QUY CHUN K THUT QUC GIA

QCVN 12-2:2011/BYT
V V SINH AN TON I VI BAO B, DNG C BNG CAO SU TIP XC
TRC TIP VI THC PHM

National technical regulation on safety and hygiene for ruber implements, container and packaging in direct
contact with foods

H NI - 2011
Li ni u
QCVN 12-2:2011/BYT do Ban son tho Quy chun k thut quc gia v bao b v cc vt liu tip xc trc
tip vi thc phm bin son, Cc An ton v sinh thc phm trnh duyt v c ban hnh theo Thng t s
34/2011/TT-BYT ngy 30 thng 8 nm 2011 ca B trng B Y t.

QUY CHUN K THUT QUC GIA

V V SINH AN TON I VI BAO B, DNG C BNG CAO SU TIP XC TRC TIP VI THC
PHM
National technical regulation on safety and hygiene for Ruber Implements, Container and Packaging in
direct contact with foods
I. QUY NH CHUNG
1. Phm vi iu chnh
Quy chun k thut quc gia (sau y gi tt l Quy chun) ny quy nh cc yu cu k thut v qun l v v
sinh an ton i vi bao b, dng c bng cao su tip xc trc tip vi thc phm (sau y gi tt l bao b,
dng c cao su).
2. i tng p dng
Quy chun ny p dng i vi:
2.1. T chc, c nhn nhp khu, sn xut, bun bn v s dng cc sn phm bao b, dng c cao su.
2.2. C quan qun l nh nc v cc t chc c nhn c lin quan khc.
3. Gii thch t ng
3.1 Dung dich ngm thi: l dung dch dng ngm mu th.
II. YU CU K THUT
1. Yu cu k thut i vi bao b, dng c cao su (khng dnh cho tr nh)
Cc bao b, dng c cao su phi t cc yu cu chung quy nh ti bng 1:
Bng 1. Yu cu chung i vi bao b, dng c cao su (khng dnh cho tr nh)

Th vt liu
Ch tiu kim
tra

Gii hn ti a

Cadmi

100g/g

Ch

100g/g

Th thi nhim
Ch tiu kim
tra

iu kin
ngm thi

Dung dch
ngm thi

Gii hn ti a

Phenol

5 g/ml
Nc

Formaldehyd
Km
2Mercaptoimidazolin (Cao su
cha Clor)

Kim loi nng

m tnh
600C trong 30
pht [5]

Acid acetic 4%

15 g/ml
1 g/ml

m tnh

Nc[3] , [6]
Acid acetic
4%[4]

Cn kh
600C trong 30
pht

60 g/ml

Ethanol 20% [1]

[2]

2. Yu cu k thut i vi bao b, dng c cao su (dnh cho tr nh)

Cc bao b, dng c cao su phi t cc yu cu chung quy nh ti bng 2:
Bng 2. Yu cu chung i vi bao b, dng c cao su (dnh cho tr nh)
Th vt liu
Ch tiu kim
tra
Cadmi

Gii hn ti a

Th thi nhim
Ch tiu kim
tra

10g/g

Dung dch
ngm thi

Gii hn ti a

Phenol
Formaldehyd

Ch

iu kin
ngm thi

10g/g

Km

5 g/ml
400C trong
24 gi

Nc

m tnh
1 g/ml

Kim loi nng

Acid acetic 4%

1 g/ml

Cn kh

Nc

40 g/ml

Ghi ch
[1]

p dng vi bao b, dng c cha ng cht bo, du n v thc phm cha cht bo.

[2]

p dng vi bao b, dng c cha ng ung c cn.

[3]

p dng vi bao b, dng c cha ng thc phm c pH ln hn 5.

[4]

p dng vi bao b, dng c cha ng thc phm c pH nh hn hoc bng 5.

[5]

p dng vi dng c s dng nhit ln hn 1000C iu kin ngm l 950C trong 30 pht.

[6]

Gii hn i vi cc dng c.

III. PHNG PHP TH V LY MU

Phng php th v ly mu c quy nh ti cc ph lc ban hnh km theo Quy chun ny nh sau:

1. Ph lc 1: Phng php th vt liu.

2. Ph lc 2: Phng php th thi nhim.
IV. YU CU QUN L
1. Cng b hp quy
1.1 Cc sn phm l bao b, dng c cao su nhp khu sn xut, bun bn v s dng 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 Quy nh v chng nhn hp
chun, chng nhn hp quy v cng b hp chun, cng b hp quy c ban hnh km theo Quyt nh
s 24/2007/Q BKHCN ngy 28 thng 09 nm 2007 ca B trng B Khoa hc v Cng ngh v cc
quy nh ca php lut.
2. Kim tra nh nc i vi bao b, dng c cao su
Vic kim tra nh nc i vi cc sn phm bao b, dng c cao su phi c thc hin theo qui nh ca
php lut.
V. TRCH NHIM CA T CHC, C NHN
1. T chc, c nhn nhp khu, sn xut, bun bn v s dng cc sn phm bao b, dng c cao su 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 Cc An ton v
sinh thc phm v bo m cht lng, v sinh an ton theo ng ni dung cng b.
2. T chc c nhn ch c php nhp khu, sn xut, bun bn v s dng cc sn phm bao b, dng c cao
su sau khi hon tt ng k bn cng b hp quy v bo m cht lng, v sinh an ton ph hp vi cc quy
nh ca php lut.
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.

PH LC 1
PHNG PHP TH VT LIU
1. Xc nh Ch v Cadmi
1.1 Chun b dung dch th:
Cn 1,0 g (chnh xc n mg) mu cho vo chn bay hi bng bch kim, thch anh hoc thy tinh chu nhit,
thm 2ml acid sulfuric, gia nhit t t cho n khi ht khi trng bay ra t acid sulfuric v phn ln mu b
than ha. Sau , cho chn vo nung trong l in ti 450C qu trnh than ha xy ra hon ton, c th lp
li qu trnh thm acid sulfuric v nung i vi cn trn chn, ngui. cn 5ml acid hydrocloric (1/2),

trn u, v cho bay hi trn b cch thy. Sau khi ngui, thm 20 ml acid nitric 0,1 mol/l,
ha tan, lc v loi b phn khng tan, thu phn dch lc lm dung dch th.
1.2 Chun b dung dch chun:
1.2.1 Cadmi

+ Dung dch chun Cadmi gc:

Cn 100 mg cadmi, ha tan trong 50 ml acid nitric 10%, c trn bp cch thy. Sau thm acid nitric 0,1 mol/l
ha tan v nh mc n 100 ml. Dung dch chun cadmi gc ny c nng 1 mg/ml.
+ Dung dch chun Cadmi lm vic (loi khng dnh cho tr nh)
Ly chnh xc 1 ml dung dch chun cadmi gc, thm acid nitric 0,1 mol/l

chun lm vic ny c nng 5 g/ml.

n 200 ml. Dung dch

+ Dung dch chun Cadmi lm vic (loi khng dnh cho tr nh)
Ly chnh xc 1 ml dung dch chun cadmi gc, thm acid nitric 0,1 mol/l n 200 ml. Tip tc ly 10 ml
dung dch trn, thm acid nitric 0,1 mol/l nh mc n 100 ml. Dung dch chun lm vic ny c nng
cadmi 0.5 g/ml.
1.2.2 Ch
+ Dung dch chun Ch gc:
Ha tan 159,8 mg ch (II) nitrat trong 10 ml acid nitric 10%, v thm nc ct nh mc n 100 ml. Dung
dch chun ch gc ny c nng 1 mg/ml.
+ Dung dch chun ch lm vic (loi khng dnh cho tr nh)
Ly chnh xc 1 ml dung dch chun ch gc, thm acid nitric 0,1 mol/l nh mc n 200 ml. Dung dch
chun lm vic ny c nng 5 g/ml.
+ Dung dch chun ch lm vic (loi khng khng dnh cho tr nh)
Ly chnh xc 1 ml dung dch chun ch gc, thm acid nitric 0,1 mol/l n 200 ml. Tip tc ly 10 ml dung
dch trn, thm acid nitric 0,1 mol/l nh mc n 100 ml. Dung dch chun lm vic ny c nng ch 0.5
g/ml.
1.3 Tin hnh
Dng quang ph hp th nguyn t hoc quang ph pht x plasma xc nh cadmi v ch trong dung dch
th.
2. Xc nh 2-mecaptoimidazolin
2.1 Chun b dung dch th
Ly 1,0 g mu cho vo ng giy lc hnh tr, v s dng h thng chit Soxhlet chit trong 8 gi vi khong
45ml methanol. C c dch chit n khong 1 ml v s dng 10 l lm dung dch th.
2.2 Chun b dung dch chun
Ly 200 mg mercaptoimidazolin-2 v ha tan trong methanol nh mc n 100 ml. Tip tc ly 1 ml dung
dch ny v thm methanol nh mc n 100 ml. Dung dch chun c nng 2-mercaptoimidazoline l 20
g/ml.
2.3 Chun b dung dch 2,6-dicloroquinon clorimid trong ethanol : Ha tan 100 mg 2,6-dichloroquinon clorimid
trong ethanol nh mc n 10 ml.
2.4 Tin hnh
- Tin hnh chy sc k lp mng i vi dung dch th v dung dch chun 2-mercaptoimidazolin, s dng
dung dch chun lm dung dch i chiu.

Dng hn hp ethyl acetat, benzen t l 5:1 ; hn hp ethyl acetat, methanol, dung dch amoniac v nc t l
30:2:1:1 lm dung mi khai trin. Bn mng s dng silica gel lm cht hp ph v c lm kh trong 1 gi
120oC.
Khi lp dung mi khai trin chy c khong 10cm th ngng trin khai v cho kh t nhin. Sau , phun
dung dch 2,6-dicloroquinon clorimid trong ethanol, sy kh 10 pht 120oC v quan st.

PH LC 2
PHNG PHP TH THI NHIM
1. Xc nh kim loi nng
1.1 Chun b dung dch th:
Ra sch mu bng nc ct, s dng dung dch ngm v iu kin theo hng dn phn quy nh k thut theo
t l 2ml /1cm2 mu (loi khng dnh cho tr nh) v t l 20ml/g (loi dnh cho tr nh)
1.2 Chun b dung dch chun ch:
+ Dung dch chun Ch gc:
Ha tan 159,8 mg ch (II) nitrat trong 10 ml acid nitric 10%, v thm nc ct nh mc n 100 ml. Dung
dch chun ch gc ny c nng 1 mg/ml.
+ Dung dch chun ch lm vic (loi khng dnh cho tr nh)
Ly chnh xc 1 ml dung dch chun ch gc, thm nc nh mc n 100 ml. Dung dch chun lm vic
ny c nng 10 g/ml.
+ Dung dch chun ch lm vic (loi dnh cho tr nh)
Ly chnh xc 1 ml dung dch chun ch gc, thm acid nitric 0,1 mol/l nh mc n 100 ml. Dung dch
chun lm vic ny c nng 0.5 g/ml.
1.3 Tin hnh
ng th: Cho 20ml dung dch th vo ng Nessler, thm nc ct n 50ml.
ng so snh: Tin hnh ng thi vi mu th, cho 2ml dung dch chun ch, thm 20ml dung dch acid acetic
4%, thm nc ct n 50ml.
Nh vo mi ng 2 git thuc th Natri sulfid, yn trong 5 pht, sau quan st c 2 ng trn nn trng.
Nu sau khi cho natri sulfid vo dung dch m xut hin mu trng c th phi cho thm dung dch amoniac
vo dung dch th a pH dung dch ln 7 hoc cao hn, sau thm dung dch kali xyanid ri tin hnh
phn ng trn dung dch ny.
2. Xc nh Phenol
2.1 Chun b dung dch th
Ra sch mu bng nc ct, ngm thi trong dung dch ngm theo t l 2ml/1cm2 mu (loi khng dnh cho
tr nh), v t l 20ml/g mu (loi dnh cho tr nh), s dng dung dch ngm v iu kin ngm theo hng
dn phn quy nh k thut
2.2 Chun b dung dch phenol chun

Dung dch chun phenol gc: Cn chnh xc 1,0 g phenol, ha tan trong 100 ml nc.
Dung dch chun trung gian: Ly chnh xc 1 ml dung dch chun gc vo bnh nh mc v thm nc ct n
100 ml.
Dung dch chun lm vic: Ly chnh xc 1 ml dung dch chun trung gian thm nc ct n 20 ml. Dung
dch chun lm vic c nng 5 g/ml.
2.3 Chun b dung dch m acid boric
Chun b 2 dung dch
+ Dung dch s 1: Ho tan 4,0 g NaOH trong nc, thm nc nh mc n 100 ml.
+ Dung dch s 2: Ha tan 6,2 g acid boric trong nc, thm nc nh mc n 100 ml.
Ly mi dung dch mt lng bng nhau ri lc u
2.4 Tin hnh:
Ly chnh xc 20 ml dung dch th, thm 3 ml dung dch m acid boric v trn u, sau thm 5 ml dung
dch antipyrin 4-amin v 2,5 ml dung dch kali fericyanid v nc n 100 ml. Trn u v yn trong 10
pht nhit phng.
Tin hnh tng t vi 20 ml dung dch chun lm vic thay cho 20 ml dung dch th.
o hp th quang ca 2 hn hp bc sng 510 nm. hp th quang ca dung dch th khng c vt
qu hp th quang ca dung dch chun lm vic.
3. Xc nh Formaldehyd
3.1 Chun b dung dch th
Ra sch mu bng nc ct, ngm thi trong dung dch ngm theo t l 2ml/1cm2 mu (loi khng dnh cho
tr nh), v t l 20ml/g mu (loi dnh cho tr nh), s dng dung dch ngm v iu kin ngm theo hng
dn phn quy nh k thut
3.2 Tin hnh
Cho vo ng o c chia vch 200 ml mt lng 10 ml dung dch mu vi 1 ml acid photphoric 20%, sau
thm 5-10 ml nc v tin hnh ko ct hi nc vi ng sinh hn ngp trong nc. Khi chng ct c khong
190 ml th ngng v thm nc nh mc 200 ml. Ly 5 ml dung dch ny cho vo ng nghim c ng
knh 15 mm v thm 5 ml thuc th acetylaceton. Khuy u v gia nhit trong cch thy si trong 10 pht.
Dung dch so snh: Mt ng nghim c ng knh 15 mm khc, cho vo 5 ml nc v 5 ml thuc th
acetylaceton. Khuy u v gia nhit trong cch thy si trong 10 pht. Quan st cc ng nghim trn nn trng,
mu th khng c thm mu hn mu so snh.
4. Xc nh km
4.1 Chun b dung dch th:
Ra sch mu bng nc ct, ngm thi trong dung dch ngm theo t l 2ml/1cm2 mu (loi khng dnh cho
tr nh), hoc t l 20ml/g mu (loi dnh cho tr nh), s dng dung dch ngm v iu kin ngm theo hng
dn phn quy nh k thut.
a) Ly 1 ml dung dch ny v thm acid acetic 4% nh mc n 15 ml (loi khng dnh cho tr nh)
b) Ly 20ml dung dch mu nh 5 git acid acetic (loi dnh cho tr nh)

4.2 Chun b dung dch chun

Cn 1,0 g km, ha tan trong acid hydrochloric nng 6 mol/l, cho bay hi v ha cn trn b cch thy.
Thm acid hydrochloric 1 mol/l vo cn nh mc n 1.000 ml. Dung dch chun gc c nng km 1mg/ml.
- Chun b dung dch chun lm vic:
Ly 1 ml dung dch km chun gc, thm nc v nh mc n 50 ml. Ly 1 ml dung dch ny v thm
nc nh mc n 20 ml. Nng km ca dung dch chun lm vic l 1 g/ml.
4.3 Tin hnh:
Phn tch km bng phng php quang ph hp th nguyn t hoc quang ph pht x plasma trong dung dch
ny, kt qu cn so snh vi chun tng ng.
5. Cn kh
5.1 Chun b dung dch th:
Ra sch cc mu bng nc ct, ngm thi trong dung dch ngm theo t l 2ml/1cm2 mu (loi khng dnh
cho tr nh), v t l 20ml/g mu (loi dnh cho tr nh), s dng dung dch ngm v iu kin ngm theo
hng dn phn quy nh k thut.
5.2 Tin hnh:
Ly 200-300 ml dung dch th cho bay hi trn b cch thy n khi bc hi ht dung dch v cn li cn cng.
Sy kh cn trong 2 gi 105 oC, ngui trong bnh ht m, cn chn v cn xc nh khi lng cn (s
chnh lch trng lng chn v cn vi trng lng b).
Tin hnh ng thi mu trng, trong thay th tch dung dch th bng th tch nc ct tng ng.
S dng cng thc sau tnh hm lng cn:
Cn kh (g/ml)
Trong :
a (mg) = s chnh lch khi lng gia chn c cn v b trong th nghim vi dung dch th.
b (mg) = s chnh lch khi lng gia chn c cn v b trong th nghim vi nc ct.