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II.L. GRAS Substances Recent Progress in the Consideration of Flavc/ring Ingredients Under the�fo·() . Additives. Amendment _� I . �· ·, . ' . .. ·� II.L. GRAS. Substances. MEMBERS OF THE FLAVORING EXTRACT MANUFACTURERS' ASSOCIATION FOOD ADDITIVES CoMMiTTEE during the period covered by this article: J. J. Broderick J. K. Krum A. T. Schramm Frank Brumburgh J. L. Laughlin F. R. Schumm A. T. Fiore R. V. Leary R. C. Sherwood C. E. Fricke J. R. Leitz H. C. Spencer L. F. Hasnaw J. H. McClumphy A. S. Wendt H. L. Janovsky J. F. Perkins R. L. Hall, Chairman David Jorysch M. F. Preiser R. L. Oser, Consultant reprinted for FLAVOR EXTRACT MANUFACTURERS' ASSOCIATION fro� "Food Technology," Vol. 19, No. 2 (Part 2). Copyright @ 1965 by lnstotute of Food TechnologlstsJ reprinted by permission of the copyright owner. All rights reserved. Printed In USA by The Garrard Press. CHEMICALS/See Cover Recent Progress In the Consideration of Flavoring Ingredients Under the Food Additives Amendment Ill. GRAS Substances RICHARD L. HALL and BERNARD L. OSER • THE Flavoring Extract these data may be used as guidelines elude all actual flavor uses, it does Manufacturers' Association has con­ to certain aspects of good manufactur­ provide widely representative data ducted a program since 1958 to de­ ing practice. from which "common use" can be termine the status of flavoring sub­ judged. stances under the Food Additives COMMON USE ·FACTOR It must be emphasized that there Amendment of 1958. The key por­ The Food Additives Amendment of can be no general recognition of safety tion of this program has involved the 1958 states that the term "food addi­ without knowledge of the conditions creation of a panel of expert pharma­ tive" means 11any substance the in­ of intended use and reasonable assur­ cologists and toxicologists to determine, tended use of which results . ance that actual use conforms appro­ on the basis of all available data, directly or indirectly, in its becoming priately to the intended conditions. including experience based on common a component . of any food . ., This statement applies as fully to those use in food, what substances are "gen­ if such substance is not generally substances which are on the Food and erally recognized as safe" (GRAS). recognized, among experts qualified by Drug Administration's "White Lists" This article, in a series describing the· scientific training and experience to as to the flavoring ingredients. which program, lists all substances which evaluate its safety, as having been are on the FEMA GRAS list. This are GRAS and the average maxinmm adequately shown through scientific report, therefore, includes both. Those use levels at which each has been re­ procedures (or, in the case of a sub­ substances which appear only on an ported to be used in different cate­ stance used in food prior to January .FDA White List are indicated in the gories of food. Inasmuch as all food 11 1958, through either scientific pro­ accompanying survey tabulation with· _ ingredients, including those that are cedures or experien.ce based .on com­ an asterisk. GRAS, must be used only in accord mon use in food) to be safe under The enormous variety of flavoring . with good manufacturing practice, the conditions of its intencled use) ...JJ ingredients and the uses to which they certain general guidelines to good The phrases from the Food Additives may be put make it completely inl­ manufacturing practice may be drawn Ame�dment inextricably couple gen­ possible to establish hard-and-fast from the available data. Such guide­ eral recognition of safety with the rules defining their use. As an illus­ lines are presented and discussed. conditions of intended use. Any ad­ tration, oil of clove may be used as Previously published articles (Anon., verse indications regarding safety de­ a trace ingredient at less than a part 1961a-f, 1962; Hall, 1959, 1960; Hall rived from experience in common use per million in the finished food at and Oser, 1961) and Committee reports may militate against general recog­ which level it is not recognizable as (Food Additives Committee, 1958- nition of safety. Almost all of the such. Or it may be t!Sed at a few parts 1964) have given in detail the chro­ flavoring ingredients contained herein per million as one of the principal nology of the . steps taken by the were in use prior to January 1, 1958. flavor notes in a product. Finally, flavoring industry in compliance with In almost every case, therefore,- com­ it may reasonably be used at more than the Food Additives Amendment of mon- use-was-a--factor,-- sometimes a ·· 1,000 parts per n1illien-wh.en -it is the 1958. The key portion of the pr.ogram major factor, in the panel's final dominant flavor. note, for- example, in has been the organization of a panel judgment. hard candy. Thus in. some cases, the of highly qualified experts who are The principal source of information use of a substance to impart a domi­ equipped by both experience and cur­ on "common use" was a survey of nant note may be at a level more than rent knowledge to determine general flavoring and representative food 1,000 times that of the same substance recognition of safety. The backgroun(l manufacturers, conducted by the Fla­ used as a trace ingredient. In general, leading to the present article will be voring Extract Manufacturers' Asso­ the upper limit of use is governed by found in the list of references, and the ciation (FEMA). Included in addition the general acceptability of the prod­ article represents the next logical stet? to the information derived from this uct. Those who have worked with in the series mentioned above. T!te survey are data on chewing gum fla­ flavors are familiar with this self­ data on levels of use which the panel vors obtained through the National limiting characteristic. employed in making its judgments are Association of Chewing Gum Manu­ A complication which should be presented in detail for each substanc.e facturers, and a limited amount of noted arises from multiple introduc­ generally recognized as safe. Also additional data on candy flavors ob­ tions of a particular · chemical entity stated and discussed are certain gen­ tained f1·om several leading manufac­ into a single food product. This occurs eral interpretive principles by which turers. While this report does not in- because a substance may be added FLAVORING INGREDIENTS: zz FEMA FLAVOR INGREDIENT SURVEY Distribution of Va.lues of o/M (Standard Devic:ttion over Av.ere19e) for the 31 most commonly used in9redienb 0.5' J,O 1.5' 2.,0 2,fi 3.0 :3,!5 4.0 4.5 Fig.%. 1 both as such, and: as a normal consti­ which may individua1ly depart widely · alternative was to use a simple .aver- tuent of one or more natural :flavoring from the mean. Usually, though not age. This meant, however, that an materials. For example, the uses re­ necessarily, the average is close to the e..-..:treme value could influence .the aver- ported here of benzaldehyde do not median, i.e., approximately half of age out of ali proportion to its actual include its use as almond oil added to the individual responses will exceed importance. This is particularly true the same food product, and the uses the average, and half be less. One or of· hig·h figures. As every food manu- of eugenol do not reflect that which a . few very low or high figures may facturer knows, progressively higher is separately listed under oil of clove. greatly influence the average. Whether flavoring levels (above the ·inost gen- or not this influence by extreme figures erally preferred or acceptable levels) GENERAL INTERPRETATIONS is misleading depends on two other r.ppeal to progressively smaller seg-· factors, neither of which was possible ments of the population. Thus, .an This report reproduces for each to control. One of . these factors is extremely high use level, even though major food category on which infor­ the reliability of the apparently aber- mation was obtained the average of actual, would ordinarily represent a rant figure, and the other is the weight the maximum use levels. reported by very limited total consumption. All which it should be· given in the total those firms pa11icipating in the survey factors considered, these use figures picture. which appears at the end of this - are reasonably accurate, even though - of article. ·The heading "Candy" is taken A maximum use level th'at appears we rnus-t·-remain constantly awar� in the broadest sense, to include choco­ to be unreasonably low may show either the qualifications which affect their late and hard candies such as sour that the reporting firm used the sub- interpretation. balls, pressed sugar tablets, lozenges, stance only as a trace. ingredient, or - -- -.-It should also be noted that the use etc. The category "Condiments" in­ that the value may actually have re- levels obtained in the survey and re- cludes salad dressings, mustard, rel­ sulted from an error in calculation ported here are those introduced into -ishes, sauces, and comparable highly (e.g., in converting ounces per 100 the food. TheY do not reflect the seasoned food products which are not gallons to parts per million). An ex- losses which may occur in later proc- · ordinarily eaten as such but are con­ tremely high value may represent a essing-through volatilization, leach- sumed in conjunction with other foods. reasonable but unusual use, or it, too, ing, or other means. - could have been erroneous. While an The · �ategory- -"Beverages"-- includes ·- THE BASIC PROBLEM primarily soft drinks, but also some �ffoi1 w!l.s made to recheck extrei'nely high figures, it clearly was not possi­ :flavored Wines and liqueurs which are We come, then, to the basic prob­ ble, many cases, to be sure whether not specifically listed separately.
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