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8
Reprinted from FOOD TECH�OLOGY, Vol. 24, �o. 5, Pages : 228, 332 & 34 RT PROGRS in the Consiration of Flavong Ingdi Under the Fꝏd Additives Amendment 4. Subsc RICHD L LL BARD L OS THE AUTHORS are rpvely vic p�dt of Moick and Co. and pidentlt of 1FT; and pridt Food •nd Dg Ra Labonotori, Inc 0 IN PIOUSLY published ai- cles (Hl 1959, 1960; Hall et al., 1961, 1965, 1968), the auon have discs the predes by which flavong inedients repo to" be in por use we conside th re- spt the pvisions of the Food Addives Amendment of 1958. The initial screening, inc luding e of all available infoa- on from indtal sources and the lie, was conduc by the Fo Addives Committee of e avor and ct Manufacre' Associa- on (). Finay, the collat da we studi by a panel of toξ- cologisʦ d pologisʦ in by þ s pel coisʦ of p "qi by nin g an d eence," whose uno a ment on genel rogtion of safety is req for a subsnce be n- ely rogniz se (GRAS) under the psions of the Fo Ad- div es Amendment e course of that review (which took place fm 1951964) 1,124 d synthe ingenʦ we d en GS under condi- o of innd e. o hundred s-seven (267) were dropp from e ause adeqte ioaon was not available meet the ca es- blish by the panel or the sub- ses in queson we not of suffi- -:ient impoce to j developing e infoation n In a few cues, e eξsng da flted - favobly on the inienʦ or other closely rela subsces, and re- sul in their disconnnce from e. One of the more recent pape (Hall et al., 1965) stress that, since almost all of the subsnces then con- sider had en in use por Jan- 1, 1958, "experience bas on common use in fo" (the lanage of the Fo Addives Amenent) was an impornt factor in dein- ing general recognition of their safety. The same sennce in the Fo Ad- dives Amendment just quot pro- vides at a subsnce not in e por Jan 1, 1958, may "genelly roized among expe qualified by scientific tining and - peence to eval safety, u hang bn aduately sho through scientifi procs (or, in the cue of a subsnce . . .) be safe under e condions of i innd u. " Inde, among e subsnces in- clud in the list in o pvio po (Hl et al., 1965), six we not in e por 1958, but were jud� by the expe panel be GS on the basis of scienfic proceds. Mo spificly, the panel reew available infoaon on the chemis - , mebolism, and xicity of the substances and closely a nalogous ones, and judg tha-under the con- dions of innd usthere would be reasoble centy among in- fo expe of their safety. NEW DATA IN THIS PAPER, we wish to report a numr of later developmenʦ. In pa these consist of acon by the expe panel on a nr of sub- snc es newly-propos for intenonal e as flavor addives. e panel hu ao review additional toξcolocal and other infoaon available on a number of ingredients previously j udg to be GRAS. is se to fi the preous judent in all but o insnces, in which the new [ 1 J infoation caused reveal of the por finding. In large part, the cteria pvi- ously esblished by the expe panel for the evaltion of safety (Hall et al., 1961) can still be appli to these n�w subsnces. pacular value were toxicological and meli da available on many of these subsnces (Pasteak et al., 1969), or othe losely relad by chemical stce, phaacological eet, or meli fa. In acco th the cauons p- viously set forth, the panel appli reasoning by alo, parcly whe the analogy appear dose, the chemical stcture was devoid of sus- picion, and the levels of use were ex- tremely low. Natu cuence e panel atch subsnal im- ponce tural occnce in food, pacly where e subsnce has bn found in a nr of dely consum foods. We have s (Hall et a!., 1968) that from a stctly toxicolocal point of view, the only basis for the popul as- sumpon that a tl flavong hs safe is the lack of evidence of a causal relation human illness due, in pa, failure even suspt it re is no scienfic ound for the lief that complex natural prucʦ would respond any better xio- logical tests for safety than their synthetic equivalents. Human expe- ence is relevant, however, and the more dely the subsnce cu, the higher the levels (where kno), and the greater the volume of consump- tion of the foods involved, the stronger the presumption of safety. It is reasonable (but unnes) to assume that such natul cuence in fo constutes "common use" within the meaning of the Fo Addi- tives Amendment. In any event, it provides an indicaon of pvious hu-

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Reprinted from FOOD TECH�OLOGY, Vol. 24, �o. 5, Pages : 25-28, 30-32 & 34

RECENT PROGRESS in the

Consicleration of Flavoring Ingredients

Under the Food Additives Amendment

4. GRAS Substances

RICHARD L. HALL aM BERNARD L. OSER

THE AUTHORS are r!!ipectively vice­p�dttnt of McCormick and Co. and president-elect of 1FT; and presidttnt of Food •nd Drvg Research Labonotories, Inc.

0 IN PREVIOUSLY published arti­cles (Hall. 1959, 1960; Hall et al., 1961, 1965, 1968), the authon have discussed the procedures by which flavoring ingredients reported to" be in prior use were considered with re­spect to the provisions of the Food Additives Amendment of 1958.

The initial screening, including gathering of all available informa­tion from industrial sources and the literature, was conducted by the Food Additives Committee of the Flavor and Extract Manufacturers' Associa­tion (FEMA). Finally, the collated data were studied by a panel of toxi­cologists and pharma.cologists re­

tained by FEMA. This panel consists of experts "qualliied by training and experience," whose un.animota agree­ment on general recognition of safety is required for a substance to be gen­erally recognized as safe (GRAS) under the provisions of the Food Ad­ditives Amendment.

In the course of that review (which took place from 195S-1964) 1,124 nat­ural and synthetic: ingredients were determined to be GRAS under condi­tions of intended use. Two hundred sixty-seven (267) were dropped from nse because adequate information was not available to meet the criteria es­tablished by the panel or the sub­stances in question were not of suffi­-:ient importance to justify developing the information needed. In a few cues, the existing data reflected un­

favorably on the ingredients or other closely related substances, and re­sulted in their discontinuance from use.

One of the more recent papers

(Hall et al., 1965) stressed that, since almost all of the substances then con­sidered had been in use prior to Jan­uary 1, 1958, "experience based on common use in food" (the language of the Food Additives Amendment) was an important factor in determin­ing general recognition of their safety.

The same sentence in the Food Ad­ditives Amendment just quoted pro­vides that a substance not in use prior to January 1, 1958, may be "generally recognized among experts qualified by scientific training and ex­perience to evaluate its safety, u

having been adequately shown through scientific: procedures (or, in the cue of a substance . . . ) to be safe under the conditions of ita intended use."

Indeed, among the substances in­cluded in the list in our previous re­

port (Hall et al., 1965), six were not in use prior to 1958, but were jud� by the expert panel to be GRAS on the basis of scientific procedures. More specifically, the panel reviewed available information on the chemis­try, metabolism, and toxicity of those substances and closely analogous ones, and judged that--under the con­ditions of intended use-there would be reasonable certainty among in­formed experts of their safety.

NEW DATA

IN THIS PAPER, we wish to report a number of later developments. In

part, these consist of action by the expert panel on a number of sub­stances newly-proposed for intentional use as flavor additives. The panel hu also reviewed additional toxicological and other information available on a number of ingredients previously judged to be GRAS. This served to affirm the previous judgment in all but two instances, in which the new

[ 1 J

information caused reversal of the prior finding.

In large part, the criteria previ­ously established by the expert panel for the evaluation of safety (Hall et al., 1961) can still be applied to these n�w substances. Of particular value were toxicological and metabolic: data available on many of these substances (Pasternak et al., 1969), or others c:losely related by chemical structure, pharmacological etf'ec:t, or metabolic: fate. In accord with the cautions pre­viously set forth, the panel applied reasoning by analogy, particularly where the analogy appeared dose, the chemical structure was devoid of sus­picion, and the levels of use were ex­tremely low.

Natural Occurrence

The panel attached substantial im­portance to natural occurrence in food, particulArly where the substance has been found in a number of widely consumed foods. We have stated (Hall et a!., 1968) that from a

strictly toxicological point of view, the only basis for the popular as­sumption that a natural flavoring hs safe is the lack of evidence of a

causal relation to human illness due, in part, to failure even to suspect it. Tht>re is no scientific ground for the belief that complex natural products would respond any better to toxic:o­logical tests for safety than their synthetic equivalents. Human experi­ence is relevant, however, and the more widely the substance occurs, the higher the levels (where known), and the greater the volume of consump­tion of the foods involved, the stronger the presumption of safety. It is reasonable (but unnecessary) to assume that such natural occurrence in food constitutes "common use" within the meaning of the Food Addi­tives Amendment. In any event, it provides an indication of previous hu-

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man coruumption agai.rult which to evaluate the propo&ed use.

GMP 1\fore Important

The panel does not consider that the proportions at which current in­formation indicates the proposed in­gredient naturally occurs, constitute a tolerance or limitation on inten­tional use. In part, such information merely retlects where, and how thor­oughly, analytical chemists happened to hav.e looked. The panel believes, however, that intended use at levels in excess of those toxicologically in­significant (National Academy of Sciences-National Research Council, 1969) would require stronger evidence of safety in the form of metabolic or toxicological data. Good manufac­turing practice ( G�iP), rather than current knowledge of natural occur­rence, is and should continue to be the governing rule on use. From this, it follows that levels of intended use figured importantly in the panel's judgments. This also conforms to past practice as well as the letter of the law.

The FE�A expert panel haa con­sidered a number of recent publica­tions (Clegg, 1965: Daniel et al, 1965; Eickholt et al, 1965; Elworthy et al, 1967; Frawley et al, 1965; Ha­gan et al, 1965; Hagan et al., 1967; Johnson. 1965) reporting the results of animal testing of a large number of flavoring ingredients previonaly judged to be GRAS, as well aa sev­eral, such u safrole, dihydroaafrole, i&o-safrole, and coumarin, no longer intentionally used aa fiavor compo­nents, and other substances never in wse. In the panel's opinion, the new data support previous judgments with one exception.

List Changes

In a recent paper (Taylor et al, 1967) the aut.'l:on reported that cala­mua oil, after 59 weeka of feeding at levels of 500 ppm and over, induced malignant tumors in rata. In view of this information, the panel concluded that calamus and ita oil or extract can no longer be claaaified aa "gen­erally recognized as sa!e."

The expert panel haa alao reviewed recently available information con­cerning- the production of cardi� le­sions by high levels of brominated veg-etable oils and the apparent ten­dency for bromine accumulation in body lipids as a result of the con­sumption of this materiaL In view of this, the panel haa concluded that Bromin.ated Vegetable Oila (No. 2,168) should continue under toxicological investigation, although at preaent

they can no long-er be regarded aa generally recognized aa safe.

No. 2,016, Alkanet Root, Extract, serves no function other than as a colorant. Since food colon are treated under a ditferent section of the sta­tute, it ia appropriate to drop this item from the GRAS liat.

No. 2,566, 2-Hexyl-4-Acetoxytetra­hydro!uran, haa been found not to have the identity indicated by this name, but instead to contain several non-isomeric components. In view of this, and shifting considerations of technological value, it is being dropped.

No. 2,744, 4-Methylqtrlnoline, is ac­tually 6-Methylquinoline. The term "p-Methylquinoline," though some­times used, is clearly a misnomer.

No. 2,786, 3-Nonanon-1-yl Acetate, haa been found actually to consist of a mixture of three related compounds. In view of this, it is being dropped, pending possible future review by the expert panel.

The names of the subrtances, No. 2,720, Methyl 2-methylthiopropion.ate, and No. 2,747, 2-methylthioproprion­aldehyde are incorrect. Utili:z::ing the same FEMA numbers, the corrected names are No. 2,720 Methyl 3-methyl­thiopropion.ate, and No. 2,747, 3-Methylthiopropionaldehyde.

Methyl Salicylate Reta.iDe«

The expert panel waa privileged to review a large ma.u a! recently avail­able data from both government and private sources, much of it u yet un­published. relating- particul.uly to the poaaible etfecta of high doaagee of methyl salicylate on reproduction eiH­ciency in rata and mice. It waa the panel's judgment that much of the data were not relevant to the quea­tion of u!ety !or man under the con­ditions of uae a! methyl aalicylate in food, including candy and chewing gum. Even greatly e,xanuated hu­man uae patterna are very far below the levela ahown to exert even a questionably toxic etfect. The meta­bolic pathways involved in the exces­sive dosages employed In the animal studies are undoubtedly different from those experienced at the low levels of human consumption. In view of the wide and much more relevant human experience with all salicylate& used

medicinally, including- methyl salicy­late, and the lack of clinical evidence of toxicity at levels conceivably aaao­ciated with food use, the panel re­affirmed ita previous judgment on the sa!ety of methyl salicylate aa a fia­voring substance and its conclusion that the substance for its intended uae in fLavoring is generally recog-­nized aa aa!e.

( 2 )

NEW LISTINGS ON THE BASIS of scientific proce­dures, the panel concludes that the substances listed in the following- ta­ble are GRAS under the conditiona of intended use listed for each. The lev­els shown correspond to the "Average Maximum Levels" defined in previous papers. While they would only rarely. be exceeded, they are not to be re­garded as setting rigid limits, but as general guidelines helping to define good manufacturing prll�ti�� in a�:­coni with the exposition contained in the 1965 paper.

REFERENCES Clen, D. J. 1965. At-x:. of t.ra�

effect of butyl.at.d by�l• IBHAI &Dd butyl.a� hyc�raxyt.o�,_ IBH'n in 111ta aDd au... Food Coenwtw: T�. a, 387.

De.niel. J. w .. aDd c.... J. c. 1965. n.. aboorpcjoa a.ad ncretioD of bvtyl.at.d by­dn:u}'101._ I BH'Ji U. tbe 111&. Food Co.m<lu: Tozicol. l, -406.

Eickholt, T. H., aDd Ben, R. H. 1965. Tos­iciti• of �t aDd Pyc� cl.Mac,,.. ..U.. Lam. LDbU.U... J. Plw.nro. &i. u. 1071.

Elworthy, P. H .. aDd Tr-. J. F. 1987. Pb)'lli'*'tPcaJ activity of IJOa.;...;, ....U.,. I&J>ta. lD "s..n.c- so-:. n:.-.-." Vol. I. "Noa-Ioaie �" 9'23. Man»l Dekbr, N- Yorit.

F111wley, J. P., KobA, F. E., Kay, J. H .. aDd C&laDdra. J. c. 1966. Procr- nopr7I'C ... multi.-.liaa rwprodactiae ....ru- Us 111ta fed buty!.at.d bydzoxy1DI-. IBHT). Food Co.,.,..lic Tr;:.zicol. J, :rn.

lUp.zo. E. C., J-. P. M., J-. W. I .. Fi�. 0. G., a_,_, J. B., a.ad Wobb, W. K. 1966. To:a:ie p� af <:ompoul><ia relat.d eo -.tn:M.t. TozU:ot. ApiX. P�t. 7, 18.

liapJ>, E. C., lu-, W. H .• Flbbud>, 0. G., J-. P. M., J-. W. I., Tay­lor, J. M., X..:.... E. L., N ...... A. A .. aDd B�. J. B. 1987. Food .daYOriD.p aDd ax>:>poUDda of ralat.d -=n. 2. Sub&cuta a.ad c:lua.ic lo:O.city. Food Co.­m•tic Tozia>t. 1, 1·U.

Hall, R. L. 19159. na...,nn. ..-�a u food ad.ditiv.a. Food T•clanol. U, 14.

Hall, R. L. 1960. � � U. the CDDo lidnaliaa ol � � u:zodoor tbe loocladdlti_... a.....dzne.t. Food T"lt,. 1'10/. u.. -4.88.

Hall, R. L., a.ad o-r, B. L. 1981. R..c.ot � U. the COC>Iidaratica of .da�..U.. �Ia UDd.w the food additi­a,.,. i ••L 2. Food T"lutol. u. 20.

Hall. R. L.. a.ad 0.., B. L. 1966. � p,.,.._ U. the CXll>llideratl(a of fta\OOrinc �Ia l1Dd.r the food additi .... ....-:!· moat. 3. GRAS ouber.a-. Food T#Cls­N>t. 11 !Part 2), 151.

Hall, R. L., aDd O..r, B. L. 1968. Ill "ReG· due R.evi...._" Vol. :U. 1. Sprizl.rw-Veriac N- York la.e., New York.

J'obaxs, A. R. 1966. A I'OoiiD.tDii:>a tioa of tbe �le t.era�c eilecta of buty!&tad hydn:n<y1oh- !BHT) aDd ita Oll!ect OD t.be rwproductive capacity of tbe ,_.., Food c�,.,..tic TC>Zicol. a, 371.

!'oalanWI. J. M., Lindo.r, A., aDd Vodcw., C. A. 1989. Tot:ieolc,.;c:al !Mia OD .e.....,.,... ma&o la111. Food Coom•n.: To:neot. 7, ..O.S.

Sp.c:ioJ Taalt Fon» of tbe Food Protactiaa Coauni ttee. 1989. Guidelli>oe for Ntima c­iq t.oxicoloorically ioai..ulkaDt 1..-.IA of c:b.omicaJ.a U. food. Natia>al Aca.dany of

Sci..,.__Natioaa! R-.rcb eo.-:..1, Wa.ob­i..,.toa.

Taylor, J. M., J=-. W. I., Hap.n. E. C .. G..,.., M. A., Davia. D. A .• aDd Cook, E. L. 1967. Tox:ic:ity of oiJ of c:ala.mue (JammtJ vanetyl. Tos=l. ApiX. Ph4nr.o· col. 10, -406.

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SURVEY OF FLAVORING INGREDIENT USAGE LEVELS

Fla,or and Extract ManufiiCture�· Association average maximum use levels (in ppm) on wnicn tne expert panel based its judg-

meniS tnat tne substances are generally recognized as safe. Those substances wnicn are to be used at NOT more tnan 10 ppm in finished food are indicated witn an asterisk.

Ice Cn-am Baked Gel.atina Chewinc FE.'fA. No. and Subetance Beverac• lc .. , Et.e. Cancl7 Goodo A Puddinn Gum Othn Ca�oi'J' UN

-----··

3.125 ACETALDEHYDE, BUTYL PHENETHYL

ACETAL 6.0 6.0 6.0 6.0 6.0

:1.126 "ACETYLPYRAZINE- · 6.0 5.0 6.0

Methyl pyra .. inyl ketone

3.i27 Condimrnt. ALLYL METHYL DISULFIDE 1.0 1.0

Mft>U.I Mcot&ueeo

1.0 PiclcUo Soupe

1.0 1.0 3.128

2·BENZOFURANCARBOL\LDEHYD!:-2-Formylbenzofuran 10. 10. 20. 10.

3.129 BIPHENYL 2.0 2.0 2.0 2.0 2.0

3.130 BUTYLAMINE 0.10 0.10 0.10 0.10 0.10

3.131 ,.<-BUTYL ETHYL ETHER 1.0 1.0 1.0 1.0

3.132 Cn"ftllo •z.ito-BUTYI-3-METHOXYPYRAZINE 0.06 0.06 0.06 0.05 0.06 0.05 0.06

Condimrnu 0.06

Mft>U.t MftliSoue'•

0.06 MUir .I

Doi.ry Pdlo. Soupe 0.06 O.Ot

3.133 6.0 6.0 5.0 - - 6.0 6.0 "2-ioo-BUTYI-3-METRYLPTRAZINE-

2-Methyl-3-i-butylpJT&Kine

Mft>U.I 3,134 MratSo�•

2-ioo-BUTYL THTAZOLE 1.0 1.0 1.0 1.0 1.0 1.0 Soup. Sauer� 1.0

1.0 y,�r..

1.0

3,135 Cn"ftllo 2-traM,4-traM-DECADil:N AL 10. 10. 10. 10. 10. 10. 10.

Mft>U.I Mftll&ueeo

10. y,plllbuo

10.

3.136 •2,3.DIETRYLPYRAZ.IN'E 1.0 1.0 1.0 1.0

3,137 Mft>U Sftllood. 2,6-DIMETHOXYPH!:NOL 3.0 2.0

Soupe o.ao

3.138 Mrau Soup. 3,4-DIMETHOXY-1-V1NYLBEN2'XN!l 2.0 2.0 2.0 2.0 2.0 2.0

3,139 p,a.-DIMETRYLBENZYL ALCOHOL-

Methyl p.tolyl <arbinol 10. 10. 10.

3.UO 2.6-DIMETRYI-4-HEPTA.NOL-

di-i•o-Butyl carbinol 20. 20. 20. 20. 20.

3.141 2,6-DIMETRYI-10-METHYLENE:-2,6,11-

DODECA TR:r.E:N Al.--G-Sinell&&l 10. 10. 10.

3.142 3,7-Dl.METHYI..+OCTENOIC ACID-

Citronellie aeid tl.5fJ 0.50 0.50 0.60 0.50

3.143 2,4-DP.>IETHYL-2-PENTENOIC ACm 1.0 1.6

3,144 p,a.-DIMETRYLSTYRENE-

1-Methyl-4-uo-prop.-nyl�•; p.i•o-Pro�nyltoluene 0.16 2.3 1.0

3.145 2,4-DIMETHYL-5-V1NYL THIA.ZOLE 0.10 0.60 0.60 0.60 0.60

r 3 J

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FEMA No. and Suboot&nee

3.146 2,2'-CDITHIODIME'I'HYLENE)-DJFURAN�

2-Furfu.ryl di.aulllde

3,147

1-ETHYL-2-ACETYLPY RROLE

."1.148

ETHYL tron.-2,cu-•-DECADIENOATE

3.149

•2-ETHYL-3.5 or 6-DIMETHYLPYR.A.Z.INE

3.150

•3-ETHYL-2.6-Dl.!(ETHYL� 2,6-DimethJ'1-3-ethJ'Ipyrasiae

3.151

2-EI'HYL-1-JJF:LUIOL

3.152

3-ETHYL-2-HYDROXY-2-CYCLO PENTI:N-1-0NE

. . ,

3.153

6-ETHYL-3-HYDROXT ...C..WrnJTL-2 C 6Bl -FURANO!fB--2,4-Dfh:rd:n:rrJ'· 3-mod!J'1-2-II""'.-ie .ad, 'l'-lactDne: 2-Etlm-3-n>othJ' 1-C-bJ'ch-orJ-dih}'dro-(2,5)-fun.J�....k>ae: 2-H:rcfroxy. 3-m.tl>J'1·'l'·2-be::tftl0lac1o1W

3.154

•2-ETHYL-6-1fin'HTLPYRAZINE .

_, : . -r .'.

.. - . . 3.155

• 3-:E:I'HYL-2-METHYLPYRAZINE

3.156

p..ETHYLPHENOL

3.151

ETHYL I P-TOLYLOXY)ACETAT!l-EthJ'1 p-.:reeo:r;'J'11Cetat.

3158

2-�JOL FORMATE 3.159

FURFURYL !dETBYL ETHER

3.160

FURFU"RYL Ml:rHYL SULFIDE 3.161

FURFURYL uo-PROPYL SULFIDE .1.162

FURFURYL TIJIOACETATE 3.163

2-FURYL METHYL KETONE-2-A<etJ"lfuraa

3,164

2.4-HEPTADI'ENAL

r�: c"""" Ca�d)o :s.-..... ..... Jceo, EtA:.

. '! .... _, .

1.0 1.0 1.0

.... . . .

6.0 6.0 5.U

10. 10. 10.

6.0 6.0

6.0 6.0 6.0

10. 10. 10.

10. 10. 10.

1.0

6.0 6.0

3.0 3.0 3.0

8.0 •o.

. .. 1.0 1.0 •• v

z.o 2.0

1.0 1.0 1.0

0.60 0.60 0.60

0.20 l.C 1.5

1.0

f')

Baked G�launa Chewi,.-Good.o 6 Puddian Gum

1.0 1.0 1.0

6.0

10.

5.0 2.0

6.0

10.

10. 10.

1.0 1.0

6.0 2.0

3.0

0.20

2.0

1.0

0.60

1.0

20.

1.0

Oth<T Cat,..ory UM

Condimrnto 1.0

Mrau& Mrot�•

1.0 Mille&

Dairy Pdt•. Soupe 1.0 1.0

Crrro.U 2.0

Condimrnt. 2.0

MNlll& Meat�•

2.0 MilJt&

Dairy Pdt.. 1.0

Cerro.U 10.

Condimrnto 10.

Mrat. & MratS<wcn

10. Millt &

DairyPdJ•. Soap. 10. 10.

Crl"fttU 2.0

Condimnrt. 2.0

M-.1-M rat So:a.oen

z.o Millt&

Dairy Pdt•. Soup. 1.0 z.o

Marrari-0.20

Saucn 2.0

Condimnrt. 20.

M-& Meat Sc.utn

20. Soupe 20.

Condiment. 1.0

Meat.& Mrat&ucr•

1.0 Soup.

1.0

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lee c�m Bu«� Ge-lati� Chrwin�r FE!dA No. and Subotance B�v�ralif'&- ic ... Ete. Candy Good. A Puddinn Gum Oth<T c.�..,. u ..

3.165 Condi.mrnlo 2-HEJ""""EN AL 1.0 1.0 1.0

MraU.i-Mrat Sau«o

1.0 Sou�

1.0

3.166 �.u.�.6. 7 ,S-HEXA HY 0 R0-6-uo-

PROPE...>;YI-�.••-01:-.!ETHYL-2t3Hl-NAi'H11fALENONL-No<>tkatone: 4a.5-0iml'thyl-1,2,3.4 •

.ta.6.,. 7 -octa.h)·dro..; ·k��3.i.o-pro""nylnaphthalme; 5,6-0iml'lhrl-8-ioo-pro""nrl bicy<lo-t 4.�.0)-d«:·l-e-n·3..one 10. 10.

3.167 Margarine 6-HEXALACTONE 10. 10. 10. 10. 10. 10.

S4Jiul Oil 10.

SADrlrni"l 10.

3.168 3,4-HEXA.SEOIO!-."E 10. 10. 10. 10.

&Uul 3.169 v, ... ,,...

trana-2-HE...'U:.."'OIC ACID 5.0 5.0 6.0 5.0 5.0 1.0 50.

Mill« .I-3.170 Dairy Pdlo.

3-HEXENOIC ACID 10. 10. 10. 10. 10. 10. 50.

3.171

cio-3-HEXEN-1-YL ACETATE 0.40 0.40 0.50 0.50

3.172

HEXYL .:.O.BUTYRATE 20. 20. 20. 20. 20.

3.173

1-HYDROXY-2-BUTA.NONE 30. 30. 30. 80.

3.174

4-HYDROXY-2,5-DIMETHYL-3 (2HJ-FURA.NONE 6.0 10. 10. 5.0

3.175

1-IONONE--+-(2.2-Dfmethyl-5-ml'lhrlme-eyeloberrl)-3-buten-2-one 10. 10. 10.

3.176

p..ME.VTHA..."'-2-0NE Tetrabyd�one; Carvomenthone 10. 10. 10.

3.1n

p..MENTHA.-3-THlOL-3-0NE--8-Mereapto-p..menthane-3-one 1.0 1.0 1.0 1.0 1.0 1.0

3.178

p..MEN'TH-1-E."'E-9-AL 2.0 z.o 2.0 2.0

3,179

p..ME.""'TR-1-EN'-S-OL-Pi;>erit.ol 20. 20. 20.

3.180 MraU.i-

2-MERCAPTOPROPIONIC ACID Mtat�•

Thiol..:tie acid 50. Sou� 50.

3.181

o-METHOXYC��AMA.LDEHYDE 30. 40. �50.

3.182

p..METHOXY -a-METHYL C I'NN .u!ALOE.HYDE i.O- Hi.

3.183

•2-,5 or 6-�fETHOXY-3-!.n:THYL-PYRA.ZL.-..."E ! Mixture o! iaomenl 2.0 4.0 4.0 2.0

3.184

1-METHYL-2-ACETYLPYRROLE 10. 10. 10. 10.

3.185

METHYLATED SILICA 11. 11. u. 100.

3.166

4-METKYLBIPHENYL-p..Ml'lhrld.lpbf!':IYI 5.0 5.0 6.0 5.0

3.187 3-!dETRYLCROTONIC ACID-

3.3-0imetbylaaylle a.c:id; tl.ti-Inml'lhrlacrylie a.c:ld; S..neeiole add 5.0 5.0 5.0 5.0

3.188 Condimrnu 2-METHYW-FURA.NTHIOL 0.25 0. 25

MNto.i-MNt&weu

o..u Soupe

o..u

[ 5)

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Ieee......, Baked c.�au- Ch ... in• FE!olA No. and Subftaaee :s.-nr. ... lc•, Et&. C&Dcb' Goodlo A PlldCinn GIIDI Othft' Cat.n..,. Uae

3.189 •z-METHYW-,5 or s-FURFURYL co,.,u,,.,,. s...-.

TIIIOPYRAZJNE (Mixture of iaomft'a) 1.0 1.0 1.0 1.0 1.0

3,190 &-METIIYL-2,3-HEXANEDIONE 20. 20.

3.191 2-METHYLHEXANOJC ACID 3.0 2.0 %.0

3.192 Mrot. &upe 2-METIIYL-S-METHOXYTRIAZOLE 2.0 4.0 2.0 2.0

3.193 1-METIIYL.VAPHTHA.LENE 1.0 1.0 1.0 1.0

3.194 2-METHYL-2-PE.VTENAL 30. 30. ao. 30. 30. ao.

3.195 CoruW!v"t. 2-:METHY'L-2-PEN'Tl:l'iOJC ACID 1.0 1.0 1.0

Mftda& Mftll&wc-r•

1.0 Soup.

1.0 3,196

. 3-WETHYL-2-(2-PEN'l"!:NYLl -2-CYCLO· PF.N'I'EN-1-0� umoae 10. 10. 10. 10.

3,197 a-METHYLP� Btrl'TRAT!:-

1-Ph..,,.J.Z-propyl butyrate o.so 3.0 1.0 a.o

3.198 ME"I'HYL PHENETHYL ETHER 20.

3.199 5-METHYL-2-PHENYL-2-HEXENAL 25. 2.5. 2.5. 2.5. 2.5. 25.

3.!!00 4-METBYL-Z-PHENYL-2-PEN"l'EN AL 1.5 1.5 1.5 1.5 1.5 1.5

3.201 Co�rde

METHYL PROPYL DISULFIDE 1.0 LO M-.A

M-� 1.0

Pi.cltl.rw 1.0

Soup. 1.0

3.:!0: METHYL 2-PYRROLYL KETONE-

2-Acrtylpyrrole 50. 50. 50. 50.

3.203 &-METBYLQUINOXA.LINE 10. 10. 10. 10.

3.204 CnwvJ.. �-ME:'I"HY1-6-TBIAZO I..E:&TRANOL-

4-M..thy 1-6-( 6-hyclzoxyethy I) -t.hiaso le 55. 65. 55. 55. 56. u. -- u.

Cort.dimlrola "·

M-& Mrat SI:DM:r•

51. Millt &

DairyPdle. 55.

&w.p. 151.

3.205 CnwvJ.. 4-METHYL-6-TBIAZQL!:XJ:llAl{OL:

ACETATE 55. 65. 55. 65. 55. 55. 55. CoruW!vrde

51. M-&

M-&wc-r• 55.

Millt & Dairy Pd.t•. &upe

65. 65.

3.206 CnwvJ..

2-M ETHYL THlOACET ALDEHYDE 0.50 0.50 0.50 0.50 0.�0 0.50 0.50 Corodi""'..U

0.50 Mrate&

Mrat &DM:r• 0.50

Millt.A Dairy Pdle. Soup.

0.50 0.50

3.207 CoruW!v..U

l-IMETRYLTH10)·2·BUTANONE 1.0 Stw.c••

1.0 Soup.

1.0

3.208 • (METHYL THIO l !U:THYLPY1lAZINE

tMillture o( !sotal'T'Ol-2-MethJ'I· 3-,5 or 6-mothyltbiop:rrasine 2.0 2.0 4.0 2.0

£ t1 I

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lee Cn.m B&k..t Gelatina Chrwin lf FEJIA No. and Sut.un ... B.v•,._.• , ••• E\e. Canc17 � " Puddlnn Gum 0 ther Cat..cory u ..

• 1.20!1 5-METiiYL-2-TRIOPHENECARBOX- CenaZ.

ALDEHYDE 0.60 0.60 0.60 0.60 0.60 0.60 0.60 Condirnrnt•

11.60 Meat• &

Meat &ue .. 0.60

Millr& Dau-y Pdt..

0.60 &upe

0.60

3.210 o-tMETHYLTHIOI-PHENOL-

2·1Mnhylthio)phe-aol: ThiolfUAiaeol 0.20 0.20 0.20 0.20

3.211 •2-METHYt...s-VINYLPYRAZINE 10. 10. 10. 10.

3.212 c .. eaZ. 2,4-NONADJENAL 0.20 0.20

Condiment• 0.20

Meat•& Meat &ucr1

0.20 Millr&

Da1ry Pdt1. &u,.. 0.20 0.20

3.213 c ..... z. 2-NON'ENAL 0.20 0.20

Condimrnt. 0.20

MNtlci' M tel So.uft•

0.20 Millt4

Da1ry Pdt1. &u,.. 0.20 0.%0

3.214 Marrarint �-OCT A LACTONE 20. 20. 20. 20. 20. 20.

54lad Oil 20.

SADrt�ninl 20.

3.215 Condiment•

2-0CTENAL 1.0 1.0 1.0 MNt.4

M rat Sa.u.c--1 1.0

.sou,.. 1.0

3.216 PARAFFIN WAX "-Petroleum wax:

Paraffin

3.211 Cenclo

2,4-PENTADIENAL 1.0 1.0 1.0 1.0 1.0 1.0 1.0 Con.dime11t1

1.0 MNt. &

M eel 5o.uft, 1.0

Millr& Dairy Pdll.

1.0 Soupe

1.0

3.218 2-PE.�TE.l'<AL 10. 10. 10.

3.219 ioo-PEN1'YI.AMn.�Am7la1Ditle:

0.10 3-Methylbut:rla.mine 0.10 0.10 0.10 0.10

3.220 PHE."'ETHY!.Al41NE 0.10 0.10 0.10 0.10 0.10

3.221 PHENETHYL HEXANOATE 1.0

3.222 PHENETHYL OCTANOATE 6.0

3.223 0.60 c .. �o PHENOL 0.60 0.60 0.60

3.224 2.0 2-PHEN YL-2-BUTEN AL 2.0 2.0 2.0 2.0 2.0

3.225 PHENYL DISULFID�Diphcn71 diauHide 1.0 1.0 1 .0 1.0

3.226 1-PHE."<YL-1.2-PROPANEOIONE 111. 10. 10. 10.

• For Ustt &a a t!.avor adjunct tn -.ceord with aOOd m.anu!a.cturin&' pra.rtice

( 7 ]

Page 8: 4. GRAS Substances - Flavor Extract Manufacturers .... GRAS Substances (3125-3249).pdf · 0 IN PREVIOUSLY published arti ... of experts "qualliied by training and ... ompoul>

Ice c._.. BU.-I c�latina Ch .... ina FE!i!A No. and Sut.t.anee Jlo-<<1qa lea, .r::t.c.. c� c-a. " Puddinp Cum Othor Ca� U•

3.221 Condim�..u PROPENYL PROPYL DlSULl"IDl!l 2.0 2..0

Mftltlrcl M"a Sou«•

2.0 Piclol�•

2.0 Soupa

2.0

3.218 Soupa Spk'• PROPYL DISULFIDE 6.0 10.

3.229 uo-PROPYL ncLATE- &lodOil s-p.

Uo-Propyl Cl·methTI erotonie aeid 5.0 1.0 10. 1.0

3.230 •PYRAZINE ETRA.NETBIOL-

Pyraziayl ethaae-tbiol 10. 10. 10.

3.231 •PYRAZINYL :!IIETHYL SUI.FIDE-

Pyrasinyl met.b71 me1.hJ'I •aU!IIe 1.0 1.0 1.0

3.232 2-PYRIDINEKE'I"HANE'l"OL-

2-Pyrid,.Jmot.hane-t.bio1 2.0 2.0 z.o 2.0

3.233 STYRENE 0.20 0.20 0.20

3.235 . 4.6.6. 7-TETRARYDR0-3.6-Dn.!E"''RYL-

BENZOFURAN-Mentho!uraa -ro. -ro. 10.

3.23S TETR.AHYDRO-'-KETHYL-2- I 2-Ja:I"HYL.

PROPEN-1-YL) PYRAN-Rooe ozi<l. 0.40 2.0 2.0

3.231 Coruum�nt. "2,3,5.6-TETR.A:!IIETHYLPYRAZINE 5.0 5.0 5.n 10.

Mraucl Mft>l&ucn

10. Mi/Jocl

Dairy Pd:U. 6.0

So,... 10.

3.238 2.2'-(TiilODIMETHYLENEl-DIFURAN- Condiment.

2-Furfuryl moaoouUI<I. 1.0 1.0 1.0 1.0 1.0 1.0 1.0 Mraucl

Mft>l S<w«• 1.0

Soupa 1.0

3.239 •-rnu J ANOL--Sabi�aehTdrua 10. 10. 10. 10.

3.240 Sauc�• So,... o-TOLUENETHIOL-2-M�J'ltbiopb...,ol 0.20 0.20 0.20

3.241 So,... TRIMETHYLA.liUNE 0.10

3.242 p.a,e�,TRIMETHYLBENZYL ALCOHOL-

poCymen-kl; DimrthJ'l p-tolyl ea.rblaol 0.20 2.3 1 0

3.243 4·( (2.6.6 1-TRDoU:THYL CYCLOH!:X·

1-ENYL) BUT-2-EN-4-0NJ: 10. 10. 10. 10. 10. 10.

3.244 CrrruJ. "2.3.5-TRI.METHYLPYRAZINE 5.0 5.0 5.0 2.0

10. 10. 10. Condim�nt. 2.0

Mrau4 MftJl�••

2.0 Mi/114

Dairy Pd.u. 1.0

Soup. 2.0

3.245 UNDECANOIC ACID 2.0

3.246 2-UNDECANOL 20.

3.247 10..UNDECENOIC ACID 0.60 0.60 0.50 0.50

3.2-18 o-VINYLANISOLE 10. 10. 10.

3.219 Condim•nto 2.6-X YLENO L-2.6-Dim<thylphenol 1.0 1.0

[ 8 1