Substances

Cellulose triacetate

Diethylaminoethyl-cellulose

Glutaraldehyde

Periodic acid (CAS Reg. No. 10450-609)..

Polyethylenimine reaction product with 1,2-dichloroethane (CAS Reg. No. 68130-97-2) is the reaction product of homopolymerization of ethylenimine in aqueous hydrochloric acid at 100 °C and of cross-linking with 1,2dichloroethane. The finished polymer has an average molecular weight of 50,000 to 70,000 as determined by gel permeation chromatography. The analytical method is entitled "Methodology for Molecular Weight Detection of Polyethylenimine," which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies may be obtained from the Division of Petition Control, Center for Food Safety and Applied Nutrition (HFS-200), 5100 Paint Branch Pkwy., College Park, MD 20740, and may be examined at the Center for Food Safety and Applied Nutrition's Library, 200 C St. SW., Washington, DC, or at the Office of the Federal Register, 800 North Capitol St. NW., Suite 700, Washington, DC.

tions in accordance with the following conditions:

(a) The materials consist of one or more of the following:

(1) Substances generally recognized as safe in food.

(2) Substances identified in this subparagraph and subject to such limitations as are provided:

Limitations

May be used as a fixing material in the immobilization of lactase for use in reducing the lactose content of milk.

May be used as a fixing material in the immobilization of glucose isomerase enzyme preparations for use in the manufacture of high fructose corn syrup, in accordance with § 184.1372 of this chapter. Do.

May be used as a fixing material in the immobilization of glucoamylase enzyme preparations from Aspergillus niger for use in the manufacture of beer.

May be used as a fixing material in the immobilization of:

1. Glucose isomerase enzyme preparations for use in the manufacture of high fructose corn syrup, in accordance with § 184.1372 of this chapter.

2. Glucoamylase enzyme preparations from Aspergillus niger for use in the manufacture of beer. Residual ethylenimine in the finished polyethylenimine polymer will be less than 1 part per million as determined by gas chromatography-mass spectrometry. The residual ethylenimine is determined by an analytical method entitled "Methodology for Ethylenimine Detection in Polyethylenimine," which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Residual 1,2-dichloroethane in the finished polyethylenimine polymer will be less than 1 part per million as determined by gas chromatography. The residual 1,2dichloroethane is determined by an analytical method entitled, "Methodology for Ethylenedichloride Detection in Polyethylenimine," which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies may be obtained from the Division of Petition Control, Center for Food Safety and Applied Nutrition (HFS-215), 5100 Paint Branch Pkwy., College Park, MD 20740, or may be examined at the Center for Food Safety and Applied Nutrition's Library, 200 C St. SW., Washington, DC, or the Office of the Federal Register, 800 North Cap-itol St. NW., suite 700, Washington, DC.

(b) The additive is used or intended for use alone or with one or more of the following substances: Carbon dioxide, nitrous oxide, and propane, as a propellant and aerating agent for foamed or sprayed food products, except for those standardized foods that do not provide for such use.

(c) To assure safe use of the additive: (1) The label of the food additive container shall bear, in addition to the other information required by the act, the following:

(i) The name of the additive, octafluorocyclobutane.

(ii) The percentage of the additive present in the case of a mixture.

(iii) The designation "food grade".

Ozone (CAS Reg. No. 10028-15-6) may be safely used in the treatment, storage, and processing of foods, including meat and poultry (unless such use is precluded by standards of identity in 9 CFR part 319), in accordance with the following prescribed conditions:

(a) The additive is an unstable, colorless gas with a pungent, characteristic odor, which occurs freely in nature. It is produced commercially by passing electrical discharges or ionizing radiation through air or oxygen.

(b) The additive is used as an antimicrobial agent as defined in

§ 170.3(0)(2) of this chapter.

(c) The additive meets the specifications for ozone in the Food Chemicals Codex, 4th ed. (1996), p. 277, which is incorporated by reference. The Director of the Office of the Federal Register approves this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20055, or may be examined at the Office of Premarket Approval (HFS-200), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 200 C St. SW., Washington, DC, and the Office of the Federal Register, 800 North Capitol St. NW., suite 700, Washington, DC.

(d) The additive is used in contact with food, including meat and poultry (unless such use is precluded by standards of identity in 9 CFR part 319 or 9 CFR part 381, subpart P), in the gaseous or aqueous phase in accordance with current industry standards of good manufacturing practice.

(e) When used on raw agricultural commodities, the use is consistent with section 201(q)(1)(B)(i) of the Federal Food, Drug, and Cosmetic Act (the act) and not applied for use under section 201(q)(1)(B)(i)(I), (q)(1)(B)(i)(II), or (q)(1)(B)(i)(III) of the act.

[66 FR 33830, June 26, 2001; 67 FR 271, Jan. 3, 2002]

(b)(1) The additive is used as an antimicrobial agent on red meat carcasses in accordance with current industry practice where the maximum concentration of peroxyacids is 220 parts per million (ppm) as peroxyacetic acid, and the maximum concentration of hydrogen peroxide is 75 ppm.

(2) The additive is used as an antimicrobial agent on poultry carcasses, poultry parts, and organs in accordance with current industry standards of good manufacturing practice (unless precluded by the U.S. Department of Agriculture's standards of identity in 9 CFR part 381, subpart P) where the maximum concentration of peroxyacids is 220 parts per million (ppm) as peroxyacetic acid, the maximum concentration of hydrogen peroxide is 110 ppm, and the maximum concentration of 1-hydroxyethylidene1,1-diphosphonic acid (HEDP) is 13 ppm.

(c) The concentrations of peroxyacids and hydrogen peroxide in the additive are determined by a method entitled "Hydrogen Peroxide and Peracid (as Peracetic Acid) Content," July 26, 2000, developed by Ecolab, Inc., St. Paul, MN, which is incorporated by reference. The concentration of 1

hydroxyethylidene-1,1-diphosphonic acid is determined by a method entitled "Determination of 1hydroxyethylidene-1,1-diphosphonic

acid (HEDP) Peroxyacid/Peroxide-Containing Solutions," August 21, 2001, developed by Ecolab, Inc., St. Paul, MN, which is incorporated by reference. The Director of the Office of the Federal Register approves these incorporations by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You may obtain copies of these methods from the Division of Petition Review, Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, or you may examine a copy

Trifluoromethane sulfonic acid has the empirical formula CF 3 SO 3H (CAS Reg. No. 1493-13-6). The catalyst (Trifluoromethane sulfonic acid) may safely be used in the production of cocoa butter substitute from palm oil (1-palmitoyl-2-oleoyl-3-stearin) (see

§ 184.1259 of this chapter) in accordance with the following conditions:

(a) The catalyst meets the following specifications:

Appearance, Clear liquid.

Color, Colorless to amber.

Neutralization equivalent, 147–151.
Water, 1 percent maximum.

Fluoride ion, 0.03 percent maximum.

Heavy metals (as Pb), 30 parts per million maximum.

Arsenic (as As), 3 parts per million maximum.

(b) It is used at levels not to exceed 0.2 percent of the reaction mixture to catalyze the directed esterification.

(c) The esterification reaction is quenched with steam and water and the catalyst is removed with the aqueous phase. Final traces of catalyst are removed by washing batches of the product three times with an aqueous solution of 0.5 percent sodium bicarbonate.

(d) No residual catalyst may remain in the product at a detection limit of 0.2 part per million fluoride as determined by the method described in “Official Methods of Analysis of the Association of Official Analytical Chemists," sections 25.049-25.055, 13th Ed.

(1980), which is incorporated by reference. Copies may be obtained from the Association of Official Analytical Chemists International, 481 North Frederick 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.

[43 FR 54237, Nov. 11, 1978, as amended at 49 FR 10106, Mar. 19, 1984; 54 FR 24897, June 12, 1989]

§ 173.400 Dimethyldialkylammonium chloride.

Dimethyldialkylammonium chloride may be safely used in food in accordance with the following prescribed conditions:

(a) The food additive is produced by one of the following methods:

(1) Ammonolysis of natural tallow fatty acids to form amines that are subsequently reacted with methyl chloride to form the quaternary ammonium compounds consisting primarily of dimethyldioctadecylammonium chlo

ride

and dimethyldihexadecylammonium chloride. The additive may contain residues of isopropyl alcohol not in excess of 18 percent by weight when used as a processing solvent.

(2) Ammonolysis of natural tallow fatty acids to form amines that are then reacted with 2-ethylhexanal, reduced, methylated, and subsequently reacted with methyl chloride to form the quaternary ammonium compound known as dimethyl (2-ethylhexyl) hydrogenated tallow ammonium chloride and consisting primarily of dimethyl(2ethylhexyl)octadecylammonium chlo

ride

and dimethyl(2-ethylhexyl)hexadecylammonium chloride. (b) The food additive described in paragraph (a)(1) of this section contains not more than a total of 2 percent by weight of free amine and amine hydrochloride. The food additive described in paragraph (a)(2) of this section contains not more than 3 percent by weight, each, of free amine and amine hydrochloride as determined by A.O.C.S. method Te 3a-64, "Acid Value and Free Amine Value of Fatty Quaternary Ammonium Chlorides," 2d printing including additions and revisions 1990, which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1

CFR part 51. Copies are available from the Center for Food Safety and Applied Nutrition (HFS-200), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, and from the American Oil Chemists' Society, P.O. Box 5037, Station A, Champaign, IL 61820, or available for inspection at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC.

(c) The food additive is used as a decolorizing agent in the clarification of refinery sugar liquors under the following limitations:

(1) The food additive described in paragraph (a)(1) of this section is added only at the defecation/clarification stage of sugar liquor refining in an amount not to exceed 700 parts per million by weight of sugar solids.

(2) The food additive described in paragraph (a)(2) of this section is used under the following conditions:

(i) The additive is adsorbed onto a support column composed of suitable polymers that are regulated for contact with aqueous food. Excess nonadsorbed additive shall be rinsed away with potable water prior to passage of sugar liquor through the column.

(ii) The residue of the additive in the decolorized sugar liquor prior to crystallization shall not exceed 1 part per million of sugar as determined by a method entitled "Colorimetric Determination of Residual Quaternary Ammonium Compounds (Arquad HTL8) in Sugar and Sugar Solutions," June 13, 1990, which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies are available from the Center for Food Safety and Applied Nutrition (HFS-200), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, or available for inspection at the Office of the Federal Register, 800 North Capitol Street, NW., suite 700, Washington, DC. (d) To assure safe use of the additive, the label and labeling of the additive shall bear, in addition to other information required by the Federal Food, Drug, and Cosmetic Act, adequate directions to assure use in compliance with paragraph (c) of this section.

[56 FR 42686, Aug. 29, 1991]

Sec.

PART 174-INDIRECT FOOD

ADDITIVES: GENERAL

174.5 General provisions applicable to indirect food additives.

174.6 Threshold of regulation for substances used in food-contact articles. AUTHORITY: 21 U.S.C. 321, 342, 348, 371.

§ 174.5 General provisions applicable to indirect food additives.

(a) Regulations prescribing conditions under which food additive substances may be safely used predicate usage under conditions of good manufacturing practice. For the purpose of this part and parts 175, 176, and 177 of this chapter, good manufacturing practice shall be defined to include the following restrictions:

(1) The quantity of any food additive substance that may be added to food as a result of use in articles that contact food shall not exceed, where no limits are specified, that which results from use of the substance in an amount not more than reasonably required to accomplish the intended physical or technical effect in the food-contact article; shall not exceed any prescribed limitations; and shall not be intended to accomplish any physical or technical effect in the food itself, except as such may be permitted by regulations in parts 170 through 189 of this chapter.

(2) Any substance used as a component of articles that contact food shall be of a purity suitable for its intended

use.

(b) The existence in the subchapter B of a regulation prescribing safe conditions for the use of a substance as an article or component of articles that contact food shall not be construed to relieve such use of the substance or article from compliance with any other provision of the Federal Food, Drug, and Cosmetic Act. For example, if a regulated food-packaging material were found on appropriate test to impart odor or taste to a specific food product such as to render it unfit within the meaning of section 402(a)(3) of the Act, the regulation would not be construed to relieve such use from compliance with section 402(a)(3).

(c) The existence in this subchapter B of a regulation prescribing safe conditions for the use of a substance as an article or component of articles that contact food shall not be construed as implying that such substance may be safely used as a direct additive in food. (d) Substances that under conditions of good manufacturing practice may be safely used as components of articles that contact food include the following, subject to any prescribed limitations:

(1) Substances generally recognized as safe in or on food.

(2) Substances generally recognized as safe for their intended use in food packaging.

(3) Substances used in accordance with a prior sanction or approval.

(4) Substances permitted for use by regulations in this part and parts 175, 176, 177, 178 and §179.45 of this chapter. [42 FR 14534, Mar. 15, 1977]

§ 174.6 Threshold of regulation for substances used in food-contact articles.

Substances used in food-contact articles (e.g., food-packaging or food-processing equipment) that migrate, or that may be expected to migrate, into food at negligible levels may be reviewed under $170.39 of this chapter. The Food and Drug Administration will exempt substances whose uses it determines meet the criteria in §170.39 of this chapter from regulation as food additives and, therefore, a food additive petition will not be required for the exempted use.

[60 FR 36596, July 17, 1995]

PART 175—INDIRECT_FOOD ADDITIVES: ADHESIVES AND COMPONENTS OF COATINGS

Subpart A [Reserved]

Subpart B-Substances for Use Only as Components of Adhesives

Sec.

175.105 Adhesives. 175.125

Pressure-sensitive adhesives.

Subpart C-Substances for Use as
Components of Coatings

175.210 Acrylate ester copolymer coating.

175.360 Vinylidene chloride copolymer coatings for nylon film.

175.365 Vinylidene chloride copolymer coatings for polycarbonate film. 175.380 Xylene-formaldehyde resins condensed with 4,4'-isopropylidenediphenolepichlorohydrin epoxy resins.

175.390 Zinc-silicon dioxide matrix coatings. AUTHORITY: 21 U.S.C. 321, 342, 348, 379e.

SOURCE: 42 FR 14534, Mar. 15, 1977, unless otherwise noted.

EDITORIAL NOTE: Nomenclature changes to part 175 appear at 61 FR 14482, Apr. 2, 1996, and 66 FR 56035, Nov. 6, 2001.

Subpart A [Reserved]

Subpart B-Substances for Use Only as Components of Adhesives $175.105 Adhesives.

(a) Adhesives may be safely used as components of articles intended for use in packaging, transporting, or holding food in accordance with the following prescribed conditions:

or

(1) The adhesive is prepared from one more of the optional substances named in paragraph (c) of this section, subject to any prescribed limitations.

(2) The adhesive is either separated from the food by a functional barrier or used subject to the following additional limitations:

(i) In dry foods. The quantity of adhesive that contacts packaged dry food shall not exceed the limits of good manufacturing practice.

(ii) In fatty and aqueous foods. (a) The quantity of adhesive that contacts packaged fatty and aqueous foods shall not exceed the trace amount at seams and at the edge exposure between packaging laminates that may occur within the limits of good manufacturing practice.

(b) Under normal conditions of use the packaging seams or laminates will remain firmly bonded without visible separation.