and Drug Administration, HHS § 172.510

Subpart E—Anticaking Agents (c) It is used or intended for use as a stabilizer in the production of beer, and § 172.410 Calcium silicate. is removed from the beer by filtration Calcium silicate, including synthetic prior to final processing. calcium silicate, may be safely used in (d) It is used or intended for use as an food in accordance with the following adsorbent for dl-a-tocopheryl acetate prescribed conditions: and pantothenyl in tableted (a) It is used as an anticaking agent for special dietary use, in an in food in an amount not in excess of amount not greater than that required that reasonably required to produce its to accomplish the intended physical or intended effect. technical effect. (b) It will not exceed 2 percent by weight of the food, except that it may § 172.490 Yellow prussiate of soda. be present up to 5 percent by weight of (a) The food additive yellow prussiate baking powder. of soda (sodium ferrocyanide decahy- drate; Na Fe(CN) ·10H O contains a § 172.430 Iron ammonium citrate. 4 6 2 minimum of 99 percent by weight of so- Iron ammonium citrate may be safe- dium ferrocyanide decahydrate. ly used in food in accordance with the (b) The additive is used or intended following prescribed conditions: for use as an anticaking agent in salt (a) The additive is the chemical and as an adjuvant in the production of green ferric ammonium citrate. dendritic crystals of salt in an amount (b) The additive is used, or intended needed to produce its intended effect for use as an anticaking agent in salt for human consumption so that the but not in excess of 13 parts per million level of iron ammonium citrate does calculated as anhydrous sodium ferro- not exceed 25 parts per million (0.0025 cyanide. percent) in the finished salt. [42 FR 14491, Mar. 15, 1977, as amended at 58 (c) To assure safe use of the additive FR 17098, Apr. 1, 1993] the label or labeling of the additive shall bear, in addition to the other in- Subpart F—Flavoring Agents and formation required by the Act: (1) The name of the additive. Related Substances (2) Adequate directions to provide a § 172.510 Natural flavoring substances final product that complies with the and natural substances used in con- limitations prescribed in paragraph (b) junction with . of this section. Natural flavoring substances and § 172.480 Silicon dioxide. natural adjuvants may be safely used The food additive silicon dioxide may in food in accordance with the fol- be safely used in food in accordance lowing conditions. with the following conditions: (a) They are used in the minimum (a) The food additive is manufactured quantity required to produce their in- by vapor phase hydrolysis or by other tended physical or technical effect and means whereby the particle size is such in accordance with all the principles of as to accomplish the intended effect. good manufacturing practice. (b) It is used as an anticaking agent, (b) In the appropriate forms ( subject to the following conditions: parts, fluid and solid extracts, con- (1) It is used in only those foods in cretes, absolutes, oils, gums, balsams, which the additive has been dem- resins, oleoresins, waxes, and dis- onstrated to have an anticaking effect. tillates) they consist of one or more of (2) It is used in an amount not in ex- the following, used alone or in com- cess of that reasonably required to bination with flavoring substances and produce its intended effect. adjuvants generally recognized as safe (3) [Reserved] in food, previously sanctioned for such (4) It is used in an amount not to ex- use, or regulated in any section of this ceed 2 percent by weight of the food. part.

49

VerDate 112000 12:37 Apr 16, 2001 Jkt 194064 PO 00000 Frm 00049 Fmt 8010 Sfmt 8010 Y:\SGML\194064T.XXX pfrm02 PsN: 194064T § 172.510 21 CFR Ch. I (4–1–01 Edition)

Common name Scientific name Limitations

Aloe ...... Aloe perryi Baker, A. barbadensis Mill., A. ferox Mill., and hybrids of this sp. with A. africana Mill. and A. spicata Baker. Althea root and flowers ...... Althea officinalis L. Amyris (West Indian sandalwood) ...... Amyris balsamifera L. Angola weed ...... Roccella fuciformis Ach ...... In alcoholic beverages only Arnica flowers ...... Arnica montana L., A. fulgens Pursh, A. sororia Do. Greene, or A. cordifolia Hooker. Artemisia (wormwood) ...... Artemisia spp ...... Finished food thujone free1 Artichoke leaves ...... Cynara scolymus L ...... In alcoholic beverages only Benzoin resin ...... Styrax benzoin Dryander, S. paralleloneurus Per- kins, S. tonkinensis (Pierre) Craib ex Hartwich, or other spp. of the Section Anthostyrax of the genus Styrax. Blackberry bark ...... Rubus, Section Eubatus. Boldus (boldo) leaves ...... Peumus boldus Mol ...... Do. Boronia flowers ...... Boronia megastigma Nees. Bryonia root ...... Bryonia alba L., or B. diocia Jacq ...... Do. Buchu leaves ...... Barosma betulina Bartl. et Wendl., B. crenulata (L.) Hook. or B. serratifolia Willd. Buckbean leaves ...... Menyanthes trifoliata L ...... Do. Cajeput ...... Melaleuca leucadendron L. and other Melaleuca spp. Calumba root ...... Jateorhiza palmata (Lam.) Miers ...... Do. Camphor tree ...... Cinnamomum camphora (L.) Nees et Eberm ...... Safrole free Cascara sagrada ...... Rhamnus purshiana DC. Cassie flowers ...... Acacia farnesiana (L.) Willd. Castor oil ...... Ricinus communis L. Catechu, black ...... Acacia catechu Willd. Cedar, white (aborvitae), leaves and twigs ... Thuja occidentalis L ...... Finished food thujone free1 Centuary ...... Centaurium umbellatum Gilib ...... In alcoholic beverages only Cherry pits ...... Prunus avium L. or P. cerasus L ...... Not to exceed 25 p.p.m. prussic acid Cherry-laurel leaves ...... Prunus laurocerasus L ...... Do. Chestnut leaves ...... Castanea dentata (Marsh.) Borkh. Chirata ...... Swertia chirata Buch.-Ham ...... In alcoholic beverages only Cinchona, red, bark ...... Cinchona succirubra Pav. or its hybrids ...... In beverages only; not more than 83 p.p.m. total cinchona alkaloids in finished beverage Cinchona, yellow, bark ...... Cinchona ledgeriana Moens, C. calisaya Wedd., or Do. hybrids of these with other spp. of Cinchona.. Copaiba ...... South American spp. of Copaifera L. Cork, oak ...... Quercus suber L., or Q. occidentalis F. Gay ...... In alcoholic beverages only Costmary ...... Chrysanthemum balsamita L ...... Do. Costus root ...... Saussurea lappa Clarke. Cubeb ...... Piper cubeba L. f. Currant, black, buds and leaves ...... Ribes nigrum L. Damiana leaves ...... Turnera diffusa Willd. Davana ...... Artemisia pallens Wall. , Indian ...... Anethum sowa Roxb. ( graveolens Benth et Hook., Anethum graveolens L.). Dittany (fraxinella) roots ...... Dictamnus albus L ...... Do. Dittany of Crete ...... Origanum dictamnus L. Dragon’s blood (dracorubin) ...... Daemonorops spp. Elder tree leaves ...... Sambucus nigra L ...... In alcoholic beverages only; not to exceed 25 p.p.m. prussic acid in the Elecampane rhizome and roots ...... Inula helenium L ...... In alcoholic beverages only Elemi ...... Canarium commune L. or C. luzonicum Miq. Erigeron ...... Erigeron canadensis L. Eucalyptus globulus leaves ...... Eucalyptus globulus Labill. Fir (‘‘pine’’) needles and twigs ...... Abies sibirica Ledeb., A. alba Mill., A. sachalinesis Masters or A. mayriana Miyabe et Kudo. Fir, balsam, needles and twigs ...... Abies balsamea (L.) Mill. Galanga, greater ...... Alpinia galanga Willd ...... Do.

50

VerDate 112000 12:37 Apr 16, 2001 Jkt 194064 PO 00000 Frm 00050 Fmt 8010 Sfmt 8010 Y:\SGML\194064T.XXX pfrm02 PsN: 194064T Food and Drug Administration, HHS § 172.510

Common name Scientific name Limitations

Galbanum ...... Ferula galbaniflua Boiss. et Buhse and other Ferula spp. Gambir (catechu, pale) ...... Uncaria gambir Roxb. Genet flowers ...... Spartium junceum L. Gentian rhizome and roots ...... Gentiana lutea L. Gentian, stemless ...... Gentiana acaulis L ...... Do. Germander, chamaedrys ...... Teucrium chamaedrys L ...... Do. Germander, golden ...... Teucrium polium L ...... Do. Guaiac ...... Guaiacum officinale L., G. santum L., Bulnesia sarmienti Lor. Guarana ...... Paullinia cupana HBK. Haw, black, bark ...... Viburnum prunifolium L. Hemlock needles and twigs ...... Tsuga canadensis (L.) Carr. or T. heterophylla (Raf.) Sarg. Hyacinth flowers ...... Hyacinthus orientalis L. Iceland moss ...... Cetraria islandica Ach ...... Do. Imperatoria ...... Peucedanum ostruthium (L.). Koch (Imperatoria ostruthium L.). Iva ...... Achillea moschata Jacq ...... Do. Labdanum ...... Cistus spp. Lemon-verbena ...... Lippia citriodora HBK ...... Do. Linaloe ...... Bursera delpechiana Poiss. and other Bursera spp. Linden leaves ...... Tillia spp ...... Do. ...... Levisticum officinale Koch. Lungmoss (lungwort) ...... Sticta pulmonacea Ach. Maidenhair fern ...... Adiantum capillus-veneris L ...... Do. Maple, mountain ...... Acer spicatum Lam. Mimosa (black wattle) flowers ...... Acacia decurrens Willd. var. dealbata. Mullein flowers ...... Verbascum phlomoides L. or V. thapsiforme Schrad Do. Myrrh ...... Commiphora molmol Engl., C. abyssinica (Berg) Engl., or other Commiphora spp. Myrtle leaves ...... Myrtus communis L ...... Do. Oak, English, wood ...... Quercus robur L ...... Do. Oak, white, chips ...... Quercus alba L. Oak moss ...... Evernia prunastri (L.) Ach., E. furfuracea (L.) Mann, Finished food thujone and other lichens. Olibanum ...... Boswellia carteri Birdw. and other Boswellia spp. Opopanax (bisabolmyrrh) ...... Opopanax chironium Koch (true opopanax) of Commiphora erythraea Engl. var. Llabrescens. Orris root ...... Iris germanica L. (including its variety florentina Dykes) and I. pallida Lam. Pansy ...... Viola tricolor L ...... In alcoholic beverages only Passion flower ...... Passiflora incarnata L. Patchouly ...... Pogostemon cablin Benth. and P. heyneanus Benth. Peach leaves ...... Prunus persica (L.) Batsch ...... In alcoholic beverages only; not to exceed 25 p.p.m. prussic acid in the flavor Pennyroyal, American ...... Hedeoma pulegioides (L.) Pers. Pennyroyal, European ...... Mentha pulegium L. Pine, dwarf, needles and twigs ...... Pinus mugo Turra var. pumilio (Haenke) Zenari. Pine, Scotch, needles and twigs ...... Pinus sylvestris L. Pine, white, bark ...... Pinus strobus L ...... In alcoholic beverages only Pine, white oil ...... Pinus palustris Mill., and other Pinus spp. Poplar buds ...... Populus balsamifera L. (P. tacamahacca Mill.), P. Do. candicans Ait., or P. nigra L. Quassia ...... Picrasma excelsa (Sw.) Planch, or Quassia amara L. Quebracho bark ...... Aspidosperma quebracho-blanco Schlecht, or Schinopsis lorentzii (Quebrachia lorentzii (Griseb)). (Griseb.) Engl. Quillaia (soapbark) ...... Quillaja saponaria Mol. Red saunders (red sandalwood) ...... Pterocarpus san alinus L ...... In alcoholic beverages only Rhatany root ...... Krameria triandra Ruiz et Pav. or K. argentea Mart. Rhubarb, garden root ...... Rheum rhaponticum L ...... Do. Rhubarb root ...... Rheum officinale Baill., R. palmatum L., or other spp. (excepting R. rhaponticum L.) or hybrids of Rheum grown in China. Roselle ...... Hibiscus sabdariffa L ...... Do. Rosin (colophony) ...... Pinus palustris Mill., and other Pinus spp ...... Do. St. Johnswort leaves, flowers, and caulis ...... Hypericum perforatum L ...... Hypericin-free alcohol dis- tillate form only; in alco- holic beverages only

51

VerDate 112000 12:37 Apr 16, 2001 Jkt 194064 PO 00000 Frm 00051 Fmt 8010 Sfmt 8010 Y:\SGML\194064T.XXX pfrm02 PsN: 194064T § 172.515 21 CFR Ch. I (4–1–01 Edition)

Common name Scientific name Limitations

Sandalwood, white (yellow, or East Indian) ... Santalum album L. Sandarac ...... Tetraclinis articulata (Vahl.), Mast ...... In alcoholic beverages only Sarsaparilla ...... Smilax aristolochiaefolia Mill., (Mexican sarsaparilla), S. regelii Killip et Morton (Honduras sarsaparilla), S. febrifuga Kunth (Ecuadorean sarsaparilla), or undetermined Smilax spp. (Ecuadorean or Central American sarsaparilla). Sassafras leaves ...... Sassafras albidum (Nutt.) Nees ...... Safrole free Senna, Alexandria ...... Cassia acutifolia Delile. Serpentaria (Virginia snakeroot) ...... Aristolochia serpentaria L ...... In alcoholic beverages only Simaruba bark ...... Simaruba amara Aubl ...... Do. Snakeroot, Canadian (wild ginger) ...... Asarum canadense L. Spruce needles and twigs ...... Picea glauca (Moench) Voss or P. mariana (Mill.) BSP. Storax (styrax) ...... Liquidambar orientalis Mill. or L. styraciflua L. Tagetes (marigold) ...... Tagetes patula L., T. erecta L., or T. minuta L. (T. As oil only glandulifera Schrank). Tansy ...... Tanacetum vulgare L ...... In alcoholic beverages only; finished alcoholic beverage thujone free1 Thistle, blessed (holy thistle) ...... Onicus benedictus L ...... In alcoholic beverages only Thymus capitatus (Spanish ‘‘origanum’’) ...... Thymus capitatus Hoffmg. et Link. Tolu ...... Myroxylon balsamum (L.) Harms. Turpentine ...... Pinus palustris Mill. and other Pinus spp. which yield terpene oils exclusively. rhizome and roots ...... Valeriana officinalis L. Veronica ...... Veronica officinalis L ...... Do. Vervain, European ...... Verbena officinalis L ...... Do. Vetiver ...... Vetiveria zizanioides Stapf ...... Do. Violet, Swiss ...... Viola calcarata L. Walnut husks (hulls), leaves, and green nuts Juglans nigra L. or J. regia L. Woodruff, sweet ...... Asperula odorata L ...... In alcoholic beverages only Yarrow ...... Achillea millefolium L ...... In beverages only; fin- ished beverage thujone free1 Yerba santa ...... Eriodictyon californicum (Hook, et Arn.) Torr. Yucca, Joshua-tree ...... Yucca brevifolia Engelm. Yucca, Mohave ...... Yucca schidigera Roezl ex Ortgies (Y. mohavensis Sarg.). 1 As determined by using the method (or, in other than alcoholic beverages, a suitable adaptation thereof) in section 9.129 of the ‘‘Official Methods of Analysis of the Association of Official Analytical Chemists,’’ 13th Ed. (1980), which is incorporated by ref- erence. Copies may be obtained from the Association of Official Analytical Chemists International, 481 North Frederic Ave., suite 500, Gaithersburg, MD 20877–2504, or may be examined at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC 20408 [42 FR 14491, Mar. 15, 1977, as amended at 43 FR 14644, Apr. 7, 1978; 49 FR 10104, Mar. 19, 1984; 54 FR 24897, June 12, 1989]

§ 172.515 Synthetic flavoring sub- food, prior-sanctioned for such use, or stances and adjuvants. regulated by an appropriate section in Synthetic flavoring substances and this part. adjuvants may be safely used in food in Acetal; acetaldehyde diethyl acetal. accordance with the following condi- Acetaldehyde phenethyl propyl acetal. tions. Acetanisole; 4′-methoxyacetophenone. ; methyl phenyl ketone. (a) They are used in the minimum Allyl anthranilate. quantity required to produce their in- Allyl butyrate. tended effect, and otherwise in accord- Allyl cinnamate. ance with all the principles of good Allyl cyclohexaneacetate. manufacturing practice. Allyl cyclohexanebutyrate. Allyl cyclohexanehexanoate. (b) They consist of one or more of the Allyl cyclohexaneproprionate. following, used alone or in combination Allyl cyclohexanevalerate. with flavoring substances and adju- Allyl disulfide. vants generally recognized as safe in Allyl 2-ethylbutyrate.

52

VerDate 112000 12:37 Apr 16, 2001 Jkt 194064 PO 00000 Frm 00052 Fmt 8010 Sfmt 8010 Y:\SGML\194064T.XXX pfrm02 PsN: 194064T Food and Drug Administration, HHS § 172.515

Allyl hexanoate; allyl caproate. Benzyl salicylate. Allyl α-ionone; 1-(2,6,6-trimethyl-2-cyclo-hex- Birch tar oil. ene-1-yl)-1,6-heptadiene-3-one. ; d-camphanol. Allyl isothiocyanate; mustard oil. Bornyl acetate. Allyl isovalerate. Bornyl formate. Allyl mercaptan; 2--1-thiol. Bornyl isovalerate. Allyl nonanoate. Bornyl valerate. Allyl octanoate. β-Bourbonene; 1,2,3,3a,3bβ,4,5,6,6aβ,6bα-deca- Allyl phenoxyacetate. hydro-lα-isopropyl-3aa-methyl-6-meth- Allyl phenylacetate. ylene-cyclobuta [1,2:3,4] dicyclopentene. Allyl propionate. 2-Butanol. Allyl sorbate; allyl 2,4-hexadienoate. 2-Butanone; methyl ethyl ketone. Allyl sulfide. Butter acids. Allyl tiglate; allyl trans-2-methyl-2- Butter . butenoate. Butyl acetate. Allyl 10-undecenoate. Butyl acetoacetate. Ammonium isovalerate. Butyl alcohol; 1-butanol. Ammonium sulfide. Butyl anthranilate. ; pentyl alcohol. Butyl butyrate. Amyl butyrate. Butyl butyryllactate; lactic acid, butyl α-Amylcinnamaldehyde. , butyrate. α-Amylcinnamaldehyde dimethyl acetal. α-Butylcinnamaldehyde. α-Amylcinnamyl acetate. Butyl cinnamate. α-Amylcinnamyl alcohol. Butyl 2-decenoate. α-Amylcinnamyl formate. Butyl ethyl malonate. α-Amylcinnamyl isovalerate. Butyl formate. Amyl formate. Butyl heptanoate. Amyl heptanoate. Butyl hexanoate. Amyl hexanoate. Butyl p-hydroxybenzoate. Amyl octanoate. Butyl isobutyrate. Anisole; methoxybenzene. Butyl isovalerate. Anisyl acetate. Butyl lactate. Anisyl alcohol; p-methoxybenzyl alcohol. Butyl laurate. Anisyl butyrate Butyl levulinate. Anisyl formate. Butyl phenylacetate. Anisyl phenylacetate. Butyl propionate. Anisyl propionate. Butyl stearate. Beechwood creosote. Butyl sulfide. Benzaldehyde dimethyl acetal. Butyl 10-undecenoate. Benzaldehyde glyceryl acetal; 2-phenyl-m-di- Butyl valerate. oxan-5-ol. Butyraldehyde. Benzaldehyde propylene glycol acetal; 4- Cadinene. methyl-2-phenyl-m-dioxolane. Camphene; 2,2-dimethyl-3-methylene- Benzenethiol; thiophenol. norbornane. Benzoin; 2-hydroxy-2-phenylacetophenone. d-Camphor. Benzophenone; diphenylketone. Carvacrol; 2-p-cymenol. Benzyl acetate. Carvacryl ethyl ether; 2-ethoxy-p-cymene. Benzyl acetoacetate. Carveol; p-mentha-6,8-dien-2-ol. Benzyl alcohol. 4-Carvomenthenol; 1-p-menthen-4-ol; 4- Benzyl benzoate. terpinenol. Benzyl butyl ether. cis Carvone oxide; 1,6-epoxy-p-menth-8-en-2- Benzyl butyrate. one. Benzyl cinnamate. Carvyl acetate. Benzyl 2,3–dimethylcrotonate; benzyl methyl Carvyl propionate. tiglate. β-Caryophyllene. Benzyl disulfide; dibenzyl disulfide. Caryophyllene alcohol. Benzyl ethyl ether. Caryophyllene alcohol acetate. Benzyl formate. β-Caryophyllene oxide; 4-12,12-trimethyl-9- 3-Benzyl-4-heptanone; benzyl dipropyl ke- methylene-5-oxatricylo [8.2.0.04, 6] dode- tone. cane. Benzyl isobutyrate. Cedarwood oil . Benzyl isovalerate. Cedarwood oil terpenes. Benzyl mercaptan; α-toluenethiol. 1,4-Cineole. Benzyl methoxyethyl acetal; acetaldehyde Cinnamaldehyde glycol acetal. benzyl β-methoxyethyl acetal. Cinnamic acid. Benzyl phenylacetate. Cinnamyl acetate. Benzyl propionate. Cinnamyl alcohol; 3-phenyl-2-propen-1-ol.

53

VerDate 112000 12:37 Apr 16, 2001 Jkt 194064 PO 00000 Frm 00053 Fmt 8010 Sfmt 8010 Y:\SGML\194064T.XXX pfrm02 PsN: 194064T § 172.515 21 CFR Ch. I (4–1–01 Edition)

Cinnamyl benzoate. α,α-Dimethylbenzyl isobutyrate; phenyldi- Cinnamyl butyrate. methylcarbinyl isobutyrate. Cinnamyl cinnamate. 2,6-Dimethyl-5-heptenal. Cinnamyl formate. 2,6-Dimethyl octanal; isodecylaldehyde. Cinnamyl isobutyrate. 3,7-Dimethyl-1-octanol; tetrahydrogeraniol. Cinnamyl isovalerate. α,α-Dimethylphenethyl acetate; benzyl- Cinnamyl phenylacetate. propyl acetate; benzyldimethylcarbinyl ac- Cinnamyl propionate. etate. Citral diethyl acetal; 3,7-dimethyl-2,6-octa- α,α-Dimethylphenethyl alcohol; dimethyl- dienal diethyl acetal. benzyl carbinol. Citral dimethyl acetal; 3,7-dimethyl-2,6-octa- α,α-Dimethylphenethyl butyrate; benzyl- dienal dimethyl acetal. dimethylcarbinyl butyrate. Citral propylene glycol acetal. α,α-Dimethylphenethyl formate; benzyldi- Citronellal; 3,7-dimethyl-6-octenal; rhodinal. methylcarbinyl formate. Citronellol; 3,7-dimethyl-6-octen-1-ol; d-cit- Dimethyl succinate. ronellol. 1,3-Diphenyl-2-propanone; dibenzyl ketone. Citronelloxyacetaldehyde. delta-Dodecalactone; 5-hydroxydodecanoic Citronellyl acetate. acid, deltalactone. γ γ Citronellyl butyrate. -Dodecalactone; 4-hydroxydodecanoic acid - Citronellyl formate. lactone. Citronellyl isobutyrate. 2-Dodecenal. Citronellyl phenylacetate. Estragole. ρ Citronellyl propionate. -Ethoxybenzaldehyde. Citronellyl valerate. Ethyl acetoacetate. Ethyl 2-acetyl-3-phenylpropionate; ethyl- p-Cresol. benzyl acetoacetate. Cuminaldehyde; cuminal; p-isopropyl benz- Ethyl aconitate, mixed esters. aldehyde. Ethyl acrylate. Cyclohexaneacetic acid. Ethyl ρ-anisate. Cyclohexaneethyl acetate. Ethyl anthranilate. Cyclohexyl acetate. Ethyl benzoate. Cyclohexyl anthranilate. Ethyl benzoylacetate. Cyclohexyl butyrate. α-Ethylbenzyl butyrate; α-phenylpropyl bu- Cyclohexyl cinnamate. tyrate. Cyclohexyl formate. Ethyl brassylate; tridecanedioic acid cyclic Cyclohexyl isovalerate. ethylene glycol diester; cyclo 1,13-ethyl- Cyclohexyl propionate. enedioxytridecan-1,13-dione. p-Cymene. 2-Ethylbutyl acetate. γ-Decalactone; 4-hydroxy-decanoic acid, γ- 2-Ethylbutyraldehyde. lactone. 2-Ethylbutyric acid. γ-Decalactone; 5-hydroxy-decanoic acid, δ- Ethyl cinnamate. lactone. Ethyl crotonate; trans-2-butenoic acid ethyl- Decanal dimethyl acetal. ester. 1-Decanol; decylic alcohol. Ethyl cyclohexanepropionate. 2-Decenal. Ethyl decanoate. 3-Decen-2-one; heptylidene . 2-Ethylfuran. Decyl actate. Ethyl 2-furanpropionate. Decyl butyrate. 4-Ethylguaiacol; 4-ethyl-2-methoxyphenol. Decyl propionate. Ethyl heptanoate. Dibenzyl ether. 2-Ethyl-2-heptenal; 2-ethyl-3-butylacrolein. 4,4-Dibutyl-γ-butyrolactone; 4,4-dibutyl-4-hy- Ethyl hexanoate. droxy-butyric acid, γ-lactone. Ethyl isobutyrate. Dibutyl sebacate. Ethyl isovalerate. Diethyl malate. Ethyl lactate. Diethyl malonate; ethyl malonate. Ethyl laurate. Diethyl sebacate. Ethyl levulinate. Diethyl succinate. Ethyl maltol; 2-ethyl-3-hydroxy-4H-pyran-4- Diethyl tartrate. one. 2,5-Diethyltetrahydrofuran. Ethyl 2-methylbutyrate. Dihydrocarveol; 8-p-menthen-2-ol; 6-methyl- Ethyl myristate. 3-isopropenylcyclohexanol. Ethyl nitrite. Dihydrocarvone. Ethyl nonanoate. Dihydrocarvyl acetate. Ethyl 2-nonynoate; ethyl octyne carbonate. m-Dimethoxybenzene. Ethyl octanoate. p-Dimethoxybenzene; dimethyl hydro- Ethyl oleate. quinone. Ethyl phenylacetate. 2,4-Dimethylacetophenone. Ethyl 4-phenylbutyrate.

54

VerDate 112000 12:37 Apr 16, 2001 Jkt 194064 PO 00000 Frm 00054 Fmt 8010 Sfmt 8010 Y:\SGML\194064T.XXX pfrm02 PsN: 194064T Food and Drug Administration, HHS § 172.515

Ethyl 3-phenylglycidate. ω-6-Hexadecenlactone; 16-hydroxy-6- Ethyl 3-phenylpropionate; ethyl hydro- hexadecenoic acid, ω-lactone; cinnamate. ambrettolide. Ethyl propionate. γ-Hexalactone; 4-hydroxyhexanoic acid, γ-lac- Ethyl pyruvate. tone; tonkalide. Ethyl salicylate. Hexanal; caproic aldehyde. Ethyl sorbate; ethyl 2,4-hexadienoate. 2,3-Hexanedione; acetyl butyryl. Ethyl tiglate; ethyl trans-2-methyl-2- Hexanoic acid; caproic acid. butenoate. 2-Hexenal. Ethyl undecanoate. 2-Hexen-1-ol. Ethyl 10-undecenoate. 3-Hexen-1-ol; leaf alcohol. Ethyl valerate. 2-Hexen-1-yl acetate. Eucalyptol; 1,8-epoxy-p-menthane; cineole. 3-Hexenyl isovalerate. Eugenyl acetate. 3-Hexenyl 2-methylbutyrate. Eugenyl benzoate. 3-Hexenyl phenylacetate; cis-3-hexenyl phen- Eugenyl formate. ylacetate. Eugenyl methyl ether; 4-allylveratrole; Hexyl acetate. methyl eugenol. 2-Hexyl-4-acetoxytetrahydrofuran. Farnesol; 3,7,11-trimethyl-2,6,10-dodecatrien- Hexyl alcohol. 1-ol. Hexyl butyrate. d-Fenchone; d-1,3,3-trimethyl-2-nor- α-Hexylcinnamaldehyde. bornanone. Hexyl formate. Fenchyl alcohol; 1,3,3-trimethyl-2-nor- Hexyl hexanoate. bornanol. 2-Hexylidene cyclopentanone. Formic acid Hexyl isovalerate. (2-Furyl)-2-propanone; furyl acetone. Hexyl 2-methylbutyrate. 1-Furyl-2-propanone; furyl acetone. Hexyl octanoate. Fusel oil, refined (mixed amyl alcohols). Hexyl phenylacetate; n-hexyl phenylacetate. Geranyl acetoacetate; trans-3,7-dimethyl-2, 6- Hexyl propionate. octadien-1-yl acetoacetate. Hydroxycitronellal; 3,7-dimethyl-7-hydroxy- Geranyl acetone; 6,10-dimethyl-5,9- octanal. undecadien-2-one. Hydroxycitronellal diethyl acetal. Geranyl benzoate. Hydroxycitronellal dimethyl acetal. Geranyl butyrate. Hydroxycitronellal; 3,7-dimethyl-1,7- Geranyl formate. octanediol. Geranyl hexanoate N-(4-Hydroxy-3-methoxybenzyl)-nonanamide; Geranyl isobutyrate. pelargonyl vanillylamide. Geranyl isovalerate. 5-Hydroxy-4-octanone; butyroin. Geranyl phenylacetate. 4-(p-Hydroxyphenyl)-2-butanone; p-hydroxy- Geranyl propionate. benzyl acetone. Glucose pentaacetate. Indole. Guaiacol; µ -methoxyphenol. α-Ionone; 4-(2,6,6-trimethyl-2-cyclohexen-1- Guaiacyl acetate; µ -methoxyphenyl acetate. yl)-3-buten-2-one. Guaiacyl phenylacetate. β-Ionone; 4-(2,6,6-trimethyl-1-cyclohexen-1- Guaiene; 1,4-dimethyl-7-isopropenyl-∆9,10- yl)-3-buten-2-one. octahydroazulene. α-Irone; 4-(2,5,6,6-tetramethyl-2-cyclohexene- Guaiol acetate; 1,4-dimethyl-7-(α-hydroxy- 1-yl)-3-buten-2-one; 6-methylionone. isopropyl)-δ9,10-octahydroazulene acetate. Isoamyl acetate. γ-Heptalactone; 4-hydroxyheptanoic acid, γ- Isoamyl acetoacetate. lactone. Isoamyl alcohol; isopentyl alcohol; 3-methyl- Heptanal; enanthaldehyde. 1-butanol. Heptanal dimethyl acetal. Isoamyl benzoate. Heptanal 1,2-glyceryl acetal. Isoamyl butyrate. 2,3-Heptanedione; acetyl valeryl. Isoamyl cinnamate. 3-Heptanol. Isoamyl formate. 2-Heptanone; methyl amyl ketone. Isoamyl 2-furanbutyrate; α-isoamyl furfuryl- 3-Heptanone; ethyl butyl ketone. propionate. 4-Heptanone; dipropyl ketone. Isoamyl 2-furanpropionate; α-isoamyl fur- cis-4-Heptenal; cis-4-hepten-1-al. furylacetate. Heptyl acetate. Isoamyl hexanoate. Heptyl alcohol; enanthic alcohol. Isoamyl isobutyrate. Heptyl butyrate. Isoamyl isovalerate. Heptyl cinnamate. Isoamyl laurate. Heptyl formate. Isoamyl-2-methylbutyrate; isopentyl-2- Heptyl isobutyrate. methylbutyrate. Heptyl octanoate. Isoamyl nonanoate. 1-Hexadecanol; cetyl alcohol. Isoamyl octanoate.

55

VerDate 112000 12:37 Apr 16, 2001 Jkt 194064 PO 00000 Frm 00055 Fmt 8010 Sfmt 8010 Y:\SGML\194064T.XXX pfrm02 PsN: 194064T § 172.515 21 CFR Ch. I (4–1–01 Edition)

Isoamyl phenylacetate. Isoquinoline. Isoamyl propionate. Isovaleric acid. Isoamyl pyruvate. cis-Jasmone; 3-methyl-2-(2-pentenyl)-2-cyclo- Isoamyl salicylate. penten-1-one. Isoborneol. Lauric aldehyde; dodecanal. Isobornyl acetate. Lauryl acetate. Isobornyl formate. Lauryl alcohol; 1-dodecanol. Isobornyl isovalerate. Lepidine; 4-methylquinoline. Isobornyl propionate. Levulinic acid. Isobutyl acetate. Linalool oxide; cis- and trans-2-vinyl-2-meth- Isobutyl acetoacetate. yl-5-(1′-hydroxy-1′-methylethyl) tetra- Isobutyl alcohol. hydrofuran. Isobutyl angelate; isobutyl cis-2-methyl-2- Linalyl anthranilate; 3,7-dimethyl-1,6- butenoate. octadien-3-yl anthranilate. Isobutyl anthranilate. Linalyl benzoate. Isobutyl benzoate. Linalyl butyrate. Isobutyl butyrate. Linalyl cinnamate. Isobutyl cinnamate. Linalyl formate. Isobutyl formate. Linalyl hexanoate. Isobutyl 2-furanpropionate. Linalyl isobutyrate. Isobutyl heptanoate. Linalyl isovalerate. Isobutyl hexanoate. Linalyl octanoate. Isobutyl isobutyrate. Linalyl propionate. α-Isobutylphenethyl alcohol; isobutyl benzyl Maltol; 3-hydroxy-2-methyl-4H-pyran-4-one. carbinol; 4-methyl-1-phenyl-2-pentanol. Menthadienol; p-mentha-1,8(10)-dien-9-ol. Isobutyl phenylacetate. p-Mentha-1,8-dien-7-ol; perillyl alcohol. Isobutyl propionate. Menthadienyl acetate; p-mentha-1,8(10)-dien- Isobutyl salicylate. 9-yl acetate. 2-Isobutylthiazole. p-Menth-3-en-1-ol. Isobutyraldehyde. 1-p-Menthen-–9-yl acetate; p-menth-1-en-9-yl Isobutyric acid. acetate. Isoeugenol; 2-methoxy-4-propenylphenol. ; 2-isopropyl-5-methylcyclohexanol. Isoeugenyl acetate. Menthone; p-menthan-3-one. Isoeugenyl benzyl ether; benzyl isoeugenol. Menthyl acetate; p-menth-3-yl acetate. Isoeugenyl ethyl ether; 2-ethoxy-5-propenyl- ; p-menth-3-yl iso- anisole; ethyl isoeugenol. valerate. Isoeugenyl formate. o-Methoxybenzaldehyde. Isoeugenyl methyl ether; 4-propenyl- p-Methoxybenzaldehyde; p-anisaldehyde. veratrole; methyl isoeugenol. o-Methoxycinnamaldehyde. Isoeugenyl phenylacetate. 2-Methoxy-4-methylphenol; 4-methyl- Isojasmone; mixture of 2-hexylidenecyclo- guaiacol; 2-methoxy-p-cresol. pentanone and 2-hexyl-2-cyclopenten-1-one. 4-(p-Methoxyphenyl)-2-butanone; anisyl ace- α-Isomethylionone; 4-(2,6,6-trimethyl-2- tone. cyclohexen-1-yl)-3-methyl-3-buten-2-one; 1-(4-Methoxyphenyl)-4-methyl-1-penten-3- methyl γ-ionone. one; methoxystyryl isopropyl ketone. Isopropyl acetate. 1-(p-Methoxyphenyl)-1-penten-3-one; α- ρ-Isopropylacetophenone. methylanisylidene acetone; ethone. ; isopropanol. 1-(p-Methoxyphenyl)-2-propanone; Isopropyl benzoate. anisylmethyl ketone; anisic ketone. ρ-Isopropylbenzyl alcohol; cuminic alcohol; 2-Methoxy-4-vinylphenol; p-vinylguaiacol. ρ-cymen-7-ol. Methyl acetate. Isopropyl butyrate. 4′-Methylacetophenone; p-methylaceto- Isopropyl cinnamate. phenone; methyl p-tolyl ketone. Isopropyl formate. 2-Methylallyl butyrate; 2-methyl-2-propenl- Isopropyl hexanoate. yl butyrate. Isopropyl isobutyrate. Methyl anisate. Isopropyl isovalerate. o-Methylanisole; o-cresyl methyl ether. ρ-Isopropylphenylacetaldehyde; ρ-cymen-7- p-Methylanisole; p-cresyl methyl ether; p- carboxaldehyde. methoxytoluene. Isopropyl phenylacetate. Methyl benzoate. 3-(ρ-Isopropylphenyl)-propionaldehyde; ρ-iso- Methylbenzyl acetate, mixed o-,m-,p-. propylhydrocinnamaldehyde; cuminyl ac- α-Methylbenzyl acetate; styralyl acetate. etaldehyde. α-Methylbenzyl alcohol; styralyl alcohol. Isopropyl propionate. α-Methylbenzyl butyrate; styralyl butyrate. Isopulegol; p-menth-8-en-3-ol. α-Methylbenzyl isobutyrate; styralyl iso- Isopulegone; p-menth-8-en-3-one. butyrate. Isopulegyl acetate. α-Methylbenzyl formate; styralyl formate.

56

VerDate 112000 12:37 Apr 16, 2001 Jkt 194064 PO 00000 Frm 00056 Fmt 8010 Sfmt 8010 Y:\SGML\194064T.XXX pfrm02 PsN: 194064T Food and Drug Administration, HHS § 172.515

α-Methylbenzyl propionate; styralyl propio- 2-Methyl-4-phenyl-2-butyl acetate; dimethyl- nate. phenylethyl carbinyl acetate. 2-Methyl-3-buten-2-ol. 2-Methyl-4-phenyl-2-butyl isobutyrate; 2-Methylbutyl isovalerate. dimethylphenyl ethylcarbinyl isobutyrate. Methyl p-tert-butylphenylacetate. 3-Methyl-2-phenylbutyraldehyde; α-isopropyl 2-Methylbutyraldehyde; methyl ethyl acetal- phenylacetaldehyde. dehyde. Methyl 4-phenylbutyrate. 3-Methylbutyraldehyde; isovaleraldehyde. 4-Methyl-1-phenyl-2-pentanone; benzyl iso- Methyl butyrate. butyl ketone. 2-Methylbutyric acid. Methyl 3-phenylpropionate; methyl hydro- α-Methylcinnamaldehyde. cinnamate. p-Methylcinnamaldehyde. Methyl propionate. Methyl cinnamate. 3-Methyl-5-propyl-2-cyclohexen-1-one. 2-Methyl-1,3-cyclohexadiene. Methyl sulfide. Methylcyclopentenolone; 3-methylcyclopen- 3-Methylthiopropionaldehyde; methional. tane-1,2-dione. 2-Methyl-3-tolylpropionaldehyde, mixed o-, Methyl disulfide; dimethyl disulfide. m-, p-. Methyl ester of rosin, partially hydrogenated 2-Methylundecanal; methyl nonyl acetal- (as defined in § 172.615); methyl dehyde. dihydroabietate. Methyl 9-undecenoate. Methyl heptanoate. Methyl 2-undecynoate; methyl decyne car- 2-Methylheptanoic acid. bonate. 6-Methyl-3,5-heptadien-2-one. Methyl valerate. Methyl-5-hepten-2-ol. 2-Methylvaleric acid. 6-Methyl-5-hepten-2-one. Myrcene; 7-methyl-3-methylene-1,6-octa- diene. Methyl hexanoate. Myristaldehyde; tetradecanal. Methyl 2-hexanoate. d-Neomenthol; 2-isopropyl-5-methylcyclo- Methyl p-hydroxybenzoate; methylparaben. hexanol. Methyl α-ionone; 5-(2,6,6-trimethyl-2-cyclo- Nerol; cis-3,7-dimethyl-2,6-octadien-1-ol. hexen-1-yl)-4-penten-3-one. Nerolidol; 3,7,11-trimethyl-1,6,10-dodecatrien- Methyl β-ionone; 5-(2,6,6-trimethyl-1-cyclo- 3-ol. hexen-1-yl)-4-penten-3-one. Neryl acetate. ∆ Methyl -ionone; 5-(2,6,6-trimethyl-3-cyclo- Neryl butyrate. hexen-1-yl-)-4-penten-3-one. Neryl formate. Methyl isobutyrate. Neryl isobutyrate. 2-Methyl-3-(p-isopropylphenyl)-propionalde- Neryl isovalerate. α hyde; -methyl-p-isopropylhydro- Neryl propionate. cinnamal- dehyde; cyclamen aldehyde. 2,6-Nonadien-1-ol. Methyl isovalerate. γ-Nonalactone; 4-hydroxynonanoic acid, γ- Methyl laurate. lactone; aldehyde C–18. Methyl mercaptan; methanethiol. Nonanal; pelargonic aldehyde. Methyl o-methoxybenzoate. 1,3-Nonanediol acetate, mixed esters. Methyl N-methylanthranilate; dimethyl an- Nonanoic acid; pelargonic acid. thranilate. 2-Nonanone; methylheptyl ketone. Methyl 2-methylbutyrate. 3-Nonanon-1-yl acetate; 1-hydroxy-3- Methyl-3-methylthiopropionate. nonanone acetate. Methyl 4-methylvalerate. Nonyl acetate. Methyl myristate. Nonyl alcohol; 1-nonanol. Methyl β-naphthyl ketone; 2′-acetonaph- Nonyl octanoate. thone. Nonyl isovalerate. Methyl nonanoate. Nootkatone; 5,6-dimethyl-8-isopropenyl- Methyl 2-nonenoate. bicyclo[4,4,0]-dec-1-en-3-one. Methyl 2-nonynoate; methyloctyne car- Ocimene; trans-β-ocimene; 3,7-dimethyl-1,3,6- bonate. octatriene. 2-Methyloctanal; methyl hexyl acetaldehyde. γ-Octalactone; 4-hydroxyoctanoic acid, γ-lac- Methyl octanoate. tone. Methyl 2-octynoate; methyl heptine car- Octanal; caprylaldehyde. bonate. Octanal dimethyl acetal. 4-Methyl-2,3-pentanedione; acetyl iso- 1-Octanol; octyl alcohol. butyryl. 2-Octanol. 4-Methyl-2-pentanone; methyl isobutyl ke- 3-Octanol. tone. 2-Octanone; methyl hexyl ketone. β-Methylphenethyl alcohol; hydratropyl al- 3-Octanone; ethyl amyl ketone. cohol. 3-Octanon-1-ol. Methyl phenylacetate. 1-Octen-3-ol; amyl vinyl carbinol. 3-Methyl-4-phenyl-3--2-one. 1-Octen-3-yl acetate.

57

VerDate 112000 12:37 Apr 16, 2001 Jkt 194064 PO 00000 Frm 00057 Fmt 8010 Sfmt 8010 Y:\SGML\194064T.XXX pfrm02 PsN: 194064T § 172.515 21 CFR Ch. I (4–1–01 Edition)

Octyl acetate. 3-Phenylpropyl formate. 3-Octyl acetate. 3-Phenylpropyl hexanoate. Octyl butyrate. 2-Phenylpropyl isobutyrate. Octyl formate. 3-Phenylpropyl isobutyrate. Octyl heptanoate. 3-Phenylpropyl isovalerate. Octyl isobutyrate. 3-Phenylpropyl propionate. Octyl isovalerate. 2-(3-Phenylpropyl)-tetrahydrofuran. Octyl octanoate. α-Pinene; 2-pinene. Octyl phenylacetate. β-Pinene; 2(10)-pinene. Octyl propionate. Pine tar oil. ω-Pentadecalactone; 15-hydroxypentadeca- Pinocarveol; 2(10)-pinen-3-ol. noic acid, ω-lactone; pentadecanolide; an- Piperidine. gelica lactone. Piperine. 2,3-Pentanedione; acetyl propionyl. d-Piperitone; p-menth-1-en-3-one. 2-Pentanone; methyl propyl ketone. Piperitenone; p-mentha-1,4(8)-dien-3-one. 4-Pentenoic acid. Piperitenone oxide; 1,2-epoxy-p-menth-4-(8)- 1-Penten-3-ol. en-3-one. Perillaldehyde; 4-isopropenyl-1-cyclohexene- Piperonyl acetate; heliotropyl acetate. 1-carboxaldehyde;p-mentha-1,8-dien-7-al. Piperonyl isobutyrate. Perillyl acetate; p-mentha-1,8-dien-7-yl ace- Polylimonene. tate. Polysorbate 20; polyoxyethylene (20) sorbitan α-Phellandrene; ρ-mentha-1,5-diene. monolaurate. Phenethyl acetate. Polysorbate 60; polyoxyethylene (20) sorbitan Phenethyl alcohol; β-phenylethyl alcohol. monostereate. Phenethyl anthranilate. Polysorbate 80; polyoxyethylene (20) sorbitan Phenethyl benzoate. monooleate. Phenethyl butyrate. Potassium acetate. Phenethyl cinnamate. Propenylguaethol; 6-ethoxy-m-anol. Phenethyl formate. Propionaldehyde. Phenethyl isobutyrate. Propyl acetate. Phenethyl isovalerate. Propyl alcohol; 1-propanol. Phenethyl 2-methylbutyrate. p-Propyl anisole; dihydroanethole. Phenethyl phenylacetate. Propyl benzoate. Phenethyl propionate. Propyl butyrate. Phenethyl salicylate. Propyl cinnamate. Phenethyl senecioate; phenethyl 3,3-di- Propyl disulfide. methylacrylate. Propyl formate. Phenethyl tiglate. Propyl 2-furanacrylate. Phenoxyacetic acid. Propyl heptanoate. 2-Phenoxyethyl isobutyrate. Propyl hexanoate. Phenylacetaldehyde; α-toluic aldehyde. Propyl p-hydroxybenzoate; propylparaben. Phenylacetaldehyde 2,3-butylene glycol ace- 3-Propylidenephthalide. tal. Propyl isobutyrate. Phenylacetaldehyde dimethyl acetal. Propyl isovalerate. Phenylacetaldehyde glyceryl acetal. Propyl mercaptan. Phenylacetic acid; α-toluic acid. α-Propylphenethyl alcohol. 4-Phenyl-2-butanol; phenylethyl methyl car- Propyl phenylacetate. binol. Propyl propionate. 4-Phenyl-3-buten-2-ol; methyl styryl car- Pulegone; p-menth-4(8)-en-3-one. binol. Pyridine. 4-Phenyl-3-buten-2-one. Pyroligneous acid extract. 4-Phenyl-2-butyl acetate; phenylethyl meth- Pyruvaldehyde. yl carbinyl acetate. Pyruvic acid. 1-Phenyl-3-methyl-3-pentanol; phenylethyl Rhodinol; 3,7-dimethyl-7-octen-1-ol; l- methyl ethyl carbinol. citronellol. 1-Phenyl-1-propanol; phenylethyl carbinol. Rhodinyl acetate. 3-Phenyl-1-propanol; hydrocinnamyl alcohol. Rhodinyl butyrate. 2-Phenylpropionaldehyde; hydratropalde- Rhodinyl formate. hyde. Rhodinyl isobutyrate. 3-Phenylpropionaldehyde; hydrocinnamal- Rhodinyl isovalerate. dehyde. Rhodinyl phenylacetate. 2-Phenylpropionalde-hyde dimethyl acetal; Rhodinyl propionate. hydratropic aldehyde dimethyl acetal. Rum ether; ethyl oxyhydrate. 3-Phenylpropionic acid; hydrocinnamic acid. Salicylaldehyde. 3-Phenylpropyl acetate. Santalol, α and β. 2-Phenylpropyl butyrate. Santalyl acetate. 3-Phenylpropyl cinnamate. Santalyl phenylacetate.

58

VerDate 112000 12:37 Apr 16, 2001 Jkt 194064 PO 00000 Frm 00058 Fmt 8010 Sfmt 8010 Y:\SGML\194064T.XXX pfrm02 PsN: 194064T Food and Drug Administration, HHS § 172.540

Skatole. spectively, in accordance with § 166.110 Sorbitan monostearate. of this chapter. Styrene. (d) BHA (butylated hydroxyanisole) Sucrose octaacetate. α-Terpinene. may be used as an antioxidant in fla- γ-Terpinene. voring substances whereby the additive α-Terpineol; p-menth-1-en-8-ol. does not exceed 0.5 percent of the es- β-Terpineol. sential (volatile) oil content of the fla- Terpinolene; p-menth-1,4(8)-diene. voring substance. Terpinyl acetate. Terpinyl anthranilate. [42 FR 14491, Mar. 15, 1977, as amended at 42 Terpinyl butyrate. FR 23148, May 6, 1977; 43 FR 19843, May 9, Terpinyl cinnamate. 1978; 45 FR 22915, Apr. 4, 1980; 47 FR 27810, Terpinyl formate. June 25, 1982; 48 FR 10812, Mar. 15, 1983; 48 FR Terpinyl isobutyrate. 51907, Nov. 15, 1983; 49 FR 5747, Feb. 15, 1984; Terpinyl isovalerate. 50 FR 42932, Oct. 23, 1985; 54 FR 7402, Feb. 21, Terpinyl propionate. 1989; 61 FR 14245, Apr. 1, 1996] Tetrahydrofurfuryl acetate. Tetrahydrofurfuryl alcohol. § 172.520 Cocoa with dioctyl sodium Tetrahydrofurfuryl butyrate. sulfosuccinate for manufacturing. Tetrahydrofurfuryl propionate. Tetrahydro-pseudo-ionone; 6,10-dimethyl-9- The food additive ‘‘cocoa with dioctyl undecen-2-one. sodium sulfosuccinate for manufac- Tetrahydrolinalool; 3,7-dimethyloctan-3-ol. turing,’’ conforming to § 163.117 of this Tetramethyl ethylcyclohexenone; mixture of chapter and § 172.810, is used or in- 5-ethyl-2,3,4,5-tetramethyl-2-cyclohexen-1- tended for use as a flavoring substance one and 5-ethyl-3,4,5,6-tetramethyl-2-cyclo- in dry beverage mixes whereby the hexen-1-one. 2-Thienyl mercaptan; 2-thienylthiol. amount of dioctyl sodium sulfo- . succinate does not exceed 75 parts per Tolualdehyde glyceryl acetal, mixed o, m, p. million of the finished beverage. The Tolualdehydes, mixed o, m, p. labeling of the dry beverage mix shall p-Tolylacetaldehyde. bear adequate directions to assure use o-Tolyl acetate; o-cresyl acetate. in compliance with this section. p-Tolyl acetate; p-cresyl acetate. 4-(p-Tolyl)-2-butanone; p-methylbenzylace- § 172.530 Disodium guanylate. tone. p-Tolyl isobutyrate. Disodium guanylate may be safely p-Tolyl laurate. used as a flavor enhancer in foods, at a p-Tolyl phenylacetate. level not in excess of that reasonably 2-(p-Tolyl)-propionaldehyde; p-methylhydra- required to produce the intended effect. tropic aldehyde. Tributyl acetylcitrate. 2-Tridecenal. § 172.535 Disodium inosinate. 2,3-Undecadione; acetyl nonyryl. The food additive disodium inosinate γ-Undecalactone; 4-hydroxyundecanoic acid may be safely used in food in accord- γ-lactone; peach aldehyde; aldehyde C–14. ance with the following prescribed con- Undecenal. 2-Undecanone; methyl nonyl ketone. ditions: 9-Undecenal; undecenoic aldehyde. (a) The food additive is the disodium 10-Undecenal. salt of inosinic acid, manufactured and Undecen-1-ol; undecylenic alcohol. purified so as to contain no more than 10-Undecen-1-yl acetate. 150 parts per million of soluble barium Undecyl alcohol. in the compound disodium inosinate Valeraldehyde; pentanal. with seven and one-half molecules of Valeric acid; pentanoic acid. Vanillin acetate; acetyl vanillin. water of crystallization. Veratraldehyde. (b) The food additive is used as a fla- Verbenol; 2-pinen-4-ol. voring adjuvant in food. Zingerone; 4-(4-hydroxy-3-methoxyphenyl)-2- butanone. § 172.540 DL–Alanine. (c) ∆-Decalactone and ∆- DL–Alanine (a racemic mixture of D- dodecalactone when used separately or and L-alanine; CAS Reg. No. 302–72–7) in combination in oleomargarine are may be safely used as a flavor enhancer used at levels not to exceed 10 parts per for sweeteners in pickling mixtures at million and 20 parts per million, re- a level not to exceed 1 percent of the

59

VerDate 112000 12:37 Apr 16, 2001 Jkt 194064 PO 00000 Frm 00059 Fmt 8010 Sfmt 8010 Y:\SGML\194064T.XXX pfrm02 PsN: 194064T § 172.560 21 CFR Ch. I (4–1–01 Edition)

pickling spice that is added to the and fractionations, using methylene pickling brine. chloride, hexane, and methyl alcohol as [56 FR 6968, Feb. 21, 1991] solvents, followed by isomerization by sodium hydroxide treatment. Residues § 172.560 Modified hop extract. of the solvents in the modified hop ex- The food additive modified hop ex- tract shall not exceed 5 parts per mil- tract may be safely used in beer in ac- lion of methylene chloride, 25 parts per cordance with the following prescribed million of hexane, and 100 parts per conditions: million of methyl alcohol. (a) The food additive is used or in- (4) The additive is manufactured tended for use as a flavoring agent in from hops by a sequence of extractions the brewing of beer. and fractionations, using , light (b) The food additive is manufactured petroleum spirits, methyl alcohol, n- by one of the following processes: butyl alcohol, and ethyl acetate as sol- (1) The additive is manufactured vents, followed by isomerization by po- from a hexane extract of hops by si- tassium carbonate treatment. Residues multaneous isomerization and selec- of solvents in the modified hop extract tive reduction in an alkaline aqueous shall not exceed 1.0 part per million of medium with sodium borohydride, benzene, 1.0 part per million of light whereby the additive meets the fol- petroleum spirits, 50 parts per million lowing specifications: of methyl alcohol, 50 parts per million (i) A solution of the food additive sol- of n-butyl alcohol, and 1 part per mil- ids is made up in approximately 0.012 n lion of ethyl acetate. The light petro- alkaline methyl alcohol (6 milliliters leum spirits and benzene solvents shall of 1 n sodium hydroxide diluted to 500 comply with the specifications in milliliters with methyl alcohol) to § 172.250 except that the boiling point show an absorbance at 253 millimicrons range for light petroleum spirits is 150 of 0.6 to 0.9 per centimeter. (This ab- °F to 300 °F. sorbance is obtained by approximately (5) The additive is manufactured 0.03 milligram solids permilliliter.) The from hops by an initial extraction and ultraviolet absorption spectrum of this fractionation using one or more of the solution exhibits the following charac- following solvents: Ethylene dichlo- teristics: An absorption peak at 253 ride, hexane, isopropyl alcohol, methyl millimicrons; no absorption peak at 325 alcohol, methylene chloride, trichloro- to 330 millimicrons; the absorbance at 268 millimicrons does not exceed the ethylene, and water; followed by absorbance at 272 millimicrons. isomerization by calcium chloride or (ii) The boron content of the food ad- magnesium chloride treatment in ditive does not exceed 310 parts per ethylene dichloride, methylene chlo- million (0.0310 percent), calculated as ride, or and a further boron. sequence of extractions and fraction- (2) The additive is manufactured ations using one or more of the sol- from hops by a sequence of extractions vents set forth in this paragraph. Resi- and fractionations, using benzene, light dues of the solvents in the modified petroleum spirits, and methyl alcohol hop extract shall not exceed 125 parts as solvents, followed by isomerization per million of hexane; 150 parts per mil- by potassium carbonate treatment. lion of ethylene dichloride, methylene Residues of solvents in the modified chloride, or trichloroethylene; or 250 hop extract shall not exceed 1.0 part parts per million of isopropyl alcohol per million of benzene, 1.0 part per mil- or methyl alcohol. lion of light petroleum spirits, and 250 (6) The additive is manufactured parts per million of methyl alcohol. from hops by an initial extraction and The light petroleum spirits and ben- fractionation using one or more of the zene solvents shall comply with the solvents listed in paragraph (b)(5) of specifications in § 172.250 except that this section followed by: Hydro- the boiling point range for light petro- genation using palladium as a catalyst leum spirits is 150 °F–300 °F. in methyl alcohol, ethyl alcohol, or (3) The additive is manufactured isopropyl alcohol acidified with hydro- from hops by a sequence of extractions chloric or sulfuric acid; oxidation with

60

VerDate 112000 12:37 Apr 16, 2001 Jkt 194064 PO 00000 Frm 00060 Fmt 8010 Sfmt 8010 Y:\SGML\194064T.XXX pfrm02 PsN: 194064T Food and Drug Administration, HHS § 172.610

peracetic acid; isomerization by cal- (a) The additive is the aqueous ex- cium chloride or magnesium chloride tract obtained from the root bark of treatment in ethylene dichloride, the plant Sassafras albidum (Nuttall) methylene chloride, or trichloro- Nees (Fam. Lauraceae). ethylene (alternatively, the hydro- (b) It is obtained by extracting the genation and isomerization steps may bark with dilute alcohol, first concen- be performed in reverse order); and a trating the alcoholic solution by vacu- further sequence of extractions and um distillation, then diluting the con- fractionations using one or more of the centrate with water and discarding the solvents listed in paragraph (b)(5) of oily fraction. this section. The additive shall meet (c) The purified aqueous extract is the residue limitations as prescribed in safrole-free. paragraph (b)(5) of this section. (d) It is used as a flavoring in food. (7) The additive is manufactured from hops as set forth in paragraph § 172.585 Sugar beet extract flavor (b)(6) of this section followed by reduc- base. tion with sodium borohydride in aque- Sugar beet extract flavor base may ous alkaline methyl alcohol, and a se- be safely used in food in accordance quence of extractions and fraction- with the provisions of this section. ations using one or more of the sol- (a) Sugar beet extract flavor base is vents listed in paragraph (b)(5) of this the concentrated residue of soluble section. The additive shall meet the sugar beet extractives from which residue limitations as prescribed in sugar and glutamic acid have been re- paragraph (b)(5) of this section, and a covered, and which has been subjected boron content level not in excess of 300 to ion exchange to minimize the con- parts per million (0.0300 percent), cal- centration of naturally occurring trace culated as boron. minerals. (8) The additive is manufactured (b) It is used as a flavor in food. from hops as a nonisomerizable non- volatile hop resin by an initial extrac- § 172.590 Yeast-malt sprout extract. tion and fractionation using one or Yeast-malt sprout extract, as de- more of the solvents listed in para- scribed in this section, may be safely graph (b)(5) of this section followed by used in food in accordance with the fol- a sequence of aqueous extractions and lowing prescribed conditions: removal of nonaqueous solvents to less (a) The additive is produced by par- than 0.5 percent. The additive is added tial hydrolysis of yeast extract (de- to the wort before or during cooking in rived from Saccharomyces cereviseae, the manufacture of beer. Saccharomyces fragilis, or Candida utilis) using the sprout portion of malt barley § 172.575 Quinine. as the source of enzymes. The additive Quinine, as the hydrochloride salt or contains a maximum of 6 percent 5′ nu- sulfate salt, may be safely used in food cleotides by weight. in accordance with the following condi- (b) The additive may be used as a fla- tions: vor enhancer in food at a level not in excess of that reasonably required to Uses Limitations produce the intended effect. In carbonated bev- Not to exceed 83 parts per million, as erages as a flavor. quinine. Label shall bear a promi- Subpart G—Gums, Chewing Gum nent declaration of the presence of quinine either by the use of the Bases and Related Substances word ‘‘quinine’’ in the name of the article or through a separate dec- § 172.610 Arabinogalactan. laration. Arabinogalactan may be safely used in food in accordance with the fol- § 172.580 Safrole-free extract of sas- lowing conditions: safras. (a) Arabinogalactan is a poly- The food additive safrole-free extract saccharide extracted by water from of sassafras may be safely used in ac- Western larch wood, having galactose cordance with the following prescribed units and arabinose units in the ap- conditions: proximate ratio of six to one.

61

VerDate 112000 12:37 Apr 16, 2001 Jkt 194064 PO 00000 Frm 00061 Fmt 8010 Sfmt 8010 Y:\SGML\194064T.XXX pfrm02 PsN: 194064T