New Zealand women capable of or planning a pregnancy is 800 mcg folic acid per day for at least four weeks before and 12 weeks after conception.

Effectiveness and safety of mandatory fortification (Chapter 3)

Children’s modelling

We continue to have concerns that 13.8% of New Zealand males aged 5-8 years and 8.2% of New Zealand females aged 5-8 years are going to exceed the upper level of intake (UL) for folic acid added at 135 mcg per 100g bread. Adjusting for a second 24-hour recall would reduce the percentage of New Zealand children exceeding the UL. We accept that the UL has a five fold safety factor built in and that low vitamin B12 is a condition that affects the elderly. However we continue to challenge the appropriateness of adopting ULs but then ignoring the results when a significant portion of a non-target group exceeds the UL.

The percentage of New Zealand children exceeding the UL was calculated using average voluntary and mandatory permissions. This is a concern we have expressed repeatedly in this area – that it would have been more informative to have included an estimate of the percentage of New Zealand children exceeding the UL based on maximum uptake of voluntary permissions and potential overages. The USA experience found higher than expected overages after mandatory fortification was implemented. If the same overages occur in New Zealand it would further increase the proportion of New Zealand children exceeding the UL. Results from the 2005 ESR report “Fortification Overages of the Food Supply – Folate and Iron”, prepared as part of a NZFSA contract for scientific services, indicate that voluntarily fortified foods could contain anything from less than one third and up to three times more of the average amount declared for folic acid on the label.

Mandatory fortification will expose the bread eating population to higher than what is currently considered normal intake of folic acid. In addition the population will be exposed to the synthetically manufactured folic acid rather than naturally occurring folate. The long term effects of this exposure is unknown therefore it is vital that the monitoring framework takes this into account.

Dietary intake assessments (Chapter 4)

The issues paper refers to the differences between the assessments for Australian and New Zealand children being due largely to different methodological approaches. We agree that there were differences in the methodology but we believe that the differences between the assessments could be due in part (how much we do not know) to different food choices and time of the year the data are collected. The Australian data were collected in 1995 and the New Zealand data in 2002 so there is scope for consumption patterns as well as the different consumption patterns between Australia and New Zealand children to change over that seven year period.

References to weighting of the New Zealand children’s data should also mention that this probably has no effect on the dietary modelling. It should be noted that the New Zealand data had to be weighted because the original sample had equal numbers of Maori, Pacific children and New Zealand European origin children. These groups have different food choices, particularly the Pacific children so the data would be meaningless as a population average unless they were weighted. Without this explanation, use of ‘weighting’ might otherwise be given undue attention.

There is a significant difference between the baseline folic acid intakes of the Australian and New Zealand populations. A fuller explanation of why the New Zealand baseline is so much lower and identification of which food groups were more highly fortified in Australia would be useful.

We question the appropriateness of using Australian data to update consumers’ food consumption patterns to validate the 1997 New Zealand NNS data. We believe that New Zealand data cannot be validated from Australian food choice data because food consumption patterns differ between the two countries.

Informing Consumers (Chapter 7)

Labelling

If no changes to labelling of unpackaged foods are planned, then ingredient and NIP information should be available at point of sale.

Nutrition Information Panel (NIP)

We do not agree with FSANZ’s conclusion that there should be no requirement for mandatory declaration of folic acid in the NIP of products mandatorily fortified with folic acid.

The objective of mandatory fortification is to increase folic acid intake in women of child bearing age to reduce the incidence of NTDs. We consider there may be a degree of complacency amongst women in the target group who may believe they are getting enough folic acid in the food they consume without having to take a supplement. Evidence from the USA indicates that folate levels in women of child bearing age are decreasing and one of the contributors is considered to be the reduction in supplement usage - a side effect of women knowing folic acid is in bread but not being aware that it isn’t enough to meet the recommended daily intake of 400 mcg. For this reason it is vital that firstly the NIPs contain this information so that some information on levels is available to women, and secondly that there is a strategy in place to inform the target population of the on-going need to take a folic acid supplement in addition to voluntary and mandatory fortification.

Some women may want to calculate their folic acid intake and for this reason we recommend that the amount of folic acid should be made mandatory in the Nutrition Information Panel (NIP) when it is added to bread and not just a requirement when making a nutrition claim for folate on those products. The requirement to declare folic acid in the ingredient list will not be sufficient for women to be able to calculate the amount of folic acid they are getting from fortified foods and thus the level of supplementation required to reach the optimum level of 400 mcg of folic acid a day. Under the FSANZ proposal for New Zealand the level of folic acid will be the same for all bread types therefore it would not be difficult to determine the amounts. This would be the same level required to comply with the standard proposed at FAR.

The Commerce Commission advises that it is looking further at the issue of non-disclosure of folic acid in the NIP with regard to whether it is potentially misleading to consumers who might expect that information to reflect what is in the product.

MED agrees that having folic acid in the NIP would be useful to some consumers but it will impose a cost to industry that may or may not outweigh the benefit to consumers.

The Ministerial Policy Guidelines for mandatory fortification state that “consideration should be given, on a case by case basis, to a requirement to include information in the Nutrition Information Panel” and it would therefore be consistent with the guidelines to require folic acid levels to be stated in the NIP.

We recommend that any reference to folic acid on food labels should use the term folic acid. However, when the relevant standards in the Code are reviewed in line with the 2006 Nutrient Reference Values for Australia and New Zealand the term dietary folate equivalents (DFEs) could be introduced into NIPs. We support this review taking place as soon as possible.

Organic exemption

We support the proposal that foods represented as organic be exempted from mandatory folic acid fortification. This will provide consumers with a greater level of choice if they do not wish to consume folic acid fortified, leavened bread. However, we would like FSANZ to be more specific in the provision to exempt breads made under or aligned with an organic certification agency or a recognised agency (recognised by the relevant competent authority). This would accommodate the range of certified standards available for organic produce in New Zealand and assist with compliance and enforcement issues.

A targeted information programme will need to be developed for consumers of organic bread to ensure they are aware that the product does not contain folic acid what the implications of this might be for them.

Implementation and transition (Chapter 8)

We support the proposed two year transition period for two main reasons:

1) This will co-ordinate better with the proposed timing of the New Zealand Adult Nutrition Survey (2008) and may therefore enable the collection of baseline folate intake and status in the New Zealand population prior to implementation. However, it will be important for industry to keep the MoH and NZFSA informed as to the timing of the uptake of mandatory fortification because any overlap with the survey will have implications for interpreting folate intake and status levels; and

2) Implementing mandatory folic acid fortification at the same time as mandatory iodine fortification will reduce re-labelling costs for industry.

Monitoring, communication and education

Monitoring

NZFSA and MoH will have joint responsibility for monitoring mandatory folic acid fortification in New Zealand. It is important that both these organisations are kept informed on the monitoring agreed to be undertaken in Australia to facilitate comparisons in the future wherever possible. The ideal situation would be for New Zealand and Australia to agree to, and use, the same monitoring framework. However if this is not possible it would still be valuable if New Zealand could be invited to participate in any discussions around Australian monitoring developments to ensure there is as much harmonisation as possible.

Communication and education

We look forward to working with FSANZ on the development and implementation of an education programme targeted to the New Zealand population, which will focus on educating people about the new standard. We believe that a number of strategies will be required to ensure that both women in the target group and industry receive the correct information in an appropriate and timely way.

Finally just a couple of editing points that require attention:

• The term ‘Pacific children’ or for adults ‘Pacific peoples’ should be used not ‘Pacific Islander’; and

• LINZ should be referred to as LINZ Research group

We look forward to the conclusion of this work.

Yours sincerely