CNG HO X HI CH NGHA VIT NAM

QCVN 9-2 : 2011/BYT

QUY CHUN K THUT QUC GIA

V THC PHM B SUNG VI CHT DINH DNG
National technical regulation
on micronutrient fortified food

H NI - 2011

Li ni u
QCVN 9-2:2011/BYT do Ban son tho quy chun k thut quc
gia v Thc phm b sung vi cht dinh dng bin son, Cc An
ton v sinh thc phm trnh duyt v c ban hnh theo Thng
t s 05/2011/TT-BYT ngy 13 thng 1 nm 2011 ca B trng
B Y t.

QUY CHUN K THUT QUC GIA

V THC PHM B SUNG VI CHT DINH DNG
National technical regulation on micronutrient fortified food

I. QUY NH CHUNG
1. Phm vi iu chnh
Quy chun k thut quc gia ny (sau y gi tt l Quy chun) quy nh cc yu cu
k thut v qun l i vi vic b sung vi cht dinh dng vo thc phm.
2. i tng p dng
Quy chun ny p dng i vi:
2.1. T chc, c nhn nhp khu, xut khu, sn xut, bun bn cc thc phm b
sung vi cht dinh dng.
2.2. C quan qun l nh nc c lin quan.
3. Gii thch t ng v k hiu vit tt:
3.1. AOAC (Association of Official Analytical Chemists): Hip hi cc nh ho
phn tch chnh thng.
3.2. KQ: Khng quy nh

II. QUY NH K THUT

1. Yu cu k thut i vi nc mm b sung vi cht
- Nc mm b sung vi cht dinh dng phi p ng cc yu cu k thut i
vi nc mm c quy nh trong Quy chun tng ng hoc cc quy nh ca
php lut c lin quan.
- Dng vi cht dinh dng b sung v hm lng vi cht dinh dng b sung
vo nc mm c quy nh nh sau:

Vi cht
dinh
dng
St (Fe)

Hm lng vi cht
dinh dng b sung
(mg/100ml)
Ti thiu

Ti a

30,0

50,0

Cht b sung

- Natri st (III) EDTA, trihydrat.

- St Sulfat, St fumarat

QCVN 9-2: 2011/BYT

2. Yu cu k thut i vi bt m b sung vi cht
- Bt m b sung vi cht dinh dng phi p ng cc yu cu k thut i vi
bt m c quy nh trong Quy chun tng ng hoc cc quy nh ca php lut
c lin quan.
- Dng vi cht dinh dng b sung v hm lng vi cht dinh dng b sung
vo bt m c quy nh nh sau:
Vi cht
dinh dng
St (Fe)
Km (Zn)
Vitamin A
Vitamin B12
Acid folic

Hm lng vi cht
dinh dng b sung
(mg/kg)
Ti thiu

Ti a

27,80
70,90
1,33
0,02
2,04

51,60
131,70
4,80
KQ
8,16

Cht b sung

St sulfat (dng kh)

Km oxyd
Retinyl palmitat (250-sd)
Cyanocobalamin
Acid folic

3. Yu cu k thut i vi du n b sung vi cht

- Du n b sung vi cht dinh dng phi p ng cc yu cu k thut i vi
Du n c quy nh trong Quy chun tng ng hoc cc quy nh ca php lut
c lin quan.
- Dng vi cht dinh dng b sung v hm lng vi cht dinh dng b sung
vo du n c quy nh nh sau:
Vi cht
dinh dng
Vitamin A

Hm lng vi cht dinh

dng b sung (mg/100g)
Ti thiu
2,75

Cht b sung

Ti a
5,50

Retinyl palmitat

4. Yu cu k thut i vi ng b sung vi cht

- ng b sung vi cht dinh dng phi p ng cc yu cu k thut i vi
ng c quy nh trong Quy chun tng ng hoc cc quy nh ca php lut
c lin quan.
- Dng vi cht dinh dng b sung v hm lng vi cht dinh dng b sung
vo ng c quy nh nh sau:
Vi cht
dinh dng
Vitamin A

Hm lng vi cht dinh

dng b sung (mg/kg)
Ti thiu
15,0

Cht b sung

Ti a
30,0

Retinyl palmitat
2

QCVN 9-2: 2011/BYT

III. PHNG PHP TH V LY MU
1. Phng php th:
Cc yu cu k thut trong quy chun k thut ny c th c th theo cc
phng php di y hoc c th th theo cc phng php tng ng khc:
1.1. Xc nh St theo AOAC 999.11: Lead, Cadmium, Copper, Iron, and Zinc
in foods Atomic Absorption Spectrophotometry after dry ashing;
1.2. Xc nh Km theo AOAC 999.11: Lead, Cadmium, Copper, Iron, and Zinc
in foods Atomic Absorption Spectrophotometry after dry ashing;
1.3. Xc nh Vitamin B12 theo AOAC 986.23: Cobalamin (Vitamin B12 Activity)
in milk-based infant fomula;
1.4. Xc nh Vitamin A theo AOAC 2002.06: Retinyl palmitate (Vitamin A) in
Fortified fluid milk Liquid chromatography;
1.5. Xc nh acid folic theo AOAC 992.05: Total folate (Pteroylglutamic acid) in
Infant formula Microbiological methods.
2. Ly mu:
Ly mu theo hng dn ti Thng t 16/2009/TT-BKHCN ngy 02 thng 6
nm 2009 ca B Khoa hc v Cng ngh v hng dn kim tra nh nc v cht
lng hng ha lu thng trn th trng v cc quy nh khc ca php lut c lin
quan.

IV. YU CU QUN L
1. Ghi nhn
- Vic ghi nhn thc phm b sung vi cht dinh dng thc hin theo cc quy
nh ti ngh nh s 89/2006/N-CP ngy 30 thng 8 nm 2006 ca Chnh ph v
nhn hng ha v cc vn bn hng dn thi hnh.
- Ngoi ra trn nhn sn phm phi ghi dng ch bng ting Vit Nam: Thc
phm b sung vi cht dinh dng.
2. Cng b hp quy
1.1. Cc thc phm b sung vi cht dinh dng phi c cng b ph hp
vi cc quy nh ti Quy chun ny.
1.2. Phng thc, trnh t, th tc cng b hp quy c thc hin theo Quy
nh v chng nhn hp chun, chng nhn hp quy v cng b hp chun, cng
b hp quy ban hnh km theo Quyt nh s 24/2007/Q-BKHCN ngy 28 thng 9
nm 2007 ca B trng B Khoa hc v Cng ngh v cc quy nh ca php lut.
3. Kim tra i vi vi cht dinh dng b sung vo thc phm
Vic kim tra cht lng, v sinh an ton i vi thc phm b sung vi cht
dinh dng phi c thc hin theo cc quy nh ca php lut.
3

QCVN 9-2: 2011/BYT

IV. TRCH NHIM CA T CHC, C NHN
1. T chc, c nhn sn xut thc phm b sung vi cht dinh dng ch
c php b sung cc vi cht dinh dng v s dng cc cht b sung vo
tng loi thc phm nht nh ng theo quy nh ca quy chun ny.
2. T chc, c nhn sn xut, nhp khu, kinh doanh thc phm b sung vi
cht dinh dng phi cng b hp quy ph hp vi cc yu cu k thut ti Quy
chun ny, ng k bn cng b hp quy ti Cc An ton v sinh thc phm v bo
m cht lng, v sinh an ton theo ng ni dung cng b.
3. T chc, c nhn ch c nhp khu, sn xut, kinh doanh v s dng
thc phm b sung vi cht dinh dng sau khi hon tt ng k bn cng b
hp quy v bo m cht lng, v sinh an ton, ghi nhn ph hp vi quy nh
ca quy chun ny v cc quy nh khc ca php lut.

V.

T CHC THC HIN

1. Giao Cc An ton v sinh thc phm ch tr, phi hp vi cc c quan chc

nng c lin quan hng dn trin khai v t chc vic thc hin Quy chun ny.
2. Cn c vo yu cu qun l, Cc An ton v sinh thc phm c trch nhim
kin ngh B Y t sa i, b sung Quy chun ny.
3. Trng hp hng dn ca quc t v phng php th, cc tiu chun v
cc quy nh ca php lut vin dn trong Quy chun ny c sa i, b sung
hoc thay th th p dng theo vn bn mi.