Thông tư 08/2004/TT-BYT của Bộ Y tế về hướng dẫn việc quản lý các sản phẩm thực phẩm chức năng

CIRCULAR

OF MINISTRY OF HEALTH NO.08/2004/TT-BYT DATED AUGUST 23, 2004 GUIDING THE MANAGEMENT OF FUNCTIONAL FOOD PRODUCTS

To uniformly manage the business of functional food products on the market; ensure health and safety for consumers and create favorable conditions for the enterprises in the business, the Ministry of Health guides the management of functional food products (hereinafter referred to as functional foods) as follows:

I. CONCEPTS AND NAME CALLED AS FUNCTIONAL FOODS

1. Functional foods are the foods used to support the function of the organs in the human body, with nutritive effect for the body s ease, increasing resistance and reducing the risk of illness.

2. Functional foods, depending on the utility, micronutrient contents, and manuals, also with other names as follows:

a) Food of Micronutrient Supplementation;

b) Food of Supplements;

c) Food for Health Protection;

d) Food of Medical Nutrition.

II. CONDITIONS TO DETERMINE FUNCTIONAL FOODS

The food products fortified with nutrients such as vitamins, mineral salt and other biological active substances if being announced by the manufacturers that the products are functional foods; to be certified conformity with law on foods or permitted circulation by the competent state agencies of the producing countries and satisfying the following conditions shall be considered as functional foods:

1. For foods supplementing micronutrients: If the amount of nutrients sent into the body daily as directed on the label of the product has at least one vitamin or mineral salt more than 3 times value ​​of recommendation table of nutritional needs RNI 2002 (Recommended nutrient intakes), attached to this Circular, they must have certificates of the competent state agencies of the manufacturing countries or the countries to permit circulation certify the safety of product and must indicate on the label or sub-label of products (for imported products) the level meeting the RNI of micronutrients added;

2. For functional foods containing biological active substances: If it is published to have effect to support functions in the human body, to increase resistance and reduce the risk of illness, it must have clinical trial report on the effect of the product or documentation to prove the effect of product components having such function or certificate of competent state agencies of the manufacturing countries or the countries allowing the circulation with content to determine the utility of the product stated on label.

3. Content labeling of functional foods must meet the conditions as prescribed by law for the label and the following conditions:

a) Contents of manuals for products having purpose of special use needs to state: Name of the group of products (food of supplements, food of health protection, functional foods, dietary foods, medical nutritional food), objects of use, the utility of product, dosage, contraindications, special precautions or side effects of the products (if any);

b) For foods that contain biological active substances, on the label or sub-label, it is required to state the line of words "This product is not a medicine, not effective to replace medicines";

c) On the label of functional food products are not indicated for the treatment any particular disease or product with effect to replace medicines.

4. For products containing vitamins and mineral salt not yet mentioned in Recommended nutrient intakes specified in clause 1 of this Section, the product produced domestically but unknown as food or product containing biological active substances having not enough materials to prove the safety and effects of the active substances, the Department of Safety and Food Hygiene is responsible for presiding over and coordinate with the Vietnam Drug Administration and Department of Traditional Medicine - Ministry of Health to consider for the classification and unified management.

III. MANAGEMENT FOR FUNCTIONAL FOODS

1. Functional foods having all the conditions specified in Section II of this Circular shall be governed by and shall comply with the provisions of the legislation on foods. These products must be published standards of hygiene and food safety at the Department of Safety and Food Hygiene - Ministry of Health in accordance with the law provisions on food before circulation on the market.

2. The information, advertising, labeling products as functional foods must be made in accordance with the law provisions on information, advertising, labeling, and must ensure the truthfulness, accuracy, clearness not causing damage to the producers, traders, and consumers.

IV. IMPLEMENTATIONORGANIZATION

1. Department of Hygiene and Food Safety - The Health Ministry is responsible for implementing, directing, examining, inspecting and monitoring the implementation of this Circular.

2. Health Departments of provinces and cities directly under the Central Government, medical agencies of all sectors are responsible for implementing, directing, inspecting, examining and monitoring the units producing and trading functional foods during the implementation of the provisions of this Circular.

3. The units trading functional foods are responsible for implementing the provisions of this Circular.

V. IMPLEMENTATION PROVISIONS

1. This Circular takes effect 15 days after its publication in the Official Gazette. To annul Circular No.20/2001/TT-BYT dated 09/11/2001 of Ministry of Health guiding the management of products of drug - food.

2. During the implementation of this Circular, if any difficulties arise, the units report to the Ministry of Health (Department of Safety and Food Hygiene) for consideration and settlement.