LATEST PROCEDURE FOR FUNCTIONAL FOOD DISCLOSURE

Figure 1. THINH TRI - Providing functional food announcement services.

• Functional foods are a popular product on the Vietnamese market today. The introduction of functional foods to the market must carry out procedures for announcing functional foods to competent state agencies. The following article will share with readers the procedure for announcing functional foods in accordance with the law.

OUTLINES

1. What are functional foods?

2. Dossiers for announcement of functional foods for domestically produced products.

3. Dossiers for declaration of functional foods for imported products.

4. Procedures for applying for the announcement of functional foods.

5. Functional food publication service – Thinh Tri Law.

1. What are functional foods?

• According to the provisions of Circular No. 43/2014/TT-BYT dated November 24, 2014 of the Ministry of Health on the management of functional foods, functional foods include complementary foods, health-protective foods, and nutritional supplements health and medical food, including food for special diets. Accordingly:

1. Supplemented Food (Health Supplement, Food Supplement, Dietary Supplement) is a common food supplemented with micronutrients and healthful elements such as:

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

b) Biological active ingredients of natural origin from animals, minerals and plants in forms such as extraction, isolation, concentration and transformation.

2. Health food (Health Supplement, Food Supplement, Dietary Supplement) is a product processed in the form of capsules, complete tablets, tablets, capsules, powders, liquids and other processed forms containing one or a mixture of the following substances:

3. Medical nutrition food, also known as nutritional food for special medical purposes (Food for Special Medical Purposes, Medical Food) is a type of food that can be eaten by mouth or by nebulizer intended to modify the patient's diet and should only be used under the supervision of medical personnel.

4. Food for Special Dietary Uses (Food for Special Dietary Uses) for dieters, the elderly and other special subjects as prescribed by the International Committee for Food Standards (CODEX) are those foods that are specially formulated or mixed to meet the specific dietary requirements of the user's physical condition or specific medical conditions and disorders. The composition of this food must be markedly different from that of ordinary foods of the same nature, if any.

• For all the products specified above, if they want to be sold on the Vietnamese market, must carry out the procedures for announcing the regulation conformity and conformity with the food safety regulations (commonly known as the procedure for announcing the functional foods).

(Article 2, Circular No. 43/2014/TT-BYT)

2. Composition of dossiers for declaration of functional foods for domestically produced products.

• For domestically produced functional food products, the profile includes:

A) Dossier of declaration of conformity with food safety regulations

1- Declaration of conformity with food safety regulations, specified in Form No. 02 issued together with Decree 38/2012/ND-CP;

2- A detailed product information sheet, specified in Form No. 03a or Form No. 03c issued together with Decree 38/2012/ND-CP;

 

3- Results of product testing within 12 months (original or notarized copy enclosed with the original for comparison or consular legalization), include the criteria required by relevant technical regulations , of a designated or accredited independent or accredited testing laboratory;

4- Sample of the product label (certified by the organization or individual);

5- Completed product samples for comparison when submitting dossiers;

6- Information and scientific documents proving the effects of each ingredient that make up the announced function (copy certified by the organization or individual);

7- Results of testing the effectiveness of the product for functional foods with new uses, made from new substances or according to new technologies, which have been released for circulation on the Vietnamese market for the first time being proven to be safe and effective;

8- The quality control plan is developed and applied according to the form specified in Form No. 04 issued together with Decree 38/2012/ND-CP (certified by organizations and individuals);

9- Periodic monitoring plan (certified by the organization or individual).

B) General legal documents

10- A business registration certificate with a food business line or a certificate of legal entity for organizations or individuals importing food (a copy certified by the organization or individual);

11- Certificate of establishments meeting food safety conditions, for importers subject to the issuance of certificates of establishments meeting food safety conditions as prescribed (a copy certified by the organization, individual);

12- Certificate of conformity with standards of HACCP or ISO 22000 or equivalent in case organizations and individuals producing products have a quality management system certified in accordance with HACCP or ISO 22000 or equivalent standards (copy) a notarized copy or a copy showing the original for comparison).

• Number of dossiers: 02 sets of dossiers for announcement of regulation conformity and 01 set of general legal documents
• In the process of preparing documents for the announcement of dietary supplements, if you need advice, please contact Thinh Tri Law immediately for a free consultation via hotline 1800 6365.

3. Components of application for declaration of functional foods for imported products::

•  Dossier for declaration of functional foods for imported products include:

A) Dossier of declaration of conformity with food safety regulations

1- Declaration of conformity with food safety regulations, specified in Form No. 02 issued together with Decree 38/2012/ND-CP;

2- A detailed product information sheet, specified in Form No. 03b promulgated together with Decree 38/2012/ND-CP (with the seal of the organization or individual);

3- A certificate of free sale or a medical certificate or an equivalent certificate issued by a competent state agency of the country of origin that states that the product is safe for consumers' health and in accordance with food legislation (original or notarized copy or consular legalization);

4- The result of product testing within 12 months (original or notarized copy enclosed with the original for comparison or consular legalization), includes the criteria required by the respective technical regulations , of a designated testing laboratory or a accredited testing laboratory.

 

5- Periodic monitoring plan (certified by organizations and individuals);

6- Product labels circulated in the country of origin and sub-labels in Vietnamese (certified by organizations or individuals);

7- Completed product samples for comparison when submitting dossiers;

8- Information and scientific documents proving the effect of each ingredient that make up the announced function (copy certified by the organization or individual).

9. Business registration certificate with food business line or certificate of legal entity for organizations or individuals importing food (a copy certified by the organization or individual);

10- Certificate of establishments meeting food safety conditions, for importers who are subject to the issuance of certificates of establishments meeting food safety conditions as prescribed (a copy certified by the organization, individual);

B) General legal dossier

11- Certificate of conformity with HACCP or ISO 22000 standards or equivalent in case organizations or individuals producing products have a quality management system certified in accordance with HACCP or ISO 22000 or equivalent standards (a notarized copy or a copy showing the original for comparison).

• Number of dossiers: 02 sets of dossiers for announcement of regulation conformity and 01 set of general legal dossier.

4. Procedures for the announcement of functional foods:

The order and procedures for the announcement of functional foods include the following 3 steps:

• Step 1: Organizations and individuals send dossiers to the Food Safety Department.
• Step 2: The Department of Food Safety receives the application and checks it. Within 30 working days from the date of receipt of complete and valid dossiers, a Certificate of Receipt of the announcement of conformity with food safety regulations must be issued. In case the Receipt is not granted, a written reply must be given to the reason for not granting it.
• Step 3: Return the receipt of the announcement of conformity with food safety regulations to the organization or individual announcing the product.

5. Functional food publication – Thinh Tri Law Firm:

 

Figure 2. THINH TRI Law Firm – Support all legal issues for clients.

• Thinh Tri Law Firm is currently the leading functional food publication consulting unit in the country. Currently, we provide a full package of functional food announcement consulting services including:

• Evaluation of the enterprise's application for publication of functional foods, specific advice on the legality of the dossier;
• Support and provide businesses with test criteria to optimize testing costs, helping to save business budgets;
• Prepare publication documents (advise on necessary procedures, draft, amend and supplement inappropriate documents);
• Submit dossiers at competent state agencies and supervise the application appraisal process, pay fees and charges on behalf of enterprises and receive notices and results, etc.
• Conduct sample product testing at the Appraisal Agency if the enterprise needs;
• Return the results of the announcement of functional foods to the enterprise on time.

• With a team of lawyers not only knowledgeable and fluent in the law but also know how to apply it to provide legal services in a beneficial direction, protect the legitimate rights and interests of customers. Our company always attracts and trains human resources to become lawyers with a warm heart, "clean" hands and a "cold" head with sharp legal thinking plus passion, Persistence and compassion will provide you with the best quality legal services.

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• Please contact us immediately via the toll-free hotline 1800 6365 for immediate advice on your issues.