Thông tư 17/2023/TT-BYT của Bộ Y tế sửa đổi, bổ sung, bãi bỏ một số văn bản quy phạm pháp luật về an toàn thực phẩm do Bộ trưởng Bộ Y tế ban hành

CIRCULAR

ON AMENDMENTS TO AND ANNULMENT OF CERTAIN LEGISLATIVE DOCUMENTS ON FOOD SAFETY PROMULGATED BY THE MINISTER OF HEALTH

Pursuant to the Law on Promulgation of Legislative Documents dated June 22, 2015 and the Law on Amendments to the Law on Promulgation of Legislative Documents No. 63/2020/QH-14 dated June 18, 2020;

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

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

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

At the request of Director of Vietnam Food Administration,

The Minister of Health promulgates a Circular on amendments to and annulment of certain legislative documents on food safety promulgated by the Minister of Health.

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1. Amendment to clause 8 Article 3:

“8. “a mixed food additive with new uses” is a food additive that contains at least two food additives and has at least one usage different from usages of each additive when used alone.”

2. Amendment to clause 4 Article 5:

“4. Flavors include those in one of the following lists:

a) The flavors that are evaluated and recognized as safe for expected intakes or acceptable daily intakes (ADI) by JECFA.

b) The flavors that are generally recognized as safe (GRAS) by Flavor and Extracts Manufacturers Association (FEMA);

c) The flavors that can be used in food products of EU approved by European Union Parliament and Council.”.

3. Supplementation of Clauses 5 and 6 to Article 5:

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

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6. When the maximum use level of a food additive in a type of food product specified in Clause 5 of this Article differs from Appendix 2B, Clause 5 of this Article shall apply."

4. Add 18 food additives to Appendix 2B - Maximum use levels of food additives in food products not been regulated in CODEX STAN 192-1995 (2018) specified in Appendix 1 promulgated together with this Circular.

5. Amendment to clause 1 Article 6:

“1. Enclosed with this Circular is Appendix 4 containing the classification and description of food groups to identify the food groups to which Appendix 2A, Appendix 2B, and Appendix 3 are applied. Appendix 4 is updated according to Annex B of the latest CAC standards on food additives.”

6. Amendment to clause 2 Article 17:

“2. The Vietnam Food Administration shall:

a) Guide to look up regulations on the use of food additives of CAC, the list or database on food flavors of JECFA, FEMA and the European Union on the website of the Vietnam Food Administration (address: https://vfa.gov.vn).

b) Propose inspection of and amendments to this Circular as per management requirements and requests of organizations and individuals involving in manufacture and sale of food additives and food.”

Article 2. Amendments to the Regulation on acceptable maximum levels for biological and chemical contaminants in food issued together with Decision No. 46/2007/QD-BYT  dated December 19, 2007 of the Minister of Health:

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“Part 7. List of processing aids permitted to be used in food production and trading, and guidance on the safe use of these processing aids.

1. List of processing aids permitted to be used in food production and trading is specified in the appendix hereto appended.

2. The safe use of processing aids in food production and trading shall follow the rules in Section 3. Principles for safe use of processing aids in National Standard TCVN 11429: 2016 (CAC / GL 75: 2010) on Guidance on use of processing aids."

2. List of processing aids permitted to be used in food production and trading is specified in Appendix 2 hereto appended.

Article 3. Amendments to Circular No. 18/2019/TT-BYT dated July 17, 2019 of the Ministry of Health on guidelines for Good Manufacturing Practices (GMP) for health supplements.

1. Amendments to Article 4:

“Article 4. Application of GMP and certificates equivalent to the Certificate of compliance with GMP for imported health supplements

1. Imported health supplements shall be manufactured by a manufacturer that has been granted one of the following certificates with forms equivalent to those of the imported health supplements by a competent authority of the manufacturing country or organization designated or acknowledged by the regulatory authority of the manufacturing country:

a) Certificate of GMP compliance if it is a manufacturer of health supplements;

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c) Regarding the countries or territories that do not issue the certificates specified in Points a and b of this Clause, a certificate which contains at least one of the following is required:

- Compliance with HACCP - Hazard Analysis and Critical Control Point;

- Compliance with ISO 22000 - International Organization for Standardization 22000;

- Compliance with IFS - International Food Standard;

- Compliance with Food Safety Global Standard of BRC - British Retailer Consortium;

- Compliance with FSSC 22000 - Food Safety System Certification 22000.

d) Regarding the countries or territories that do not issue the certificates specified in Points a, b and c Clause 1 of this Article, a certificate or written certification which demonstrates that the manufacturer meets the legislation of that country or territory is required.

2. The certificate specified in clause 1 of this Article shall at least contain:

a) Name of the issuing authority;

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c) Expiration date (if the expiration date is not written on the certificate, an assessment report or periodic inspection record is required to prove that the manufacturer still maintains its fulfillment of food safety conditions, or prescribes a time limit for periodic inspection, or assesses the food according to legislation of the country of origin/manufacture);

d) Full name and signature of the issuing person;

dd) Name and address of the certificate holder;

e) Scope covered by the certificate and product types.”

2. Amendments to section 7.11 part VII Quality control in the Appendix hereto:

“7.11. Samples are taken at locations free of  from contamination, cross-contamination and mix-ups and following appropriate procedures, including the following:”

Article 4. Amendments to Circular 43/2014/TT-BYT dated November 24, 2014 of the Minister of Health on the management of functional foods

1. Amendments to Article 3: “Article 3. Product self-declaration and product disclosure.”

2. Amendment to clause 3 Article 3:

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a) Procedures for product self-declaration are laid down in Chapter II of Decree No. 15/2018/ND-CP dated February 2, 2018 on elaboration of the Law on Food Safety, and clause 1 Article 3 of Chapter I of Decree No. 155/2018/ND-CP dated November 12, 2018 on amendments to regulations on business conditions under authority of the Ministry of Health;

b) Procedures for registration of product disclosure are laid down in Chapter III of Decree No. 15/2018/ND-CP.”

3. Amendment to clause 2, clause 4 Article 4:

“2. The test for effects on human health must be conducted at the organizations licensed to do biomedical research in accordance with Circular No. 04/2020/TT-BYT dated March 5, 2020 of the Minister of Health on establishment, functions, tasks, and rights of Research Ethics Committees in biomedical research and comply with procedures and regulations of law on science and technology.”

“4. If a new problem arises that is not covered by this circular, the receiving agency must report it to the immediate superior agency for timely resolution, taking into account the following factors: compliance with relevant laws and regulations, ensuring the health and safety of consumers, and minimizing disruption to food production and trading of organizations and individuals.”

4. Amendments point a, point b clause 1 Article 8:

“a) A substance shall not be declared if its content is less than 10% RNI threshold or less than 10% of the intake of that substance stated in the given scientific evidence (for a substance without RNI threshold);

b) If a substance reaches at least 10% RNI threshold or at least 10% of the intake of that substance stated in the given scientific evidence (for a substance without RNI threshold), its name and content in a serving or 100g of the product shall be declared;”

5. Amendment to clause 2 Article 8:

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a) Health claims about a supplementary substance shall be made only when its content in the product reaches at least 10% RNI threshold and is supported with specific scientific evidence;

b) For a supplementary ingredient without RNI threshold, a health claim shall be made on the label only when the content of such ingredient reaches at least 10% of the intake of such ingredient stated in the given the scientific evidence;

c) Health claims must be clear, consistent, and suitable for the given scientific evidence.”

6. Amendments point b, point d clause 1 Article 10:

“b) The contents of vitamins, minerals in the foods in recommended nutrition intakes provided by manufacturers shall reach at least 15% RNI thresholds specified in Appendix 01 issued together with this Circular or at least 15% of the intakes of those ingredients stated in the given scientific evidence;”

“d) In case Vietnam does not have RNI thresholds and maximum intake thresholds, provisions of CODEX or relevant international organizations shall apply.”

7. Amendments point d, point dd clause 2 Article 10:

“d) When the daily intakes of vitamins and minerals of a product reach at least 15% RNI thresholds or at least 15% of the intakes of those ingredients in the given scientific evidence, their effects may be claimed, provided suitable users and doses are specified;

“dd) When an ingredient does not reach the RNI threshold or but its daily intake reaches at least 15% of its intake in the given scientific evidence, their effects may be claimed, provided suitable users and doses are specified.”

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“a) The suitable users must be consistent with claimed effects and approved by competent authority that receives and proves the product disclosure.”

9. Amendments to Article 11:

“Labels of health supplements must comply with the labeling provisions and the following provisions:”

10. Amendment to clause 4 Article 11:

“4. There must be a phrase: “Attention: This food is not a medicine, and is not a substitute for medicines” right after the product’s effects or with other recommendations (if any).”

Article 5. Amendments to Circular 48/2015/TT-BYT dated December 1, 2015 of the Minister of Health on regulations on food safety inspection in food production and trading under the administration of the Ministry of Health.

1. Amendments to clause 1, clause 3 Article 2:

“1. Entities producing and/or trading in food products and groups; goods under the authority of the Ministry of Health specified in Appendix II promulgated together with the Government's Decree No. 15/2018/ND-CP dated February 02, 2018 on elaboration of the implementation of a number of articles of the Law on Food Safety.”

"3. Entities producing and trading food under the management of many agencies or local governments and the cases specified in Clauses 8, 10, Article 36, 5, Article 41 of Decree No. 15/2018/ND-CP that the health sector is assigned to manage and inspect."

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“2. No duplication of inspected entities, location, and time of inspection.  Any duplication of the inspection plan of the subordinate food safety authorities and that of the superior authorities shall be solved with the order of priority as follows:

a) If the inspection plan of the subordinate authority coincides with the inspection plan of the superior authority, the latter inspection plan shall prevail;

b) If the interdisciplinary inspection plan coincides with an inspection plan of a branch, the former inspection plan shall prevail;

c) If the inspection plan of a superior authority of product or product group, under the delegation of state management of food safety in Article 36 of Decree No. 15/2018/ND-CP, coincides with an inspection plan of another authority, the former inspection shall prevail.”

3. Amendments point b, point c clause 1 Article 4:

“b) The Departments of Health, Sub-Departments of Food Safety, food safety authorities of provinces and central-affiliated cities (hereinafter referred to as provinces) shall inspect food safety within their provinces;

c) People’s Committees of suburban districts, urban districts, towns, provincial cities, cities affiliated to central-affiliated cities (hereinafter referred to as districts) shall inspect food safety within their districts; the Health Committee Division, the Health Center, or a specialized agency shall assist the People’s Committee of district in inspecting food safety within the district;”

4. Amendments point a, point b, and point h clause 1 Article 6:

“a) Administrative records and legal certificates:

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b) Acknowledgement of Registration of Product Disclosure, Product Self-declaration, Certificate of advertisement content verification. Evaluate the certificates according to Articles 4, 5, 6, 7, 8, 26 and 27 of Decree No. 15/2018/ND-CP;”

“h) Food samples shall be taken, if necessary. Food sampling shall comply with regulations in the Article 6 of Circular No. 26/2012/TT-BKHCN dated December 12, 12 of the Minister of Science and Technology on the state inspection of the quality of goods circulating on the market and Clauses 3 and 8 Article 1 of Circular No. 12/2017/TT-BKHCN dated September 28, 9 of the Minister of Science and Technology on amendments to  Circular No. 26/2012/TT-BKHCN for sampling."

5. Amendments point a, point c clause 2 Article 6:

“a) Administrative records and legal certificates: Inspect according to point a clause 1 of this Article;”

“c) Collect sample of food, food additives, food processing aids, and ingredients and products used for processing and eat for testing, if necessary. Comply with the regulations specified in point h clause 1 of this Article in the process of taking samples for testing.”

6. Amendment to clause 3 Article 7:

"3. The planned inspection frequency shall not exceed 1 time per year, except for the case of unscheduled inspection specified in Article 8 of this Circular."

7. Amendments to Part 10:

“Article 10. Actions against inspection result

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2. Some particular cases of actions against food safety violations are specified as follows:

a) Any violations of food labeling be dealt with in accordance with 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 related legal documents;

b) Food products that fail to meet safety standards based on unsatisfactory sample test results must be handled in accordance with Circular No. 23/2018/TT-BYT of the Minister of Health, dated September 14, 2018 on recall and disposal of disqualified foods under the management of the Ministry of Health and relevant legislative documents;

c) If sample test results fail but do not meet the criteria specified in point b of this clause, the guidance in clause 2 of Article 9 of Circular No. 26/2012/TT-BKHCN, as amended and supplemented by clause 6 of Article 1 of Circular No. 12/2017/TT-BKHCN, and Clause 8 of Article 1 of Circular No. 12/2017/TT-BKHCN and other relevant legal documents shall apply to the handling of such cases;

d) In the event of complaints or disputes regarding food safety related to test results, the inspection agency shall resolve the matter based on Articles 47 and 48 of the Law on Food Safety, Clause 6 of Article 37 of Decree No. 15/2018/ND-CP, and other relevant laws. If a complaint is resolved and the sample is determined to have passed the test, the inspection agency must issue a notice within two working days of receiving the test results, stating that the goods may continue to be circulated on the market. If a complaint is resolved and the sample is determined to have failed the test, the inspection agency shall take actions as prescribed in clause 1 of this Article, point b or point c of this clause.

3. If the jurisdiction of the inspecting agency is exceeded, the documentation shall be transferred to a higher level of authority for processing or to the investigating agency for verification and processing in accordance with the law.

8. Amendments to Part 14:

“Article 14. Implementation

The Chief of Ministry Office ; Director General of the Food Safety Administration; Ministerial Chief Inspector; Heads of units affiliated to the Ministry of Health; Directors of Health Departments of provinces and cities; Heads of food safety authorities under People's Committees of provinces and centrally-affiliated cities; Heads of health agencies of ministries, and relevant agencies, organizations and individuals shall implement this Circular."

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Article 6. Amendments to Circular No. 49/2015/TT-BYT dated December 11, 12 of the Minister of Health on declaration of conformity with national regulations and declaration of conformity with other regulations on tobacco

1. Amend the phrase "At the request of the Director of the Food Safety Administration" with the phrase "At the request of the Director of the Food Safety Administration, Director of the Department of Health Environment Management" in the legal grounds of Circular No. 49/2015/TT-BYT.

2. Amendments point b clause 2 Article 4, point b clause 2 Article 5 as follows:

“b) Step 2: Registration of declaration of conformity with national regulations

Applicants shall make an application for declaration of conformity with national regulations as prescribed in Clause 1 of this Article and submit the application online to the receiving authority as prescribed in Article 7 of this Circular.

Applicants shall access the website of the Health Environment Management Agency affiliated to the Ministry of Health (https://vihema.gov.vn), which is linked to the website of the Ministry of Health (https://moh.gov.vn) to make the declaration of conformity online.”

3. Amendments point b clause 2 Article 6:

“b) Step 2: Registration of declaration of conformity with other regulations

Applicants shall make an application for declaration of conformity with other regulations as prescribed in Clause 1 of this Article and submit the application online to the receiving authority as prescribed in Article 7 of this Circular.

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4. Replace the phrase "Cục An toàn thực phẩm" ("Food Safety Administration") with the phrase "Cục Quản lý Môi trường y tế" ("Department of Health Environment Management") in Clauses 1, 2 and 3 Article 7; Clause 2, Clause 4 of Article 8; Article 9; Article 11; Clause 2 of Article 16; replace the phrase "vfa.gov.vn" with the phrase "vihem.gov.vn" in Clause 3 of Article 9.

5. Remove the phrase "hoặc Chi cục An toàn vệ sinh thực phẩm tỉnh, thành phố trực thuộc trung ương nơi có cơ sở sản xuất, kinh doanh thuốc lá đóng trên địa bàn” ("or the Food Safety and Sanitation Sub-Department of the province or centrally-affiliated city where the tobacco producer/trader is located") in Article 11.

6. Remove the phrase “hoặc đề nghị Chi cục An toàn vệ sinh thực phẩm tỉnh, thành phố trực thuộc trung ương nơi có cơ sở sản xuất, kinh doanh thuốc lá đóng trên địa bàn thực hiện” ("or request the Food Safety and Sanitation Sub-Department of the province or centrally-affiliated city where the tobacco producer/trader is located to take tobacco samples regularly") in Article 11.

7. Replace the phrase "Cục An toàn thực phẩm" ("Department of Food Safety") with the phrase "Cục Quản lý Môi trường y tế" ("Department of Health Environment Management") in Forms No. 06, 07, 08, 09 and 10; replace the phrase ".../ATTP-TNCB" with the phrase ".../MT-TNCB" in Form No. 06 and Form No. 09; replace the phrase ".../ATTP-XNCB" with the phrase ".../MT-XNCB" in Form No. 07 and Form No. 10 issued together with Circular No. 49/2015/TT-BYT.

Article 7. Annulment of certain legislative documents promulgated by the Minister of Health

1. Annul Circular No. 14/2011/TT-BYT dated April 01, 04 of the Minister of Health on guidance on sampling for inspection of food quality, hygiene and safety.

2. Partially annul the following legislative documents promulgated by the Minister of Health

a) Annul the following sections in Decision No. 46/2007/QD-BYT dated December 19, 2007 of the Minister of Health on promulgation of “Regulation of maximum levels of biological and chemical contaminants in food”: Part 1 General Provisions: section 4 (Interpretation of terms) and section 5 (Inspection, supplementation); Part 4. Regulation of hygienic safety for wrapping and tools containing food: section 4.5 (Standards for detergents used for cleaning food-contacted tools and section 4.6 (Maximum Level of heavy metals leaching from food containers for preservation or cooking (excluding those made of ceramic or glass); Part 6. Limit of micro-organisms in food: section 6.5 (Limit of micro-organism in cereal and cereal products), section 6.8 (Limit of micro-organism in flavors and sauces), section 6.11 (Limit of micro-organism in canned food), and section 6.12 (Limit of micro-organism in fats and oils); Part 7 (List of processing aids permitted to be used in food production);

b) Annul Points b, c, d and dd, Clause 10, Article 1 of Circular No. 29/2020/TT-BYT dated December 31, 2020 of the Minister of Health on amendments to and annulment of certain legislative documents promulgated and jointly promulgated by the Minister of Health;

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d) Annul point dd clause 1 Article 6 Circular 48/2015/TT-BYT dated December 1, 2015 of the Minister of Health on regulations on food safety inspection in food production and trading under the administration of the Ministry of Health;

dd) Annul Clauses 2, 3, 4 and 5 of Article 2; Clause 1, Clause 2 of 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 of Article 11; Point a, Clause 1, Article 12; Article 13; Clause 2 of Article 14; Clause 2 of Article 15; Chapter VII of Circular No. 43/2014/TT-BYT dated November 24, 11 of the Minister of Health on the management of functional foods.

Article 8. Transitional provisions

1. Food processing aids and foods using food processing aids that have been granted the Acknowledgement of Declaration of Conformity with National Regulations or the Certificate of Declaration of Conformity with Other Regulations on Food Safety before the effective date of this Circular shall continue to be used until the expiry of the validity period of Acknowledgement or Certificate, or the end of shelf life of the product.

2. Food processing aids, foods using food processing aids that obtain the self-declaration or registered product disclosure before the effective date of this Circular, if not in accordance with the provisions of this Circular, shall continue to be used until the expiry date of the product.

Article 9. Terms of reference

In case any legislative documents referred to in this Circular are amended, supplemented, or replaced, the new documents shall prevail.

Article 10. Entry into force

This Circular comes into force as of November 9, 2023.

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

PP. MINISTERDEPUTY MINISTERDo Xuan Tuyen

APPENDIX 1

MAXIMUM USE LEVELS OF FOOD ADDITIVES NOT SPECIFIED IN CODEX STAN 192-1995 (2018) (Issued together with Circular No. 17/2023/TT-BYT dated September 25, 2023 of the Minister of Health)

ASCORBYL PALMITATE

INS

304

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Ascorbyl palmitate

Food category

ML(mg/kg)

Notes

Dietetic foods intended for special medical purposes (excluding products of food category 13.1 (food category 13.3 of Annex 4)

500

10

ERYTHROSINE

INS

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Name of additive

Erythrosine

Food category

ML(mg/kg)

Notes

Food supplements (food category 13.6 of Annex 4)

GMP

POLYGLYCEROL ESTERS OF INTERESTERIFIED RICINOLEIC ACID

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476

Name of additive

Polyglycerol esters of interesterified ricinoleic acid

Food category

ML(mg/kg)

Notes

Shortening (food category 02.1 of Annex 4)

20000

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INS

100(i)

Name of additive

Curcumin

Food category

ML(mg/kg)

Notes

Dietetic foods intended for special medical purposes (excluding products of food category 13.1 (food category 13.3 of Annex 4)

50

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TURMERIC

INS

100(i)

Name of additive

Turmeric

Food category

ML(mg/kg)

Notes

Dietetic foods intended for special medical purposes (excluding products of food category 13.1 (food category 13.3 of Annex 4)

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Food supplements (food category 13.6 of Annex 4)

GMP

DISODIUM SUCCINATE

INS

100(i)

Name of additive

Disodium succinate

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ML(mg/kg)

Notes

Salts, spices, soups, sauces, salads, protein products (food category 12.0 of Annex 4)

GMP

TARTRAZINE

INS

102

Name of additive

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Food category

ML(mg/kg)

Notes

Dietetic formulae for slimming purposes and weight reduction (food category 13.4 of Annex 4)

50

PROPYLENE GLYCOL ALGINATE

INS

405

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Propylene glycol alginate

Food category

ML(mg/kg)

Notes

Non-emulsified sauces (food category 12.6.2 of Annex 4)

6000

CARAMEL I - PLAIN CARAMEL

INS

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Name of additive

Caramel I- plain caramel

Food category

ML(mg/kg)

Notes

Non-alcoholic (“soft”) beverages (food category 14.1 of Annex 4)

GMP

ANNATTO EXTRACT, BIXIN BASED

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160(i)

Name of additive

Annatto extract, bixin based

Food category

ML(mg/kg)

Notes

Edible ices, including sherbet and sorbet (food category 03.0 of Annex 4)

25

8

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15

Singly or in combination: food additive INS 160b(ii)

ANNATTO EXTRACT, NORBIXIN - BASED

INS

160b(ii)

Name of additive

Annatto extract, norbixin-based

Food category

ML(mg/kg)

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Edible ices, including sherbet and sorbet (food category 03.0 of Annex 4)

20

185

Processed cheese (food category 01.6.4 of Annex 4)

8

SODIUM ALUMINO SILICATE

INS

554

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Sodium alumino silicate

Food category

ML(mg/kg)

Notes

Cocoa products and chocolate products including imitations and chocolate substitutes (food category 05.1 of Annex 4)

20000

TAGETES EXTRACT

INS

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Name of additive

Tagetes extract

Food category

ML(mg/kg)

Notes

Confectionery including hard and soft candy, nougats, etc. other than food categories 05.1, 05.3, and 05.4 (food category 05.2 of Annex 4)

300

Chewing gum (food category 05.3 of Annex 4)

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NITRITES

INS

249

250

Name of additive

Potassium nitrite

Sodium nitrite

Food category

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Notes

Cured (including salted) non-heat treated processed meat, poultry, and game products in whole pieces or cuts (food category 08.2.1 of Annex 4)

80

32

Heat-treated processed meat, poultry, and game products in whole pieces or cuts (food category 08.2.2 of Annex 4)

80

32

Non-heat treated processed comminuted meat, poultry, and game products (food category 08.3.1 of Annex 4)

80

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Heat-treated processed comminuted meat, poultry, and game products (food category 08.3.2 of Annex 4)

80

32

NITRATES

INS

251

252

Name of additive

Sodium nitrate

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Food category

ML(mg/kg)

Notes

Cured (including salted) non-heat treated processed meat, poultry, and game products in whole pieces or cuts (food category 08.2.1 of Annex 4)

100

30

Non-heat treated processed comminuted meat, poultry, and game products (food category 08.3.1 of Annex 4)

100

30

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INS

414

Name of additive

Gum arabic

Food category

ML(mg/kg)

Notes

Infant formulae (food category 13.1.1 of Annex 4)

10

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Follow-up formulae (food category 13.1.2 of Annex 4)

10

65 & 72

Formulae for special medical purposes intended for infants (food category 13.1.3 of Annex 4)

10

65 & 72

SILICON DIOXIDE, AMORPHOUS

INS

551

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...

Silicon dioxide, amorphous

Food category

ML(mg/kg)

Notes

Infant formulae (food category 13.1.1 of Annex 4)

10

65 & 72

Follow-up formulae (food category 13.1.2 of Annex 4)

10

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...

Formulae for special medical purposes intended for infants (food category 13.1.3 of Annex 4)

10

65 & 72

STARCH SODIUM OCTENYL SUCCINATE

INS

1450

Name of additive

Starch sodium octenyl succinate

Food category

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Notes

Infant formulae (food category 13.1.1 of Annex 4)

100

65 & 72

Follow-up formulae (food category 13.1.2 of Annex 4)

100

65 & 72

Formulae for special medical purposes intended for infants (food category 13.1.3 of Annex 4)

100

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APPENDIX 2

LIST OF PROCESSING AIDS PERMITTED TO BE USED IN FOOD PRODUCTION AND TRADING (Issued together with Circular No. 17/2023/TT-BYT dated September 25, 2023 of the Minister of Health)

No.

Vietnamese name

English name

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MRL(mg/kg)

I

Các chất chống tạo bọt

Antifoam agents

1

Methyl este của acid béo

Fatty acid methyl ester

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2

Este poly alkyl glycol của acid béo

Fatty acid polyalkylene glycol ester

Vegetable protein

3

Alcohol béo C8-C30

Fatty alcohols (C8-C30)

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4

Dầu dừa hydro hóa

Hydrogenated coconut oil

Confectionery

5-15

5

Các oxoalcohol C9-C30)

Oxoalcohols (C9-C30)

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6

Este polyoxyethylen của acid béo C8-C30

Polyoxyethylene esters of C8-C30 fatty acids

Vegetable protein

7

Este polyoxyethylen của oxoalcohol C9-C30

Polyoxyethylene esters of C9-C30 oxoalcohols

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8

Hỗn hợp este polyoxyethylen và polyoxypropylen của các acid béo C8-C30

Mixtures of polyoxyethylene and polyoxypropylene esters of C8-C30 fatty acids

Vegetable protein

II

Catalysts

Catalysts

...

...

...

9

Nhôm

Aluminum

Hydrogenated food oils

10

Chromi

Chromium

...

...

...

< 0,1

11

Đồng

Copper

Hydrogenated food oils

< 0,1

12

Đồng chromat

Copper chromate

...

...

...

13

Đồng chromite

Copper chromite

14

Mangan

Manganese

...

...

...

< 0,4

15

Molypden

Molybdenum

Hydrogenated food oils

< 0,1

16

Paladi

Palladium

...

...

...

< 0,1

17

Platin

Platinum

Hydrogenated food oils

< 0,1

18

Kali kim loại

Potassium metal

...

...

...

< 1

19

Kali methylat (methoxide)

Potassium methylate (methoxide)

Dầu thực phẩm este hóa

< 1

20

Kali ethylat (ethoxide)

Potassium ethylate (ethoxide)

...

...

...

< 1

21

Bạc

Silver

Hydrogenated food oils

< 0,1

22

Natri amid

Sodium amide

...

...

...

< 1

23

Natri ethylen (natri ethylat)

Sodium ethylene (sodium ethylate)

Interesterified food oils

< 1

24

Natri methylat (methoxide)

Sodium methylate (methoxide)

...

...

...

< 1

25

Acid trifluormethan sulfonic

Trifluoromethane sulfonic acid

Cocoa butter substitute

< 0,01

26

Zirconi

Zirconium

...

...

...

27

Nickel

Nickel

Polyols

III

Các chất làm trong/các chất trợ lọc

Clarifying agents/ filtration aids

...

...

...

28

Albumin

Albumin

29

Amiăng

Asbestos

...

...

...

30

Bentonite

Bentonite

Starch hydrolysis

31

Diatomit

Diatomaceous earth

...

...

...

32

Copolyme divinylbenzen- ethylvinylbenzen

Divinylbenzene- ethylvinylbenzene copolymer

Aqueous foods (excluding carbonated beverages)

0.00002  ex-tractives from copolymer

33

Magnesi acetat

Magnesium acetate

...

...

...

34

Peclit

Perlite

Starch hydrolysis

35

Acid polymaleic và natri polymaleat

Polymaleic acid and sodium polymaleate

...

...

...

< 5

36

Than hoạt tính (Carbon thực vật có hoạt tính)

Vegetable carbon (activated)

Starch hydrolysis

37

Than không có hoạt tính (Carbon thực vật không có hoạt tính)

Vegetable carbon (unactivated)

...

...

...

38

Đất sét hấp thụ (tẩy trắng, đất tự nhiên hoặc đất hoạt tính)

Absorbent clays (bleaching, natural or activated earths)

Starch hydrolysis

39

Nhựa divinylbenzen chloromethyl hóa và amin hóa

Chloromethylated animated styrene- divinylbenzene resin

...

...

...

< 1

40

Nhựa trao đổi ion

Ion exchange resins (see Ion exchange Resins)

Fruit juices

41

Isinglass (Thạch)

Isinglass (Agar)

...

...

...

42

Cao lanh

Kaolin

Fruit juices

43

Tanin

Tannin (to be specified) Tannic Acid

...

...

...

GMP

44

Gelatin (từ collagen da)

Gelatin (from skin collagen)

Fruit juices

IV

Các chất làm lạnh và làm mát

Contact freezing & cooling agents

...

...

...

45

Dichlorofluormethan

Dichlorofluormethane

Frozen food

100

V

Các chất làm khô/ Các chất chống đông vón

Desiccating agent/anticaking agents

...

...

...

46

Nhôm stearat

Aluminum Stearate

47

Calci Stearat

Calcium Stearate

...

...

...

48

Magnesi Stearat

Magnesium stearate

49

Octadecyl amoni acetat (trong amoni chloride)

Octadecyl ammonium acetate (in ammonium chloride)

...

...

...

50

Kali nhôm silicat

Potassium aluminum silicate

51

Natri calci silicoaluminat

Sodium calcium silicoaluminate

...

...

...

52

Calci phosphat (tricalci phosphat)

Calcium phosphate (tricalcium phosphate)

VI

Các chất tẩy rửa (Các chất làm ẩm)

Detergents (wetting agents)

...

...

...

53

Dioctyl natri sulfosuccinat

Dioctyl sodium sulfosuccinate

Fruit drinks

< 10

54

Hợp chất amoni bậc bốn

Quaternary ammonium compounds

...

...

...

55

Natri lauryl sulphat

Sodium lauryl sulphate

Food fats and oils

< 1

56

Natri xylen sulphonat

Sodium xylene sulphonate

...

...

...

< 1

VII

Các chất cố định enzym và chất mang

Enzyme immobilization agents & supports

57

Polyethylenimin

Polyethylenimine

...

...

...

58

Glutaraldehyde

Glutaraldehyde

59

Diethylaminoethyl Cellulose

Diethylaminoethyl Cellulose

...

...

...

VIII

Các chất keo tụ

Flocculating agents

60

Nhựa acrylat-acrylamid

Acrylate-acrylamide resin

...

...

...

10 in sugar liquor

61

Chitin/Chitosan

Chitin/Chitosan

62

Phức của muối nhôm hòa tan và acid phosphoric

Complexes of soluble aluminum salt and phosphoric acid

...

...

...

63

Copolyme dimethylamin - epichlorohydrin

Dimethylamine - epichlorohydrin copolymer

Sugar processing

< 5

64

Huyết tương khô và dạng bột

Dried and powdered blood plasma

...

...

...

65

Nhựa acrylamid biến tính

Modified acrylamide resin

Sugar, boiler water

66

Acid polyacrylic

Polyacrylic acid

...

...

...

67

Polyacrylamid

Polyacrylamide

Sugar (sugar beet)

68

Natri polyacrylat

Sodium polyacrylate

...

...

...

69

Trinatri diphosphat

Trisodium diphosphate

70

Trinatri orthophosphat

Trisodium orthophosphate

...

...

...

IX

Nhựa trao đổi ion, màng và rây phân tử

Ion exchange resins, membranes, and molecular sieves

71

Copolyme của methyl acrylat, divinylbenzen và acrylonitril bị thủy phân hoàn toàn

Completely hydrolyzed copolymers of methyl acrylate, divi-nylbenzene and acrylonitrile

...

...

...

72

Diethylentriamin, triethylentetramin, tetraethylenpentamin được tạo mạng liên kết chéo với epichlorohydrin

Diethylenetriamine, triethylenetetramine, tetraethylenepentamine cross - linked with epichlorohydrin

73

Copolyme của acid metacrylic-divinylbenzen

Methacrylic acid- divinylbenzene copolymer

...

...

...

74

Copolyme của acid metacrylic-divinylbenzen với các nhóm hoạt động RCOO

Methacrylic acid- divinylbenzene copolymer with RCOO active groups

75

Polystyren - divinylbenze cầu hóa bằng các nhóm trimethylamoni

Polystyrene divinylbenzene reticulum with trimethylammonium groups

...

...

...

Migrants from resin <1

X

Chất bôi trơn, các chất loại bỏ và chống kẹt cứng, trợ khuôn

Lubricants, release and anti stick agents, moulding aids

76

Dimethylpolysiloxan

Dimethylpolysiloxane

...

...

...

77

Bentonit

Bentonite

Confectionery

XI

Các chất kiểm soát vi sinh vật

Micro-organism control agents

...

...

...

78

Chlor dioxide

Chlorine dioxide

Flours

79

Hypochlorit

Hypochlorite

...

...

...

80

Iodophors

Iodophors

Food oils

81

Hệ enzym lactoperoxidase (latoperoxidase, gluco oxidase, muối thiocynat)

Lactoperoxidase system (lactoperoxidase, glucose oxidase, thiocyanate salt)

...

...

...

82

Acid Peracetic

Peracetic acid

83

Hợp chất amoni bậc bốn

Quaternary ammonium compounds

...

...

...

84

Muối của acid sulfur trioxide

Salts of sulfurous acid

Starch hydrolysis of milled corn

< 100

XII

Các chất nuôi dưỡng vi sinh vật và chất nuôi dưỡng vi sinh vật bổ sung

Microbial nutrients and microbial nutrient adjuncts

...

...

...

85

Amoni phosphat

Ammonium phosphates

Fermented food

86

Biotin

Biotin

...

...

...

87

Đồng sulfat

Copper sulphate (Cupic sulphate)

Fermented food

88

Niacin

Niacin

...

...

...

89

Acid pantothenic

Pantothenic acid

Fermented food

90

Kẽm Sulfat

Zinc sulfate

...

...

...

91

Sắt (II) sulfat

Ferrous sulfate

Fermented food

92

Inositol

Inositol

...

...

...

93

Magnesi sulfat

Magnesium sulfate

Fermented food

94

Polysorbat 80

Polysorbate 80

...

...

...

95

Silic dioxide

Silicon dioxide

Fermented food

96

Gôm Acacia

Acacia Gum

...

...

...

97

Acid phosphoric

Phosphoric acid

Fermented food

98

Acid nitric

Nitric acid

...

...

...

99

Acid citric

Citric acid

Fermented food

100

Glycin

Glycine

...

...

...

101

Natri bicacbonat

Sodium bicarbonate

Fermented food

102

Lecithin đậu tương

Soy lecithin

...

...

...

103

Amoni chloride

Ammonium chloride

Fermented food

104

Natri lauryl sulfat

Sodium lauryl sulphate

...

...

...

105

Amoni sulfat

Ammonium sulphate

Fermented food

106

Propyl galat

Propyle gallate

...

...

...

107

Natri phosphat, monobasic

Sodium phosphate, monobasic

Fermented food

XIII

Các chất đẩy tơi và các khí bao gói

Propellant and packaging gases

...

...

...

108

Không khí

Air

109

Argon

Argon

...

...

...

110

Carbon dioxide

Carbon dioxide

111

Chloropentafluoroethan

Chloropentafluoroethane

...

...

...

112

Heli

Helium

113

Hydro

Hydrogen

...

...

...

114

Nito oxide

Nitrous oxide

115

Octa fluorocyclobutan

Octafluorocyclobutane

...

...

...

116

Propan

Propane

117

Triclorofluoromethan (F11)

Trichlorofluoromethane (F11)

...

...

...

118

Dichlorodifluoromethan (F12)

Dichlorodifluoromethane (F12)

XIV

Các dung môi, quá trình chiết và chế biến

Solvents, extraction & processing

...

...

...

119

Amyl Acetat

Amyl acetate

Flavourings, colors

120

Benzyl alcohol

Benzyl alcohol

...

...

...

121

Butan 1,3-diol

Butane-1,3-diol

Flavourings

122

Butyl acetat

Butyl acetate

...

...

...

123

Cyclohexan

Cyclohexane

Flavourings and food oils

< 1

124

Dibutyl ete

Dibutyl ether

...

...

...

< 2

125

1,2 Dichloroethan

1,2 Dichloroethane

Decaffeination of products

< 5

126

Dichlorodifluoromethan

Dichlorodifluoromethane

...

...

...

< 1

127

Diethyl citrat

Diethyl citrate

Flavourings, colors

128

Diethyl ete

Diethyl ether

...

...

...

129

Ethyl acetat

Ethyl acetate

130

Ethyl methyl keton (Butanon)

Ethyl methyl ketone (butanone)

...

...

...

131

Glycerol tributyrat

Glycerol tributyrate

Flavourings, colors

132

Isobutan

Isobutane

...

...

...

< 1

133

Các hydrocacbon từ isoparafinic dầu mỏ

Isoparaffinic petroleum hydrocarbons

Citric acid

134

Isopropyl myristat

Isopropyl myristate

...

...

...

135

Methylen chloride (Dichloromethan)

Methylene chloride (dichloromethane)

Food oils

< 0,02

136

Methyl propanol-I

Methyl propanol-I

...

...

...

1

137

n-Octyl alcohol

n-Octyl alcohol

Citric acid

138

Pentan

Pentane

...

...

...

< 1

139

Ete dầu hỏa

Petroleum ether (light petroleum)

Flavourings and food oils

< 1

140

Propan 1,2 - diol

Propane-1,2-diol

...

...

...

141

Propan-1-ol

Propane-1-ol

Fatty acids, flavourings, colors

142

1,1,2 - trichloroethylen

1,1,2-Trichloroethylene

...

...

...

143

Tridodecylamin

Tridodecylamine

Citric acid

144

Toluen

Toluene

...

...

...

< 1

145

Aceton (Dimethyl keton)

Acetone (Dimethyl ketone)

Flavourings, colors, food oils

146

Butan

Butane

...

...

...

< 1,01

147

Ethanol

Ethanol

Vegetable protein

148

Hexan

Hexane

...

...

...

1

149

Tert butyl alcohol

Tertiary butyl alcohol

Flavourings, colors, food oils

150

Trichlorofluoromethan

Trichlorofluoromethane

...

...

...

< 1

151

Butan -1-ol

Fatty acids

< 1000

152

Butan -2-ol

...

...

...

1

153

Glycerol tripropionat

Glycerol tripropionate

Flavourings, colors

XV

Các chất tẩy rửa và bóc vỏ

Washing and peeling agents

...

...

...

154

Amoni orthophosphat

Ammonium orthophosphate

Vegetables and fruits

155

Diamoni orthophosphat nồng độ 5% trong nước

Diammonium orthophosphate: 5% aqueous solution

...

...

...

156

Dithiocacbamat

Dithiocarbamate

Sugar beet

157

Ethylen dichloride

Ethylene dichloride

...

...

...

0,00001 trong củ cải đường; và không được có trong đường

158

Ete ethylen glycol monobutyl

Ethylene glycol monobutyl ether

Sugar beet

0,00003 trong củ cải đường; và không được có trong đường

159

Monoethanolamin

Monoethanolamine

...

...

...

0,0001 trong củ cải đường; và không được có trong đường

160

Natri hypochloride

Sodium hypochlorite

Vegetables and fruits

161

Tetrakali pyrophosphat

Tetrapotassium pyrophosphate

...

...

...

0,00002 trong củ cải đường, không được có trong đường

162

Tetranatri ethylendiamintetraacetat

Tetrasodium ethylenediaminetetraacetate

Sugar beet

0,000003 trong củ cải đường, không được có trong đường

163

Triethanolamin

Triethanolamine

...

...

...

0,00005 trong củ cải đường, không được có trong đường

164

Hydro peroxide

Hydrogen peroxide

165

Kali bromide

Potassium bromide

...

...

...

166

Amoni chloride (bậc 4)

Ammonium chloride (quaternary)

167

Acid sulfuric

Sulfuric acid

...

...

...

168

Natri dodecylbenzen sunfonat

Sodium dodecylbenzene sulphonate

Fruits and

XVI

Các enzym thực phẩm (kể cả các enzym đã được cố định trên chất mang)

Food Enzymes (including immobilized enzymes)

...

...

...

169

Men rượu (Saccharomyces cerevisaa)

Alcohol dehydrogenase (Saccharomyces cerevisia)

170

Catalase (Gan bò)

Catalase (bovine liver)

...

...

...

171

Chymosin (bê, dê non, cừu non)

Chymosin (calf, kid, or lamb abomasum)

172

Lipase (dạ dày bò) (tuyến nước bọt hoặc thực quản của bê, dê non, cừu non) (Tụy lợn hoặc tuỵ bò)

Lipase (bovine stomach) (salivary glands or fore stomach of calf, kid, or lamb) (hog or bovine pancreas)

...

...

...

173

Lysozim (Lòng trắng trứng)

Lysozime (egg whites)

Butter, cheese

174

Pepsin A (của gia cầm)

Pepsin A - Poultry proventicum

...

...

...

175

Phospholipase A (tuỵ bò)

Phospholipase A - Bovine pancreas

Baking

176

Rennet (dạ dày bê, dê non, cừu non)

Rennet (calf or kid, lamb stomach)

...

...

...

177

Chymosin (Escherichia coli K-12)

Chymosin (Escherichia coli K-12)

Milk clotting in cheese and other milk-derived products

178

Chymosin B

Chymosin B

...

...

...

179

Chymopapain (từ quả đu đủ)

Chymopapain (Carica papaya)

180

Alpha galactosidase (Melibiaza)

Alpha galactosidase (Melibiase)

...

...

...

181

Arabinofuranosidase

Arabinofuranosidase

182

Beta glucanase

Beta glucanase

...

...

...

183

Dextranase

Dextranase

184

Endo beta glucanase

Endo beta glucanaza

...

...

...

185

Esterase

Esterase

186

Exo-alpha glucosidase (được cố định trên chất mang) (cùng nguồn như trên) không nhiều hơn 10 mg/kg glutaraldehyde)

Exo-alpha glucosidase (immobilized) (same source as above) no more than 10 mg/kg glutaraldehyde

...

...

...

187

Glucoamylase hoặc amyloglucosidase

Glucoamylase or amyloglucosidase

Starch hydrolysis, Gluco syrup production

188

Glucose isomerase

Glucose isomerase

...

...

...

189

Hemicellulase

Hemicellulase

Vegetable processing, fruit juice processing, baking, beer production,  starch production, coffee/tea/spices extraction

190

Inulinase

Inulinase

...

...

...

191

Invertase

Invertase

192

Isoamylase

Isoamylase

...

...

...

193

Lactase

Lactase

Production of milk products

194

Decacboxylase đối với acid malic

Malic acid decarboxylase

...

...

...

195

Maltase hoặc alpha glucosidase

Maltase or alpha glucosidase

196

Enzym khử nitrat

Nitrate reductase

...

...

...

197

Pectin lyase

Pectin lyase

198

Pectin esterase

Pectin esterase

...

...

...

199

Polygalacturonase

Polygalacturonase

200

Protease (bao gồm các enzym đông tụ sữa)

Protease (including milk clotting enzymes)

...

...

...

201

Pullulanase

Pullulanase

Starch hydrolysis

202

Serin proteinase

Serine proteinase

...

...

...

203

Tannase

Tannase

204

Xenlulase

Cellulase

...

...

...

205

Cellobiase (Beta d- glucosidase)

Cellobiase (Beta d- glucosidase)

XVII

Phụ gia nước nồi hơi

Boiler water additives

...

...

...

206

Natri tripolyphosphat

Sodium tripolyphosphate

Boiler water

207

Polyethylen glycol

Polyethylene glycols

...

...

...

208

Tetranatri diphosphat

Tetrasodium diphosphate

Boiler water

209

Natri hexameta phosphat

Sodium hexametaphosphate

...

...

...

210

Magnesi sulfat

Magnesium sulfate

Boiler water

211

Natri polyacrylat

Sodium polyacrylate

...

...

...

XVIII

Các chất hỗ trợ chế biến khác

Other Processing aids

212

Nhôm oxide

Aluminum oxide

...

...

...

213

Acid Erythorbic

Erythorbic acid

214

Calci tactrat

Calcium tartrate

...

...

...

215

Acid Giberelic

Gibberellic acid

216

Magnesi tartrat

Magnesium tartrate

...

...

...

217

Kali giberelat

Potassium gibberellate

218

Natri

Sodium

...

...

...

219

Natri silicat

Sodium silicate

220

Ethyl parahydroxybenzoat

Ethyl parahydroxybenzoate

...

...

...

221

Acid citric

Citric acid

Dầu và chất béo

222

Other processing aids assessed as safe in accordance with point 3.3 and 3.4 Section 3. Principles for safe use of processing aids in National Standard TCVN 11429: 2016 (CAC / GL 75: 2010) on “Guidance on use of processing aids permitted to be used in food production and trading”.

NotesMRL means maximum residue limit.

...

...

...

APPENDIX 3

FORMS USED IN INSPECTION OPERATIONS (Issued together with Circular No. 17/2023/TT-BYT dated September 25, 2023 of the Minister of Health)

Form No.

Description

Form No. 01

Food safety inspection plan

Form No. 02

Food safety inspection decision

Form No. 03

...

...

...

Form No. 04

Report of inspection of food and beverage establishments

Form No. 05

Report of inspection of street food vendors

Form No. 06

Report on food safety inspection findings

Form No. 01

………………..(1)………………………..(2)-------

...

...

...

No.      /KH-…(3)

[Location]………….[date]………………

PLAN

Inspection …………. (4)

Pursuant to the Law of Food Safety dated June 17, 2010;

Pursuant to ….(5);

Pursuant to Circular 48/2015/TT-BYT dated December 1, 2015 of the Minister of Health on regulations on food safety inspection in food production and trading under the administration of the Ministry of Health;

Pursuant to Circular No.   /2023/TT-BYT on amendments to and annulment of certain legislative documents on food safety promulgated by the Minister of Health.

...

...

...

I. Purposes and requirements

1. Purposes

2. Requirements

II. Plan details

1. Inspected entities, checklist, location, and time of inspection: …(6)

2. Establishment of inspection team:...(7)

3. Resources to implement the plan:….(8)

III. Implementation

1. Assignments:...(9)

...

...

...

HEAD OF INSPECTION AGENCY(Signature, full name, seal)

Notes

(1)Name of the governing body.

(2)Name of inspection agency.

(3)Symbol of the inspection agency

(4)Name of the plan and year of implementation.

(5)Related Laws and Decrees.

(6)Pursuant to Article 7 of this Circular; based on analysis of food safety situation and management requirements to make a plan; determine the inspection area, inspection time...

...

...

...

(8)Resources: human resources, funding, means... to implement the plan.

(9)Specify the names and responsibilities of the units and individuals leading/coordinating the implementation of the plan.

(10)Others (if any).

Form No. 02

………………..(1)

………………………..(2)-------

THE SOCIALIST REPUBLIC OF VIETNAMIndependence - Freedom - Happiness---------------

No.      /QD-…(3)

...

...

...

DECISION (*)

Inspection …………. (4)

AUTHORITY TO PROMULGATE DOCUMENTS(5)

Pursuant to the Law of Food Safety dated June 17, 2010;

Pursuant to ….(6);

Pursuant to Circular 48/2015/TT-BYT dated December 1, 2015 of the Minister of Health on regulations on food safety inspection in food production and trading under the administration of the Ministry of Health;

Pursuant to Circular No.   /2023/TT-BYT on amendments to and annulment of certain legislative documents on food safety promulgated by the Minister of Health;

Pursuant to ….(7);

...

...

...

At the request of...(9).

HEREBY DECIDES:

Article 1.Inspect ...(10)

Inspection form: ...(11)

Inspection time limit: ......(12)days from the date of announcement of the Inspection Decision.

Inspection period: ...(13)

Article 2.Establish an inspection team composed of the following members:

1. Full name and position:………………………………………………………… Head of inspection team.

2. Full name and position:………………………………………….  Deputy head of inspection team (if any).

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Article 3.The inspection team has the following duties:...(14)

Article 4.This Decision comes into force from the date of signing.

Article 5....(15)

HEAD OF INSPECTION AGENCY(Signature, full name, seal)

Notes

(*)This form is used to issue the Inspection Decision specified in Article 9 of this Circular.  In case of thematic inspection (food advertising/product disclosure registration, product self-declaration/food safety conditions...), record information relevant to the inspection.

(1)Name of the governing body.

(2)Name of inspection agency.

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(4)Name of inspection.

(5)Authority of the agency to make the inspection decision: For example: Director of the Food Safety Department, Director of the Food Safety and Hygiene Sub-Department, People's Committee of District...

(6)Related Laws and Decrees.

(7)Document regulating the functions, tasks, and powers of the inspection agency.

(8)The inspection plan that has been approved by the competent authority for planned inspection: signs of violation according to Article 8 of this Circular for unscheduled inspection.

(9)Unit that submitted the Decision.

(10)Name of the inspection, inspected entities, inspection area. In case the inspected entities include many establishments, a list can be included.

(11)Scheduled or unscheduled.

(12)Number of inspection days.

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14)  Inspect the establishments named in Article 1 of this Decision if they meet requirements... (in accordance with the inspection requirements and checklist); sampling for testing:  take actions, request actions to be taken as per the law; perform duties and powers specified in Article 70 of the Law on Food Safety, etc.

(15)Responsibilities of inspected entities...

Form No. 03

………………..(1)………………………..(2)-------

CỘNG HÒA XÃ HỘI CHỦ NGHĨA VIỆT NAMĐộc lập - Tự do - Hạnh phúc---------------

No.(3)/BB-KT

[Location]………….[date]………………

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Inspection …………. (4)

Pursuant to ....(5), today at……….. [time]………….[date] at (**)..,…(2)….We undertake an inspection visit of(6)

Reasons for making an inspection report at the inspection agency/inspection team's headquarters or another location:...

I. Composition of the Inspection Team

1 ……………………………… Position:                       Head of Inspection Team

2 ……………………………… Member

3 ………………………………

II. Representative of inspected entity

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III. With the participation of (if any):

IV. Checklist and inspection findings

……………………………………………………………………………………………………(7)

………………………………………………………………………………………………………

V. Comments, recommendations, and actions

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...

VI. Opinions of the inspected entity

………………………………………………………………………………………………………

The inspection report was made at [time] on [date]. The report was then read to the inspection members and the representative of the inspected entity for their acknowledgment and signatures. The report is prepared in three identical copies with equal legal value. One copy is given to the inspected entity, and the Inspection Team retains the other two copies./.

Reason for not signing the inspection report: ………………………….

Representative of inspected entity(***)(Signature, full name), seal (if any)

Head of inspection team(Signature, full name)

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Witnesses(Signature, full name), (if any)

Government representative(Signature, position, and full name), (if any)

Notes

(*)This form is used to make an inspection report for the entity mentioned in Clause 1, Article 6 of this Circular. In case of thematic inspection (food advertising/product disclosure registration, product self-declaration/food safety conditions...), record information relevant to the inspection.

(**)Insert the address where the inspection will be conducted (address of headquarters, business location; place where food is stored, etc.). Reasons for making an inspection report at the inspection agency/inspection team's headquarters or another location.

(***)If the representative of the inspected entity refuses to sign the report, the person authorized to prepare the report must secure the signature of the representative of the People's Committee of the commune/ward/town where the violation occurs or of at least one witness.

- In case of a witness, insert the full name, occupation, and address of that person.

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(1)Name of inspection agency.

(2)Inspection team of Decision No...., for example: Inspection team of Decision No. 01/QD-ATTP.

(3)Insert the ordinary number of the inspected entities, for example: If the inspection team in Decision No. 01/QD-ATTP is assigned the task of inspecting 9 entities, the inspection report will be numbered from 01, 02, 03... to 09.

(4)Insert the name, title, or summary of the Inspection Decision.

(5)Insert the inspection decision number.

(6)Name, address, phone, and information about the inspected entity according to business registration, Receipt of product disclosure registration/Product self-declaration, Certificate of eligibility for food safety conditions...

(7)Inspect and evaluate the contents in Clause 1, Article 6 of this Circular (The report fully records the inspection checklist and evaluation if the inspected entity complies with relevant regulations. For example: evaluation if the inspected entity complies with regulations on product self-declaration according to Articles 4 and 5 of Decree No. 15/2018/ND-CP; product disclosure registration according to Articles 6, 7 and 8 of Decree No. 15/2018/ ND-CP; general conditions for ensuring food safety in food production and trading according to Section 1 Chapter IV of the Law on Food Safety, Decree No. 155/2018/ND-CP; advertising according to Articles 26 and 27 of Decree No. 15/2018/ND-CP; food safety conditions in the production of health supplements according to Article 28 of Decree No. 15/2018/ND- CP, Circular No. 18/2019/TT-BYT dated July 17, 2019 of the Ministry of Health guiding good manufacturing practices (GMP) in the production and trading of health supplements; labeling products according to Articles 24 and 25 of Decree No. 15/2018/ND-CP, Decree No. 43/2017/ND-CP dated April 14, 2017 of the Government on goods labels, Decree No. 111/2021/ND -CP dated December 9, 2021 of the Government on amendments to Decree No. 43/2017/ND-CP etc.). If samples are taken, make a sampling report attached; request the presentation of documents for inspection, evaluation, and collection of copies with the inspected entity’s seal of relevant documents.

(8)Matters in which the inspected entity has complied with relevant regulations.

9)(

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Form No. 04

………………..(1)………………………..(2)-------

THE SOCIALIST REPUBLIC OF VIETNAMIndependence - Freedom - Happiness---------------

No.(3)/BB-KT

[Location]………….[date]………………

REPORT

Inspection …………. (4)

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I. Composition of the Inspection Team

1 ………………….               Position:                              Head of Inspection Team

2 ………………….                                                           Member

3 ………………….

II. Representative of inspected entity

1 ………………….             Position:

2 ………………….

III. With the participation of (if any):

1 ………………….             Position:

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IV. Checklist and inspection findings(7)

1. Administrative records and legal certificates:

- Enterprise registration certificate/Household business registration certificate: (Yes/No) ………………………………………….

…………………………………………………………………………………………………….

- Certificate of eligibility for food safety conditions (inspected and evaluated according to the type of entity that is subject to or exempt from issuance specified in Articles 11, 12, 28 of Decree No. 15/2018/ND -CP).

……………………………………………………………………………………………………….

- Number of employees:…………… In which: Direct employees:…………… Indirect employees: ………………

- Check if regulated entities obtain Certificates of fitness for work and Certificates of training in food safety knowledge as per the regulations.

………………………………………………………………………………………………………

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2. Food safety conditions:

No.

Checklist

Passed

Failed

Notes

2. 1

The kitchen is arranged to prevent cross-contamination between unprocessed and processed foods.

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2. 2

There is a sufficient supply of water that meets technical standards for processing and business activities.

2. 3

Have adequate tools to collect and store waste to ensure sanitation.

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2. 4

Sewers in the shop and kitchen areas must be clear, free of stagnation, and covered.

2. 5

The restaurant must be well-ventilated, cool, well-lit, clean, and have measures in place to prevent pests.

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2. 6

Have equipment for food preservation, toilets, hand washing facilities, and daily waste collection.

2. 7

Have separate utensils and containers for raw and cooked foods.

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2. 8

Cooking and processing utensils must be safe and hygienic.

2. 9

Eating utensils must be made of safe materials and kept clean and dry.

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2. 10

Food and food ingredients must be of clear origin and safe.

2. 11

Food must be processed safely and hygienically.

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2. 12

Food displayed for sale must be kept in glass cabinets or hygienic storage equipment that is resistant to dust, rain, sun, and pests, and must be sold on a table or above the ground.

2. 13

Conduct three-step food authentication and store food samples in accordance with the Ministry of Health's instructions.

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2. 14

Equipment and means of transporting and storing food must be hygienic and prevent food contamination.

2. 15

Others:

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3. Check and evaluate other matters:(8)

………………………………………………………………………………………………………

………………………………………………………………………………………………………

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4. Take samples for testing:

………………………………………………………………………………………………………

(Request to present documents for inspection, evaluate and collect copies with the entity’s seal of relevant documents).

V. Comments, recommendations, and actions

3...(11)

VI. Opinions of the inspected entity

………………………………………………………………………………………………………

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Reason for not signing the inspection report: …………………………..

Representative of inspected entity(*)(Signature, full name), seal (if any)

Head of inspection team(Signature, full name)

Inspection members(Signature, full name)

Witnesses(Signature, full name), (if any)

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Government representative(Signature, position, and full name), (if any)

Notes

(*)If the representative of the inspected entity refuses to sign the report, the person authorized to prepare the report must secure the signature of the representative of the People's Committee of the commune/ward/town where the violation occurs or of at least one witness.

- In case of a witness, insert the full name, occupation, and address of that person.

- In case of a representative of the commune-level government, insert the full name, position of the representative and the name of the People's Committee of the commune/ward/town where the violation occurred.

(1)Name of inspection agency.

(2)Inspection team of Decision No...., for example: Inspection team of Decision No. 01/QD-ATTP.

(3)Insert the ordinary number of the inspected entity, for example: If the inspection team in Decision No. 01/QD-ATTP is assigned the task of inspecting 9 entities, the inspection report will be numbered from 01, 02, 03... to 09.

(4)Insert the name, title, or summary of the Inspection Decision.

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(6)Name, address, telephone, and other information about the inspected entity.

(7)Checklist and inspection findings.

(8)Check and evaluate the matters in Clause 2, Article 6 of this Circular, except for the matters in Sections 1 and 2, Part IV of this Report.

(9)Matters in which the inspected entity has complied with relevant regulations.

(10)Identify specific inadequacies and breaches.

(11)Specify matters that the Inspection Team requires the inspected entity to implement, comply with, or correct, along with deadlines for corrective actions, etc. for example: The Inspection Team orders entity A to take corrective actions against the inadequacies and breaches mentioned above, and then send a report on corrective actions to the Inspection Agency, at … [address] by…. [date] etc...

Form No. 05

………………..(1)………………………..(2)-------

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No.(3)/BB-KT

[Location]………….[date]………………

REPORT

Inspection …………. (4)

Pursuant to ....(5), today at……….. [time]………….[date] at (**)..,…(2)….We undertake an inspection visit of……………….(6).

I. Composition of the Inspection Team

1 …………………….              Position:                         Head of Inspection Team

2 …………………….                                                     Member

...

...

...

II. Representative of inspected entity

1 …………………….             Position:

2 …………………….

III. With the participation of (if any):

1 …………………….            Position:

2 …………………….

IV. Checklist and inspection findings(7)

4.1. Administrative records and legal certificates:

- (Based on reality) …………………….…………………….…………………….………………

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...

- Check if regulated entities obtain Certificates of fitness for work and Certificates of training in food safety knowledge as per the regulations.

…………………….…………………….…………………….…………………….………………

- Others: …………………….…………………….…………………….……………

4.2. Food safety conditions:

4.2.1. Business location, environment: ... …………………….………………………………

4.2.2. Business design and layout:

a) Place to store raw materials:  …………………….…………………….………………………

b) Place of preliminary processing and processing: …………………….…………………….………………………………

c) Place of sale, business, eating and drinking: …………………….…………………….……

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4.2.3. Origin of raw materials and food: …………………….………………………….

4.2.4. Equipment, utensils, and tools:

a) Equipment and tools for preserving raw materials: …………………….………………………

b) Raw food processing utensils: …………………….…………………….…………………

c) Cooked food processing utensils: …………………….…………………….………………….

d) Eating and drinking utensils: …………………….…………………….…………………….……

dd) Food containers: …………………….…………………….…………………….

e) Food display equipment and tools (tables, racks, shelves): …………………….……………

g) Food transport equipment: …………………….…………………….………………

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i) Packaging and materials in direct contact with food: …………………….

k) Equipment to protect against sun, rain, dirt, and pests:

…………………….…………………….…………………….…………………….……………….

4.2.5. Water for processing and business: …………………….…………………………..

4.2.6. Others: …………………….…………………….…………………………….

4.3. Check and evaluate other matters:(8)

…………………….…………………….…………………….…………………….……………….

4.4. Take samples for testing:

…………………….…………………….…………………….…………………….……………….

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3...(11)

VI. Opinions of the inspected entity

…………………….…………………….…………………….…………………….………………

The inspection report was made at …. [time] on….[date] ; The report was then read to the inspection members and the representative of the inspected entity for their acknowledgment and signatures. The report is prepared in three identical copies with equal legal value. One copy is given to the inspected entity, and the Inspection Team retains the other two copies./.

Reason for not signing the inspection report: …………………….

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...

...

Head of inspection team(Signature, full name)

Inspection members(Signature, full name)

Witnesses(Signature, full name), (if any)

Government representative(Signature, position, and full name), (if any)

Notes

(*)If the representative of the inspected entity refuses to sign the report, the person authorized to prepare the report must secure the signature of the representative of the People's Committee of the commune/ward/town where the violation occurs or of at least one witness.

...

...

...

- In case of a representative of the commune-level government, insert the full name, position of the representative and the name of the People's Committee of the commune/ward/town where the violation occurred.

(1)Name of inspection agency.

(2)Inspection team of Decision No...., for example: Inspection team of Decision No. 01/QD-ATTP.

(3)Insert the ordinary number of the inspected entity, for example: If the inspection team in Decision No. 01/QD-ATTP is assigned the task of inspecting 9 entities, the inspection report will be numbered from 01, 02, 03... to 09.

(4)Insert the name, title, or summary of the Inspection Decision.

(5)Insert the inspection decision number.

(6)Name, address, telephone, and other information about the inspected entity.

(7)Checklist and inspection findings.

(8)Check and evaluate the matters in Clause 2, Article 6 of this Circular, except for the matters in Sections 4.1 and 4.2, Part IV of this Report.

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(10)Identify specific inadequacies and breaches.

(11)Specify matters that the Inspection Team requires the inspected entity to implement, comply with, or correct, along with deadlines for corrective actions, etc. for example: The Inspection Team orders entity A to take corrective actions against the inadequacies and breaches mentioned above, and then send a report on corrective actions to the Inspection Agency, at … [address] by…. [date] etc...

Form No. 06

………………..(1)

………………………..(2)-------

THE SOCIALIST REPUBLIC OF VIETNAMIndependence - Freedom - Happiness---------------

No.   /BC-….

[Location]………….[date]………………

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REPORT …(3)

…………………(4)

I. GENERAL SITUATION …(5)

II. INSPECTION FINDINGS

1. Number of inspected entities, inspection areas...(6)

2. Evaluate compliance with food safety regulations...(7)

3. Actions taken and actions proposed to be taken...(8)

III. GENERAL EVALUATION...(9)

IV. RECOMMENDATIONS, SUGGESTIONS...(10)

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HEAD OF INSPECTION AGENCYor INSPECTION TEAM LEADER(Signature, full name)

Notes

(1)Name of the governing body of the inspection agency (if any) or name of the inspection agency.

(2)Insert the name of the Inspection Team according to the inspection decision number, ands symbol of issuing authority

(3)Quick report or report.

(4)Name of inspection.

(5)Summary of inspected entities and the inspection areas; inspection agency, inspection coordination and inspection team.

(6)Summary of inspection entities and areas, evaluation based on the inspection checklist.

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(8)If it is a quick report, insert actions taken and actions proposed to be taken; and then summarize the actions against violations.

(9)General evaluation of compliance with food safety laws, advantages, and disadvantages; difficulties and inadequacies of policies and laws through inspection and recommendations of inspected entities.

(10)Insert recommendations and suggestions on actions against inspection findings; recommend promulgation of and amendment to legislative documents (if any).