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Coeus - VN - e2.DINH DƯ NG CÔNG TH C ĂN B SUNG 6 36
Coeus - VN - e2.DINH DƯ NG CÔNG TH C ĂN B SUNG 6 36
Coeus - VN - e2.DINH DƯ NG CÔNG TH C ĂN B SUNG 6 36
QCVN 11-3:2012/BYT
H NI 2012
Li ni u
QCVN 11-3:2012/BYT do Ban son tho quy chun k thut quc gia
v Thc n cho tre s sinh v tr nh
QCVN 11-3:2012/BYT
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 cng thc vi mc ch n b sung 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 sn xut, nhp khu, kinh doanh sn phm dinh dng
cng thc vi mc ch n b sung 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 cng thc vi mc ch n b sung cho tr t 6 n 36
thng tui (sau y gi tt l sn phm): Sn phm dng bt hoc dng lng, c ch
bin t:
- Sa b hoc sa ng vt khc v (hoc);
- Cc thnh phn c ngun gc ng vt, thc vt.
Sn phm phi p ng nhu cu v dinh dng cho s pht trin bnh thng ca tr
giai on t 6 n 36 thng tui. Sn phm dng lng c th s dng trc tip hoc pha long
vi nuc trc khi s dng; sn phm dng bt phi pha vi nc trc khi s dng.
- GMP (Good Manufacturing Practice): Thc hnh sn xut tt.
- CODEX: y ban Tiu chun ha thc phm quc t.
- IU (International Unit): n v quc t.
- RE (Retinol Equivalent): Retinol tng ng.
QCVN 11-3:2012/BYT
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 bo m cht lng,
an ton v sinh thc phm; ng thi thch hp cho tiu ha ca tr t 6 n 36 thng tui.
1.1.2. Sn phm c ch bin t:
- Sa b hoc sa ng vt khc v (hoc);
- Ch phm protein ng vt v (hoc) thc vt ( c chng minh ph hp vi tr
t 6 n 36 thng tui);
- Nguyn liu khc cn thit t c yu cu i vi sn phm quy nh ti Khon
1.2 v 1.3, Phn II ca Quy chun ny.
1.1.3. Sn phm c thnh phn c bn l sa c sn xut t nguyn liu c
quy nh ti im 1.1.2, Phn II ca Quy chun ny v phi m bo trong 100 kcal sn
phm (pha ch theo hng dn ca nh sn xut s dng trc tip) cha t nht 3 g
protein (hay 0,7 g/100 kJ) c ngun gc t sa tch bo, sa nguyn kem v chim ti
thiu 90% tng lng protein trong sn phm; c th iu chnh hm lng protein nhng
khng c lm gim hm lng vitamin v cht khong trong sa.
1.2. Nng lng
Sn phm (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
85
kJ/100 ml
250
355
Ti a
g/100 kcal
3,0
5,5
g/100 kJ
0,7
1,3
n v
Ghi ch
(1)
QCVN 11-3:2012/BYT
C th b sung acid amin thit yu ci thin gi tr dinh dng ca sn phm.
Trong trung hp ny, ch c b sung acid amin thit yu dng ng phn L vi hm
lng va nhm ci thin cht lng protein.
1.3.2. Hm lng lipid
n v
Ti thiu
Ti a
g/100 kcal
3,0
6,0
g/100 kJ
0,7
1,4
mg/100 kcal
300
mg/100 kJ
71,7
Cht bo tng s
Ti thiu
Ti a
IU/100 kcal
250
750
g RE /100 kcal
75
225
IU/100 kJ
60
180
g RE/100 kJ
18
54
IU/100 kcal
40
120
g/100 kcal
IU/100 kJ
10
30
g/100 kJ
0,25
0,75
Ghi ch
Vitamin A
Vitamin D
QCVN 11-3:2012/BYT
IU/100 kcal
0,7(2)
IU/100 kJ
0,15(2)
mg/100 kcal
8,0
mg/100 kJ
1,9
g/100 kcal
40
g/100 kJ
10
g/100 kcal
60
g/100 kJ
14
g/100 kcal
250
g/100 kJ
60
g/100 kcal
45(3)
g/100 kJ
11(3)
g/100 kcal
g/100 kJ
g/100 kcal
300
g/100 kJ
70
g/100 kcal
0,15
g/100 kJ
0,04
Vitamin B1 (thiamin)
Vitamin B2 (riboflavin)
Nicotinamid
Vitamin B6
Acid folic
Acid pantothenic
Vitamin B12
(3)
QCVN 11-3:2012/BYT
Vitamin K1
g/100 kcal
g/100 kJ
g/100 kcal
1,5
g/100 kJ
0,4
Vitamin H (Biotin)
Ti thiu
Ti a
mg/100 kcal
20
85
mg/100 kJ
21
mg/100 kcal
80
mg/100 kJ
20
mg/100 kcal
55
mg/100 kJ
14
mg/100 kcal
90
mg/100 kJ
22
mg/100 kcal
60
mg/100 kJ
14
1,0
2,0
Ghi ch
Natri
Kali
Clorid
Calci
Phospho
T l calci/phospho
QCVN 11-3:2012/BYT
n v
Ti thiu
Ti a
mg/100 kcal
6,0
mg/100 kJ
1,4
mg/100 kcal
1,0
2,0
mg/100 kJ
0,25
0,50
g/100 kcal
5,0
g/100 kJ
1,2
mg/100 kcal
0,5
mg/100 kJ
0,12
Ghi ch
Magnesi
St
Iod
Km
QCVN 11-3:2012/BYT
6. Cht nhim bn
6.1. 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.
6.2. Melamin
n v
mg/kg sn phm
Mc ti a
Ghi ch
2,5
QCVN 11-3:2012/BYT
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.
IV. QUY NH V QUN L
1. Cng b hp quy
1.1. Sn phm dinh dng cng thc vi mc ch n b sung 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
Vic kim tra cht lng, v sinh an ton i vi cc sn phm dinh dng cng
thc vi mc ch n b sung cho tr t 6 n 36 thng tui phi 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 n b sung cho tr t 6 n 36 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 dinh dng
cng thc vi mc ch n b sung cho tr t 6 n 36 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.
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.
QCVN 11-3:2012/BYT
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 .
QCVN 11-3:2012/BYT
Ph lc
DANH MC PHNG PHP TH CC CH TIU AN TON THC PHM I VI CC SN
PHM DINH DNG CNG THC VI MC CH N B SUNG CHO TR T 6 N 36
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
II. Lipid
3. 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.
4. 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)
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 omega3 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. EN 12823-1:2000 Foodstuffs Determination of vitamin A by high performance
liquid chromatography Part 1: Measurements of all-trans-retinol and 13-cisretinol
10. EN 12823-2:2000 Foodstuffs Determination of vitamin A by high performance
liquid chromatography Part 2: Measurements of Beta-carotene
11. AOAC 974.29 Vitamin A in Mixed Feeds, Premixes, and Human and Pet Foods.
Colorimetric Method
12. AOAC 941.15 Carotene in Fresh Plant Materials and Silages. Spectrophotometric
Method
10
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13. AOAC 992.06 Vitamin A (Retinol) in Milk-Based Infant Formula. Liquid
Chromatographic Method
14. AOAC 992.04 Vitamin A (Retinol Isomers) in Milk and Milk-Based Infant Formula.
Liquid Chromatographic Method
15. EN 12821:2009 Foodstuffs Determination of vitamin D by high performance
liquid chromatography Measurement of cholecalciferol (D3) or ergocalciferol
(D2)
16. AOAC 936.14 Vitamin D in Milk, Vitamin Preparations, and Feed Concentrates
17. AOAC 995.05 Vitamin D in Infant Formulas and Enteral Products. Liquid
Chromatographic Method
18. AOAC 992.26 Vitamin D3 (Cholecalciferol) in Ready-To-Feed Milk-Based Infant
Formula. Liquid Chromatographic Method
19. TCVN 8276:2010 (EN 12822:2000) Thc phm Xc nh vitamin E bng sc k
lng hiu nng cao nh lng v tocopherol
20. AOAC 971.30 -Tocopherol and
Colorimetric Method
11
QCVN 11-3:2012/BYT
in Vitamin Preparations. Microbiological Methods
31. AOAC 961.14 Niacin and Niacinamide in Drugs, Foods, and Feeds. Colorimetric
Method
32. EN 14164:2008 Foodstuffs Determination of vitamin B6 by HPLC
33. EN 14166:2009 Foodstuffs Determination of vitamin B6 by microbiological
assay
34. EN 14663:2005 Foodstuffs Determination of vitamin B6 (including its
glycosylated forms) by HPLC
35. AOAC 961.15 Vitamin B6 (Pyridoxine, Pyridoxal, Pyridoxamine) in Food Extracts.
Microbiological Method
36. AOAC 985.32 Vitamin B6 (Pyridoxine, Pyridoxal, Pyridoxamine) in Ready-toFeed Milk-Based Infant Formula. Microbiological Method
37. AOAC 986.23 Cobalamin (Vitamin B12 Activity) in Milk-Based Infant Formula.
Turbidimetric Method
38. AOAC 952.20 Cobalamin (Vitamin B12 Activity) in Vitamin Preparations.
Microbiological Methods
39. AOAC 992.07 Pantothenic Acid in Milk-Based Infant Formula. Microbiological
Turbidimetric Method
40. AOAC 945.74 Pantothenic Acid in Vitamin Preparations. Microbiological Methods
41. EN 14131:2003 Foodstuffs Determination of folate by microbiological assay
42. AOAC 992.05 Folic Acid (Pteroylglutamic Acid) in Infant Formula. Microbiological
Methods
43. AOAC 944.12 Folic Acid (Pteroylglutamic Acid) in Vitamin Preparations.
Microbiological Methods
44. EN 14130:2003 Foodstuffs Determination of vitamin C by HPLC
45. AOAC 985.33 Vitamin C (Reduced Ascorbic Acid) in Ready-to-Feed Milk-Based
Infant Formula. 2,6-Dichloroindophenol Titrimetric Method
46. AOAC 967.22 Vitamin C (Total) in Vitamin Preparations. Microfluorometric
Method
47. AOAC 984.26 Vitamin C (Total) in Food. Semiautomated Fluorometric Method
48. EN 15607:2009 Foodstuffs Determination of d-biotin by HPLC
V. Cht khong v cc nguyn t vi lng
49. TCVN 6269:2008 (ISO 8070:2007) Sa v sn phm sa Xc nh hm lng
12
QCVN 11-3:2012/BYT
canxi, natri, kali v magie Phng php o ph hp th nguyn t
50. 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)
51. TCVN 6838:2001 (ISO 12081:1998) Sa Xc nh hm lng canxi Phng
php chun
52. TCVN 6271:2007 (ISO 9874:2006) Sa Xc nh hm lng phospho tng s
Phng php o ph hp th phn t
53. 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
54. AOAC
986.24
Phosphorus
in
Infant
Formula
and
Enteral
Products.
Spectrophotometric Method
55. AOAC 976.25 Sodium in Foods for Special Dietary Use. Ion Selective Electrode
Method
56. AOAC 985.35 Minerals in Infant Formula, Enteral Products, and Pet Foods.
Atomic Absorption Spectrophotometric Method
57. AOAC 984.27 Calcium, Copper, Iron, Magnesium, Manganese, Phosphorus,
Potassium, Sodium, and Zinc in Infant Formula. Inductively Coupled Plasma
Emission Spectroscopic Method
58. AOAC 986.26 Chloride in Milk-Based Infant Formula. Potentiometric Method
59. EN 15111:2007 Foodstuffs Determination of trace elements Determination of
iodine by ICP-MS (inductively coupled plasma mass spectrometry)
60. AOAC 992.24 Iodide in Ready-To-Feed Milk-Based Infant Formula. Ion-Selective
Electrode Method
61. AOAC 986.15 Arsenic, Cadmium, Lead, Selenium, and Zinc in Human and Pet
Foods. Multielement Method
62. 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
VI. Cht nhim bn
63. TCVN 7602:2007 Thc phm Xc nh hm lng ch bng phng php
quang ph hp th nguyn t (AOAC 972.25)
64. 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
65. TCVN 7788:2007 hp thc phm Xc nh hm lng thic bng phng
php quang ph hp th nguyn t
13
QCVN 11-3:2012/BYT
66. TCVN 7730:2007 (ISO/TS 9941:2005) Sa v sa c c ng hp Xc nh
hm lng thic Phng php o ph
67. ISO 15495:2010 Milk, milk products and infant formulae Guidelines for the
quantitative determination of melamine and cyanuric acid by LC-MS/MS
68. 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
69. 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
70. 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
71. TCVN 4829:2005 (ISO 6579:2002, Cor 1:2004) Vi sinh vt trong thc phm v
thc n chn nui Phng php pht hin Salmonella trn a thch
14