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MEDGATE TECHNOLOGY AND INVESTMENT JSC.
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THE MINISTRY OF
HEALTH OF VIETNAM
-------
THE SOCIALIST REPUBLIC OF VIETNAM
Independence – Freedom – Happiness
-----------------------
No. 12/VBHN-BYT Hanoi, November 02, 2023
CIRCULAR
PRESCRIBING MANAGEMENT OF FUNCTIONAL FOODS
The Circular No. 43/2014/TT-BYT dated November 24, 2014 of the Minister of Health
prescribing management of functional foods, coming into force from February 01, 2015,
is amended by:
The Circular No. 17/2023/TT-BYT dated September 25, 2023 of the Minister of Health
of Vietnam providing amendments to and abrogation of some legislative documents on
food safety, coming into force from November 09, 2023.
Pursuant to the Law on Food Safety dated June 17, 2010;
Pursuant to the Government's Decree No. 38/2012/ND-CP dated April 25, 2012
elaborating the Law of Food Safety;
Pursuant to the Government’s Decree No. 63/2012/ND-CP dated August 31, 2012
defining functions, tasks, powers and organizational structure of the Ministry of Health of
Vietnam;
At the request of the Director of Vietnam Food Administration;
The Minister of Health of Vietnam promulgates a Circular providing regulations on
management of functional foods. [1]
Chapter I
GENERAL PROVISIONS
Article 1. Scope and regulated entities
1. This Circular provides for the activities relating to production, trading, product
declaration, labeling and provision of instructions for use of functional foods such as
supplemented foods, health supplements and medical foods, including foods for special
dietary uses.
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2. This Circular does not apply to nutritional formulas for children. Production, trading,
product declaration, labeling and provision of instructions for use of these products shall
comply with corresponding technical regulations and regulations of law on trading and
use of nutritional products for children.
Article 2. Definitions
For the purposes of this Circular, the terms below shall be construed as follows:
1. “supplemented food” means a normal food that is supplemented with micronutrients
and other ingredients food for health such as vitamins, minerals, amino acids, fatty acids,
enzymes, probiotics, prebiotics and other biologically active substances.
2 [2]. (abrogated)
3[3]. (abrogated).
4 [4]. (abrogated).
5[5]. (abrogated).
6. Recommended nutrition intake (RNI) for Vietnamese means the intake level of a
particular nutrient considered sufficient for Vietnamese people as recommended by the
National Institute of Nutrition (affiliated to the Ministry of Health of Vietnam).
Chapter II
GENERAL REQUIREMENTS FOR FUNCTIONAL FOODS
Article 3. Product self-declaration and registration of product disclosure [6]
1[7]. (abrogated).
2[8]. (abrogated).
3[9]. Procedures for product self-declaration and registration of product disclosure:
a) Procedures for product self-declaration are laid down in Chapter II of the
Government’s Decree No. 15/2018/ND-CP dated February 02, 2018 on elaboration of the
Law on Food Safety and clause 1 Article 3 Chapter I of the Government’s Decree No.
155/2018/ND-CP dated November 12, 2018 providing amendments to regulations on
investment and business conditions in sectors under the state management of the Ministry
of Health of Vietnam;
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b) Procedures for registration of product disclosure are laid down in Chapter III of the
Government’s Decree No. 15/2018/ND-CP dated February 02, 2018.
Article 4. Requirements attached to efficacy testing reports
1. Effects on human health of the following products must be tested:
a[10]) (abrogated)
b) Products whose new effects are disclosed but have not yet been recognized by any
countries in the world;
c) Products containing new active ingredients the use of which is not yet permitted;
d) Health supplements which are put on the market for the first time and have formulas
different from those of products supported by adequate scientific evidences;
dd) Products derived from plants/animals and put on the market for the first time, the
composition of which is different from that of the ancient traditional remedy or
dose-adjusted ancient traditional remedy products published in academic journals;
e) Medical foods and foods for special dietary uses which have not been permitted by
competent authorities or authorized authorities or law of the country of origin, or the
effects, suitable users and usage instructions on the label have not been confirmed by the
exporting country.
2[11]. The test for effects on human health must be conducted in accordance with
regulations on biomedical research involving human participants laid down in the
Circular No. 04/2020/TT-BYT dated March 05, 2020 of the Minister of Health of
Vietnam prescribing establishment, functions, tasks, and rights of Research Ethics
Committees, and procedures and regulations of the Law on Science and Technology.
3. If the test for the effects on human health is conducted overseas, it must be performed
by entities accredited by competent authorities of home country.
4[12]. Any issue that arises beyond the scope of this Circular shall be reported by the
receiving authority to its supervisory authority for timely resolution, taking into account
the following factors: compliance with relevant laws and regulations, assurance of the
health and interests of consumers, and no influence on food production and trading of
organizations and individuals.
Article 5[13]. (abrogated)
Article 6[14]. (abrogated)
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Article 7[15]. (abrogated)
Chapter III
REQUIREMENTS FOR FUNCTIONAL FODOS
Article 8. Requirements regarding claims
1. Nutrient content claims:
When supplementing foods with vitamins, minerals, amino acids, fatty acids, enzymes,
probiotics, prebiotics or other biologically active substances, the claims about the
contents of such substances in foods according to recommended nutrition intakes (RNI)
for Vietnamese are specified in Appendix No. 01 enclosed herewith as follows:
a) [16] A substance shall not be mentioned if its content is below 10% RNI or 10% of the
intake of that substance stated in a given scientific evidence (for a substance for which
the RNI is not disclosed);
b) [17] If the content of a substance reaches at least 10% RNI or at least 10% of the
intake of that substance stated in a given scientific evidence (for a substance for which
the RNI is not disclosed), its name and its content in a serving or 100g of the product
shall be specified;
c) The maximum contents of vitamins and minerals in foods according to RNI levels
provided by manufacturers shall not exceed the tolerable upper intake levels of such
vitamins and minerals specified in Appendix 02 enclosed herewith.
If RNI levels and tolerable upper intake levels of Vietnam are not available, they shall be
determined according to regulations of CODEX or relevant international organizations.
2. Health claims:
a) [18] Health claims about a supplemental substance shall be made only when its content
in the food reaches 10% RNI or above and is proven with specific scientific evidence;
b) [19] Regarding a supplemental ingredient for which RNI level is yet to be announced,
health claims shall be made on the product’s label only when its content reaches at least
10% of its intake stated in the given scientific evidence;
c) [20] Health claims must be clear, consistent, and suitable for the given scientific
evidence;
Article 9 [21] . (abrogated)
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Chapter IV
HEALTH SUPPLEMENTS
Article 10. Requirements regarding claims
1. Contain claims:
a) [22] (abrogated);
b) [23] The content of vitamins or minerals in foods according to RNI levels provided by
manufacturers shall reach at least 15% of RNI levels for Vietnamese or at least 15% of
their intakes stated in the given scientific evidence;
c) The maximum contents of vitamins and minerals in foods according to RNI levels
provided by manufacturers shall not exceed the tolerable upper intake levels of such
vitamins and minerals specified in Appendix 02 enclosed herewith;
d) [24] If RNI levels and tolerable upper intake levels of Vietnam are not available, they
shall be determined according to regulations of CODEX or relevant international
organizations.
2. Health claims:
a) Health claims must reflect the product nature. The claim about effects of ingredients
having main or combined effects shall be made only when there is scientific evidence.
The effects of ingredients must not be enumerated as effects of the product;
b) Claims about health, dose, suitable users and usage instructions must be consistent and
in conformity with the documents;
c) [25] (abrogated)
d) [26] If the contents of vitamins and minerals in a product and reach at least 15% RNI
or at least 15% of their intakes stated in the given scientific evidence, their effects shall
be claimed, provided suitable users and doses are specified;
dd) [27] If the daily intake of an ingredient for which the RNI level is yet to be
announced reaches at least 15% of its intake stated in the given scientific evidence, its
effects shall be claimed, provided suitable users and doses are specified.
3. Users:
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a) [28] The suitable users must be determined in conformity with claimed effects and
approved by the authority receiving the application for registration of product disclosure
by giving certification of product disclosure;
b) Prohibited users (if any) must be specified.
Article 11. Vietnamese labels
[29] Labeling of health supplements must comply with regulations on labeling and the
following provisions:
1[30]. (abrogated)
2[31]. (abrogated)
3. Mechanism of action of the product shall not be written on its label.
4[32]. The phrase “Thực phẩm này không phải là thuốc và không có tác dụng thay thế
thuốc chữa bệnh” (“This food is not a medicine, and is not a substitute for medicines”)
shall be specified on the label right after the product’s effects or with other claims (if
any).
Chapter V
MEDICAL FOODS AND FOODS FOR SPECIAL DIETARY USES
Article 12. Requirements regarding claims
1. Nutrient content claims:
a) [33] (abrogated);
b) RNI levels of vitamins and minerals in a serving or their contents in 100g product must
be specified;
c) The maximum contents of vitamins and minerals in foods according to RNI levels
provided by manufacturers shall not exceed the tolerable upper intake levels of such
vitamins and minerals specified in Appendix 02 enclosed herewith.
If RNI levels and tolerable upper intake levels of Vietnam are not available, they shall be
determined according to regulations of CODEX or relevant international organizations.
2. Health claims:
The health claims must specify the RNI levels applied to various users.
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3. Users:
The product claims must specify the suitable users and prohibited users (if any).
4. Dose:
The dose for each specific user for a given period of time must be specified.
Article 13 [34]. (abrogated)
Chapter VI
CONDITIONS FOR PRODUCTION, TRADING AND INSTRUCTIONS FOR USE
OF FUNCTIONAL FOODS [35]
Article 14[36]. (abrogated).
Article 15[37] (abrogated).
Chapter VII
RECALL AND DISPOSAL OF UNSAFE FUNCTIONAL FOODS [38]
Article 16[39]. (abrogated).
Article 17[40]. (abrogated).
Article 18[41]. (abrogated).
Chapter VIII
IMPLEMENTATION [42]
Article 19. Implementation
This Circular comes into force from February 01, 2015.
The Circular No. 08/2004/TT-BYT dated August 23, 2004 of the Minister of Health of
Vietnam providing guidelines for management of functional foods is abrogated from the
date of entry into force of this Circular.
Article 20. Transition
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Certificate of Declaration of Conformity or Certificate of submission of Declaration of
Conformity with food safety regulations granted to a functional food before the effective
date of this Circular shall still remain valid until its expiry date.
Article 21. Implementation organization
1. Vietnam Food Administration affiliated to the Ministry of Health of Vietnam plays the
leading role and cooperate with functional authorities of the Ministry of Industry and
Trade of Vietnam and the Ministry of Public Security of Vietnam, within the ambit of
their assigned power, in organizing, directing, inspecting and monitoring the
implementation of this Circular.
2. Provincial Departments of Health shall organize, and direct branches of Vietnam Food
Administration and relevant authorities to carry out, inspection and supervision of local
manufacturers and traders of functional foods.
3. Authorities, organizations or individuals having products whose effects on human
health need to be tested shall pay testing costs in accordance with current regulations.
4. Manufacturers and traders of functional foods are responsible for implementation of
this Circular.
Difficulties that arise during the implementation of this Circular should be reported to the
Ministry of Health of Vietnam (via Vietnam Food Administration) for consideration./.
CERTIFIED BY
PP. MINISTER
DEPUTY MINISTER
Do Xuan Tuyen
APPENDIX NO. 01
TABLE OF RECOMMENDED NUTRITION INTAKES (RNI) FOR VIETNAMESE
(Enclosed with the Circular No. 43/2014/TT-BYT dated November 24, 2014 of the
Minister of Health of Vietnam)
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1. RNI levels of minerals and micronutrients
Age and gender Ca
(Calcium)
(mg/day)
Mg
(Magnesium)
(mg/day)
P
(Phosphorus)
(mg/day)
Selenium *
(μg/day)
Infants
< 6 months old 300 36 90 6
6-11 months old 400 54 275 10
Children
1-3 years old 500 65 460 17
4-6 years old 600 76 500 22
7-9 years old 700 100 500 21
Adolescents (male)
10-12 years old
1.000
155
1.250 32
13-15 years old 225
16-18 years old 260
Adults (male)
19-49 years old 700
205 700
34
50-60 years old
1.000
> 60 years old 33
Adolescents (female)
10-12 years old (under the age
of menstruation)
1.000
160
1.250 26
10-12 years old
13-15 years old 220
16-18 years old 240
Adults (female)
19-49 years old 700
205 700
26
50-60 years old
1.000
> 60 years old 25
Pregnant women
First trimester 1.000 205 700 26
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Second trimester 28
Third trimester 30
Breastfeeding women (during
breastfeeding period)
1.000 250 700
First 6 months 35
Last 6 months 42
* RNI levels are determined according to the average intakes +2 SD.
2. RNI levels of iodine, iron and zinc
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Age Iodine
(μg/day)
I
o
d
i
n
e
(
μ
g
/
d
a
y
)
Iron (mg/day) according
to biological value
Iron
(mg/day)
according
to
biological
value
I
r
o
n
(
m
g
/
d
a
y
)
a
c
c
o
r
d
i
n
g
t
o
b
i
o
l
o
g
i
c
a
l
v
a
l
u
e
Zinc (mg/day) Z
i
n
c
(
m
g
/
d
a
y
)
Z
i
n
c
(
m
g
/
d
a
y
)
5%1
10%2
15%3 High
absorption
Average
absorption
Poor
absorption
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Infants
I
n
f
a
n
t
s
I
n
f
a
n
t
s
I
n
f
a
n
t
s
I
n
f
a
n
t
s
I
n
f
a
n
t
s
I
n
f
a
n
t
s
I
n
f
a
n
t
s
I
n
f
a
n
t
s
0-6 months old 90
9
0
0,93 1,15
2,86
6,57
6-11 months old 90
9
0
18,6 12,4 9,3 0,8-2,58
4,18
8,38
Children
C
h
i
l
d
r
e
n
C
h
i
l
d
r
e
n
C
h
i
l
d
r
e
n
C
h
i
l
d
r
e
n
C
h
i
l
d
r
e
n
C
h
i
l
d
r
e
n
C
h
i
l
d
r
e
n
C
h
i
l
d
r
e
n
1-3 years old 90
9
0
11,6 7,7 5,8 2,4 4,1 8,4
4-6 years old 90
9
0
12,6 8,4 6,3 3,1 5,1 10,3
7-9 years old 90
9
0
17,8 11,9 8,9 3,3 5,6 11,3
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Adolescents (male)
A
d
o
l
e
s
c
e
n
t
s
(
m
a
l
e
)
A
d
o
l
e
s
c
e
n
t
s
(
m
a
l
e
)
A
d
o
l
e
s
c
e
n
t
s
(
m
a
l
e
)
A
d
o
l
e
s
c
e
n
t
s
(
m
a
l
e
)
A
d
o
l
e
s
c
e
n
t
s
(
m
a
l
e
)
A
d
o
l
e
s
c
e
n
t
s
(
m
a
l
e
)
A
d
o
l
e
s
c
e
n
t
s
(
m
a
l
e
)
A
d
o
l
e
s
c
e
n
t
s
(
m
a
l
e
)
10-14 years old 120
1
2
0
29,2 19,5 14,6 5,7 9,7 19,2
15-18 years old 150
1
5
0
37,6 25,1 18,8 5,7 9,7 19,2
Adolescents (female)
A
d
o
l
e
s
c
e
n
t
s
(
f
e
m
a
l
e
)
A
d
o
l
e
s
c
e
n
t
s
(
f
e
m
a
l
e
)
A
d
o
l
e
s
c
e
n
t
s
(
f
e
m
a
l
e
)
A
d
o
l
e
s
c
e
n
t
s
(
f
e
m
a
l
e
)
A
d
o
l
e
s
c
e
n
t
s
(
f
e
m
a
l
e
)
A
d
o
l
e
s
c
e
n
t
s
(
f
e
m
a
l
e
)
A
d
o
l
e
s
c
e
n
t
s
(
f
e
m
a
l
e
)
A
d
o
l
e
s
c
e
n
t
s
(
f
e
m
a
l
e
)
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10-14 years old
1
0
-
1
4
y
e
a
r
s
o
l
d
120 28,0 18,7 14,0 4,6 7,8 15,5
15-18 years old
1
5
-
1
8
y
e
a
r
s
o
l
d
150 65,4 43,6 32,7 4,6 7,8 15,5
Adults
A
d
u
l
t
s
A
d
u
l
t
s
A
d
u
l
t
s
A
d
u
l
t
s
A
d
u
l
t
s
A
d
u
l
t
s
A
d
u
l
t
s
A
d
u
l
t
s
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Male, ≥ 19 years
old
M
a
l
e
,
≥
1
9
y
e
a
r
s
o
l
d
150 27,4 18,3 13,7 4,2 7,0 14,0
Female, ≥ 19 years
old
F
e
m
a
l
e
,
≥
1
9
y
e
a
r
s
o
l
d
150 58,8 39,2 29,4 3,0 4,9 9,8
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Middle-aged adults (≥ 50 years old)
M
i
d
d
l
e
-
a
g
e
d
a
d
u
l
t
s
(
≥
5
0
y
e
a
r
s
o
l
d
)
M
i
d
d
l
e
-
a
g
e
d
a
d
u
l
t
s
(
≥
5
0
y
e
a
r
s
o
l
d
)
M
i
d
d
l
e
-
a
g
e
d
a
d
u
l
t
s
(
≥
5
0
y
e
a
r
s
o
l
d
)
M
i
d
d
l
e
-
a
g
e
d
a
d
u
l
t
s
(
≥
5
0
y
e
a
r
s
o
l
d
)
M
i
d
d
l
e
-
a
g
e
d
a
d
u
l
t
s
(
≥
5
0
y
e
a
r
s
o
l
d
)
M
i
d
d
l
e
-
a
g
e
d
a
d
u
l
t
s
(
≥
5
0
y
e
a
r
s
o
l
d
)
M
i
d
d
l
e
-
a
g
e
d
a
d
u
l
t
s
(
≥
5
0
y
e
a
r
s
o
l
d
)
M
i
d
d
l
e
-
a
g
e
d
a
d
u
l
t
s
(
≥
5
0
y
e
a
r
s
o
l
d
)
Male
M
a
l
e
3,0 4,9 9,8
Female
F
e
m
a
l
e
22,6 15,1 11,3 3,0 4,9 9,8
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Pregnant women
P
r
e
g
n
a
n
t
w
o
m
e
n
200 +30,04
+20,04
+15,04
Breastfeeding
women
B
r
e
a
s
t
f
e
e
d
i
n
g
w
o
m
e
n
200
1
Serving size with low biological value of iron (about 5% of iron is absorbed): simple
and monotonous regimen, containing under 30g of meat and/or fish per day or under 25
mg of vitamin C per day.
2
Serving size with average biological value of iron (about 10% of iron is absorbed):
containing 30g – 90g of meat and/or fish per day or 25 mg – 75 mg of vitamin C per day.
3
Serving size with high biological value of iron (about 15% of iron is absorbed):
containing over 90g of meat and/or fish per day or over 75 mg of vitamin C per day.
4
Pregnant women are recommended to take iron pills during the gestation. A pregnant
woman with anaemia should take a higher dose.
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5
Breast-fed children
6
Formula-fed children
7
Children fed by formula milk with great amount plant-based protein and phytates
8
Excluding purely breast-fed children
8
High absorption: high biological value of zinc, equal to 50% (serving contains a lot of
protein from animal or fish derivatives); average absorption: average biological value of
zinc, equal to 30% (serving contains an average amount of protein from animal or fish
derivatives; ratio of phytate and zinc is at 5:15); low absorption: low biological value of
zinc, equal to 15% (serving contains very little or does not contain protein from animal or
fish derivatives).
3. RNI level of vitamins/day
Age and gender A
mcga
D
mcgc
E
mgd
K
mcg
C
mgb
B1
mg
B2
mg
B3
mg
NEe
B6
mg
B9
mcgf
B12
mcg
Infants and children
I
n
f
a
n
t
s
a
n
d
c
h
i
l
d
r
e
n
I
n
f
a
n
t
s
a
n
d
c
h
i
l
d
r
e
n
I
n
f
a
n
t
s
a
n
d
c
h
i
l
d
r
e
n
I
n
f
a
n
t
s
a
n
d
c
h
i
l
d
r
e
n
I
n
f
a
n
t
s
a
n
d
c
h
i
l
d
r
e
n
I
n
f
a
n
t
s
a
n
d
c
h
i
l
d
r
e
n
I
n
f
a
n
t
s
a
n
d
c
h
i
l
d
r
e
n
I
n
f
a
n
t
s
a
n
d
c
h
i
l
d
r
e
n
I
n
f
a
n
t
s
a
n
d
c
h
i
l
d
r
e
n
I
n
f
a
n
t
s
a
n
d
c
h
i
l
d
r
e
n
I
n
f
a
n
t
s
a
n
d
c
h
i
l
d
r
e
n
< 6 months old 375 5 3 6 25 0,2 0,3 2 0,1 80 0,3
6-11 months old 400 5 4 9 30 0,3 0,4 4 0,3 80 0,4
1-3 years old 400 5 5 13 30 0,5 0,5 6 0,5 160 0,9
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4-6 years old 450 5 6 19 30 0,6 0,6 8 0,6 200 1,2
7-9 years old 500 5 7 24 35 0,9 0,9 12 1 300 1,8
Adolescents (male)
A
d
o
l
e
s
c
e
n
t
s
(
m
a
l
e
)
A
d
o
l
e
s
c
e
n
t
s
(
m
a
l
e
)
A
d
o
l
e
s
c
e
n
t
s
(
m
a
l
e
)
A
d
o
l
e
s
c
e
n
t
s
(
m
a
l
e
)
A
d
o
l
e
s
c
e
n
t
s
(
m
a
l
e
)
A
d
o
l
e
s
c
e
n
t
s
(
m
a
l
e
)
A
d
o
l
e
s
c
e
n
t
s
(
m
a
l
e
)
A
d
o
l
e
s
c
e
n
t
s
(
m
a
l
e
)
A
d
o
l
e
s
c
e
n
t
s
(
m
a
l
e
)
A
d
o
l
e
s
c
e
n
t
s
(
m
a
l
e
)
A
d
o
l
e
s
c
e
n
t
s
(
m
a
l
e
)
10-12 years old
600 5
10 34
65 1,2 1,3 16 1,3 400 2,4
13-15 years old 12 50
16-18 years old 13 58
Adults (male)
A
d
u
l
t
s
(
m
a
l
e
)
A
d
u
l
t
s
(
m
a
l
e
)
A
d
u
l
t
s
(
m
a
l
e
)
A
d
u
l
t
s
(
m
a
l
e
)
A
d
u
l
t
s
(
m
a
l
e
)
A
d
u
l
t
s
(
m
a
l
e
)
A
d
u
l
t
s
(
m
a
l
e
)
A
d
u
l
t
s
(
m
a
l
e
)
A
d
u
l
t
s
(
m
a
l
e
)
A
d
u
l
t
s
(
m
a
l
e
)
A
d
u
l
t
s
(
m
a
l
e
)
19-50 years old
600
10
12
59
70 1,2 1,3 16
1,3
400 2,4
51-60 years old 10
1,7
≥60 years old 15
MEDGATE TECHNOLOGY AND INVESTMENT JSC.
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Adolescents (female)
A
d
o
l
e
s
c
e
n
t
s
(
f
e
m
a
l
e
)
A
d
o
l
e
s
c
e
n
t
s
(
f
e
m
a
l
e
)
A
d
o
l
e
s
c
e
n
t
s
(
f
e
m
a
l
e
)
A
d
o
l
e
s
c
e
n
t
s
(
f
e
m
a
l
e
)
A
d
o
l
e
s
c
e
n
t
s
(
f
e
m
a
l
e
)
A
d
o
l
e
s
c
e
n
t
s
(
f
e
m
a
l
e
)
A
d
o
l
e
s
c
e
n
t
s
(
f
e
m
a
l
e
)
A
d
o
l
e
s
c
e
n
t
s
(
f
e
m
a
l
e
)
A
d
o
l
e
s
c
e
n
t
s
(
f
e
m
a
l
e
)
A
d
o
l
e
s
c
e
n
t
s
(
f
e
m
a
l
e
)
A
d
o
l
e
s
c
e
n
t
s
(
f
e
m
a
l
e
)
10-12 years old
600 5
11 35
65 1,1 1 16 1,2 400 2,4
13-15 years old 12 49
16-18 years old 12 50
Adults (female)
A
d
u
l
t
s
(
f
e
m
a
l
e
)
A
d
u
l
t
s
(
f
e
m
a
l
e
)
A
d
u
l
t
s
(
f
e
m
a
l
e
)
A
d
u
l
t
s
(
f
e
m
a
l
e
)
A
d
u
l
t
s
(
f
e
m
a
l
e
)
A
d
u
l
t
s
(
f
e
m
a
l
e
)
A
d
u
l
t
s
(
f
e
m
a
l
e
)
A
d
u
l
t
s
(
f
e
m
a
l
e
)
A
d
u
l
t
s
(
f
e
m
a
l
e
)
A
d
u
l
t
s
(
f
e
m
a
l
e
)
A
d
u
l
t
s
(
f
e
m
a
l
e
)
19-50 years old
500
10
12
51
70
1,2
1,1 14
1,3
400 2,4
51-60 years old 10 1,1
1,5
> 60 years old 600 15 70 1,1
Pregnant women 800 5 12 51 80 1,4 1,4 18 1,9 600 2,6
MEDGATE TECHNOLOGY AND INVESTMENT JSC.
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Breastfeeding
women
850 5 18 51 95 1,5 1,6 17 2 500 2,8
a
These following conversion factors may be used for vitamin A:
01 mcg of vitamin A or retinol = 01 retinol equivalent (RE)
01 IU (International unit) is equivalent to 0.3 mcg of vitamin A
01 mcg of b-carotene = 0.167 mcg of vitamin A
01 mcg of other carotenes = 0.084 mcg of vitamin A
b
Excluding the loss during processing and cooking activities because Vitamin C is
destroyed easily by the oxidization, light, alkali and temperature.
c
These following conversion factors may be used for vitamin D:
01 IU is equivalent to 0.03 mcg of vitamin D3, or 01 mcg of vitamin D3 = 40 IU
d
IU conversion factors (according to IOM-FNB 2000): 01 mg a-tocopherol = 1 IU; 01
mg b-tocopherol = 0,5 IU; 01 mg g-tocopherol = 0,1 IU; 0,1 mg s-tocopherol = 0,02 IU.
e
Niacin or Niacin equivalent
f
These following conversion factors may be used for Folic acid:
01 folic acid = 1 folate x 1.7, or 01 g of folic acid equivalent = 01 g of folate in food +
(1.7 x amount of synthetic folic acid (in gram)).
Note: This table will be updated according to current regulations of the Ministry of
Health of Vietnam.
APPENDIX NO. 02
TOLERABLE UPPER INTAKE LEVELS
(Enclosed with the Circular No. 43/2014/TT-BYT dated November 24, 2014 of the
Minister of Health of Vietnam)
1. Vitamin
Age Vitamin
A
(μg/day)
Vitamin
C
(mg/day)
Vitamin
D
(μg/day)
Vitamin
E
(mg/day)
Vitamin
K
(μg/day)
Vitamin
B1
(mg/day)
Riboflavin
(mg/day)
Niacin
(mg/day)
Vitamin
B6
(mg/day)
Acid
Folic
(μg/day)
Vitamin
B12
(μg/day)
Pantothenic
(mg/day)
Biotin
(μg/day)
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Infants I
n
f
a
n
t
s
I
n
f
a
n
t
s
I
n
f
a
n
t
s
I
n
f
a
n
t
s
I
n
f
a
n
t
s
I
n
f
a
n
t
s
I
n
f
a
n
t
s
I
n
f
a
n
t
s
I
n
f
a
n
t
s
I
n
f
a
n
t
s
I
n
f
a
n
t
s
I
n
f
a
n
t
s
I
n
f
a
n
t
s
0-6 months
old
600 N/A 25 N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A
6-12 months
old
600 N/A 38 N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A
Children C
h
il
d
r
e
n
C
h
il
d
r
e
n
C
h
il
d
r
e
n
C
h
il
d
r
e
n
C
h
il
d
r
e
n
C
h
il
d
r
e
n
C
h
il
d
r
e
n
C
h
il
d
r
e
n
C
h
il
d
r
e
n
C
h
il
d
r
e
n
C
h
il
d
r
e
n
C
h
il
d
r
e
n
C
h
il
d
r
e
n
1-3 years old 600 400 63 200 N/A N/A N/A 10 30 300 N/A N/A N/A
4-8 years old 900 650 75 300 N/A N/A N/A 15 40 400 N/A N/A N/A
Teenagers (9-13 years old) T
e
e
n
a
g
e
r
s
(
9
-
1
3
y
e
a
r
s
o
l
d
)
T
e
e
n
a
g
e
r
s
(
9
-
1
3
y
e
a
r
s
o
l
d
)
T
e
e
n
a
g
e
r
s
(
9
-
1
3
y
e
a
r
s
o
l
d
)
T
e
e
n
a
g
e
r
s
(
9
-
1
3
y
e
a
r
s
o
l
d
)
T
e
e
n
a
g
e
r
s
(
9
-
1
3
y
e
a
r
s
o
l
d
)
T
e
e
n
a
g
e
r
s
(
9
-
1
3
y
e
a
r
s
o
l
d
)
T
e
e
n
a
g
e
r
s
(
9
-
1
3
y
e
a
r
s
o
l
d
)
T
e
e
n
a
g
e
r
s
(
9
-
1
3
y
e
a
r
s
o
l
d
)
T
e
e
n
a
g
e
r
s
(
9
-
1
3
y
e
a
r
s
o
l
d
)
T
e
e
n
a
g
e
r
s
(
9
-
1
3
y
e
a
r
s
o
l
d
)
T
e
e
n
a
g
e
r
s
(
9
-
1
3
y
e
a
r
s
o
l
d
)
T
e
e
n
a
g
e
r
s
(
9
-
1
3
y
e
a
r
s
o
l
d
)
T
e
e
n
a
g
e
r
s
(
9
-
1
3
y
e
a
r
s
o
l
d
)
Male 1.700 1.200 100 600 N/A N/A N/A 20 60 600 N/A N/A N/A
Female 1.700 1.200 100 600 N/A N/A N/A 20 60 600 N/A N/A N/A
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Adolescents (14-18 years old) A
d
o
l
e
s
c
e
n
t
s
(
1
4
-
1
8
y
e
a
r
s
o
l
d
)
A
d
o
l
e
s
c
e
n
t
s
(
1
4
-
1
8
y
e
a
r
s
o
l
d
)
A
d
o
l
e
s
c
e
n
t
s
(
1
4
-
1
8
y
e
a
r
s
o
l
d
)
A
d
o
l
e
s
c
e
n
t
s
(
1
4
-
1
8
y
e
a
r
s
o
l
d
)
A
d
o
l
e
s
c
e
n
t
s
(
1
4
-
1
8
y
e
a
r
s
o
l
d
)
A
d
o
l
e
s
c
e
n
t
s
(
1
4
-
1
8
y
e
a
r
s
o
l
d
)
A
d
o
l
e
s
c
e
n
t
s
(
1
4
-
1
8
y
e
a
r
s
o
l
d
)
A
d
o
l
e
s
c
e
n
t
s
(
1
4
-
1
8
y
e
a
r
s
o
l
d
)
A
d
o
l
e
s
c
e
n
t
s
(
1
4
-
1
8
y
e
a
r
s
o
l
d
)
A
d
o
l
e
s
c
e
n
t
s
(
1
4
-
1
8
y
e
a
r
s
o
l
d
)
A
d
o
l
e
s
c
e
n
t
s
(
1
4
-
1
8
y
e
a
r
s
o
l
d
)
A
d
o
l
e
s
c
e
n
t
s
(
1
4
-
1
8
y
e
a
r
s
o
l
d
)
A
d
o
l
e
s
c
e
n
t
s
(
1
4
-
1
8
y
e
a
r
s
o
l
d
)
Male 2.800 1.800 100 800 N/A N/A N/A 30 80 800 N/A N/A N/A
Female 2.800 1.800 100 800 N/A N/A N/A 30 80 800 N/A N/A N/A
Adults, ≥ 19 years old A
d
u
lt
s,
≥
1
9
y
e
a
r
s
o
l
d
A
d
u
lt
s,
≥
1
9
y
e
a
r
s
o
l
d
A
d
u
lt
s,
≥
1
9
y
e
a
r
s
o
l
d
A
d
u
lt
s,
≥
1
9
y
e
a
r
s
o
l
d
A
d
u
lt
s,
≥
1
9
y
e
a
r
s
o
l
d
A
d
u
lt
s,
≥
1
9
y
e
a
r
s
o
l
d
A
d
u
lt
s,
≥
1
9
y
e
a
r
s
o
l
d
A
d
u
lt
s,
≥
1
9
y
e
a
r
s
o
l
d
A
d
u
lt
s,
≥
1
9
y
e
a
r
s
o
l
d
A
d
u
lt
s,
≥
1
9
y
e
a
r
s
o
l
d
A
d
u
lt
s,
≥
1
9
y
e
a
r
s
o
l
d
A
d
u
lt
s,
≥
1
9
y
e
a
r
s
o
l
d
A
d
u
lt
s,
≥
1
9
y
e
a
r
s
o
l
d
Male 3.000 2.000 100 1.000 N/A N/A N/A 35 100 1.000 N/A N/A N/A
Female 3.000 2.000 100 1.000 N/A N/A N/A 35 100 1.000 N/A N/A N/A
Old people, ≥ 51 years old O
l
d
p
e
o
p
l
e
,
≥
5
1
y
e
a
r
s
o
l
d
O
l
d
p
e
o
p
l
e
,
≥
5
1
y
e
a
r
s
o
l
d
O
l
d
p
e
o
p
l
e
,
≥
5
1
y
e
a
r
s
o
l
d
O
l
d
p
e
o
p
l
e
,
≥
5
1
y
e
a
r
s
o
l
d
O
l
d
p
e
o
p
l
e
,
≥
5
1
y
e
a
r
s
o
l
d
O
l
d
p
e
o
p
l
e
,
≥
5
1
y
e
a
r
s
o
l
d
O
l
d
p
e
o
p
l
e
,
≥
5
1
y
e
a
r
s
o
l
d
O
l
d
p
e
o
p
l
e
,
≥
5
1
y
e
a
r
s
o
l
d
O
l
d
p
e
o
p
l
e
,
≥
5
1
y
e
a
r
s
o
l
d
O
l
d
p
e
o
p
l
e
,
≥
5
1
y
e
a
r
s
o
l
d
O
l
d
p
e
o
p
l
e
,
≥
5
1
y
e
a
r
s
o
l
d
O
l
d
p
e
o
p
l
e
,
≥
5
1
y
e
a
r
s
o
l
d
O
l
d
p
e
o
p
l
e
,
≥
5
1
y
e
a
r
s
o
l
d
Male 3.000 2.000 100 1.000 N/A N/A N/A 35 100 1.000 N/A N/A N/A
Female 3.000 2.000 100 1.000 N/A N/A N/A 35 100 1.000 N/A N/A N/A
MEDGATE TECHNOLOGY AND INVESTMENT JSC.
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Pregnant
women
3.000 2.000 100 1.000 N/A N/A N/A 35 100 1.000 N/A N/A N/A
Breastfeeding
women
3.000 2.000 100 1.000 N/A N/A N/A 35 100 1.000 N/A N/A N/A
2. Minerals
Age Arsenic Boron
(mg/day)
ChroniumC
h
r
o
n
i
u
m
Copper
(μg/day)
C
o
p
p
e
r
(
μ
g
/
d
a
y
)
Fluoride
(mg/day)
F
l
u
o
r
i
d
e
(
m
g
/
d
a
y
)
Iodine
(μg/day)
Iodine
(μg/day
)
Iron
(mg/day)
I
r
o
n
(
m
g
/
d
a
y
)
Magnesium
(mg/day)
Magnesium
(mg/day)
Manganese
(mg/day)
M
a
n
g
a
n
e
s
e
(
m
g
/
d
a
y
)
Molybde
num
(μg/day)
Nic
(mg/d
Infants
0-6 months
old
N/A N/A N/A N
/
A
N/A N
/
A
0,7 0
,
7
N/A N/A 40 4
0
N/A N/A N/A N
/
A
N/A N/
6-12 months
old
N/A N/A N/A N
/
A
N/A N
/
A
0,9 0
,
9
N/A N/A 40 4
0
N/A N/A N/A N
/
A
N/A N/
Children
1-3 years old N/A 3 3 N/A N/A 1.000 1
.
0
0
0
1,3 1
,
3
200 2
0
0
40 4
0
65 2 300 3
0
0
0,2
4-8 years old N/A 6 6 N/A N/A 3.000 3
.
0
0
0
2,2 2
,
2
300 3
0
0
40 4
0
110 3 600 6
0
0
0,3
MEDGATE TECHNOLOGY AND INVESTMENT JSC.
Website: Medgate.vn
Hotline: 098.546.1894
Teenagers (9-13 years old)
Male N/A 11 11 N/A N/A 5.000 5
.
0
0
0
10 1
0
600 6
0
0
40 4
0
350 9 1.100 1
.
1
0
0
0,6
Female N/A 11 11 N/A N/A 5.000 5
.
0
0
0
10 1
0
600 6
0
0
40 4
0
350 9 1.100 1
.
1
0
0
0,6
Adolescents (14-18 years old)
Male N/A 17 17 N/A N/A 8.000 8
.
0
0
0
10 1
0
900 9
0
0
45 4
5
350 11 1.700 1
.
7
0
0
1,0
Female N/A 17 17 N/A N/A 8.000 8
.
0
0
0
10 1
0
900 9
0
0
45 4
5
350 11 1.700 1
.
7
0
0
1,0
MEDGATE TECHNOLOGY AND INVESTMENT JSC.
Website: Medgate.vn
Hotline: 098.546.1894
Adults, ≥ 19 years old
Male N/A 20 20 N/A N/A 10.000 1
0
.
0
0
0
10 1
0
1.100 1
.
1
0
0
45 4
5
350 11 2.000 2
.
0
0
0
1,0
Female N/A 20 20 N/A N/A 10.000 1
0
.
0
0
0
10 1
0
1.100 1
.
1
0
0
45 4
5
350 11 2.000 2
.
0
0
0
1,0
Old people, ≥ 51 years old
Male N/A 20 20 N/A N/A 10.000 1
0
.
0
0
0
10 1
0
1.100 1
.
1
0
0
45 4
5
350 11 2.000 2
.
0
0
0
1,0
Female N/A 20 20 N/A N/A 10.000 1
0
.
0
0
0
10 1
0
1 100 1
1
0
0
45 4
5
350 11 2.000 2
.
0
0
0
1,0
Pregnant
women
N/A 20 20 N/A N/A 10.000 1
0
.
0
0
0
10 1
0
1.100 1
.
1
0
0
45 4
5
350 11 2.000 2
.
0
0
0
1,0
MEDGATE TECHNOLOGY AND INVESTMENT JSC.
Website: Medgate.vn
Hotline: 098.546.1894
Breastfeeding
women
N/A 20 20 N/A N/A 10.000 1
0
.
0
0
0
10 1
0
1.100 1
.
1
0
0
45 4
5
350 11 2.000 2
.
0
0
0
1,0
Tolerable upper intake level means the highest level of micronutrient intake that is likely
to cause no poison or pose no risk of adverse health effects.
N/A: There is not enough information to determine the tolerable upper intake level
Note: This table will be updated according to current regulations of the Ministry of
Health of Vietnam.
[1] The Circular No. 17/2023/TT-BYT dated September 25, 2023 of the Minister of
Health of Vietnam providing amendments to and abrogation of some legislative
documents on food safety 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/QH12 dated June 17, 2010;
The Government's Decree No. 15/2018/ND-CP dated February 02, 2018 on elaboration
of the Law on Food Safety;
The Government’s Decree No. 95/2022/ND-CP dated November 15, 2022 defining
functions, tasks, powers and organizational structure of the Ministry of Health of
Vietnam;
And at the request of the Director of Vietnam Food Administration,”
[2] This clause is abrogated according to point dd clause 2 Article 7 of the Circular
No.17/2023/TT-BYT, coming into force from November 09, 2023.
[3] This clause is abrogated according to point dd clause 2 Article 7 of the Circular
No.17/2023/TT-BYT, coming into force from November 09, 2023.
MEDGATE TECHNOLOGY AND INVESTMENT JSC.
Website: Medgate.vn
Hotline: 098.546.1894
[4] This clause is abrogated according to point dd clause 2 Article 7 of the Circular
No.17/2023/TT-BYT, coming into force from November 09, 2023.
[5] This clause is abrogated according to point dd clause 2 Article 7 of the Circular
No.17/2023/TT-BYT, coming into force from November 09, 2023.
[6] This Article is amended according to clause 1 Article 4 of the Circular
No.17/2023/TT-BYT, coming into force from November 9, 2023.
[7] This clause is abrogated according to point dd clause 2 Article 7 of the Circular
No.17/2023/TT-BYT, coming into force from November 09, 2023.
[8] This clause is abrogated according to point dd clause 2 Article 7 of the Circular
No.17/2023/TT-BYT, coming into force from November 09, 2023.
[9] This clause is amended according to clause 3 Article 4 of the Circular
No.17/2023/TT-BYT, coming into force from November 09, 2023.
[10] This point is abrogated according to point dd clause 2 Article 7 of the Circular
No.17/2023/TT-BYT, coming into force from November 09, 2023.
[11] This clause is amended according to clause 3 Article 4 of the Circular
No.17/2023/TT-BYT, coming into force from November 09, 2023.
[12] This clause is amended according to clause 3 Article 4 of the Circular
No.17/2023/TT-BYT, coming into force from November 09, 2023.
[13] This Article is abrogated according to point dd clause 2 Article 7 of the Circular
No.17/2023/TT-BYT, coming into force from November 09, 2023.
[14] This Article is abrogated according to point dd clause 2 Article 7 of the Circular
No.17/2023/TT-BYT, coming into force from November 09, 2023.
[15] This Article is abrogated according to point dd clause 2 Article 7 of the Circular
No.17/2023/TT-BYT, coming into force from November 09, 2023.
[16] This point is amended according to clause 4 Article 4 of the Circular No.
17/2023/TT-BYT, coming into force from November 09, 2023.
[17] This point is amended according to clause 4 Article 4 of the Circular No.
17/2023/TT-BYT, coming into force from November 09, 2023.
[18] This point is amended according to clause 5 Article 4 of the Circular No.
17/2023/TT-BYT, coming into force from November 09, 2023.
MEDGATE TECHNOLOGY AND INVESTMENT JSC.
Website: Medgate.vn
Hotline: 098.546.1894
[19] This point is amended according to clause 5 Article 4 of the Circular No.
17/2023/TT-BYT, coming into force from November 09, 2023.
[20] This point is amended according to clause 5 Article 4 of the Circular No.
17/2023/TT-BYT, coming into force from November 09, 2023.
[21] This Article is abrogated according to point dd clause 2 Article 7 of the Circular
No.17/2023/TT-BYT, coming into force from November 09, 2023.
[22] This point is abrogated according to point dd clause 2 Article 7 of the Circular
No.17/2023/TT-BYT, coming into force from November 09, 2023.
[23] This point is amended according to clause 6 Article 4 of the Circular No.
17/2023/TT-BYT, coming into force from November 09, 2023.
[24] This point is amended according to clause 6 Article 4 of the Circular No.
17/2023/TT-BYT, coming into force from November 09, 2023.
[25] This clause is abrogated according to point dd clause 2 Article 7 of the Circular
No.17/2023/TT-BYT, coming into force from November 09, 2023.
[26] This point is amended according to clause 7 Article 4 of the Circular No.
17/2023/TT-BYT, coming into force from November 09, 2023.
[27] This point is amended according to clause 7 Article 4 of the Circular No.
17/2023/TT-BYT, coming into force from November 09, 2023.
[28] This point is amended according to clause 8 Article 4 of the Circular No.
17/2023/TT-BYT, coming into force from November 09, 2023.
[29] This sentence is amended according to clause 9 Article 4 of the Circular No.
17/2023/TT-BYT, coming into force from November 09, 2023.
[30] This point is abrogated according to point dd clause 2 Article 7 of the Circular
No.17/2023/TT-BYT, coming into force from November 09, 2023.
[31] This clause is abrogated according to point dd clause 2 Article 7 of the Circular
No.17/2023/TT-BYT, coming into force from November 09, 2023.
[32] This clause is amended according to clause 10 Article 4 of the Circular
No.17/2023/TT-BYT, coming into force from November 09, 2023.
[33] This point is abrogated according to point dd clause 2 Article 7 of the Circular
No.17/2023/TT-BYT, coming into force from November 09, 2023.
MEDGATE TECHNOLOGY AND INVESTMENT JSC.
Website: Medgate.vn
Hotline: 098.546.1894
[34] This Article is abrogated according to point dd clause 2 Article 7 of the Circular
No.17/2023/TT-BYT, coming into force from November 09, 2023.
[35] This Chapter is abrogated according to point dd clause 2 Article 7 of the Circular
No.17/2023/TT-BYT, coming into force from November 09, 2023.
[36] This Article is abrogated according to point dd clause 2 Article 7 of the Circular
No.17/2023/TT-BYT, coming into force from November 09, 2023.
[37] This Article is abrogated according to point dd clause 2 Article 7 of the Circular
No.17/2023/TT-BYT, coming into force from November 09, 2023.
[38] This Chapter is abrogated according to point dd clause 2 Article 7 of the Circular
No.17/2023/TT-BYT, coming into force from November 09, 2023.
[39] This Article is abrogated according to point dd clause 2 Article 7 of the Circular
No.17/2023/TT-BYT, coming into force from November 09, 2023.
[40] This Article is abrogated according to point dd clause 2 Article 7 of the Circular
No.17/2023/TT-BYT, coming into force from November 09, 2023.
[41] This Article is abrogated according to point dd clause 2 Article 7 of the Circular
No.17/2023/TT-BYT, coming into force from November 09, 2023.
[42] Articles 9, 10 and 11 of the Circular No.17/2023/TT-BYT, coming into force from
November 09, 2023, stipulate as follows:
Article 9. Terms of reference
If any legislative documents referred to in this Circular are amended, supplemented or
superseded, the new ones shall apply.
Article 10. Effect
This Circular comes into force from November 09, 2023.
Article 11. Responsibility for implementation
The Chief of the Ministry Office, the Director General of the Vietnam Food
Administration, the Ministry’s Chief Inspector, heads of units of and affiliated to the
Ministry, Directors of provincial Departments of Health, heads of food safety authorities
affiliated to provincial People’s Committees, heads of health agencies of ministries and
central-government authorities, and relevant authorities, organizations and individuals
are responsible for the implementation of this Circular./.
MEDGATE TECHNOLOGY AND INVESTMENT JSC.
Website: Medgate.vn
Hotline: 098.546.1894
------------------------------------------------------------------------------------------------------
This translation is made by THƯ VIỆN PHÁP LUẬT, Ho Chi Minh City, Vietnam and
for reference purposes only. Its copyright is owned by THƯ VIỆN PHÁP LUẬT and
protected under Clause 2, Article 14 of the Law on Intellectual Property.Your comments
are always welcomed

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Circular 12/VBHN-BYT: Prescribing Management of Functional Foods

  • 1. MEDGATE TECHNOLOGY AND INVESTMENT JSC. Website: Medgate.vn Hotline: 098.546.1894 THE MINISTRY OF HEALTH OF VIETNAM ------- THE SOCIALIST REPUBLIC OF VIETNAM Independence – Freedom – Happiness ----------------------- No. 12/VBHN-BYT Hanoi, November 02, 2023 CIRCULAR PRESCRIBING MANAGEMENT OF FUNCTIONAL FOODS The Circular No. 43/2014/TT-BYT dated November 24, 2014 of the Minister of Health prescribing management of functional foods, coming into force from February 01, 2015, is amended by: The Circular No. 17/2023/TT-BYT dated September 25, 2023 of the Minister of Health of Vietnam providing amendments to and abrogation of some legislative documents on food safety, coming into force from November 09, 2023. Pursuant to the Law on Food Safety dated June 17, 2010; Pursuant to the Government's Decree No. 38/2012/ND-CP dated April 25, 2012 elaborating the Law of Food Safety; Pursuant to the Government’s Decree No. 63/2012/ND-CP dated August 31, 2012 defining functions, tasks, powers and organizational structure of the Ministry of Health of Vietnam; At the request of the Director of Vietnam Food Administration; The Minister of Health of Vietnam promulgates a Circular providing regulations on management of functional foods. [1] Chapter I GENERAL PROVISIONS Article 1. Scope and regulated entities 1. This Circular provides for the activities relating to production, trading, product declaration, labeling and provision of instructions for use of functional foods such as supplemented foods, health supplements and medical foods, including foods for special dietary uses.
  • 2. MEDGATE TECHNOLOGY AND INVESTMENT JSC. Website: Medgate.vn Hotline: 098.546.1894 2. This Circular does not apply to nutritional formulas for children. Production, trading, product declaration, labeling and provision of instructions for use of these products shall comply with corresponding technical regulations and regulations of law on trading and use of nutritional products for children. Article 2. Definitions For the purposes of this Circular, the terms below shall be construed as follows: 1. “supplemented food” means a normal food that is supplemented with micronutrients and other ingredients food for health such as vitamins, minerals, amino acids, fatty acids, enzymes, probiotics, prebiotics and other biologically active substances. 2 [2]. (abrogated) 3[3]. (abrogated). 4 [4]. (abrogated). 5[5]. (abrogated). 6. Recommended nutrition intake (RNI) for Vietnamese means the intake level of a particular nutrient considered sufficient for Vietnamese people as recommended by the National Institute of Nutrition (affiliated to the Ministry of Health of Vietnam). Chapter II GENERAL REQUIREMENTS FOR FUNCTIONAL FOODS Article 3. Product self-declaration and registration of product disclosure [6] 1[7]. (abrogated). 2[8]. (abrogated). 3[9]. Procedures for product self-declaration and registration of product disclosure: a) Procedures for product self-declaration are laid down in Chapter II of the Government’s Decree No. 15/2018/ND-CP dated February 02, 2018 on elaboration of the Law on Food Safety and clause 1 Article 3 Chapter I of the Government’s Decree No. 155/2018/ND-CP dated November 12, 2018 providing amendments to regulations on investment and business conditions in sectors under the state management of the Ministry of Health of Vietnam;
  • 3. MEDGATE TECHNOLOGY AND INVESTMENT JSC. Website: Medgate.vn Hotline: 098.546.1894 b) Procedures for registration of product disclosure are laid down in Chapter III of the Government’s Decree No. 15/2018/ND-CP dated February 02, 2018. Article 4. Requirements attached to efficacy testing reports 1. Effects on human health of the following products must be tested: a[10]) (abrogated) b) Products whose new effects are disclosed but have not yet been recognized by any countries in the world; c) Products containing new active ingredients the use of which is not yet permitted; d) Health supplements which are put on the market for the first time and have formulas different from those of products supported by adequate scientific evidences; dd) Products derived from plants/animals and put on the market for the first time, the composition of which is different from that of the ancient traditional remedy or dose-adjusted ancient traditional remedy products published in academic journals; e) Medical foods and foods for special dietary uses which have not been permitted by competent authorities or authorized authorities or law of the country of origin, or the effects, suitable users and usage instructions on the label have not been confirmed by the exporting country. 2[11]. The test for effects on human health must be conducted in accordance with regulations on biomedical research involving human participants laid down in the Circular No. 04/2020/TT-BYT dated March 05, 2020 of the Minister of Health of Vietnam prescribing establishment, functions, tasks, and rights of Research Ethics Committees, and procedures and regulations of the Law on Science and Technology. 3. If the test for the effects on human health is conducted overseas, it must be performed by entities accredited by competent authorities of home country. 4[12]. Any issue that arises beyond the scope of this Circular shall be reported by the receiving authority to its supervisory authority for timely resolution, taking into account the following factors: compliance with relevant laws and regulations, assurance of the health and interests of consumers, and no influence on food production and trading of organizations and individuals. Article 5[13]. (abrogated) Article 6[14]. (abrogated)
  • 4. MEDGATE TECHNOLOGY AND INVESTMENT JSC. Website: Medgate.vn Hotline: 098.546.1894 Article 7[15]. (abrogated) Chapter III REQUIREMENTS FOR FUNCTIONAL FODOS Article 8. Requirements regarding claims 1. Nutrient content claims: When supplementing foods with vitamins, minerals, amino acids, fatty acids, enzymes, probiotics, prebiotics or other biologically active substances, the claims about the contents of such substances in foods according to recommended nutrition intakes (RNI) for Vietnamese are specified in Appendix No. 01 enclosed herewith as follows: a) [16] A substance shall not be mentioned if its content is below 10% RNI or 10% of the intake of that substance stated in a given scientific evidence (for a substance for which the RNI is not disclosed); b) [17] If the content of a substance reaches at least 10% RNI or at least 10% of the intake of that substance stated in a given scientific evidence (for a substance for which the RNI is not disclosed), its name and its content in a serving or 100g of the product shall be specified; c) The maximum contents of vitamins and minerals in foods according to RNI levels provided by manufacturers shall not exceed the tolerable upper intake levels of such vitamins and minerals specified in Appendix 02 enclosed herewith. If RNI levels and tolerable upper intake levels of Vietnam are not available, they shall be determined according to regulations of CODEX or relevant international organizations. 2. Health claims: a) [18] Health claims about a supplemental substance shall be made only when its content in the food reaches 10% RNI or above and is proven with specific scientific evidence; b) [19] Regarding a supplemental ingredient for which RNI level is yet to be announced, health claims shall be made on the product’s label only when its content reaches at least 10% of its intake stated in the given scientific evidence; c) [20] Health claims must be clear, consistent, and suitable for the given scientific evidence; Article 9 [21] . (abrogated)
  • 5. MEDGATE TECHNOLOGY AND INVESTMENT JSC. Website: Medgate.vn Hotline: 098.546.1894 Chapter IV HEALTH SUPPLEMENTS Article 10. Requirements regarding claims 1. Contain claims: a) [22] (abrogated); b) [23] The content of vitamins or minerals in foods according to RNI levels provided by manufacturers shall reach at least 15% of RNI levels for Vietnamese or at least 15% of their intakes stated in the given scientific evidence; c) The maximum contents of vitamins and minerals in foods according to RNI levels provided by manufacturers shall not exceed the tolerable upper intake levels of such vitamins and minerals specified in Appendix 02 enclosed herewith; d) [24] If RNI levels and tolerable upper intake levels of Vietnam are not available, they shall be determined according to regulations of CODEX or relevant international organizations. 2. Health claims: a) Health claims must reflect the product nature. The claim about effects of ingredients having main or combined effects shall be made only when there is scientific evidence. The effects of ingredients must not be enumerated as effects of the product; b) Claims about health, dose, suitable users and usage instructions must be consistent and in conformity with the documents; c) [25] (abrogated) d) [26] If the contents of vitamins and minerals in a product and reach at least 15% RNI or at least 15% of their intakes stated in the given scientific evidence, their effects shall be claimed, provided suitable users and doses are specified; dd) [27] If the daily intake of an ingredient for which the RNI level is yet to be announced reaches at least 15% of its intake stated in the given scientific evidence, its effects shall be claimed, provided suitable users and doses are specified. 3. Users:
  • 6. MEDGATE TECHNOLOGY AND INVESTMENT JSC. Website: Medgate.vn Hotline: 098.546.1894 a) [28] The suitable users must be determined in conformity with claimed effects and approved by the authority receiving the application for registration of product disclosure by giving certification of product disclosure; b) Prohibited users (if any) must be specified. Article 11. Vietnamese labels [29] Labeling of health supplements must comply with regulations on labeling and the following provisions: 1[30]. (abrogated) 2[31]. (abrogated) 3. Mechanism of action of the product shall not be written on its label. 4[32]. The phrase “Thực phẩm này không phải là thuốc và không có tác dụng thay thế thuốc chữa bệnh” (“This food is not a medicine, and is not a substitute for medicines”) shall be specified on the label right after the product’s effects or with other claims (if any). Chapter V MEDICAL FOODS AND FOODS FOR SPECIAL DIETARY USES Article 12. Requirements regarding claims 1. Nutrient content claims: a) [33] (abrogated); b) RNI levels of vitamins and minerals in a serving or their contents in 100g product must be specified; c) The maximum contents of vitamins and minerals in foods according to RNI levels provided by manufacturers shall not exceed the tolerable upper intake levels of such vitamins and minerals specified in Appendix 02 enclosed herewith. If RNI levels and tolerable upper intake levels of Vietnam are not available, they shall be determined according to regulations of CODEX or relevant international organizations. 2. Health claims: The health claims must specify the RNI levels applied to various users.
  • 7. MEDGATE TECHNOLOGY AND INVESTMENT JSC. Website: Medgate.vn Hotline: 098.546.1894 3. Users: The product claims must specify the suitable users and prohibited users (if any). 4. Dose: The dose for each specific user for a given period of time must be specified. Article 13 [34]. (abrogated) Chapter VI CONDITIONS FOR PRODUCTION, TRADING AND INSTRUCTIONS FOR USE OF FUNCTIONAL FOODS [35] Article 14[36]. (abrogated). Article 15[37] (abrogated). Chapter VII RECALL AND DISPOSAL OF UNSAFE FUNCTIONAL FOODS [38] Article 16[39]. (abrogated). Article 17[40]. (abrogated). Article 18[41]. (abrogated). Chapter VIII IMPLEMENTATION [42] Article 19. Implementation This Circular comes into force from February 01, 2015. The Circular No. 08/2004/TT-BYT dated August 23, 2004 of the Minister of Health of Vietnam providing guidelines for management of functional foods is abrogated from the date of entry into force of this Circular. Article 20. Transition
  • 8. MEDGATE TECHNOLOGY AND INVESTMENT JSC. Website: Medgate.vn Hotline: 098.546.1894 Certificate of Declaration of Conformity or Certificate of submission of Declaration of Conformity with food safety regulations granted to a functional food before the effective date of this Circular shall still remain valid until its expiry date. Article 21. Implementation organization 1. Vietnam Food Administration affiliated to the Ministry of Health of Vietnam plays the leading role and cooperate with functional authorities of the Ministry of Industry and Trade of Vietnam and the Ministry of Public Security of Vietnam, within the ambit of their assigned power, in organizing, directing, inspecting and monitoring the implementation of this Circular. 2. Provincial Departments of Health shall organize, and direct branches of Vietnam Food Administration and relevant authorities to carry out, inspection and supervision of local manufacturers and traders of functional foods. 3. Authorities, organizations or individuals having products whose effects on human health need to be tested shall pay testing costs in accordance with current regulations. 4. Manufacturers and traders of functional foods are responsible for implementation of this Circular. Difficulties that arise during the implementation of this Circular should be reported to the Ministry of Health of Vietnam (via Vietnam Food Administration) for consideration./. CERTIFIED BY PP. MINISTER DEPUTY MINISTER Do Xuan Tuyen APPENDIX NO. 01 TABLE OF RECOMMENDED NUTRITION INTAKES (RNI) FOR VIETNAMESE (Enclosed with the Circular No. 43/2014/TT-BYT dated November 24, 2014 of the Minister of Health of Vietnam)
  • 9. MEDGATE TECHNOLOGY AND INVESTMENT JSC. Website: Medgate.vn Hotline: 098.546.1894 1. RNI levels of minerals and micronutrients Age and gender Ca (Calcium) (mg/day) Mg (Magnesium) (mg/day) P (Phosphorus) (mg/day) Selenium * (μg/day) Infants < 6 months old 300 36 90 6 6-11 months old 400 54 275 10 Children 1-3 years old 500 65 460 17 4-6 years old 600 76 500 22 7-9 years old 700 100 500 21 Adolescents (male) 10-12 years old 1.000 155 1.250 32 13-15 years old 225 16-18 years old 260 Adults (male) 19-49 years old 700 205 700 34 50-60 years old 1.000 > 60 years old 33 Adolescents (female) 10-12 years old (under the age of menstruation) 1.000 160 1.250 26 10-12 years old 13-15 years old 220 16-18 years old 240 Adults (female) 19-49 years old 700 205 700 26 50-60 years old 1.000 > 60 years old 25 Pregnant women First trimester 1.000 205 700 26
  • 10. MEDGATE TECHNOLOGY AND INVESTMENT JSC. Website: Medgate.vn Hotline: 098.546.1894 Second trimester 28 Third trimester 30 Breastfeeding women (during breastfeeding period) 1.000 250 700 First 6 months 35 Last 6 months 42 * RNI levels are determined according to the average intakes +2 SD. 2. RNI levels of iodine, iron and zinc
  • 11. MEDGATE TECHNOLOGY AND INVESTMENT JSC. Website: Medgate.vn Hotline: 098.546.1894 Age Iodine (μg/day) I o d i n e ( μ g / d a y ) Iron (mg/day) according to biological value Iron (mg/day) according to biological value I r o n ( m g / d a y ) a c c o r d i n g t o b i o l o g i c a l v a l u e Zinc (mg/day) Z i n c ( m g / d a y ) Z i n c ( m g / d a y ) 5%1 10%2 15%3 High absorption Average absorption Poor absorption
  • 12. MEDGATE TECHNOLOGY AND INVESTMENT JSC. Website: Medgate.vn Hotline: 098.546.1894 Infants I n f a n t s I n f a n t s I n f a n t s I n f a n t s I n f a n t s I n f a n t s I n f a n t s I n f a n t s 0-6 months old 90 9 0 0,93 1,15 2,86 6,57 6-11 months old 90 9 0 18,6 12,4 9,3 0,8-2,58 4,18 8,38 Children C h i l d r e n C h i l d r e n C h i l d r e n C h i l d r e n C h i l d r e n C h i l d r e n C h i l d r e n C h i l d r e n 1-3 years old 90 9 0 11,6 7,7 5,8 2,4 4,1 8,4 4-6 years old 90 9 0 12,6 8,4 6,3 3,1 5,1 10,3 7-9 years old 90 9 0 17,8 11,9 8,9 3,3 5,6 11,3
  • 13. MEDGATE TECHNOLOGY AND INVESTMENT JSC. Website: Medgate.vn Hotline: 098.546.1894 Adolescents (male) A d o l e s c e n t s ( m a l e ) A d o l e s c e n t s ( m a l e ) A d o l e s c e n t s ( m a l e ) A d o l e s c e n t s ( m a l e ) A d o l e s c e n t s ( m a l e ) A d o l e s c e n t s ( m a l e ) A d o l e s c e n t s ( m a l e ) A d o l e s c e n t s ( m a l e ) 10-14 years old 120 1 2 0 29,2 19,5 14,6 5,7 9,7 19,2 15-18 years old 150 1 5 0 37,6 25,1 18,8 5,7 9,7 19,2 Adolescents (female) A d o l e s c e n t s ( f e m a l e ) A d o l e s c e n t s ( f e m a l e ) A d o l e s c e n t s ( f e m a l e ) A d o l e s c e n t s ( f e m a l e ) A d o l e s c e n t s ( f e m a l e ) A d o l e s c e n t s ( f e m a l e ) A d o l e s c e n t s ( f e m a l e ) A d o l e s c e n t s ( f e m a l e )
  • 14. MEDGATE TECHNOLOGY AND INVESTMENT JSC. Website: Medgate.vn Hotline: 098.546.1894 10-14 years old 1 0 - 1 4 y e a r s o l d 120 28,0 18,7 14,0 4,6 7,8 15,5 15-18 years old 1 5 - 1 8 y e a r s o l d 150 65,4 43,6 32,7 4,6 7,8 15,5 Adults A d u l t s A d u l t s A d u l t s A d u l t s A d u l t s A d u l t s A d u l t s A d u l t s
  • 15. MEDGATE TECHNOLOGY AND INVESTMENT JSC. Website: Medgate.vn Hotline: 098.546.1894 Male, ≥ 19 years old M a l e , ≥ 1 9 y e a r s o l d 150 27,4 18,3 13,7 4,2 7,0 14,0 Female, ≥ 19 years old F e m a l e , ≥ 1 9 y e a r s o l d 150 58,8 39,2 29,4 3,0 4,9 9,8
  • 16. MEDGATE TECHNOLOGY AND INVESTMENT JSC. Website: Medgate.vn Hotline: 098.546.1894 Middle-aged adults (≥ 50 years old) M i d d l e - a g e d a d u l t s ( ≥ 5 0 y e a r s o l d ) M i d d l e - a g e d a d u l t s ( ≥ 5 0 y e a r s o l d ) M i d d l e - a g e d a d u l t s ( ≥ 5 0 y e a r s o l d ) M i d d l e - a g e d a d u l t s ( ≥ 5 0 y e a r s o l d ) M i d d l e - a g e d a d u l t s ( ≥ 5 0 y e a r s o l d ) M i d d l e - a g e d a d u l t s ( ≥ 5 0 y e a r s o l d ) M i d d l e - a g e d a d u l t s ( ≥ 5 0 y e a r s o l d ) M i d d l e - a g e d a d u l t s ( ≥ 5 0 y e a r s o l d ) Male M a l e 3,0 4,9 9,8 Female F e m a l e 22,6 15,1 11,3 3,0 4,9 9,8
  • 17. MEDGATE TECHNOLOGY AND INVESTMENT JSC. Website: Medgate.vn Hotline: 098.546.1894 Pregnant women P r e g n a n t w o m e n 200 +30,04 +20,04 +15,04 Breastfeeding women B r e a s t f e e d i n g w o m e n 200 1 Serving size with low biological value of iron (about 5% of iron is absorbed): simple and monotonous regimen, containing under 30g of meat and/or fish per day or under 25 mg of vitamin C per day. 2 Serving size with average biological value of iron (about 10% of iron is absorbed): containing 30g – 90g of meat and/or fish per day or 25 mg – 75 mg of vitamin C per day. 3 Serving size with high biological value of iron (about 15% of iron is absorbed): containing over 90g of meat and/or fish per day or over 75 mg of vitamin C per day. 4 Pregnant women are recommended to take iron pills during the gestation. A pregnant woman with anaemia should take a higher dose.
  • 18. MEDGATE TECHNOLOGY AND INVESTMENT JSC. Website: Medgate.vn Hotline: 098.546.1894 5 Breast-fed children 6 Formula-fed children 7 Children fed by formula milk with great amount plant-based protein and phytates 8 Excluding purely breast-fed children 8 High absorption: high biological value of zinc, equal to 50% (serving contains a lot of protein from animal or fish derivatives); average absorption: average biological value of zinc, equal to 30% (serving contains an average amount of protein from animal or fish derivatives; ratio of phytate and zinc is at 5:15); low absorption: low biological value of zinc, equal to 15% (serving contains very little or does not contain protein from animal or fish derivatives). 3. RNI level of vitamins/day Age and gender A mcga D mcgc E mgd K mcg C mgb B1 mg B2 mg B3 mg NEe B6 mg B9 mcgf B12 mcg Infants and children I n f a n t s a n d c h i l d r e n I n f a n t s a n d c h i l d r e n I n f a n t s a n d c h i l d r e n I n f a n t s a n d c h i l d r e n I n f a n t s a n d c h i l d r e n I n f a n t s a n d c h i l d r e n I n f a n t s a n d c h i l d r e n I n f a n t s a n d c h i l d r e n I n f a n t s a n d c h i l d r e n I n f a n t s a n d c h i l d r e n I n f a n t s a n d c h i l d r e n < 6 months old 375 5 3 6 25 0,2 0,3 2 0,1 80 0,3 6-11 months old 400 5 4 9 30 0,3 0,4 4 0,3 80 0,4 1-3 years old 400 5 5 13 30 0,5 0,5 6 0,5 160 0,9
  • 19. MEDGATE TECHNOLOGY AND INVESTMENT JSC. Website: Medgate.vn Hotline: 098.546.1894 4-6 years old 450 5 6 19 30 0,6 0,6 8 0,6 200 1,2 7-9 years old 500 5 7 24 35 0,9 0,9 12 1 300 1,8 Adolescents (male) A d o l e s c e n t s ( m a l e ) A d o l e s c e n t s ( m a l e ) A d o l e s c e n t s ( m a l e ) A d o l e s c e n t s ( m a l e ) A d o l e s c e n t s ( m a l e ) A d o l e s c e n t s ( m a l e ) A d o l e s c e n t s ( m a l e ) A d o l e s c e n t s ( m a l e ) A d o l e s c e n t s ( m a l e ) A d o l e s c e n t s ( m a l e ) A d o l e s c e n t s ( m a l e ) 10-12 years old 600 5 10 34 65 1,2 1,3 16 1,3 400 2,4 13-15 years old 12 50 16-18 years old 13 58 Adults (male) A d u l t s ( m a l e ) A d u l t s ( m a l e ) A d u l t s ( m a l e ) A d u l t s ( m a l e ) A d u l t s ( m a l e ) A d u l t s ( m a l e ) A d u l t s ( m a l e ) A d u l t s ( m a l e ) A d u l t s ( m a l e ) A d u l t s ( m a l e ) A d u l t s ( m a l e ) 19-50 years old 600 10 12 59 70 1,2 1,3 16 1,3 400 2,4 51-60 years old 10 1,7 ≥60 years old 15
  • 20. MEDGATE TECHNOLOGY AND INVESTMENT JSC. Website: Medgate.vn Hotline: 098.546.1894 Adolescents (female) A d o l e s c e n t s ( f e m a l e ) A d o l e s c e n t s ( f e m a l e ) A d o l e s c e n t s ( f e m a l e ) A d o l e s c e n t s ( f e m a l e ) A d o l e s c e n t s ( f e m a l e ) A d o l e s c e n t s ( f e m a l e ) A d o l e s c e n t s ( f e m a l e ) A d o l e s c e n t s ( f e m a l e ) A d o l e s c e n t s ( f e m a l e ) A d o l e s c e n t s ( f e m a l e ) A d o l e s c e n t s ( f e m a l e ) 10-12 years old 600 5 11 35 65 1,1 1 16 1,2 400 2,4 13-15 years old 12 49 16-18 years old 12 50 Adults (female) A d u l t s ( f e m a l e ) A d u l t s ( f e m a l e ) A d u l t s ( f e m a l e ) A d u l t s ( f e m a l e ) A d u l t s ( f e m a l e ) A d u l t s ( f e m a l e ) A d u l t s ( f e m a l e ) A d u l t s ( f e m a l e ) A d u l t s ( f e m a l e ) A d u l t s ( f e m a l e ) A d u l t s ( f e m a l e ) 19-50 years old 500 10 12 51 70 1,2 1,1 14 1,3 400 2,4 51-60 years old 10 1,1 1,5 > 60 years old 600 15 70 1,1 Pregnant women 800 5 12 51 80 1,4 1,4 18 1,9 600 2,6
  • 21. MEDGATE TECHNOLOGY AND INVESTMENT JSC. Website: Medgate.vn Hotline: 098.546.1894 Breastfeeding women 850 5 18 51 95 1,5 1,6 17 2 500 2,8 a These following conversion factors may be used for vitamin A: 01 mcg of vitamin A or retinol = 01 retinol equivalent (RE) 01 IU (International unit) is equivalent to 0.3 mcg of vitamin A 01 mcg of b-carotene = 0.167 mcg of vitamin A 01 mcg of other carotenes = 0.084 mcg of vitamin A b Excluding the loss during processing and cooking activities because Vitamin C is destroyed easily by the oxidization, light, alkali and temperature. c These following conversion factors may be used for vitamin D: 01 IU is equivalent to 0.03 mcg of vitamin D3, or 01 mcg of vitamin D3 = 40 IU d IU conversion factors (according to IOM-FNB 2000): 01 mg a-tocopherol = 1 IU; 01 mg b-tocopherol = 0,5 IU; 01 mg g-tocopherol = 0,1 IU; 0,1 mg s-tocopherol = 0,02 IU. e Niacin or Niacin equivalent f These following conversion factors may be used for Folic acid: 01 folic acid = 1 folate x 1.7, or 01 g of folic acid equivalent = 01 g of folate in food + (1.7 x amount of synthetic folic acid (in gram)). Note: This table will be updated according to current regulations of the Ministry of Health of Vietnam. APPENDIX NO. 02 TOLERABLE UPPER INTAKE LEVELS (Enclosed with the Circular No. 43/2014/TT-BYT dated November 24, 2014 of the Minister of Health of Vietnam) 1. Vitamin Age Vitamin A (μg/day) Vitamin C (mg/day) Vitamin D (μg/day) Vitamin E (mg/day) Vitamin K (μg/day) Vitamin B1 (mg/day) Riboflavin (mg/day) Niacin (mg/day) Vitamin B6 (mg/day) Acid Folic (μg/day) Vitamin B12 (μg/day) Pantothenic (mg/day) Biotin (μg/day)
  • 22. MEDGATE TECHNOLOGY AND INVESTMENT JSC. Website: Medgate.vn Hotline: 098.546.1894 Infants I n f a n t s I n f a n t s I n f a n t s I n f a n t s I n f a n t s I n f a n t s I n f a n t s I n f a n t s I n f a n t s I n f a n t s I n f a n t s I n f a n t s I n f a n t s 0-6 months old 600 N/A 25 N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A 6-12 months old 600 N/A 38 N/A N/A N/A N/A N/A N/A N/A N/A N/A N/A Children C h il d r e n C h il d r e n C h il d r e n C h il d r e n C h il d r e n C h il d r e n C h il d r e n C h il d r e n C h il d r e n C h il d r e n C h il d r e n C h il d r e n C h il d r e n 1-3 years old 600 400 63 200 N/A N/A N/A 10 30 300 N/A N/A N/A 4-8 years old 900 650 75 300 N/A N/A N/A 15 40 400 N/A N/A N/A Teenagers (9-13 years old) T e e n a g e r s ( 9 - 1 3 y e a r s o l d ) T e e n a g e r s ( 9 - 1 3 y e a r s o l d ) T e e n a g e r s ( 9 - 1 3 y e a r s o l d ) T e e n a g e r s ( 9 - 1 3 y e a r s o l d ) T e e n a g e r s ( 9 - 1 3 y e a r s o l d ) T e e n a g e r s ( 9 - 1 3 y e a r s o l d ) T e e n a g e r s ( 9 - 1 3 y e a r s o l d ) T e e n a g e r s ( 9 - 1 3 y e a r s o l d ) T e e n a g e r s ( 9 - 1 3 y e a r s o l d ) T e e n a g e r s ( 9 - 1 3 y e a r s o l d ) T e e n a g e r s ( 9 - 1 3 y e a r s o l d ) T e e n a g e r s ( 9 - 1 3 y e a r s o l d ) T e e n a g e r s ( 9 - 1 3 y e a r s o l d ) Male 1.700 1.200 100 600 N/A N/A N/A 20 60 600 N/A N/A N/A Female 1.700 1.200 100 600 N/A N/A N/A 20 60 600 N/A N/A N/A
  • 23. MEDGATE TECHNOLOGY AND INVESTMENT JSC. Website: Medgate.vn Hotline: 098.546.1894 Adolescents (14-18 years old) A d o l e s c e n t s ( 1 4 - 1 8 y e a r s o l d ) A d o l e s c e n t s ( 1 4 - 1 8 y e a r s o l d ) A d o l e s c e n t s ( 1 4 - 1 8 y e a r s o l d ) A d o l e s c e n t s ( 1 4 - 1 8 y e a r s o l d ) A d o l e s c e n t s ( 1 4 - 1 8 y e a r s o l d ) A d o l e s c e n t s ( 1 4 - 1 8 y e a r s o l d ) A d o l e s c e n t s ( 1 4 - 1 8 y e a r s o l d ) A d o l e s c e n t s ( 1 4 - 1 8 y e a r s o l d ) A d o l e s c e n t s ( 1 4 - 1 8 y e a r s o l d ) A d o l e s c e n t s ( 1 4 - 1 8 y e a r s o l d ) A d o l e s c e n t s ( 1 4 - 1 8 y e a r s o l d ) A d o l e s c e n t s ( 1 4 - 1 8 y e a r s o l d ) A d o l e s c e n t s ( 1 4 - 1 8 y e a r s o l d ) Male 2.800 1.800 100 800 N/A N/A N/A 30 80 800 N/A N/A N/A Female 2.800 1.800 100 800 N/A N/A N/A 30 80 800 N/A N/A N/A Adults, ≥ 19 years old A d u lt s, ≥ 1 9 y e a r s o l d A d u lt s, ≥ 1 9 y e a r s o l d A d u lt s, ≥ 1 9 y e a r s o l d A d u lt s, ≥ 1 9 y e a r s o l d A d u lt s, ≥ 1 9 y e a r s o l d A d u lt s, ≥ 1 9 y e a r s o l d A d u lt s, ≥ 1 9 y e a r s o l d A d u lt s, ≥ 1 9 y e a r s o l d A d u lt s, ≥ 1 9 y e a r s o l d A d u lt s, ≥ 1 9 y e a r s o l d A d u lt s, ≥ 1 9 y e a r s o l d A d u lt s, ≥ 1 9 y e a r s o l d A d u lt s, ≥ 1 9 y e a r s o l d Male 3.000 2.000 100 1.000 N/A N/A N/A 35 100 1.000 N/A N/A N/A Female 3.000 2.000 100 1.000 N/A N/A N/A 35 100 1.000 N/A N/A N/A Old people, ≥ 51 years old O l d p e o p l e , ≥ 5 1 y e a r s o l d O l d p e o p l e , ≥ 5 1 y e a r s o l d O l d p e o p l e , ≥ 5 1 y e a r s o l d O l d p e o p l e , ≥ 5 1 y e a r s o l d O l d p e o p l e , ≥ 5 1 y e a r s o l d O l d p e o p l e , ≥ 5 1 y e a r s o l d O l d p e o p l e , ≥ 5 1 y e a r s o l d O l d p e o p l e , ≥ 5 1 y e a r s o l d O l d p e o p l e , ≥ 5 1 y e a r s o l d O l d p e o p l e , ≥ 5 1 y e a r s o l d O l d p e o p l e , ≥ 5 1 y e a r s o l d O l d p e o p l e , ≥ 5 1 y e a r s o l d O l d p e o p l e , ≥ 5 1 y e a r s o l d Male 3.000 2.000 100 1.000 N/A N/A N/A 35 100 1.000 N/A N/A N/A Female 3.000 2.000 100 1.000 N/A N/A N/A 35 100 1.000 N/A N/A N/A
  • 24. MEDGATE TECHNOLOGY AND INVESTMENT JSC. Website: Medgate.vn Hotline: 098.546.1894 Pregnant women 3.000 2.000 100 1.000 N/A N/A N/A 35 100 1.000 N/A N/A N/A Breastfeeding women 3.000 2.000 100 1.000 N/A N/A N/A 35 100 1.000 N/A N/A N/A 2. Minerals Age Arsenic Boron (mg/day) ChroniumC h r o n i u m Copper (μg/day) C o p p e r ( μ g / d a y ) Fluoride (mg/day) F l u o r i d e ( m g / d a y ) Iodine (μg/day) Iodine (μg/day ) Iron (mg/day) I r o n ( m g / d a y ) Magnesium (mg/day) Magnesium (mg/day) Manganese (mg/day) M a n g a n e s e ( m g / d a y ) Molybde num (μg/day) Nic (mg/d Infants 0-6 months old N/A N/A N/A N / A N/A N / A 0,7 0 , 7 N/A N/A 40 4 0 N/A N/A N/A N / A N/A N/ 6-12 months old N/A N/A N/A N / A N/A N / A 0,9 0 , 9 N/A N/A 40 4 0 N/A N/A N/A N / A N/A N/ Children 1-3 years old N/A 3 3 N/A N/A 1.000 1 . 0 0 0 1,3 1 , 3 200 2 0 0 40 4 0 65 2 300 3 0 0 0,2 4-8 years old N/A 6 6 N/A N/A 3.000 3 . 0 0 0 2,2 2 , 2 300 3 0 0 40 4 0 110 3 600 6 0 0 0,3
  • 25. MEDGATE TECHNOLOGY AND INVESTMENT JSC. Website: Medgate.vn Hotline: 098.546.1894 Teenagers (9-13 years old) Male N/A 11 11 N/A N/A 5.000 5 . 0 0 0 10 1 0 600 6 0 0 40 4 0 350 9 1.100 1 . 1 0 0 0,6 Female N/A 11 11 N/A N/A 5.000 5 . 0 0 0 10 1 0 600 6 0 0 40 4 0 350 9 1.100 1 . 1 0 0 0,6 Adolescents (14-18 years old) Male N/A 17 17 N/A N/A 8.000 8 . 0 0 0 10 1 0 900 9 0 0 45 4 5 350 11 1.700 1 . 7 0 0 1,0 Female N/A 17 17 N/A N/A 8.000 8 . 0 0 0 10 1 0 900 9 0 0 45 4 5 350 11 1.700 1 . 7 0 0 1,0
  • 26. MEDGATE TECHNOLOGY AND INVESTMENT JSC. Website: Medgate.vn Hotline: 098.546.1894 Adults, ≥ 19 years old Male N/A 20 20 N/A N/A 10.000 1 0 . 0 0 0 10 1 0 1.100 1 . 1 0 0 45 4 5 350 11 2.000 2 . 0 0 0 1,0 Female N/A 20 20 N/A N/A 10.000 1 0 . 0 0 0 10 1 0 1.100 1 . 1 0 0 45 4 5 350 11 2.000 2 . 0 0 0 1,0 Old people, ≥ 51 years old Male N/A 20 20 N/A N/A 10.000 1 0 . 0 0 0 10 1 0 1.100 1 . 1 0 0 45 4 5 350 11 2.000 2 . 0 0 0 1,0 Female N/A 20 20 N/A N/A 10.000 1 0 . 0 0 0 10 1 0 1 100 1 1 0 0 45 4 5 350 11 2.000 2 . 0 0 0 1,0 Pregnant women N/A 20 20 N/A N/A 10.000 1 0 . 0 0 0 10 1 0 1.100 1 . 1 0 0 45 4 5 350 11 2.000 2 . 0 0 0 1,0
  • 27. MEDGATE TECHNOLOGY AND INVESTMENT JSC. Website: Medgate.vn Hotline: 098.546.1894 Breastfeeding women N/A 20 20 N/A N/A 10.000 1 0 . 0 0 0 10 1 0 1.100 1 . 1 0 0 45 4 5 350 11 2.000 2 . 0 0 0 1,0 Tolerable upper intake level means the highest level of micronutrient intake that is likely to cause no poison or pose no risk of adverse health effects. N/A: There is not enough information to determine the tolerable upper intake level Note: This table will be updated according to current regulations of the Ministry of Health of Vietnam. [1] The Circular No. 17/2023/TT-BYT dated September 25, 2023 of the Minister of Health of Vietnam providing amendments to and abrogation of some legislative documents on food safety 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/QH12 dated June 17, 2010; The Government's Decree No. 15/2018/ND-CP dated February 02, 2018 on elaboration of the Law on Food Safety; The Government’s Decree No. 95/2022/ND-CP dated November 15, 2022 defining functions, tasks, powers and organizational structure of the Ministry of Health of Vietnam; And at the request of the Director of Vietnam Food Administration,” [2] This clause is abrogated according to point dd clause 2 Article 7 of the Circular No.17/2023/TT-BYT, coming into force from November 09, 2023. [3] This clause is abrogated according to point dd clause 2 Article 7 of the Circular No.17/2023/TT-BYT, coming into force from November 09, 2023.
  • 28. MEDGATE TECHNOLOGY AND INVESTMENT JSC. Website: Medgate.vn Hotline: 098.546.1894 [4] This clause is abrogated according to point dd clause 2 Article 7 of the Circular No.17/2023/TT-BYT, coming into force from November 09, 2023. [5] This clause is abrogated according to point dd clause 2 Article 7 of the Circular No.17/2023/TT-BYT, coming into force from November 09, 2023. [6] This Article is amended according to clause 1 Article 4 of the Circular No.17/2023/TT-BYT, coming into force from November 9, 2023. [7] This clause is abrogated according to point dd clause 2 Article 7 of the Circular No.17/2023/TT-BYT, coming into force from November 09, 2023. [8] This clause is abrogated according to point dd clause 2 Article 7 of the Circular No.17/2023/TT-BYT, coming into force from November 09, 2023. [9] This clause is amended according to clause 3 Article 4 of the Circular No.17/2023/TT-BYT, coming into force from November 09, 2023. [10] This point is abrogated according to point dd clause 2 Article 7 of the Circular No.17/2023/TT-BYT, coming into force from November 09, 2023. [11] This clause is amended according to clause 3 Article 4 of the Circular No.17/2023/TT-BYT, coming into force from November 09, 2023. [12] This clause is amended according to clause 3 Article 4 of the Circular No.17/2023/TT-BYT, coming into force from November 09, 2023. [13] This Article is abrogated according to point dd clause 2 Article 7 of the Circular No.17/2023/TT-BYT, coming into force from November 09, 2023. [14] This Article is abrogated according to point dd clause 2 Article 7 of the Circular No.17/2023/TT-BYT, coming into force from November 09, 2023. [15] This Article is abrogated according to point dd clause 2 Article 7 of the Circular No.17/2023/TT-BYT, coming into force from November 09, 2023. [16] This point is amended according to clause 4 Article 4 of the Circular No. 17/2023/TT-BYT, coming into force from November 09, 2023. [17] This point is amended according to clause 4 Article 4 of the Circular No. 17/2023/TT-BYT, coming into force from November 09, 2023. [18] This point is amended according to clause 5 Article 4 of the Circular No. 17/2023/TT-BYT, coming into force from November 09, 2023.
  • 29. MEDGATE TECHNOLOGY AND INVESTMENT JSC. Website: Medgate.vn Hotline: 098.546.1894 [19] This point is amended according to clause 5 Article 4 of the Circular No. 17/2023/TT-BYT, coming into force from November 09, 2023. [20] This point is amended according to clause 5 Article 4 of the Circular No. 17/2023/TT-BYT, coming into force from November 09, 2023. [21] This Article is abrogated according to point dd clause 2 Article 7 of the Circular No.17/2023/TT-BYT, coming into force from November 09, 2023. [22] This point is abrogated according to point dd clause 2 Article 7 of the Circular No.17/2023/TT-BYT, coming into force from November 09, 2023. [23] This point is amended according to clause 6 Article 4 of the Circular No. 17/2023/TT-BYT, coming into force from November 09, 2023. [24] This point is amended according to clause 6 Article 4 of the Circular No. 17/2023/TT-BYT, coming into force from November 09, 2023. [25] This clause is abrogated according to point dd clause 2 Article 7 of the Circular No.17/2023/TT-BYT, coming into force from November 09, 2023. [26] This point is amended according to clause 7 Article 4 of the Circular No. 17/2023/TT-BYT, coming into force from November 09, 2023. [27] This point is amended according to clause 7 Article 4 of the Circular No. 17/2023/TT-BYT, coming into force from November 09, 2023. [28] This point is amended according to clause 8 Article 4 of the Circular No. 17/2023/TT-BYT, coming into force from November 09, 2023. [29] This sentence is amended according to clause 9 Article 4 of the Circular No. 17/2023/TT-BYT, coming into force from November 09, 2023. [30] This point is abrogated according to point dd clause 2 Article 7 of the Circular No.17/2023/TT-BYT, coming into force from November 09, 2023. [31] This clause is abrogated according to point dd clause 2 Article 7 of the Circular No.17/2023/TT-BYT, coming into force from November 09, 2023. [32] This clause is amended according to clause 10 Article 4 of the Circular No.17/2023/TT-BYT, coming into force from November 09, 2023. [33] This point is abrogated according to point dd clause 2 Article 7 of the Circular No.17/2023/TT-BYT, coming into force from November 09, 2023.
  • 30. MEDGATE TECHNOLOGY AND INVESTMENT JSC. Website: Medgate.vn Hotline: 098.546.1894 [34] This Article is abrogated according to point dd clause 2 Article 7 of the Circular No.17/2023/TT-BYT, coming into force from November 09, 2023. [35] This Chapter is abrogated according to point dd clause 2 Article 7 of the Circular No.17/2023/TT-BYT, coming into force from November 09, 2023. [36] This Article is abrogated according to point dd clause 2 Article 7 of the Circular No.17/2023/TT-BYT, coming into force from November 09, 2023. [37] This Article is abrogated according to point dd clause 2 Article 7 of the Circular No.17/2023/TT-BYT, coming into force from November 09, 2023. [38] This Chapter is abrogated according to point dd clause 2 Article 7 of the Circular No.17/2023/TT-BYT, coming into force from November 09, 2023. [39] This Article is abrogated according to point dd clause 2 Article 7 of the Circular No.17/2023/TT-BYT, coming into force from November 09, 2023. [40] This Article is abrogated according to point dd clause 2 Article 7 of the Circular No.17/2023/TT-BYT, coming into force from November 09, 2023. [41] This Article is abrogated according to point dd clause 2 Article 7 of the Circular No.17/2023/TT-BYT, coming into force from November 09, 2023. [42] Articles 9, 10 and 11 of the Circular No.17/2023/TT-BYT, coming into force from November 09, 2023, stipulate as follows: Article 9. Terms of reference If any legislative documents referred to in this Circular are amended, supplemented or superseded, the new ones shall apply. Article 10. Effect This Circular comes into force from November 09, 2023. Article 11. Responsibility for implementation The Chief of the Ministry Office, the Director General of the Vietnam Food Administration, the Ministry’s Chief Inspector, heads of units of and affiliated to the Ministry, Directors of provincial Departments of Health, heads of food safety authorities affiliated to provincial People’s Committees, heads of health agencies of ministries and central-government authorities, and relevant authorities, organizations and individuals are responsible for the implementation of this Circular./.
  • 31. MEDGATE TECHNOLOGY AND INVESTMENT JSC. Website: Medgate.vn Hotline: 098.546.1894 ------------------------------------------------------------------------------------------------------ This translation is made by THƯ VIỆN PHÁP LUẬT, Ho Chi Minh City, Vietnam and for reference purposes only. Its copyright is owned by THƯ VIỆN PHÁP LUẬT and protected under Clause 2, Article 14 of the Law on Intellectual Property.Your comments are always welcomed