Natural flavoring substances and natural adjuvants may be safely used in food in accordance with the following conditions.
(a) They are used in the minimum quantity required to produce their intended physical or technical effect and in accordance with all the principles of good manufacturing practice.
(b) In the appropriate forms (plant parts, fluid and solid extracts, concentrates, absolutes, oils, gums, balsams, resins, oleoresins, waxes, and distillates) they consist of one or more of the following, used alone or in combination with flavoring substances and adjuvants generally recognized as safe in food, previously sanctioned for such use, or regulated in any section of this part.
| Common name | Scientific name | Limitations |
|---|---|---|
| Aloe | ||
| Althea root and flowers | ||
| Amyris (West Indian sandalwood) | ||
| Angola weed | In alcoholic beverages only | |
| Arnica flowers | Do. | |
| Artemisia (wormwood) | Finished food thujone free 1 | |
| Artichoke leaves | In alcoholic beverages only | |
| Benzoin resin | ||
| Blackberry bark | ||
| Boldus (boldo) leaves | Do. | |
| Boronia flowers | ||
| Bryonia root | Do. | |
| Buchu leaves | ||
| Buckbean leaves | Do. | |
| Cajeput | ||
| Calumba root | Do. | |
| Camphor tree | Safrole free | |
| Cascara sagrada | ||
| Cassie flowers | ||
| Castor oil | ||
| Catechu, black | ||
| Cedar, white (aborvitae), leaves and twigs | Finished food thujone free 1 | |
| Centuary | In alcoholic beverages only | |
| Cherry pits | Not to exceed 25 p.p.m. prussic acid | |
| Cherry-laurel leaves | Do. | |
| Chestnut leaves | ||
| Chirata | In alcoholic beverages only | |
| Cinchona, red, bark | In beverages only; not more than 83 p.p.m. total cinchona alkaloids in finished beverage | |
| Cinchona, yellow, bark | Do. | |
| Copaiba | South American spp. of | |
| Cork, oak | In alcoholic beverages only | |
| Costmary | Do. | |
| Costus root | ||
| Cubeb | ||
| Currant, black, buds and leaves | ||
| Damiana leaves | ||
| Davana | ||
| Dill, Indian | ||
| Dittany (fraxinella) roots | Do. | |
| Dittany of Crete | ||
| Dragon's blood (dracorubin) | ||
| Elder tree leaves | In alcoholic beverages only; not to exceed 25 p.p.m. prussic acid in the flavor | |
| Elecampane rhizome and roots | In alcoholic beverages only | |
| Elemi | ||
| Erigeron | ||
| Eucalyptus globulus leaves | ||
| Fir (“pine”) needles and twigs | ||
| Fir, balsam, needles and twigs | ||
| Galanga, greater | Do. | |
| Galbanum | ||
| Gambir (catechu, pale) | ||
| Genet flowers | ||
| Gentian rhizome and roots | ||
| Gentian, stemless | Do. | |
| Germander, chamaedrys | Do. | |
| Germander, golden | Do. | |
| Guaiac | ||
| Guarana | ||
| Haw, black, bark | ||
| Hemlock needles and twigs | ||
| Hyacinth flowers | ||
| Iceland moss | Do. | |
| Imperatoria | ||
| Iva | Do. | |
| Labdanum | ||
| Lemon-verbena | Do. | |
| Linaloe wood | ||
| Linden leaves | Do. | |
| Lovage | ||
| Lungmoss (lungwort) | ||
| Maidenhair fern | Do. | |
| Maple, mountain | ||
| Mimosa (black wattle) flowers | ||
| Mullein flowers | Do. | |
| Myrrh | ||
| Myrtle leaves | Do. | |
| Oak, English, wood | Do. | |
| Oak, white, chips | ||
| Oak moss | Finished food thujone free 1 | |
| Olibanum | ||
| Opopanax (bisabolmyrrh) | ||
| Orris root | ||
| Pansy | In alcoholic beverages only | |
| Passion flower | ||
| Patchouly | ||
| Peach leaves | In alcoholic beverages only; not to exceed 25 p.p.m. prussic acid in the flavor | |
| Pennyroyal, American | ||
| Pennyroyal, European | ||
| Pine, dwarf, needles and twigs | ||
| Pine, Scotch, needles and twigs | ||
| Pine, white, bark | In alcoholic beverages only | |
| Pine, white oil | ||
| Poplar buds | Do. | |
| Quassia | ||
| Quebracho bark | ||
| Quillaia (soapbark) | ||
| Red saunders (red sandalwood) | In alcoholic beverages only | |
| Rhatany root | ||
| Rhubarb, garden root | Do. | |
| Rhubarb root | ||
| Roselle | Do. | |
| Rosin (colophony) | Do. | |
| St. Johnswort leaves, flowers, and caulis | Hypericin-free alcohol distillate form only; in alcoholic beverages only | |
| Sandalwood, white (yellow, or East Indian) | ||
| Sandarac | In alcoholic beverages only | |
| Sarsaparilla | ||
| Sassafras leaves | Safrole free | |
| Senna, Alexandria | ||
| Serpentaria (Virginia snakeroot) | In alcoholic beverages only | |
| Simaruba bark | Do. | |
| Snakeroot, Canadian (wild ginger) | ||
| Spruce needles and twigs | ||
| Storax (styrax) | ||
| Tagetes (marigold) | As oil only | |
| Tansy | In alcoholic beverages only; finished alcoholic beverage thujone free 1 | |
| Thistle, blessed (holy thistle) | In alcoholic beverages only | |
| Tolu | ||
| Turpentine | ||
| Valerian rhizome and roots | ||
| Veronica | Do. | |
| Vervain, European | Do. | |
| Vetiver | Do. | |
| Violet, Swiss | ||
| Walnut husks (hulls), leaves, and green nuts | ||
| Woodruff, sweet | In alcoholic beverages only | |
| Yarrow | In beverages only; finished beverage thujone free 1 | |
| Yerba santa | ||
| Yucca, Joshua-tree | ||
| Yucca, Mohave |
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 reference. Copies may be obtained from the AOAC INTERNATIONAL, 481 North Frederick Ave., suite 500, Gaithersburg, MD 20877, or may be examined at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to:
Synthetic flavoring substances and adjuvants may be safely used in food in accordance with the following conditions.
(a) They are used in the minimum quantity required to produce their intended effect, and otherwise in accordance with all the principles of good manufacturing practice.
(b) They consist of one or more of the following, used alone or in combination with flavoring substances and adjuvants generally recognized as safe in food, prior-sanctioned for such use, or regulated by an appropriate section in this part.
(c) Δ-Decalactone and Δ-dodecalactone when used separately or in combination in oleomargarine are used at levels not to exceed 10 parts per million and 20 parts per million, respectively, in accordance with § 166.110 of this chapter.
(d) BHA (butylated hydroxyanisole) may be used as an antioxidant in flavoring substances whereby the additive does not exceed 0.5 percent of the essential (volatile) oil content of the flavoring substance.
The food additive “cocoa with dioctyl sodium sulfosuccinate for manufacturing,” conforming to § 163.117 of this chapter and § 172.810, is used or intended for use as a flavoring substance in dry beverage mixes whereby the amount of dioctyl sodium sulfosuccinate does not exceed 75 parts per million of the finished beverage. The labeling of the dry beverage mix shall bear adequate directions to assure use in compliance with this section.
Disodium guanylate may be safely used as a flavor enhancer in foods, at a level not in excess of that reasonably required to produce the intended effect.
The food additive disodium inosinate may be safely used in food in accordance with the following prescribed conditions:
(a) The food additive is the disodium salt of inosinic acid, manufactured and purified so as to contain no more than 150 parts per million of soluble barium in the compound disodium inosinate with seven and one-half molecules of water of crystallization.
(b) The food additive is used as a flavoring adjuvant in food.
DL-Alanine (a racemic mixture of D- and L-alanine; CAS Reg. No. 302-72-7) may be safely used as a flavor enhancer for sweeteners in pickling mixtures at a level not to exceed 1 percent of the pickling spice that is added to the pickling brine.
The food additive modified hop extract may be safely used in beer in accordance with the following prescribed conditions:
(a) The food additive is used or intended for use as a flavoring agent in the brewing of beer.
(b) The food additive is manufactured by one of the following processes:
(1) The additive is manufactured from a hexane extract of hops by simultaneous isomerization and selective reduction in an alkaline aqueous medium with sodium borohydride, whereby the additive meets the following specifications:
(i) A solution of the food additive solids is made up in approximately 0.012 n alkaline methyl alcohol (6 milliliters of 1 n sodium hydroxide diluted to 500 milliliters with methyl alcohol) to show an absorbance at 253 millimicrons of 0.6 to 0.9 per centimeter. (This absorbance is obtained by approximately 0.03 milligram solids permilliliter.) The ultraviolet absorption spectrum of this solution exhibits the following characteristics: An absorption peak at 253 millimicrons; no absorption peak at 325 to 330 millimicrons; the absorbance at 268 millimicrons does not exceed the absorbance at 272 millimicrons.
(ii) The boron content of the food additive does not exceed 310 parts per million (0.0310 percent), calculated as boron.
(2) The additive is manufactured from hops by a sequence of extractions and fractionations, using benzene, light petroleum spirits, and methyl alcohol as solvents, followed by isomerization by potassium carbonate treatment. Residues of solvents in the modified hop extract shall not exceed 1.0 part per million of benzene, 1.0 part per million of light petroleum spirits, and 250 parts per million of methyl alcohol. The light petroleum spirits and benzene solvents shall comply with the specifications in § 172.250 except that the boiling point range for light petroleum spirits is 150 °F-300 °F.
(3) The additive is manufactured from hops by a sequence of extractions and fractionations, using methylene chloride, hexane, and methyl alcohol as solvents, followed by isomerization by sodium hydroxide treatment. Residues of the solvents in the modified hop extract shall not exceed 5 parts per million of methylene chloride, 25 parts per million of hexane, and 100 parts per million of methyl alcohol.
(4) The additive is manufactured from hops by a sequence of extractions and fractionations, using benzene, light petroleum spirits, methyl alcohol, n-butyl alcohol, and ethyl acetate as solvents, followed by isomerization by potassium carbonate treatment. Residues of solvents in the modified hop extract shall not exceed 1.0 part per million of benzene, 1.0 part per million of light petroleum spirits, 50 parts per million of methyl alcohol, 50 parts per million of n-butyl alcohol, and 1 part per million of ethyl acetate. The light petroleum spirits and benzene solvents shall comply with the specifications in § 172.250 except that the boiling point range for light petroleum spirits is 150 °F to 300 °F.
(5) The additive is manufactured from hops by an initial extraction and fractionation using one or more of the following solvents: Ethylene dichloride, hexane, isopropyl alcohol, methyl alcohol, methylene chloride, trichloroethylene, and water; followed by isomerization by calcium chloride or magnesium chloride treatment in ethylene dichloride, methylene chloride, or trichloroethylene and a further sequence of extractions and fractionations using one or more of the solvents set forth in this paragraph. Residues of the solvents in the modified hop extract shall not exceed 125 parts per million of hexane; 150 parts per million of ethylene dichloride, methylene chloride, or trichloroethylene; or 250 parts per million of isopropyl alcohol or methyl alcohol.
(6) The additive is manufactured from hops by an initial extraction and fractionation using one or more of the solvents listed in paragraph (b)(5) of this section followed by: Hydrogenation using palladium as a catalyst in methyl alcohol, ethyl alcohol, or isopropyl alcohol acidified with hydrochloric or sulfuric acid; oxidation with peracetic acid; isomerization by calcium chloride or magnesium chloride treatment in ethylene dichloride, methylene chloride, or trichloroethylene (alternatively, the hydrogenation and isomerization steps may be performed in reverse order); and a further sequence of extractions and fractionations using one or more of the solvents listed in paragraph (b)(5) of this section. The additive shall meet the residue limitations as prescribed in paragraph (b)(5) of this section.
(7) The additive is manufactured from hops as set forth in paragraph (b)(6) of this section followed by reduction with sodium borohydride in aqueous alkaline methyl alcohol, and a sequence of extractions and fractionations using one or more of the solvents listed in paragraph (b)(5) of this section. The additive shall meet the residue limitations as prescribed in paragraph (b)(5) of this section, and a boron content level not in excess of 300 parts per million (0.0300 percent), calculated as boron.
(8) The additive is manufactured from hops as a nonisomerizable nonvolatile hop resin by an initial extraction and fractionation using one or more of the solvents listed in paragraph (b)(5) of this section followed by a sequence of aqueous extractions and removal of nonaqueous solvents to less than 0.5 percent. The additive is added to the wort before or during cooking in the manufacture of beer.
Quinine, as the hydrochloride salt or sulfate salt, may be safely used in food in accordance with the following conditions:
| Uses | Limitations |
|---|---|
| In carbonated beverages as a flavor | Not to exceed 83 parts per million, as quinine. Label shall bear a prominent declaration of the presence of quinine either by the use of the word “quinine” in the name of the article or through a separate declaration. |
The food additive safrole-free extract of sassafras may be safely used in accordance with the following prescribed conditions:
(a) The additive is the aqueous extract obtained from the root bark of the plant Sassafras albidum (Nuttall) Nees (Fam. Lauraceae).
(b) It is obtained by extracting the bark with dilute alcohol, first concentrating the alcoholic solution by vacuum distillation, then diluting the concentrate with water and discarding the oily fraction.
(c) The purified aqueous extract is safrole-free.
(d) It is used as a flavoring in food.
Sugar beet extract flavor base may be safely used in food in accordance with the provisions of this section.
(a) Sugar beet extract flavor base is the concentrated residue of soluble sugar beet extractives from which sugar and glutamic acid have been recovered, and which has been subjected to ion exchange to minimize the concentration of naturally occurring trace minerals.
(b) It is used as a flavor in food.
Yeast-malt sprout extract, as described in this section, may be safely used in food in accordance with the following prescribed conditions:
(a) The additive is produced by partial hydrolysis of yeast extract (derived from Saccharomyces cereviseae, Saccharomyces fragilis, or Candida utilis) using the sprout portion of malt barley as the source of enzymes. The additive contains a maximum of 6 percent 5′ nucleotides by weight.
(b) The additive may be used as a flavor enhancer in food at a level not in excess of that reasonably required to produce the intended effect.