QCVN 4-23:2011/BYT

QUY CHUN K THUT QUC GIA V PH GIA THC PHM - CHT TO BT

National technical regulation on Food Additive Foaming agent

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 cht to bt 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 cht to bt 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. Cht to bt: l ph gia thc phm c cho vo thc phm nhm to ra hoc duy tr s phn tn ng nht ca pha kh trong thc phm dng lng hoc dng rn. 3.2. 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. 3.3. M s C.A.S (Chemical Abstracts Service): M s ng k ha cht ca Hip hi Ha cht Hoa K. 3.4. TS (test solution): Dung dch thuc th. 3.5. ADI (Acceptable daily intake): Lng n vo hng ngy chp nhn c. 3.6. 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 cht chit xut t Quillaia s dng lm cht to bt c quy nh ti ph lc ban hnh km theo Quy chun ny.

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

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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 YU CU K THUT V PHNG PHP TH I VI CHT CHIT XUT T QUILLAIA (DNG 1) 1. Tn khc, ch s Quillaja extract, Soapbark extract, Quillay bark extract, Bois de Panama, Panama bark extract, Quillai extract. ADI : 0 - 1mg/kg th trng (tnh cho c dng 1 v 2) INS 999i 2. nh ngha Cht chit xut t quillaia (dng 1) thu c t qu trnh chit vi nc v hoc g ca thn v cnh Quillaja saponaria Molina (h Rosaceae). Ch phm cha saponin triterpenoid trong ch yu l glycosid ca acid quillaic. Polyphenol v tanin l nhng thnh phn chnh, ngoi ra cn c mt vi loi ng v calci oxalat. Ch phm chit xut t quillaia (dng 1) thng mi dng lng hoc bt sy phun c cht mang nh lactose, maltitol hoc maltodextrin. Sn phm dng lng thng c bo qun bng natri benzoat hoc ethanol. Tn ha hc M s C.A.S. Khi lng phn t Saponin triterpenoid (quillaia saponin), glycosid ca acid quillaic 68990-67-0 Cc saponin dng monomer c khi lng phn t khong 1.800 2.300, ph hp vi mt triterpen gm 8 10 monosaccharid. Dng lng mu nu hoc dng bt mu nu sng c nh hng Cht nh ho, cht to bt

3. Cm quan 4. Chc nng 5. Yu cu k thut 5.1. nh tnh tan To bt Sc k

Tan tt trong nc ; khng tan trong ethanol, aceton, methanol v butanol. Phi c phn ng to bt c trng. Thi gian lu ca pic chnh ca mu tng ng vi pic saponin chnh (QS-18) ca chun (m t trong phn Phng php th) Phi c mu sc v c c trng.

Mu sc v c 5.2. tinh khit Nc

Dng bt : Khng c qu 6% (theo phng php Karl Fischer)

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Gim khi lng khi sy kh pH Tro Dng lng : 50 80% (sy 2 g mu nhit 1050C trong 5 gi) 3,7 5,5 ( i vi nng dung dch 4%) Khng c qu 14% theo ch phm kh (dng 1 g mu i vi dng bt; i vi mu dng lng s dng phn cn li sau khi sy kh) Khng c qu 8% theo ch phm kh (m t trong phn Phng php th) Khng c qu 2,0 mg/kg. Hm lng saponin : khng c thp hn 20% v khng c qu 26% tnh theo ch phm kh.

Tanin Ch 5.3. Hm lng 6. Phng php th 6.1. nh tnh To bt

Ho tan 0,5 g mu dng bt trong 9,5 g nc hoc 1 ml mu dng lng trong 9 ml nc. Cho 1 ml hn hp v 350 ml nc vo trong ng ong loi 1.000 ml. Bt kn ng ong v lc mnh 30 ln, yn. Ghi li mc bt (ml) sau 30 pht. Bnh thng mc bt t khong 150 ml bt. i vi dng bt : Ho tan 0,5 g mu trong 9,5 g nc. Dung dch khng c. hp th ca dung dch so vi nc bc sng 520 nm phi nh hn 1,2.

Mu sc v c

6.2. tinh khit Tanin Cn 3,0 g mu dng bt hoc lng mu dng lng tng ng tnh theo lng ch phm kh sau khi sy. Ho tan mu trong 250 ml nc. iu chnh pH = 3,5 bng acid acetic. Sy 25 ml dung dch thu c nhit 1050C trong thi gian 5 gi v xc nh khi lng cht kh theo n v g (Wi). Trn 50 ml dung dch trn vi 360 mg polyvinyl polypyrrolidon, sau khuy trong 30 pht nhit phng; li tm vi tc 8.000 vng/pht. Ly phn dung dch trong pha trn, sy nhit 1050C, thi gian 5 gi. Cn phn cht kh thu c (Wf, n v tnh g). Hm lng tanin (%) trong mu c tnh nh sau : % Tanin (theo ch phm kh) = 100 x (Wi - Wf/2)/Wi - Th theo JECFA monograph 1 - Vol.4. - Xc nh bng k thut quang ph hp th nguyn t thch hp cho hm lng quy nh. La chn c mu th v phng php chun b mu da trn nguyn tc ca phng php m t trong JECFA monograph 1 - Vol.4 phn cc phng php phn tch cng c.

Ch

6.3. nh lng

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Nguyn tc: Saponin QS-7,QS-17, QS-18 v QS-21 c tch bng HPLC pha o, kt qu nh lng c xem l tng hm lng saponin c trong cht chit xut t Quillaia (dng 1) Chun b mu: i vi mu dng bt: Cn 0,5 g mu v ho tan trong 9,5 g nc. Lc qua b lc c 0,2 m. Dch chit nc (khong 550 mg cht kh/ml): Cn 1 g mu v pha vi 9 g nc. Lc qua b lc c 0,2 m. Trong c hai trng hp trn, th tch mu khong 10 ml. Chun b mu chun: Cn 1,5 g saponin tinh sch (ca cc hng SuperSap, Natural Response, Chil; Quil-A, Superfos, an Mch hoc tng ng, bit hm lng saponin), ho tan trong 100 ml nc. Lc qua b lc c 0,2 m. iu kin HPLC : - Ct : Vydac 214TP54 ( di 4,6 x 250 mm, l 5 m) hoc loi tng ng - Nhit ct : nhit phng - Bm : t ch gradient - Dung mi A : 0,15% TFA (acid trifloroacetic) trong nc dng cho HPLC - Dung mi B : 0,15% TFA (acid trifloroacetic) trong acetonitril dng cho HPLC - Gradient : Thi gian (pht) 0 40 45 - Tc dng : 1 ml/pht - Bc sng pht hin : 220 nm - Th tch bm mu : 20 l Tnh kt qu: Nng saponin (mg/ml) trong dung dch c chun b nh trn l : Cmu = (Amu/Achun)Cchun Trong : % Dung mi A 70 55 70 % Dung mi B 30 45 30

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- Cmu : Nng saponin (mg/ml) trong mu th - Cchun: Nng saponin chun (mg/ml) c bm vo (v d : Cchun = 13,5 mg/ml nu hm lng saponin ca 1,5 g mu chun l 90%) - Amu v Achun : Tng din tch cc pic tng ng vi 4 loi saponin chnh (QS-7,QS-17, QS-18, QS-21) c trong mu cn phn tch v mu chun. (Tanin v polyphenol c tch gii trc saponin. Cc pic ca saponin xut hin sau pic chnh ca polyphenol xem hnh ph lc). % Saponin c trong mu th c tnh nh sau : % Saponin = 100 x Cmu/(0,1 Wmu) Trong : - Wmu : Khi lng mu (mg) c ly chun b mu v 0,1 l nghch o ca th tch mu (10 ml). Sc k ca cht chun (15 mg cht kh/ml tng ng vi 13,5 mg saponin/ml)

Sc k ca cht chit xut t Quillaia (dng 1) (55 mg cht kh/ml)

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