Circular No. 43/2014/TT-BYT on the management of functional foods

CIRCULAR

Regulations on the Management of Health Foods

Pursuant to the Food Safety Law dated June 17, 2010;

WHEREAS, Decree No. 38/2012/NĐ-CP dated April 25, 2012 of the Government detailing implementation of certain provisions of the Food Safety Law;

This Circular prescribes procedures for receiving, providing health care for domestic violence victims and statistical reports on domestic violence victims at medical facilities.

At the proposal of the Director of the Food Safety Administration;

The Minister of Health issues this Circular to regulate the management of health foods.

PART I
GENERAL PROVISIONS

Article 1. Scope of Regulation and Application

1. This Circular stipulates activities related to production, business, product declaration, labeling, and usage instructions for health foods including dietary supplements, health protection foods, and medical nutrition foods, including special diet foods.

2. This Circular does not apply to infant formula products. Production, business, product declaration, labeling, and usage instructions for these products shall be carried out according to corresponding technical standards and legal regulations governing the business and use of infant nutritional products.

Article 2. Interpretation of Terms

In this Circular, the following terms shall be understood as follows:

1. Dietary Supplements (Supplemented Food) refers to ordinary food supplemented with micronutrients and other beneficial elements for health such as vitamins, minerals, amino acids, fatty acids, enzymes, probiotics, prebiotics, and other biologically active substances.

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

b) Natural biological active substances from animals, minerals, and plants in forms such as extraction, isolation, concentration, and transformation.

6. Recommended Nutrient Intake for Vietnamese People (RNI - Recommended Nutrition Intakes) refers to the recommended nutrient intake for Vietnamese people announced by the National Institute of Nutrition (Ministry of Health).

Chapter II
GENERAL REQUIREMENTS FOR HEALTH FOODS

Article 4. Requirements for reporting on efficacy testing

1. Products must undergo efficacy testing for health effects including:

b) Products declaring new functions not recognized in other countries worldwide;

c) Products containing new active ingredients not yet permitted for use;

d) Health protection products with formulas different from those scientifically proven products already on the market, being introduced to the market for the first time;

đ) Products derived from plants or animals, being introduced to the market for the first time, with compositions different from traditional medicinal formulas or modified traditional formulas published in scientific journals;

e) Medical nutrition foods and special diet foods not yet permitted by competent authorities or authorized bodies or by the laws of the exporting country, which have not been confirmed regarding their functions, target users, and permitted usage instructions on product labels.

3. In cases where efficacy testing for health effects is conducted abroad, the testing must be performed at units recognized or accredited by the competent authority of the host country, or the test results must be published in scientific journals.

The organization and operation of the Scientific Council shall be implemented in accordance with the provisions of the law.

Functional food testing for compliance with food safety regulations and periodic testing must comply with the provisions of Circular No. 19/2012/TT-BYT dated November 9, 2012, issued by the Minister of Health guiding the declaration of conformity and compliance with food safety regulations, and the following provisions:

1. For main active ingredients creating the product's function, if domestic testing units can perform quantitative testing, they must quantify these main active ingredients in the product.

2. If domestic testing units do not have testing methods or standard samples for quantitative testing of main active ingredients, the product's declaration must include the content of components containing the main active ingredient in the declaration dossier.

In addition to complying with labeling regulations for prepackaged foods regarding product name, product composition, and mandatory labeling contents stipulated in Chapter II of the Regulations on Labeling and Labeling Methods set forth in Joint Circular No. 34/2014/TTLT-BYT-BNNPTNT-BCT dated October 27, 2014, issued by the Ministers of Health, Agriculture and Rural Development, and Industry and Trade guiding labeling for prepackaged foods, food additives, and food processing aids, specific labeling for functional foods must also comply with Articles 9, 11, and 13 of this Circular and the following provisions:

1. Declaration of risk warnings, if applicable.

2. Product name and label contents must correspond to the declared content and accompanying documents in the product declaration dossier.

1. The advertising of functional foods must be conducted in accordance with the laws on advertising.

2. When advertising health protection foods through audiovisual media, there must be a notice stating: "This product is not a medicine and does not replace the treatment effects of medicines"; the writing and reading must be clearly visible and audible under normal conditions.

Chapter III
REQUIREMENTS FOR SUPPLEMENTARY FOODS

Article 8. Requirements for content disclosure

1. Nutrient content claims:

When adding vitamins, minerals, amino acids, fatty acids, enzymes, probiotics, prebiotics, or other biologically active substances to food, the disclosure of the content of these substances in the food based on the recommended daily intake for Vietnamese people (RNI) as specified in Appendix No. 01 issued together with this Circular shall be as follows:

c) The maximum amount of vitamins and minerals in the food based on the manufacturer's recommended daily dose shall not exceed the maximum tolerable levels of vitamins and minerals as specified in Appendix No. 02 issued together with this Circular.

In cases where Vietnam has not established RNI and maximum tolerable levels, the provisions of CODEX or relevant international organizations shall apply.

a) Health claims regarding supplements may only be disclosed if the content of the substance in the food reaches 10% RNI or more and there is specific scientific evidence to prove it;

b) For components without established RNI according to regulations, health claims about such components can only be disclosed on the product label when there is scientific evidence proving them or when the content of these components aligns with the recommended levels in published scientific literature;

c) Health claims must be clearly and consistently stated, appropriate to the target group and dosage already disclosed.

In addition to complying with the requirements stipulated in Article 6 of this Circular, labels for supplementary foods must also meet the following requirements:

1. The phrase indicating the category of food: "Supplementary Food" or the name of the category in the national technical standard must be prominently displayed on the label.

2. The specific target group must be clearly indicated, consistent with the recommended dosage already disclosed or consistent with the scientifically proven recommended dosage for components without established levels.

Chapter IV
REQUIREMENTS FOR HEALTH PROTECTION FOODS

Article 10. Requirements for content disclosure

1. Disclosure of content:

c) The maximum content of vitamins and minerals in the food based on the manufacturer's recommended daily dose shall not exceed the maximum tolerable levels of vitamins and minerals as specified in Appendix No. 02 issued together with this Circular;

In cases where Vietnam has not established RNI and maximum tolerable levels, the provisions of CODEX or relevant international organizations shall apply.

2. Health claims:

a) Health claims must accurately reflect the nature of the product, disclosing only the efficacy of the primary constituent parts or the combined efficacy of the constituent parts when supported by scientific evidence, and not listing the efficacy of individual components;

b) Health claims, dosage, target users, and appropriate usage methods must be consistent and aligned with the documentation in the file;

3. Target Users:

b) A warning must be given for users who should not use the product (if applicable).

In addition to complying with the requirements stipulated in Article 6 of this Circular, labels of health food must also meet the following regulations:

a) The active ingredient content in that component if quantifiable; or

b) The content of that component if the active ingredient cannot be quantified.

3. The mechanism of action shall not be stated on the product label.

Chapter V
REQUIREMENTS FOR MEDICAL NUTRITION FOOD AND SPECIAL DIETARY FOOD AND FOOD FOR SPECIFIC DIETARY USES

Article 12. Requirements for Content Disclosure

1. Nutrient content claims:

b) The level of fulfillment according to the Recommended Nutrient Intake (RNI) for vitamins and minerals per serving size (serving size) or the content per 100g of the product must be disclosed;

c) The maximum amount of vitamins and minerals in the food based on the manufacturer's recommended daily dose shall not exceed the maximum tolerable levels of vitamins and minerals as specified in Appendix No. 02 issued together with this Circular.

In cases where Vietnam has not established RNI and maximum tolerable levels, the provisions of CODEX or relevant international organizations shall apply.

2. Health claims:

The disclosure must clearly state health recommendations suitable for the nutritional fulfillment level for specific individuals.

3. Target Users:

Product disclosure must specify the target user along with a warning for those who are not permitted to use it (if applicable).

4. Dosage:

The dosage appropriate for the target user over a specific period of time must be disclosed.

In addition to complying with the requirements stipulated in Article 6 of this Circular, labels of medical nutrition food and special dietary food must meet the following conditions:

1. Medical nutrition food must display the phrase indicating the group name of food: "Medical Nutrition Food" on the main part of the label to distinguish it from regular food and the phrase: "For use under medical supervision".

2. Special dietary food must display the phrase: "Nutritional Product (for specific individuals)" on the main part of the label to distinguish it from regular food.

3. Detailed instructions on cleaning equipment and mixing methods to ensure hygiene, safety, and adequate nutrition, suitable for the health condition of the user, must be provided.

4. Requirements for usage instructions:

a) Must be clear and detailed in the product disclosure dossier;

b) Must warn against unauthorized users, if applicable.

Chapter VI
PRODUCTION, DISTRIBUTION AND USAGE GUIDELINES FOR HEALTH FOOD GUIDELINES FOR THE USE OF FUNCTIONAL FOODS

Article 14. Conditions for Producing Health Food

1. Physical facilities, equipment, tools, production materials, packaging containers, and direct producers must comply with the provisions set forth in Article 3 of Circular No. 16/2012/TT-BYT dated October 22, 2012, issued by the Minister of Health regarding food safety conditions for food production and business establishments, tools, and packaging materials under the management of the Ministry of Health.

3. Mandatory implementation of the Good Manufacturing Practice (GMP) system and Hazard Analysis and Critical Control Points (HACCP) as prescribed by the Minister of Health.

Article 15. Conditions for operating, storing, and transporting functional foods

1. Material infrastructure, equipment, tools, and individuals directly involved in business operations must comply with the provisions set forth in Articles 4, 5, and 6 of Circular No. 16/2012/TT-BYT dated October 22, 2012, issued by the Minister of Health regarding food safety conditions for production and business establishments, tools, and packaging materials under the management of the Ministry of Health.

Article 16. Withdrawal of functional foods

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

a) Exceeding the expiration date;

b) Not meeting technical standards or food safety regulations of the Ministry of Health;

c) Information about the product circulating in the market does not match the content confirmed by the agency issuing the Certificate of Acceptance of Declaration of Compliance or does not conform to the content of the Certificate of Confirmation of Compliance with Food Safety Regulations or violates other legal provisions;

d) Circulating in the market without certification of compliance or confirmation of compliance with food safety regulations;

e) When competent authorities of other countries or international organizations issue warnings, and the National Food Safety Agency of the Ministry of Health confirms the lack of safety of the product.

2. Organizations and individuals producing and trading in functional foods are responsible for withdrawing such products and reporting to the National Food Safety Agency of the Ministry of Health.

Article 17. Handling of functional foods that do not meet safety requirements

Organizations and individuals producing and trading in functional foods that do not meet safety requirements are responsible for handling such foods and bear all costs associated with the withdrawal and disposal of the products in accordance with legal provisions.

Article 18. Tracing the origin of non-compliant products

1. The tracing of the origin is conducted at the final packaging location of the product. Production and trading establishments of functional foods must provide complete information on the origin, quality, safety of raw materials, production and processing procedures, and storage to competent state management agencies during inspections and checks.

2. The tracing of the origin of raw materials causing food safety issues is investigated at the establishment where the non-compliant product originates and through inspection and investigation activities to trace back to the source supplier or the production region of the raw materials.

Chapter VIII
IMPLEMENTING PROVISIONS

Article 19. Implementation Provisions

This Circular takes effect from February 1, 2015.

Repeal Circular No. 08/2004/TT-BYT dated August 23, 2004, issued by the Minister of Health on guiding the management of functional food products from the effective date of this Circular.

Article 20. Transitional Provisions

Functional food products that have been issued a Certificate of Acceptance of Declaration of Compliance or a Certificate of Confirmation of Compliance with Food Safety Regulations before the effective date of this Circular may continue to be used until the expiration date indicated in the Certificate of Acceptance of Declaration of Compliance or the Certificate of Confirmation of Compliance with Food Safety Regulations.

Article 21. Organization of Implementation

1. The National Food Safety Agency of the Ministry of Health shall take the lead in coordinating with relevant agencies of the Ministry of Industry and Trade, the Ministry of Public Security within their respective jurisdictions to organize the implementation, direct, inspect, and supervise the enforcement of this Circular.

2. Provincial Departments of Health shall be responsible for organizing the implementation, directing Food Safety and Hygiene Inspection Centers and related units to inspect and supervise local production and trading establishments of functional foods.

3. Agencies, organizations, and individuals with products requiring testing for efficacy concerning human health must bear responsibility for the testing costs according to current regulations.

4. Production and trading establishments of functional foods must comply with the provisions of this Circular.

In the process of implementing this Circular, if there are difficulties or obstacles, agencies, organizations, and individuals are advised to report to the Ministry of Health (National Food Safety Agency) for consideration and resolution./.