Circular No. 43/2014/TT-BYT providing for the management of functional food

14 THE MINISTRY OF HEALTH No. 43/2014/TT-BYT OFFICIAL GAZETTE Issue nos 11-12/January 2015 THE SOCIALIST REPUBLIC OF VIETNAM Independence - Freedom - Happiness Hanoi, November 24, 2014 CIRCULAR Providing the management of functional foods(*J Pursuant to the June 17, 2010 Law on Food Safety; Pursuant to the Government's Decree No. 38/2012/ND-CP of April 25, 2012, detailing a number of articles of the Law on Food Safety,· Pursuant to the Government's Decree No. 63/2012/ND-CP of August 31, 2012, defining the functions, tasks, powers and organizational structure of the Minishy of Health,· At the proposal of the Director of the Vr.etnam Food Administration, The Minister of Health promulgates the Circular providing the management of functional foods. Chapter I GENERAL PROVISIONS Article 1. Scope of regulation and application 1. This Circular provides activities related to the production, trading, announcement and labeling of, and provision of use instm ctions for, functional foods, including supplemented foods, health supplements/food supplements/dietaiy supplements and medical foods (foods for special medical purposes), and also foods for special dieta1y uses. 2. This Circulai· does not apply to infant fo1mulas. The production, trading, announcement and labeling of, and provision of use instmctions for, infant fo1mulas must comply with relevant technical regulations and the provisions on trading and use of infant fo1mulas. Article 2. Interpretation of te1ms In this Circular, the te1m s below are constm ed as follows: 1. Supplemented foods means ordinaiy foods added with healthy micro-nutrients and elements, such as vitamins, minerals, amino acids, fatty acids, enzymes, probiotics, prebiotics and substances having other biological activities. 2. Health supplements/food supplements/dietary supplements means products processed in the fo1m of capsules, pills, tablets, glue, granules, powder or liquids and othe1wise processed, which contain one or a mixture of the following substances: a/ Vitamins, minerals, amino acids, fatty acids, enzymes, probiotics and substances having other biological activities; b/ Biological active elements of natural origins from animals, minerals and plants in such fo1ms as extracts, subdivisions, concentrations and metabolisms. ('J Cong Bao Nos 09-10 (04/1/2015) © Vietnam Law and Legal F omm Issue nos 11-12/January 2015 OFFICIAL GAZETTE 15 3. Medkal foods or foods for special medical purposes means a type of foods for oral feeding or tube feeding which are intended for the dieta1y management of patients and may be used only under medical supervision. 4. Foods for sped al dietary uses for dieters, the elderly and other special persons under the provisions of the CODEX Alimentarius Commission means foods processed or mixed by special fo1mulas to meet distinctive dietaiy requirements depending on the habitus or pathological status and specific disorders of users. The ingredients of these foods must be distinctive from those of ordina1y foods of the same essence, if any. 5. Scientific evidence means scientific info1mation and documents from scientific reseai·ches accepted after test by competent state management agencies in charge of scientific reseai·ch or published by domestic or foreign science jomnals, or documents on traditional medicine, medicinal plants or remedies published in science publications. 6. Recommended nutrition intakes (RNI) for Vietnamese means nutritional needs recommended for Vietnamese which are announced by the National Institute of Nutrition (the Ministty of Health). Chapter II GENERALREQUIREMENTSFORFUNCTIONALFOODS Article 3. Announcement of regulation conformity or conformity with food safety regulations 1. Impo1ied and domestically produced functional foods for which technical regulations are available shall be subject to regulation confo1mity announcement, and written announcements of regulation confo1mity shall be registered with the Ministty of Health (the Vietnam Food Administration) before such foods are marketed. 2. Impotied and domestically produced functional foods for which no technical regulations are available shall be subject to announcement of confo1mity with food safety regulations, and written announcements of confo1mity with food safety regulations shall be registered with the Ministty of Health (the Vietnam FoodAdministt·ation) before such foods are marketed. 3. The order and dossier for registration of written announcements of regulation confo1mity or confo1mity with food safety regulations for imported and domestically produced functional foods must comply withAiiicles 6 and 7 of the Government's Decree No. 38/2012/ ND-CP of April 25, 2012, detailing a number of aiiicles of the Law on Food Safety, andAiiicles 4, 5, 7 and 9 of the Minister of Health's Circular No. 19/2012/TT-BYT of November 9, 2012, guiding the announcement of regulation confo1mity or confo1mity with food safety regulations. Article 4. Requirements on repo1is on testing of utility effects 1. Products subject to testing of their utility effects on human health include: a/ Products with announced recommendations about their disease treatment suppo1i effects; b/ Products with announced new utilities not yet recognized in other countt·ies in the world; c/ Products containing new active elements not yet pe1mitted for use; d/ Health supplements which have fo1mulas different from those of products accompanied by scientific evidences and which are marketed for the first time; dd/ Products of animal or plant origin which are marketed for the first time and have ©Vietnam Law and Legal Fornm 16 OFFICIAL GAZETTE Issue nos 11-12/January 2015 ingredients different from those of traditional medicine products or traditional medicine products with increased or decreased ingredients or doses, and which have been published in science journals; e/ Medical foods and foods for special dietaiy uses which have not yet been permitted by competent agencies or authorized agencies or laws of countries of origin, or of which utilities, users and use instrnctions permitted to be induded in labels have not yet been ce1tified by exp01ting countries. 2. The testing of products ' utility effects on human health shall be conducted at organizations with the function of scientific research in medicine. Paiticularly, the testing of products with announced recommendations about their disease treatment suppo1t effects shall be conducted at provincial- or higher-level hospitals with the function of scientific research. 3. In case the testing of products' utility effects on human health is conducted overseas, it shall be conducted at units accredited or recognized by competent agencies of host countries, or the testing results shall be published in science jomnals. 4. The Vietnam Food Administration (the Ministry of Health) shall form a science council composed of expe1is in relevant fields to appraise reports on testing of utility effects of products and scientific evidences ah-eady announced. The organization and operation of the Science Council must comply with law. Article 5. Testing requirements The testing of functional foods for announcement of their confo1mity with food safety regulations and regular testing must comply with the Minister of Health's Circular No. 19/2012/TT-BYT of November 9, 2012, guiding the announcement ofregulation confo1mity or confo1mity with food safety regulations, and the following provisions: 1. Main active elements responsible for utilities of a product, which can be tested by domestic testing units, shall be quantified in such product. 2. For main active elements for which domestic testing units have no testing methods or standai·d samples for testing and quantification, the contents of ingredients containing such main active elements shall be stated in announcement dossiers. Article 6. Requirements on labeling of functional foods In addition to the provisions on labeling of packaged foods with respect to product names and ingredients and compulso1y details subject to labeling provided in Chapter II on labeling and labeling methods of Joint Circular No. 34/2014/TTLT-BYT-BNNPTNT-BCT of October 27, 2014, of the Ministry of Health, Ministry of Agricultme and Rm-al Development and Ministry of Industry and Trade, guiding the labeling of foods, food additives and food processing supplements for packaged foods, the labeling of each specific group of functional foods must comply with Alticles 9, 11 and 13 of this Circular and the following provisions: 1. Recommendations about risks, if any, shall be announced. 2. Names of products and details on labels must be consistent with the announced contents and enclosed documents in product announcement dossiers. Article 7. Adve1tising of functional foods 1. The adve1tising of functional foods must comply with the law on adve1tising. 2. When advertising health supplements in audiovisual aids, the phrase "Caution: These products are not medicines and do not substitute curative medicines" shall be shown; the scripts or spoken words must be easy to see or hear under normal conditions. © Vietnam Law and Legal F ornm Issue nos 11-12/January 2015 OFFICIAL GAZETTE Chapter III REQUIREMENTS ON SUPPLEMENTED FOODS Article 8. Requirements on to-be-annmmced contents 1. Nutrient content claims: 17 When adding vitamins, minerals, amino acids, fatty acids, enzymes, probiotics, prebiotics or substances having other biological activities to foods, the announcement of their contents in the foods shall be based on RNI for Vietnamese as provided in Appendix No. 01 to this Circular, specifically as follows: a/ When the content of a substance is below 10% of RNI, the announcement of such substance is not allowed; b/ When the content of a substance is 10% or more ofRNI, the specific name and content of such substance may be announced for each meal ration or for eve1y 1 00g of product; c/ The maximum content of vitamins and minerals in foods calculated based on producers ' RNI must not exceed the maximum intake limits of vitamins and minerals provided in Appendix No. 02 to this Circular. In case Vietnam has no RNI and maximum intake limits, the provisions of CODEX or relevant international organizations shall apply. 2. Health claims: a/ Health claims for added substances shall be announced only when the contents of such substances in foods reach 10% or more ofRNI, which are accompanied by scientific evidences; b/ For added ingredients for which no RNI are available, health claims for such ingredients shall be announced on product labels only when they are accompanied by scientific evidences or when the contents of such ingredients confo1m to the recommended intakes in scientific documents ah-eady announced; c/ Health claims must be written clearly and consistently as suitable to users and intakes ah-eady announced. Article 9. Requirements on labeling in Vietnamese In addition to the requirements provided in Aliicle 6 of this Circular, a supplemented food label must comply with the following provisions: 1. The phrase "Supplemented foods" or the phrase stating the name of the foods as in the national technical regulation must be written in the main pa1i of the label. 2. The specific users suitable to response levels of recommended intakes already announced, or suitable to accompanied scientific evidences on recommended intakes for ingredients for which no response levels are available, must be written. Chapter IV REQUIREMENTS ON HEALTH SUPPLEMENTS Article 10. Requirements on to-be-announced contents 1. Content claims: a/ The main ingredient responsible for utilities of a product must be listed first together with its full name and content. Other ingredients shall be listed later in the order of their gradually reduced volumes; ©Vietnam Law and Legal Fomm 18 OFFICIAL GAZETTE Issue nos 11-12/January 2015 b/ The content of vitamins and minerals in foods calculated based on daily intakes recommended by producers must reach at least 15% ofRNI as provided in Appendix No. 01 to this Circular; c/ The maximum content of vitamins and minerals in foods calculated based on daily intakes recommended by producers must not exceed the maximum intake limits of vitamins and minerals provided in Appendix No. 02 to this Circular; d/ The content of vitamins and minerals in a product must be written on its label in numbers and percentage (%) of RNI, based on such product's daily recommended intakes or based on a serving size. In case Vietnam has no RNI and maximum intake limits, the provisions of CODEX or relevant international organizations shall apply. 2 . Health claims: a/ Health claims must be announced strictly based on the essence of a product; the utilities of ingredients responsible for main utilities or the component utilities of ingredients shall be announced only when they are accompanied by scientific evidences; not to make announcement by listing the utilities of ingredients; b/ Health claims, intakes, users and use instructions must be announced in consistency with documents in dossiers; c/ When the content of vitamins, minerals and biological active elements in a product is smaller than that stated in accompanied scientific documents, such product's utilities may not be announced; d/ When the content of vitamins, minerals and biological active elements of a product is the same as that recommended in scientific documents, such product's utilities may be announced provided that appropriate users and intakes must be stated; dd/ When there are no RNI for ingredients, it is necessa1y to provide scientific documents proving the utilities of such ingredients together with recommended intakes upon announcement. 3. Users: a/ Users must suit the announced utilities as approved by competent state agencies through the written ce1tifications of announcement of confonnity with food safety regulations; b/ There must be warnings about non-users (if any). Article 11. Requirements on labeling in Vietnamese In addition to the requirements provided in Alticle 6 of this Circular, a label of health supplements must comply with the following provisions: 1. The phrase "Health supplements" must be written in the main pa1t of the label to distinguish them from ordina1y foods and medicines. 2 . When taking the main ingredient responsible for the utilities of a product as the product's name, the following details must be written beside or below the product's name in the main pa1t of the label and in the ingredients in the label: a/ The content of active elements in such ingredient if these active elements can be quantified; or, b/ The content of such ingredient if active elements in such ingredient cannot be quantified. © Vietnam Law and Legal F ornm Issue nos 11-12/January 2015 OFFICIAL GAZETTE 19 3. The effect mechanism shall not be written in the product's label. 4. The phrase "Caution: These products are not medicines and do not substitute curative medicines" shall be written right below the label's section for writing utilities of the products or in the same place with other recommendations, if any. This phrase must be in a color in contrast with the background color of the label and the height of letters must be at least 1.2 mm; in case the area of a side of the package for labeling is smaller than 80 cm2, the height of letters must be at least 0.9 mm. Chapter V REQUIREMENTS ON MEDICAL FOODS AND FOODS FOR SPECIAL DIETARY USES Article 12. Requirements on to-be-announced contents 1. Nutrient content claims: a/ The names of ingredients of food products shall be fully listed in the order of their gradually reduced volumes; b/ The response levels based on RNI for vitamins and minerals in serving sizes or contents per 1 00g of products shall be announced; c/ The maximum content of vitamins and minerals in foods calculated based on daily intakes recommended by producers must not exceed the maximum intake limits of vitamins and minerals provided in Appendix No. 02 to this Circular. In case Vietnam has no RNI and maximum intake limits, the provisions of CODEX or relevant international organizations shall apply. 2. Health claims: The announcement must clearly state health claims suitable to nutritive response levels for specific users. 3. Users: The announcement must clearly state users enclosed with warnings about non-users (if any). 4. Intakes: To announce intakes suitable to users in a given period of time. Article 13. Requirements on labeling in Vietnamese In addition to the requirements provided in Article 6 of this Circular, a label of medical foods or foods for special dietaiy uses must satisfy the following conditions: 1. For medical foods, the phrase "Medical foods" shall be written on the main side of the label to distinguish them from ordinaiy foods, and the phrase "For use under medical supervision" shall be written. 2. For foods for special dietaiy uses, the phrase ''Nutritious products (for specific users)" shall be written on the main side of the label to distinguish them from ordina1y foods. 3. There must be detailed instructions on the instrument cleansing process and prepai·ation method to ensure food hygiene and safety and sufficient nuu-ition, as suitable to the health status of users. 4. Requirements on use instructions: a/ Use instructions must be elem· and detailed in product announcement dossiers; b/ There must be wainings about non-users, if any. ©Vietnam Law and Legal Fomm 20 OFFICIAL GAZETTE Issue nos 11-12/January 2015 Chapter VI CONDITIONS FOR PRODUCTION AND TRADING OF, AND USE INSTRUCTIONS FOR, FUNCTIONAL FOODS Article 14. Conditions for production of functional foods 1. Physical foundations, equipment, instruments, production materials, containers and employees directly engaged in production must comply with Ait icle 3 of the Minister of Health's Circular No. 16/2012/TT-BYT of October 22, 2012, on food safety conditions for establishments engaged in production and trading of foods, instrnments, and food packaging and containing materials under the Minist:Iy of Health's management. 2. Phaimaceuticals production establishments akeady granted good manufacture practice (GMP) ce1tificates when producing functional foods shall be exempted from food safety eligibility ce1t ificates. 3. To comply with the Minist:Iy of Health 's regulations on a roadmap for compulso1y application of GMP and hazard analysis and critical conti·ol points (HACCP) systems. Article 15. Conditions for ti·ading, preservation and t:I'ansportation of functional foods 1. Physical foundations, equipment, inst:Iuments and traders shall comply withAiticles 4, 5 and6 oftheMinister ofHealth's Circular No. 16/2012/TT-BYT of October 22, 2012, on food safety conditions for establishments engaged in production and ti·ading of food, inst:Iuments, and food packaging and containing materials under the Minist:Iy of Health's management. 2. Health supplements must be displayed for sale separately from places for display and sale of other foods. Pha1macies must have separate places for display and sale of functional foods. Chapter VII RECALL AND DISPOSAL OF UNSAFE FUNCTIONAL FOODS Article 16. Recall of functional foods 1. Functional foods shall be recalled in the following cases: a/ They expire; bl They fail to confo1m to technical regulations or the Minist:Iy of Health's food safety regulations; c/ Info1mation on mai·keted products is inconsistent with the contents ce1t ified by the agency that has issued receipts of the written announcements of regulation confo1mity or with the contents of the written announcements of confo1mity with food safety regulations, or violates other regulations; d/ They are mai·keted without regulation conf01mity ce1t ificates or written ce1t ifications of confo1mity with food safety regulations; dd/ There are warnings of competent agencies of related counu-ies or international organizations that the products are unsafe and such is confirmed by the Vietnam Food Administi·ation of the Minist:Iy of Health. 2. Producers and ti·aders of functional foods shall recall unsafe functional foods and report such to the Vietnam FoodAdministi·ation of the Minist:Iy of Health. © Vietnam Law and Legal F ornm Issue nos 11-12/January 2015 OFFICIAL GAZETTE 21 Article 17. Disposal of unsafe functional foods Producers and traders of unsafe functional foods shall dispose of such foods and bear all expenses for the recall and disposal of such foods in accordance with law. Article 18. Tracking of origin of unsafe products 1. The trncking of the origin of a product shall be conducted at the last place of packaging of such product. Producers and traders of functional foods shall provide sufficient infonnation on the origin, quality, materials and production, processing and preservation processes to competent state management agencies upon inspection or examination. 2. The tracking of the origin of materials that make foods unsafe shall be inspected at establishments where unsafe products are made, and through inspection and examination operations, material suppliers or material production zones shall be thoroughly tracked. Chapter VIII IMPLEMENTATION PROVISIONS Article 19. Implementation provisions This Circular takes effect on Febrnaiy 1, 2015. To annul the Minister of Health 's Circular No. 08/2004/TT-BYT of August 23, 2004, guiding the management of functional food products, from the effective date of this Circulai·. Article 20. Transitional provision Functional food products for which receipts of written announcements of regulation confo1mity or written ce1t ifications of conf01mity with food safety regulations are issued before the effective date of this Circulai· may be used till their expi1y date stated in such receipts or ce1t ifications. Article 21. Organization of implementation 1. The Vietnam Food Administration of the Ministry of Health shall assume the prime responsibility for, and coordinate with functional agencies of the Ministry of Industry and Trade and the Ministry of Public Security in, organizing, directing, examining and supervising the implementation of this Circular within the ambit of their vested powers. 2. Provincial-level Health Departments shall examine and supervise, and direct provincial-level FoodAdministr·ations and related units in examining and supervising, producers and tr·aders of functional foods in their localities. 3. Agencies, organizations and persons that have products subj ect to testing of their utility effects for human health shall bear testing expenses under cmTent regulations. 4. Producers and tr·aders of functional foods shall implement this Circular. Any problems or difficulties ai·ising in the course of implementation of this Circular should be repo1ted to the Ministry of Health (the Vietnam Food Administr·ation) for consideration and settlement. For the Minister of Health Deputy Minister NGUYEN THANH LONG * All appendices to this Circular are not translated. ©Vietnam Law and Legal Fomm