OUTLINE OF PRESENTATION

REGULATORY ASPECTS OF VITAMIN D Fatimah Sulong Food Safety and Quality Division Ministry of Health Malaysia ILSI Seminar Update on Vitamin D in Human Nutrition 12 November 2013, Kuala Lumpur OUTLINE OF PRESENTATION FOOD REGULATIONS 1985 o Related regulations o Part IV, V and Part VIII FORTIFICATION o Voluntary and mandatory o Related Tables / Schedule CLAIMS ON VITAMIN D o Descriptions o Conditions: minimum levels OTHER COUNTRIES o ASEAN o Other countries 2 1

FOOD ACT 1983 Food (Issuance of Health Certificate for Export of Fish & Fish Product to the European Union) Regulations 2009 Food Hygiene Regulations 2009 Food Regulations 1985 FOOD ACT 1983 Food Irradiation Regulations 2011 3 FOOD ACT 1983 & REGULATIONS To ensure the public is protected against: Health hazards; and Fraud in the preparation, sale and use of food and for matters connected to it Application of Food Regulations 1985 For all foods sold in Malaysia Locally produced, prepared or packaged Imported foods Food Act 1983 and Regulations made there under 4 2

FOOD REGULATIONS 1985 Part I Part II Part III Part IV Part V Part VI Part VII Part VIII Part XI Part X Arrangement of Regulations Preliminary Warranty Approval for sale Modern biotechnology Procedure for taking samples Labelling Food additive and ADDED NUTRIENT Packages for food Incidental constituent Standards and particular labelling requirements Water, ice & steam Miscellaneous 5 ADDITION OF NUTRIENTS TO FOOD Essential nutrients may be added to food in order to achieve any of the following: restoration of nutrients lost during processing; nutritional equivalence of substitute foods; fortification; ensuring the appropriate nutrient composition for a special purpose food. 6 3

FOOD FORTIFICATION Selection of an appropriate vehicle is important: commonly consumed by the target population; constant consumption pattern with a low risk of excess consumption; good stability during storage; relatively low in cost; have no interaction between the fortificant and the carrier food. There are a limited number of food vehicles suitable for vitamin D fortification margarine vegetable oils dairy products 7 VOLUNTARY FORTIFICATION Voluntary basis (except otherwise specifically required in the regulations) Definition of added nutrient includes - vitamin & mineral - nucleotides - amino acid - other food components - fatty acid To improve nutritional value of the food 8 4

TABLE I OF THE TWELFTH SCHEDULE 9 LABELLING REQUIREMENT Vitamin and mineral (optional labelling) Regulation 18B (9) 10 5

PERMITTED CLAIMS Claims * Nutrient / Component * Nutrient content claim Nutrient comparative claim Nutrient function claim Other function claim Nutrient enrichment or fortification claims Nutritious claim Vitamin & mineral Fatty acid (Omega 3) Dietary fibre Vitamin & mineral Other food components Dietary fibre Vitamin & mineral Amino acids Fatty acids Vitamin & mineral * Must meet conditions required for making claims 11 NUTRIENT CONTENT CLAIM source of ; high in (or other words with similar meaning) FIFTH A SCHEDULE (Regula(on 18C) TABLE II CONDITIONS FOR NUTRIENT CONTENTS FOR USE OF NUTRITION CLAIMS Component Claim Condi-ons Not less than Vitamins and Minerals Source 15% of NRV per 100 g (solids) 7.5% of NRV per 100 ml (liquids) or 5% of NRV per 100 kcal High (at least 2 (mes the values for source ) 12 6

LIST OF NUTRIENT REFERENCE VALUE (NRV) (Regulation 18B Nutrition Labelling) 2.4 1000 Panthothenate mg 5 Biotin µg 30 1.2 1.2 15 1.3 Carbohydrate g 300 Fat g 66.7 Choline mg 550 13 MINIMUM LEVELS FOR NUTRIENT CONTENT CLAIM NRV for Vitamin D = 5 µg per 100 g (solids) per 100 ml (liquids) per 100 kcal source of 15% of NRV 5% of NRV 5% of NRV 0.75 µg 0.25 µg 0.25 µg high in (2 times) 1.5 µg 0.50 µg 0.50 µg 14 7

NUTRIENT COMPARATIVE CLAIM A product that has a new formulation with INCREASED or EXTRA nutrient level The food being compared should be different versions of the similar food cheese A (old formulation) vs cheese B (new formulation) Identified as a percentage, fraction or absolute amount 50% EXTRA Vitamin D ; 1/3 INCREASED Vitamin D ; 5µg MORE Vitamin D Micronutrient content between compared foods must differ by at least 10% (micronutrient vitamin D) Minimum absolute difference in nutrient content the value required for claim as source 15 NUTRIENT FUNCTION CLAIM (q) Vitamin D (i) Vitamin D helps the body utilise calcium and phosphorus; (ii) Vitamin D is necessary for the absorption and utilization of calcium and phosphorus 16 8

NUTRIENT ENRICHMENT OR FORTIFICATION CLAIMS Enriched, fortified, vitaminised, supplemented or strengthened (or similar meaning) Regulation 26 (7) 17 TABLE II OF THE TWELFTH SCHEDULE Food Category Vitamin D (I.U.)* Vitamin D (µg) Reference Quantity: 100 grams Bread 83 2.075 Breakfast cereal (as purchased) 333 8.325 Condensed milk; filled milk; condensed filled milk (sweetened/unsweetened) 111 2.775 Dried milk powder (full cream or skimmed) 333 8.325 Wheat flour 167 4.175 Malted milk powder 667 16.675 Extract of meat / vegetable / yeast (modified or not) 2000 50.000 Other solid food (excl CF & CBF (for infants and young children)) Liquid food (incl vege/fruit juice, juice concentrate, syrup) 167 4.175 100 2.500 18 9

NUTRIENT ENRICHMENT OR FORTIFICATION CLAIMS Quality claimed as aforesaid - Enriched - Supplemented - Fortified - Strengthened - Vitaminised - (or similar meaning) Name of vitamin(s) or mineral(s) or both Vitamin or mineral as listed in Table II, 12 th Schedule Amount of vitamin(s) or mineral(s) or both Unit as expressed in Table II, 12 th Schedule) This food is [ quality claimed as aforesaid ] with [ amount (IU or µg) ] of Vitamin D 19 MAXIMUM AMOUNT PERMITTED Regulation 26 (10) Vitamin and mineral There is a maximum dosage of vitamin and mineral that been added to food The level of the added nutrient shall not exceed the amount as specified in the said Table 20 10

TABLE III OF THE TWELFTH SCHEDULE 21 MANDATORY FORTIFICATION Limited number of food items require mandatory fortification for certain nutrients Specific regulations under commodity standards Regulations for foods targeted to certain vulnerable groups Applied to the fortification of food with micronutrients List of essential nutrients Vitamins A; D Iodine 22 11

MANDATORY FORTIFICATION Commodity standards Regulation Micronutrient Level 94 Evaporated milk Vitamin A 670 IU / 100g 95 Condensed milk Vitamin A 670 IU / 100g 97 Filled milk Vitamin A 670 IU / 100g 185 Margarine Vitamin A Vitamin D 2500 3500 IU / 100g 250 350 IU / 100g 285 Iodised salt Iodine 20 40 mg/kg Ferum Wheat flour Folic acid 43 * Thiamine Enriched flour Riboflavin Niacin * Subject to official approval and gazettement process 6.0 mg/100g 260 µg/100g 0.42 mg/100g 0.67 mg/100g 4.6 mg/100g 23 MANDATORY FORTIFICATION Regulation 185 Margarine 24 12

MANDATORY SPECIFICATION Vitamin D in special purpose foods Regulation 389 Infant formula 389A 390 391 91B Follow-up formula Canned food for infants and children Cereal-based food for infants and children Formulated milk powder for children (FMPC) Current Level (per 100 kcal) 40 80 IU (1 2 µg) 40 120 IU (1 3 µg) 40 80 IU (1 2 µg) 40 120 IU (1 3 µg) Remarks 1 2.5 µg (Vitamin D 3 ) Review by Codex Including 391 Products (1) (c)(ii) 1.5 µg per 100 g Minimum 389B * IF for medical purposes - preterm infant formula (new) (new) * Subject to official approval and gazettement process 25 OTHER COUNTRIES: VITAMIN D FORTIFICATION REGULATIONS 26 13

REGULATION IN OTHER COUNTRIES AUSTRALIA/ NEW ZEALAND EUROPEAN UNION ASEAN CANADA UNITED STATES 27 ASEAN COUNTRIES: SPECIFIC STANDARD COUNTRY FOOD LEVEL LEGISLATION Brunei Margarine 55 µg/kg (2200 IU/kg) Food Regulation (Regulation 124) Indonesia Margarine 62.5-87.5 µg/kg (2500-3500 IU/kg) Decree No 02240/B/ SK/VII/91 Malaysia Margarine 62.5-75 µg/kg (2500-3000 IU/kg) Food Regulation (Regulation 185) Singapore Margarine 55 µg/kg (2200 IU/kg) Food Regulation (Regulation 91) 28 14

ASEAN COUNTRIES: SPECIFIC STANDARD COUNTRY FOOD MINIMUM LEVEL (USP units = IU) LEGISLATION Philippines (Voluntary) Evaporated milk 25 per 29.57 cc Administrative Order No 132s Reconstituted milk 7.5 per 28.5 gram Administrative Order No 132s Filled milk 400 per 411 gram Administrative Order No 132s Margarine 1500 per 454 gram Administrative Order No 1325 USP United States Pharmacopeia 29 AUSTRALIA/NEW ZEALAND: SPECIFIC STANDARD COUNTRY FOOD LEVEL LEGISLATION Australia/ New Zealand Spreadable oils Margarine 55 µg/kg (2200 IU/kg) Food Standard Code Standard 2.4.2 30 15

EUROPEAN UNION: SPECIFIC PROVISIONS BY MEMBER STATES MEMBER STATE FOOD LEVEL LEGISLATION Belgium Margarine Spreadable fats 75 µg/kg (3000 IU/kg) Royal Decree (October 2, 1980) Netherlands Spreadable fats 75 µg/kg (3000 IU/kg) Decree No 428 (September 22, 1999) Sweden Margarine Spreadable fats 75-100 µg/kg SLV 1983:2 H35 United Kingdom Margarine 70.5-88.2 µg/kg Statutory Instrument 1999 No 2457 Information regarding national provisions on the mandatory addition of vitamin D referred to in Article 11 of Regulation (EC) No 1925/2006 31 CANADA: SPECIFIC STANDARD FOOD CATEGORY LEVEL REMARKS Margarine and similar butter substitutes Milk, milk powder (whole, skim, partly skimmed, flavoured, evaporated) Goat's milk, goat's milk powder/products Formulated liquid diets, food for very low energy diets, meal replacements 530 IU/100 g (132.5 µg/kg) 300-400 IU/ reasonable daily intake 35-45 IU/100ml when ready-toserve Mandatory. Mandatory. Reasonable Daily Intake = 30 fl. oz., or 852 ml. Voluntary. Also require specific levels of vitamin A. Mandatory levels of vitamin D are also required Source: Food and Drugs Regulations (C.R.C., c. 870), 2009 32 16

UNITED STATES: SPECIFIC STANDARD Direct food substances (GRAS) MAXIMUM LEVELS (as served) Soy products MAXIMUM LEVELS (as served) IU/kg µg/kg IU/kg µg/kg Breakfast cereals 3500 87.5 Soy beverages 500 12.5 Grain products and pastas 900 22.5 Milk 420 10.5 Milk products 890 22.25 Source: Code of Federal Regulations CFR 21: Part 184, 2008 Soy beverage products Soy-based butter substitute spreads Soy-based cheese substitutes/products 890 22.25 3300 82.5 2700 67.5 Source: Code of Federal Regulations CFR 21: Part 172.379, 2009 33 UNITED STATES: SPECIFIC STANDARD Other food products 100% fruit juice and fruit juice drinks Soy-protein based meal replacement beverages Meal replacement bars Cheese and cheese products MAX LEVELS (as served) 100 IU/240 ml REMARKS Not including infant juices. Must also contain an established calcium level. 140 IU/240 ml Powder or liquid 40 IU/100 g 81 IU/30 g Including other-type bars for reducing or maintaining body weight. Not including cottage cheese, ricotta cheese, and hard grating cheeses. Margarine 1500 IU/pound 1 pound = 453.59 grams Source: Code of Federal Regulations CFR 21: Part 172.379, 2009 34 17

ASEAN: NUTRIENT CONTENT CLAIMS COUNTRY DESCRIPTION CONDITION LEVEL (µg) Brunei 1 Presence: contain ; added Rich source: rich in ; enriched ; fortified ; ennobled 1/6 of the RDA in per reference quantity of food (RDA = 2.5 µg) 50% of the RDA in per reference quantity of food 0.42 1.25 Singapore 2 Presence or source: source Excellent source: high in ; rich in ; good 1/6 of the RDA in per reference quantity of food (RDA = 2.5 µg) 50% of the RDA in per reference quantity of food 0.42 1.25 1 Brunei Food Act (Chapter 182 Regulations 16) 2 Singapore Food Act (Chapter 283) 35 ASEAN: NUTRIENT CONTENT CLAIMS COUNTRY DESCRIPTION CONDITION LEVEL (µg) Indonesia 3 source ; contains high in 15% of ALG per 100g ; or 7.5% of ALG per 100ml (ALG = 10 µg general) 2 times the values for source 1.50 0.75 3.00 1.50 Philippines 4 source high in 15% of RENI per 100g ; or 7.5% of RENI per 100ml (NRV = 5 µg) 2 times the values for source 0.75 0.38 1.50 0.75 3 HK03.1.23.11.11.09909 Tahun 2011 4 Bureau Circular 2007-002 36 18

ASEAN: NUTRIENT CONTENT CLAIMS COUNTRY DESCRIPTION CONDITION LEVEL (µg) good source ; contains ; provides 10-19% of RDI in per reference quantity of food (RDI = 5 µg) 0.50 0.95 Thailand 5 excellent source ; high in ; rich in 15% of RDI per 100g ; or 7.5% of RDI per 100ml; or 5% of RDI per 100kcal 20% of RDI in per reference quantity of food 0.75 0.38 0.25 1.00 30% of RDI per 100g ; or 15% of RDI per 100ml; or 10% of RDI per 100kcal 1.50 0.75 0.50 5 (No. 182) B.E. 2541 (1998) unofficial translation 37 OTHERS: NUTRIENT CONTENT CLAIMS COUNTRY DESCRIPTION CONDITION LEVEL (µg) Australia/ New Zealand 6 good source 25% of RDI per reference quantity of food (RDI = 10 µg) 2.5 Canada 7 source ; contains good source of ; high in excellent source ; very high in ; rich in 5% of RDI per reference quantity of food (RDA = 5 µg) 15% of RDI per reference quantity of food 25% of RDI per reference quantity of food 0.25 0.75 1.25 fortified/enriched ; added Mandatory/voluntary (eg margarine, milk..) Minimum & maximum 6 Standard 1.2.7 7 D.01.004; D.02.002; B.01.401; B.01.402; related standards 38 19

OTHERS: NUTRIENT CONTENT CLAIMS COUNTRY DESCRIPTION CONDITION LEVEL (µg) European Union 8 source ; contains high in 15% of RDA per 100g or per 100ml (RDA = 5 µg) 2 times the values for source 0.75 1.50 good source ; contains ; provides 10-19% of DV per RACC (DV = 10 µg or 400 IU) 1.00 1.90 United States 9 high in ; rich in ; excellent source more ; added ; plus fortified ; enriched 20% of DV per RACC (RACC = Reference Amount Customarily Consumed) 10% or more of DV per RACC 2.00 1.00 8 EC No 1924/2006; EC No 1925/2006; Directive 90/496/EEC 9 21 CFR 101.54 39 Country Source High Very high Fortified Brunei Indonesia contains; added 1/6 RDA (0.42) source; provides Malaysia (Codex) (0.75) Philippines source (Codex) (0.75) Singapore Thailand Aust/NZ Canada EU US SUMMARY: NUTRIENT CONTENT CLAIMS source 1/6 RDA (0.42) good source; contains 10% RDI (0.50) source; contains 5% RDI (0.25) source; contains 15% RDA (0.75) good source; contains 10% DV (1.00) rich; enriched 50%RDA (1.25) source; contains (Codex) (1.50) high; rich (Codex) (1.50) high (Codex) (1.50) good; high; rich 50% RDA (1.25) high; rich; excel 20% RDI (1.00) good source; high 15% RDI (0.75) high 30% RDA (1.50) high; rich; excel 20% DV (2.00) high (Codex) (3.00) good source 25% RDI (2.50) very high; rich; excel 25% RDI (1.25) fortified; enriched (as in standard) added; enriched (as in standard) more;plus; enriched >10% DV (>1.00) 20

SUMMARY: NUTRIENT COMPARATIVE CLAIMS Country Indonesia Description increased; extra; more; fortified; enriched Malaysia Thailand Canada increased; extra; more increased; extra; more; added; fortified; added; enriched increased; higher EU increased 41 SUMMARY: NUTRIENT FUNCTION CLAIMS Country Brunei Indonesia Malaysia Philippines Singapore Thailand Description / Claims No positive list Positive list, but none on Vitamin D a) Vitamin D helps the body utilize calcium and phosphorus. b) Vitamin D is necessary for the absorption and utilization of calcium and phosphorus. No positive list a) Vitamin D 3 helps the body utilize calcium and phosphorus. b) Vitamin D 3 helps support calcium absorption and improves bone strength. c) Vitamin K and Vitamin D work synergistically on bone metabolism to improve bone strength/build strong Vitamin D is required for the absorption and utilization of calcium and phosphorus. 42 21

SUMMARY: NUTRIENT FUNCTION CLAIMS Country Australia/ New Zealand European Union Canada US Description / Claims a) Vitamin D contributes to normal absorption and utilisation of calcium and phosphorus. b) Vitamin D contributes to normal blood calcium levels. c) Vitamin D contributes to the normal bone structure. d) Vitamin D contributes to the maintenance of normal muscle function. e) Vitamin D contributes to the maintenance of normal teeth. f) Vitamin D contributes to normal cell division. g) Vitamin D contributes to the normal function of the immune system. h) Vitamin D contributes to normal growth and development of bone in children. a) Vitamin D factor in the formation and maintenance of bones and teeth. b) Vitamin D helps build strong bones and teeth. c) Vitamin D builds and maintains strong bones and teeth. d) Vitamin D enhances calcium and phosphorus absorption and utilisation. e) Vitamin D improves calcium absorption. f) Vitamin D improves calcium and phosphorus absorption. No positive list SUMMARY: HEALTH CLAIMS Country Description / Claims Singapore A healthy diet with adequate calcium and vitamin D, with regular exercise, helps to achieve strong bones and may reduce the risk of osteoporosis. (state the name of the food) is a good source of/ high in/enriched in/fortified with calcium. Australia/ New Zealand Canada Calcium, vitamin D and osteoporosis: - Reduces risk of osteoporosis. - Reduces risk of osteoporotic fracture. A healthy diet with adequate calcium and vitamin D, and regular physical activity, helps to achieve strong bones and may reduce the risk of osteoporosis. (state the name of the food) is an [excellent source] / [very high in] of calcium and vitamin D. United States Calcium, vitamin D and osteoporosis: Adequate calcium and vitamin D, as part of a well balanced diet, along with physical activity, may reduce the risk of osteoporosis. 44 22

CONCLUSION Regulations dealing with addition of nutrient: Safety evaluations of nutrient compounds Levels should be evaluated and adjusted o Protect public from receiving either toxic or nutritionally ineffective levels o According to bioavailability of the nutrient(s) in the diets of target populations o The essential nutrient, if added: Ø should be present at a level such that intakes are neither insignificant nor excessive, considering amounts from other sources in the diet 45 CONCLUSION Incorporating general principles of nutrient addition into domestic law requires a clear understanding of the nutrition problem involved so that a sustainable, enforceable, and technically sound programme can be implemented to best meet the needs involved. Addressing micronutrient deficiencies also requires a broader strategy such a strategy will include non-regulatory mechanisms. must involve stake holders from the public and private sectors, and from the wider community. 46 23

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