(, 100021) :, FAOΠWHO (J ECFA), : ; ; Regulations of enzyme preparations used in foods in some countries and international organizations in the world Luo Xueyun (National institute for Nutrition and Food Safety, China CDC, Beijing 100021) Abstract : The regulation of enzyme preparation used in foods has aroused great attention by governments worldwide, especially the microorganisms and genetically modified modified production strains. In order to strengthen the regulation of enzyme preparations in China, the article focuses on the recommendation of the regulations and safety evaluation of the United States, European Union and Joint FAOΠWHO Expert Committee on Food Additives, the decision tree for evaluating the safety of microbially derived food enzymes as well. Key Words : Food ; Enzymes ; Safety Management, 2 000,5060 (enzyme preparations),,,,, :, ; ; ;,,, : DNA,, ( ),,, FAOΠWHO (J ECFA) 1 [1 ], 194 CHINESE JOURNAL OF FOOD HYGIENE 2003 15 3
; ( Internation2 al Union of Biochemistry,IUB) [2 ], /,12 000, 2, - - -,,,,,,,,,,,,,,,,,,,, FDA,(self2certify), 3,,, 311 ( Food and Drugs Act) ( Food and Drug Regulations),, ( GMO), GMO 312 Π [3 ] ( Food Standards Code) Π (AustraliaΠNew Zealand Food Authority,ANZ2 FA) /,,ANZFA J ECFA [1 ], 313 76 314 (FDA) ( Code of Federal Regulations, CFR) 173 ( sec2 ondary direct food additives),cfr 184 ( GRAS) FDA, GRAS, : 1958 ;, GRAS GRAS FDA,,(U. S. Food and Drug Administration, Center for Food Safety and Applied 195
Nutrition, Office of Premarket Approval, Chemistry Re2 view Branch) 1993 1 : GRAS ( Enzyme Prepara2 tions : Chemistry Recommendations for Food Additive and GRAS Affirmation Petitions) [1 ] : : (1), EC ( Recommendation of the Nomenclature Committee of In2 ternational Union of Biochemistry) ( Enzyme Commission EC) / CAS (Chemical Abstract Service, CAS), ph,,,,,, DNA, DNA,,, -,,, : 5 ( ),, ( Total Organic Solids, TOS) TOS TOS : TOS ( %) = 100 % - A - W - D : A = %, W = %, D = % (2), (Food Chemicals Codex, FCC) [4 ], DNA,, DNA,,,,, (3) 5, FCC ( ) / DNA, CFR 173,357 (a) (2) GRAS, (4), TOS (mg) ( A. niger var. ),, 196 CHINESE JOURNAL OF FOOD HYGIENE 2003 15 3
(5),,1996 [4 ] ( Food Chemical Codex, 4 th ed. ; FCC -,1996 ) ( GMP),, GMP,,,,,,, : 8510 %11510 % ;(Pb ) : < 30 mgπkg ; ( Pb) : < 5 mgπkg ; : < 30Πg ; : Π25 g FDA GMO GMO FDA Pariza Foster ( 1983 ) [5 ] Pariza Johnson (2001) [6 ] (decision tree safety assessments) Pariza Johnson 315 [7 ], ( The Scientific Committee for Food, SCF) 1991 4 Guidelines for the pre2 sentation of data on food enzymes,,, 31511 3151111 ( ) ( ),,,, 3151112 3151113,, 3151114 (unin2 tended reaction products) 3151115 (),,,,,,,,,, ( Pen2 icillium) ( Aspergillus),,,( A. oryzae) ( A. flavus),,, ( ), ph,,,,,,,,, 31512 197
3151211 (Active components) EC, (UΠg UΠmL),, 3151212 (source materials),,, ( Identification keys),,,,, ( ) DNA ; ;,,, DNA( DNA) () ( ) (- ), ( / ) ( ) DNA ( DNA ), DNA ( ) DNA, 3151213 (Manufacturing process),,,,, 3151214 ( Carries,other additives and Ingredients) ( ),,,,,, ( TOS), 3151215 (Usage), : 3151216 ( Stability and fate in the food) : () ; ; 3151217 ( General requirement and specifications), : (a),,, ; (b), 198 CHINESE JOURNAL OF FOOD HYGIENE 2003 15 3
; 30/ g ; 10 2 10 4 / g ; 3151219 3151218 ( Basic toxicological requirements),, : (a) 90 d (b) 2,( ),,, ( ECΠOECD) /,,,,,,,,,,,,,, ( International Food Biotechnology,,,,,,,,,,, (no2observed2effect2level,no2 EL), 3. 6 FAOΠWHO (J EC2 [8,9 ] FA) J ECFA, En2 vironmental Health Criteria ( EHC) 70 (1987) - 5 : (1) ; (2) ; (3) ; ; (4) (5) (1) (3), (4) (5) :a ;b c a, ADI ; b, ADI ;c, ADI 2001,J ECFA, : (side activities) Pariza Foster (1983) [5 ] Council,IFBC) (1990) [10 ] (Scientific Committee for Food,SCF) (1992) [7 ] Pariza John2 son (2001) [6 ],GMO : (1) 199
/, (unexpected genetic material),, (2),, DNA (3) DNA,,, 1983 Pariza Foster [5 ], :, ;,, :,,,,, (proteinbreeding ),, Pariza Johnson (Decision tree) [6 ],,, ( GMP), FCC [4 ] / J ECFA [9 ] / rdna : ; DNA ; : Pariza Johnson [6 ] (1)? (2), (6) (2) rdna? (3), (5) (3) DNA,3a - 3e (3a) DNA,? (3c), (3b) (3b) (NOAEL),? (3c), (12) (3c) DNA? (3e), (3d) (3d),? (12), (3e) (3e) DNA,? (4), (12) (4) DNA? (5), (6) (5),? (6), (7) (6),?,, (7) (7)? (8), (12) (8)? (9), (12) (9)? (11), (12) 200 CHINESE JOURNAL OF FOOD HYGIENE 2003 15 3
(10)? (11), (12) (11), NOAEL,?,, (12) (12) 4,, 2002, 19,,,,,, : [ 1 ] FDA. Enzyme Preparations : Chemistry recommendations for food additive and GRAS affirmation petitions[ M]. Version 1. 1 ; 1993. [ 2 ] International Union of Biochemistry ( IUB). Enzyme nomen2 clature : Recommendations of the nomenclature committee of the international Union of biochemistry and molecular biolo2 gy on the nomenclature and classification of enzymes[ M]. Academic Press, San Diego. 1992. [ 3 ] National Food Authority. Food Standards Code [M]. Com2 monwealth of Australia, 1996. [ 4 ] Food Chemical Codex[M]. 4 th ed. Monograph Specifica2 tions, 1996. [ 5 ] Pariza M W, Foster E M. Determining the safety of enzymes used in food processing [ J ]. J Food Protect. 1983, 46 : 453 463. [ 6 ] Pariza M W,Johnson E A. Evaluating the safety of microbial enzyme preparations used in food Processing : Update for a new century[j ]. Regulatory Toxicology and Pharmacology. 2001, 33 :173 186. [ 7 ] Scientific Committee for Food. Guidelines for the presenta2 tion of Data on food enzymes 27 th report series[ R ]. EUR 14181 EN, 1992,13 22. [ 8 ] Joint FAOΠWHO Expert Committee on Food Additives (J EC2 FA). Environmental Health Criteria ( EHC) 70 ( 1987) 2 Guidelines for assessing food enzyme preparations [ R ]. 1987. [ 9 ] Joint FAOΠWHO Expert Committee on Food Additives (J EC2 FA). Compendium of food additive specifications[j ]. Gen2 eral Specifications for Enzyme Preparations Used Food Pro2 cessing, 1992,1 :1 3. [10 ] International food Biotechnology Council ( IFBC). Safety evaluation of foods and food ingredients derived from micro2 organisms in biotechnologies and food : Assuring the safety of foods produced by genetic modification [J ]. Regul Toxicol Pharmacol. 1990,12 :S1 S196. [ :2003-03 - 05 ] :R15 ;TS20213 :A :1004-8456 (2003) 03-0194 - 08 [2003 ]39 : ( [2002 ]76 ),,: ( GB 2760 1996),,,, 201