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MINISTRY OF HEALTH
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SOCIALIST REPUBLIC OF VIETNAM
Independence - Freedom – Happiness
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No. 08/VBHN-BYT
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Hanoi, November 02, 2023
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CIRCULAR
MANAGEMENT AND USE OF FOOD ADDITIVES
Circular No. 24/2019/TT-BYT
dated August 30, 2019 of the Minister of Health on management and use of food
additives, which comes into force from October 16, 2019, is amended by:
Circular No.
17/2023/TT-BYT dated September 25, 2023 of the Minister of Health on amendments
to and annulment of certain legislative documents on food safety promulgated by
the Minister of Health, which comes into force from November 09, 2023;
Pursuant to the Law on
Food Safety dated June 17, 2010;
Pursuant to
Government’s Decree No. 15/2018/ND-CP dated February 02, 2018 on elaboration of
the Law on Food Safety;
Pursuant to
Government’s Decree No. 75/2017/ND-CP dated June 20, 2017 on functions, tasks,
powers and organizational structure of the Ministry of Health;
At the request of
Director of Vietnam Food Safety
Authority;
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Chapter
I
GENERAL
PROVISIONS
Article
1. Scope
This Circular provides for
the list of food additives; use and management of food additives and
responsibilities of relevant agencies, organizations and individuals.
Article
2. Regulated entities
This Circular applies to
organizations and individuals involved in manufacture, trade and import of food
and food additives in Vietnam and relevant agencies, organizations and
individuals.
Article
3. Definitions
In this Circular, the
undermentioned terms and abbreviations shall be defined as follows
1. “CAC” stands
for the Codex Alimentarius Commission.
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3. “Flavoring” (food
additive) is a substance added to food to affect, change or increase food
flavor. Flavorings include flavoring substances, natural flavoring complexes;
flavorings used in heat processing or smoke flavorings and their mixtures; may
contain non-flavoring food ingredients with conditions prescribed in section
3.5 of the National Standard TCVN 6417:2010 on guidelines for the use of
flavorings. Flavorings do not include substances that simply create sweetness,
sourness or saltiness (such as sugar, vinegar or salt); and flavor enhancers
that are considered as food additives in the CAC/GL 36-1989 Codex Class Names
and the International Numbering System for Food Additives.
4. “Non-flavoring food
ingredient” means an ingredient that is used as a food additive/food
ingredient and is necessary for the manufacture, preservation and transport of
flavorings or dissolution, disperse or dilution of flavorings.
5. “Acceptable daily
intake” (“ADI”) means the daily intake of a food additive over a lifetime
without an appreciable risk to human health and is expressed as mg per kg of
body weight.
6. “Acceptable daily
intake not specified/not limited” means the daily intake of a food additive
with very low toxicity on the basis of available chemical, biochemical and
toxicological data and other factors. Such intake is maintained at an amount
necessary to achieve the desired effects and acceptable without an appreciable
risk to human health.
7. “Maximum use level”
(“ML”) means the highest amount of a food additive that is determined to be
functionally effective for one kind of food or food group; usually expressed as
mg of additive per kg of food or mg of additive per liter of food.
8 [2]. “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.
Chapter
II
LIST OF
PERMITTED FOOD ADDITIVES
Article
4. Rules for compilation of the list of permitted food additives
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2. Complying with
international standards and regulations on management and use of food
additives.
3. Being up-to-date with
recommendations on risk management for food additives of Vietnamese, CAC, JECFA
and foreign competent authorities.
Article
5. List of permitted food additives and maximum use level
1. Enclosed with this
Circular is Appendix 1 on the list of permitted food additives.
2. Enclosed with this
Circular is Appendix 2A and Appendix 2B on the maximum use level of food
additives.
3. Enclosed with this
Circular is Appendix 3 on the list of permitted food additives and food using
food additives according to GMP.
4 [3]. Flavors
include those in one of the following lists:
a) Flavors that are
evaluated and recognized as safe flavors for expected intakes or acceptable
daily intakes (ADI) by JECFA.
b) Flavors that are
generally recognized as safe flavors (GRAS) by Flavor and Extracts
Manufacturers Association (FEMA);
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5 [4]. 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).
Any food additives not
specified in Appendix 2A and Appendix 3 but regulated in CAC standards on food
products may be used in accordance with this standard.
6 [5]. When the
maximum use level of a food additive in a type of food product specified in
Clause 5 of this Article differs from that in Appendix 2B, Clause 5 of this
Article shall apply."
Article
6. Classification and description of groups of food using food additives
1 [6]. Enclosed
with this Circular is Appendix 4 on 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 Appendix B of the
latest CAC standards on food additives.
2. Food classification
prescribed in Clause 1 herein shall not be used to regulate product naming and
goods labeling.
3. Rules for application
of food group codes:
a) If a food additive is
permitted for use in one food group, it may also be used for subgroups of such
group unless otherwise provided for;
b) If a food additive is
permitted for use in one subgroup, it may also be used for subordinate groups
of such subgroup or for individual foods of such subgroup unless otherwise
provided for.
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MANAGEMENT
AND USE OF FOOD ADDITIVES
Article
7. General rules for use of food additives
1. Use of food additives
must ensure that:
a) The food additive is
permitted for use and is used for the right food;
b) The amount of food
additive used does not exceed the maximum use level applied to one kind of food
or food group;
c) Food additives shall
be used with the minimum amount necessary to produce the desired technical
effects.
2. Food additives shall only
be used if such use could produce the desired effects without harming human
health or deceiving consumers. Food additives shall only be used for one or
more than one of their functions to achieve the following purposes in case
other options more economically and technologically effective to achieve such
purposes are not available.
a) Maintenance of
nutritional value of food. Products for special uses where food additives are
used as food ingredients (e.g. dietary sugar) are not regulated by this Circular;
b) Increase in
maintenance of food quality or stability or organoleptic improvement without
effect on the nature or quality of food with a view to deceiving consumers;
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3. Food additives must
satisfy technical and food safety requirements according to the following
documents:
a) National technical regulations
or regulations of legislative documents promulgated by competent authorities in
case where there is no applicable national technical regulation yet;
b) National standards in
case where the regulations prescribed in Point a herein are not yet applicable;
c) CAC and JECFA
standards and regional and foreign standards in case where the regulations
prescribed in Points a and b herein are not yet applicable;
d) Manufacturer standards
in case where the regulations prescribed in Points a, b and c herein are not
yet applicable.
4. Besides appearing in
food when used in manufacture, food additives may also appear in food when the
ingredients or components for manufacture of such food have already contained
food additives. Such cases shall comply with regulations of Article 9 herein.
Article
8. Rules for determination of maximum use level of food additives according to
Good Manufacturing Practice (GMP) regulations
1. Food additives shall
be used with the minimum amount necessary to produce the desired technical
effects.
2. The amount of food
additives used in manufacture must not alter the nature of food or food
manufacturing technology.
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Article
9. Food additives brought into food by the ingredients or components for
manufacture of such food
1. Food additives brought
into food by the ingredients or components for manufacture of such food must
satisfy the following requirements:
a) They are permitted for
use in ingredients or components (including in food additives);
b) They must not exceed
maximum use level applied to use in ingredients or components (including in
food additives);
c) The food containing
food additives that originate from its ingredients or components shall ensure
that the amount of such food additives do not exceed the maximum use level
applied to the ingredients or components for manufacture of such food according
to manufacture procedures and technology.
2. Food additives that
are not permitted for use in ingredients or components for food manufacture may
be used in or added to such ingredients or components if such food additives
are manufactured or imported for internal use within an enterprise or the
importing and distributing enterprises have signed a contract with food
manufacturers. Such cases must satisfy the following requirements:
a) Such ingredients or
components shall be used to manufacture only one kind of food;
b) Food additives must be
permitted for use and the use amount shall not exceed the maximum use level
applied to that kind of food;
c) Food additives must
have their product declarations registered according to Clause 2 of Article 11
herein.
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a) Formula products for
newborns and infants, formula products for special medical uses for newborns
(food group code: 13.1);
b) Supplementary food for
newborns and infants (food group code: 13.2).
4. If a food additive is
brought into food by ingredients or components for manufacture of such food but
it does not constitute the uses of the finished product, it does not have to be
listed in the composition of such food.
Article
10. Requirements for dividing, filling, repacking and mixing food additives
1. Requirements for
dividing, filling and repacking food additives are as follows:
a) Additives shall only
be divided, filled and repacked upon the written agreement of the
organizations/individuals manufacturing or holding responsibilities for the
products;
b) Food additives shall
be divided, filled and repacked in such a manner that does not affect product
quality and safety or cause any risk to human health;
c) Labels of food
additives that have been divided, filled or repacked must include the date of
such dividing, filling or repacking. The expiry date shall be determined
based on the date of manufacture on the original labels of the food additives
prior to food additives are divided, filled and repacked;
d) Food additives shall
be divided, filled and repacked in accordance with other regulations on
manufacture and sale of food additives.
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a) Food additives shall
only be mixed when such mixing does not cause any risk to human health;
b) Ingredient quantity of
each food additive shall be included in the product composition;
c) Guidelines for maximum
use level, the food using food additives and functions of food additives shall
be provided;
d) Food additives shall
be mixed in accordance with other regulations on manufacture and sale of food
additives.
Chapter
IV
MANAGEMENT
OF FOOD ADDITIVES
Article
11. Product declaration
1. Food additives must be
declared before being distributed on the market, except for the food additives prescribed
in Clause 2 of this Article and Clause 2 of Article 4 of the Government’s
Decree No. 15/2018/ND-CP dated February 02, 2018 on elaboration of some
articles of the Law of Food Safety. Procedures for product declaration shall be
carried out according to Article 5 of the Decree No. 15/2018/ND-CP and Point a
of Clause 1 of Article 3 of the Government’s Decree No. 155/2018/ND-CP dated
November 12, 2018 on amendments to some articles related to business conditions
under state management of the Ministry of Health.
2. Mixed food additives
with new uses and food additives not included in the list of permitted food
additives prescribed in this Circular must have their declarations registered
with the Vietnam Food Safety Authority and Ministry of Health before official
use or distribution on the market. Procedures for registration of product
declaration shall be carried out according to Articles 7 and 8 of the
Government’s Decree No. 15/2018/ND-CP dated February 02, 2018 on elaboration of
some articles of the Law of Food Safety.
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Food additive labeling
shall be carried out according to the Government’s Decree No. 43/2017/ND-CP
dated April 14, 2017 on goods labeling and relevant documents.
Article
13. Handling of administrative violations against regulations on food safety
applied to manufacture, trade and use of food additives
Administrative violations
against regulations on food safety in manufacture, trade and use of food
additives shall be handled according to the Government’s Decree No. 115/2018/ND-CP
dated September 04, 2018 on penalties for administrative violations against
regulations on food safety and relevant documents. In case there are
aggravating circumstances in a violation as prescribed in the Law on Handling
Administrative Violations, competent persons shall consider and decide to
impose the fine up to the highest and revocation of the certificate of
registered product declaration.
Chapter
V
IMPLEMENTING
PROVISIONS [7]
Article
14. Transitional clauses
1. Food additives and food
products using food additives that have been granted the certificate of
declaration of conformity or certificate of declaration of conformity with the
food safety regulations before the effective date of this Circular may continue
to be used until the expiration dates of such certificates or products,
excluding the cases where there are food safety warnings.
2. Food additives and
food products using food additives that have completed product declaration or
have been granted the certificate of product declaration registration before
the effective date of this Circular, if not conforming with the regulations of
this Circular, may continue to be used until the expiration dates of such
products, excluding the cases where there are food safety warnings.
Article
15. Terms of reference
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Article
16. Effect
1. This Circular comes
into force from October 16, 2019.
2. The Minister of
Health’s Circular No. 27/2012/TT-BYT , the Minister of Health’s Circular No.
08/2015/TT-BYT and Part III of the Minister of Health’s Decision No.
3742/2001/QD-BYT are annulled from the effective date of this Circular.
Article
17. Implementation responsibilities
1. The Vietnam Food Safety
Authority shall be responsible for taking charge and cooperating with relevant
competent authorities in organizing the implementation and inspection of the
implementation of this Circular in nationwide.
2 [8]. The Vietnam
Food Safety Authority shall:
a) Provide guidance on
search for 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 Safety Authority (address: https://vfa.gov.vn).
b) Propose inspection of
and amendments to this Circular as per management requirements and requests of
organizations and individuals involved in manufacture and sale of food
additives and food.
3. Organizations and
individuals involved in manufacture, trade and import of food additives and
food must satisfy the following requirements:
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b) When a food additive
is found to have violated a regulation of this Circular, manufacture, trade and
import of such food additive shall be suspended and relevant competent
authorities shall be notified of such violation;
c) Food additives that
violate safety regulations shall be revoked and handled according to applicable
regulations.
d) In case of request for
addition of a food additive or kind of food not provided for in this Circular,
organizations and individuals must provide scientific proofs for the safety of
such product for consideration.
4. Head of Office of the
Ministry of Health, chief inspector of the Ministry of Health, heads of
departments and affiliates of the Ministry of Health and relevant agencies,
organizations and individuals shall be responsible for the implementation of
this Circular.
During the implementation
of this Circular, if any problem arise, agencies, organizations and individuals
shall promptly report to the Ministry of Health (Vietnam Food Safety Authority)
for consideration and/or resolution./.
CERTIFIED BY
PP. MINISTER
DEPUTY MINISTER
Do Xuan Tuyen
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[1]
Circular No. 17/2023/TT-BYT dated
September 25, 2023 of the Minister of Health on amendments to and annulment of
certain legislative documents on food safety promulgated by the Minister of
Health is promulgated pursuant to:
“The Law on
Promulgation of Legislative Documents No. 80/2015/QH13 dated June 22, 2015 and
the Law on amendments to the Law on Promulgation of Legislative Documents No.
63/2020/QH14 dated June 18, 2020;
The Law on Food Safety
No. 55/2010/QH10 dated June 17, 2010;
Government’s Decree No.
15/2018/ND-CP dated February 02, 2018 on elaboration of the Law on Food Safety;
Government’s Decree
No. 95/2022/ND-CP dated November 15, 2022 on functions, tasks, powers and
organizational structure of the Ministry of Health of Vietnam;
At the request of
Director of Vietnam Food Safety
Authority,
The Minister of Health
promulgates Circular on amendments to and annulment of certain legislative
documents on food safety promulgated by the Minister of Health.”
[2]
This Clause is amended by Clause 1 Article
1 of Circular No. 17/2023/TT-BYT dated September 25, 2023 of the Minister of
Health, which comes into force from November 09, 2023.
[3]
This Clause is amended by Clause 2 Article
1 of Circular No. 17/2023/TT-BYT dated September 25, 2023 of the Minister of
Health, which comes into force from November 09, 2023.
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[5]
This Clause is added by Clause 3 Article 1
of Circular No. 17/2023/TT-BYT dated September 25, 2023 of the Minister of
Health, which comes into force from November 09, 2023.
[6]
This Clause is amended by Clause 5 Article
1 of Circular No. 17/2023/TT-BYT dated September 25, 2023 of the Minister of
Health, which comes into force from November 09, 2023.
[7]
Articles 9, 10 and 11 of Circular No.
17/2023/TT-BYT dated September 25, 2023 of the Minister of Health stipulate
that:
“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 from November 09, 2023.
Article 11.
Implementation
The Chief of Ministry
Office; Director of Vietnam Food Safety
Authority; 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
central-affiliated cities; Heads of health agencies of ministries, and relevant
agencies, organizations and individuals shall implement this Circular./.
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