(b) In addition to the substances listed in paragraph (a) of this section, chewing gum base may also include substances generally recognized as safe in food.

(c) To assure safe use of the additive, in addition to the other information required by the act, the label and labeling of the food additive shall bear the name of the additive, "chewing gum base." As used in this paragraph, the term "chewing gum base" means the manufactured or partially manufactured nonnutritive masticatory substance comprised of one or more of the ingredients named and so defined in paragraph (a) of this section.

[42 FR 14491, Mar. 15, 1977, as amended at 45 FR 56051, Aug. 22, 1980; 49 FR 5747, Feb. 15, 1984; 49 FR 10105, Mar. 19, 1984; 66 FR 38153, July 23, 2001; 66 FR 53711, Oct. 24, 2001]

§ 172.620 Carrageenan.

The food additive carrageenan may be safely used in food in accordance with the following prescribed conditions:

(a) The food additive is the refined hydrocolloid prepared by aqueous extraction from the following members of the families Gigartinaceae and Solieriaceae of the class Rodophyceae (red seaweed):

Chondrus crispus. Chondrus ocellatus. Eucheuma cottonii.

Eucheuma spinosum.

Gigartina acicularis.

Gigartina pistillata. Gigartina radula. Gigartina stellata.

(b) The food additive conforms to the following conditions:

(1) It is a sulfated polysaccharide the dominant hexose units of which are galactose and anhydrogalactose.

(2) Range of sulfate content: 20 percent to 40 percent on a dry-weight basis.

(c) The food additive is used or intended for use in the amount necessary for an emulsifier, stabilizer, or thickener in foods, except for those standardized foods that do not provide for such use.

(d) To assure safe use of the additive, the label and labeling of the additive shall bear the name of the additive, carrageenan.

Carrageenan otherwise meeting the definition and specifications of § 172.620 (a) and (b) and salts of carrageenan otherwise meeting the definition of § 172.626(a) may be safely produced with the use of polysorbate 80 meeting the specifications and requirements of §172.840 (a) and (b) in accordance with the following prescribed conditions:

(a) The polysorbate 80 is used only to facilitate separation of sheeted carrageenan and salts of carrageenan from drying rolls.

(b) The carrageenan and salts of carrageenan contain not more than 5 percent by weight of polysorbate 80, and the final food containing the additives contains polysorbate 80 in an amount not to exceed 500 parts per million.

(c) The carrageenan and salts of carrageenan so produced are used only in producing foods in gel form and only for the purposes defined in §§ 172.620(c) and 172.626(b), respectively.

(d) The carrageenan and salts of carrageenan so produced are not used in foods for which standards of identity exist unless the standards provide for the use of carrageenan, or salts of carrageenan, combined with polysorbate 80.

(e) The carrageenan and salts of carrageenan produced in accordance with this section, and foods containing the same, in addition to the other requirements of the Act, are labeled to show the presence of polysorbate 80, and the label or labeling of the carrageenan and salts of carrageenan so produced bear adequate directions for use.

§ 172.626 Salts of carrageenan.

The food additive salts of carrageenan may be safely used in food in accordance with the following prescribed conditions:

(a) The food additive consists of carrageenan, meeting the provisions of § 172.620, modified by increasing the concentration of one of the naturally occurring salts (ammonium, calcium, potassium, or sodium) of carrageenan to the level that it is the dominant salt in the additive.

(b) The food additive is used or intended for use in the amount necessary

for an emulsifier, stabilizer, or thickener in foods, except for those standardized foods that do not provide for such use.

(c) To assure safe use of the additive, the label and labeling of the additive shall bear the name of the salt of carrageenan that dominates the mixture by reason of the modification, e.g., "sodium carrageenan", "potassium carrageenan", etc.

§ 172.655 Furcelleran.

The food additive furcelleran may be safely used in food in accordance with the following prescribed conditions:

(a) The food additive is the refined hydrocolloid prepared by aqueous extraction of furcellaria fastigiata of the class Rodophyceae (red seaweed).

(b) The food additive conforms to the following:

(1) It is a sulfated polysaccharide the dominant hexose units of which are galactose and anhydrogalactose.

(2) Range of sulfate content: 8 percent to 19 percent, on a dry-weight basis.

(c) The food additive is used or intended for use in the amount necessary for an emulsifier, stabilizer, or thickener in foods, except for those standardized foods that do not provide for such use.

(d) To assure safe use of the additive, the label and labeling of the additive shall bear the name of the additive, furcelleran.

§ 172.660 Salts of furcelleran.

The food additive salts of furcelleran may be safely used in food in accordance with the following prescribed conditions:

(a) The food additive consists of furcelleran, meeting the provisions of § 172.655, modified by increasing the concentration of one of the naturally occurring salts (ammonium, calcium, potassium, or sodium) of furcelleran to the level that it is the dominant salt in the additive.

(b) The food additive is used or intended for use in the amount necessary for an emulsifier, stabilizer, or thickener in foods, except for those standardized foods that do not provide for such use.

The food additive gellan gum may be safely used in food in accordance with the following prescribed conditions:

(a) The additive is a high molecular weight polysaccharide gum produced from Pseudomonas elodea by a pure culture fermentation process and purified by recovery with isopropyl alcohol. It is composed of tetrasaccharide repeat units, each containing one molecule of rhamnose and glucuronic acid, and two molecules of glucose. The glucuronic acid is neutralized to a mixed potassium, sodium, calcium, and magnesium salt. The polysaccharide may contain acyl (glyceryl and acetyl) groups as the O-glycosidically linked esters.

(b) The strain of P. elodea is nonpathogenic and nontoxic in man and animals.

(c) The additive is produced by a process that renders it free of viable cells of P. elodea.

(d) The additive meets the following specifications:

(1) Positive for gellan gum when subjected to the following identification tests:

(i) A 1-percent solution is made by hydrating 1 gram of gellan gum in 99 milliliters of distilled water. The mixture is stirred for about 2 hours, using a motorized stirrer and a propellertype stirring blade. A small amount of the above solution is drawn into a wide bore pipet and transferred into a solution of 10-percent calcium chloride. A tough worm-like gel will form instantly.

(ii) To the 1-percent distilled water solution prepared for identification test (i), 0.50 gram of sodium chloride is added. The solution is heated to 80 °C with stirring, held at 80 °C for 1 minute, and allowed to cool to room temperature without stirring. A firm gel will form.

(2) Residual isopropyl alcohol (IPA) not to exceed 0.075 percent as determined by the procedure described in

the Xanthan Gum monograph, the "Food Chemicals Codex," 4th ed. (1996), pp. 437-438, which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available from the National Academy Press, Box 285, 2101 Constitution Ave. NW., Washington, DC 20055 (Internet address "http://www.nap.edu"), or may be examined at the Center for Food Safety and Applied Nutrition's Library, Food and Drug Administration, 200 C St. SW., Washington, DC, or at the Office of the Federal Register, 800 North Capitol St. NW., suite 700, Washington, DC.

(e) The additive is used or intended for use in accordance with current good manufacturing practice as a stabilizer and thickener as defined in § 170.3(o)(28) of this chapter. The additive may be used in foods where standards of identity established under section 401 of the Federal Food, Drug, and Cosmetic Act do not preclude such use.

(f) To assure safe use of the additive: (1) The label of its container shall bear, in addition to other information required by the Federal Food, Drug, and Cosmetic Act, the name of the additive and the designation "food grade".

(2) The label or labeling of the food additive container shall bear adequate directions for use.

[55 FR 39614, Sept. 28, 1990, as amended at 57 FR 55445, Nov. 25, 1992; 64 FR 1758, Jan. 12, 1999]

§ 172.695 Xanthan gum.

The food additive xanthan gum may be safely used in food in accordance with the following prescribed conditions:

(a) The additive is a polysaccharide gum derived from Xanthomonas campestris by a pure-culture fermentation process and purified by recovery with isopropyl alcohol. It contains Dglucose, D-mannose, and D-glucuronic acid as the dominant hexose units and is manufactured as the sodium, potassium, or calcium salt.

(b) The strain of Xanthomonas campestris is nonpathogenic and nontoxic in man or other animals.

(c) The additive is produced by a process that renders it free of viable cells of Xanthomonas campestris.

(d) The additive meets the following specifications:

(1) Residual isopropyl alcohol not to exceed 750 parts per million.

(2) An aqueous solution containing 1 percent of the additive and 1 percent of potassium chloride stirred for 2 hours has a minimum viscosity of 600 centipoises at 75 °F, as determined by Brookfield Viscometer, Model LVF (or equivalent), using a No. 3 spindle at 60 r.p.m., and the ratio of viscosities at 75 °F and 150 °F is in the range of 1.02 to 1.45.

(3) Positive for xanthan gum when subjected to the following procedure:

LOCUST BEAN GUM GEL TEST

Blend on a weighing paper or in a weighing pan 1.0 gram of powdered locust bean gum with 1.0 gram of the powdered polysaccharide to be tested. Add the blend slowly (approximately 2 minute) at the point of maximum agitation to a stirred solution of 200 milliliters of distilled water previously heated to 80 °C in a 400-milliliter beaker. Continue mechanical stirring until the mixture is in solution, but stir for a minimum time of 30 minutes. Do not allow the water temperature to drop below 60 °C.

Set the beaker and its contents aside to cool in the absence of agitation. Allow a minimum time of 2 hours for cooling. Examine the cooled beaker contents for a firm rubbery gel formation after the temperature drops below 40 °C.

In the event that a gel is obtained, make up a 1 percent solution of the polysaccharide to be tested in 200 milliliters of distilled water previously heated to 80 °C (omit the locust bean gum). Allow the solution to cool without agitation as before. Formation of a gel on cooling indicates that the sample is a gelling polysaccharide and not xanthan gum.

Record the sample as "positive" for xanthan gum if a firm, rubbery gel forms in the presence of locust bean gum but not in its absence. Record the sample as "negative" for xanthan gum if no gel forms or if a soft or brittle gel forms both with locust bean gum and in a 1 percent solution of the sample (containing no locust bean gum).

(4) Positive for xanthan gum when subjected to the following procedure:

PYRUVIC ACID TEST

Pipet 10 milliliters of an 0.6 percent solution of the polysaccharide in distilled water (60 milligrams of water-soluble gum) into a 50-milliliter flask equipped with a standard taper glass joint. Pipet in 20 milliliters of 1N hydrochloric acid. Weigh the flask. Reflux the mixture for 3 hours. Take precautions to

avoid loss of vapor during the refluxing. Cool the solution to room temperature. Add distilled water to make up any weight loss from the flask contents.

Pipet 1 milliliter of a 2,4-dinitrophenylhydrazine reagent (0.5 percent in 2N hydrochloric acid) into a 30-milliliter separatory funnel followed by a 2-milliliter aliquot (4 milligrams of water-soluble gum) of the polysaccharide hydrolyzate. Mix and allow the reaction mixture to stand at room temperature for 5 minutes. Extract the mixture with 5 milliliters of ethyl acetate. Discard the aqueous layer.

Extract the hydrazone from the ethyl acetate with three 5 milliliter portions of 10 percent sodium carbonate solution. Dilute the combined sodium carbonate extracts to 100 milliliters with additional 10 percent sodium carbonate in a 10-milliliter volumetric flask. Measure the optical density of the sodium carbonate solution at 375 millimicrons.

Compare the results with a curve of the optical density versus concentration of an authentic sample of pyruvic acid that has been run through the procedure starting with the preparation of the hydrazone.

Record the percent by weight of pyruvic acid in the test polysaccharide. Note "positive" for xanthan gum if the sample contains more than 1.5 percent of pyruvic acid and "negative" for xanthan gum if the sample contains less than 1.5 percent of pyruvic acid by weight.

(e) The additive is used or intended for use in accordance with good manufacturing practice as a stabilizer, emulsifier, thickener, suspending agent, bodying agent, or foam enhancer in foods for which standards of identity established under section 401 of the Act do not preclude such use.

(f) To assure safe use of the additive: (1) The label of its container shall bear, in addition to other information required by the Act, the name of the additive and the designation "food grade".

(2) The label or labeling of the food additive container shall bear adequate directions for use.

Subpart H-Other Specific Usage Additives

§ 172.710 Adjuvants for pesticide use dilutions.

The following surfactants and related adjuvants may be safely added to pesticide use dilutions by a grower or applicant prior to application to the growing crop:

n-Alkyl (C8-C18) amine acetate, where the alkyl groups (C8-C18) are derived from coconut oil, as a surfactant in emulsifier blends at levels not in excess of 5 percent by weight of the emulsifier blends that are added to herbicides for application to corn and sorghum.

Di-n-alkyl (C8-C18) dimethyl ammonium chloride, where the alkyl groups (C8-C18) are derived from coconut oil, as surfactants in emulsifier blends at levels not in excess of 5 percent by weight of emulsifier blends that are added to herbicides for application to corn or sorghum.

Diethanolamide condensate based on a mixture of saturated and unsaturated soybean oil fatty acids (C16-C18) as a surfactant in emulsifier blends that are added to the herbicide atrazine for application to corn.

Diethanolamide condensate based on stripped coconut fatty acids (C10 C18) as a surfactant in emulsifier blends that are added to the herbicide atrazine for application to corn.

a-(p-Dodecylphenyl)-omega-hydroxypoly (oxyethylene) produced by the condensation of 1 mole of dodecylphenol (dodecyl group is a proplyene tetramer isomer) with an average of 4-14 or 30-70 moles of ethylene oxide; if a blend of products is used, the average number of moles of ethylene oxide reacted to produce any product that is a component of the blend shall be in the range of 4-14 or 3070.

Ethylene dichloride. Polyglyceryl phthalate ester of coconut oil fatty acids.

a-[p-(1,1,3,3-Tetramethylbutyl) omega-hydroxypoly(oxyethylene)

phenyl]produced

(a) It is prepared by the aldol condensation of acetaldehyde followed by catalytic hydrogenation.

(b) The food additive shall conform to the identity and specifications listed in the monograph entitled "1,3-Butylene Glycol" in the Food Chemicals Codex, 4th ed. (1996), p. 52, which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available from the Office of Premarket Approval, Center for Food Safety and Applied Nutrition, 5100 Paint Branch Pkwy., College Park, MD 20740, or may be examined at the Center for Food Safety and Applied Nutrition's Library, Food and Drug Administration, 200 C St. SW., Washington, DC, or at the Office of the Federal Register, 800 North Capitol St. NW., suite 700, Washington, DC.

(c) It is used in the manufacture of sausage casings as a formulation aid as defined in §170.3(o)(14) of this chapter and as a processing aid as defined in § 170.3(0)(24) of this chapter.

[62 FR 26228, May 13, 1997]

§ 172.723 Epoxidized soybean oil.

Epoxidized soybean oil may be safely used in accordance with the following prescribed conditions:

(a) The additive is prepared by reacting soybean oil in toluene with hydrogen peroxide and formic acid.

(b) It meets the following specifications:

re

(1) Epoxidized soybean oil contains oxirane oxygen, between 7.0 and 8.0 percent, as determined by the American Oil Chemists' Society (A.O.C.S.) method Cd 9-57, "Oxirane Oxygen," approved 1989, which is incorporated by reference in accordance with 5 U.S.C 552(a) and 1 CFR part 51. Copies are available from the American Oil Chemists' Society, P. O. Box 3489, Champaign, IL 61826-3489, or may be examined at the Division of Petition Control (HFS-215), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 1110 Vermont Ave. NW., suite 1200, Washington, DC, or at the Office of the Federal Register, 800 North Capitol St. NW., suite 700, Washington, DC.

(2) The maximum iodine value is 3.0, as determined by A.O.C.S. method Cd 1-25, "Iodine Value of Fats and Oils Wijs Method," revised 1993, which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. The availability of this incorporation by reference is given in paragraph (b)(1) of this section.

(3) The heavy metals (as Pb) content cannot be more than 10 parts per million, as determined by the "Heavy Metals Test," of the "Food Chemicals Codex," 4th ed. (1996), pp. 760-761, Method II (with a 2-gram sample and 20 microgram of lead ion in the control), which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available from the National Academy Press, Box 285, 2101 Constitution Ave. NW., Washington, DC 20055 (Internet address "http://www.nap.edu"), or may be examined at the Center for Food Safety and Applied Nutrition's Library, Food and Drug Administration, 200 C St. SW., Washington, DC, or at the Office of the Federal Register, 800 North Capitol St. NW., suite 700, Washington, DC.