Thông tư 43/2014/TT-BYT về quản lý thực phẩm chức năng do Bộ trưởng Bộ Y tế ban hành

CIRCULAR

REGULATING THE MANAGEMENT OF FUNCTIONAL FOODS

Pursuant to the Law of Food safety dated June 17, 2010;

Pursuant to the Government's Decree No. 38/2012/ND-CP dated April 25, 2012, detailing the implementation of some articles of the Law of Food safety;

Pursuant to the Government's Decree No. 63/2012/NĐ-CP dated August 31, 2012 defining the functions, tasks, powers and organizational structure of the Ministry of Health.

At the request of the Director of Vietnam Food Administration;

The Minister of Health promulgates the Circular regulating the management of functional foods.

Chapter I

GENERAL PROVISIONS

Article 1. Scope

1. This Circular regulates the activities related to production, trading, product announcement, labeling and giving instructions on functional foods including supplemented foods, health protection foods, medical foods and foods used for special dietary uses.

2. This Circular does not apply to nutritional formula for children. The production, trading, product announcement, labeling and giving instructions for this product shall be implemented in accordance with corresponding technical regulations and the laws on trading and using nutritional products for children.

Article 2. Interpretations of terms

In this Circular, the following terms are construed as follows:

1. Supplemented Food means ordinary food supplemented with micronutrients and other elements conducive to health such as vitamins, minerals, amino acids, fatty acids, enzymes, probiotics, prebiotics and other biologically active substances.

2. Health Supplement, Food Supplement, Dietary Supplement means product made in the form of capsules, pellets, tablets, glues, granules, powder, liquid and other processed forms containing one or combination of the following substances:

a) Vitamins, minerals, amino acids, fatty acids, enzymes, probiotics and other biologically active substances;

b) Active ingredients naturally derived from animals, minerals, and plants through extraction, isolation, concentration, and metabolism processes.

3. Food for Special Medical Purposes or Medical Food means food administered orally or with feeding tubes which are designated to regulate the patient's diet and are only used under the supervision of health workers.

4. Food for Special Dietary Uses for dieters, the elderly and other special users prescribed by The Codex Alimentarius Commission (CODEX) means food processed or blended according to special formulae to meet the requirements of particular diets suitable for certain physical or medical conditions and disorders of users. The composition of this food is distinctly different from that of other ordinary foods having the same nature, if any.

5. Scientific evidence means scientific information and documentation from scientific research conducted by competent State management agencies on scientific research or accepted by domestic or foreign academic journals or documentation of traditional medicine, herbs, and herbal ingredients published in scientific publications.

6. Recommended Nutrition Intakes for Vietnamese means recommended nutrient intakes that an ordinary Vietnamese person needs announced by National Institute of Nutrition (the Ministry of Health).

Chapter II

GENERAL REQUIREMENTS FOR FUNCTIONAL FOODS

Article 3. Declaration of conformity and declaration of compliance to food safety regulations

1. There must be a declaration of conformity and registration of declaration of conformity at the Ministry of Health (Vietnam Food Administration) for imported and domestically produced functional foods that are regulated by technical regulations before they are put on the market.

2. There must be a declaration of compliance to food safety regulations and registration of declaration of compliance to food safety regulations at the Ministry of Health (Vietnam Food Administration) for imported and domestically produced functional foods that are not regulated by any technical regulations before they are put on the market.

3. Procedures, application for registration of declaration of conformity and declaration of compliance to food safety regulations for imported and domestically produced functional foods are defined in Article 6, Article 7 of the Government's Decree No. 38/2012/NĐ-CP dated April 25, 2012, detailing the implementation of some articles of the Law of Food safety and Article 4, 5, 7, 9 of the Circular No. 19/2012/TT-BYT dated November 09, 2012 of the Minister of Health guiding the Declaration of conformity and declaration of compliance to food safety regulations.

Article 4. Report on effect testing results

1. The following products must be tested for effects on human health:

a) The products with claimed therapeutic effects (i.e. to aid in treatment of diseases);

b) The products having new effects which have not been recognized by other countries;

c) The products having new active ingredients which have not been permitted;

d) Health supplements put on the market for the first time which have different formulae from those of other products having scientific evidence.

dd) The products derived from plants, animals and put on the market for the first time, the composition of which is different from that of the traditional medicines published in academic journals.

e) Medical foods and foods for special dietary uses which have not been permitted by competent authorities or authorized agencies or law of the country of origin, or the effects, suitable users and usage on the label have not been confirmed by the exporting country.

2. The test for effects on human health must be conducted at the organizations licensed to do scientific research in medicine. The products with claimed therapeutic effects must be tested at the provincial hospitals (or above) licensed to do scientific research.

3. If the test for the effects on human health is conducted overseas, it must be performed by agencies accredited by competent authorities of home country or test results are published in academic journals.

4. Food Administration (the Ministry of Health) shall establish the Scientific Council which consists of experts in appropriate fields to assess the reports on the product’s effects and scientific evidence announced.

The organizational structure and operation of Scientific Council shall comply with the provisions of law.

Article 5. Testing

The test of functional foods serving declaration of compliance to food safety regulations and periodic testing shall comply with the provisions the Circular No. 19/2012/TT-BYT dated November 09, 2012 of the Minister of Health, which provides guidelines for Declaration of conformity and declaration of compliance to food safety regulations and the following provisions:

1. If active ingredients creating the main effects can be tested by Vietnamese units, the amounts of active ingredients in the products shall be determined.

2. With regard to active ingredients which do not have testing method or standard sample to be quantified by domestic agencies, the amount of substances that contain the main active ingredients shall be specified in the declaration document.

Article 6. Labeling functional foods

Besides complying with regulations on labeling packaged foods with the name, the composition and the mandatory label contents defined in Chapter II on regulations on labeling of joint Circular No. 34/2014/TTLT-BYT-BNNPTNT-BCT dated October 27, 2014 by the Minister of Health, the Ministry of Agriculture and Rural development, the Ministry of Industry and Trade on labeling of packaged foods, food additives and food processing aids, labeling functional foods for each specific food groups must also comply with the provisions of Articles 9, 11 and 13 of this Circular and the following provisions:

1. Warning of risks, if any.

2. The name of the product and the information on the label must be consistent with the claims and materials attached to the declaration document.

Article 7. Advertising functional foods

1. Advertisements for functional foods must comply with regulations of law on advertising.

2. There must be the notice: “This product is not a medicine, and is not a substitute for medicines" in every advertisement for health supplements on audio-visual media; letters, words must be easy to read and hear in normal conditions.

Chapter III

REQUIREMENTS FOR FUNCTIONAL FOODS

Article 8. Requirements for claims

1. Nutrient content claims:

When supplementing foods with vitamins, minerals, amino acids, fatty acids, enzymes, probiotics, prebiotics and other biologically active substances, the claims about the contents of such substances in foods according to recommended nutrition intakes (RNI) for Vietnamese are specified in Appendix No. 01 issued together with this Circular as follows:

a) A substance shall not be mentioned if its content is below 10% RNI;

b) If the content of a substance is from 10% RNI, its content in a serving or 100g of the product shall be specified;

c) The maximum contents of vitamins, minerals in the foods according to recommended nutrition intakes provided by manufacturers shall not exceed the permissible maximum contents of vitamins and minerals in functional foods defined in Appendix 02 issued together with this Circular.

The maximum contents shall comply with regulations of CODEX or relevant international organizations if there is no RNI in Vietnam.

2. Health claims:

a) Health claims about a supplementary substance shall be made only when its content in the product reaches 10% RNI or above and is proven with specific scientific evidence.

b) For supplementary ingredients without RNI, health claims shall be made on the label only when they are proven with the scientific evidence or contents of such ingredients are conformable with recommendations on published scientific documents.

c) Health claims must be clear, consistent, and suitable for the suitable users and dosage.

Article 9. Requirements for Vietnamese labels

Labels of supplement foods must comply with the provisions in Article 6 of this Circular and the following provisions:

1. On the main part of the label, there must be a phrase expressing the food group as “Supplement foods” or the heading name in a national technical regulation.

2. The users to which RNI apply or conformable with scientific evidence of the recommended dose (if no RNI are available) must be specified.

Chapter IV

HEALTH SUPPLEMENTS

Article 10. Claim contents

1. Nutrient content claims:

a) The main ingredients that create the effects of the product must be enumerated first together with their full names and contents. The other ingredients shall be enumerated next and sorted by weight in descending order;

c) The contents of vitamins, minerals in the foods in recommended nutrition intakes provided by manufacturers shall be at least 15% RNI specified in Appendix 01 issued together with this Circular.

c) The maximum contents of vitamins, minerals in the foods in recommended nutrition intakes provided by manufacturers shall not exceed the permissible maximum contents of vitamins and minerals in functional foods defined in Appendix 02 issued together with this Circular.

d) Vitamin and mineral contents in the product must be written on the label in number and percentage (%) of RNI according to recommended nutrition intakes of the product or based in a serving size.

In case Vietnam does not have RNI, provisions of CODEX or relevant international organizations shall apply.

2. Health claims:

a) Health claims must reflect the product nature, the claim about effects of ingredients having main or combined effects shall be made only when there is scientific evidence, the effects of ingredients must not be enumerated as effects of the product;

b) Claims about health, dosage, suitable users and suitable usage must be consistent and in conformity with the documents;

c) The effects of the vitamins, minerals and active ingredients of which the contents are smaller than those in the scientific documents shall not be claimed;

c) The effects of vitamins, minerals and active ingredients of which the contents are the same as those in the scientific documents shall be claimed, provided suitable users and doses are specified;

dd) Scientific evidence of effects of ingredients and recommended intakes must be provided if such ingredients do not have RNI.

3. Users:

Article 3. The suitable users must be consistent with claimed effects and approved by competent State agencies with written declaration of compliance to food safety regulations;

b) Prohibited users (if any) must be specified.

Article 11. Vietnamese labels

Labels of health supplements must comply with the provisions in Article 6 of this Circular and the following provisions:

1. On main part of the label, there must be a phrase expressing the food group as “Health supplement” to distinguish ordinary foods from medicines.

2. When using the main ingredient that create the product effects as the product name, the following information must be written next to or below the product name on the main part and the ingredient sheet of the label:

a) Contents of active ingredient in such main ingredient if they can be determined;

a) Content of the main ingredient if the active ingredient contents cannot be determined;

3. Pharmacokinetics of the product shall not be written on the label.

4. There must be a phrase: “Attention: This product is not a medicine, and is not a substitute for medicines” right after the product’s effects or with other recommendations (if any). This phrase must have a contrasting color to the background color of the label and the letters must be at leapt 1.2 millimeters. The letters must be at least 0.9 millimeters if one side of the package is smaller than 80 square centimeters.

Chapter V

MEDICAL FOODS AND FOODS FOR SPECIAL DIETARY USES

Article 12. Claim contents

1. Nutrient content claims:

a) The ingredients of the food must be sorted by weight in descending order;

b) RNI of vitamins and minerals in a serving or their contents in 100g product must be specified;

c) The maximum contents of vitamins, minerals in the foods according to recommended nutrition intakes provided by manufacturers shall not exceed the permissible maximum contents of vitamins and minerals in functional foods defined in Appendix 02 issued together with this Circular.

In case Vietnam does not have corresponding RNI, provisions of CODEX or relevant international organizations shall apply.

2. Health claims:

The health claims must specify the RNI applied to various users.

3. Users:

The health claim must specify the suitable users and prohibited users.

4. Dosage:

The dose for specific users for a period of time must be specified.

Article 13. Vietnamese labels

Labeling medical foods and foods for special dietary uses must comply with the provisions in Article 6 of this Circular and the following provisions:

1. On the main side of the label, there must be a phrase expressing food group as “medical foods” to distinguish ordinary foods from medical foods and the sentence: “used under the supervision of health workers”.

2. In main side of the label, there must be a phrase expressing the food group as “dietary products (for specific users)” to distinguish ordinary foods from foods for special dietary uses.

3. There must be a detailed guidance on cleaning and preparation to ensure hygiene, food safety and proper nutrition suitable for health conditions of the users.

4. Requirements for giving instructions:

a) The instructions provided in the declaration document must be clear and detailed;

b) Prohibited users (if any) must be specified.

Chapter VI

CONDITIONS FOR PRODUCTION, TRADING AND GIVING INSTRUCTIONS FOR FUNCTIONAL FOODS

Article 14. Conditions for producing functional foods

1. Facilities, equipment, tools, materials, packages and the direct producer are defined in Article 3 of the Circular No. 16/2012/TT-BYT dated October 22, 2012 of the Minister of Health regulating food safety conditions applied to manufacturers and sellers of foods, instruments and materials for wrapping and storing food under the management of the Ministry of Health.

2. Any pharmaceutical manufacturer that has obtained the Certificate of Good Manufacturing Practices (GMP) in producing functional foods shall be exempt from obtainment of the Certificate of Food safety.

3. Pharmaceutical manufacturers must adhere to the mandatory roadmap for Good Manufacturing Practices (GMP) and Hazard Analysis and Critical Control Points (HACCP) under provisions of the Minister of Health.

Article 15. Conditions for trading, preserving and transporting functional foods

1. Facilities, equipment, tools, materials and the direct producer are defined in Article 4, 5 and 6 of the Circular No. 16/2012/TT-BYT dated October 22, 2012 of the Minister of Health regulating food safety conditions applicable to the facilities that produce and trade foods, instruments and materials for wrapping and storing food under the management of the Ministry of Health.

2. Health supplements must be sold separately from the areas of other foods. There must be a separate area in the pharmacy where functional foods are sold.

Chapter VII

RECALLING AND DISPOSING UNSAFE FUNCTIONAL FOODS

Article 16. Recalling functional foods

1. Functional foods must be recalled in the following cases:

a) The products have expired;

The products are not conformable with the Ministry of Health’s technical standards or regulations on food safety.

c) The information on the products sold on the market is inconsistent with the claims confirmed by the agency granting the Certificate of Declaration of conformity or inconsistent with the Certificate of Declaration of conformity with the food safety regulations or violate other laws;

d) The products are sold on the market without conformity certification or confirmation of satisfying food safety regulations;

dd) There is a safety warning of the product from competent authorities of the countries or international organizations and confirmation from Vietnam Food Administration- the Ministry of Health

2. Individuals, organizations producing and trading functional foods shall recall unsafe products and submit reports to Vietnam Food Administration - the Ministry of Health.

Article 17. Disposing unsafe functional foods

Manufacturers and sellers of unsafe functional foods shall dispose those products and bear all the recall and disposal costs.

Article 18. Tracing the origins of violations

1. Origins tracing shall be carried out at the final packaging place. Manufacturers and sellers of functional foods have a responsibility to provide sufficient information about the origin, quality, material safety, manufacturing process, processing, preserving to the competent State management agencies during inspection.

2. Origins of materials threatening food safety shall be investigated at the facilities considered origins of such materials in order to identify the supplier of such materials or the area where such materials are produced.

Chapter VIII

IMPLEMENTATION

Article 19. Effect

This Circular takes effect on January 15, 2015 and replaces Circular No. 08/2004/TT-BYT dated August 23, 2004 of the Minister of Health on management of functional foods.

Article 20. Transition

Any functional food granted the Certificate of Declaration of conformity or Certificate of Declaration of compliance with the food safety regulations before the effective date of this Circular shall be still effective until the expiry of the Certificate of Declaration of conformity or Certificate of declaration of compliance to food safety regulations

Article 21. Implementation

1. Vietnam Food Administration - the Ministry of Health shall take charge and cooperate with functional agencies of The Ministry of Industry and Trade, the Ministry of Public Security under competence to plan, direct, inspect and supervise the implementation of this Circular.

2. The Department of Health of provinces shall implement, direct the Branch of food safety and hygiene and relevant agencies to inspect local manufacturing and trading affiliates of functional foods.

3. Agencies, organizations, and having the effectiveness of the use of human health tested shall bear all the cost of testing in accordance with current regulations.

4. Manufacturing and trading establishments of functional foods shall implement the provisions of this Circular.

Difficulties that arise during the implementation of this Circular should be reported to the Ministry of Health (Vietnam Food Administration) for consideration./.

APPENDIX 01

TABLE OF RECOMMENDED NUTRITION INTAKES FOR VIETNAMESE
(Enclosed with the Circular No. 43/2014/TT-BYT dated November 24, 2014 by the Minister of Health)

1. Recommended intakes of minerals and micronutrients

* Recommended nutrition intakes are determined according to the average intakes +2 SD

2. Recommended intakes of iodine, iron and zinc

1 Serving size with low biological value of iron (about 5% of iron is absorbed): simple and monotonous regimen, containing under 30g of meat and/or fish per day or under 25 mg of vitamin C per day.

2 Serving size with average biological value of iron (about 10% of iron is absorbed): containing 30g – 90g of meat and/or fish per day or 25 mg – 75 mg of vitamin C per day.

3 Serving size with high biological value of iron (about 15% of iron is absorbed): containing over 90g of meat and/or fish per day or over 75 mg of vitamin C per day.

4 Pregnant women are recommended to take iron pills during the gestation. A higher dose shall be given if they have anaemia.

5 Breast-fed children

6 Children fed by formula milk

7 Children fed by formula milk with great amount plant-based protein and phytates.

8 Excluding purely breast-fed children

8 High absorption: high biological value of zinc, equal to 50% (serving contains a lot of protein from animal or fish derivatives); average absorption: average biological value of zinc, equal to 30% (serving contains an average amount of protein from animal or fish derivatives; ratio of phytate and zinc is at 5:15); low absorption: low biological value of zinc, equal to 15% (serving contains very little or does not contain protein from animal or fish derivatives).

3. Recommended daily intakes of vitamins

a These following conversion factors may be used for vitamin A:

01 mcg of vitamin A or retinol = 01 retinol equivalent (RE)

01 IU (International unit) is equivalent to 0.3 mcg of vitamin A

01 mcg of -carotene = 0.167 mcg of vitamin A

01 mcg of other carotenes = 0.084 mcg of vitamin A

b Excluding the loss during processing and cooking activities because Vitamin C is destroyed easily by the oxidization, light, alkali and temperature.

c These following conversion factors may be used for vitamin D:

01 IU is equivalent to 0.03 mcg of vitamin D3, or 01 mcg of vitamin D3 = 40 IU

d IU conversion factors (according to IOM-FNB 2000):
01 mg of -tocopherol = 1 IU;
01 mg of -tocopherol = 0.5 IU;
01 mg of -tocopherol = 0.1 IU;
0.1 mg of -tocopherol = 0.02 IU.

e Niacin or Niacin equivalent

f These following conversion factors may be used for Folic acid:

01 folic acid = 1 folate x 1.7, or 01 g of folic acid equivalent = 01 g of folate in food + (1.7 x amount of synthetic folic acid (in gram)).

Note: This table above will be updated according to current regulations of the Ministry of Health.

APPENDIX 02

MAXIMUM INTAKE LEVELS
(Enclosed with the Circular No. 43/2014/TT-BYT dated November 24, 2014 by the Minister of Health)

1. Vitamin

2. Minerals

Maximum intake level means the maximum amount of a micronutrient that can be taken into the body without harm.

N/A: not enough information to determine the maximum intake level

Note: The table above will be updated according to current regulations of the Ministry of Health.

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