CNG BO/S 327 + 328/Ngy 16-04-2012 33

B Y T

B Y T CNG HA X HI CH NGHA VIT NAM

c lp - T do - Hnh phc

S: 05/2012/TT-BYT H Ni, ngy 01 thng 3 nm 2012

THNG T
Ban hnh Quy chun k thut quc gia
i vi nhim vi sinh vt trong thc phm

Cn c Lut An ton thc phm ngy 17 thng 6 nm 2010;

Cn c Lut Tiu chun v Quy chun k thut ngy 29 thng 6 nm 2006 v
Ngh nh s 127/2007/N-CP ngy 01 thng 8 nm 2007 ca Chnh ph quy nh
chi tit thi hnh mt s iu ca Lut Tiu chun v Quy chun k thut;
Cn c Ngh nh s 188/2007/N-CP ngy 27 thng 12 nm 2007 ca Chnh
ph quy nh chc nng, nhim v, quyn hn v c cu t chc ca B Y t;
Theo ngh ca Cc trng Cc An ton v sinh thc phm, V trng V
Khoa hc v o to, V trng V Php ch,

QUY NH:

iu 1. Ban hnh km theo Thng t ny:

QCVN 8-3: 2012/BYT - Quy chun k thut quc gia i vi nhim vi sinh
vt trong thc phm.
iu 2. Thng t ny c hiu lc t ngy 01 thng 9 nm 2012.
iu 3. Cc trng Cc An ton v sinh thc phm, Th trng cc n v
thuc B Y t, cc n v trc thuc B Y t; Gim c S Y t cc tnh, thnh
ph trc thuc Trung ng v cc t chc, c nhn c lin quan chu trch nhim
thi hnh Thng t ny./.

KT. B TRNG
TH TRNG

Nguyn Thanh Long

34 CNG BO/S 327 + 328/Ngy 16-04-2012

QCVN 8-3: 2012/BYT

QUY CHUN K THUT QUC GIA

I VI NHIM VI SINH VT TRONG THC PHM

National technical regulation

of Microbiological contaminants in food

Li ni u
QCVN s 8-3:2012/BYT do Ban son tho Quy chun k thut quc gia v
gii hn nhim ha hc v sinh hc bin son, Cc An ton v sinh thc phm
trnh duyt v c ban hnh theo Thng t s 05/2012/TT-BYT ngy 01 thng 3
nm 2012 ca B trng B Y t
 CNG BO/S 327 + 328/Ngy 16-04-2012 35

QUY CHUN K THUT QUC GIA

I VI NHIM VI SINH VT TRONG THC PHM
National technical regulation
of Microbiological contaminants in food

I. QUY NH CHUNG
1. Phm vi iu chnh
Quy chun ny quy nh mc gii hn v nhim vi sinh vt trong thc phm
i vi cc sn phm hoc nhm sn phm: sa v sn phm sa; trng v sn
phm trng; tht v sn phm tht; thy sn v sn phm thy sn; sn phm dinh
dng cng thc dnh cho tr t 0 n 36 thng tui; nc khong thin nhin
ng chai, nc ung ng chai v nc dng lin; kem; rau, qu v sn phm
rau, qu (sau y gi tt l thc phm) v cc yu cu qun l c lin quan.
2. i tng p dng
Quy chun ny p dng i vi:
2.1. Cc t chc, c nhn xut nhp khu, sn xut, kinh doanh cc thc phm
quy nh ti khon 1.
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. Gii hn nhim vi sinh vt trong thc phm l mc gii hn ti a vi
sinh vt c php c trong thc phm.
3.2. Phn loi ch tiu
Ch tiu loi A: l ch tiu bt buc phi kim nghim khi tin hnh nh gi
hp quy.
Ch tiu loi B: l ch tiu khng bt buc phi kim nghim khi tin hnh
nh gi hp quy nu nh sn xut thc hin kim sot mi nguy trong qu trnh
sn xut (theo HACCP hoc GMP). Trong trng hp nh sn xut khng p dng
kim sot mi nguy trong qu trnh sn xut th bt buc phi kim nghim cc ch
tiu ny.
3.3. K hiu vit tt
- n: s mu cn ly t l hng kim nghim.
- c: s mu ti a cho php c kt qu kim nghim nm gia m v M. Trong n
mu kim nghim c php c ti a c mu cho kt qu kim nghim nm ga m
v M.
- m: gii hn di, nu trong n mu kim nghim tt c cc kt qu khng
vt qu gi tr m l t.
36 CNG BO/S 327 + 328/Ngy 16-04-2012

- M: gii hn trn, nu trong n mu kim nghim ch 01 mu cho kt qu vt

qu gi tr M l khng t.
- TSVSVHK: Tng s vi sinh vt hiu kh.
- KPH: Khng pht hin.
II. QUY NH K THUT
1. Gii hn nhim vi sinh vt trong sa v sn phm sa

Gii hn
K
cho php
hoch Phn
(CFU/ml
TT Sn phm Ch tiu ly loi ch
hoc
mu tiu
CFU/g)
n c m M
Cc sn phm Enterobacteriaceae 5 2 <1 5 A
1.1
sa dng lng L. monocytogens (1)
5 0 102
A
Enterobacteriaceae 5 0 101 A
Staphylococci dng
5 2 101 102 A
tnh vi coagulase
Ni c t ca
Cc sn phm
1.2 Staphylococcus
sa dng bt 5 0 KPH (2) B
(Staphylococcal
enterotoxin)
L. monocytogens(1) 5 0 102 A
Salmonella 5 0 KPH (2) A
1.3 Cc sn phm phomat
Staphylococci dng
5 2 104 105 A
tnh vi coagulase
Phomat c Ni c t ca
sn xut t Staphylococcus
1.3.1 5 0 KPH (2) B
sa ti (Staphylococcal
nguyn liu enterotoxin)
L. monocytogens(1) 5 0 102 A
Salmonella 5 0 KPH (2) A
(1)
Ghi ch: i vi sn phm dng ngay
(2)
trong 25g hoc 25ml
 CNG BO/S 327 + 328/Ngy 16-04-2012 37

Gii hn
K
cho php
hoch Phn
(CFU/ml
TT Sn phm Ch tiu ly loi ch
hoc
mu tiu
CFU/g)
n c m M
2
E. coli 5 2 10 103 A
Staphylococci
dng tnh vi 5 2 102 103 A
Phomat c coagulase
sn xut t sa Ni c t ca
1.3.2
qua x l Staphylococcus
5 0 KPH (2) B
nhit (Staphylococcal
enterotoxin)
L. monocytogens(1) 5 0 102 A
Salmonella 5 0 KPH (2) A
E. coli 5 2 102 103 A
Staphylococci
dng tnh vi 5 2 102 103 A
Phomat whey coagulase
(sn xut t
1.3.3 Ni c t ca
whey qua x
l nhit) Staphylococcus
5 0 KPH (2) B
(Staphylococcal
enterotoxin)
L. monocytogens(1) 5 0 102 A
Staphylococci
Phomat ti dng tnh vi 5 2 101 102 A
c sn xut coagulase
t sa hoc Ni c t ca
1.3.4
whey (sa hoc Staphylococcus
5 0 KPH (2) B
whey qua x (Staphylococcal
l nhit) enterotoxin)
L. monocytogens(1) 5 0 102 A
Cc sn phm
1.3.5 L. monocytogens(1) 5 0 102 A
phomat khc
(1)
Ghi ch: i vi sn phm dng ngay
(2)
trong 25g hoc 25ml
38 CNG BO/S 327 + 328/Ngy 16-04-2012

Gii hn
K
cho php
hoch Phn
(CFU/ml
TT Sn phm Ch tiu ly loi ch
hoc
mu tiu
CFU/g)
n c m M
1.4 Cc sn phm cht bo t sa
E. coli 5 2 101 102 A
1.4.1 Cream v b L. monocytogens(1) 5 0 102 A
Salmonella 5 0 KPH (2) A
Cht bo sa,
du b, cht
bo sa tch
1.4.2 nc, du b L. monocytogens(1) 5 0 102 A
tch nc v
cht bo t sa
dng pht
1.5 Cc sn phm sa ln men
Cc sn phm Enterobacteriaceae 5 2 <1 5 A
sa ln men (1)
1.5.1
qua x l nhit L. monocytogens 5 0 102 A
Cc sn phm
sa ln men
1.5.2 L. monocytogens(1) 5 0 102 A
khng qua x
l nhit

2. Gii hn nhim vi sinh vt trong trng v sn phm trng

K Gii hn cho
hoch php Phn
ly loi
TT Sn phm Ch tiu (CFU/ml
mu ch
hoc CFU/g)
tiu
n c m M
Cc sn phm Enterobacteriaceae 5 2 101 102 B
2.1
trng Salmonella 5 0 KPH (2) A
(1)
Ghi ch: i vi sn phm dng ngay
(2)
trong 25g hoc 25ml
 CNG BO/S 327 + 328/Ngy 16-04-2012 39

3. Gii hn nhim vi sinh vt trong tht v sn phm tht

K hoch Gii hn cho Phn
Sn phm Ch tiu ly mu php (CFU/g) loi ch
TT
n c m M tiu
Tht v sn TSVSVHK 5 2 5x105 5x106 B
phm ch bin E. coli 5 2 5x101 5x102 B
t tht s dng
3.1
trc tip khng Salmonella 5 0 KPH (2) A
cn x l nhit
Tht v sn TSVSVHK 5 2 5x105 5x106 B
phm ch bin E. coli 5 2 5x102 5x103 B
t tht phi qua
3.2 x l nhit
trc khi s Salmonella 5 0 KPH (2) A
dng
Gelatine v
3.3 Salmonella 5 0 KPH (2) A
collagen

4. Gii hn nhim vi sinh vt trong thy sn v sn phm thy sn

K Gii hn Phn
Ch tiu hoch cho php loi ch
TT Sn phm ly mu (CFU/g) tiu
n c m M
Nhuyn th hai E. coli 1 0 230(3) 700(3) B
mnh v, ng vt
chn bng, ng
4.1
vt da gai, hi tiu
Salmonella 5 0 KPH (2) A
(tunicates) cn
sng
E. coli 5 2 1 101 B
Gip xc v ng
Staphylococci
vt thn mm c
dng tnh vi 5 2 102 103 B
4.2 v hoc b v
coagulase
gia nhit
Salmonella 5 0 KPH (2) A

(2)
Ghi ch: trong 25g hoc 25ml
(3)
MPN/100g c tht v ni dch
40 CNG BO/S 327 + 328/Ngy 16-04-2012

5. Gii hn nhim vi sinh vt trong sn phm dinh dng cng thc

dnh cho tr t 0 n 36 thng tui

K
hoch Gii hn cho Phn
ly php (CFU/g) loi
TT Sn phm Ch tiu
mu ch
tiu
n c m M
Salmonella 30 0 KPH (2) A
Sn phm Enterobacter
dinh dng 30 0 KPH (4) A
sakazakii
5.1 cng thc sng
bt cho tr n Enterobacteriaceae 10 0 KPH (4) B
12 thng tui Bacillus cereus gi
5 1 5x101 5x102 B
nh
Sn phm Salmonella 30 0 KPH (2) A
dinh dng Enterobacter
cng thc vi 30 0 KPH (4) A
sakazakii
5.2 cc mc ch y
t c bit cho Enterobacteriaceae 10 0 KPH (4) B
tr n 12 Bacillus cereus gi
thng tui 5 1 5x101 5x102 B
nh
Sn phm Enterobacteriaceae 5 0 KPH (4) B
dinh dng
cng thc vi
5.3 mc ch n
dm cho tr t Salmonella 30 0 KPH (2) A
6 n 36 thng
tui
Thc phm Coliform 5 2 <3 20 A
ch bin t
5.4 ng cc cho
tr t 6 n 36 Salmonella 10 0 KPH (2) A
thng tui

(2)
Ghi ch: trong 25g hoc 25ml
(4)
trong 10g hoc 10ml
 CNG BO/S 327 + 328/Ngy 16-04-2012 41

6. Gii hn nhim vi sinh vt trong rau, qu v sn phm rau, qu

Gii hn
K hoch Phn
cho php
TT Sn phm Ch tiu ly mu loi ch
(CFU/g)
tiu
n c m M
Rau mm (n
6.1 ngay khng qua Salmonella 5 0 KPH (2) A
x l nhit)
E. coli 5 2 102 103 B
6.2 Rau n sng
Salmonella 5 0 KPH (2) A
E. coli 5 2 102 103 B
6.3 Qu n ngay
Salmonella 5 0 KPH (2) A
7. Gii hn nhim vi sinh vt trong kem
K Gii hn cho Phn
hoch php loi
Ch tiu
TT Sn phm ly (CFU/ml ch
mu hoc CFU/g) tiu
n c m M
1
Kem Enterobacteriaceae 5 2 10 102 B
7.1 (i vi cc loi
Salmonella 5 0 KPH (2) A
kem c cha sa)
(2)
Ghi ch: trong 25g hoc 25ml

8. Gii hn nhim vi sinh vt trong nc khong thin nhin ng chai,

nc ung ng chai v nc dng lin
8.1. Kim tra ln u
Lng Phn loi
TT Ch tiu Yu cu
mu (ml) ch tiu
E. coli hoc coliform
8.1.1 1 x 250 KPH A
chu nhit
8.1.2 Coliform tng s 1 x 250 A
8.1.3 Streptococci fecal 1 x 250 Nu s vi khun (bo A
t) 1 v 2 th tin
Pseudomonas hnh kim tra ln th 2
8.1.4 1 x 250 A
aeruginosa Nu s vi khun (bo
Bo t vi khun k t) > 2 th loi b
8.1.5 1 x 50 A
kh kh sulfit
42 CNG BO/S 327 + 328/Ngy 16-04-2012

8.2. Kim tra ln th hai

Gii hn cho php Phn
K hoch ly mu
TT Ch tiu (CFU/ml) loi
n c m M ch tiu
8.2.1 Coliform tng s 4 1 0 2 A
Streptococci
8.2.2 4 1 0 2 A
fecal
Pseudomonas
8.2.3 4 1 0 2 A
aeruginosa
Bo t vi khun
8.2.4 4 1 0 2 A
k kh kh sulfit

III. PHNG PHP LY MU V PHNG PHP TH

1. Ly mu
Ly mu theo hng dn ti Thng t s 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.
2. Phng php th
Yu cu k thut quy nh trong Quy chun ny c th theo cc phng
php di y (cc phng php ny khng bt buc p dng, c th s dng
phng php th khc tng ng):
- TCVN 4884: 2005 (ISO 4833:2003) Vi sinh vt trong thc phm v thc n
chn nui - Phng php nh lng vi sinh vt trn a thch - K thut m
khun lc 300C.
- TCVN 4829: (ISO 6579: 2002) Vi sinh vt trong thc phm v thc n chn
nui - Phng php pht hin Salmonella trn a thch.
- TCVN 7924-1: 2008 (ISO 16649 -1: 2001) Vi sinh vt trong thc phm v
thc n chn nui - Phng php nh lng Escherichia coli dng tnh -
glucuronidaza, Phn 1: K thut m khun lc 44oC s dng mng lc v 5-
bromo-4-clo-3-indolyl -D-glucuronid.
- TCVN 7924-2: 2008 (ISO 16649 -2: 2001) Vi sinh vt trong thc phm v
thc n chn nui - Phng php nh lng Escherichia coli dng tnh -
glucuronidaza, Phn 2: K thut m khun lc 44oC s dng 5-bromo-4-clo-3-
indolyl -D-glucuronid.
- TCVN 7924-3: 2008 (ISO 16649 -3: 2001) Vi sinh vt trong thc phm v
thc n chn nui - Phng php nh lng Escherichia coli dng tnh
 CNG BO/S 327 + 328/Ngy 16-04-2012 43

-glucuronidaza, Phn 3: K thut m s c xc sut ln nht s dng 5-bromo-

4-clo-3-indolyl- -d-glucuronid.
- TCVN 7700-2: 2007 (ISO 11290-2:1998, 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 2: Phng php nh lng.
- TCVN 4830-1:2005 (ISO 6888-1:1999, with Amd, 1:2003) Vi sinh vt trong
thc phm v thc n chn nui - Phng php nh lng Staphylococci c phn
ng dng tnh vi coagulase (Staphylococcus aureus v cc loi khc) trn a
thch, Phn 1: K thut s dng mi trng Baird-Parker.
- TCVN 4830-2:2005 (ISO 6888-2:1999, with Amd, 1:2003) Vi sinh vt trong
thc phm v thc n chn nui - Phng php nh lng Staphylococci c phn
ng dng tnh vi coagulase (Staphylococcus aureus v cc loi khc) trn a
thch, Phn 2: K thut s dng mi trng thch fibrinogen huyt tng th.
- TCVN 4830-3:2005 (ISO 6888-3: 2003) Vi sinh vt trong thc phm v thc
n chn nui - Phng php nh lng Staphylococci c phn ng dng tnh vi
coagulase (Staphylococcus aureus v cc loi khc) trn a thch, Phn 3: Pht
hin v dng k thut m s c xc xut ln nht (MPN) m s lng nh.
- TCVN 6191-2:1996 (ISO 6461-2:1986) Cht lng nc - Pht hin v m
s bo t vi khun k kh kh sulfit (Clostridia), Phn 2: Phng php mng lc.
- TCVN 4882:2007 (ISO 4831: 2006) Vi sinh vt trong thc phm v thc
n chn nui - Phng php nh lng coliforms - K thut m s c xc
sut ln nht.
- TCVN 6848:2007 (ISO 4832: 2006) Vi sinh vt trong thc phm v thc n
chn nui - Phng php nh lng coliforms - K thut m khun lc.
- 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.
- TCVN 7850-2008 (ISO/TS 22964:2006) Vi sinh vt trong thc phm v thc
n chn nui - Phng php pht hin v nh lng Enterobacter sakazakii.
- ISO 16266:2006 Water quality - Detection and enumeration of Pseudomonas
aeruginosa - Method by membrane filtration (Cht lng nc - Pht hin v nh
lng Pseudomonas aeruginosa - Phng php lc mng).
- ISO 7899-2:2000 Water quality - Detection and enumeration of intestinal
enterococci, Part 2: Membrane filtration method (Cht lng nc - Pht hin v
m khun lin cu khun ng rut, Phn 2: Phng php lc mng).
IV. QUY NH V QUN L
Cc thc phm quy nh ti Mc II phi c kim tra cht lng, an ton
m bo nhim vi sinh vt khng vt qu gii hn quy nh ti Quy chun ny.
44 CNG BO/S 327 + 328/Ngy 16-04-2012

i vi cc thc phm c quy nh trong Quy nh gii hn ti a

nhim sinh hc v ha hc trong thc phm ban hnh km theo Quyt nh s
46/2007/Q-BYT ngy 19/12/2007 ca B Y t nhng cha c quy nh trong
Quy chun k thut ny s tip tc p dng theo Quyt nh s 46/2007/Q-BYT.
V. TRCH NHIM CA T CHC, C NHN
T chc, c nhn ch c php sn xut, kinh doanh v xut khu, nhp khu
cc thc phm ph hp vi gii hn nhim vi sinh vt c quy nh ti Quy
chun k thut ny.
VI. 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. Trong 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 mi./.