CONG HOA XA HO! CHU NGHIA VIET NAM QCVN 3-5 : 2011/BYT QUY CHUAN KY THUAT QUOC GIA BOI VO CAC CHAT DUOC SU’ DUNG DE BO SUNG MAGNESI VAO THU'C PHAM National technical regulation on substances may be added for magnesium fortification in food HA NOI - 2011Loi noi dau QCVN 3-5:2011/BYT do Ban soan thao quy chudn ky thuat quéc gia vé Thue phdm bé sung vi chat dinh duéng bién soan, Cuc An toan vé sinh thurc pham trinh duyét va duoc ban hanh theo Théng tu s6 03/2014/TT-BYT ngay 13 thang 01 nam 2011 cia BS trvdng BS Y 18.QUY CHUAN KY THUAT QUOC GIA OI VOl CAC CHAT DUOC SUP DUNG DE BO SUNG MAGNESI VAO THU'C PHAM National technical regulation on substances may be added for magnesium fortification in food 1. QUY DINH CHUNG 4. Pham vi diéu chinh Quy chun ky thuat quéc gia (sau day goi tat la Quy chudn) nay quy dinh cdc yéu cau ky thuat va quan ly vé cht iwong, vé sinh an toan déi voi cdc chat duoc sir dung voi muc dich bé sung magnesi vao thye phdm. 2. Déi twong ap dung Quy chudn nay ap dung déi voi: 2.1. Té chive, c& nhan nhap khdu, xuat khdu, san xudt, buén ban va str dung cae cht bd sung magnesi vao thurc phdm (sau day goi tat la td chirc, ca nhan). 2.2. Co quan quan ly nha nuée ¢¢ lién quan. 3. Giai thich tir ngt va che viét tat 3.1. Cac chat bd sung magnesi vao thurc pham: la cac chat doe chti déng cho vao thure phdm voi muc dich bé sung magnesi. 3.2. JECFA monograph 1 - Vol. 4: JECFA monographs 1 - Combined compendium - 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): Cac yéu cau ky thuat déi voi phu gia thurc phdm, Tap 4 Cac phwong phap phan tich, quy trinh tht nghiém, dung dich thir nghiém dugc str dung (hoa tham chiéu) trong yéu cau ky thuat déi voi phu gia thurc phdm; JECFA bién soan; FAO ban hanh nam 2006. 3.3. Ma s6 C.A.S (Chemical Abstracts Service): Ma sé dang ky héa chat cia Higp héi Héa chat Hoa Ky. 3.4, TS (test solution): Dung dich thuéc thir 3.5. INS (International numbering system): Hé théng ma sé quéc té déi voi phu gia thy pham.QCVN 3-5: 2011/BYT I YEU CAU KY THUAT, PHUONG PHAP THU VA LAY MAU 4. Yéu cau ky thuat va phuong phap thir déi véi cdc chat bd sung magnesi vao thue pham duoc quy dinh tai cdc phu luc ban hanh kém theo Quy chudn nay nhu sau 4.1. Phuluct: Yéu cdu ky thuat va phwong phap thir d6i voi magnesi hydroxyd carbonat. 1.2. Phuluc2: Yéu cau ky thuat va phyong phap thir déi voi magnesi clorid. 1.3. Phuluc3: Yéu cau ky thuat va phuong phap thir déi voi magnesi gluconat, 2. Cac yéu cau ky thuat quy dinh trong quy chuan nay duoc thir theo JECFA monograph 1 - Vol. 4, ngoai trir mét sé phép thir riéng duoc mé ta trong cae phu luc; ¢6 thé sir dung cdc phuong phap thtr khac tung durong. 3. Lay mu theo huéng dan tai Théng tu 16/2009/TT-BKHCN ngay 02 thang 6 nm 2009 ctia Bé Khoa hoc va Céng nghé vé huéng dan kiém tra nha nuée ve chat Ivong hang héa lwu théng trén thi tréng va cde quy dinh khac ctia phdp luat 6 lién quan. lll, YEU CAU QUAN LY 1. Céng bé hop quy 1.1 TAt ca cdc cht bé sung magnesi vao thye phdm phai duoc céng bé phi: hop véi cdc quy dinh tai Quy chuan nay. 1.2 Phyong thie, trinh ty, thi tue céng bé hop quy duvc thu hién theo Quy dinh vé ching nhan hop chuan, chteng nhan hop quy va céng bé hop chuadn, céng bé hop quy ban hanh kém theo Quyét dinh sé 24/2007/QD-BKHCN ngay 28 thang 9 nm 2007 cla Bé truéng Bé Khoa hoc va Céng nghé va cdc quy dinh cia phap lat. 2. Kiém tra d6i voi cdc chat bé sung magnesi vao thuc pham Viée kiém tra chat long, vé sinh an toan déi vi cdc cht bd sung magnesi vao thye phdm phai dug thu hign theo cdc quy dinh clia phap luatQCVN 3-5: 2011/BYT IV. TRACH NHIEM CUA TO CHUc, CA NHAN 1. Té chive, ca nhan phai céng bé hop quy phu hop vdi cac yéu cau ky thuat tai Quy chuan nay, dang ky ban céng bé hop quy tai Cuc An toan vé sinh thc pham va bao dam chat Iwong, vé sinh an toan theo ding néi dung da céng bé. 2. Té chive, c& nhan chi duoc nhap khdu, xuat khdu, san xudt, buén ban va st? dung cc chat bé sung magnesi vao thye pham sau khi hoan tat dang ky ban céng bé hop quy va bao dam chat Ivong, vé sinh an toan, ghi nhan phit hop véi cde quy dinh ctia phap luat V. TO CHUC THUC HIEN 41. Giao Cuc An toan vé sinh the pham chu tri, phdi hop voi cdc co’ quan chtrc nng cé lién quan hwéng dn trién khai va té chire viée thuc hién Quy chuan nay. 2. C&n ci? vao yéu cu quan ly, Cuc An toan vé sinh thc pham c6 trach nhiém kién nghi B6 Y té stva déi, bé sung Quy chudn nay. 3. Truéng hop huéng dan ctia quéc té vé phuwong phap thir va cdc quy dinh cla phap luat vién dan trong Quy chuan nay dure stva déi, bd sung hoc thay thé thi p dung theo van ban méiQCVN 3-5: 2011/BYT Phy luc 4 YEU CAU KY THUAT VA PHUONG PHAP THU DOI VOI MAGNESI HYDROXYD CARBONAT 1. Tén khac, chi sé 2. Dinh nghia Tén héa hoc 3. Cam quan 4. Chire nang 5. Yéu cau ky thuat 5.1. Binh tinh 6 tan Tinh kiém Magnesi 5.2. B6 tinh khiét Muéi tan Calei Chat khéng tan trong acid chi 5.3. Ham lwong MgO 6. Phuong phap thir 6.1. Dé tinh khiét Muéi tan Magnesium subcarbonate (nhe hoae nang), hydrated basic magnesium carbonate, magnesium carbonate hydroxide; INS 504(ii) Magnesi carbonat hydroxyd hydrat hoa Bét trang, thé, be, khéng mui Tac nhan kiém, lam khé, gicr mau, chat mang, chat chéng déng von Khéng tan trong née va ethanol. Phai c6 phan teng kiém dc trung. Phai cé phan ting dc trung ctia magnesi Khéng duge qua 1,0% Khéng dug qua 1,0% Khéng duoc qua 0,05%. Khéng duge qua 2,0 mg/kg Khéng duge thap hon 40,0% va khéng duoc qué 45,0% Can 2 g mau, trén voi 100 ml hén hop n-propanol/nuée (1/4). Bun séi hén hop, khudy lién tuc trong khi dun. Dé ngudi vé nhiét 46 phdng, thém nude cét dén du 100 mI va loc. Lay 50 ml dich loc, cho bay hoi trén bé cach thiy dén khé, sdy cn tai 105°C trong 1 gi. Can can, khéi lwong cn thu duge khéng duro qué 10,0 mg.QCVN 3-5: 2011/BYT Calei Chat khéng tan trong acid Chi 6.2. Binh lvong Cn 1 g mau thir (chinh xac dén mg), héa tan trong hén hop gém 3 mi acid sulfuric va 22 ml nude. Thém 50 mi ethanol va dén yén hén hop qua dém. Néu trong hén hgp tao thanh tinh thé magnesi sulfat thi dung néng hén hop dén 50°C dén héa tan hét tinh thé. Loc hén hop qua chén loc Gooch cé chiva tam lét amian, tam lot nay da duge riva bang dung dich acid sulfuric loang (TS), nuée, ethanol sau dé nung va can bi. Rwva tinh the trén t&m lét amian bang hén hop ethanol acid sulfuric loang (TS) (ty 1 thé tich 2/1). Nung 46 chén Gooch chita cn trong 1d, dé ngudi va can. Khéi lvong magnesi sulfat thu duoc nhan voi 0,2944 thu duoc long calci co trong mau thir, Can 5 g m&u thir, trén voi 75 mi nude, thém mét lvong nhé acid hydrochloric, [ac manh cho dén khi mau tan tdi da. Bun séi trong 5 phut. Néu van cén can chva héa tan, loc, riva bang nurée cho dén khi dich riva khéng con clorid. Nung, dé ngudi va can. - Thi theo huéng dan tai JECFA monograph 1 - Vol.4 - X&c dinh bang ky thuat hap thu nguyén tir thich hop cho ham Ivong quy dinh. Lya chon c& mau thir va phwong phap chuan bi mau da trén nguyén tac cla phuong phdp mé ta tai JECFA monograph 1 - Vol.4 phan cdc phuong phdp phan tich céng cu. Can 1g mau thir (chinh xdc dén mg), héa tan trong 30 ml acid sulfuric 1/N, thém dung dich chi thi da cam methyl (TS), chudn acid dw bang dung dich natri hydroxid 1 N. Lay gia tri thé tich acid sulfuric 1 .N str dung (sau khi da trir lvong du) trir di thé tich acid sulfuric 1 N tuong duong tuong tng véi lveng calci oxid trong mau dinh long, Hiéu sé thé tich acid sulfuric 1 N tuong tng véi lugng magnesi oxid trong mau thir, Méi mi dung dich acid sulfuric 1 N tong tng voi 20,15 mg MgO.QCVN 3-5: 2014/BYT Phy luc 2 YEU CAU KY THUAT VA PHU'ONG PHAP THU DOI VOI MAGNESI CLORID 1. Ten khac, chi sé 2. Dinh nghia Tén héa hoc Ma S6 CAS. Céng thiic phan tik Khdi luong phan tir 3. Cam quan 4. Chir nang 5. Yéu cau ky thuat 5.1. Binh tinh 6 tan Clorid Magnesi 5.2. Bé tinh khiét Nhém chi 5.3. Ham long 6. Phong phap thi 6.1. D6 tinh khiét Nhém Chi INS 511 Magnesi clorid hexahydrat 7786-30-3 MgCl2.6H20 203,30 Dang hat, cue, tinh thé khéng mau, khéng mili; dé tan chay Chat lam ran chac, chat gitr mau Dé tan trong née va ethanol Phai o6 phan ting trung ctia clorid. Phai cé phan teng trung ctia magnesi Khéng duc qua 50 mg/kg Khéng duoc qua 2,0 mg/kg Khéng thap hon 99,0% va khéng dure qué 105,0%. Can 1 g mau thir, hda tan trong 90 ml nuée cat, thém tir tiv 10 ml dung dich natri hydroxid (1/10) méi dun séi, 48 ngudi. Dé yén hén hop cho 6n dinh. Gan dy 20 mI dung dich phia trén vao ‘éng so mau (dng thtr), pha loang dén 50 ml bang nuée cat, them 2 mi dung dich Nessler's (TS). Tién hanh déng théi mét éng chudn gdm cé 48 mi dung dich nuée chira1Oug ion amoni (NH4) va 2 ml dung dich natri hydroxid. Mau cia éng thir khéng doe dam hon mau ctia éng chuan - Thir theo huéng dan tai JECFA monograph 1 - Vol.4 - Xde dinh bang ky thuat h4p thu nguyén tlr thich hop cho ham Ivong quy dinh. Lua chon c& mau thir va phuong phaép chudn bi mau dva trén nguyén tac cla phuong phap mé ta tai JECFA monograph 1 - Vol.4 phan cdc phuong php phan tich céng cu.QCVN 3-5: 2011/BYT 6.2. Binh lvong Can 450 mg méu thir (chinh xée dén 0,1 mg), héa tan trong 25 ml nuéc cat, thém S ml dung dich dém amoniac/amoni clorid (TS) va 0,1 ml dung dich den eriochrom (TS) va chudn dé véi dung dich dinatri ethylendiamintetraacetat 0,05 M dén khi dung dich c6 mau xanh lam. Mai mi dinatri ethylendiamintetraacetat 0,05 M tong duong véi 10,16 mg MgCl,.6H20QCVN 3-5: 2014/BYT Phy luc 3 YEU CAU KY THUAT VA PHUONG PHAP THU’ 4, Tan khac, chi sé 2. inh nghia Tén héa hoc M& sé C.A.S. Céng thite héa hoc Céng thie phan tur Khéi luong phan ti 3. Cam quan 4, Chic nang 5. Yéu cau ky thuat 5.1. Binh tinh 6 tan Magnesi Gluconat 5.2. D6 tinh khiét Nube Cac chat khir chi 5.3, Ham lwong 01 VOI MAGNESI GLUCONAT INS 580 Dang hop chat duoc ban duéi dang khan, dihydrat hoe hén hop dang khan va dihydrat Magnesi di-D-gluconat Dang khan: 3632-91-5 Dang dihydrat: 59625-89-7 CiaHaMgO14 OH OHH OH Mg 2® Dang khan: 414,60 Dang dihydrat: 450,63 Dang bét mau trang dén khéng mau, khong mui Chat diéu chinh d6 acid, chat lam ran ch&c, chat dinh duréng cho men, chat bé sung dinh duéng Tan trong nuée, khé tan trong ethanol Phai c6 phan ting dc trung cia magnesi Phai cé phan tng dac trung ctia gluconat Tir 3,0% dén 12,0% (phuong phép Karl Fischer) Khéng duge qué 1,0% tinh theo D-glucose (Phuong phap!) Khéng duoc qué 2,0 mg/kg, Khéng duge th4p hon 98,0% va khéng duoc qué 102,0% tinh theo ché pham khanQCVN 3-5: 2011/BYT 6. Phuong phap thir 6.1. D6 tinh khiét chi 6.2. Dinh lwong 10 - Thit theo huéng dan tai JECFA monograph 1 - Vol.4 - XAe dinh bang ky thuat hap thu nguyén tir thich hop cho ham lvong quy dinh. Lua chon c& mau thir va phuong phap chuan bi mau dua trén nguyén tac ctia phuong phap mé ta tai JECFA monograph 1 - Vol4 phan cae phuong phap phan tich céng cu Cén 0,6 g mau thir (chinh xac dén mg), héa tan trong 50 ml nuéc c&t, them 10 mi dung dich dém ammoniac/amoni clorid va 5 giot dung dich chi thi den eriochrom (TS). Chuan 46 v6i dung dich dinatri ethylenediaminetetraacetat 0,05 M cho dén khi dung dich ¢6 mau xanh lam thdm. Tinh % magnesi gluconat dang dihydrat theo céng thive: Voinatieota X CM anatieota x 45,07 m mau ther Trong dé: V: thé tich dung dich DinatriEDTA (ml) Cm: néng dé dung dich dinatriEDTA (M) m: trong lveng mau tht (g) 45,07 = hé sé tuong durong déi vei magnesi gluconat dang dihydrat