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Final Assessment Report Proposal P230

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12 February 2008 [1-08] FINAL ASSESSMENT REPORT PROPOSAL P230 CONSIDERATION OF MANDATORY FORTIFICATION WITH IODINE FOR NEW ZEALAND For Information on matters relating to this Report or the assessment process generally, please refer to http://www.foodstandards.gov.au/standardsdevelopment/ Executive Summary This Final Assessment Report considers mandatory fortification with iodine as a means of addressing the re-emergence of iodine deficiency in New Zealand. Iodine deficiency such, as that reported in New Zealand, has can have a negative impact on mental and nervous system development in children, and increases the risk of some forms of hyperthyroidism, especially in the elderly. In May 2004, the Australia and New Zealand Food Regulation Ministerial Council (Ministerial Council) requested that Food Standards Australia New Zealand (FSANZ) give priority consideration to mandatory fortification with iodine. In response, FSANZ prepared this Proposal (Proposal P230). In October 2005, the Ministerial Council noted the advice of the Australian Health Ministers’ Advisory Council and Australian Health Ministers’ Conference that mandatory fortification with iodine is an effective public health strategy subject to clinical safety and cost- effectiveness. FSANZ was asked to progress consideration of mandatory fortification with iodine as a matter of priority and on this basis has expedited this process. In September 2007, FSANZ was advised that Australian Health Ministers were re-evaluating the evidence on the prevalence and severity of iodine deficiency in Australia, and that FSANZ should defer its consideration of mandatory iodine fortification for Australia until further advice is received. In addition Health Ministers noted that the situation in New Zealand presents a significant health problem, and that mandatory fortification with iodine is considered the most effective strategy to address it. While the severity and prevalence in Australia is being further considered, a separate standard for New Zealand was suggested, using the provisions in the Agreement between the Government of Australia and the Government of New Zealand Concerning a Joint Food Standards system (the Treaty) Annex D(I) which state: (1) Where the analysis or consultation undertaken by the Authority in the preparation of a food standard indicates that for exceptional health and safety or environmental reasons separate food standards will be required for New Zealand and Australia, the Authority shall approve food standards that relate to each Member State and notify those standards to the Council. The New Zealand Government subsequently asked FSANZ to develop a separate Standard for New Zealand. The Government also notes that there is clear evidence of population-wide iodine deficiency in New Zealand and that the seriousness of the iodine deficiency in New Zealand satisfies the criteria for exceptional health and safety reasons allowing the development of a New Zealand only standard in accordance with Annex D(1) of the Treaty. In light of this advice FSANZ was satisfied that exceptional health and safety reasons exist that require the development of a separate standard for New Zealand, while the Australian situation is being further investigated. FSANZ has therefore prepared this Final Assessment Report approving a Standard for mandatory fortification with iodine for New Zealand only under Annex D(1) of the Treaty. ii The Decision The mandatory replacement of non-iodised salt with iodised salt in breads is the preferred option to address the re-emergence of iodine deficiency in New Zealand. The salt iodisation level is to be in the range of 25-65 mg of iodine per kg of salt. Bread represented as organic are to be exempt from this requirement. The voluntary permission for iodine in iodised salt and reduced salt will be retained at the current range of 25-65 mg per kg, to be consistent with the mandatory requirement. Reasons for the Decision Amendments to the Australia New Zealand Food Standards Code (the Code), outlined in Attachment 1, are approved for the following reasons: • Replacement of non-iodised salt with iodised salt in bread would address iodine deficiency across much of the New Zealand population, and prevent it from getting even more serious in the future. • Replacement of non-iodised salt with iodised salt in bread is technologically feasible and well tested internationally. • Use of iodised salt to reduce the prevalence of iodine deficiency is consistent with international guidance and experience. • The Tasmanian voluntary program using iodised salt in bread, at an average of 45 mg iodine per kg salt, led to an improvement in the iodine status of a mildly deficient population. • Based on the available evidence, including overseas experience with mandatory fortification, the proposed level of fortification does not pose a risk to general public health and safety. The level has been set to minimise any potential health risks. In groups that are generally more sensitive to increases in iodine intake, e.g. individuals with existing thyroid conditions, the risk of a negative impact on health is still considered to be very low. • FSANZ considers that this Proposal would deliver net-benefits to New Zealand. Mandatory fortification with iodine will provide important benefits to the New Zealand population. This benefit compares well with a small ongoing cost of fortification of around three cents per person each year. • The Centre for Health Economics Research and Evaluation (CHERE) assessed this Proposal in terms of cost-effectiveness ratios. CHERE concluded that in terms of cost- effectiveness ratios, the cost of reducing the risk of iodine deficiency disorders appears small compared with the potential benefits associated with improved health, reduced health care costs and/or gains in productivity and GDP. • It is consistent with Ministerial policy guidance on mandatory fortification. iii Monitoring is considered an essential component of implementing this Proposal consistent with Ministerial policy guidance. It will provide a means of ensuring the ongoing effectiveness and safety of this strategy to sustain reductions in the prevalence of iodine deficiency in New Zealand. Consultation FSANZ received a total of 68 written submissions in response to the Draft Assessment Report for this Proposal during the public consultation period from 18 August to 18 September 2006. At Draft Assessment, FSANZ’s preferred option was the mandatory replacement of non-iodised salt with iodised salt in bread, breakfast cereals and biscuits for both Australia and New Zealand. The majority of submissions from government, health professionals, and consumer organisations supported the preferred option of mandatory fortification. Many public health professionals were concerned that the preferred option does ‘not go far enough’ in increasing iodine intakes. They believe FSANZ has been overly constrained by not wishing to exceed the Upper Level of Intake (UL) for young children. Overall, submitters considered that the small manageable risks associated with mandatory fortification were outweighed by the public good. The majority of industry submitters opposed mandatory fortification, preferring a voluntary approach. Due to the unavoidable delay in finalising this Proposal, FSANZ released an Issues Paper in May 2007 for a four-week consultation period. The paper addressed the major issues that arose from submissions to the Draft Assessment and outlined the proposed changes under consideration for the Final Assessment, especially the removal of breakfast cereals and biscuits as food vehicles. FSANZ received 48 comments in response to the Issues Paper. At that time, the majority of government stakeholders, public health professionals and consumer groups indicated support for the mandatory fortification Proposal. There was general acknowledgement of the inability of this Proposal to fully meet the substantially increased iodine requirements of pregnant and lactating women given the desire not to bring about exceedance of the UL for iodine in young children. Some stakeholders still viewed this mandatory fortification Proposal as an initial step and only ‘part of the solution’, but noted that mandatory fortification is preferable to voluntary fortification as it provides greater certainty, sustainability, equity, and reach. A few public health professionals believed that Universal Salt Iodisation (USI) would provide higher iodine intakes for pregnant and lactating women. Consumer organisations were generally supportive of the Proposal but noted the need for effective monitoring and education/health promotion strategies. Most industry stakeholders continued to oppose mandatory fortification citing the increased regulatory burden, costs to industry, removal of consumer choice, and trade impacts as reasons for their opposition. They considered mandatory fortification was not the most effective public health strategy and stated a strong preference for voluntary fortification. Industry considered that international studies and the Tasmanian results demonstrate the success of voluntary fortification in decreasing iodine deficiency. iv Issues identified from public submissions and consultations formed the basis of further targeted consultation with key stakeholder groups . FSANZ commissioned a number of consultants and experts to consult with industry regarding issues raised during consultations. FSANZ also involved the Fortification Standards Development Advisory Committee (SDAC) to help identify
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