Circular 17/2023/TT-BYT amend legal documents relating to food safety

CIRCULAR

Amending, supplementing and annulling a number of legal documents relating to food safety issued by the Minister of Health

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Pursuant to the Law No. 80/2015/QH13 on Promulgation of Legal Documents dated June 22, 2015; the Law No. 63/2020/QH14 on Amending and Supplementing a Number of Articles of the Law on Promulgation of Legal Documents dated June 18, 2020;

Pursuant to the Law No. 55/2010/QH10 on Food Safety dated June 17, 2010;

Pursuant to the Government’s Decree No. 15/2018/ND-CP dated February 02, 2018 on detailing the implementation of a number of articles of the Law on Food Safety;

Pursuant to the Government's Decree No. 95/2022/ND-CP dated November 15, 2022 on defining the functions, tasks, powers and organizational structure of the Ministry of Health;

At the proposal of the Director of Vietnam Food Administration;

The Minister of Health promulgates the Circular amending, supplementing and annulling a number of legal documents relating to food safety issued by the Minister of Health.

Article 1. Amending and supplementing a number of articles of the Minister of Health’s Circular No. 24/2019/TT-BYT dated August 30, 2019 on prescribing the management and use of food additives

1. To amend Clause 8 Article 3 as follows:

“8. Complex food additive with new uses means a good additive containing two (02) or more additive substances and having at least one (01) uses different from those assigned for each of those additive substances.”

2. To amend and supplement Clause 4 Article 5 as follows:

“4. Flavorings for use in food include flavorings in one of the following lists:

a) Flavorings assessed and determined by JECFA to be safe in estimated intakes or acceptable daily intakes (ADI);

b) Flavorings generally recognized as safe (GRAS) by the United States’ Flavor and Extract Manufacturers Association (FEMA);

c) Flavorings for use in food of the European Union issued by the European Parliament and the Council of the European Union.”.

3. To add Clause 5 and Clause 6 to Article 5 as follows:

“5. Appendix 2A and Appendix 3 are updated according to Table 1 and Table 3 of the latest standards of the General Standard for Food Additives (CODEX STAN 192-1995) of the Codex Alimentarius Commission (CAC).

For food additives that are not specified in Appendix 2A and Appendix 3 but are defined in the standards of CAC for food products, they are allowed to be used in accordance with such standards.

6. In case the maximum use level of a food additive in a type of food product specified in Clause 5 of this Article is different from that defined in Appendix 2B, Clause 5 of this Article shall apply.”

4. To add 18 food additives to Appendix 2B - Maximum use level of food additives in food that have not been regulated according to CODEX STAN 192-1995 standard (2018) in Appendix 1 issued together with this Circular.

5. To amend and supplement Clause 1 Article 6 as follows:

“1. To promulgate together with this Circular Classification and description of food groups in Appendix 4 to apply to codes of food group specified in Appendix 2A, Appendix 2B and Appendix 3. Appendix 4 is updated according to Annex B of CAC’s latest standards on food additives.”

6. To amend and supplement Clause 2 Article 17 as follows:

“2. The Vietnam Food Administration shall be responsible for:

a) Guiding the lookup of regulations on the use of food additives of CAC, list or database on food flavorings of JECFA, FEMA and the European Union on the website of the Vietnam Food Administration (https://vfa.gov.vn).

b) Proposing to review and amend this Circular according to management requirements or at the requests of organizations and individuals producing and trading of food additives and food.”

Article 2. Amending and supplementing the Regulations on maximum limits of biological and chemical contamination in food issued together with the Minister of Health’s Decision No. 46/2007/QD-BYT dated December 19, 2007 as follows:

1. To amend and supplement Part 7 as follows:

“Part 7. List of processing aids permitted for use in food production and trading, guidance on safe use of processing aids in food production and trading.

1. List of processing aids permitted for use in food production and trading is defined in Appendix issued together herewith.

2. The safe use of processing aids in food production and trading shall comply with principles specified in Section 3. Principles for safe use of processing aids in the National Standard TCVN 11429:2016 (CAC/GL 75:2010) on Guidelines on substances used as processing aids.”

2. List of processing aids permitted for use in food production and trading is defined in Appendix 2 issued together with this Circular.

Article 3. Amending and supplementing a number of articles of the Minister of Health’s Circular No. 18/2019/TT-BYT dated July 17, 2019 providing for Guidelines on good manufacturing practice (GMP) in production and trading of health supplements

1. To amend Article 4 as follows:

“Article 4. Regulations on application of GMP and certificates equivalent to certificate of food safety eligibility according to good manufacturing practice (GMP) requirements for imported health supplements

1. An imported health supplement must be made at an establishment that has been granted one of the following certificates presenting that the establishment has forms of products in conformity with forms of imported health supplement products by a competent agency of the country of manufacturing or an organization designated or recognized by a competent agency or another country's agency or organization recognized by a competent agency of the country of manufacturing:

a) Certificate of good manufacturing practice (GMP), for producers of health supplement products;

b) Certificate or assessment of good manufacturing practice (GMP) satisfaction, for drug or food producers;

c) For countries or territories that do not issue the certificates specified at Points a and b Clause 1 of this Article, the organization or individual shall submit a certificate that contains one of the following contents:

- Conformity with standards of the Hazard Analysis and Critical Control Point (HACCP);

- Conformity with the International Organization for Standardization 22000 (ISO 22000);

- Conformity with the International Food Standard (IFS);

- Conformity with Global Standard for Food Safety of British Retailer Consortium (BRC);

- Conformity with standards of Food Safety System Certification 22000 (FSSC 22000).

d) In case a country or territory does not issue the certificates specified at Points a, b and c Clause 1 of this Article, a certificate or written confirmation with the content that the producer meets law regulations of such country or territory is required.

2. A certificate specified in Clause 1 of this Article must contain at least the following information:

a) Name of issuing agency/organization;

b) Date of issue;

c) Validity duration (In case the certificate does not state the validity duration, an assessment report or periodic inspection record is required to ensure the production establishment’s maintenance of food safety conditions or assessment or periodic inspection duration under regulations of the country of origin/manufacturing of the product);

d) Full name and signature of the issuing person;

dd) Name and address of the establishment granted;

e) Scope and form of products.”

2. To amend the content of Section 7.11 Part VII Quality control in the Appendix issued together with this Circular as follows:

“7.11. Taking samples must avoid pollution, cross-contamination, confusion and must follow appropriate procedures, including the following contents:”

Article 4. Amending and supplementing a number of articles of the Minister of Health’s Circular No. 43/2014/TT-BYT dated November 24, 2014 defining the management of functional food

1. To amend the title of Article 3 as follows: “Article 3. Product self-declaration and registration of product declarations.”

2. To amend Clause 3 Article 3 as follows:

“3. Procedures for product self-declaration and procedures for registration of product declarations:

a) Procedures for product self-declaration are defined in Chapter II of the Government’s Decree No. 15/2018/ND-CP dated February 02, 2018, on detailing a number of articles of the Law on Food Safety and Clause 1 Article 3 Chapter I of the Government’s Decree No. 155/2018/ND-CP dated November 12, 2018, on amending and supplementing a number of regulations concerning business investment conditions under the state management of the Ministry of Health;

b) Procedures for registration of product declarations are specified in Chapter III of the Decree No. 15/2018/ND-CP.”

3. To amend Clause 2 and Clause 4 Article 4 as follows:

“2. The trial on effectiveness on people’s health must be carried out in accordance with biomedical research involving human participants specified in the Minister of Health’s Circular No. 04/2020/TT-BYT dated March 05, 2020, defining the establishment, functions, tasks and powers of council of ethics in biomedical research and must comply with processes, procedures and law regulations on science and technology.”

“4. In case an issue not regulated in this Circular arises, the receiving agency shall be responsible for reporting to the direct superior agency for a timely solution based on compliance with relevant law regulations, ensuring the health and rights of consumers and not affecting the food production and trading activities of organizations and individuals.”

4. To amend Points a and b Clause 1 Article 8 as follows:

“a) In case a nutrient’s content is less than 10% of RNI (Recommended Nutrition Intakes) or less than 10% of the usage amount of that ingredient stated in scientific evidence (for nutrients without RNI), claim of that nutrient is not allowed;

b) In case a nutrient’s content is at least 10% of RNI or at least 10% of the usage amount of that ingredient stated in scientific evidence (for nutrients without RNI), name and content of that nutrient per serve or per 100g of product may be claimed;”

5. To amend Clause 2 Article 8 as follows:

“2. Health claims:

a) Health claims for an additional nutrient shall only be implemented if such nutrient’s content in the food reaches at least 10% of RNI with concrete scientific evidence;

b) Health claims for an additional nutrient without RNI as specified shall be presented in the product label if such ingredient’s content reaches at least 10% of the usage amount of that ingredient stated in scientific evidence;

c) Health recommendations must be stated clearly and consistently, in conformity with the scientific evidence.”

6. To amend Points b and d Clause 1 Article 10 as follows:

“b) Content of a vitamin or mineral in the food calculated under the producer’s recommended daily intakes must be at least 15% of RNI defined in the Appendix No. 01 issued together with this Circular or at least 15% of the usage amount of that ingredient stated in scientific evidence;”

“d) For those of which Vietnam does not define RNI levels and tolerable upper intake levels, CODEX Alimentarius or relevant international organizations’ regulations shall apply.”

7. To amend Points d and dd Clause 2 Article 10 as follows:

“d) In case the daily intake of a vitamin or mineral in a product reaches at least 15% of RNI or at least 15% of the usage amount of that ingredient stated in scientific evidence, the product’s effects may be declared but its users and appropriate dosage must be stated;

dd) For an ingredient without RNI as defined, if its daily intake reaches at least 15% of the usage amount of that ingredient stated in scientific evidence, the product’s effects may be declared but its users and appropriate dosage must be stated.”

8. To amend Point a Clause 3 Article 10 as follows:

“a) The intended users must conform with the declared effects and be approved by the agency receiving the registration of product declaration via the organization or individual’s registration of product declaration.”

9. To amend first paragraph of Article 11 as follows:

“Addition to compliance with regulations on labeling, label of health supplements must satisfy the following regulations:”

10. To amend Clause 4 Article 11 as follows:

“4. The phrase “Thực phẩm này không phải là thuốc và không có tác dụng thay thế thuốc chữa bệnh” (This product is not a medicine and cannot replace medical treatment) must be written on the product’s label, right after the content of the product’s effects or at the same position as other recommendations (if any).”

Article 5. Amending and supplementing a number of articles of the Minister of Health’s Circular No. 48/2015/TT-BYT dated December 01, 2015 defining the food safety inspection in food production and trading under the management of the Ministry of Health

1. To amend and supplement Clauses 1 and 3 Article 2 as follows:

“1. Producers and traders of food products and product groups; goods under the management of the Ministry of Health specified in the Appendix II issued together with the Government's Decree No. 15/2018/ND-CP dated February 02, 2018, detailing a number of articles of the Law on Food Safety.”

“3. Food producers and traders within the management of many sectors or localities and the cases specified in Clause 8, Clause 10 Article 36, Clause 5 Article 41 of Decree No. 15/2018/ND-CP that the health sector is assigned to manage and assumes the prime responsibility for inspection.”

2. To amend and supplement Clause 2 Article 3 as follows:

“2. There is no overlap of objects, contents, locations and time of inspection. In case of overlap between inspection by a food safety management agency and inspection by its higher-level food safety management agency, between sectors and levels, to handle in the following order:

a) In case of overlap between inspection by the agency and inspection by its higher-level agency, to carry out according to the higher-level agency’s decision;

b) In case of overlap between an inter-sector inspection and one-sector inspection, the inter-sector inspection shall be carried out;

c) In case of overlap between inspection by an agency directly managing a product or product group according to the principles of assignment of responsibilities for state management of food safety defined in Article 36 of Decree No. 15/2018/ND-CP and inspection of another agency, the agency directly managing the product or product group shall carry out the inspection.”

3. To amend and supplement Points b and c Clause 1 Article 4 as follows:

“b) Departments of Health, Food Safety and Hygiene Sub-Departments, food safety management agencies of People's Committees of provinces and centrally-run cities (hereinafter referred to as provincial level) shall inspect the food safety in their provincial-level localities;

c) People's Committees of rural districts, urban districts, towns, provincial cities and cities of centrally-run cities (hereinafter referred to as district level) shall inspect the food safety in their district-level localities; assign the Health Divisions, Health Centers or specialized agencies to advise and assist district-level People's Committees in state management of food safety and performance of the task of food safety inspection in the localities;”

4. To amend and supplement Points a, b and h Clause 1 Article 6 as follows:

“a) Administrative and legal dossiers of an establishment:

enterprise registration certificate or business household registration certificate; certificate of food safety eligibility (inspect and assess according to type of establishments required or not required to possess a certificate as specified in Articles 11, 12 and 28 of the Decree No. 15/2018/ND-CP); health certificates, certificates of training in knowledge about food safety and hygiene of subjects as defined;

b) Dossier relating to the receipt of the registration of product declaration, product self-declaration, certificate of advertisement contents. To inspect and assess according to subjects and contents specified in Articles 4, 5, 6, 7, 8, 26 and 27 of Decree No. 15/2018/ND-CP;”

“h) Taking samples for testing if necessary. The sampling shall comply with the guidance in Article 6 of the Minister of Science and Technology’s Circular No. 26/2012/TT-BKHCN dated December 12, 2012, on defining the state inspection of the quality of goods in circulation and Clause 3, Clause 8 Article 1 of the Minister of Science and Technology’s Circular No. 12/2017/TT-BKHCN dated September 28, 2017, amending and supplementing a number of articles of Circular No. 26/2012/TT-BKHCN.”

5. To amend and supplement Points a and c Clause 2 Article 6 as follows:

“a) Administrative and legal dossiers of an establishment: To inspect according to the contents specified at Point a Clause 1 of this Article;”

“c) Sampling food, food additives, food processing aids and materials, products serving processing and eating for testing, when necessary. Taking samples for testing shall apply Point h Clause 1 of this Article.”

6. To amend and supplement Clause 3 Article 7 as follows:

“3. The planned inspection frequency must not exceed once a year, except for cases of unscheduled inspection specified in Article 8 of this Circular.”

7. To amend and supplement Article 10 as follows:

“Article 10. Handling of inspection results

1. Handling of violations in the course of food safety inspection shall comply with Point c Clause 1 Article 69 of the Law on Food Safety. In case an organization or individual commits an administrative violation, to make a written record of the administrative violation for handling in accordance with regulations. Making of written records of administrative violations shall comply with Article 12 of the Government's Decree No. 118/2021/ND-CP dated December 23, 2021, on detailing a number of articles of, and measures to implement, the Law on Handling of Administrative Violations.

2. A number of specific cases:

a) For food products not satisfying requirements for good labels, to apply Clause 1 Article 9 of Circular No. 26/2012/TT-BKHCN; Clause 6, Clause 8 Article 1 of Circular No. 12/2017/TT-BKHCN and relevant legal documents for handling;

b) For cases of unsatisfactory sample testing results that being unsafe food products, to comply with the Minister of Health’s Circular No. 23/2018/TT-BYT dated September 14, 2018, prescribing the recall and disposal of unsafe food under the management of the Ministry of Health and relevant legal documents for handling;

c) For cases of unsatisfactory sample testing results other than those specified at Point b of this Clause, to apply Clause 2 Article 9 of Circular No. 26/2012/TT-BKHCN, amended and supplemented in Clause 6 Article 1 of Circular No. 12/2017/TT-BKHCN; Clause 8 Article 1 of Circular No. 12/2017/TT-BKHCN and relevant legal documents for handling;

d) In case there arises a complaint or dispute of food safety relating to testing results, the inspection agency shall resolve it based on Article 47, Article 48 of Law on Food Safety, Clause 6 Article 37 of Decree No. 15/2018/ND-CP and relevant law regulations. Upon resettlement of the complaint, if concluding that the sample is satisfactory, the inspection agency must issue a notice on the goods’ continuation of circulation no later than 02 working days from the date of receiving the testing results. If concluding that the sample is unsatisfactory, the inspection agency shall implement the handling in accordance with Clause 1 of this Article, Point b or Point c of this Clause.

3. For cases beyond the competence, the inspection agency shall transfer the dossier to the superior level for settlement or to the investigation agency for verifying and handling in accordance with law regulations.”

8. To amend and supplement Article 14 as follows:

“Article 14. Implementation responsibility

Chief of Ministry Office; Director of the Vietnam Food Administration; Chief Inspector of Ministry; Heads of units under the Ministry of Health; Directors of Departments of Health of provinces and cities; Heads of food safety management agencies of People's Committees of provinces and centrally-run cities; Heads of health agencies under ministries and sectors, relevant agencies, organizations and individuals shall implement this Circular.”

9. To replace Appendices No. 01, 02, 03, 04, 05, 06 to the Minister of Health’s Circular No. 48/2015/TT-BYT dated December 01, 2015 defining the food safety inspection in food production and trading under the management of the Ministry of Health with the corresponding forms in Appendix 3 issued together with this Circular.

Article 6. Amending and supplementing a number of articles of the Minister of Health’s Circular No. 49/2015/TT-BYT dated December 11, 2015 on declaration of technical regulation conformity and declaration of conformity with regulations for tobacco products

1. To amend the phrase “At the proposal of the Director of Vietnam Food Administration” in the part of bases for promulgation of Circular No. 49/2015/TT-BYT as follows: “At the proposal of the Director of Vietnam Food Administration, Director of Health Environment Management Agency” .

2. To amend and supplement Point b Clause 2 Article 4, Point b Clause 2 Article 5 as follows:

“b) Step 2: Registration of declarations of technical regulation conformity

Organizations and individuals declaring conformity with the technical regulation shall make a declaration dossier prescribed in Clause 1 of this Article and submit it online to the registration receiving agency defined in Article 7 of this Circular.

Organizations and individuals shall access the website of Health Environment Management Agency - the Ministry of Health (https://vihema.gov.vn) that is linked to the Ministry of Health’s website (https://moh.gov.vn) to carry out online declaration.”

3. To amend and supplement Point b Clause 2 Article 6 as follows:

“b) Step 2: Registration of declarations of conformity with regulations

Organizations and individuals declaring conformity with regulations shall make a declaration dossier prescribed in Clause 1 of this Article and submit it online to the registration receiving agency defined in Article 7 of this Circular.

Organizations and individuals shall access the website of Health Environment Management Agency - the Ministry of Health (https://vihema.gov.vn) that is linked to the Ministry of Health’s website (https://moh.gov.vn) to carry out online declaration.”

4. To replace the phrase “the Vietnam Food Administration” with the phrase “the Health Environment Management Agency” in Clauses 1, 2 and 3 Article 7; Clause 2, Clause 4 Article 8; Article 9; Article 11; Clause 2 Article 16; to replace the phrase “vfa.gov.vn” with the phrase “vihem.gov.vn” in Clause 3 Article 9.

5. To annul the phrase “or Food Safety and Hygiene Sub-Department of the province or centrally-run city where the producer or trader of tobacco products is located” in Article 11.

6. To annul the phrase “or request Food Safety and Hygiene Sub-Department of the province or centrally-run city where the producer or trader of tobacco products is located to implement” in Clause 1 Article 12.

7. To replace the phrase “the Vietnam Food Administration” with the phrase “the Health Environment Management Agency” in Forms No. 06, 07, 08, 09 and 10; to replace the phrase “.../ATTP-TNCB” with the phrase “.../MT-TNCB” in Form No. 06 and Form No. 09; to replace the phrase “.../ATTP-XNCB” with the phrase “.../MT-XNCB” in Form No. 07 and Form No. 10 to the Circular No. 49/2015/TT-BYT.

Article 7. Annulling a number of legal documents issued by the Minister of Health

1. To annul the Minister of Health’s Circular No.  14/2011/TT-BYT dated April 01, 2011 on guiding food sampling for inspection and examination of food quality, hygiene and safety.

2. To annul part of the following legal documents issued by the Minister of Health:

a) To annul Section 4 interpretation of terms, Section 5 reviewing and supplementation in Part 1 General provisions of the Regulations on maximum limits of biological and chemical contamination in food; Section 4.5 defining hygiene and safety of detergents used to wash utensils in contact with food; Section 4.6 defining maximum limits of heavy metals released from food storage, preservation and cooking utensils (except ceramic and glass utensils) in Part 4 regulations on hygiene and safety for food packaging and containers of the Regulations on maximum limits of biological and chemical contamination in food; Section 6.5 defining allowable limits of microorganisms in cereals and cereal products; Section 6.8 defining allowable limits of microorganisms in condiments and sauces; Section 6.11 defining allowable limits of microorganisms in canned food and Section 6.12 allowable limits of microorganisms in vegetable oils and animal fats in Part 6 limits of microorganisms in food and List of processing aids permitted for use in food production and processing in Part 7 List of processing aids permitted for use in food production and processing issued together with the Minister of Health’s Decision No. 46/2007/QD-BYT dated December 19, 2007, on promulgating the Regulations on maximum limits of biological and chemical contamination in food;

b) To annul Points b, c, d and dd Clause 10 Article 1 of the Minister of Health’s Circular No. 29/2020/TT-BYT dated December 31, 2020, on amending, supplementing and annulling a number of legal documents promulgated or  jointly promulgated by the Minister of Health;

c) To annul No. 32 of “Interpretation of terms”; annul Sections 3.11.2; 3.17; 3.29 and 3.49 Part III Production establishments and equipment in the Appendix issued together with the Minister of Health’s Circular No. 18/2019/TT-BYT dated July 17, 2019 providing for Guidelines on good manufacturing practice (GMP) in production and trading of health supplements;

d) To annul Point dd Clause 1 Article 6 of the Minister of Health’s Circular No. 48/2015/TT-BYT dated December 01, 2015 defining the food safety inspection in food production and trading under the management of the Ministry of Health;

dd) To annul Clauses 2, 3, 4 and 5 Article 2; Clause 1, Clause 2 Article 3; Point a Clause 1 Article 4; Article 5; Article 6; Article 7; Article 9; Point a Clause 1, Point c Clause 2 Article 10; Clause 1, Clause 2 Article 11; Point a Clause 1 Article 12; Article 13; Clause 2 Article 14; Clause 2 Article 15; Chapter VII of the Minister of Health’s Circular No. 43/2014/TT-BYT dated November 24, 2014 defining the management of functional food.

              Article 8. Transitional provisions

1. Food processing aids, food with food processing aids for which receipts of declarations of technical regulation conformity and certificates of declaration of conformity with food safety regulations have been granted before the effective date of this Circular may be used until the end of validity duration stated in such paper or the expiration date of the products.

2. Food processing aids, food with food processing aids with self-declaration or registration of product declaration implemented before the effective date of this Circular that do not conform with this Circular may be used until the expiration date of the products.

Article 9. Terms of reference

In case legal documents mentioned herein are amended, supplemented or replaced, these amending, supplementing or replacing documents shall apply.

Article 10. Effect

This Circular takes effect on November 09, 2023.

Article 11. Implementation responsibility

Chief of Ministry Office; Director of the Vietnam Food Administration; Chief Inspector of Ministry; Heads of units under the Ministry; Directors of Departments of Health of provinces and cities; Heads of food safety management agencies of People's Committees of provinces and centrally-run cities; Heads of health agencies under ministries and sectors, relevant agencies, organizations and individuals shall implement this Circular./.

* All Appendices are not translated herein.