CNG HA X HI CH NGHA VIT NAM

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

H NI - 2012

Li ni u
QCVN s 8-3:2012/BYT do Ban son tho Quy chun k thut
quc gia v gii hn nhim ho 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.

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

QCVN 8-3:2012/BYT
(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 gia 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.
- 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.

QCVN 8-3:2012/BYT

II. QUY NH K THUT

1. Gii hn nhim vi sinh vt trong sa v sn phm sa

Sn phm

TT

1.1

1.2

1.3

1.3.1

Cc sn phm
sa dng lng

Ch tiu

Gii hn cho
K hoch
php
ly mu (CFU/ml hoc Phn loi
ch tiu
CFU/g)
n

Enterobacteriaceae

<1

L. monocytogens(1)

102

Enterobacteriaceae

101

Staphylococci dng
tnh vi coagulase

Ni c t ca
Staphylococcus
(Staphylococcal
enterotoxin)

KPH (2)

L. monocytogens(1)

102

Salmonella

KPH (2)

Staphylococci dng
tnh vi coagulase

Ni c t ca
Staphylococcus
(Staphylococcal
enterotoxin)

KPH (2)

L. monocytogens(1)

102

Salmonella

KPH (2)

Cc sn phm
sa dng bt

101

102

Cc sn phm phomat

Phomat c sn
xut t sa ti
nguyn liu

Ghi ch: :

(1)

i vi sn phm dng ngay

(2)

trong 25g hoc 25ml

104

105

QCVN 8-3:2012/BYT

Sn phm

TT

1.3.2

1.3.3

1.3.4

1.3.5

Phomat c sn
xut t sa
qua x l nhit

Phomat
whey
(sn xut t whey
qua x l
nhit)

Phomat
ti
c sn xut t
sa hoc whey
(sa hoc whey
qua x l
nhit)

Cc sn phm
phomat khc

Ghi ch: :

Ch tiu

Gii hn cho
K hoch
php
ly mu (CFU/ml hoc Phn loi
CFU/g)
ch tiu
n

E. coli

102

103

Staphylococci dng
tnh vi coagulase

102

103

Ni c t ca
Staphylococcus
(Staphylococcal
enterotoxin)

KPH (2)

L. monocytogens(1)

102

Salmonella

KPH (2)

E. coli

102

103

Staphylococci dng
tnh vi coagulase

102

103

Ni c t ca
Staphylococcus
(Staphylococcal
enterotoxin)

KPH (2)

L. monocytogens(1)

102

Staphylococci dng
tnh vi coagulase

Ni c t ca
Staphylococcus
(Staphylococcal
enterotoxin)

KPH (2)

L. monocytogens(1)

102

L. monocytogens(1)

102

(1)

i vi sn phm dng ngay

(2)

trong 25g hoc 25ml

101

102

QCVN 8-3:2012/BYT

Sn phm

TT

1.4

1.4.1

1.4.2

1.5

1.5.1

1.5.2

Ch tiu

Gii hn cho
K hoch
php
ly mu (CFU/ml hoc Phn loi
CFU/g)
ch tiu
n

E. coli

101

102

L. monocytogens(1)

102

Salmonella

KPH (2)

L. monocytogens(1)

102

Enterobacteriaceae

L. monocytogens(1)

102

L. monocytogens(1)

102

Cc sn phm cht bo t sa

Cream v b

Cht bo sa,
du b, cht bo
sa

tch
nc, du b
tch nc v cht
bo t sa dng
pht

Cc sn phm sa ln men
Cc sn phm
sa ln men
qua x l nhit
Cc sn phm
sa
ln
men
khng qua x l
nhit

<1

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

Sn phm

TT

2.1

Cc sn phm
trng

Ghi ch:

: (1)
(2)

Ch tiu

Gii hn cho
K hoch
php
ly mu (CFU/ml hoc Phn loi
CFU/g)
ch tiu
n

Enterobacteriaceae

101

102

Salmonella

KPH (2)

B
A

i vi sn phm dng ngay

trong 25g hoc 25ml
7

QCVN 8-3:2012/BYT
3. Gii hn nhim vi sinh vt trong tht v sn phm tht

Sn phm

TT

3.1

3.2

3.3

Ch tiu

Tht v sn phm
ch bin t tht
s dng trc tip
khng cn x l
nhit

Tht v sn phm
ch bin t tht
phi qua x l
nhit trc khi s
dng
Gelatine v
collagen

K hoch
ly mu

Gii hn cho
php (CFU/g)

Phn loi
ch tiu

TSVSVHK

5x105

5x106

E. coli

5x101

5x102

Salmonella

TSVSVHK

5x105

5x106

E. coli

5x102

5x103

Salmonella

KPH (2)

Salmonella

KPH (2)

KPH (2)

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

TT

4.1

4.2

Ch tiu

Sn phm

Ghi ch: :
(3)

(2)

Gii hn cho
php (CFU/g)

Phn loi
ch tiu

E. coli

230(3)

700(3)

Salmonella

E. coli

101

Staphylococci dng
tnh vi coagulase

102

103

Salmonella

Nhuyn th hai
mnh v, ng vt
chn bung, ng
vt da gai, hi tiu
(tunicates) cn
sng

Gip xc v ng
vt thn mm co
v hoc b v
gia nhit

K hoch
ly mu

KPH (2)

KPH (2)

trong 25g hoc 25ml

MPN/100g c tht v ni dch

8

QCVN 8-3:2012/BYT

5. Gii hn nhim vi sinh vt trong sn phm dinh dng cng thc dnh cho tr
t 0 n 36 thng tui

Sn phm

TT

5.1

5.2

5.3

5.4

Ch tiu

Sn phm dinh
dng cng thc
dng bt cho tr
n 12 thng tui

Sn phm dinh
dng cng thc
vi cc mc ch y
t c bit cho tr
n 12 thng tui

Sn phm dinh
dng cng thc
vi mc ch n
dm cho tr t 6
n 36 thng tui

K hoch
ly mu

Gii hn cho
php (CFU/g)

Salmonella

30

KPH (2)

Enterobacter
sakazakii

30

KPH (4)

Enterobacteriaceae

10

KPH (4)

Bacillus cereus gi nh

Salmonella

30

KPH (2)

Enterobacter
sakazakii

30

KPH (4)

Enterobacteriaceae

10

KPH (4)

Bacillus cereus gi nh

Enterobacteriaceae

KPH (4)

Salmonella

30

KPH (2)

Coliform

Salmonella

10

Thc phm ch
bin t ng cc
cho tr t 6 n
36 thng tui

Phn loi
ch tiu

5x101

5x101

<3

5x102

5x102

20

KPH (2)

A
A

Ghi ch: : (2) trong 25g hoc 25ml

(4)

trong 10g hoc 10ml

(5)

Ch quy nh i vi sn phm dnh cho tr n 12 thng tui

QCVN 8-3:2012/BYT

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

Sn phm

TT

6.1

6.2

6.3

Ch tiu

Rau mm (n ngay
khng qua x l
nhit)

K hoch
ly mu
n

Salmonella

E. coli

Salmonella

E. coli

Salmonella

Gii hn cho
php (CFU/g)
m

KPH (2)

102

Phn loi
ch tiu

103

Rau n sng
KPH (2)
102

103

A
B

Qu n ngay
KPH (2)

7. Gii hn nhim vi sinh vt trong kem

TT

Ch tiu

Sn phm

Gii hn cho
K hoch
Phn loi
php (CFU/ml
ly mu
ch tiu
hoc CFU/g)
n

101

102

Kem

Enterobacteriaceae

(i vi cc loi
kem c cha sa)

Salmonella

7.1

Ghi ch: :

(2)

KPH (2)

B
A

trong 25g hoc 25ml

10

QCVN 8-3:2012/BYT

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

TT

Ch tiu

Lng mu (ml)

Yu cu

Phn loi
ch tiu

8.1.1

E. coli hoc coliform

chu nhit

1x 250

KPH

8.1.2

Coliform tng s

1x 250

8.1.3

Streptococci fecal

1x 250

Nu s vi khun (bo t)
1 v 2 th tin hnh kim
tra ln th2.

8.1.4

Pseudomonas
aeruginosa

1x 250

Nu s vi khun (bo t)
>2 th loi b

8.1.5

Bo t vi khun k
kh kh sulfit

8.2

1x50

Kim tra ln th hai

K hoch ly mu

TT

Ch tiu

Gii hn cho php

(CFU/ml)

Phn loi
ch tiu

8.2.1

Coliform tng s

8.2.2

Streptococci fecal

8.2.3

Pseudomonas
aeruginosa

8.2.4

Bo t vi khun k
kh kh sulfit

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QCVN 8-3:2012/BYT

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 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 p h p t h k h c t n g n g ) :
- 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 5bromo-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-3indolyl -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 glucuronidaza, Phn 3: K thut m s c xc sut ln nht s dng 5-bromo-4clo-3-indolyl- -d-glucuronid.

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QCVN 8-3:2012/BYT
- 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

13

QCVN 8-3:2012/BYT
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.
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.

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