§ 172.575 21 CFR Ch. I (4–1–13 Edition)

than 0.5 percent. The additive is added § 172.590 Yeast-malt sprout extract. to the wort before or during cooking in Yeast-malt sprout extract, as de- the manufacture of beer. scribed in this section, may be safely § 172.575 Quinine. used in food in accordance with the fol- lowing prescribed conditions: Quinine, as the hydrochloride salt or sulfate salt, may be safely used in food (a) The additive is produced by par- in accordance with the following condi- tial hydrolysis of yeast extract (de- tions: rived from Saccharomyces cereviseae, Saccharomyces fragilis, or Candida utilis) Uses Limitations using the sprout portion of malt barley as the source of enzymes. The additive In carbonated bev- Not to exceed 83 parts per million, as erages as a flavor. quinine. Label shall bear a promi- contains a maximum of 6 percent 5′ nu- nent declaration of the presence of cleotides by weight. quinine either by the use of the (b) The additive may be used as a fla- word ‘‘quinine’’ in the name of the article or through a separate dec- vor enhancer in food at a level not in laration. excess of that reasonably required to produce the intended effect. § 172.580 Safrole-free extract of sas- safras. Subpart G—Gums, The food additive safrole-free extract Bases and Related Substances of sassafras may be safely used in ac- cordance with the following prescribed § 172.610 Arabinogalactan. conditions: Arabinogalactan may be safely used (a) The additive is the aqueous ex- in food in accordance with the fol- tract obtained from the root bark of lowing conditions: the Sassafras albidum (Nuttall) (a) Arabinogalactan is a poly- Nees (Fam. Lauraceae). saccharide extracted by water from (b) It is obtained by extracting the Western larch wood, having galactose bark with dilute alcohol, first concen- units and arabinose units in the ap- trating the alcoholic solution by vacu- proximate ratio of six to one. um distillation, then diluting the con- (b) It is used in the following foods in centrate with water and discarding the the minimum quantity required to oily fraction. produce its intended effect as an emul- (c) The purified aqueous extract is sifier, stabilizer, binder, or bodying safrole-free. (d) It is used as a flavoring in food. agent: Essential oils, nonnutritive sweeteners, flavor bases, nonstandard- § 172.585 Sugar beet extract flavor ized dressings, and pudding mixes. base. § 172.615 Chewing gum base. Sugar beet extract flavor base may be safely used in food in accordance The food additive chewing gum base with the provisions of this section. may be safely used in the manufacture (a) Sugar beet extract flavor base is of chewing gum in accordance with the the concentrated residue of soluble following prescribed conditions: sugar beet extractives from which (a) The food additive consists of one sugar and glutamic acid have been re- or more of the following substances covered, and which has been subjected that meet the specifications and limi- to ion exchange to minimize the con- tations prescribed in this paragraph, centration of naturally occurring trace used in amounts not to exceed those re- minerals. quired to produce the intended physical (b) It is used as a flavor in food. or other technical effect.

MASTICATORY SUBSTANCES NATURAL (COAGULATED OR CONCENTRATED LATICES) OF VEGETABLE ORIGIN

Family Genus and species

Sapotaceae: Chicle ...... zapotilla Gilly and Manilkara chicle Gilly. Chiquibul ...... Manilkara zapotilla Gilly.

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MASTICATORY SUBSTANCES—Continued NATURAL (COAGULATED OR CONCENTRATED LATICES) OF VEGETABLE ORIGIN

Family Genus and species

Crown gum ...... Manilkara zapotilla Gilly and Manilkara chicle Gilly. Gutta hang kang ...... Palaquium leiocarpum Boerl. and Palaquium oblongifolium Burck. Massaranduba balata (and the solvent-free Manilkara huberi (Ducke) Chevalier. resin extract of Massaranduba balata). Massaranduba chocolate ...... Manilkara solimoesensis Gilly. Nispero ...... Manilkara zapotilla Gilly and Manilkara chicle Gilly. Rosidinha (rosadinha) ...... Micropholis (also known as Sideroxylon) spp. Venezuelan chicle ...... Manilkara williamsii Standley and related spp. Apocynaceae: Jelutong ...... Dyera costulata Hook, F. and Dyera lowii Hook, F. Leche caspi (sorva) ...... Couma macrocarpa Barb. Rodr. Pendare ...... Couma macrocarpa Barb. Rodr. and Couma utilis (Mart.) Muell. Arg. Perillo ...... Couma macrocarpa Barb. Rodr. and Couma utilis (Mart.) Muell. Arg. Moraceae: Leche de vaca ...... Brosimum utile (H.B.K.) Pittier and Poulsenia spp.; also Lacmellea standleyi (Woodson), Monachino (Apocynaceae). Niger gutta ...... Ficus platyphylla Del. Tunu (tuno) ...... Castilla fallax Cook. Euphorbiaceae: Chilte ...... Cnidoscolus (also known as Jatropha) elasticus Lundell and Cnidoscolus tepiquensis (Cost. and Gall.) McVaugh. Natural rubber (smoked sheet and latex sol- Hevea brasiliensis. ids).

Synthetic Specifications

Butadiene-styrene rubber ...... Basic polymer. Isobutylene-isoprene copolymer (butyl rub- Do. ber). Paraffin ...... Synthesized by Fischer-Tropsch process from carbon monoxide and hydro- gen which are catalytically converted to a mixture of paraffin hydrocarbon. Lower molecular weight fractions are removed by distillation. The residue is hydrogenated and further treated by percolation through activated charcoal. The product has a congealing point of 93°–99 °C as determined by ASTM method D938–71 (Reapproved 1981), ‘‘Standard Test Method for Con- gealing Point of Petroleum Waxes, Including Petrolatum,’’ a maximum oil content of 0.5 percent as determined by ASTM method D721–56T, ‘‘Ten- tative Method of Test for Oil Content of Petroleum Waxes,’’ and an absorp- tivity of less than 0.01 at 290 millimicrons in decahydronaphthalene at 88 °C as determined by ASTM method D2008–80, ‘‘Standard Test Method for Ultraviolet Absorbance and Absorptivity of Petroleum Products,’’ which are incorporated by reference. Copies may be obtained from the American So- ciety for Testing Materials, 100 Barr Harbor Dr., West Conshohocken, Philadelphia, PA 19428-2959, or may be examined at the National Ar- chives and Records Administration (NARA). For information on the avail- ability of this material at NARA, call 202–741–6030, or go to: http:// www.archives.gov/federallregister/codeloflfederallregulations/ ibrllocations.html. Petroleum wax ...... Complying with § 172.886. Petroleum wax synthetic ...... Complying with § 172.888. Polyethylene ...... Molecular weight 2,000–21,000. Polyisobutylene ...... Minimum molecular weight 37,000 (Flory). Polyvinyl acetate ...... Molecular weight, minimum 2,000.

PLASTICIZING MATERIALS (SOFTENERS)

Glycerol ester of partially dimerized rosin ...... Having an acid number of 3–8, a minimum drop-softening point of 109 °C, and a color of M or paler. Glycerol ester of partially hydrogenated gum or Having an acid number of 3–10, a minimum drop-softening point of 79 °C, wood rosin. and a color of N or paler. Glycerol ester of polymerized rosin ...... Having an acid number of 3–12, a minimum melting-point of 80 °C, and a color of M or paler. Glycerol ester of gum rosin ...... Having an acid number of 5–9, a minimum drop-softening point of 88 °C, and a color of N or paler. The ester is purified by steam stripping. Glycerol ester of tall oil rosin ...... Having an acid number of 2–12, a softening point (ring and ball) of 80°–88 °C, and a color of N or paler. The ester is purified by steam stripping. Glycerol ester of wood rosin ...... Having an acid number of 3–9, a drop-softening point of 88 °C–96 °C, and a color of N or paler. The ester is purified by steam stripping. Lanolin ......

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MASTICATORY SUBSTANCES—Continued NATURAL (COAGULATED OR CONCENTRATED LATICES) OF VEGETABLE ORIGIN

Family Genus and species

Methyl ester of rosin, partially hydrogenated ...... Having an acid number of 4–8, a refractive index of 1.5170–1.5205 at 20 °C, and a viscosity of 23–66 poises at 25 °C. The ester is purified by steam stripping. Pentaerythritol ester of partially hydrogenated Having an acid number of 7–18, a minimum drop-softening point of 102 °C, gum or wood rosin. and a color of K or paler. Pentaerythritol ester of gum or wood rosin ...... Having an acid number of 6–16, a minimum drop-softening point of 109 °C, and a color of M or paler. Rice bran wax ...... Complying with § 172.890. Stearic acid ...... Complying with § 172.860. Sodium and potassium stearates ...... Complying with § 172.863.

TERPENE RESINS

Synthetic resin ...... Consisting of polymers of apinene, bpinene, and/or dipentene; acid value less than 5, saponification number less than 5, and color less than 4 on the Gardner scale as measured in 50 percent mineral spirit solution. Natural resin ...... Consisting of polymers of a-pinene; softening point minimum 155 °C, deter- mined by U.S.P. closed-capillary method, United States Pharmacopeia XX (1980) (page 961).

ANTIOXIDANTS

Butylated hydroxyanisole ...... Not to exceed antioxidant content of 0.1% when used alone or in any com- bination. Butylated hydroxytoluene ...... Do. Propyl gallate ...... Do.

MISCELLANEOUS

Sodium sulfate ...... Sodium sulfide ...... Reaction-control agent in synthetic polymer production.

(b) In addition to the substances list- (a) The food additive is the refined ed in paragraph (a) of this section, hydrocolloid prepared by aqueous ex- chewing gum base may also include traction from the following members of substances generally recognized as safe the families Gigartinaceae and Solier- in food. iaceae of the class Rodophyceae (red (c) To assure safe use of the additive, seaweed): in addition to the other information re- Chondrus crispus. quired by the act, the label and label- Chondrus ocellatus. ing of the food additive shall bear the Eucheuma cottonii. name of the additive, ‘‘chewing gum Eucheuma spinosum. base.’’ As used in this paragraph, the Gigartina acicularis. term ‘‘chewing gum base’’ means the Gigartina pistillata. Gigartina radula. manufactured or partially manufac- Gigartina stellata. tured nonnutritive masticatory sub- stance comprised of one or more of the (b) The food additive conforms to the ingredients named and so defined in following conditions: paragraph (a) of this section. (1) It is a sulfated polysaccharide the dominant hexose units of which are ga- [42 FR 14491, Mar. 15, 1977, as amended at 45 lactose and anhydrogalactose. FR 56051, Aug. 22, 1980; 49 FR 5747, Feb. 15, (2) Range of sulfate content: 20 per- 1984; 49 FR 10105, Mar. 19, 1984; 66 FR 38153, cent to 40 percent on a dry-weight July 23, 2001; 66 FR 53711, Oct. 24, 2001] basis. (c) The food additive is used or in- § 172.620 Carrageenan. tended for use in the amount necessary The food additive carrageenan may for an emulsifier, stabilizer, or thick- be safely used in food in accordance ener in foods, except for those stand- with the following prescribed condi- ardized foods that do not provide for tions: such use.

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(d) To assure safe use of the additive, to the level that it is the dominant salt the label and labeling of the additive in the additive. shall bear the name of the additive, (b) The food additive is used or in- carrageenan. tended for use in the amount necessary for an emulsifier, stabilizer, or thick- § 172.623 Carrageenan with poly- ener in foods, except for those stand- sorbate 80. ardized foods that do not provide for Carrageenan otherwise meeting the such use. definition and specifications of § 172.620 (c) To assure safe use of the additive, (a) and (b) and salts of carrageenan the label and labeling of the additive otherwise meeting the definition of shall bear the name of the salt of car- § 172.626(a) may be safely produced with rageenan that dominates the mixture the use of polysorbate 80 meeting the by reason of the modification, e.g., specifications and requirements of ‘‘sodium carrageenan’’, ‘‘potassium § 172.840 (a) and (b) in accordance with carrageenan’’, etc. the following prescribed conditions: (a) The polysorbate 80 is used only to § 172.655 Furcelleran. facilitate separation of sheeted carra- The food additive furcelleran may be geenan and salts of carrageenan from safely used in food in accordance with drying rolls. the following prescribed conditions: (b) The carrageenan and salts of car- (a) The food additive is the refined rageenan contain not more than 5 per- hydrocolloid prepared by aqueous ex- cent by weight of polysorbate 80, and traction of furcellaria fastigiata of the the final food containing the additives class Rodophyceae (red seaweed). contains polysorbate 80 in an amount (b) The food additive conforms to the not to exceed 500 parts per million. following: (c) The carrageenan and salts of car- (1) It is a sulfated polysaccharide the rageenan so produced are used only in dominant hexose units of which are ga- producing foods in gel form and only lactose and anhydrogalactose. for the purposes defined in §§ 172.620(c) and 172.626(b), respectively. (2) Range of sulfate content: 8 per- (d) The carrageenan and salts of car- cent to 19 percent, on a dry-weight rageenan so produced are not used in basis. foods for which standards of identity (c) The food additive is used or in- exist unless the standards provide for tended for use in the amount necessary the use of carrageenan, or salts of car- for an emulsifier, stabilizer, or thick- rageenan, combined with polysorbate ener in foods, except for those stand- 80. ardized foods that do not provide for (e) The carrageenan and salts of car- such use. rageenan produced in accordance with (d) To assure safe use of the additive, this section, and foods containing the the label and labeling of the additive same, in addition to the other require- shall bear the name of the additive, ments of the Act, are labeled to show furcelleran. the presence of polysorbate 80, and the label or labeling of the carrageenan § 172.660 Salts of furcelleran. and salts of carrageenan so produced The food additive salts of furcelleran bear adequate directions for use. may be safely used in food in accord- ance with the following prescribed con- § 172.626 Salts of carrageenan. ditions: The food additive salts of carra- (a) The food additive consists of fur- geenan may be safely used in food in celleran, meeting the provisions of accordance with the following pre- § 172.655, modified by increasing the scribed conditions: concentration of one of the naturally (a) The food additive consists of car- occurring salts (ammonium, calcium, rageenan, meeting the provisions of potassium, or sodium) of furcelleran to § 172.620, modified by increasing the the level that it is the dominant salt in concentration of one of the naturally the additive. occurring salts (ammonium, calcium, (b) The food additive is used or in- potassium, or sodium) of carrageenan tended for use in the amount necessary

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for an emulsifier, stabilizer, or thick- temperature without stirring. A firm ener in foods, except for those stand- gel will form. ardized foods that do not provide for (2) Residual isopropyl alcohol (IPA) such use. not to exceed 0.075 percent as deter- (c) To assure safe use of the additive, mined by the procedure described in the label and labeling of the additive the Xanthan Gum monograph, the shall bear the name of the salt of fur- ‘‘Food Chemicals Codex,’’ 4th ed. (1996), celleran that dominates the mixture by pp. 437–438, which is incorporated by reason of the modification, e.g., ‘‘so- reference in accordance with 5 U.S.C. dium furcelleran’’, ‘‘potassium furcel- 552(a) and 1 CFR part 51. Copies are leran’’, etc. available from the National Academy Press, Box 285, 2101 Constitution Ave. § 172.665 Gellan gum. NW., Washington, DC 20055 (Internet address http://www.nap.edu), or may be The food additive gellan gum may be examined at the Center for Food Safety safely used in food in accordance with and Applied Nutrition’s Library, Food the following prescribed conditions: and Drug Administration, 5100 Paint (a) The additive is a high molecular Branch Pkwy., College Park, MD 20740, weight polysaccharide gum produced or at the National Archives and from Pseudomonas elodea by a pure cul- Records Administration (NARA). For ture fermentation process and purified information on the availability of this by recovery with isopropyl alcohol. It material at NARA, call 202–741–6030, or is composed of tetrasaccharide repeat go to: http://www.archives.gov/ units, each containing one molecule of federallregister/ rhamnose and glucuronic acid, and two codeloflfederallregulations/ molecules of glucose. The glucuronic ibrllocations.html. acid is neutralized to a mixed potas- (e) The additive is used or intended sium, sodium, calcium, and magnesium for use in accordance with current good salt. The polysaccharide may contain manufacturing practice as a stabilizer acyl (glyceryl and acetyl) groups as the and thickener as defined in § 170.3(o)(28) O-glycosidically linked esters. of this chapter. The additive may be (b) The strain of P. elodea is non- used in foods where standards of iden- pathogenic and nontoxic in man and tity established under section 401 of animals. the Federal Food, Drug, and Cosmetic (c) The additive is produced by a Act do not preclude such use. process that renders it free of viable (f) To assure safe use of the additive: cells of P. elodea. (1) The label of its container shall (d) The additive meets the following bear, in addition to other information specifications: required by the Federal Food, Drug, (1) Positive for gellan gum when sub- and Cosmetic Act, the name of the ad- jected to the following identification ditive and the designation ‘‘food tests: grade’’. (i) A 1-percent solution is made by (2) The label or labeling of the food hydrating 1 gram of gellan gum in 99 additive container shall bear adequate milliliters of distilled water. The mix- directions for use. ture is stirred for about 2 hours, using [55 FR 39614, Sept. 28, 1990, as amended at 57 a motorized stirrer and a propeller- FR 55445, Nov. 25, 1992; 64 FR 1758, Jan. 12, type stirring blade. A small amount of 1999] the above solution is drawn into a wide bore pipet and transferred into a solu- § 172.695 Xanthan gum. tion of 10-percent calcium chloride. A The food additive xanthan gum may tough worm-like gel will form in- be safely used in food in accordance stantly. with the following prescribed condi- (ii) To the 1-percent distilled water tions: solution prepared for identification (a) The additive is a polysaccharide test (i), 0.50 gram of sodium chloride is gum derived from Xanthomonas added. The solution is heated to 80 °C campestris by a pure-culture fermenta- with stirring, held at 80 °C for 1 tion process and purified by recovery minute, and allowed to cool to room with isopropyl alcohol. It contains D-

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glucose, D-mannose, and D-glucuronic (4) Positive for xanthan gum when acid as the dominant hexose units and subjected to the following procedure: is manufactured as the sodium, potas- sium, or calcium salt. PYRUVIC ACID TEST (b) The strain of Xanthomonas Pipet 10 milliliters of an 0.6 percent solu- campestris is nonpathogenic and tion of the polysaccharide in distilled water nontoxic in man or other animals. (60 milligrams of water-soluble gum) into a (c) The additive is produced by a 50-milliliter flask equipped with a standard process that renders it free of viable taper glass joint. Pipet in 20 milliliters of 1N cells of Xanthomonas campestris. hydrochloric acid. Weigh the flask. Reflux (d) The additive meets the following the mixture for 3 hours. Take precautions to specifications: avoid loss of vapor during the refluxing. Cool the solution to room temperature. Add dis- (1) Residual isopropyl alcohol not to tilled water to make up any weight loss from exceed 750 parts per million. the flask contents. (2) An aqueous solution containing 1 Pipet 1 milliliter of a 2,4-dinitrophenyl- percent of the additive and 1 percent of hydrazine reagent (0.5 percent in 2N hydro- potassium chloride stirred for 2 hours chloric acid) into a 30-milliliter separatory has a minimum viscosity of 600 centi- funnel followed by a 2-milliliter aliquot (4 poises at 75 °F, as determined by milligrams of water-soluble gum) of the Brookfield Viscometer, Model LVF (or polysaccharide hydrolyzate. Mix and allow the reaction mixture to stand at room tem- equivalent), using a No. 3 spindle at 60 perature for 5 minutes. Extract the mixture r.p.m., and the ratio of viscosities at 75 with 5 milliliters of ethyl acetate. Discard °F and 150 °F is in the range of 1.02 to the aqueous layer. 1.45. Extract the hydrazone from the ethyl ace- (3) Positive for xanthan gum when tate with three 5 milliliter portions of 10 per- subjected to the following procedure: cent sodium carbonate solution. Dilute the combined sodium carbonate extracts to 100 milliliters with additional 10 percent sodium LOCUST BEAN GUM GEL TEST carbonate in a 10-milliliter volumetric flask. Blend on a weighing paper or in a weighing Measure the optical density of the sodium pan 1.0 gram of powdered locust bean gum carbonate solution at 375 millimicrons. with 1.0 gram of the powdered polysaccharide Compare the results with a curve of the op- to be tested. Add the blend slowly (approxi- tical density versus concentration of an au- mately 1⁄2 minute) at the point of maximum thentic sample of pyruvic acid that has been agitation to a stirred solution of 200 milli- run through the procedure starting with the liters of distilled water previously heated to preparation of the hydrazone. 80 °C in a 400-milliliter beaker. Continue me- Record the percent by weight of pyruvic chanical stirring until the mixture is in solu- acid in the test polysaccharide. Note ‘‘posi- tion, but stir for a minimum time of 30 min- tive’’ for xanthan gum if the sample contains utes. Do not allow the water temperature to more than 1.5 percent of pyruvic acid and drop below 60 °C. ‘‘negative’’ for xanthan gum if the sample Set the beaker and its contents aside to contains less than 1.5 percent of pyruvic acid cool in the absence of agitation. Allow a by weight. minimum time of 2 hours for cooling. Exam- ine the cooled beaker contents for a firm (e) The additive is used or intended rubbery gel formation after the temperature for use in accordance with good manu- drops below 40 °C. facturing practice as a stabilizer, emul- In the event that a gel is obtained, make sifier, thickener, suspending agent, up a 1 percent solution of the polysaccharide bodying agent, or foam enhancer in to be tested in 200 milliliters of distilled foods for which standards of identity water previously heated to 80 °C (omit the lo- cust bean gum). Allow the solution to cool established under section 401 of the Act without agitation as before. Formation of a do not preclude such use. gel on cooling indicates that the sample is a (f) To assure safe use of the additive: gelling polysaccharide and not xanthan gum. (1) The label of its container shall Record the sample as ‘‘positive’’ for xan- bear, in addition to other information than gum if a firm, rubbery gel forms in the required by the Act, the name of the presence of locust bean gum but not in its additive and the designation ‘‘food absence. Record the sample as ‘‘negative’’ for xanthan gum if no gel forms or if a soft or grade’’. brittle gel forms both with locust bean gum (2) The label or labeling of the food and in a 1 percent solution of the sample additive container shall bear adequate (containing no locust bean gum). directions for use.

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