TIVES: PAPER and PAPERBOARD COMPONENTS Subpart A
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Food and Drug Administration, HHS § 176.130 (d) The coating in the finished form Subpart A [Reserved] in which it is to contact food, when ex- tracted with the solvent or solvents Subpart B—Substances for Use characterizing the type of food, and under the conditions of its intended use Only as Components of Paper as shown in table 1 and 2 of § 175.300(d) and Paperboard (using 20 percent alcohol as the solvent § 176.110 Acrylamide-acrylic acid res- when the type of food contains approxi- ins. mately 20 percent alcohol) shall yield total extractives not to exceed those Acrylamide-acrylic acid resins may prescribed in § 175.300(c)(3); lithium ex- be safely used as components of arti- tractives not to exceed 0.025 milligram cles intended for use in producing, per square inch of surface; and chro- manufacturing, packing, processing, mium extractives not to exceed 0.05 preparing, treating, packaging, trans- microgram per square inch of surface. porting, or holding food, subject to the (e) The coatings are used as food-con- provisions of this section. tact surfaces for bulk reusable con- (a) Acrylamide-acrylic acid resins are tainers intended for storing, handling, produced by the polymerization of ac- and transporting food. rylamide with partial hydrolysis or by the copolymerization of acrylamide and acrylic acid. PART 176—INDIRECT FOOD ADDI- (b) The acrylamide-acrylic acid res- TIVES: PAPER AND PAPERBOARD ins contain less than 0.2 percent resid- COMPONENTS ual monomer. (c) The resins are used as adjuvants Subpart A [Reserved] in the manufacture of paper and paper- board in amounts not to exceed that Subpart B—Substances for Use Only as necessary to accomplish the technical Components of Paper and Paperboard effect and not to exceed 2 percent by Sec. weight of the paper or paperboard. 176.110 Acrylamide-acrylic acid resins. 176.120 Alkyl ketene dimers. § 176.120 Alkyl ketene dimers. 176.130 Anti-offset substances. Alkyl ketene dimers may be safely 176.150 Chelating agents used in the manu- used as a component of articles in- facture of paper and paperboard. tended for use in producing, manufac- 176.160 Chromium (Cr III) complex of N- turing, packing, processing, preparing, ethyl-N-heptadecylfluoro-octane sulfonyl treating, packaging, transporting, or glycine. holding food, subject to the provisions 176.170 Components of paper and paperboard of this section. in contact with aqueous and fatty foods. 176.180 Components of paper and paperboard (a) The alkyl ketene dimers are man- in contact with dry food. ufactured by the dehydrohalogenation 176.200 Defoaming agents used in coatings. of the acyl halides derived from the 176.210 Defoaming agents used in the manu- fatty acids of animal or vegetable fats facture of paper and paperboard. and oils. 176.230 3,5-Dimethyl-1,3,5,2H- (b) The alkyl ketene dimers are used tetrahydrothiadiazine-2-thione. as an adjuvant in the manufacture of 176.250 Poly-1,4,7,10,13-pentaaza-15- paper and paperboard under such condi- hydroxyhexadecane. tions that the alkyl ketene dimers and 176.260 Pulp from reclaimed fiber. their hydrolysis products dialkyl 176.300 Slimicides. ketones do not exceed 0.4 percent by 176.320 Sodium nitrate-urea complex. weight of the paper or paperboard. 176.350 Tamarind seed kernel powder. (c) The alkyl ketene dimers may be AUTHORITY: 21 U.S.C. 321, 342, 346, 348, 379e. used in the form of an aqueous emul- SOURCE: 42 FR 14554, Mar. 15, 1977, unless sion which may contain sodium otherwise noted. lignosulfonate as a dispersant. EDITORIAL NOTE: Nomenclature changes to § 176.130 Anti-offset substances. part 176 appear at 61 FR 14482, Apr. 2, 1996, 66 FR 56035, Nov. 6, 2001, and 70 FR 72074, Dec. Substances named in paragraphs (b) 1, 2005. and (c) of this section may be safely 201 VerDate Sep<11>2014 08:58 Jul 06, 2015 Jkt 235072 PO 00000 Frm 00211 Fmt 8010 Sfmt 8010 Y:\SGML\235072.XXX 235072 Lhorne on DSK7TPTVN1PROD with CFR § 176.150 21 CFR Ch. I (4–1–15 Edition) used to prevent the transfer of inks to accomplish the intended technical employed in printing and decorating effect nor greater than any specific paper and paperboard used for food limitation, where such is provided. packaging in accordance with the pro- visions of this section: § 176.160 Chromium (Cr III) complex (a) The substances are applied to the of N-ethyl-N-heptadecylfluoro-oc- nonfood contact, printed side of the tane sulfonyl glycine. paper or paperboard in an amount not The chromium (Cr III) complex of N- greater than that required to accom- ethyl - N -heptadecylfluoro-octane plish the technical effect nor greater sulfonyl glycine containing up to 20 than any specific limitations, where percent by weight of the chromium (Cr such are provided. III) complex of heptadecylfluoro-octane (b) Anti-offset powders are prepared sulfonic acid may be safely used as a from substances that are generally rec- component of paper for packaging dry ognized as safe in food, substances for food when used in accordance with the which prior sanctions or approvals following prescribed conditions. were granted and which are used in ac- (a) The food additive is used as a cordance with the specific provisions of component of paper in an amount not such sanction or approval, and sub- to exceed 0.5 percent by weight of the stances named in paragraph (c) of this paper. section. (b)(1) The food-contact surface of the (c) The substances permitted are as paper is overcoated with a polymeric or follows: resinous coating at least 1⁄3-mil in Substances Limitations thickness, that meets the provision of § 176.170; or Carbon tetrachloride. (2) The treated paper forms one or Methyl hydrogen polysiloxanes. more plies of a paper in a multiwall Industrial starch—modified .... Complying with § 178.3520 of bag and is separated from the food by this chapter. at least one ply of packaging films or Stannous oleate. Zinc-2-ethyl hexoate. grease-resistant papers which serves as a functional barrier between the food additive and the food. Such packaging § 176.150 Chelating agents used in the manufacture of paper and paper- films or grease-resistant papers con- board. form with appropriate food additive regulations. The substances named in paragraph (c) The labeling of the food additive (a) of this section may be safely used in the manufacture of paper and paper- shall contain adequate directions for board, in accordance with the condi- its use to insure compliance with the tions prescribed in paragraphs (b) and requirements of paragraphs (a) and (b) (c) of this section: of this section. (a) Chelating agents: § 176.170 Components of paper and pa- List of substances Limitations perboard in contact with aqueous and fatty foods. Ammonium fructoheptonate. Ammonium glucoheptonate. Substances identified in this section Disodium ethylenediamine tetraacetate. may be safely used as components of Pentasodium salt of diethylenetriamine the uncoated or coated food-contact pentaacetate. Sodium fructoheptonate. surface of paper and paperboard in- Sodium glucoheptonate. tended for use in producing, manufac- Tetrasodium ethylenediamine tetra- turing, packaging, processing, pre- acetate. Trisodium N-hydroxyethyl ethylene- paring, treating, packing, transporting, diamine triacetate. or holding aqueous and fatty foods, subject to the provisions of this sec- (b) Any one or any combination of tion. Components of paper and paper- the substances named is used or in- board in contact with dry food of the tended for use as chelating agents. type identified under Type VIII of table (c) The substances are added in an 1 in paragraph (c) of this section are amount not greater than that required subject to the provisions of § 176.180. 202 VerDate Sep<11>2014 08:58 Jul 06, 2015 Jkt 235072 PO 00000 Frm 00212 Fmt 8010 Sfmt 8010 Y:\SGML\235072.XXX 235072 Lhorne on DSK7TPTVN1PROD with CFR Food and Drug Administration, HHS § 176.170 (a) Substances identified in para- graph (a) are present in the food-con- graph (a) (1) through (5) of this section tact surface of such paper or paper- may be used as components of the food- board. contact surface of paper and paper- (1) Substances generally recognized board. Paper and paperboard products as safe in food. shall be exempted from compliance (2) Substances generally recognized with the extractives limitations pre- as safe for their intended use in paper scribed in paragraph (c) of this section: and paperboard products used in food Provided, That the components of the packaging. food-contact surface consist entirely of (3) Substances used in accordance one or more of the substances identi- with a prior sanction or approval. fied in this paragraph: And provided fur- (4) Substances that by regulation in ther, That if the paper or paperboard parts 170 through 189 of this chapter when extracted under the conditions may be safely used without extractives prescribed in paragraph (c) of this sec- limitations as components of the tion exceeds the limitations on extrac- uncoated or coated food-contact sur- tives contained in paragraph (c) of this face of paper and paperboard in contact section, information shall be available with aqueous or fatty food, subject to from manufacturing records from the provisions of such regulation. which it is possible to determine that (5) Substances identified in this para- only substances identified in this para- graph, as follows: List of Substances Limitations Acetyl peroxide ............................................................................ For use only as polymerization catalyst. Acrylamide-methacrylic acid-maleic anhydride copolymers con- For use only as a retention aid employed prior to the sheet- taining not more than 0.2 percent of residual acrylamide forming operation in the manufacture of paper and paper- monomer and having an average nitrogen content of 14.9 board in such an amount that the finished paper and paper- percent such that a 1 percent by weight aqueous solution board will contain the additive at a level not in excess of has a minimum viscosity of 600 centipoises at 75 °F, as de- 0.05 percent by weight of dry fibers in the finished paper and termined by LVG-series Brookfield viscometer (or equivalent) paperboard.