MINISTRY
OF HEALTH
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|
THE
SOCIALIST REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
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No.
17/2023/TT-BYT
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Hanoi,
September 25, 2023
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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.
MINISTER
DEPUTY MINISTER
Do 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
...
...
...
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9
Nhôm
Aluminum
Hydrogenated
food oils
10
Chromi
Chromium
...
...
...
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<
0,1
11
Đồng
Copper
Hydrogenated
food oils
<
0,1
12
Đồng chromat
Copper chromate
...
...
...
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13
Đồng chromite
Copper chromite
14
Mangan
Manganese
...
...
...
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<
0,4
15
Molypden
Molybdenum
Hydrogenated
food oils
<
0,1
16
Paladi
Palladium
...
...
...
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<
0,1
17
Platin
Platinum
Hydrogenated
food oils
<
0,1
18
Kali kim loại
Potassium metal
...
...
...
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<
1
19
Kali methylat (methoxide)
Potassium methylate (methoxide)
Dầu
thực phẩm este hóa
<
1
20
Kali ethylat (ethoxide)
Potassium ethylate (ethoxide)
...
...
...
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<
1
21
Bạc
Silver
Hydrogenated
food oils
<
0,1
22
Natri amid
Sodium amide
...
...
...
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<
1
23
Natri ethylen (natri ethylat)
Sodium ethylene (sodium ethylate)
Interesterified
food oils
<
1
24
Natri methylat (methoxide)
Sodium methylate (methoxide)
...
...
...
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<
1
25
Acid trifluormethan sulfonic
Trifluoromethane sulfonic acid
Cocoa
butter substitute
<
0,01
26
Zirconi
Zirconium
...
...
...
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27
Nickel
Nickel
Polyols
III
Các chất làm trong/các chất trợ
lọc
Clarifying agents/ filtration
aids
...
...
...
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28
Albumin
Albumin
29
Amiăng
Asbestos
...
...
...
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30
Bentonite
Bentonite
Starch
hydrolysis
31
Diatomit
Diatomaceous earth
...
...
...
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32
Copolyme divinylbenzen-
ethylvinylbenzen
Divinylbenzene- ethylvinylbenzene
copolymer
Aqueous
foods (excluding carbonated beverages)
0.00002
ex-tractives from copolymer
33
Magnesi acetat
Magnesium acetate
...
...
...
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34
Peclit
Perlite
Starch
hydrolysis
35
Acid polymaleic và natri
polymaleat
Polymaleic acid and sodium
polymaleate
...
...
...
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<
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)
...
...
...
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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
...
...
...
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<
1
40
Nhựa trao đổi ion
Ion exchange resins (see Ion
exchange Resins)
Fruit
juices
41
Isinglass (Thạch)
Isinglass (Agar)
...
...
...
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42
Cao lanh
Kaolin
Fruit
juices
43
Tanin
Tannin (to be specified) Tannic
Acid
...
...
...
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GMP
44
Gelatin (từ collagen da)
Gelatin (from skin collagen)
Fruit
juices
IV
Các chất làm lạnh và làm mát
Contact freezing & cooling
agents
...
...
...
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45
Dichlorofluormethan
Dichlorofluormethane
Frozen
food
100
V
Các chất làm khô/ Các chất chống
đông vón
Desiccating agent/anticaking
agents
...
...
...
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46
Nhôm stearat
Aluminum Stearate
47
Calci Stearat
Calcium Stearate
...
...
...
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48
Magnesi Stearat
Magnesium stearate
49
Octadecyl amoni acetat (trong
amoni chloride)
Octadecyl ammonium acetate (in
ammonium chloride)
...
...
...
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50
Kali nhôm silicat
Potassium aluminum silicate
51
Natri calci silicoaluminat
Sodium calcium silicoaluminate
...
...
...
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52
Calci phosphat (tricalci
phosphat)
Calcium phosphate (tricalcium
phosphate)
VI
Các chất tẩy rửa (Các chất làm
ẩm)
Detergents (wetting agents)
...
...
...
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53
Dioctyl natri sulfosuccinat
Dioctyl sodium sulfosuccinate
Fruit
drinks
<
10
54
Hợp chất amoni bậc bốn
Quaternary ammonium compounds
...
...
...
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55
Natri lauryl sulphat
Sodium lauryl sulphate
Food
fats and oils
<
1
56
Natri xylen sulphonat
Sodium xylene sulphonate
...
...
...
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<
1
VII
Các chất cố định enzym và chất
mang
Enzyme immobilization agents
& supports
57
Polyethylenimin
Polyethylenimine
...
...
...
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58
Glutaraldehyde
Glutaraldehyde
59
Diethylaminoethyl Cellulose
Diethylaminoethyl Cellulose
...
...
...
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VIII
Các chất keo tụ
Flocculating agents
60
Nhựa acrylat-acrylamid
Acrylate-acrylamide resin
...
...
...
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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
...
...
...
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63
Copolyme dimethylamin -
epichlorohydrin
Dimethylamine - epichlorohydrin
copolymer
Sugar
processing
<
5
64
Huyết tương khô và dạng bột
Dried and powdered blood plasma
...
...
...
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65
Nhựa acrylamid biến tính
Modified acrylamide resin
Sugar,
boiler water
66
Acid polyacrylic
Polyacrylic acid
...
...
...
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67
Polyacrylamid
Polyacrylamide
Sugar
(sugar beet)
68
Natri polyacrylat
Sodium polyacrylate
...
...
...
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69
Trinatri diphosphat
Trisodium diphosphate
70
Trinatri orthophosphat
Trisodium orthophosphate
...
...
...
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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
...
...
...
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<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
...
...
...
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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
...
...
...
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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
...
...
...
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77
Bentonit
Bentonite
Confectionery
XI
Các chất kiểm soát vi sinh vật
Micro-organism control agents
...
...
...
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78
Chlor dioxide
Chlorine dioxide
Flours
79
Hypochlorit
Hypochlorite
...
...
...
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80
Iodophors
Iodophors
Food
oils
81
Hệ enzym lactoperoxidase
(latoperoxidase, gluco oxidase, muối thiocynat)
Lactoperoxidase system (lactoperoxidase,
glucose oxidase, thiocyanate salt)
...
...
...
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82
Acid Peracetic
Peracetic acid
83
Hợp chất amoni bậc bốn
Quaternary ammonium compounds
...
...
...
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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
...
...
...
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85
Amoni phosphat
Ammonium phosphates
Fermented
food
86
Biotin
Biotin
...
...
...
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87
Đồng sulfat
Copper sulphate (Cupic sulphate)
Fermented
food
88
Niacin
Niacin
...
...
...
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89
Acid pantothenic
Pantothenic acid
Fermented
food
90
Kẽm Sulfat
Zinc sulfate
...
...
...
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91
Sắt (II) sulfat
Ferrous sulfate
Fermented
food
92
Inositol
Inositol
...
...
...
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93
Magnesi sulfat
Magnesium sulfate
Fermented
food
94
Polysorbat 80
Polysorbate 80
...
...
...
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95
Silic dioxide
Silicon dioxide
Fermented
food
96
Gôm Acacia
Acacia Gum
...
...
...
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97
Acid phosphoric
Phosphoric acid
Fermented
food
98
Acid nitric
Nitric acid
...
...
...
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99
Acid citric
Citric acid
Fermented
food
100
Glycin
Glycine
...
...
...
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101
Natri bicacbonat
Sodium bicarbonate
Fermented
food
102
Lecithin đậu tương
Soy lecithin
...
...
...
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103
Amoni chloride
Ammonium chloride
Fermented
food
104
Natri lauryl sulfat
Sodium lauryl sulphate
...
...
...
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105
Amoni sulfat
Ammonium sulphate
Fermented
food
106
Propyl galat
Propyle gallate
...
...
...
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107
Natri phosphat, monobasic
Sodium phosphate, monobasic
Fermented
food
XIII
Các chất đẩy tơi và các khí
bao gói
Propellant and packaging gases
...
...
...
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108
Không khí
Air
109
Argon
Argon
...
...
...
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110
Carbon dioxide
Carbon dioxide
111
Chloropentafluoroethan
Chloropentafluoroethane
...
...
...
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112
Heli
Helium
113
Hydro
Hydrogen
...
...
...
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114
Nito oxide
Nitrous oxide
115
Octa fluorocyclobutan
Octafluorocyclobutane
...
...
...
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116
Propan
Propane
117
Triclorofluoromethan (F11)
Trichlorofluoromethane (F11)
...
...
...
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118
Dichlorodifluoromethan (F12)
Dichlorodifluoromethane (F12)
XIV
Các dung môi, quá trình chiết
và chế biến
Solvents, extraction &
processing
...
...
...
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119
Amyl Acetat
Amyl acetate
Flavourings,
colors
120
Benzyl alcohol
Benzyl alcohol
...
...
...
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121
Butan 1,3-diol
Butane-1,3-diol
Flavourings
122
Butyl acetat
Butyl acetate
...
...
...
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123
Cyclohexan
Cyclohexane
Flavourings
and food oils
<
1
124
Dibutyl ete
Dibutyl ether
...
...
...
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<
2
125
1,2 Dichloroethan
1,2 Dichloroethane
Decaffeination
of products
<
5
126
Dichlorodifluoromethan
Dichlorodifluoromethane
...
...
...
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<
1
127
Diethyl citrat
Diethyl citrate
Flavourings,
colors
128
Diethyl ete
Diethyl ether
...
...
...
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<2
129
Ethyl acetat
Ethyl acetate
130
Ethyl methyl keton (Butanon)
Ethyl methyl ketone (butanone)
...
...
...
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<2
131
Glycerol tributyrat
Glycerol tributyrate
Flavourings,
colors
132
Isobutan
Isobutane
...
...
...
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<
1
133
Các hydrocacbon từ isoparafinic dầu
mỏ
Isoparaffinic petroleum
hydrocarbons
Citric
acid
134
Isopropyl myristat
Isopropyl myristate
...
...
...
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135
Methylen chloride
(Dichloromethan)
Methylene chloride
(dichloromethane)
Food
oils
<
0,02
136
Methyl propanol-I
Methyl propanol-I
...
...
...
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1
137
n-Octyl alcohol
n-Octyl alcohol
Citric
acid
138
Pentan
Pentane
...
...
...
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<
1
139
Ete dầu hỏa
Petroleum ether (light petroleum)
Flavourings
and food oils
<
1
140
Propan 1,2 - diol
Propane-1,2-diol
...
...
...
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141
Propan-1-ol
Propane-1-ol
Fatty
acids, flavourings, colors
142
1,1,2 - trichloroethylen
1,1,2-Trichloroethylene
...
...
...
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<2
143
Tridodecylamin
Tridodecylamine
Citric
acid
144
Toluen
Toluene
...
...
...
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<
1
145
Aceton (Dimethyl keton)
Acetone (Dimethyl ketone)
Flavourings,
colors, food oils
146
Butan
Butane
...
...
...
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<
1,01
147
Ethanol
Ethanol
Vegetable
protein
148
Hexan
Hexane
...
...
...
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1
149
Tert butyl alcohol
Tertiary butyl alcohol
Flavourings,
colors, food oils
150
Trichlorofluoromethan
Trichlorofluoromethane
...
...
...
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<
1
151
Butan -1-ol
Fatty
acids
<
1000
152
Butan -2-ol
...
...
...
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1
153
Glycerol tripropionat
Glycerol tripropionate
Flavourings,
colors
XV
Các chất tẩy rửa và bóc vỏ
Washing and peeling agents
...
...
...
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154
Amoni orthophosphat
Ammonium orthophosphate
Vegetables
and fruits
155
Diamoni orthophosphat nồng độ 5%
trong nước
Diammonium orthophosphate: 5%
aqueous solution
...
...
...
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156
Dithiocacbamat
Dithiocarbamate
Sugar
beet
157
Ethylen dichloride
Ethylene dichloride
...
...
...
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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
...
...
...
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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
...
...
...
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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
...
...
...
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0,00005
trong củ cải đường, không được có trong đường
164
Hydro peroxide
Hydrogen peroxide
165
Kali bromide
Potassium bromide
...
...
...
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166
Amoni chloride (bậc 4)
Ammonium chloride (quaternary)
167
Acid sulfuric
Sulfuric acid
...
...
...
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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)
...
...
...
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169
Men rượu (Saccharomyces
cerevisaa)
Alcohol dehydrogenase (Saccharomyces
cerevisia)
170
Catalase (Gan bò)
Catalase (bovine liver)
...
...
...
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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)
...
...
...
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173
Lysozim (Lòng trắng trứng)
Lysozime (egg whites)
Butter,
cheese
174
Pepsin A (của gia cầm)
Pepsin A - Poultry proventicum
...
...
...
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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)
...
...
...
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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
...
...
...
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179
Chymopapain (từ quả đu đủ)
Chymopapain (Carica papaya)
180
Alpha galactosidase (Melibiaza)
Alpha galactosidase (Melibiase)
...
...
...
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181
Arabinofuranosidase
Arabinofuranosidase
182
Beta glucanase
Beta glucanase
...
...
...
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183
Dextranase
Dextranase
184
Endo beta glucanase
Endo beta glucanaza
...
...
...
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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
...
...
...
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187
Glucoamylase hoặc
amyloglucosidase
Glucoamylase or amyloglucosidase
Starch
hydrolysis, Gluco syrup production
188
Glucose isomerase
Glucose isomerase
...
...
...
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189
Hemicellulase
Hemicellulase
Vegetable
processing, fruit juice processing, baking, beer production, starch
production, coffee/tea/spices extraction
190
Inulinase
Inulinase
...
...
...
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191
Invertase
Invertase
192
Isoamylase
Isoamylase
...
...
...
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193
Lactase
Lactase
Production
of milk products
194
Decacboxylase đối với acid malic
Malic acid decarboxylase
...
...
...
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195
Maltase hoặc alpha glucosidase
Maltase or alpha glucosidase
196
Enzym khử nitrat
Nitrate reductase
...
...
...
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197
Pectin lyase
Pectin lyase
198
Pectin esterase
Pectin esterase
...
...
...
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199
Polygalacturonase
Polygalacturonase
200
Protease (bao gồm các enzym đông
tụ sữa)
Protease (including milk clotting
enzymes)
...
...
...
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201
Pullulanase
Pullulanase
Starch
hydrolysis
202
Serin proteinase
Serine proteinase
...
...
...
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203
Tannase
Tannase
204
Xenlulase
Cellulase
...
...
...
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205
Cellobiase (Beta d- glucosidase)
Cellobiase (Beta d- glucosidase)
XVII
Phụ gia nước nồi hơi
Boiler water additives
...
...
...
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206
Natri tripolyphosphat
Sodium tripolyphosphate
Boiler
water
207
Polyethylen glycol
Polyethylene glycols
...
...
...
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208
Tetranatri diphosphat
Tetrasodium diphosphate
Boiler
water
209
Natri hexameta phosphat
Sodium hexametaphosphate
...
...
...
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210
Magnesi sulfat
Magnesium sulfate
Boiler
water
211
Natri polyacrylat
Sodium polyacrylate
...
...
...
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XVIII
Các chất hỗ trợ chế biến khác
Other Processing aids
212
Nhôm oxide
Aluminum oxide
...
...
...
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213
Acid Erythorbic
Erythorbic acid
214
Calci tactrat
Calcium tartrate
...
...
...
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215
Acid Giberelic
Gibberellic acid
216
Magnesi tartrat
Magnesium tartrate
...
...
...
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217
Kali giberelat
Potassium gibberellate
218
Natri
Sodium
...
...
...
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219
Natri silicat
Sodium silicate
220
Ethyl parahydroxybenzoat
Ethyl parahydroxybenzoate
...
...
...
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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.
...
...
...
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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
...
...
...
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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)
-------
...
...
...
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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.
...
...
...
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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)
...
...
...
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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...
...
...
...
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(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 VIETNAM
Independence - Freedom - Happiness
---------------
No.
/QD-…(3)
...
...
...
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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);
...
...
...
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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 NAM
Độc 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
1……………….
Position:
...
...
...
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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)
...
...
...
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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./.
<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)
...
...
...
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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 VIETNAM
Independence - 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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...
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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
1… (9)
2…. (10)
3...(11)
VI. Opinions of the inspected
entity
………………………………………………………………………………………………………
...
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<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)
...
...
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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
...
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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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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: …………………….
...
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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.
...
...
...
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- 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 VIETNAM
Independence - 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 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.
...
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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).