Circular 24/2019/TT-BYT prescribing the management and use of food additives

CIRCULAR

Prescribing the management and use of food additives^[1]

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

Pursuant to the Government’s Decree No. 15/2018/ND-CP of February 2, 2018, detailing a number of articles of the Law on Food Safety;

Pursuant to the Government’s Decree No. 75/2017/ND-CP of June 20, 2017, defining the functions, tasks, powers and organizational structure of the Ministry of Health;

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

The Minister of Health promulgates the Circular prescribing the management and use of food additives.

Chapter I

GENERAL PROVISIONS

Article 1. Scope of regulation

This Circular promulgates the list of food additives, prescribes the use and management of food additives, and defines responsibilities of related agencies, organizations and individuals.

Article 2. Subjects of application

This Circular applies to organizations and individuals that produce, trade in or import food and food additives for sale in Vietnam and related agencies, organizations and individuals.

Article 3. Interpretation of terms

In this Circular, the terms and abbreviations below are construed as follows:

1. CAC stands for the Codex Alimentarius Commission.

2. JECFA stands for the Joint FAO/WHO (the United Nations’ Food and Agriculture Organization/World Health Organization) Expert Committee on Food Additives.

3. Flavorings (categorized as food additives) means substances that are added to food to impact, modify, or enhance the flavor of food. Flavorings may include flavoring substances, natural flavoring complexes, thermal process flavorings or smoke flavorings and mixtures thereof and may contain non-flavoring food ingredients within the conditions referred to in Section 3.5 of national standard TCVN 6417:2010 Guidelines for the use of flavorings. Flavorings do not include substances that have exclusively a sweet, sour, or salty taste (e.g., sugar, vinegar, and table salt); and flavor enhancers considered food additives under the Codex Class Names and the International Numbering System for Food Additives - CAC/GL 36-1989).

4. Non-flavoring food ingredients means food ingredients used as food additives; foods that are necessary for the production, storage and transport of flavorings or can be added to flavorings for dissolving, dispersing, or diluting flavorings.

5. Acceptable daily intake (ADI) means an estimate of the amount of a food additive that can be ingested daily over a lifetime without appreciable risks to human health, expressed on a body weight basis (mg/kg).

6. Acceptable daily intake “not specified” or “not limited” means the daily dietary intake of a food additive of very low toxicity which, on the basis of the available data (chemical, biochemical, toxicological, and other), and the total dietary intake of the substance arising from its use at the levels necessary to achieve the desired effects and from its acceptable background levels in food, does not represent appreciable risks to human health.

7. Maximum use level (ML) means the highest concentration of a food additive determined to be functionally effective in a food or food category and generally expressed as milligram of food additive per kilogram of food or milligram of food additive per liter of food.

8. Complex food additive with new uses means a good additive containing two (2) or more additive substances and having uses different from those assigned for each of those additive substances.

Chapter II

LIST OF FOOD ADDITIVES PERMITTED FOR USE

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

1. Ensuring safety for human health.

2. Being in harmony with international standards and regulations on management and use of food additives.

3. Being updated according to recommendations on management of food additive-related risks of Vietnamese authorities, CAC, JECFA and foreign authorities.

Article 5. List of food additives permitted for use and level of maximum use in food

1. Promulgated together with this Circular is the List of food additives permitted for use in food in Appendix 1.

2. Promulgated together with this Circular are levels of maximum use of food additives in food in Appendix 2A and Appendix 2B.

3. Promulgated together with this Circular are the List of food additives and foods in which food additives can be used according to GMP in Appendix 3.

4. Flavorings for use in food include flavorings assessed and determined by JECFA to be safe in estimated intakes or acceptable daily intakes. These flavorings must meet the relevant technical requirements on identification and purity and conform to national standard TCVN 6417:2010 Guidelines for the use of flavorings, and comply with this Circular.

Article 6. Categorization and description of food categories using food additives

1. Promulgated together with this Circular are food categories and descriptions thereof in Appendix 4 for determining food categories subject to Appendix 2A and Appendix 3.

2. The food categories mentioned in Clause 1 of this Article shall not be used for prescribing the product reference and naming and goods labeling.

3. Principles of application of codes of food categories:

a/ When a food additive is used in food of a category, it may also be used for sub-categories of such category, unless otherwise provided by law;

b/ When a food additive is used in food of a sub-category of a category, it may also be used for other smaller sub-categories or specific food in such sub-category, unless otherwise provided by law.

Chapter III

USE OF FOOD ADDITIVES

Article 7. General principles on use of food additives

1. The use of a food additive in food must ensure that:

a/ It is permitted for use and used in appropriate food;

b/ It is used in a food or food category not in excess of the maximum use level;

c/ Its use level necessary to achieve the desired technical effects is minimal.

2. Food additives may only be used when their use achieves the desired effects without posing risks to human health or deceiving consumers and for the only purpose of utilizing one or more than one function of such food additives according to the following requirements in case such requirements cannot be met by more economically and technologically effective methods:

a/ Maintaining the nutritional value of food. Products used for special purposes in which food additives are among their ingredients (e.g., dietary sugar) are not subject to control under this Circular;

b/ Enhancing the maintenance of quality or stability or improving sensory appearance of food without changing the food nature or quality for the purpose of deceiving consumers;

c/ Supporting the food production or transport not for the purpose of concealing effects caused by the use of inferior-quality materials or inappropriate manufacturing and technical practices.

3. Food additives must meet the technical and food safety requirements prescribed in:

a/ National technical regulations or provisions of legal documents of competent state agencies in case of absence of national technical regulations;

b/ National standards in case of absence of regulations or provisions mentioned at Point a of this Clause;

c/ Standards of CAC and JECFA, regional standards and foreign standards in case of absence of regulations or provisions mentioned at Points a and b of this Clause;

d/ Standards of producers in case of absence of regulations or provisions mentioned at Points a, b and c of this Clause.

4. In addition to being found in food due to their use in the food production, food additives may be contained in food due to the use of materials or ingredients for food production which already contain them and must comply with Article 9 of this Circular.

Article 8. Principles of determining the maximum use level of food additives according to good manufacturing practices (GMP)

1. Their use levels necessary to achieve the desired technical effects are minimal.  

2. Their use levels in the food production do not change the food nature or food production technology.

3. They are of quality and safe for use in food and processed and transported like food materials.

Article 9. Food additives found in food due to the use of materials or ingredients for food production which already contain additives

1. Food additives found in food due to the use of materials or ingredients for food production must meet the following requirements:

a/ They are permitted for use in food materials or ingredients (including also food additives);

b/ They are used not in excess of the maximum use level in  food materials or ingredients (including also food additives);

c/ Food containing food additives due to the use of materials or ingredients must ensure that the content of such food additives does not exceed the maximum use levels in materials or ingredients used for food production according to the production process or technology.

2. Food additives not permitted for use in materials or ingredients for food production may be used in or added to such materials or ingredients if they are produced or imported for use in internal production of enterprises or if their importers and distributors have entered into contracts with their producers and must meet the following requirements:

a/ Such materials or ingredients are used exclusively for production of a specific food;

b/ Food additives are permitted for use and used not in excess of the maximum use level prescribed for such food;

c/ Product declaration is registered under Clause 2, Article 11 of this Circular.

3. Product categories for which food additives contained in materials and ingredients for food production are not accepted, unless such additives are specified in Appendices 2A, 2B and 3 to this Circular, including:

a/ Formula nutritional products for newborns and infants, and formula nutritional products used for special medical purposes for newborns (food category heading 13.1);

b/ Supplements for newborns and infants (food category heading 13.2).

4. Food additives found in food due to the use of materials or ingredients for food production without creating uses of ultimate food products are not required to be listed as ingredients of such products.

Article 10. Requirements on portioning, division into servings, filling, repackaging and mixing of food additives

1. Requirements on portioning, division into servings, filling and repackaging of food additives:

a/ Food additives may be portioned, divided into servings, filled or repackaged only when written consents of their producers or entities responsible for them are obtained;

b/ The portioning, division into servings, filling and repackaging of food additives do not affect the quality and safety of food products and pose no risks to human health;

c/ Labels of food additives that are portioned, divided into servings, filled or repackaged must also show the date of portioning, division into servings, filling or repackaging. The expiry date must be counted from the date of production of food additives shown in their original labels before they are portioned, divided into servings, filled or repackaged;

d/ The portioning, division into servings, filling and repackaging of food additives must comply with other relevant regulations on production of and trading in food additives.

2. Requirements on mixing of food additives and mixed food additives:

a/ Food additives may only be mixed if the mixed products pose no risks to human health;

b/ Quantitative ingredients of each food additive must be listed;

c/ Instructions on the maximum use level, food in which food additives may be used and functions of food additives must be provided;

d/ The mixing of food additives and mixed food additives must comply with other relevant regulations on production of and trading in food additives.

Chapter IV

MANAGEMENT OF FOOD ADDITIVES

Article 11. Declaration of products

1. Food additives are subject to product declaration by their producers before being marketed, except those specified in Clause 2 of this Article and Clause 2, Article 4 of the Government’s Decree No. 15/2018/ND-CP of February 2, 2018, detailing a number of articles of the Law on Food Safety (below referred to as Decree No. 15/2018/ND-CP). The order and procedures for product declaration must comply with Article 5 of Decree No. 15/2018/ND-CP and Point a, Clause 1, Article 3 of the Government’s Decree No. 155/2018/ND-CP of November 12, 2018, amending and supplementing a number of regulations on business investment conditions subject to the state management by the Ministry of Health.

2. For mixed food additives with new uses, food additives not on the list of food additives permitted for use or used for ineligible persons under this Circular, written product declarations must be registered with the Vietnam Food Administration of the Ministry of Health before such food additives are put into use or marketed. The order and procedures for registration of written product declarations must comply with Articles 7 and 8 of Decree No. 15/2018/ND-CP.

Article 12. Labeling

The labeling of food additives must comply with the Government’s Decree No. 43/2017/ND-CP of April 14, 2017, on goods labeling, and other relevant legal documents.

Article 13. Handling of food safety-related administrative violations in the production of, trading in and use of food additives

Food safety-related administrative violations in the production of, trading in and use of food additives shall be sanctioned under the Government’s Decree No. 115/2018/ND-CP of September 4, 2018, prescribing the sanctioning of food safety-related administrative violations, and other relevant legal documents. For violations involving aggravating circumstances as prescribed in the Law on Handling of Administrative Violations, competent persons shall consider and decide on monetary fines to be imposed and deprive the right to use receipts for registration of product declarations.

Chapter V

IMPLEMENTATION PROVISIONS

Article 14. Transitional provisions   

1. Food additives and food products using food additives for which receipts of written regulation conformity declarations or written certifications of declaration of food safety regulation conformity are issued before the effective date of this Circular may continue to be used until the expiration of the validity duration stated in such receipts or certifications or expiry date of products, unless there are food safety warnings.

2. Food additives and food products using food additives for which product self-declaration is made by producers or for which receipts for registration of product declarations are issued before the effective date of this Circular and which fail to comply with this Circular may continue to be used until their expiry date, unless there are food safety warnings.

Article 15. References

In case documents referred to in this Circular are revised or replaced, the revising or replacing documents prevail.

Article 16. Effect

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

2. To annul the Minister of Health’s Circular No. 27/2012/TT-BYT of November 30, 2012, guiding the management of food additives, Circular No. 08/2015/TT-BYT of May 11, 2015, amending and supplementing a number of provisions of Circular No. 27/2012/TT-BYT, and Part III of the Minister of Health’s Decision No. 3742/2001/QD-BYT of August 31, 2001, promulgating the list of food additives permitted for use in food, as from the effective date of this Circular.

Article 17. Implementation responsibility

1. The Vietnam Food Administration shall assume the prime responsibility for, and coordinate with related competent agencies in, organizing, examining and inspecting the implementation of this Circular nationwide.

2. The Vietnam Food Administration shall propose amendments to this Circular once every two (2) years or when finding it necessary to meet the management requirements based on updated CAC standards and proposals of food additive and food producers and traders.

3. Food additive and food producers, traders and importers shall:

a/ Produce, trade in, import and use food additives under this Circular;

b/ Stop producing, trading in or importing food additives detected as not satisfying the safety requirements prescribed in this Circular, and notify such to related competent agencies;

c/ Recall and dispose of food additives not satisfying the safety requirements in accordance with current laws;

d/ In case of requesting addition of food additives, food types sand categories and use levels not yet specified in this Circular, provide scientific documents to prove product safety for consideration.

4. The Chief of the Office, Chief Inspector, directors of departments or administrations, and general directors of the administrations, departments and directorates of the Ministry of Health and related agencies, organizations and individuals shall implement this Circular.

Any problems arising in the course of implementation of this Circular should be promptly reported to the Ministry of Health (the Vietnam Food Administration) for consideration and solution.-

For the Minister of Health
Deputy Minister
TRUONG QUOC CUONG

 * The appendices to this Circular are not translated.