CNG HO X HI CH NGHA VIT NAM

QCVN 4 - 19: 2011/BYT

QUY CHUN K THUT QUC GIA

V PH GIA THC PHM - ENZYM

National technical regulation on Food Additive Enzyme














H NI - 2011
QCVN 4 -19 : 2011/BYT
2









Li ni u
QCVN 4-19:2011/BYT do Ban son tho quy chun k thut
quc gia v Ph gia thc phm v cht h tr ch bin bin
son, Cc An ton v sinh thc phm trnh duyt v c ban
hnh theo Thng t s 01/2011/TT-BYT ngy 13 thng 01
nm 2011 ca B trng B Y t.



QCVN 4 -19 : 2011/BYT
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QUY CHUN K THUT QUC GIA
V PH GIA THC PHM - ENZYM
National technical regulation on Food Additive Enzyme


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 cht lng, v sinh an ton i vi cc enzym c s dng vi
mc ch lm ph gia thc phm.

2. i tng p dng
Quy chun ny p dng i vi:
2.1. T chc, c nhn nhp khu, xut khu, sn xut, bun bn v s dng cc
enzym lm ph gia thc phm (sau y gi tt l t chc, c nhn).
2.2. C quan qun l nh nc c lin quan.

3. Gii thch t ng v ch vit tt:
3.1. JECFA monograph 1 - Vol. 4 (JECFA monographs 1 - Combined
compendium of food additive specifications; Joint FAO/WHO expert committee on
food additives; Volume 4 - Analytical methods, test procedures and laboratory
solutions used by and referenced in the food additive specifications; FAO, 2006): Cc
yu cu k thut i vi ph gia thc phm, Tp 4 Cc phng php phn tch, quy
trnh th nghim, dung dch th nghim c s dng (hoc tham chiu) trong yu
cu k thut i vi ph gia thc phm; JECFA bin son; FAO ban hnh nm 2006.
3.2. M s C.A.S (Chemical Abstracts Service): M s ng k ha cht ca
Hip hi Ha cht Hoa K.
3.3. TS (test solution): Dung dch thuc th.
3.4. ADI (Acceptable daily intake): Lng n vo hng ngy chp nhn c.
3.5. INS (International numbering system): H thng m s quc t v ph gia
thc phm.

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II. YU CU K THUT, PHNG PHP TH V LY MU
1. Yu cu k thut v phng php th i vi cc enzym c quy nh ti
cc ph lc ban hnh km theo Quy chun ny nh sau:
1.1. Ph lc 1: Yu cu k thut v phng php th i vi -amylase
v glucoamylase
1.2. Ph lc 2: Yu cu k thut v phng php th i vi protease
1.3. Ph lc 3: Yu cu k thut v phng php th i vi papain
1.4. Ph lc 4: Yu cu k thut v phng php th i vi
bromelain
1.5. Ph lc 5: Yu cu k thut v phng php th i vi glucose
oxidase v catalase

2. Cc yu cu k thut quy nh trong Quy chun ny c th theo JECFA
monograph 1 - Vol. 4, ngoi tr mt s php th ring c m t trong cc ph lc.
Cc phng php th c hng dn trong Quy chun ny khng bt buc phi
p dng, c th s dng cc phng php th khc c gi tr tng ng.

3. Ly mu theo hng dn ti Thng t 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.

III. YU CU QUN L

1. Cng b hp quy
1.1. Cc enzym phi c cng b 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 ban hnh km theo Quyt nh s 24/2007/Q-BKHCN ngy 28 thng 9
nm 2007 ca B trng B Khoa hc v Cng ngh v cc quy nh ca php lut.

2. Kim tra i vi enzym
Vic kim tra cht lng, v sinh an ton i vi cc enzym phi thc hin theo
cc quy nh ca php lut.

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IV. TRCH NHIM CA T CHC, C NHN

1. T chc, c nhn 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 nhp khu, xut khu, sn xut, bun bn v s dng
cc enzym sau khi hon tt ng k bn cng b hp quy v bo m cht lng, v
sinh an ton, ghi nhn ph hp vi cc quy nh ca php lut.

V. 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. Trng hp hng dn ca quc t v phng php th v cc quy nh
ca php lut vin dn trong Quy chun ny c sa i, b sung hoc thay th th
p dng theo vn bn mi.
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Ph lc 1
YU CU K THUT V PHNG PHP TH
I VI -AMYLASE V GLUCOAMYLASE

1. Tn khc, ch s INS 1100
2. nh ngha c to ra bng cch ln men c kim sot cc chng
khng gy c v khng gy bnh ca Aspergillus oryzae
v c phn tch t mi trng sinh trng
Cc hot cht
alpha-Amilase (tn khc: diastase, ptyalin, glycogenase)
Glucan 1,4-alpha glucosidase (tn khc: amyloglucosidase,
acid maltase, lysosomal alpha-glucosidase, exo-1,4-alpha-
glucosidase)
Tn v m s h thng 1,4-alpha-D-Glucan glucanohydrolase
EC 3.2.1.1
Cc phn ng c xc
tc
alpha-Amylase thy phn cc lin kt 1,4-alpha-glucosidic
trong polysaccharid sinh ra dextrin, oligosaccharid v
glucose
Glucoamylase thy phn cc lin kt 1,4-alpha- v 1,6-
alpha-glucosidic trong polysaccharide to ra glucose
Hot tnh enzym th cp
Lipase (EC 3.1.1.3)
Tannase (EC 3.1.1.20)
Cellulase (EC 3.2.1.4)
Endo-1,3-beta-glucanase (EC 3.2.1.6)
Pectinase (EC 3.2.1.15)
Maltase (EC 3.2.1.20)
Lactase (EC 3.2.1.23)
Endo-1,4-beta-mannanase (EC 3.2.1.78)
Protease
3. Cm quan Dng bt v nh hnh mu vng nu hoc dng lng mu
vng nu n nu m c th phn tn trong dch pha
long (tinh khit dng cho thc phm) v c th cha cht
n nh v cht bo qun; tan trong nc, kh tan trong
ethanol v ether
4. Chc nng Ch phm enzym.
c s dng trong qu trnh thy phn ng cc v tinh
bt; trong qu trnh ch bin cc sn phm rau qu,
ung, ng, cc sn phm bnh ko v mt ong.
5. Yu cu k thut
Phi ph hp vi cc Yu cu k thut chung i vi cc
ch phm enzym s dng trong qu trnh ch bin thc
phm
5.1. nh tnh

Hot tnh alpha-amylase
Phi c phn ng th hin hot tnh alpha-amylase (t
nm) c trng (Th theo JECFA monograph 1 - Vol.4)
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Hot tnh glucoamylase
Phi c phn ng th hin hot tnh glucoamylase c
trng (Th theo JECFA monograph 1 - Vol.4)
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Ph lc 2
YU CU K THUT V PHNG PHP TH
I VI PROTEASE (T NM)
1. Tn khc, ch s INS 1101(i)
2. nh ngha c to ra bng cch ln men c kim sot cc chng
khng gy c v khng gy bnh ca Aspergillus oryzae
v c phn tch t mi trng sinh trng
Cc hot cht
Endo- v exopeptidases
Tn v m s h thng
1. Aminopeptidases (EC 3.4.11)
2. Serine endopeptidases (EC 3.4.21)
3. Aspartic endopeptidases (EC 3.4.23)
Cc phn ng c xc
tc
1. Thy phn cc protein ti N-terminal, gii phng cc
amino acid
2. Thy phn cc protein c cha cc lin kt serine
peptid
3. Thy phn cc protein c cha lin kt acid aspartic

Hot tnh enzym th cp
alpha-amylase (EC 3.2.1.1)
3. Cm quan Dng bt v nh hnh t trng nht n vng nu c th
phn tn trong mi trng phn tn hoc cht mang (tinh
khit dng cho thc phm; c th cha cht n nh v
cht bo qun; tan trong nc v kh tan trong ethanol v
ether
4. Chc nng Ch phm enzym.
c s dng trong qu trnh ch bin sn phm tht v
thy sn, ung, sp v nc dng, cc sn phm sa
v bnh ko.
5. Yu cu k thut
Phi ph hp vi cc Yu cu k thut chung i vi cc
ch phm enzym s dng trong qu trnh ch bin thc
phm (xem phn Hng dn)
5.1. nh tnh

Hot tnh proteolytic
Phi c phn ng th hin hot tnh proteolytic c trng
(S dng phng php th hot tnh proteolytic, Fungal
(HUT))

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Ph lc 3
YU CU K THUT V PHNG PHP TH
I VI PAPAIN
1. Tn khc, ch s INS 1101(ii)
2. nh ngha L cc cht proteolytic c tinh ch t qu u Carica
Papaya (L) (Fam.Caricaceae)
Cc hot cht
1. Papain (papaya peptidase I, cystein proteinase)
2. Chymopapain (cystein proteinase)
Tn v m s h thng
1. Khng (EC 3.4.22.2)
2. Khng (EC 3.4.22.6)
Cc phn ng c xc
tc
Cc enzyme ny thy phn cc polypeptid, cc amid v
ester, c bit ti cc lin kt ca cc amino acid c tnh
base, hoc leucin hoc glycin, to ra cc peptid vi phn t
lng nh hn.
3. Cm quan Dng bt v nh hnh hoc dng lng c mu trng n
vng nu nht; tan trong nc, dung dch t khng mu
n vng nht v i khi c mu trng c; khng tan trong
cn, clorform v ether
4. Chc nng Ch phm enzym.
c s dng trong qu trnh x l ch bin tht b, x l
tht, ch bin ng cc v sn xut dch thy phn protein
5. Yu cu k thut
Phi ph hp vi cc Yu cu k thut chung i vi cc
ch phm enzyme s dng trong qu trnh ch bin thc
phm (xem phn Hng dn)
5.1. nh tnh

Hot tnh papain
Phi c phn ng th hin hot tnh proteolytic thc vt
c trng

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Ph lc 4
YU CU K THUT V PHNG PHP TH
I VI BROMELAIN
1. Tn khc, ch s INS 1101(iii)
2. nh ngha L cc cht proteolytic c tinh ch t qu da Ananas
comosus v Ananas bracteatus (L)
Hot cht
Bromelain (crystein proteinase)
Tn v m s h thng
Khng (EC 3.4.22.4)
Cc phn ng c xc
tc
Enzym thy phn cc polypeptid, cc amid v ester, c
bit l cc lin kt ca amino acid c tnh base, hoc
leucin hoc glycin, to ra cc peptid c phn t lng thp
hn
3. Cm quan Dng bt v nh hnh c mu trng n vng nu nht;
tan trong nc, dung dch c mu trng hoc vng nht v
i khi c mu trng c; khng tan trong cn, clorform v
ether
4. Chc nng Ch phm enzym.
c s dng trong qu trnh x l tht b, ch bin tht,
s ch ng cc v sn xut dch thy phn protein

5. Yu cu k thut
Phi ph hp vi cc Yu cu k thut chung i vi cc
ch phm enzyme s dng trong qu trnh ch bin thc
phm
5.1. nh tnh

Hot tnh bromelain
Phi c phn ng th hin hot tnh proteolytic thc vt
c trng (xem phn Hot tnh Proteolytic, thc vt)

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Ph lc 5
YU CU K THUT V PHNG PHP TH
I VI GLUCOSE OXIDASE V CATALASE T ASPERGILLUS NIGER var.

1. Tn khc, ch s Glucose oxyhydrase, glucose aerodehydrogenase, notatin,
aero-glucose dehydrogenase;
INS 1102
2. nh ngha L cc ch phm enzyme c to ra t qu trnh ln men
nm Aspergillus niger var., c kim sot
Hot cht
1. Glucose oxidase
2. Catalase
Tn v m s h thng
1. -D-glucose: oxygen 1-oxidoreductase (EC 1.1.3.4)
2. Hydrogen-peroxide: hydrogen-peroxide oxidoreductase
(EC 1.11.1.6)
Cc phn ng c xc
tc
1. -D-glucose + O
2
--> D-glucono-delta-lactone + H
2
O
2

2. H
2
O
2
+ H
2
O
2
--> 2H
2
O + O
2
Hot tnh enzym th cp Invertase (EC 3.2.1.26)
3. Cm quan Dng lng c mu trng nht n mu nu; tan trong
nc v khng tan trong ethanol, chloroform v ether
4. Chc nng Ch phm enzym.
c s dng trong qu trnh ch bin, hoc s dng
sa, pho mt, trng, ung v sa lt

5. Yu cu k thut
Phi ph hp vi cc Yu cu k thut chung i vi cc
ch phm enzym s dng trong qu trnh ch bin thc
phm
5.1. nh tnh

Hot tnh glucose oxidase
Phi c phn ng th hin hot tnh glucose oxidase (xem
Vol 4.)
Hot tnh catalase
Phn c phn ng th hin hot tnh catalase c trng
(xem Vol 4.)