Circular No. 24/2019/TT-BYT of the Ministry of Health stipulates on the management and use of food additives

CIRCULAR

Regulations on the management and use of food additives

Pursuant to the Law on Food Safety Control dated June 17, 2010;rime Minister cPursuant to Decree No. 15/2018/NĐ-CP dated February 2, 2018 of the Government detailing a number of articles of the Law on Food Safety Control;

Pursuant to DecreeNo. Pursuant to Decree No. 75/2017/NĐ-CP dated June 20, 2017 of the Government stipulating the functions, tasks, powers, and organizational structure of ministries and ministerial-level agencies."b) In addition to the lists of public services issued according to the provisions of Clause 2, Article 4 of this Decree, specialized agencies under provincial People's Committees shall report to the provincial People's Committee for decision-making on amending, supplementing, or issuing the list of public services funded by the state budget within their jurisdiction and consistent with the local budget capacity within the approved budget by the Provincial People's Assembly, and send it to the Ministry of Finance and relevant ministries and sectors for supervision during implementation."The Minister of Health issues this Circular on the management and use of food additives.rime Minister c;

This Circular stipulates the list of food additives; the use and management of food additives, and the responsibilities of relevant agencies, organizations, and individuals.of the Government stipulating functions, tasks, powers, and organizational structure of the Ministry of Home Affairsu t, amended and supplemented by Decree No. 109/2025/NĐ-CP and Decree No. 193/2025/NĐ-CP based on Decree No. 24/2014/ND-CP dated April 4, 2014 issued by the Governmentpolicies;

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

This Circular applies to organizations and individuals producing, trading, importing food and food additives for circulation in Vietnam, and relevant agencies, organizations, and individuals.rime Minister cm shall be used.

PART I

GENERAL PROVISIONS

Article 1. Scope of Regulation

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

Article 2. Applicability

CAC

Article 3. Explanation of Terms

is the abbreviation for the English name of the Codex Alimentarius Commission.

1. JECFA is the abbreviation for the English name of the Joint FAO/WHO Expert Committee on Food Additives.

2. Flavoring substance (a type of food additive) is a substance added to food to affect, adjust, or enhance its flavor. Flavoring substances include natural flavoring substances, nature-identical flavoring substances, artificial flavoring substances, and smoke flavorings, and mixtures thereof; they may contain non-flavoring food components under the conditions specified in Clause 3.5 of National Standard TCVN 6417:2010 Guidelines for the Use of Flavoring Substances. Flavoring substances do not include substances that solely provide sweetness, sourness, or saltiness (such as sugar, vinegar, or table salt); flavor enhancers are considered food additives under the Codex Classification System for Food Additives (CAC/GL 36-1989 Codex Class Names and the International Numbering System for Food Additives).

3. Non-flavoring food component is a food component used as a food additive; types of food necessary for the production, preservation, transportation of flavoring substances, or added to dissolve, disperse, or dilute them.

4. Acceptable Daily Intake (ADI) is the daily intake of a food additive throughout life without appreciable risk to health, expressed in milligrams per kilogram of body weight.

5. Acceptable Daily Intake "Not Specified" or "Not Limited" is the daily intake of a food additive with very low toxicity based on available scientific data on chemistry, biochemistry, toxicology, and other factors sufficient to achieve the desired effect and be acceptable in food without appreciable risk to health.

6. Maximum Usage Level (ML) is the maximum amount of a food additive used effectively for a specific function in a particular food or group of foods; it is usually expressed in milligrams of additive per kilogram of food or milligrams of additive per liter of food.

7. New Function Mixed Food Additive is a food additive containing two or more food additives and having a function different from those prescribed for each individual food additive.

PART II

PROVISIONS ON THE LIST OF FOOD ADDITIVES PERMITTED FOR USEALLOWED TO BE USED

Article 4. Principles for compiling the list of food additives permitted for use

1. Ensuring safety for human health.

2. Harmonizing with international standards and regulations on managing and using food additives.

3. Updating according to risk management recommendations for food additives issued by competent Vietnamese authorities, CAC, JECFA, and foreign countries.

1. The list of food additives permitted for use in food at Appendix 1 is promulgated together with this Circular.

2. The maximum usage levels of food additives in food at Appendices 2A and 2B are promulgated together with this Circular.

3. The list of food additives and food categories for use according to GMP at Appendix 3 is promulgated together with this Circular.

Article 6. Classification and description of food groups using food additives

2. The food classification specified in Clause 1 of this Article shall not be used to name products or label goods.

3. Principles for applying food group codes:

a) When a food additive is used for a large food group, it may also be used for subgroups within that large group, unless otherwise specified;

b) When a food additive is used in a subgroup, it may also be used in smaller subgroups or individual foods within that subgroup, unless otherwise specified.

Chapter III

REGULATIONS ON THE USE OF FOOD ADDITIVES

Article 7. General principles for using food additives

1. Using food additives in food must ensure:

a) The food additive is permitted for use and appropriate for the type of food;

b) Not exceeding the maximum usage level for a particular food or food group;

c) Minimizing the amount of food additive necessary to achieve the desired technical effect.

2. Food additives may only be used if their use achieves the desired effect without posing a risk to human health, misleading consumers, and solely to fulfill one or more functions of food additives as follows when these effects cannot be achieved by other economically and technologically more effective means:

a) Maintaining the nutritional value of food. For products intended for special purposes where food additives are used as food components (such as artificial sweeteners), compliance with the provisions of this Circular is not required;

b) Enhancing the maintenance of quality or stability of food or improving sensory characteristics but not altering the nature or quality of the food to mislead consumers;

c) Supporting production and transportation but not to conceal the impact of using low-quality raw materials or unsuitable production techniques.

3. Food additives must meet technical and food safety requirements as stipulated in the following documents:

a) National technical standards or regulations in normative legal documents of competent state agencies in cases where there are no national technical standards;

b) National standards in cases where there are no provisions under point a of this clause;

c) Standards of CAC, JECFA, regional standards, and foreign standards in cases where there are no provisions under points a and b of this clause;

d) Manufacturer's standards in cases where there are no provisions under points a, b, and c of this clause.

4. In addition to being present in food due to their use during food production, food additives may also be present in food due to their presence in raw materials or components used to produce food, and must comply with the provisions of Article 9 of this Circular.

Article 8. Principles for Determining the Maximum Level of Food Additives According to Good Manufacturing Practices (GMP)

1. Minimize the amount of food additives used to achieve the desired technical effect.

2. The quantity of food additives used in the production process must ensure that they do not alter the nature of the food or the food production technology.

3. Food additives must ensure quality and safety for use in food and be processed and transported like food ingredients.

Article 9. Food Additives Present in Food Due to Being Introduced from Ingredients or Components Already Containing Additives

1. Food additives present in food due to being introduced from ingredients or components used in food production must meet the following requirements:

a) Permitted for use in ingredients or components (including food additives);

b) Not exceeding the maximum usage level in ingredients or components (including food additives);

c) Food containing food additives introduced from ingredients or components must ensure that the quantity of such food additives does not exceed the maximum usage level in the ingredients or components used in the food production process according to the production technology.

2. Food additives not permitted for use in ingredients or components for food production may be used or added to those ingredients or components if produced or imported for internal production purposes of the enterprise or enterprises importing and distributing, upon agreement by the food producing enterprise and must meet the following requirements:

a) Such ingredients or components can only be used for the production of a specific type of food;

b) Food additives must be permitted for use and the usage quantity must not exceed the maximum usage level for that type of food;

c) Must be registered for product declaration in accordance with Clause 2, Article 11 of this Circular.

3. Product groups that do not accept additives brought in from components and ingredients for food production, except when such additives are specifically provided for in Appendix 2A, Appendix 2B, and Appendix 3 issued together with this Circular, include:

a) Formula nutrition products for infants and young children, formula nutrition products with special medical purposes for infants (food group code 13.1);

b) Supplementary foods for infants and young children (food group code 13.2).

4. Food additives introduced into food from ingredients or components for food production but which do not create an effect on the final product are not required to be listed in the composition of the food.

Article 10. Requirements for Dividing, Repackaging, Refilling, and Blending Food Additives

1. Requirements for dividing, repackaging, refilling:

a) Dividing, repackaging, refilling, and repackaging of food additives can only be done with the written consent of the organization or individual producing or responsible for the product;

b) Dividing, repackaging, refilling, and repackaging of food additives must ensure that it does not affect the quality and safety of the product and does not pose a risk to human health;

c) The label of divided, repackaged, refilled, and repackaged food additives must indicate the date of division, repackaging, refilling, and repackaging. The shelf life must be calculated from the production date of the food additive indicated on the original label before division, repackaging, refilling, and repackaging;

d) Comply with other relevant regulations related to the production and business of food additives.

2. Requirements for blending food additives, mixed food additives:

a) Blending of food additives is only allowed when it does not cause any risk to human health;

b) List the quantitative composition for each food additive in the composition;

c) Provide guidance on the maximum usage level, food category, and function.

d) Comply with other relevant regulations related to the production and business of food additives.

Chapter IV

REGULATIONS ON FOOD ADDITIVE MANAGEMENT

Article 11. Announcement of Products

1. Food additives must self-declare their products before circulating on the market, except for food additives specified in Clause 2 of this Article and Clause 2 of Article 4 of Decree No. 15/2018/NĐ-CP dated February 2, 2018, guiding detailed implementation of certain provisions of the Law on Food Safety. The procedures for self-declaration of products shall be carried out in accordance with Article 5 of Decree No. 15/2018/NĐ-CP dated February 2, 2018, guiding detailed implementation of certain provisions of the Law on Food Safety and Point a, Clause 1, Article 3 of Decree No. 155/2018/NĐ-CP dated November 12, 2018, amending and supplementing certain regulations related to investment conditions within the scope of management of the Ministry of Health.

2. Mixed food additives with new functions, food additives not included in the list of permitted food additives or not in accordance with the prescribed usage objects under this Circular must register their product declarations at the National Food Safety Authority, Ministry of Health, before use or circulation on the market. The procedures for registering product declarations shall be carried out in accordance with Articles 7 and 8 of Decree No. 15/2018/NĐ-CP dated February 2, 2018, guiding detailed implementation of certain provisions of the Law on Food Safety.

Article 12. Labeling

The labeling of food additives shall be implemented in accordance with Decree No. 43/2017/NĐ-CP dated April 14, 2017, on product labeling and other relevant documents.

Cases of administrative violations concerning food safety in the production, business, and use of food additives will be punished according to the provisions of Decree No. 115/2018/NĐ-CP dated September 4, 2018, on administrative sanctions for violations of food safety laws and other relevant documents. In cases where there are aggravating circumstances as stipulated in the Law on Administrative Sanctions, the competent authority shall impose fines and revoke the right to use the Registration Acceptance Certificate for Product Declarations at the highest level.

CHAPTER V

IMPLEMENTING PROVISIONS

Article 14. Transitional Provisions

1. Food additives and food products using food additives that have been issued a Registration Acceptance Certificate for Compliance Declaration or a Confirmation Certificate for Compliance with Food Safety Regulations prior to the effective date of this Circular shall continue to be used until the expiration date stated in the Registration Acceptance Certificate or Confirmation Certificate or the expiration date of the product, except in cases of food safety warnings.

2. Food additives and food products using food additives that have completed self-declaration of products or received a Registration Acceptance Certificate for Product Declarations prior to the effective date of this Circular, if they do not comply with the provisions of this Circular, shall continue to be used until the expiration date of the product, except in cases of food safety warnings.

Article 15. Reference Provisions

In cases where the referenced documents in this Circular are amended, supplemented, or replaced, the new documents shall apply.

Article 16. Effective Date

1. This Circular takes effect from October 16, 2019.

2. Abolish Circular No. 27/2012/TT-BYT dated November 30, 2012, guiding the management of food additives by the Minister of Health, Circular No. 08/2015/TT-BYT dated May 11, 2015, amending and supplementing certain provisions of Circular No. 27/2012/TT-BYT dated November 30, 2012, guiding the management of food additives by the Minister of Health, and Part III of Decision No. 3742/2001/QĐ-BYT dated August 31, 2001, specifying the list of permitted substances for use in food by the Minister of Health, from the date this Circular takes effect.

Article 17. Responsibility for Implementation

1. The National Food Safety Authority is responsible for organizing the implementation, inspection, and supervision of the enforcement of this Circular nationwide, in collaboration with relevant agencies.

3. Organizations and individuals engaged in the production, business, and importation of food additives and food must ensure:

a) The production, business, importation, and use of food additives in accordance with the provisions of this Circular;

b) Cease production, business, importation, and notify relevant authorities when discovering food additives that do not meet the requirements of this Circular;

c) Recall and handle food additives that do not meet safety requirements in accordance with current laws.

d) In cases where additional food additives or food objects not specified in this Circular are proposed, organizations and individuals must provide scientific evidence to prove the safety of the product to be considered.

4. The Director of the Ministry's Office, the Inspector General of the Ministry, Heads of Departments, Directors of Agencies, and General Directors of Departments and Agencies under the Ministry of Health, and other relevant organizations and individuals are responsible for implementing this Circular.

During the implementation process, if there are difficulties, relevant agencies, organizations, and individuals should promptly report to the Ministry of Health (National Food Safety Authority) for consideration and resolution./.