| Số hiệu | 17/2023/TT-BYT |
| Loại văn bản | Thông tư |
| Cơ quan | Bộ Y tế |
| Ngày ban hành | 25/09/2023 |
| Người ký | Đỗ Xuân Tuyên |
| Ngày hiệu lực | 09/11/2023 |
| Tình trạng | Còn hiệu lực |
MINISTRY OF HEALTH | THE SOCIALIST REPUBLIC OF VIETNAM |
No. 17/2023/TT-BYT | Hanoi, September 25, 2023 |
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.”
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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.
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:”
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).”
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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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.
In case any legislative documents referred to in this Circular are amended, supplemented, or replaced, the new documents shall prevail.
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. MINISTER
DEPUTY MINISTER
Do Xuan Tuyen
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
...
...
...
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
...
...
...
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
...
...
...
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
...
...
...
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
...
...
...
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
...
...
...
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
...
...
...
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
...
...
...
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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...
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
...
...
...
MRL
(mg/kg)
I
Các chất chống tạo bọt
Antifoam agents
1
Methyl este của acid béo
Fatty acid methyl ester
...
...
...
2
Este poly alkyl glycol của acid béo
Fatty acid polyalkylene glycol ester
Vegetable protein
3
Alcohol béo C8-C30
Fatty alcohols (C8-C30)
...
...
...
4
Dầu dừa hydro hóa
Hydrogenated coconut oil
Confectionery
5-15
5
Các oxoalcohol C9-C30)
Oxoalcohols (C9-C30)
...
...
...
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
...
...
...
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
...
...
...
<1 (calculated at total organic carbon)
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
...
...
...
<2
129
Ethyl acetat
Ethyl acetate
130
Ethyl methyl keton (Butanon)
Ethyl methyl ketone (butanone)
...
...
...
<2
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
...
...
...
<2
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”.
Notes MRL means maximum residue limit.
...
...
...
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
………………..(1)
………………………..(2)
-------
...
...
...
No. /KH-…(3)
[Location]………….[date]………………
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).
………………..(1)
………………………..(2)
-------
THE SOCIALIST REPUBLIC OF VIETNAM
Independence - 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).
...
...
...
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.
...
...
...
(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.
...
...
...
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...
………………..(1)
………………………..(2)
-------
CỘNG HÒA XÃ HỘI CHỦ NGHĨA VIỆT NAM
Độc lập - Tự do - Hạnh phúc
---------------
No. (3)/BB-KT
[Location]………….[date]………………
...
...
...
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
1………………. Position:
...
...
...
III. With the participation of (if any):
1………………. Position:
2……………….
IV. Checklist and inspection findings
……………………………………………………………………………………………………(7)
………………………………………………………………………………………………………
V. Comments, recommendations, and actions
1….. (8)
2…. (9)
...
...
...
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./.
<In case the representative does not sign the inspection report>
Reason for not signing the inspection report: ………………………….
Representative of inspected entity (***)
(Signature, full name), seal (if any)
Head of inspection team
(Signature, full name)
...
...
...
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.
...
...
...
(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)(
...
...
...
………………..(1)
………………………..(2)
-------
THE SOCIALIST REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
---------------
No. (3)/BB-KT
[Location]………….[date]………………
Inspection …………. (4)
...
...
...
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:
...
...
...
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.
………………………………………………………………………………………………………
...
...
...
2. Food safety conditions:
No.
Checklist
Passed
Failed
Notes
2. 1
The kitchen is arranged to prevent cross-contamination between unprocessed and processed foods.
...
...
...
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.
...
...
...
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.
...
...
...
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.
...
...
...
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.
...
...
...
2. 10
Food and food ingredients must be of clear origin and safe.
2. 11
Food must be processed safely and hygienically.
...
...
...
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.
...
...
...
2. 14
Equipment and means of transporting and storing food must be hygienic and prevent food contamination.
2. 15
Others:
...
...
...
...
...
...
...
...
...
3. Check and evaluate other matters:(8)
………………………………………………………………………………………………………
………………………………………………………………………………………………………
...
...
...
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
1… (9)
2…. (10)
3...(11)
VI. Opinions of the inspected entity
………………………………………………………………………………………………………
...
...
...
<In case the representative does not sign the inspection report>
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)
...
...
...
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.
...
...
...
(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...
………………..(1)
………………………..(2)
-------
...
...
...
No. (3)/BB-KT
[Location]………….[date]………………
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) …………………….…………………….…………………….………………
...
...
...
- 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: …………………….…………………….……
...
...
...
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: …………………….…………………….………………
...
...
...
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:
…………………….…………………….…………………….…………………….……………….
...
...
...
1…. (9)
2…. (10)
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./.
<In case the representative does not sign the inspection report>
Reason for not signing the inspection report: …………………….
...
...
...
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.
...
...
...
(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...
………………..(1)
………………………..(2)
-------
THE SOCIALIST REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
---------------
No. /BC-….
[Location]………….[date]………………
...
...
...
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)
...
...
...
HEAD OF INSPECTION AGENCY
or 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.
...
...
...
(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).
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| Số hiệu | 17/2023/TT-BYT |
| Loại văn bản | Thông tư |
| Cơ quan | Bộ Y tế |
| Ngày ban hành | 25/09/2023 |
| Người ký | Đỗ Xuân Tuyên |
| Ngày hiệu lực | 09/11/2023 |
| Tình trạng | Còn hiệu lực |
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