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MINISTRY OF HEALTH OF VIETNAM
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THE SOCIALIST REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
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No. 09/VBHN-BYT
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Hanoi, September 06, 2024
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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 and partially annulled 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;
Circular No.
08/2024/TT-BYT dated May 24, 2024 of the Minister of Health on partial
annulment of certain legislative documents promulgated by the Minister of
Health, which comes into force from May 24, 2024;
Chapter I
GENERAL PROVISIONS
Article 1. Scope
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Article 2.
Regulated entities
This Circular is
applicable to organizations and individuals involving in manufacture, trade and
import of food and food additives in Vietnam and relevant agencies,
organizations and individuals.
Article 3. Term
interpretation
In this Circular, the
undermentioned terms and abbreviations shall be defined as follows:
1. “CAC” stands
for the Codex Alimentarius Commission.
2. “JECFA” stands
for the Joint FAO/WHO Expert Committee on Food Additives.
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 guiding 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 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.
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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. “mixed food
additive with new uses” means 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
The list of permitted
food additives shall be compiled on the basis of:
1. Protection of human
health.
2. Compliance 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.
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1. Enclosed with this
Circular is Appendix 1 containing the list of permitted food additives
2. Enclosed with this
Circular is Appendix 2A and Appendix 2B containing the maximum use level of
food additives.
3. Enclosed with this
Circular is Appendix 3 containing the list of permitted food additives and food
using food additives according to GMP.
4.
Flavorings include those in one of the following lists:
a)
The flavorings that are evaluated and recognized as safe for expected intakes
or acceptable daily intakes (ADI) by JECFA;
b)
The flavorings that are generally recognized as safe (GRAS) by Flavor and
Extracts Manufacturers Association (FEMA);
c)
The flavorings that can be used in food products of EU approved by European
Union Parliament and Council.”
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).
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.
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Article 6.
Classification and description of groups of food using food additives
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.
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.
Chapter III
USE OF FOOD ADDITIVES
Article 7. General
rules for use of food additives
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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 function 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 of
maintenance of food quality or stability or organoleptic improvement without
affecting the nature or quality of food to deceive consumers;
c) Support for
manufacture and transport but not for the purpose of hiding the effects
resulted from use of low quality ingredients or improper
manufacturing/technical practice.
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 if there is no applicable national technical regulation yet;
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c) CAC and JECFA
standards and regional and foreign standards in case the regulations prescribed
in points a and b herein are not yet applicable;
d) Manufacturer
standards in case 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 must comply with the 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.
3. Food additives must
ensure quality and safety for use in food and shall be processed and
transported in the same way as food ingredients.
Article 9. Food
additives brought into food by the ingredients or components for manufacture of
such food
1. The food additives
brought into food by the ingredients or components for manufacture of such food
must satisfy the following requirements:
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b) Not exceeding
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 contracts 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) The 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) The food additives
must have their product declarations registered according to clause 2 of
Article 11 herein.
3. Additives brought
into food by ingredients or components for manufacture of such food are not
permitted for the following product groups, unless such additives are
stipulated in Appendix 2A, Appendix 2B and Appendix 3 enclosed with this
Circular:
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).
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Article 10.
Requirements for dividing, filling, repacking and mixing of food additives
1. Requirements for
dividing, filling and repacking of food additives are as follows:
a) Dividing, filling
and repacking of food additives shall only be carried out upon the written
agreement of the organizations/individuals manufacturing or holding
responsibilities for the products;
b) Dividing, filling
and repacking of food additives must 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 dividing, filling or repacking;
d) Dividing, filling
and repacking of food additives shall comply with other regulations relating to
manufacture and sale of food additives.
2. Requirements for
mixing of food additives and mixed food additives are as follows:
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;
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d) Mixing of food
additives shall comply with other regulations relating to 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 dated February 02, 2018 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 or serving users other than the ones prescribed in this Circular must
have their declarations registered with the Vietnam Food Administration 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.
Article 12.
Labeling
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. (Annulled)
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IMPLEMENTATION CLAUSE
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 date this Circular comes into effect, 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
In case the documents
referred to herein are amended or superseded, the new documents shall be
applied.
Article 16. Effect
1. This Circular comes
into effect 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 date this Circular comes into effect.
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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 throughout the country.
2. The Vietnam Food
Safety Authority shall:
a) Give guidance on
looking 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 Safety Authority (address: https://vfa.gov.vn).
b) Propose inspection
of and amendments to this Circular as per management requirements and at the
request of organizations and individuals involving in manufacture and sale of
food additives and food.
3. Organizations and
individuals involving in manufacture, sale and import of food additives and
food must satisfy the following requirements:
a) Manufacture, sale,
import and use of food additives shall be carried out according to regulations
of this Circular;
b) When a food
additive is found to have violated a regulation of this Circular, manufacture,
sale 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, kind of food, group of food or use level not
provided for in this Circular, organizations and individuals must provide
scientific proofs for the safety of such product for consideration.
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Difficulties that
arise during the implementation of this Circular should be reported to the
Vietnam Food Safety Authority (affiliated to the Ministry of Health) for
consideration./.
CERTIFIED BY
PP. MINISTER
DEPUTY MINISTER
Do Xuan Tuyen