The Addition of Vitamins and Minerals to Food-type Dietary Supplements. NZFSA Public Information Paper; no. 09/08

Transcription

1 The Addition of Vitamins and Minerals to Food-type Dietary Supplements NZFSA Public Information Paper; no. 09/08 25 July 2008

2 [Online] ISSN number ISBN number [Print] ISSN number ISBN number

3 IMPORTANT DISCLAIMER Every effort has been made to ensure the information in this report is accurate. NZFSA does not accept any responsibility or liability whatsoever for any error of fact, omission, interpretation or opinion that may be present, however it may have occurred. Further copies Requests for further copies should be directed to: New Zealand Food Safety Authority P O Box 2835 WELLINGTON Telephone : (04) Fax : (04) Website A copy of this document can be found at 1

4 Executive Summary The objective of this paper is two-fold. Firstly, to identify and characterise the risk presented to the New Zealand consumer from the addition of vitamins and minerals to food-type dietary supplements and secondly to make recommendations on the appropriate addition of vitamins and minerals to foodtype dietary supplements. The New Zealand Food Safety Authority followed general principles for setting maximum quantities per daily serving, taking into account upper levels of intake for vitamins and minerals established by scientific risk assessment and taking into consideration the varying degrees of sensitivity of different consumer groups and the daily intake of vitamins and minerals from other dietary sources. When considering permissions for the addition of vitamins and minerals to food-type dietary supplements, it was the New Zealand Food Safety Authority s aim to mitigate the risk of the individual consuming these nutrients from all sources in amounts that may cause them to routinely exceed known upper levels of intake. The New Zealand Food Safety Authority considered two risk management approaches: Approach A considered weighted permissions for the addition of vitamins and minerals based on the highest mean intake and the upper level of intake for the vitamin or mineral Approach B considered a universal level for the addition of vitamins and minerals. This was set at 50% of the upper level of intake for adult males. In both approaches restrictions on the addition of vitamins and minerals would not be set if an upper level of intake did not currently exist. Approach B is preferred by the New Zealand Food Safety Authority as it provides a simplified risk management process but nevertheless still attempts to fulfil the aim that the potential sum of intakes from all sources does not exceed the established upper level of intake. As such, the New Zealand Food Safety Authority favours Approach B. Following the establishment of proposed permissions for vitamins and minerals, a safety check found that in setting permissions at 50% of the upper level of intake for adult males, there was a potential risk that children 8 years consuming the maximum quantity per daily serving for the food-type dietary supplements could exceed their age-sex specific upper level of intake for a range of vitamins and minerals. As such, Approach B has been amended to propose that food-type dietary supplements specifically marketed for children should be manufactured to conditions where a maximum quantity per daily serving does not exceed 50% of the age-sex specific upper level of intake for a child 8 years. 2

5 Table of Contents Executive Summary Introduction Objectives Current Regulatory Framework Policy Guideline Fortification of Food with Vitamins and Minerals Standard Preliminary Provisions: Application, Interpretation and General Prohibitions Standard Vitamins and Minerals Standard Formulated Supplementary Sports Foods Dietary Supplement Regulations Policy Guidelines and Regulation in Other Countries Codex Alimentarius European Union Health Canada Estimated Consumption of Food-type Dietary Supplements Addition of Vitamins and Minerals to Food-type Dietary Supplements Upper Levels for Vitamins and Minerals Assessing and Categorising Nutrient Risk Vitamins and Minerals from Food Vitamins and Minerals from Dietary Supplements Changes in Nutrient Intake over time Risk Management Approach Approach A Weighted Permissions Approach B Universal Permissions Preferred Approach Safety of Vulnerable Population Groups...21 Useful Definitions...28 References

6 1 Introduction Some industry groups, health professionals and members of the public argue that optimal health may depend on higher levels of vitamins and minerals than those recommended today on the basis of estimated average requirements (EARs). As a result products that contribute to the intake of vitamins and minerals beyond levels that would be provided by the natural content of foods have increased considerably on the New Zealand market 1. These may be food supplements but also foods to which vitamins and minerals have been added. The Australia New Zealand Food Standards Code (the Code) does not adequately capture these highly fortified foods, as such businesses are often choosing to manufacture and market these foods under provisions set out in the New Zealand Dietary Supplement Regulations 2,3. These regulations include compositional and labelling requirements quite different from those in the Code. The New Zealand Food Safety Authority (NZFSA) is creating a New Zealand Standard that captures these highly fortified foods and attempts to align them as much as possible with aspects of the Code. As part of this process NZFSA is considering the safety of vitamin and mineral additions to these foods, with the aim of ensuring that the potential intake of vitamins and minerals from all sources should not undermine public health and safety which is NZFSA s primary role. 2 Objectives The objective of this paper is two-fold. Firstly, to identify and characterise the risk presented to the New Zealand consumer from the addition of vitamins and minerals to food-type dietary supplements (FTDS) and secondly to make recommendations on the appropriate addition of vitamins and minerals to FTDS. 3 Current Regulatory Framework Currently permissions under the Code allow the addition of a range of vitamins and minerals to specified foods at specified levels 2. Vitamins and minerals include: thiamin, riboflavin, niacin, vitamin B 6, vitamin B 12, pantothenic acid, folic acid, vitamin C, vitamin A, carotene forms of vitamin A, vitamin D, vitamin E, calcium, phosphorous, magnesium, zinc, iron and iodine. 4

7 3.1 Policy Guideline Fortification of Food with Vitamins and Minerals The Australia New Zealand Food Regulation Ministerial Council has provided a policy guideline on the development of permissions for the addition of vitamins and minerals to food 4. The Guideline does not apply to special purpose foods, the formulation and presentation of which are governed by specific Standards in Part 2.9 of the Code. Further, the Guideline does not apply to products that should be or are regulated as therapeutic goods. The Guideline assumes the continuation of a requirement for an explicit permission for the addition of a particular vitamin or mineral to particular categories of foods to be included within the Code, the majority of which are contained in Standard Vitamins and Minerals. The Guideline covers both mandatory and voluntary fortification. The Guideline states that the voluntary addition of vitamins and minerals to food should be permitted only: where there is an actual clinical or sub-clinical evidence of deficiency or by data indicating low levels of intake, or where data indicates that deficiencies in the intake of a vitamin or mineral in one or more population groups are likely to develop because of changes taking place in food habits, or where there is generally accepted scientific evidence that an increase in the intake of a vitamin and/or mineral can deliver a health benefit, or to enable the nutritional profile of foods to be maintained at pre-processing levels as far as possible after processing (through modified restoration), or to enable the nutritional profile of specific substitute foods to be aligned with the primary food (through nutritional equivalence). 3.2 Standard Preliminary Provisions: Application, Interpretation and General Prohibitions Standard sets out the preliminary provisions which apply to the Code 2. It includes the permitted forms of vitamins and minerals, reference to recommended dietary intakes (RDIs) and estimated safe and adequate daily dietary intakes (ESADDIs) for vitamins and minerals as well as reference to the source document for these figures. Recommended dietary intakes or ESADDIs are provided for adults 19+ yrs and children aged 1-3 yrs. The source document referred to in the Code is the National Health and Medical Research Council s (NHMRC) 1991 publication of RDIs 5. Although still officially applying 5

8 to the Code, this document was officially rescinded by the NHMRC in 2005 to be replaced by the more current Nutrient Reference Values for Australia and New Zealand including Recommended Dietary Intakes ( Standard Vitamins and Minerals Standard regulates the addition of vitamins and minerals to foods, and the claims which can be made about the vitamin and mineral content of food 2. The Standard provides prescription on the maximum claim per reference quantity of food type as a proportion of the RDI. These claims seldom exceed 50% of the RDI but are typically 15-25% of the RDI depending on the food type. Maximum permitted quantities of vitamins and minerals are also specified for select food groups including dairy products, edible oil and spreads, analogues derived from legumes and analogues derived from cereals. Source claims in relation to the presence of a vitamin or mineral may be made where at least 10% of the RDI or ESADDI for the vitamin or mineral is present in the food (either from naturally occurring or added sources). A claim that a food is a good source of a vitamin or mineral can only be made when that food contains no less than 25% of the RDI or ESADDI for that vitamin or mineral. 3.4 Standard Formulated Supplementary Sports Foods Standard regulates the composition and labelling of specially formulated foods to assist sports people in achieving specific nutritional or performance goals 2. The Standard provides prescription on the maximum claim per one day quantity as well as maximum amount per one day quantity. Products complying with this Standard must include statements to the effect that The food is not a sole source of nutrition and should be consumed in conjunction with a nutritious diet, The food should be used in conjunction with an appropriate physical training or exercise program, and Not suitable for children under 15 years of age or pregnant women: Should be used under medical or dietetic supervision. The Standard also provides scope for the addition of other forms of vitamins and minerals not previously captured under Standard or Standard Note that this Standard is currently on hold for review pending policy guidance on the intent of Standards in 2.9 of the Code. 3.5 Dietary Supplement Regulations These regulations set out the compositional and labelling provisions for dietary supplements sold in New Zealand 3. Dietary supplements in this context are interpreted as any amino acid, edible substances, foodstuffs, herbs, minerals, synthetic nutrients, and vitamins sold singly or in mixtures in controlled dosage forms. Permissions for vitamins and minerals are generally set such that a 6

9 maximum daily dose does not exceed the maximum level specified in the current edition of Recommended Dietary Allowances published by the US Academy of Sciences. 4 Policy Guidelines and Regulation in Other Countries 4.1 Codex Alimentarius Codex Alimentarius has not established a specific standard for FTDS although general guidelines have been developed for the addition of vitamins and minerals to foods and food supplements. Codex General Principles for the Addition of Essential Nutrients to Foods (1991) propose that the addition of vitamins and minerals to general purpose foods and special purpose foods should not be permitted where no adequate nutritional rationale can be provided 7. Regulatory principles that are elaborated in accordance with this Guideline aim to prevent the indiscriminate addition of essential nutrients to foods, thereby reducing the risk of health hazards due to essential nutrient excesses, deficits or imbalances. Specifically, the four basic principles whereby essential nutrients may be added to foods are for the purposes of restoration, nutritional equivalence of substitute foods, fortification and ensuring the appropriate nutrient composition of a special purpose food. More recently Codex published Guidelines for Vitamin and Minerals Food Supplements (2005) 8. Food supplements in this guideline are those marketed in forms such as capsules, tablets, powders, solution etc., that are not designed to be in conventional food form. This Guideline covers the composition, content, packaging and labelling of food supplements. It suggests that the content of vitamins and minerals per daily portion of consumption should not exceed 15% of the RDI as determined by the Food and Agricultural Organisation (FAO) and the World Health Organisation (WHO). Maximum amounts of vitamins and minerals per daily portion as recommended by the manufacturer are set taking into account the upper levels of intake (UL) and daily intake of vitamins and minerals from other dietary sources. Further when the maximum levels are set, due account is taken of reference intake values of vitamins and minerals for the population. 4.2 European Union In the European Union, European Parliamentary Directive 2002/46EC on the approximation of the laws of the Member States relating to food supplements seeks to control the addition of vitamins and minerals to the food supply 9. In the Directive, food supplements refer to foodstuffs marketed in dose 7

10 form such as capsules, tablets, pills and other similar forms, sachets of powder etc. The Directive establishes a positive list of vitamins and minerals with revision of the list on an as need basis. Article 5 of the Directive describes the risk assessment process. It notes that due consideration should be made of reference intake amounts when setting maximum levels. Maximum amounts of vitamins and minerals present in food supplements per daily portion of consumption recommended by the manufacturer shall be set, taking account of ULs, intake of vitamins and minerals from other sources, reference intakes for the population and minimum amounts needed. Further, to ensure a significant amount of the vitamin or mineral is present in the food supplements, minimum amounts per daily portion as recommended by the manufacturer shall be set. Annex 1 of the Directive defines a positive list of 13 vitamins and 15 minerals. It is worth noting that Article 10 of the Directive suggests Member States might require the manufacturers or the person placing the product on the market to notify the competent authority by forwarding it a model of the label used for the product. In 2006, Directive 1925/2006EC provided a framework and regulation for the addition of vitamins and minerals and of certain other substances to conventional foods 10. Directive 1925/2006EC borrows content from Directive 2002/46EC in setting guidance on the addition of vitamins and minerals to foods. However, as it is covering conventional foods it goes further in placing restrictions on the types of foods that vitamins and minerals may be added to, for example, vitamins and minerals cannot be added to unprocessed foods such as fruit, vegetables, meat, poultry and fish. Further, it recommends that when setting maximum amounts where reference intakes are close to the UL, the contribution of the individual products to the overall diet and the nutrient profile of the product be considered. 4.3 Health Canada In 2005 Health Canada completed a review on the addition of vitamins and minerals to foods 11. The Health Canada proposal considers the Codex General Principles for the Addition of Essential Nutrients to Foods (refer Section 4.1) as a basis for its decision-making with some adaptation in the risk assessment process. Health Canada propose that vitamin and mineral additions are only permitted for the purposes of restoration and nutritional equivalence of substitute foods. The policy defines which vitamins and minerals can be added to foods based on their level of preassessed risk. Discretionary fortification of vitamins and minerals would be based on eligible foods, nutrient risk categories and the level of addition which is scaled based on the nutrient risk profile. Nutrient risk categories currently being considered by Health Canada for the addition of vitamins and minerals to foods include: Risk category A nutrients: Those nutrients for which no UL was set because of no reports of adverse effects, and no concern expressed; and those nutrients for which a UL was set but with a 8

11 wide margin of safe intake; and those nutrients with a narrow margin of safety, but non-serious critical adverse effects. Risk category B nutrients: Those nutrients with serious adverse effects, but with low risk of excessive intake at the proposed level of addition for discretionary fortification. Risk category C nutrients (to be excluded from discretionary fortification): Those nutrients with a narrow margin of safety, and with serious adverse effects, and/or with current levels of exposure to intakes above the UL by vulnerable subgroups. Nutrients in this category are currently permitted or required to be added to a range of foods for either purposes of restoration, mandatory fortification, nutritional equivalence of substitute foods or to make a special purpose food such as a meal replacement. New or further additions for these purposes would continue to be subject to the applicable regulatory requirements. Other nutrients for which a risk category has not been assigned are proposed to be excluded from discretionary fortification for a variety of reasons Estimated Consumption of Food-type Dietary Supplements In drafting Initial Assessment Report Proposal Review of Food-type Dietary Supplements, Food Standards Australia New Zealand (FSANZ) noted that in 2001 the New Zealand market for FTDS was reflected by four broad categories that included liquids, bars, powders and others 12. Later work commissioned in 2003 reported that beverages dominated the New Zealand market with growth expected in the herbal and fruit teas segment 13. NZFSA is also aware that from 2003 the number of general fortified food products available to New Zealanders has increased, continuing a 10 year trend 1. In 2003 the number of fortified food products on the New Zealand market was approximately 472, in 2007 this had increased to just over 600 food products. For the purpose of this paper NZFSA has undertaken no formal work to accurately assess the current number and type of FTDS on the New Zealand market. NZFSA did undertake an informal rapid audit of retail stores in the Wellington Central Business District and of New Zealand web-sites promoting and distributing FTDS in May This was not an exhaustive audit and was in no way intended to capture all products currently on the market in New Zealand. Through this audit NZFSA identified approximately 35 food and beverage products from 12 different manufacturers. Information from the 9

12 rapid audit of nutritional information on the vitamin and mineral content of the food was recorded where that nutrient had an established UL. The maximum quantity per daily serving as recommended by the manufacturer was collected for all products. Where this information was not immediately available, NZFSA contacted the manufacturers to obtain the information directly. 6 Addition of Vitamins and Minerals to Food-type Dietary Supplements The key priority for the food regulatory system is to protect public health and safety. The current risk posed by the consumption of FTDS appears to be low. This could be due to the limited number of FTDS on the market, their relatively low consumption, the levels of nutrients added into FTDS and/or the fact that they are consumed by small numbers of people infrequently. It could also be that attributing a defined risk to one particular food category or more specifically a nutrient within that food matrix is extremely difficult to do, particularly with the latency of many micronutrient disorders. Generally, vitamins and minerals are the most common nutritive substances added to FTDS. They are usually added in amounts that represent a moderate to high proportion of the RDI. As discussed, maximum permissions are set in the Code for the addition of vitamins and minerals to foods 2. These are considered conservative as they are based on a percentage of the RDI generally not exceeding 50% per reference quantity as recommended by the manufacturer. In part these levels are set conservatively because of the potential adverse effects posed by the addition of large concentrations of vitamins and minerals into the food supply. These include chronic toxicity, negative interactions with other nutrients or non-nutrients, including the issue of bioavailability. Some vitamins and minerals may interfere with an individual s disease management and at high doses vitamins and minerals can have pro-oxidant effects 14. Additionally, the proliferation of fortified food products could potentially increase the number of people consuming excessive intakes of certain nutrients, particularly if these foods replace non-fortified foods in the diet. Expert groups have considered the safety of vitamins and minerals and acknowledge that the risk of potential harm differs for each vitamin and mineral and depends on the amount and form of the substance consumed, as well as the period of time over which it is consumed and the susceptibility of the individual 6,14. 10

13 6.1 Upper Levels for Vitamins and Minerals To help mitigate the risk posed by vitamins and minerals, ULs have been established for a range of nutrients deemed essential to human health (Tables 1 and 2) 6. For each nutrient, the UL unless otherwise specified, includes intake from all sources including foods, nutrients added to foods, pills, capsules or medicines. The UL is the highest average daily nutrient intake level likely to pose no adverse health effects to almost all individuals in the general population 6. The UL is not a recommended level of intake and is based on risk assessments of nutrients that involve establishment of a No Observed Adverse Effect Level (NOAEL) and/or a Lowest Observed Adverse Effect Level (LOAEL). Upper levels do not exist for all vitamins and minerals including thiamin, riboflavin, pantothenic acid, biotin, vitamin K, chromium and potassium either due to the absence of appropriate evidence or the absence of harm within the evidence. A UK Expert Group on Vitamins and Minerals has established guidance levels (GLs) for these nutrients where ULs cannot be established and these maybe useful in nutritional risk assessments 14. Much less certainty exists around the establishment of these GLs due to lack of appropriate data. The existing New Zealand Dietary Supplements Regulations (1985) also establish maximum daily doses for a small number of vitamins and minerals; these are also reported in Tables 1 and 2 3. It is unclear how the nutrient levels contained within these regulations were established. 6.2 Assessing and Categorising Nutrient Risk Vitamins and Minerals from Food NZFSA decided that it would assess the risk associated with essential vitamins and minerals where there was an identified UL reported in the NHMRC (2005) report ( 6. Other essential vitamins and minerals were not considered in the risk assessment process due in part to the absence of any NOAEL and/or LOAEL. NZFSA followed general principles for setting maximum quantities per daily serving, taking into account: upper levels of intake for vitamins and minerals established by scientific risk assessment and consideration of the varying degrees of sensitivity of different consumer groups and the daily intake of vitamins and minerals from other dietary sources 8. Components of the risk management process from the European Responsible Nutrition Alliance (ERNA) were adapted for categorising risk to the population from consuming the vitamins and 11

14 minerals 15. The Population Safety Index (PSI) was used to assess and categorise the risk associated with exposure to intakes exceeding the UL (based on calculated PSI value above or below 1.5): PSI = UL (MHI + IW) / RLV where MHI is mean highest intake, IW is intake from water and RLV is the reference labelling value 16. The PSI approach assumes that where the PSI value is higher than 1.5 the chance of exceeding the UL is low. Ninetieth percentile intakes of vitamins and minerals for adult males aged yrs participating in the 1997 Adult National Nutrition Survey (NNS97) were used as the reference group for assessment as this group is generally considered to have the highest total nutrient intake (Tables 1 and 2) 17. For essential vitamins and minerals identified in the NHMRC (2005) report, 18 had recorded ULs 6. Upper levels were not available for all nutrients. In this situation NZFSA could have used the GLs that were recommended by the UK Expert Group on Vitamins and Minerals but chose not to because of the uncertainty associated with their establishment. Quantitative assessment was possible for five vitamins and seven minerals where New Zealand dietary intake data was available (Table 3). Several factors complicated the risk assessment. Firstly, New Zealand has very little information on nutrient intakes from water. Other than geographical variations in fluoride through fluoridated water supply, vitamin and mineral intake from water is assumed to have a negligible impact on total dietary intake and was calculated as zero in the PSI equation 18. Secondly, RLVs are not well defined in the Code. As such, the average RDI or AI for adult males aged yrs was used. Finally, dietary intake at the 90th percentile was not available for vitamin D, vitamin K, choline, fluoride, molybdenum and sodium and required qualitative risk assessments using previously published reports on safety (Table 4) 6, Vitamins and Minerals from Dietary Supplements Having determined the PSI for a limited number of essential vitamins and minerals from foods, the ERNA risk management process suggests it is helpful to consider intakes from dietary supplements to determine if any population groups may be at risk of exceeding the UL. Unfortunately this type of data is not available for New Zealand consumers. National surveys have recorded dietary supplement use but not consumption. In NNS97, about onequarter of adults 15+ yrs used vitamin and mineral supplements on an occasional basis and a further 28% on a regular basis 17. More females than males reported using the supplements and highest use was reported by females yrs (69% regular and occasional use combined). Most consumers of the dietary supplements chose combinations rather than single vitamins and minerals (Table 5). A wide variety of other dietary supplements were also recorded in the NNS97. The three most commonly chosen categories included garlic preparations, oils and botanicals. It is known that supplement users 12

15 have nutrient intakes that are significantly higher from non-supplement users for specific nutrients. In males these nutrients include folate (12%), riboflavin (7%), and calcium (21%) and in females include vitamin C (12%), folate (7%) and niacin (5%) Changes in Nutrient Intake over time Ninetieth percentile intake data for vitamins and minerals with an established UL were compared across national nutrition surveys [1989 Life in New Zealand Survey (LINZ89) and NNS97] among men yrs 17,20. Data were available for five vitamins and four minerals (Table 6). Only niacin demonstrated increases greater than 10%. 13

16 Table 1. Figures used to derive Population Safety Assessments for Vitamin additions to Food-type Dietary Supplements. Nutrients Mean * 90 th percentile * RDI + UL + (DSR UL # ) Thiamin mg/d ^ Riboflavin mg/d ^ Niacin mg/d (100) Vitamin B 6 mg/d Vitamin B 12 mcg/d ^ (50) Folic Acid mcg/d (300) Vitamin A (RE) mcg/d ^^ 3000 (3000) Vitamin C mg/d Vitamin D mcg/d ** ** (25) Vitamin E mg/d Vitamin K mcg/d Choline mg/d ** ** ** ** Footnotes: * Intake data for males yrs from the NNS97 (unless otherwise specified) Levels established by the NHMRC (unless otherwise specified) 6. # Maximum daily doses described in the Dietary Supplements Regulations (1985) 3. ^ Guidance level set by the UK Expert Group on Vitamins and Minerals 14. ^^ As retinol equivalents (RE) and not only retinol. ** No data available. 14

17 Table 2. Figures used to derive Population Safety Assessments for Mineral additions to Food-type Dietary Supplements. Nutrients Mean * 90 th percentile * RDI + UL + (DSR UL # ) Calcium mg/d Phosphorous mg/d Zinc mg/d (15) Iron mg/d (24) Iodine mcg/d Selenium mcg/d (150) Molybdenum mcg/d ** ** Copper mg/d (5) Manganese mg/d ^ Fluoride mg/d ** ** 4 10 Sodium mg/d 3537^^ ** Footnotes: * Intake data for males yrs from the NNS97 (unless otherwise specified) Levels established by the NHMRC (unless otherwise specified) 6. # Maximum daily doses described in the Dietary Supplements Regulations (1985) 3. Upper bound figure from the 2003/04 Total Diet Survey 22. ^ Guidance level set by the UK Expert Group on Vitamins and Minerals 14. ^^ Estimated intakes from regional surveys reported in the Ministry of Health s Nutrition and Burden of Disease Report. ** No data available. 15

18 Table 3. Classification of Vitamins and Minerals based on potential risk of exceeding Upper Levels of Intake. Low risk of exceeding the UL PSI Potential risk at excessive intakes PSI Copper 4.5 Calcium 1.1 Folic Acid 1.6 Zinc 1.4 Iodine 6.6 Iron 3.2 Niacin 52.8 Phosphorous 1.7 Selenium 4.5 Vitamin A (retinol only) 2.4 Vitamin B Vitamin E

19 Table 4. Qualitative Risk Assessment where the Population Safety Index could not be determined 6,21. Nutrient Choline Fluoride Magnesium Molybdenum Sodium Vitamin D Vitamin K Qualitative Risk Characterisation Widely distributed in the food supply. Milk, liver, eggs and peanuts are good sources. Adverse effects from excessive intakes are rare but may include hypotension. A UL has been set at 3,500 mg/d for adults. Fluoride intakes from foods are generally quite low (< 0.05 mg/100g). Most dietary sources of fluoride will come from water in fluoridated areas, beverages reconstituted from fluoridated water and some marine fish. A UL of 10.0 mg/d is set for adults on the basis of moderate enamel fluorosis. Few reports have shown adverse effects when magnesium is consumed from food sources. However, for children and adults a LOAEL of 360 mg from nonfood sources has been established. A UL of 350 mg/d has been set for magnesium from non-food sources for all people > 8 years. Toxicity in humans results in diarrhoea, anaemia and elevated uric acid levels which can lead to gout and interfere with copper metabolism. It is assumed that the form of molybdenum will determine toxicity level, with hexavalent forms likely to be toxic at lower doses and trivalent forms safer. Upper levels have been set at 2,000 mcg/d for adults. Sodium is found in many foods as sodium chloride, sodium bicarbonate and monosodium glutamate. A UL of 2,300 mg/d has been set for adults on the basis of population studies showing low levels of hypertension. As the relationship between sodium and blood pressure is continuous and progressive further benefit can be obtained from much lower levels of sodium. A NOAEL of 1,600 mg/d is set for adults and recommended for the majority of New Zealand Adults with the co-morbidities of pre-existing hypertension and overweight or obesity. Very few foods contain significant amounts of vitamin D and blood analyses from adult surveys suggests about one in four adults have vitamin D insufficiency (defined as serum 25(OH) D < 37.5 nmol/l). A UL of 80 mcg/d has been set for adult men and women based on studies assessing vitamin D s effect on serum calcium levels leading to hypercalcaemia. The Dietary Supplements Regulation (1985) establish a maximum daily dose of 25 mcg/d. No adverse effects or UL was reported by NHMRC. Subsequent nutritional risk assessments by NZFSA have indicated that increased exposure to vitamin K for patients prescribed warfarin medication can interfere with their management. The water soluble forms of vitamin K, particularly K 3 (menadione) are more active and can be toxic at high doses in humans. Use of menadione in FTDS is therefore undesirable. 17

20 Table 5. Vitamin and Mineral Supplement use in Males Females Total Consumption Frequency % (,000) Regular consumption * 21 (269) 34 (468) 28 (744) Occasional consumption^ 21 (269) 25 (344) 23 (611) Population consuming Supplements % (,000) Multivitamin and/or mineral 14 (179) 24 (330) 19 (505) Antioxidant and other multi-nutrients 2 (26) 4 (55) 3 (80) Vitamin B complex 12 (154) 9 (124) 10 (266) Single B vitamins 0 (0) 1 (14) 1 (27) Folic acid 0 (0) 1 (14) 1 (27) Vitamin C 8 (102) 5 (69) 7 (186) Fat soluble vitamins and β-carotene 2 (26) 2 (28) 2 (54) Iron 1 (13) 7 (96) 4 (106) Calcium 1 (13) 4 (55) 2 (54) Other individual minerals 2 (26) 2 (28) 2 (54) Footnotes: * Regular includes all those who used any supplement at least once per week, during the last year. ^ Occasional includes all those who used any supplement, no more than 3 times per month, during the last year. 18

21 Table 6. Percentage change in intake of selected Vitamins and Minerals in Adult Men yrs between 1989 and ,20. LINZ89 NNS97 Absolute Percent Nutrient 90th percentile 90th percentile Difference Difference Calcium mg/d % Copper mg/d % Folic Acid mcg/d % Iron mg/d % Magnesium mg/d % Niacin mg/d % Vitamin A (RE) mcg/d % Vitamin B 6 mg/d % Vitamin C mg/d % Zinc mg/d % 19

22 7 Risk Management Approach The Addition of Vitamins and Minerals to Food-type Dietary Supplements When considering permissions for the addition of vitamins and minerals to FTDS, it was NZFSA s aim to mitigate the risk of the individual consuming these nutrients from all sources, in amounts that may cause them to routinely exceed known ULs. It was previously determined in the risk assessment that specific quantities will not be prescribed for vitamins and minerals where there was no identified UL. For managing vitamins and minerals with identified ULs NZFSA considered two risk management approaches. 7.1 Approach A Weighted Permissions NZFSA considered setting maximum FTDS levels based on several variables including the MHI and the UL for the specific vitamin or mineral 15. Maximum FTDS levels where there was a low risk of exceeding the UL were calculated as follows: For vitamins: Maximum FTDS levels = UL (MHI x 150%) For minerals: Maximum FTDS levels = UL [(MHI x 110%) + IW] Using the 90 th percentile intake of vitamins and minerals for adult males aged yrs from NNS97, this approach produced maximum FTDS levels for vitamins and minerals as reported in Tables 7 and 8. Further, for those nutrients where there was a higher risk of exceeding the UL or where precaution was determined based on qualitative risk assessment, maximum FTDS levels were set at 25% of the UL. In the case of magnesium, a UL was set for supplemental magnesium at 350 mg/d. In applying this approach to products found in the most recent rapid audit of FTDS, up to 15 of the 37 products (41%) would fail to comply with at least one of the proposed vitamin and mineral permissions. Sodium (15 products), niacin (14 products), calcium (10 products) and zinc (8 products) were the nutrients most frequently exceeding proposed permissions. There did not appear to be any single manufacturer particularly affected by the proposed vitamin and mineral permissions with a broad range of companies affected. The type of products most commonly exceeding proposed vitamin and mineral permissions were typically sports foods including powders and bars. 7.2 Approach B Universal Permissions Under this approach a universal level of 50% UL was applied to all vitamins and minerals (Tables 9 and 10). Applying this approach, up to 6 of the 37 products (15%) found in the most recent audit would fail to comply with at least one of the proposed vitamin and mineral permissions. Calcium (6 products), magnesium (5 products), niacin (5 products), vitamin A (4 products) and zinc (4 products) were the 20

23 nutrients most frequently exceeding proposed permissions. Two manufacturers of sports bars and powdered supplements were most affected by the proposed vitamin and mineral permissions. 7.3 Preferred Approach There are strengths and weaknesses to both approaches. Approach A provides a useful step-wise risk management approach to setting permissions for vitamins and minerals taking into account current intakes and ULs. It would however present major compliance problems for the sample of foods that were captured in the audit. Approach B provides a simplified risk management process but nevertheless still attempts to fulfil the aim that vitamins and minerals are permitted to be added to FTDS in amounts that will ensure the potential sum of intakes from all sources does not exceed the established UL. Further, it does this without adversely affecting many of the products on the market that may in the future be captured under this Standard. As it does not rely on dietary intake data being available, a greater range of permissions can also be set providing there is an established UL. As such, NZFSA favours Approach B. Additionally, NZFSA acknowledges that FTDS will concurrently be regulated by other components of the Code including Standards related to labelling and other information requirements. Combined, these measures should be sufficient to protect public health, provide the consumer wanting foods with higher levels of vitamins and minerals in their diets with that choice, and the information to make an informed decision based on labelling requirements. It should be noted that decisions made in this background paper were based on the best available evidence at the time of publication. All decisions made will be subject to ongoing review of international evidence and the opinions of expert working groups recognised by NZFSA. 7.4 Safety of Vulnerable Population Groups Following the categorisation of risk, NZFSA performed a safety check to determine if the proposed levels for the addition of vitamins and minerals to FTDS might present a risk to other age-sex specific groups. The proposed values from Approach B were compared to the ULs for infants, children, pregnant and lactating women. It was found that in setting permissions at 50% of the UL for adult males, there was a potential risk that children 8 years consuming the maximum quantity per daily serving for the FTDS could exceed their age-sex specific UL for a range of vitamins and minerals (Tables 11 and 12). On average the proposed levels in Approach B were approximately 125% (range: %) of the age-sex specific ULs for children 8 years. As such, in addition to aforementioned permissions and labelling requirements, NZFSA proposes that FTDS specifically marketed for children should be manufactured to conditions where a maximum quantity per daily serving does not exceed 50% of the age-sex specific UL for a child 8 years. 21

24 Table 7. Approach A - Maximum Food-type Dietary Supplements levels for Vitamins and Minerals where risk is assessed as low. Low risk of exceeding the UL Biotin Copper Folic Acid Iodine Iron Nicotinic acid Nicotinamide Pantothenic acid Phosphorous Riboflavin Selenium Thiamin Vitamin A as retinol Vitamin B 12 Vitamin B 6 Vitamin C Vitamin E Maximum Quantity per one day serving No mcg quantity set 7 mg 434 mcg 985 mcg 24 mg 3.5 mg 816 mg No mg quantity set 1441 mg No mg quantity set 305 mcg No mg quantity set 1764 mcg No mcg quantity set 47 mg 706 mg 276 mg 22

25 Table 8. Approach A - Maximum Food-type Dietary Supplements levels for Vitamins and Minerals where risk of exceeding the Upper Level of Intake is high or where precaution needs to be applied. Potential risk at excessive intakes Calcium Fluoride Magnesium Molybdenum Sodium Vitamin D Vitamin K Zinc Maximum Quantity per one day serving 625 mg 2.5 mg 350 mg 500 mcg 305 mcg 20 mcg No limit but include warning statement for patients prescribed warfarin medication 10 mg 23

26 Table 9. Approach B - Maximum Food-type Dietary Supplements levels for Vitamins per day. Nutrient Biotin Choline Folate Nicotinic acid Nicotinamide Pantothenic acid Riboflavin Thiamin Vitamin A as retinol Vitamin B 12 Vitamin B 6 Vitamin C Vitamin D Vitamin E as alpha-tocopherol equivalents Vitamin K Maximum Quantity per one day serving No mcg quantity set 1750 mg 500 mcg 17.5 mg 450 mg No mg quantity set No mg quantity set No mg quantity set 1500 mcg No mcg quantity set 25 mg 500 mg 40 mcg 150 mg No mcg quantity set but include warning statement for patients prescribed warfarin medication 24

27 Table 10. Approach B - Maximum Food-type Dietary Supplements levels for Minerals per day. Nutrient Calcium Chromium Copper Fluoride Iodine Iron Magnesium Manganese Molybdenum Phosphorous Potassium Selenium Sodium Zinc Maximum Quantity per one day serving 1250 mg No mcg quantity set 5 mg 5 mg 550 mcg 22.5 mg 175 mg No mg quantity set 1000 mcg 2000 mg No mg quantity set 200 mcg 1150 mg 20 mg 25

28 Table 11. Identification of Population Sub-groups at risk of exceeding Upper Levels of Intake for Vitamins when consuming the Maximum Quantity per one day serving proposed for Food-type Dietary Supplements 6. Vitamins Maximum Life-stage Upper Levels of Intake Quantity per one day Children (yrs) Boys (yrs) Girls (yrs) Pregnancy (yrs) Lactating (yrs) serving Choline mg/d * 1000 * 1000 * * Folic acid mcg/d * 400 * Nicotinic acid mg/d * 15 * Nicotinamide mg/d * 250 * Retinol mcg/d * 900 * Vitamin B 6 mg/d * 20 * Vitamin D mcg/d Vitamin E mg/d * 100 * Footnote: * Proposed Maximum Quantity per one day serving exceeds UL. 26

29 Table 12. Identification of Population Sub-groups at risk of exceeding Upper Levels of Intake for Minerals when consuming the Maximum Quantity per one day serving proposed for Food-type Dietary Supplements 6. Minerals Maximum Life-stage Upper Levels of Intake Quantity per one day Children (yrs) Boys (yrs) Girls (yrs) Pregnancy (yrs) Lactating (yrs) serving Calcium mg/d Copper mg/d 5 1 * 3 * 5 * 8 5 * Fluoride mg/d * 2.2 * Iodine mcg/d * 300 * Iron mg/d * Magnesium mg/d * 110 * Molybdenum mcg/d * 600 * Phosphorous mg/d Selenium mcg/d * 150 * Sodium mg/d * Zinc mg/d 20 7 * 12 * Footnote: * Proposed Maximum Quantity per one day serving exceeds UL. 27

30 Useful Definitions Estimated Average Requirement (EAR) A daily nutrient level estimated to meet the requirements of half the healthy individuals in a particular life stage and gender group. Lowest Observed Adverse Effect Level (LOAEL) The lowest tested dose of a substance that has been reported to cause harmful (adverse) health effects on people or animals. Maximum Quantity per one day serving The amount of the specified food which is to be consumed in one day in accordance with directions specified in the label. No Observed Adverse Effect Level (NOAEL) The highest tested dose of a substance that has been reported to have no harmful (adverse) health effects on people or animals. Recommended Dietary Intake (RDI) The average daily dietary intake that is sufficient to meet the nutrient requirements of nearly all (97-98%) healthy individuals in a particular life stage and gender group. Upper Level of Intake (UL) The highest average daily nutrient intake level likely to pose no adverse health effects to almost all individuals in the general population. As intake increases above the UL, the potential risk of adverse effects increases. NZFSA Public Information Paper; no. 09/ July 2008

31 References 1. Manufactured Food Database. Fortified Foods available in New Zealand Food Standards Australia New Zealand. Food Standards Code. Standard Nutrition Information Requirements. 3. Ministry of Health. Dietary Supplements Regulations. 1985;SR 1985/ Food Standards Australia New Zealand. Policy Guideline: Fortification of Food with Vitamins and Minerals National Health and Medical Research Council. Recommended Dietary Intakes for use in Australia National Health and Medical Research Council. Nutrient Reference Values for Australia and New Zealand Including Recommended Dietary Intakes Codex Committee on Nutrition and Foods for Special Dietary Uses. General Principles for the Addition of Essential Nutrients to Foods. 1991;CAC/GL Codex Alimentarius. Guidelines for Vitamin and Mineral Food Supplements. 2005;CAC/GL European Parliament. Directive 2002/46/EC of the European Parliament and of the Council of 10 June 2002 on the approximation of the laws of the Member States relating to food supplements European Parliament. Regulation (EC) No 1925/2006 of the European Parliament and of the Council of 20 December 2006 on the addition of vitamins and minerals and of certain other substances to foods. 2006;1925/ Health Canada. Addition of Vitamins and Minerals to Foods, 2005: Health Canada's Proposed Policy and Implementation Plans Food Standards Australia New Zealand. Initial Assessment Report. Proposal Review of Food-type Dietary Supplements. 2002;P Food Concepts and Design Limited (NZ). The New Zealand Market for Food-type Dietary Supplements Expert Group on Vitamins and Minerals. Safe Upper Levels for Vitamins and Minerals NZFSA Public Information Paper; no. 09/ July 2008

32 15. European Responsible Nutrition Alliance. Vitamin and Mineral Supplements: A Risk Management Model Richardson DP. Risk management of vitamins and minerals: a risk categorisation model for the setting of maximum levels in food supplements and fortified foods. Food Sci Tech Bull 2007;4(6): Russell DG, Parnell WR, Wilson N, Faed J, Ferguson E, Herbison P, et al. NZ Food: NZ People: Key results of the 1997 National Nutrition Survey Ministry of Health. Drinking-water Standards for New Zealand ;HP Smith C, Wilson NC, Parnell WR. Dietary supplements: Characteristics of supplement users in New Zealand. Nutr Diet 2005;62(4): Horwarth C, Parnell WR, Birkbeck JA, Wilson N, Russell DG, Herbison P. Life in New Zealand Commission Report Volume VI: Nutrition New Zealand Food Safety Authority. Vitamin K in Milk - Anlene Risk Assessment New Zealand Food Safety Authority. 2003/04 New Zealand Total Diet Survey. Agricultural Compound Residues, Selected Contaminants and Nutrients NZFSA Public Information Paper; no. 09/ July 2008