Decision No. 6289/2003 promulgating the Regulation on addition of micronutrients to food

10 OFFICIAL GAZETTE Issue nos 05-06lAugust 2008 (Gong Bao nos 467-4iJIl'!llJgusI22, 2008) DECISION No. 628912003/QD-BYT OF DECEMBER 9, 2003, PROMULGATING THE REGULATION ON ADDITION OF MICRONUTRIENTS TO FOOD THE MINISTER OF HEALTH Pursl@JttotheGovernmentsDecreeNo.49/ 20031ND CP of May 15, 2003, defining the [unctioru, tasks, powers and organizational structure ofthe Ministry ofIlealth; Pursuantto theGovernments DecreeNo.86/ CP ofDecember 8, 1995, on the assignment of state management responsibilities for goods quality; At the proposal uJ the director uJ the Fuud Safety and Hygiene Department, the director of the Legal Department and the director of the Science and Training Department under the Ministry o.fHealth, DEcmE~: Article 1.- To promulgate together with this Decision the Regulation on addition of micronutt:ients tofood. ArtU:lf2.- ThisDecision takes effect 15 days after its publication in "CONG BAO:' Arlicle3.-Thedirector of theOffice, thechief inspector, and the directors of the Science and Training Departmentand the Legal Department of theMinistry ofHealth;thedirectorof theFood Safety and Hygiene Department. directors of provincial/municipal Health Services, andheads of units attached to the Ministry of Health shall implementthisDecision. For the Minister ofHealth Vice Minister TRAN CHI LIEM REGULATION ON ADDITION OF MICRONUTRIENTS TO FOOD (Promulgated together withtheHealth Ministers n~t:isinn Nn fi?RQI)()(H/Qn RYT nfDecember 9, ZOO3) C1Mpterl GENERAL PROVISIONS Aracte 1.- This negutaucn gUVl:I'IlS the additionof micronutrients to food. Article2.-This Regulation applies to Vietnam based producers,processors and traders of food added with micronutrients. Artkle 3.-In thisRegulation, the termsbelow areconstruedas follows: L Micronutrtents include vitamins and minerals of a very small quantity (weighed in microgramor milligram) whichareessential for the growth. development andmaintenance of life of human bodies. © VII=Tt.lll.M I ll.W II. I 1=r::ll.1 I=nRllM Issue nos 05006IAugust 2008 (GOng Baonos 487-468'Auqust 22.2008) OFFICIAL GAZETTE 11 2. Addition of micronutrients to food means the intentional insertion of a certain quantity of one or many micronutrients into food. Chapteell REQUIREMENTS ON MICRONUTRIENTS AND SOME KINDS OF FOOD TO BE ADDED WITH MICRONUTRIENTS Arlicle 4.- Micronutrients to be added to food are subject to state inspection of their quality, hygiene and safety. Article 5.- Micronutrients to be added to food must satisfy the following conditions: 1.Not affecting thenatureoffood (color, smell, taste, structure or processingCharacteristics); 2. Not reducing products' use duration. .irlick 6. 1.The addition ofmicronutrientsto food must complywith regulations applicable to each kind offood: aJ Babyfood mustcomplywiththeregulations in Appendix 1. blFish sauce mustcomplywiththeregulations inAppendix 2. cl Wheat flour must comply with the regulations in Appendix 3. d! Cooking oil must comply with the regulations in Appendix -l. e! Edible sugar must comply with the regulations inAppendix 5. 2. The addition of vitamins and minerals to baby food and wheat flour must comply withthe regulations inAppendix 6. Clu1pterIII REQIJIRRMRNTS ON PROm!rF.RS, PROCESSORS AND TRADERS OF FOOD ADDED WITH MICRONUTRIENTS Article 7.- Before putting products iato circulation on the market, producers, processors and traders of food added with micronutrients shallcarry outprocedures forfoodqualttj, hygiene and safety standard announcement with the Ministry ofHealth (the Food Safetyand Hygiene Department). Article 8.- Producers and processors of food added with micronutrients shall 3d1:isfy food hygiene and safety conditions specified by law. Establishments producingandprocessingfood addedwithmicronutrients areencouraged toapply Hazard Analysis and Critical Contro\ Points (HACCP) or Good Manufacture Practices (liMP). Article 9,~ Producers and processors of food added with micronutrients are responsible for the quality, hygieneand safety of their food products andshallconductperiodical inspections aceOIding to regulations to ensure the quality and quanti~ of micronutrientsas announced. Chapter IV REQUIREMENTS ON LABELING, PACKING, PRESERVATIONAND TRANSPORTATION OF FOOD ADDED WITHMICRONUTRIENTS © VIETNAM LAW & LEGAL FORUM 12 OFFICIAL GAZETTE Issue nos(J5.I}6/August 2008 (C6no BaD nos 467-46&1August 22, 2008) Arock 10.- The labeling of products must comply with the Prime Minister's Decision No. 17811999IQD-TTg of August 30, 1999, promulgating the Regulation on labeling of domestically circulated, imported and exported goods, and guiding legal documents. In addition, aproductlabel must bearthephrase "Thue pham bo sung vi chatdinh duong" (Food added with micronutrients). Article 11.- Containers of food added with micronutrients must ensure tood hygiene and safety so as not to denature the food, and suit preservarion andtransportation conditions. Articie 12.- The preservation and transportation offoodadded with micronutrients must satRfy food hygiene and safety conditions prescribed bylaw andmustnotreduce thequantity of rnicronutrients in food. Chapter V EXAMINATION, INSPECTlON,AND HANDLING OF VIOLATIONS Article13. 1. The f ood Satery and Hygiene Uepartment shall assarne the prime responsibility for, and coordinele with the Inspectorate and functional Departments ami Bureaus under the Ministry or Health andconcernedagenciesin,examining and inspecting the implementationof thisRegulation nationwide. 2. ProvinciaVmunicipaJ HealthServices shall coordinatewithconcernedagencies in examining and inspecting the implementation of this Regulation in theirlocalities. Article 14.-Organizations or individuals that violate this Regulation shall, depending on the nature and severity of their violations, be administrativelyhandled or examined for penal liability and,ifcausingdamage,pay compensation thereforin accordance with law. Chapter VI IMPLEMENTATION PROVISIONS Anicle l S.• 1 Producer", proce""or.'; and rraders of food. added with micronutrients shall implement this Regulation. 2. The Food Safety and Hygiene Department shall assume the prime responsibility for, and coordinate with functional Departments and BureausundermeMinistryof Health,the National Institute of Nutrition and concerned agencies in, guiding and directing the implementation of this Regulation. 3. Provincial/municipalHealth Services shall organize the implementation of this Regulation in their localities. For the Minister ofHealth VICe Minister TRAN CHI LIEM © VIETNAM LAW & LEGAL FORUM Issuenos 05=06lAugust 2008 (r.nn{) RAn nn.~ 4R7~81AII(J(I~t 22, ?nnR) OFFICIAL GAZETTE Appendix 1 \3 Regulations on addition of nlieronutrients to baby food Baby food means additional food for infants aged 6 months or older, which are produced from such main cereals as rice, wheat, soybeans, green peas and powdered milk, added with vitamins and minerals in a quantity estimated to satisfy around 30-50% of daily needs of infants Content/IOO Keal Added substances Minimum Maximum I. Vitamin A (RE) 250 IU 500 IU . 2. Vitamin D 401U 801U 3. Vitamin C g ma 40mg 4. Vitamin 81 40a. 200 a. " Vit,nnin B.2 60 ". 300 !-l-S 6. Folic acid 4 uc 20~g 7. Vitamin 812 0.15 na 1.5 ue 8. Vitamin K 4 ag auna 9. Calcium (Ca) 50mg 250mg 10. Iron (Fe) 0 " me 2 5 TnO 11. Zinc (2n) 0.3 mg 2mg Appendix 2 Regulatiulls UII addlLluli uf Iron tu fish sauce Usable form of iron: NaFeEDTA Added dose: Minimum: 30 mg of element iron/loo m1 offish sauce Maximum: 50 mg of element iron/IOu ml of fish sauce Allowable NaF~EDTAstandard: Scientific name: Sodium Iron (III) Ethylene Daminte Tra Acetate, trihydrate Chemical formula: CIOH12FeN2NaOs·3H20 Molecular weight: 421.09 (trihydrate) © VIETNAM LAW & LEGAL FORUM 14 OFFICIAL GAZETTE Purity: according to JECFA standard. Issue nos 05-06lAugust 2008 (COngBao Mt 467-46B1Augurl22, 2008) Characteristics Allowable content Iron component 12.5 - 13.5% FnTA comoonenr 6'.; 70.;% DR of I%-solution 3.5 - 5.5 Water-insoluble rate Maximum 0.1% Nitrilotrlacetic acid <0.1% Arsenic (As) Maximum I mg/kg T...ad (Ph) Maximum 1 m.o:/h:r Appemnx :3 Regulations on addition of micronutrieots to wheat flour Added.sahsrances Added quantity L Iron (Fe) 60 rnz/ka 2. Zinc (zn) 30 mg/kg 3. Thiamine (vitamin HI) 2.5 mz/ka 4. RibofLavin (vitamin B2) 4 rug/kg 5. Folic acid 2 me/ke Appendix 4 Regulations on addition of vitamin A to cooking oil Usable form ofvitamin A: vitamin Apalmitate Added dose: Minimum: SOlD/gram of oil MaAiJlllJHJ; 100 ill/glitlll uf vii Preservationconditions: Cooking oil added with vitamin A must be preserved in colored cans to avoid direct sunlight. 50% of the quantity of vitamin Acan be preserved within 6~9 months. © VIETNAM LAW & LEGAL FORUM Issue nos05-06JAugust 2008 ((',anO RAnn{l~ dfi746R/AII(}II.~I?J, 7(/()/f) OFFICIAL GAZETTE Appendix 5 Regulations on addition of vitamin A to edible sugar Usable form of vitamin A: vitamin A palmitate Added dose: Minimum: 15 ng/gram of sugar Maximum: 30 Jig/gram of sugar Precervation r.nnrlitinno;:· ~ Sugar added with vitamin A must be preserved in airtight boxes to avoid direct sunlight. 50% of the quantity of vitamin A can be preserved within 6 months. AppemliA 6 Regulations on addition of vitamins and minerals to baby food and flout Vitamin Form of vitamin Purity 1. Vitamin A Retinyl acetate USP, BP, Ph.Eur, FCC Retinyl palmitate USP, BP, Ph.Eur, FCC Retiyl propionate USP, BP, Ph.Eur, FCC Beta-carotene FAOIWHO, FCC 2. Vitamin D Ergocalciferol (vitamin D2) USP, BP, Ph.Bur, FCC Cholecalciferol (vitamin D3) USP.FCC 3. Vitamin C Ascorbic acid USP, BP.. Ph.Bur Sodium ascorbate FAOIWHO, FCC Calcium ascorbate USP, FAOIWHO, FCC 4. Vitamin Bl Thiamine chloride USP, BP, Ph.Eur. FCC hydrochloride Thiamine mononitrare USP,FCC 5. Vitamin B2 Riboflavin USP, BP, Ph.Eur, Riboflavin 5' -sodium FAOIWHO, FCC I phosphate 6. Folic Folic acid USP, BP 7. Vitamin BIZ Xyanocolbalamin USP, BP, Ph.EuT Hydroxocobalamin NF,BP © VIETNAM LAW & LEGAL FORUM 16 OFFICIAL GAZETTE Issue nos Os.oGlAugust 2008 (Cling BaonOS 467-4&Augus' 22, 2(08) 8. Vitamin K Phytylmenaquinone USP BP 9. Calcium (Ca) sources Calcium carbonate FCC, FAOIWHO Calcium citrate FCC, FAOIWHO Calcium Iactate FCC, 'FA.OfWHO Calcium phosphate, tribasic FCC, FAOIWHO 10. Iron (Fe) Ferrous fumate FCC PCITOUS gluconatc FCC, FAOIWHO Ferrous lactate MI Ferrous sulfate FCC 11. ZinqZN) sources ZInc acetate MI Zinc oxide MI Zinc sulfate FCC Notes: US?: United States Pharmacopoeia NF: United States National Formulary BP:BritishPharmacopoeia BPC:BritishPharmaceutical Codex Ph.Eer:EuropeanPharmacopoeia • MI: Merck Index FAOIWHO: General Principles for the Use of Food Additives, Codex A1iml:"nt~rim:, Volume 1 DAR Deutsches Arzneibuch 7 FCC: FoodChemicalsCodex. @I VIETNAM LAW" LEQAL FORUM