CNG HA X HI CH NGHA VIT NAM

QCVN 11-4:2012/BYT

QUY CHUN K THUT QUC GIA

I VI SN PHM DINH DNG CH BIN
T NG CC CHO TR T 6 N 36 THNG TUI
National technical regulation on processed cereal-based foods
for infants from 6th month on
and young children up to 36 months of age

H NI 2012
Li ni u

QCVN 11-4:2012/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
23/2012/TT-BYT ngy 15 thng 11 nm 2012 ca B trng B Y
t.
 QCVN 11-4:2012/BYT

QUY CHUN K THUT QUC GIA

I VI SN PHM DINH DNG CH BIN
T NG CC CHO TR T 6 N 36 THNG TUI

National technical regulation on processed cereal-based foods

for infants from 6th month on
and young children up to 36 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

i vi vic qun l sn phm dinh dng ch bin t ng cc cho tr t 6 n 36
thng tui.

2. i tng p dng
Quy chun ny p dng i vi:

2.1. Cc t chc, c nhn nhp khu, sn xut, kinh doanh cc sn phm dinh
dng ch bin t ng cc cho tr t 6 n 36 thng tui ti 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 v k hiu vit tt di y c hiu nh

sau:

3.1. Sn phm dinh dng ch bin t ng cc cho tr t 6 n 36 thng tui:

sn phm c ch bin ch yu t mt hoc nhiu loi ng cc xay, trong ng
cc chim t nht 25% thnh phn hn hp cui cng tnh theo khi lng cht kh.
Sn phm chia thnh cc nhm nh sau:

3.1.1. Sn phm cha ng cc c n km vi sa hoc sn phm dinh

dng dng lng thch hp khc;

3.1.2. Ng cc c b sung thc phm giu protein, c n km vi nc

hoc cc sn phm dinh dng dng lng thch hp khc khng cha protein;

3.1.3. M (pasta) c n sau khi nu chn bng nc hoc sn phm dng

lng thch hp khc;
3.1.4. Bnh m gin (rusk) v bnh quy (biscuit) c n trc tip hoc nghin,
c th dng km vi nc, sa hoc cc sn phm dng lng thch hp khc.

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3.2. PER (Protein Efficiency Ratio): Hiu qu s dng protein.

3.3. CODEX: y ban tiu chun ha thc phm quc t.

3.4. GMP (Good Manufacturing Practice): Thc hnh sn xut tt.

II. QUY NH V K THUT

1. Thnh phn c bn

1.1. Yu cu chung
- Cc sn phm quy nh ti Khon 3.1, Phn I ca Quy chun ny c ch
bin t mt hoc nhiu loi ng cc xay nh la m, go, la mch, yn mch, la
mch en, ng, k, la min (sorghum) v kiu mch (buckwheat). Ngoi ra, nguyn
liu ch bin cng c th bao gm u (), c c tinh bt (c dong, khoai lang hoc
sn) hoc cy c tinh bt; ht c du vi t l nh hn. Cc thnh phn phi bo
m cht lng an ton thc phm theo quy nh.
- Qu trnh x l v sy kh phi c thc hin gim thiu nhng tn tht
v gi tr dinh dng, c bit v cht lng protein.
- m ca sn phm phi tun th GMP i vi tng nhm sn phm ring.
m phi mc cc vi sinh vt khng th pht trin, ng thi m bo gim
thiu mc tn tht gi tr dinh dng ca sn phm.

1.2. Nng lng

n v Ti thiu Ti a

kcal/g 0,8 -

kJ/g 3,3 -

1.3. Hm lng thnh phn dinh dng

1.3.1. Protein
Ch s ha hc ca protein trong nguyn liu phi t ti thiu 80% so vi
casein chun hoc ch s PER ca protein trong hn hp phi t ti thiu 70% so
vi casein chun. Ch c b sung acid amin dng ng phn L vi t l ph hp
vo sn phm ci thin gi tr dinh dng ca hn hp protein.

Hm lng protein phi p ng cc yu cu sau:

Nhm sn phm Ti thiu(1) Ti a(2)

g/100 kcal g/100 kJ g/100 kcal g/100 kJ

Sn phm quy nh ti im 3.1.2, 2,0 0,48 5,5 1,3

Phn I ca Quy chun ny

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Nhm sn phm Ti thiu(1) Ti a(2)

Sn phm quy nh ti im 3.1.4, 1,5 0,36 5,5 1,3

Phn I ca Quy chun ny

Ghi ch:
(1)
i vi lng protein b sung
(2)
i vi hm lng protein trong sn phm

1.3.2. Lipid

Hm lng lipid phi p ng yu cu sau:

Nhm sn phm Ti thiu Ti a

g/100 kcal g/100 kJ g/100 kcal g/100 kJ

Sn phm quy nh ti im 3.1.2, - - 4,5 1,1

Phn I ca Quy chun ny (3)

Sn phm quy nh ti im 3.1.1 - - 3,3 0,8

v im 3.1.4 Phn I ca Quy
chun ny
(3)
Nu hm lng lipid vt qu 0,8 g/100kJ (3,3g/100 kcal) th hm lng acid
linoleic v acid lauric trong sn phm phi p ng nh sau:
n v Ti thiu Ti a

Hm lng acid linoleic (di dng triglycerid-linoleat)

mg/100 kcal 300 1.200

mg/100 kJ 70 285

Hm lng acid lauric

%/lipid tng s - 15

Hm lng acid myristic

%/lipid tng s - 15

1.3.3. Carbohydrat
- Nu sn phm quy nh ti im 3.1.1 v im 3.1.4 Phn I ca Quy chun
ny s dng sucrose, fructose, glucose, xir glucose hoc mt ong th phi p ng
cc yu cu sau:
n v Ti thiu Ti a

Tng lng carbohydrat b sung t cc ngun nu trn

g/100 kcal - 7,5

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QCVN 11-4:2012/BYT

g/100 kJ - 1,8

Lng fructose b sung

g/100 kcal - 3,75

g/100 kJ - 0,9

- Nu sn phm quy nh ti im 3.1.2, Phn I ca Quy chun ny s dng

sucrose, fructose, glucose, xir glucose hoc mt ong th phi p ng cc yu cu
sau:
n v Ti thiu Ti a

Tng lng carbohydrat b sung t cc ngun nu trn

g/100 kcal - 5,0

g/100 kJ - 1,2

Lng fructose b sung

g/100 kcal - 2,5

g/100 kJ - 0,6

1.4. Vitamin
n v Ti thiu Ti a Ghi ch

Vitamin B1 i vi 04 nhm sn phm phn loi trong Khon 3.1, Phn I ca

Quy chun ny.
g/100 kcal 50 -

g/100 kJ 12,5 -

Vitamin A - Tnh theo retinol tng ng

- i vi nhm sn phm quy nh ti im 3.1.2, Phn I ca Quy

g/100 kcal 60 180
chun ny v cc nhm sn phm khc quy nh ti Khon 3.1,
g/100 kJ 14 43 Phn I ca Quy chun ny nu c b sung vitamin A

Vitamin D i vi nhm sn phm quy nh ti im 3.1.2, Phn I ca Quy

chun ny v cc nhm sn phm khc quy nh ti Khon 3.1,
g/100 kcal 1 3 Phn I ca Quy chun ny nu c b sung vitamin D

g/100 kJ 0,25 0,75

Cc dng vitamin b sung vo sn phm dinh dng ch bin t ng cc dnh cho

tr t 6 n 36 thng tui 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).

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1.5. Cht khong

n v Ti thiu Ti a Ghi ch

Natri i vi 04 nhm sn phm phn loi trong Khon 3.1, Phn I ca

Quy chun ny.
mg/100 kcal - 100

mg/100 kJ - 24

Calci

mg/100 kcal 80 - i vi nhm sn phm quy nh ti im 3.1.2, Phn I ca Quy

chun ny
mg/100 kJ 20 -

mg/100 kcal 50 - Ch p dng i vi nhm sn phm quy nh ti im 3.1.4, Phn

I ca Quy chun ny khi dng km vi sa
mg/100 kJ 12 -

Cc dng cht khong b sung vo sn phm dinh dng ch bin t ng cc

dnh cho tr t 6 n 36 thng tui 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).

1.6. Cc thnh phn b sung khc

1.6.1. Ngoi cc thnh phn quy nh trong Khon 1.1, Phn II ca Quy chun
ny, c th s dng cc thnh phn khc thch hp cho tr t 6 n 36 thng tui.

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

1.6.3. Nu sn phm cha mt ong hoc xir t nha cy phong th qu trnh
ch bin cn phi bo m dit c cc bo t Clostridium botulinum.

1.7. Hng liu

n v Ti thiu Ti a Ghi ch

Chit xut hoa qu t nhin v chit xut vanilla

mg/100g - GMP

Ethyl vanillin v vanillin i vi sn phm pha ch theo

hng dn ca nh sn xut s
mg/100g - 7 dng trc tip

1.8. Yu cu i vi sn phm khi s dng

- Khi ch bin theo hng dn s dng ghi trn nhn, cc thc phm ch bin

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t ng cc phi ph hp cho vic n bng tha cho i tng tr thch hp (c

tui t 6 36 thng tui).
- Bnh m gin (rusk) v bnh quy (biscuit) c th c dng dng kh
khuyn khch tr nhai hoc c th c s dng di dng lng bng cch trn vi
nc hoc cht lng thch hp khc, c st tng t nh i vi ng cc dng
kh.
1.9. X l bng bc x ion v s dng cc cht bo hydro ho bn phn

- Khng c x l bng bc x ion i vi sn phm v cc nguyn liu

sn xut.

- Khng c s dng cht bo hydro ho bn phn cho cc sn phm ny.

2. Ph gia thc phm

Cc cht ph gia thc phm s dng trong sn phm dinh dng t ng cc

cho tr t 6 n 36 thng tui theo quy nh ca B Y t.

3. Cht nhim bn
3.1. D lng thuc bo v thc vt

Sn phm phi c ch bin theo 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.
3.2 Kim loi nng

Theo QCVN 8-2:2011/BYT Quy chun k thut quc gia i vi gii hn

nhim kim loi nng trong thc phm.

3.3. c t vi nm
Theo QCVN 8-1:2011/BYT Quy chun k thut quc gia i vi gii hn
nhim c t vi nm trong thc phm.
3.4. Melamin
Ch tiu Ti a Ghi ch

Melamin, mg/kg 2,5

3.5. Cht nhim bn khc

Khng c cha tn d hormon, khng sinh v cc cht nhim khc, c

bit khng c cha cc cht c dc tnh.
4. Vi sinh v t

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Theo QCVN 8-3:2012/BYT Quy chun k thut quc gia i vi gii hn

nhim vi sinh vt trong thc phm.
5. Ghi nhn

Vic ghi nhn cc sn phm sn phm dinh dng ch bin t ng cc cho tr

t 6 n 36 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,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 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.

III. QUY NH V QUN L

1. Cng b hp quy

1.1. Sn phm dinh dng ch bin t ng cc cho tr t 6 n 36 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.
2. Kim tra v cht lng

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QCVN 11-4:2012/BYT

Vic kim tra cht lng, v sinh an ton i vi sn phm dinh dng ch
bin t ng cc cho tr t 6 n 36 thng tui phi c thc hin theo cc quy
nh ca php lut.

IV. TRCH NHIM CA T CHC, C NHN

1. T chc, c nhn sn xut, nhp khu, kinh doanh sn phm dinh dng
ch bin t ng cc cho tr t 6 n 36 thng 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 dinh

dng ch bin t ng cc cho tr t 6 n 36 thng 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.

V. 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 .

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Ph lc
DANH MC PHNG PHP TH CC CH TIU I VI
SN PHM DINH DNG CH BIN T NG CC DNH CHO TR
T 6 N 36 THNG TUI

I. Protein
1. TCVN 8125:2009 (ISO 20483:2006) Ng cc v u Xc nh hm lng
nit v tnh hm lng protein th Phng php Kjeldahl.
2. ISO 16634-2:2009 Food products Determination of the total nitrogen content by
combustion according to the Dumas principle and calculation of the crude protein
content Part 2: Cereals, pulses and milled cereal products

3. AOAC 960.48. Protein Efficiency Ratio

II. Lipid

4. TCVN 6555:1999 (ISO 7302:1982) Ng cc v sn phm ng cc Xc nh

tng hm lng cht bo

5. AOAC 996.06 Fat (Total, Saturated, and Unsaturated) in Foods. Hydrolytic

Extraction Gas Chromatographic Method

6. ISO 23065:2009 Milk fat from enriched dairy products Determination of omega-3
and omega-6 fatty acid content by gas-liquid chromatography

7. AOAC 992.25 Linoleic Acid in Ready-To-Feed Milk-Based Infant Formula. Gas

Chromatographic Method

III. Carbohydrat
8. AOAC 986.25 Proximate Analysis of Milk-Based Infant Formula

IV. Vitamin
9. TCVN 5164:2008 (EN 14122:2003) Thc phm Xc nh vitamin B1 bng sc
k lng hiu nng cao (HPLC)
10. AOAC 942.23 Thiamine (Vitamin B1) in Human and Pet Foods. Fluorometric
Method
11. 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

12. EN 12823-2:2000 Foodstuffs Determination of vitamin A by high performance

liquid chromatography Part 2: Measurements of Beta-carotene

13. AOAC 974.29 Vitamin A in Mixed Feeds, Premixes, and Human and Pet Foods.
Colorimetric Method

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QCVN 11-4:2012/BYT

14. EN 12821:2009 Foodstuffs Determination of vitamin D by high performance liquid

chromatography Measurement of cholecalciferol (D3) or ergocalciferol (D2)
15. AOAC 936.14 Vitamin D in Milk, Vitamin Preparations, and Feed Concentrates

16. AOAC 995.05 Vitamin D in Infant Formulas and Enteral Products. Liquid
Chromatographic Method

V. Cht khong
17. EN 15505:2008 Foodstuffs Determination of trace elements Determination of
sodium and magnesium by flame atomic absorption spectrometry (AAS) after
microwave digestion

18. AOAC 985.35 Minerals in Infant Formula, Enteral Products, and Pet Foods.
Atomic Absorption Spectrophotometric Method

19. AOAC 976.25 Sodium in Foods for Special Dietary Use. Ion Selective Electrode
Method

Cht nhim bn
20. 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
21. 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

22. TCVN 7602:2007 Thc phm Xc nh hm lng ch bng phng php

quang ph hp th nguyn t (AOAC 972.25)
23. TCVN 7788:2007 hp thc phm Xc nh hm lng thic bng phng
php quang ph hp th nguyn t
24. TCVN 7596:2007 (ISO 16050:2003) Thc phm Xc nh aflatoxin B1, v hm
lng tng s aflatoxin B1, B2, G1 v G2 trong ng cc, cc loi ht v cc sn
phm ca chng Phng php sc k lng hiu nng cao
25. TCVN 7930:2008 (EN 12955:1999) Thc phm Xc nh aflatoxin B1 v tng aflatoxin
B1, B2, G1 v G2 trong ng cc, qu c v v sn phm ca chng Phng php sc
k lng hiu nng cao c dn sut sau ct v lm sch bng ct i lc min dch

26. EN 15851:2010 Foodstuffs - Determination of aflatoxin B1 in cereal based foods

for infants and young children - HPLC method with immunoaffinity column
cleanup and fluorescence detection
27. TCVN 7595-1:2007 (ISO 15141-1:1998) Thc phm Xc nh ocratoxin A
trong ng cc v sn phm ng cc Phn 1: Phng php sc k lng hiu
nng cao lm sch bng silicagel

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28. TCVN 7595-2:2007 (ISO 15141-2:1998) Thc phm Xc nh ocratoxin A

trong ng cc v sn phm ng cc Phn 2: Phng php sc k lng hiu
nng cao lm sch bng bicacbonat
29. EN 15835:2010 Foodstuffs Determination of ochratoxin A in cereal based foods
for infants and young children HPLC method with immunoaffinity column
cleanup and fluorescence detection
30. EN 15791:2009 Animal feeding stuffs Determination of Deoxynivalenol in
animal feed HPLC method with UV detection and immunoaffinity column clean-
up
31. EN 15850:2010 Foodstuffs - Determination of zearalenone in maize based baby
food, barley flour, maize flour, polenta, wheat flour and cereal based foods for
infants and young children - HPLC method with immunoaffinity column cleanup
and fluorescence detection
32. ISO 6870:2002 Animal feeding stuffs Qualitative determination of zearalenone
33. ISO 17372:2008 Animal feeding stuffs Determination of zearalenone by
immunoaffinity column chromatography and high performance liquid
chromatography
34. EN 15792:2009 Animal feeding stuffs Determination of zearalenone in animal
feed High performance liquid chromatographic method with fluorescence
detection and immunoaffinity column clean-up
35. TCVN 8162:2009 (EN 13585:2001) Thc phm Xc nh fumonisin B1 v B2
trong ng Phng php sc k lng hiu nng cao c lm sch bng chit pha
rn
36. EN 14352:2004 Foodstuffs Determination of fumonisin B1 and B2 in maize
based foods HPLC method with immunoaffinity column clean up
37. 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

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