BỘ Y TẾ - FSI

1 B Y T C NG H A X H I CH NGH A VI T NAM. c l p - T do - H nh ph c S : 27/2012/TT-BYT H N i, ng y 30 th ng 11 n m 2012. TH NG T . H ng d n vi c qu n l ph gia th c ph m C n c Lu t an to n th c ph m ng y 17 th ng 6 n m 2010;. C n c Ngh nh s 38/2012/N -CP ng y 25 th ng 4 n m 2012 c a Ch nh ph v vi c quy nh chi ti t thi h nh m t s i u c a Lu t an to n th c ph m;. C n c Ngh nh s 63/2012/N -CP ng y 31 th ng 8 n m 2012 c a Ch nh ph v Quy nh ch c n ng, nhi m v , quy n h n v c c u t ch c c a B Y t ;. Theo ngh c a C c tr ng C c An to n th c ph m;. B tr ng B Y t ban h nh Th ng t h ng d n vi c qu n l ph gia th c m ph : i u 1. Ph m vi i u ch nh Th ng t n y quy nh v : 1.

2 Danh m c ph gia c ph p s d ng trong s n xu t, ch bi n v kinh doanh th c ph m v gi i h n t i a i v i c c ch t ph gia trong c c s n ph m th c ph m;. 2. Y u c u v qu n l i v i ph gia th c ph m . i u 2. Gi i th ch t ng k hi u vi t t t Trong Th ng t n y, t ng v k ki u vi t t t d i y c hi u nh sau: 1. CAC (Codex Alimentarius Committee): y ban Ti u chu n th c ph m qu c t ;. 2. GMP (Good Manufacturing Practices): th c h nh s n xu t t t;. 3. ML (Gi i h n t i a - Maximum Level) l h m l ng t i a c a m t ch t ph gia th c ph m c x c nh l c hi u qu v an to n khi s d ng cho m i lo i th c ph m ho c nh m th c ph m. Gi i h n t i a c t nh theo mg ch t ph . gia/kg th c ph m (mg/kg).

3 4. INS (International Numbering System) l h th ng ch s nh s cho m i ch t ph gia do CAC x y d ng;. 5. M nh m th c ph m (Food Category Number) l s c x p cho m i lo i, nh m th c ph m theo H th ng ph n lo i th c ph m do CAC x y d ng . qu n l ph gia th c ph m;. 6. S d ng ph gia th c ph m bao g m: a) S n xu t, ch bi n, kinh doanh, nh p kh u ph gia th c ph m;. 1. b) S n xu t, ch bi n, kinh doanh v s d ng c c s n ph m th c ph m c . ch a ph gia th c ph m. i u 3. C c h nh vi c m trong s d ng ph gia th c ph m 1. S d ng ph gia th c ph m kh ng c trong danh m c ch t ph gia th c ph m c ph p s d ng quy nh t i Ph l c 1 c ban h nh k m theo Th ng t . n y. 2. S d ng ph gia th c ph m qu gi i h n cho ph p, kh ng ng i t ng th c ph m quy nh t i Ph l c 2 c ban h nh k m theo Th ng t n y.

4 3. S d ng ph gia th c ph m kh ng p ng y c c y u c u qu n l . quy nh t i i u 6 c a Th ng t n y. 4. S d ng ph gia th c ph m kh ng r ngu n g c, xu t x ho c qu th i h n s d ng. i u 4. Danh m c ph gia c ph p s d ng trong th c ph m Danh m c c c ph gia c ph p s d ng trong th c ph m c quy nh t i Ph l c 1 ban h nh k m theo Th ng t n y. i u 5. M c gi i h n t i a i v i c c ph gia trong th c ph m M c gi i h n t i a i v i ph gia trong th c ph m c quy nh t i Ph . l c 2 ban h nh k m theo Th ng t n y. i u 6. Y u c u v qu n l i v i ph gia th c ph m 1. C s s n xu t, kinh doanh ph gia th c ph m ph i p ng y c c y u c u c quy nh t i Th ng t s 16/2012/TT -BYT ng y 22 th ng 10 n m 2012 c a B Y t v vi c Quy nh i u ki n an to n th c ph m i v i c s s n xu t, kinh doanh th c ph m, d ng c , v t li u bao g i, ch a ng th c ph m thu c ph m vi qu n l c a B Y t.

5 2. Ph gia th c ph m ph i c c ng b h p quy ho c c ng b ph h p quy nh an to n th c ph m tr c khi s n xu t, kinh doanh, nh p kh u v s d ng ph . gia s n xu t, ch bi n th c ph m. Tr nh t , th t c c ng b h p quy ho c c ng b ph h p quy nh an to n th c ph m th c hi n theo Th ng t s 19/2012/TT -BYT ng y 09 th ng 11 n m 2012 c a B Y t v h ng d n vi c c ng b h p quy ho c c ng b ph h p quy nh an to n th c ph m. 3. p d ng GMP trong qu tr nh s n xu t, ch bi n th c ph m c n tu n th : a) H n ch t i m c th p nh t l ng ph gia th c ph m c n thi t ph i s . d ng p ng y u c u v k thu t;. b) L ng ph gia c s d ng trong trong qu tr nh s n xu t, ch bi n, b o qu n, bao g i v v n chuy n th c ph m ph i m b o kh ng l m thay i b n ch t c a th c ph m.

6 4. Ghi nh n ph gia th c ph m th c hi n theo quy nh hi n h nh c a ph p lu t. 2. i u 7. Quy nh chuy n ti p Ph gia th c ph m, s n ph m th c ph m c s d ng ph gia th c ph m . c c p Gi y ch ng nh n ti u chu n s n ph m tr c ng y Th ng t n y c hi u l c ti p t c c s d ng n h t th i h n hi u l c c ghi trong Gi y ch ng nh n. i u 8. So t x t, s a i, b sung C n c nhu c u qu n l theo t ng th i k , tr n c s ti u chu n s n ph m ho c c c h ng d n c a CAC, C c An to n th c ph m s xem x t, xu t B Y t . s a i, b sung Th ng t n y nh m ph t tri n s n xu t trong n c v ph h p v i th ng l qu c t . i u 9 . i u kho n tham chi u Trong tr ng h p c c v n b n quy ph m ph p lu t v c c quy nh c vi n d n trong Th ng t n y c s thay i, b sung ho c c thay th th p d ng theo v n b n quy ph m ph p lu t m i.

7 I u 10. i u kho n thi h nh 1. Th ng t n y c hi u l c t ng y 01 th ng 02 n m 2013. B i b c c quy nh li n quan n ph gia th c ph m (kh ng bao g m c c ch t t o h ng c ph p s d ng trong th c ph m) t i: Quy nh danh m c c c ch t ph gia c ph p s d ng trong th c ph m ban h nh k m theo Quy t nh s 37 42/2001/Q - BYT ng y 31 th ng 8 n m 2001 v Quy nh v i u ki n b o m v sinh an to n th c ph m trong s n xu t, kinh doanh, s d ng ph gia th c ph m ban h nh k m theo Quy t nh s 928/2002/Q -BYT ng y 21 th ng 3 n m 2002 c a B tr ng B Y t k t ng y Th ng t n y c hi u l c . 2. C c An to n th c ph m c tr ch nhi m ch tr , ph i h p v i c c c quan ch c n ng c li n quan h ng d n tri n khai v t ch c vi c th c hi n Th ng t.

8 N N i nh n: KT. B TR NG. - VPCP (V n x , C ng b o, C ng TT T Ch nh ph ); TH TR NG. - C c B , c quan ngang B , c quan thu c CP;. - B T ph p (C c Ki m tra VBQPPL); TH TR NG. - B tr ng Nguy n Th Kim Ti n ( b o c o); ( k ). - UBND c c t nh , th nh ph tr c thu c TW;. - S Y t c c t nh, th nh ph tr c thu c TW;. - Chi c c ATVSTP c c t nh, th nh ph tr c thu c TW;. - TTYTDP c c t nh, th nh ph tr c thu c TW;. - C c c quan KTNN v th c ph m nh p kh u; Nguy n Thanh Long - T ng c c Ti u chu n - o l ng - Ch t l ng ;. - C ng TT T B Y t ;. - L u: VT, PC, ATTP. 3. 4. PH L C I. DANH M C PH GIA C PH P S D NG TRONG TH C PH M. (Ban h nh k m theo Th ng t s 27 /2012/TT-BYT ng y 30 th ng 11 n m 2012 ).

9 I. Danh m c ph gia th c ph m c ph p s d ng x p theo INS. T N PH GIA Quy nh ST INS Ch c n ng ML. T Ti ng Vi t Ti ng Anh (trang). 1 100(i) Curcumin Curcumin Ph m m u 89. 2 100(ii) Turmeric Turmeric Ph m m u 90. 3 101(i) Riboflavin Riboflavin Ph m m u 90. 4 101(ii) Natri Riboflavin 5'- Riboflavin 5'- Ph m m u 90. phosphat phosphate sodium 5 101(iii) Riboflavin t Riboflavin from Ph m m u 90. Bacillus subtilis Bacillus subtilis 6 102 Tartrazin Tartrazine Ph m m u 94. 7 104 Quinolin Quinoline Yellow Ph m m u 95. 8 110 Sunset yellow FCF Sunset Yellow FCF Ph m m u 95. 9 120 Carmin Carmines Ph m m u 99. 10 122 Carmoisin Azorubine Ph m m u 103. (Carmoisine). 11 123 Amaranth Amaranth Ph m m u 103.

10 12 124 Ponceau 4R Ponceau 4R Ph m m u 103. 13 127 Erythrosin Erythrosine Ph m m u 106. 14 129 Allura red AC Allura Red AC Ph m m u 107. 15 132 Indigotin Indigotine Ph m m u 110. (Indigocarmin). 16 133 Brilliant blue FCF Brilliant Blue FCF Ph m m u 112. 17 140 Clorophyl Chlorophylls Ph m m u 116. 18 141(i) Ph c clorophyl Chlorophyll Copper Ph m m u 116. ng Complex 19 141(ii) Ph c clorophyl Chlorophyll Copper Ph m m u 116. ng (mu i Natri, Complex, Sodium kali c a n ) And Potassium Salts 20 143 Fast green FCF Fast Green FCF Ph m m u 119. 21 150a Caramen nh m I Caramel I- Plain Ph m m u 121. (kh ng x l ). 22 150b Caramen nh m II Caramel II- Sulfite Ph m m u 122.