Flavoring Substances 24
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BY R.L. SMITH, W.J. WADDELL, S.M. COHEN, V.J. FERON, L.J. MARNETT, P.S. PORTOGHESE, I.M.C.M. RIETJENS, T.B. ADAMS, C. LUCAS GAVIN, M.M. MCGOWEN, S.V. TAYLOR, and M.C. WILLIAMS t is now half of a century since passage of the 1958 Food Additives Amendment I (FAA) to the Federal Food, Drug, and Cosmetic Act—Public Law 85-929, 72 Stat. 1784 (1958), codifi ed at 21 U.S.C. Sec. 348 (1988)—that exempted from food additive status those substances “generally recognized as safe” (GRAS) under conditions of intended use. In order for the use of a substance to qualify for GRAS status, the safety of the substance must be evaluated by experts qualifi ed by training and experience and adequately shown through scientifi c procedures to be “generally recognized as safe.” For almost fi ve decades, the Expert Panel of the Flavor and Extract Manufacturers Association (FEMA) has maintained an independent program to evaluate the safety of substances for their intended use as fl avor ingredients. During that time, more than 2,600 fl avor ingredients achieved GRAS status, approximately 200 candidates were withdrawn from GRAS consideration due to lack of available data or safety concerns, FLAVORING SUBSTANCES 24 and 11 substances had their previous GRAS status revoked (or “DeGRASed”) due to specifi c safety concerns or an absence of requested safety data. The 24th publication by the FEMA Expert Panel presents At the beginning of the FEMA GRAS Program, FEMA fl avor manufacturers submitted data on approximately 1,400 safety and usage data on 236 new generally recognized fl avoring substances that had been in commerce in the United States at the time as safe flavoring ingredients. the 1958 Amendment was adopted. In the fi rst round of safety evaluations, the Expert Panel systematically considered data on these chemically defi ned substances and concluded that 1,124 of these fl avor ingredients were GRAS under conditions of their intended use in food fl avorings. In accordance with the provisions of the 1958 Amendment that the use of these substances be “generally recognized as safe,” the Expert Panel published the fi rst list of GRAS fl avoring substances in 1965 (Hall and Oser, 1965). This began a tradition of periodic publication of GRAS lists of fl avor- ing substances, including their principal name, synonyms, and their recommended average added usual and maximum use levels. In addition, there was a desire to publish the background scientifi c data upon which GRAS deliberations were based. Under contract to the U.S. Food and Drug Administration (FDA), relevant safety data pg 46 06.09 • www.ift.org GRAS FLAVORING SUBSTANCES 24 Photo courtesy of Wild Flavors Inc. were compiled on approximately fl avoring substances, suggesting Food and Agriculture Organization 1,300 substances and published that there may be an upper limit Joint Expert Committee on Food in a series of Scientifi c Literature to the number of commercially Additives (JECFA) adopted a novel Reviews (SLRs) between 1974 and viable fl avoring substances. fl avor evaluation procedure in 1995 1979. Each SLR was organized However, two mutually con- that allowed for the systematic into groups of structurally nected initiatives drastically altered evaluation of chemical groups of related fl avoring ingredients that the rate of GRAS evaluations. First, fl avoring ingredients beginning in participated in common pathways in 1994, the Expert Panel began a 1996. These chemical groups of fl a- vor ingredients had been previously evaluated by the FEMA Expert The FEMA Expert Panel published the fi rst list of GRAS fl avoring Panel in the GRASr program. substances in 1965. Every year since 1996, FDA has requested that the Codex Commit- tee on Food Additives (CCFA) place of metabolism and exhibited second comprehensive evaluation groups of GRAS fl avor ingredients similar toxicological potential. of the safety of all chemically on the JECFA agenda for evaluation These reviews served as the defi ned GRAS fl avoring substances at its annual meeting. As of 2008, foundation for the fi rst comprehen- in a program designated GRAS JECFA has evaluated more than sive re-evaluation and affi rmation reaffi rmation (GRASr). Second, 1,750 substances and concluded of the GRAS status of more than in conjunction with FDA, the that these fl avoring agents are “safe 1,740 fl avor ingredients in a pro- fl avor industry supported a new, under current conditions of intake.” gram known as GRAS affi rmation more-comprehensive initiative to The JECFA list is updated annually (GRASa). The GRASa Program expedite the global evaluation of all following each JECFA meeting. began in 1975 and was completed existing fl avoring substances. After The consistent conclusions in 1985. In the next 10-year more than 30 years of evaluating rendered by the FEMA Expert period (1985–1995), relatively few the safety of individual fl avoring Panel and JECFA have, to a con- new substances (approximately substances, the World Health siderable extent, created an open 75) were GRASed for use as Organization and United Nations positive list of fl avoring substances 06.09 • www.ift.org 47 pg GRAS FLAVORING SUBSTANCES 24 for use in the U.S. and in WHO member countries that wish to adopt the FEMA and/or JECFA lists. In other industrial- ized regions, such as the European Union (EU) and Japan, open positive lists of FEMA GRAS LISTS fl avoring substances either are being developed or are currently in existence. published in Food Technology, in chronological order In the EU, a positive list is being compiled based on the safety evaluations performed by JECFA prior to 2000 and thereafter Hall, R.L. 1960. Recent progress in the substances. Food Technol. 39(11): 108-117. by the European Food Safety Authority. consideration of fl avoring ingredients under Burdock, G.A., Wagner, B.M., Smith, the Food Additives Amendment. Food R.L., Munro, I.C., and Newberne, P.M. In Japan, the Ministry of Health, Labor, Technol. 14: 488-495. 1990. Recent progress in the consideration and Welfare maintains a list of currently Hall, L. and Oser, B.L. 1961. Recent progress of fl avoring ingredients under the Food approved fl avoring substances, and recent in the consideration of fl avoring ingredients Additives Amendment. 15. GRAS substances. under the Food Additives Amendment. II. Food Technol. 44(2): 78, 80, 82, 84, 86. safety evaluations of specifi c groups of fl a- Food Technol. 15(12): 20, 22-26. Smith, R.L. and Ford, R.A. 1993. Recent progress vor ingredients (e.g., pyrazine derivatives) Hall, R.L. and Oser, B.L. 1965. Recent progress in the consideration of fl avoring ingredients under have added new groups of structurally in the consideration of fl avoring ingredients the Food Additives Amendment. 16. GRAS related substances to the existing list. under the Food Additives Amendment. 3. GRAS substances. Food Technol. 47(6): 104-117. As the JECFA list has developed, substances. Food Technol. 19(2, Part 2): 151-197. Smith, R.L., Newberne, P., Adams, T.B., Ford, Hall, R.L. and Oser, B.L. 1970. Recent progress R.A., Hallagan, J.B., and the FEMA Expert flavor manufacturers in these other in the consideration of fl avoring ingredients Panel. 1996a. GRAS fl avoring substances industrialized regions (Europe and under the Food Additives Amendment. 4. GRAS 17. Food Technol. 50(10): 72-78, 80-81. Asia) have, quite understandably, taken substances. Food Technol. 24(5): 25-34. Smith, R.L., Newberne, P., Adams, T.B., Ford, Oser, B.L. and Hall, R.L. 1972. Recent progress R.A., Hallagan, J.B., and the FEMA Expert an interest in having existing flavoring in the consideration of fl avoring ingredients Panel. 1996b. Correction to GRAS fl avoring ingredients specific to their regions under the Food Additives Amendment. 5. GRAS substances 17. Food Technol. 51(2): 32. added to the FEMA and JECFA lists. substances. Food Technol. 26(5): 35-42. Newberne, P., Smith, R.L., Doull, J., Goodman, Hence, both EU and Japanese flavor Oser, B.L. and Ford, R.A. 1973a. Recent progress J.I., Munro, I.C., Portoghese, P.S., Wagner, in the consideration of fl avoring ingredients B.M., Weil, C.S., Woods, L.A., Adams, T.B., manufacturers have, through their under the Food Additives Amendment. 6. GRAS Hallagan, J.B., and Ford, R.A. 1998. GRAS respective international and national substances. Food Technol. 27(1): 64-67. fl avoring substances 18. Food Technol. trade associations, submitted these 52(9): 65-66, 68, 70, 72, 74, 76, 79- 92. Oser, B.L. and Ford, R.A. 1973b. Recent progress substances for safety evaluation, first in the consideration of fl avoring ingredients Newberne, P., Smith, R.L., Doull, J., Goodman, under the Food Additives Amendment. 7. GRAS J.I., Munro, I.C., Portoghese, P.S., Wagner, B.M., by the FEMA Expert Panel and then substances. Food Technol. 27(11): 56-57. Weil, C.S., Woods, L.A., Adams, T.B., Hallagan, by JECFA. As a result, there has been Oser, B.L. and Ford, R.A. 1974. Recent progress J.B., and Ford, R.A. 1999. Correction to GRAS renewed interest in the GRAS Program. in the consideration of fl avoring ingredients fl avoring substances 18. Food Technol. 53(3): 104. under the Food Additives Amendment. 8. GRAS Newberne, P., Smith, R.L., Doull, J., Feron, Beginning with the publication of substances. Food Technol. 28(9): 76-80. V.J., Goodman, J.I., Munro, I.C., Portoghese, GRAS 18 in 1998, there has been a signif- Oser, B.L. and Ford, R.A.