CNG HA X HI CH NGHA VIT NAM

QCVN 11-2:2012/BYT

QUY CHUN K THUT QUC GIA

I VI SN PHM DINH DNG CNG THC
VI MC CH Y T C BIT
CHO TR N 12 THNG TUI
National technical regulation
on formulas for special medical purposes intended for infants
(up to 12 months of age)

H NI 2012

Li ni u
QCVN 11-2:2012/BYT do Ban son tho quy chun k thut quc gia
v Thc n cho tre s sinh v tr nh

bin son, Cc An ton thc

phm trnh duyt v c ban hnh theo Thng t s 21/2012/TTBYT ngy 15 thng 11 nm 2012 ca B trng B Y t.

QCVN 11-2:2012/BYT

QUY CHUN K THUT QUC GIA

I VI SN PHM DINH DNG CNG THC
VI MC CH Y T C BIT CHO TR N 12 THNG TUI
National technical regulation
on formulas for special medical purposes intended for infants
(up to 12 months of age)
I. QUY NH CHUNG
1. Phm vi iu chnh
Quy chun ny quy nh cc ch tiu cht lng, an ton thc phm v yu cu qun
l i vi sn phm dinh dng cng thc vi mc ch y t c bit cho tr n 12 thng tui.
2. i tng p dng
Quy chun ny p dng i vi:
2.1. T chc, c nhn nhp khu, sn xut, kinh doanh sn phm dinh dng cng
thc vi mc ch y t c bit cho tr n 12 thng tui lu thng trn th trng Vit
Nam.
2.2. C quan qun l nh nc c lin quan.
3. Gii thch t ng v k hiu vit tt
Trong Quy chun ny, cc t ng di y c hiu nh sau:
3.1. Sn phm dinh dng cng thc vi mc ch y t c bit cho tr n 12 thng
tui: Sn phm c dng lng hoc dng bt ch bin t cc thnh phn tng hp hoc t
nhin c ngun gc ng vt hoc thc vt, c sn xut nhm p ng cc nhu cu dinh
dng c bit cho tr n 12 thng tui b bnh, ri lon hoc cn chm sc y t.
Sn phm dinh dng cng thc vi mc ch y t c bit cho tr n 12 thng tui
c th c s dng nh l ngun thc n thay th sa m theo quy nh ti Thng t lin
tch s 10/2006/TTLT/BYT-BTM-BVHTT-UBDSGTE ngy 25/8/2006 v vic hng dn thi
hnh Ngh nh s 21/2006/N-CP ngy 27/2/2006 ca Chnh ph v vic kinh doanh v s
dng cc sn phm dinh dng dng cho tr nh.
3.2. GUL (Guidance Upper Levels): Mc hng dn gii hn ti a. Mc ny c p
dng i vi cc cht dinh dng khng c thng tin nh gi nguy c da trn c
s khoa hc. Cc gi tr ny c thit lp trn c s p ng yu cu dinh dng vi mc
ch y t c bit cho tr n 12 thng tui v d liu v s dng an ton, c th c iu
chnh da trn c s tin b khoa hc cng ngh c lin quan. Mc ch ca GUL l cung
cp hng dn cho nh sn xut v khng c hiu l gi tr cn t ti. Hm lng dinh
dng trong sn phm dinh dng cng thc vi mc ch y t c bit cho tr n 12
1

QCVN 11-1:2012/BYT
thng tui khng c vt qu cc gi tr GUL tr trng hp c mc dinh dng cao
hn do s thay i ca thnh phn nguyn liu hoc v l do cng ngh. Nh sn xut
khng c tng cc mc dinh dng t n gi tr GUL khi dng sn phm c mc
thp hn gi tr GUL.
3.3. GMP (Good Manufacturing Practice): Thc hnh sn xut tt.
3.4. DHA: Acid docosahexaenoic.
3.5. IU (International Unit): n v quc t.
3.6. PUFA (Poly-unsaturated Fatty Acids): Cc acid bo cha bo ha a.
II. QUY NH V K THUT
1. Thnh phn c bn
1.1. Yu cu chung
1.1.1. Nguyn liu v ph gia thc phm a vo sn xut phi m bo cht lng,
an ton v sinh thc phm, khng c cha gluten v thch hp cho tiu ho ca tr n
12 thng tui.
1.1.2. Thnh phn sn phm dinh dng cng thc vi mc ch y t c bit cho tr
n 12 thng tui phi c xy dng trn cc nguyn l dinh dng v y hc.
1.1.3. An ton dinh dng v kh nng p ng y dinh dng ca sn phm
phi c chng minh khoa hc v kh nng h tr s pht trin cho tr n 12 thng tui
vi mc ch y t c bit ng thi c kh nng h tr s pht trin cho i tng tr m
sn phm hng ti.
1.1.4. Cc yu nng lng v thnh phn dinh dng sn phm dinh dng cng
thc vi mc ch y t c bit cho tr n 12 thng tui phi tun th quy nh ti Khon
1.2 v 1.3, Phn II ca Quy chun ny. Tuy nhin, c th iu chnh thnh phn sn phm
nhm p ng cc nhu cu dinh dng c bit ca tr (do bnh tt, cc ri lon v cn
chm sc y t).
1.2. Nng lng
Sn phm dinh dng cng thc vi mc ch y t c bit cho tr n 12 thng tui
(pha ch theo hng dn ca nh sn xut s dng trc tip) phi p ng:
n v

Ti thiu

Ti a

kcal/100 ml

60

70

kJ/100 ml

250

295

1.3. Thnh phn dinh dng

Sn phm dinh dng cng thc vi mc ch y t c bit cho tr n 12 thng tui
(pha ch theo hng dn ca nh sn xut s dng trc tip) phi p ng:

QCVN 11-2:2012/BYT
1.3.1. Hm lng Protein1), 2), 3)
n v

Ti thiu 4)

Ti a

GUL

1,8

3,0

2,25

3,0

0,45

0,7

i vi sn phm ch bin t protein sa b.

0,5

0,7

i vi sn phm ch bin t protein u

tng.

g/100 kcal

g/100 kJ

Ghi ch
i vi sn phm ch bin t protein sa b.
i vi sn phm ch bin t protein u
tng.

Ghi ch:
1)

Hm lng protein ca sn phm dinh dng cng thc vi mc ch y t c bit cho tr n 12 thng tui (pha
ch theo hng dn ca nh sn xut s dng trc tip) c tnh bng N x 6,25 (N l hm lng nit). Phi c
bng chng khoa hc khi p dng h s chuyn i khc. Mc protein quy nh trong Quy chun ny da trn h s
chuyn i nit 6,25. Gi tr 6,38 thng c thit lp theo h s c th thch hp cho vic chuyn i nit v protein
trong sn phm t sa khc v gi tr 5,71 l h s chuyn i nit v protein trong sn phm t u tng.
2)

i vi gi tr nng lng tng ng th sn phm phi cha lng sn c ca mi loi acid amin thit yu hoc
thit yu c iu kin t nht bng lng cha trong sa m (Gi tr hm lng tham kho ti Ph lc 1 ca Quy chun
ny); tnh ton th hm lng ca tyrozin v phenylalanin c th c tnh gp vi nhau. Nu t l hm lng
methionin v cystein nh hn 2:1 th c th tnh gp; nu t l nm trong khong t 2:1 n 3:1 th mc ph hp
ca sn phm ny cn c chng minh bng th nghim lm sng.
3)

Cc acid amin n l c th c b sung vo sn phm dinh dng cng thc vi mc ch y t c bit cho tr
n 12 thng tui ch nhm tng gi tr dinh dng. C th b sung cc acid amin thit yu hoc thit yu c iu kin
ch vi cc lng cn thit nhm tng cht lng protein. Ch c s dng cc acid amin dng ng phn L-.
4)

Nu sn phm dinh dng cng thc vi mc ch y t c bit cho tr n 12 thng tui ch bin t protein sa
khng thu phn vi hm lng nh hn 2 g protein/100 kcal hoc ch bin t protein thu phn vi hm lng nh hn
2,25 g protein/100 kcal th cn c nh gi lm sng.

1.3.2. Hm lng Lipid

n v

Ti thiu

Ti a

GUL

Cht bo tng s 5), 6)

Ghi ch
5)

g/100 kcal

4,4

6,0

g/100 kJ

1,05

1,4

Khng c s dng cc loi m v du

hydro ho sn xut sn phm dinh dng cng
thc vi mc ch y t c bit cho tr n 12 thng
tui .
6)

Acid lauric v acid mystiric l cc thnh phn ca

cht bo nhng tng ca chng khng c qu

Acid linoleic
mg/100 kcal

300

1.400

mg/100 kJ

70

330

mg/100 kcal

50

mg/100 kJ

12

Acid -linolenic

T l gia acid linoleic /acid -linolenic

20% acid bo tng s. Hm lng acid bo dng

trans khng c qu 3% acid bo tng s. Acid
bo dng trans l cc thnh phn ni sinh ca cht
bo sa. Chp nhn n 3% acid bo dng trans
cho php s dng cht bo sa trong cc sn phm
dinh dng cng thc vi mc ch y t c bit
cho tr n 12 thng tui . Hm lng acid erucic
khng c qu 1% acid bo tng s. Hm lng
phospholipid khng c qu 300 mg/100 kcal (72
mg/100 kJ).

QCVN 11-1:2012/BYT
n v

Ti thiu

Ti a

GUL

5:1

15:1

Ghi ch

1.3.3. Hm lng Carbohydrat

n v

Ti thiu

Ti a

GUL

Ghi ch
7)

u tin s dng lactose v glucose cao phn t l

ngun carbohydrat trong sn phm c ngun gc

Carbohydrat tng s 7)
g/100 kcal

9,0

14,0

g/100 kJ

2,2

3,3

Ti a

GUL

protein t sa b v protein thy phn. Ch c b

sung tinh bt s ch v/hoc gelatin ho khng
cha gluten t nhin vo sn phm vi hm lng
khng qu 30% carbohydrat tng s v khng qu 2
g/100 ml. V cc nguy c tim n i vi tr nh
khng dung np c fructose do di truyn, ch s
dng sucrose v fructose trong sn phm khi cn thit

1.3.4. Hm lng Vitamin

n v

Ti thiu

Ghi ch
8)

Vitamin A
g8)/100 kcal

60

180

g8)/100 kJ

14

43

g all-trans retinol. Hm lng retinol phi c to ra

bi cc tin retinol, khng tnh n lng carotenoid
vo hm lng vitamin A trong sn phm

9)

Vitamin D3
g9) /100kcal

2,5

g9) /100 kJ

0,25

0,6

mg10)/100
kcal

0,511)

mg10)/100 kJ

0,1211)

1,2

Tnh theo -tocopherol tng ng (-TE).

1 mg -TE = 1 mg d--tocopherol
11)

Tnh theo calciferol.

1 g calciferol = 40 IU vitamin D

10)

Vitamin E

Tnh theo g RE. 1 g RE = 3,33 IU vitamin A = 1

Hm lng vitamin E ti thiu phi t 0,5 mg -

TE/g PUFA, s dng cc h s tng ng sau y

chp nhn hm lng vitamin E ti thiu i vi s
lng cc lin kt i ca acid bo trong sn phm:
0,5 mg -TE /g acid linoleic (18:2 n-6); 0,75 -TE/g
acid -linolenic (18:3 n-3); 1,0 mg -TE/g acid
arachidonic

(20:4

n-6);

1,25

mg

-TE/g

acid

eicosapentaenoic (20:5 n-3); 1,5 mg -TE/g acid

docosahexaenoic (22:6 n-3)

Vitamin K
g/100 kcal

27

g/100 kJ

6,5

Vitamin B1 (Thiamin)
4

QCVN 11-2:2012/BYT
n v

Ti thiu

Ti a

GUL

g/100 kcal

60

300

g/100 kJ

14

72

Ghi ch

Vitamin B2 (Riboflavin)
g/100 kcal

80

500

g/100 kJ

19

119
12)

Niacin12)
g/100 kcal

300

1.500

g/100 kJ

70

360

g/100 kcal

35

175

g/100 kJ

8,5

45

0,1

1,5

0,025

0,36

i vi tin niacin

Vitamin B6

Vitamin B12
g/100 kcal
g/100 kJ

Acid pantothenic
g/100 kcal

400

2.000

g/100 kJ

96

478

g/100 kcal

10

50

g/100 kJ

2,5

12

Acid folic

13)

Vitamin C

mg13)/100kcal

10

70 14)

mg13)/100 kJ

2,5

17 14)

g/100 kcal

1,5

10

g/100 kJ

0,4

2,4

tnh theo acid ascorbic

14)

Mc ny tnh n kh nng hao ht ln trong

thi hn s dng sn phm dng lng; sn phm dng
bt cn quy nh mc thp hn.

Vitamin H (Biotin)

Cc dng vitamin b sung vo sn phm theo quy nh ca B Y t. Trong trng hp

cha c quy nh ca B Y t th thc hin theo hng dn ca CODEX ti CAC/GL 10-

QCVN 11-1:2012/BYT
1979, Rev.1-2008 Advisory List of Mineral Salts and Vitamin compounds for Use in Foods for
Infants and Children (Danh mc khuyn co v cc hp cht vitamin v mui khong s
dng trong thc phm dnh cho tr s sinh v tr nh).
1.3.5. Hm lng cc cht khong v nguyn t vi lng
n v

Ti thiu

Ti a

GUL

mg/100 kcal

0,45

mg/100 kJ

0,1

mg/100 kcal

50

140

mg/100 kJ

12

35

Ghi ch

St

Calci

15)

Phospho
mg/100 kcal

25

100(15)

mg/100 kJ

24(15)

1 :1

2 :1

15

1,2

3,6

mg/100 kcal

20

60

mg/100 kJ

14

mg/100 kcal

50

160

mg/100 kJ

12

38

mg/100 kcal

60

180

mg/100 kJ

14

43

100

T l calci/phospho

Magnesi
mg/100 kcal
mg/100 kJ
Natri

Clorid

Kali

Mangan
g/100 kcal
6

Gi tr GUL ny cn xem xt cc nhu cu cao hn

vi cc sn phm dinh dng dnh vi mc ch y t
c bit cho tr n 12 thng tui c s dng u
tng.

QCVN 11-2:2012/BYT
n v

Ti thiu

Ti a

GUL

0,25

24

g/100 kcal

10

60

g/100 kJ

2,5

14

0,24

2,2

g/100 kcal

35

120

g/100 kJ

8,5

29

mg/100 kcal

0,5

1,5

mg/100 kJ

0,12

0,36

g/100 kcal

1,5

10

g/100 kJ

0,4

2,4

g/100 kcal

1,5

10

g/100 kJ

0,4

2,4

g/100 kJ

Ghi ch

Iod

Selen
g/100 kcal
g/100 kJ
ng

Km

Chrom

Molybden

Cc dng cht khong v nguyn t vi lng b sung vo sn phm theo quy nh

ca B Y t. Trong trng hp cha c quy nh ca B Y t th thc hin theo hng dn
ca CODEX ti CAC/GL 10-1979, Rev.1-2008 Advisory List of Mineral Salts and Vitamin
compounds for Use in Foods for Infants and Children (Danh mc khuyn co v cc hp
cht vitamin v mui khong s dng trong thc phm dnh cho tr s sinh v tr nh).
1.3.6. Hm lng cc thnh phn khc
n v

Ti thiu

Ti a

GUL

50

1,7

12

Ghi ch

Cholin
mg/100 kcal
mg/100 kJ

QCVN 11-1:2012/BYT
n v

Ti thiu

Ti a

GUL

mg/100 kcal

40

mg/100 kJ

9,5

mg/100 kcal

1,2

mg/100 kJ

0,3

Ghi ch

Myo-inositol

L-carnitin

2. Cc thnh phn ty chn

Ngoi cc thnh phn quy nh trong Khon 1.3, Phn II ca Quy chun ny, cung
cp cc cht thng c trong sa m, sn phm dinh dng cng thc vi mc ch y t
c bit cho tr n 12 thng tui mc cc bnh, ri lon hoc cn chm sc y t c th b
sung thm cc thnh phn khc.
Trong trng hp b sung phi c bng chng khoa hc v an ton, ph hp vi nhu
cu dinh dng vi mc ch y t c bit. Hm lng cc thnh phn ny trong sn phm
dinh dng cng thc vi mc ch y t c bit cho tr n 12 thng tui phi t
c hiu qu nh cng b.
Quy nh c th i vi mt s thnh phn ty chn:
n v

Ti thiu

Ti a

GUL

i vi sn phm c pha ch s dng trc

tip theo hng dn ca nh sn xut

Taurin
mg/100 kcal

12

mg/100 kJ

i vi sn phm c pha ch s dng trc

tip theo hng dn ca nh sn xut

Acid docosahexaenoic 16)

% acid bo

Ghi ch

0,5

16)

Nu b sung DHA (22:6 n-3) vo sn phm dinh

dng cng thc vi mc ch y t c bit cho tr n
12 thng tui th hm lng acid arachidonic (20:4 n-6)
khng c thp hn hm lng DHA. Hm lng
acid eicosapentaenoic (20:5 n-3) c trong cc ngun
LC-PUFA khng c qu hm lng DHA.

- Ch c s dng chng vi sinh vt sinh acid L(+) lactic.

3. Fluorid
- Khng c b sung fluorid vo sn phm dinh dng cng thc vi mc ch y t
c bit cho tr n 12 thng tui .
- Hm lng fluorid c quy nh nh sau:

QCVN 11-2:2012/BYT
n v

Ti a

Ghi ch

g/100 kcal

100

i vi sn phm c pha ch s dng trc tip theo hng

dn ca nh sn xut

g/100 kJ

24

4. Trng thi ca sn phm sau khi pha ch

Khi pha ch theo hng dn s dng ghi trn nhn, sn phm phi thch hp vi mc
ch y t c bit cho tr n 12 thng tui , khng c hin tng vn cc.
5. X l bng bc x ion
Sn phm v nguyn liu ban u khng c x l bng bc x ion.
6. Ph gia thc phm
Cc cht ph gia thc phm s dng trong sn phm dinh dng cng thc dnh vi
mc ch y t c bit cho tr n 12 thng tui theo quy nh ca B Y t.
7. Cht nhim bn
7.1. D lng thuc bo v thc vt
Sn phm phi c ch bin theo nguyn tc GMP khng cn tn d thuc bo
v thc vt ( c s dng trong sn xut, bo qun hoc x l nguyn liu th/thnh
phn thc phm). Trong trng hp v l do k thut vn cn tn d thuc bo v thc vt
th hm lng ca chng phi c gim ti a c th p ng theo quy nh hin hnh.
7.2. Melamin
n v
mg/kg

Ti a

Ghi ch

i vi sn phm dng cng thc dnh vi mc ch y t c bit

cho tr n 12 thng tui dng bt

7.3. Kim loi nng

Theo quy nh ca QCVN 8-2:2011/BYT Quy chun k thut quc gia i vi gii hn
nhim kim loi nng trong thc phm
7.4. c t vi nm
Theo quy nh ca QCVN 8-1:2011/BYT Quy chun k thut quc gia i vi gii hn
nhim c t vi nm trong thc phm
7.5. Cht nhim bn khc
Khng c cha cc cht nhim bn/cc cht khng mong mun (v d: cc cht c
hot tnh sinh hc) vi hm lng c th gy nguy hi ti tr.
Sn phm thuc phm vi iu chnh ca Quy chun ny cn tun theo gii hn ti a

QCVN 11-1:2012/BYT
cho php trong quy nh ca B Y t, trong trng hp B Y t cha c quy nh c th th
p dng theo quy nh ca Codex.
8. Vi sinh vt
Theo quy nh ca QCVN 8-3:2012/BYT Quy chun k thut quc gia i vi gii hn
nhim c t vi nm trong thc phm.
9. Ghi nhn
Vic ghi nhn sn phm dinh dng cng thc vi mc ch y t c bit cho tr n
12 thng tui phi theo ng quy nh ti Ngh nh s 89/2006/N-CP ngy 30 thng 8
nm 2006 ca Chnh ph v nhn hng ho, Ngh nh s 21/2006/N-CP ngy 27 thng 2
nm 2006 ca Chnh ph v vic kinh doanh v s dng cc sn phm dinh dng dng
cho tr nh v cc vn bn hng dn thi hnh v cc quy nh ca php lut.
III. PHNG PHP LY MU V PHNG PHP TH
1. Ly mu
Ly mu theo hng dn ti Thng t 16/2009/TT-BKHCN ngy 2 thng 6 nm 2009
ca B Khoa hc v Cng ngh v hng dn kim tra Nh nc v cht lng hng ho
lu thng trn th trng; Thng t 14/2011/TT-BYT ngy 01 thng 4 nm 2011 ca B Y t
v hng dn chung v ly mu thc phm phc v thanh tra, kim tra cht lng, v sinh
an ton thc phm v cc quy nh khc ca php lut c lin quan.
2. Phng php th
Yu cu k thut quy nh trong Quy chun ny c th theo cc phng php
trong Ph lc 2 ca Quy chun ny (cc phng php ny khng bt buc p dng, c th
s dng phng php th khc tng ng)
Trong trng hp cn kim tra cc ch tiu cha quy nh phng php th ti Quy
chun ny, B Y t s quy nh cn c theo cc phng php hin hnh trong nc hoc
nc ngoi c xc nhn gi tr s dng.
IV. QUY NH V QUN L
1. Cng b hp quy
1.1. Sn phm dinh dng cng thc vi mc ch y t c bit cho tr n 12 thng
tui trc khi nhp khu, sn xut, kinh doanh trong nc phi c cng b hp quy 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 Ngh nh s
38/2012/N-CP ngy 25 thng 4 nm 2012 ca Chnh ph quy nh chi tit thi hnh mt s
iu ca Lut an ton thc phm, Thng t s 19/2012/TT-BYT ngy 11 thng 9 nm 2012
ca B Y t hng dn vic cng b hp quy v cng b ph hp quy nh an ton thc
phm v cc quy nh khc ca php lut.
10

QCVN 11-2:2012/BYT
2. Kim tra v cht lng
Vic kim tra cht lng, an ton i vi sn phm dinh dng cng thc vi mc
ch y t c bit cho tr n 12 thng tui c thc hin theo cc quy nh ca php lut.
V. TRCH NHIM CA T CHC, C NHN
1. T chc, c nhn sn xut, nhp khu, kinh doanh sn phm dinh dng cng thc
vi mc ch y t c bit cho tr n 12 thng tui phi cng b hp quy ph hp vi cc
quy nh k thut ti Quy chun ny, ng k bn cng b hp quy ti c quan qun l nh
nc c thm quyn theo phn cp ca B Y t v bo m cht lng, an ton theo ng
ni dung cng b.
2. T chc, c nhn ch c, sn xut, nhp khu, kinh doanh sn phm sn phm
dinh dng cng thc vi mc ch y t c bit cho tr n 12 thng tui sau khi hon tt
ng k bn cng b hp quy v bo m cht lng, an ton, ghi nhn ph hp vi cc
quy nh ca php lut.
VI. T CHC THC HIN
1. Cc An ton 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 thc phm c trch nhim kin ngh B Y
t sa i, b sung Quy chun ny.
3. Trng hp cc tiu chun v quy nh php lut c vin dn trong Quy chun
ny c s thay i, b sung hoc c thay th th p dng theo vn bn php lut .

11

QCVN 11-1:2012/BYT
Ph lc 1
HM LNG THAM KHO
CC ACID AMIN THIT YU V THIT YU C IU KIN TRONG SA M

Hm lng trung bnh

TT

Acid amin

mg/g nit

mg/g protein

mg/100 kcal

Cystein

131

21

38

Histidin

141

23

41

Iso-leucin

319

51

92

Leucin

586

94

169

Lysin

395

63

114

Methionin

85

14

24

Phenylalanin

282

45

81

Threonin

268

43

77

Trytophan

114

18

33

10

Tyrosin

259

42

75

11

Valin

315

50

90

12

QCVN 11-2:2012/BYT
Ph lc 2
DANH MC PHNG PHP TH CC CH TIU I VI
SN PHM DINH DNG CNG THC VI MC CH Y T C BIT
CHO TR N 12 THNG TUI

I. Protein
1. TCVN 8099-5:2009 (ISO 8968-5:2001) Sa Xc nh hm lng nit Phn 5:
Phng php xc nh hm lng nit protein
2. TCVN 8100:2009 (ISO 14891:2002) Sa v sn phm sa Xc nh hm lng
nit Phng php thng dng theo nguyn tc t chy Dumas
3. AOAC 960.48 Protein Efficiency Ratio
II. Lipid
4. TCVN 6688-1:2007 (ISO 8262-1:2005) Sn phm sa v thc phm t sa Xc
nh hm lng cht bo bng phng php khi lng Weibull Berntrop
(Phng php chun) Phn 1: Thc phm dnh cho tr s sinh
5. TCVN 7084:2002 (ISO 1736:2000) Sa bt v sn phm sa bt Xc nh hm
lng cht bo Phng php khi lng (Phng php chun)
6. AOAC 996.06 Fat (Total, Saturated, and Unsaturated) in Foods. Hydrolytic
Extraction Gas Chromatographic Method
7. ISO 23065:2009 Milk fat from enriched dairy products Determination of omega-3
and omega-6 fatty acid content by gas-liquid chromatography
8. AOAC 992.25 Linoleic Acid in Ready-To-Feed Milk-Based Infant Formula. Gas
Chromatographic Method
III. Carbohydrat
9. AOAC 986.25 Proximate Analysis of Milk-Based Infant Formula
IV. Vitamin
10. EN 12823-1:2000 Foodstuffs Determination of vitamin A by high performance
liquid chromatography Part 1: Measurements of all-trans-retinol and 13-cis-retinol
11. EN 12823-2:2000 Foodstuffs Determination of vitamin A by high performance
liquid chromatography Part 2: Measurements of Beta-carotene
12. AOAC 974.29 Vitamin A in Mixed Feeds, Premixes, and Human and Pet Foods.
Colorimetric Method
13. AOAC 941.15 Carotene in Fresh Plant Materials and Silages. Spectrophotometric
Method

13

QCVN 11-1:2012/BYT
14. AOAC 992.06 Vitamin A (Retinol) in Milk-Based Infant Formula. Liquid
Chromatographic Method
15. AOAC 992.04 Vitamin A (Retinol Isomers) in Milk and Milk-Based Infant Formula.
Liquid Chromatographic Method
16. EN 12821:2009 Foodstuffs Determination of vitamin D by high performance liquid
chromatography Measurement of cholecalciferol (D3) or ergocalciferol (D2)
17. AOAC 936.14 Vitamin D in Milk, Vitamin Preparations, and Feed Concentrates
18. AOAC 995.05 Vitamin D in Infant Formulas and Enteral Products. Liquid
Chromatographic Method
19. AOAC 992.26 Vitamin D3 (Cholecalciferol) in Ready-To-Feed Milk-Based Infant
Formula. Liquid Chromatographic Method
20. TCVN 8276:2010 (EN 12822:2000) Thc phm Xc nh vitamin E bng sc k
lng hiu nng cao nh lng v tocopherol
21. AOAC 971.30 -Tocopherol and
Colorimetric Method

-Tocopheryl Acetate in Foods and Feeds.

22. AOAC 992.03 Vitamin E Activity (All-rac- -Tocopherol) in Milk-Based Infant

Formula. Liquid Chromatographic Method
23. EN 14148:2003 Foodstuffs Determination of vitamin K1 by HPLC
24. AOAC 999.15 Vitamin K in Milk and Infant Formulas. Liquid Chromatographic
Method
25. AOAC 992.27 trans-Vitamin K1 (Phylloquinone) in Ready-To-Feed Milk-Based
Infant Formula. Liquid Chromatographic Method
26. TCVN 5164:2008 (EN 14122:2003) Thc phm Xc nh vitamin B1 bng sc
k lng hiu nng cao (HPLC)
27. AOAC 942.23 Thiamine (Vitamin B1) in Human and Pet Foods. Fluorometric
Method
28. AOAC 986.27 Thiamine (Vitamin B1) in Milk-Based Infant Formula. Fluorometric
Method
29. EN 14152:2003 Foodstuffs Determination of vitamin B2 by HPLC
30. AOAC 970.65 Riboflavin (Vitamin B2) in Foods and Vitamin Preparations.
Fluorometric Method
31. EN 15652:2009 Foodstuffs Determination of niacin by HPLC
32. AOAC 985.34 Niacin and Niacinamide (Nicotinic Acid and Nicotinamide)
in Ready-to-Feed Milk-Based Infant Formula. Microbiological-Turbidimetric Method
33. AOAC 944.13 Niacin and Niacinamide (Nicotinic Acid and Nicotinamide)
14

QCVN 11-2:2012/BYT
in Vitamin Preparations. Microbiological Methods
34. AOAC 961.14 Niacin and Niacinamide in Drugs, Foods, and Feeds. Colorimetric
Method
35. EN 14164:2008 Foodstuffs Determination of vitamin B6 by HPLC
36. EN 14166:2009 Foodstuffs Determination of vitamin B6 by microbiological assay
37. EN 14663:2005 Foodstuffs Determination of vitamin B6 (including its
glycosylated forms) by HPLC
38. AOAC 961.15 Vitamin B6 (Pyridoxine, Pyridoxal, Pyridoxamine) in Food Extracts.
Microbiological Method
39. AOAC 985.32 Vitamin B6 (Pyridoxine, Pyridoxal, Pyridoxamine) in Ready-to-Feed
Milk-Based Infant Formula. Microbiological Method
40. AOAC 986.23 Cobalamin (Vitamin B12 Activity) in Milk-Based Infant Formula.
Turbidimetric Method
41. AOAC 952.20 Cobalamin (Vitamin B12 Activity) in Vitamin Preparations.
Microbiological Methods
42. AOAC 992.07 Pantothenic Acid in Milk-Based Infant Formula. Microbiological
Turbidimetric Method
43. AOAC 945.74 Pantothenic Acid in Vitamin Preparations. Microbiological Methods
44. EN 14131:2003 Foodstuffs Determination of folate by microbiological assay
45. AOAC 992.05 Folic Acid (Pteroylglutamic Acid) in Infant Formula. Microbiological
Methods
46. AOAC 944.12 Folic Acid (Pteroylglutamic Acid) in Vitamin Preparations.
Microbiological Methods
47. EN 14130:2003 Foodstuffs Determination of vitamin C by HPLC
48. AOAC 985.33 Vitamin C (Reduced Ascorbic Acid) in Ready-to-Feed Milk-Based
Infant Formula. 2,6-Dichloroindophenol Titrimetric Method
49. AOAC 967.22 Vitamin C (Total) in Vitamin Preparations. Microfluorometric Method
50. AOAC 984.26 Vitamin C (Total) in Food. Semiautomated Fluorometric Method
51. EN 15607:2009 Foodstuffs Determination of d-biotin by HPLC
V. Cht khong v cc nguyn t vi lng
52. TCVN 8126:2009 Thc phm Xc nh ch, cadimi, km, ng v st Phng
php o ph hp th nguyn t sau khi phn hy bng vi sng (AOAC 999.10)
53. AOAC 984.27 Calcium, Copper, Iron, Magnesium, Manganese, Phosphorus,
Potassium, Sodium, and Zinc in Infant Formula. Inductively Coupled Plasma

15

QCVN 11-1:2012/BYT
Emission Spectroscopic Method
54. AOAC 985.35 Minerals in Infant Formula, Enteral Products, and Pet Foods. Atomic
Absorption Spectrophotometric Method
55. TCVN 6269:2008 (ISO 8070:2007) Sa v sn phm sa Xc nh hm lng
canxi, natri, kali v magie Phng php o ph hp th nguyn t
56. TCVN 6838:2001 (ISO 12081:1998) Sa Xc nh hm lng canxi Phng
php chun
57. TCVN 6271:2007 (ISO 9874:2006) Sa Xc nh hm lng phospho tng s
Phng php o ph hp th phn t
58. AOAC 986.24 Phosphorus
Spectrophotometric Method

in

Infant

Formula

and

Enteral

Products.

59. AOAC 976.25 Sodium in Foods for Special Dietary Use. Ion Selective Electrode
Method
60. AOAC 986.26 Chloride in Milk-Based Infant Formula. Potentiometric Method
61. TCVN 7080:2002 (ISO 14378:2000) Sa v sa bt Xc nh hm lng ioua
Phng php s dng sc k lng hiu nng cao
62. EN 15111:2007 Foodstuffs Determination of trace elements Determination of
iodine by ICP-MS (inductively coupled plasma mass spectrometry)
63. AOAC 992.24 Iodide in Ready-To-Feed Milk-Based Infant Formula. Ion-Selective
Electrode Method
64. EN 14627:2005 Foodstuffs Determination of trace elements Determination of
total arsenic and selenium by hydride generation atomic absorption spectrometry
(HGAAS) after pressure digestion
65. AOAC 986.15 Arsenic, Cadmium, Lead, Selenium, and Zinc in Human and Pet
Foods. Multielement Method
66. AOAC 974.15 Selenium in Human and Pet Food. Fluorometric Method
67. TCVN 7086:2007 (ISO 5738:2004) Sa v sn phm sa Xc nh hm lng
ng Phng php o quang (Phng php chun)
68. TCVN 6841:2001 (ISO 11813:1998) Sa v sn phm sa Xc nh hm lng
km Phng php o ph hp th nguyn t ngn la
69. TCVN 7929:2008 (EN 14083:2003) Thc phm Xc nh cc nguyn t vt
Xc nh ch, cadimi, crom, molypden bng o ph hp th nguyn t dng l
graphit (GFAAS) sau khi phn hu bng p lc
VI. Cc cht dinh dng khc
70. AOAC 999.14 Choline in Infant Formula and Milk Enzymatic Colorimetric Method

16

QCVN 11-2:2012/BYT
71. AOAC 991.39 Fatty Acids in Encapsulated Fish Oils and Fish Oil Methyl and Ethyl
Esters. Gas Chromatographic Method
VII. Fluorid
72. AOAC 944.08 Fluorine in Food. Distillation Method
73. AOAC 961.16 Microchemical Determination of Fluorine. Titrimetric Method
VIII. Cht nhim bn
74. TCVN 7602:2007 Thc phm Xc nh hm lng ch bng phng php
quang ph hp th nguyn t
75. TCVN 7933:2009 (ISO/TS 6733:2006) Sa v sn phm sa Xc nh hm
lng ch Phng php quang ph hp th nguyn t dng l graphit
76. TCVN 7788:2007 hp thc phm Xc nh hm lng thic bng phng
php quang ph hp th nguyn t
77. TCVN 7730:2007 (ISO/TS 9941:2005) Sa v sa c c ng hp Xc nh
hm lng thic Phng php o ph
78. ISO 15495:2010 Milk, milk products and infant formulae Guidelines for the
quantitative determination of melamine and cyanuric acid by LC-MS/MS
79. TCVN 6685:2009 (ISO 14501:2007) Sa v sa bt Xc nh hm lng
aflatoxin M1 Lm sch bng sc k i lc min dch v xc nh bng sc k
lng hiu nng cao
80. TCVN 7785:2007 (ISO 14674:2005) Sa v sa bt Xc nh hm lng
aflatoxin M1 Lm sch bng sc k i lc min dch v xc nh bng sc k lp
mng
81. TCVN 7700-1:2007 (ISO 11290-1:1996, With Amd 1:2004) Vi sinh vt trong thc
phm v thc n chn nui Phng php pht hin v nh lng Listeria
monocytogenes Phn 1: Phng php pht hin
82. TCVN 7850:2008 (ISO/TS 22964:2006)
Enterobacter sakazakii

Sa v sn phm sa Pht hin

83. TCVN 5518-1:2007 (ISO 21528-1:2004) Vi sinh vt trong thc phm v thc n
chn nui Phng php pht hin v nh lng Enterobactericeae Phn 1:
Pht hin v nh lng bng k thut MPN c tin tng sinh

17