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205 Part 176—Indirect Food Addi- Tives: Paper

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205 Part 176—Indirect Food Addi- Tives: Paper Food and Drug Administration, HHS § 176.110 extractives limitations when tested by tractives not to exceed 0.025 milligram the methods provided in § 175.300(e): per square inch of surface; and chro- (1) The coating when extracted with mium extractives not to exceed 0.05 distilled water at 180 °F for 24 hours microgram per square inch of surface. yields total extractives not to exceed (e) The coatings are used as food-con- 0.05 milligram per square inch of food- tact surfaces for bulk reusable con- contact surface. tainers intended for storing, handling, (2) The coating when extracted with and transporting food. 50 percent (by volume) ethyl alcohol in distilled water at 180 °F for 24 hours PART 176—INDIRECT FOOD ADDI- yields total extractives not to exceed TIVES: PAPER AND PAPERBOARD 0.05 milligram per square inch. COMPONENTS § 175.390 Zinc-silicon dioxide matrix coatings. Subpart A [Reserved] Zinc-silicon dioxide matrix coatings Subpart B—Substances for Use Only as may be safely used as the food-contact Components of Paper and Paperboard surface of articles intended for use in producing, manufacturing, packing, Sec. processing, preparing, treating, pack- 176.110 Acrylamide-acrylic acid resins. 176.120 Alkyl ketene dimers. aging, transporting, or holding food, 176.130 Anti-offset substances. subject to the provisions of this sec- 176.150 Chelating agents used in the manu- tion; facture of paper and paperboard. (a) The coating is applied to a metal 176.160 Chromium (Cr III) complex of N- surface, cured, and washed with water ethyl-N-heptadecylfluoro-octane sulfonyl to remove soluble substances. glycine. (b) The coatings are formulated from 176.170 Components of paper and paperboard in contact with aqueous and fatty foods. optional substances which include: 176.180 Components of paper and paperboard (1) Substances generally recognized in contact with dry food. as safe. 176.200 Defoaming agents used in coatings. (2) Substances for which safe condi- 176.210 Defoaming agents used in the manu- tions of use have been prescribed in facture of paper and paperboard. § 175.300. 176.230 3,5-Dimethyl-1,3,5,2H- (3) Substances identified in para- tetrahydrothiadiazine-2-thione. graph (c) of this section, subject to the 176.250 Poly-1,4,7,10,13-pentaaza-15- hydroxyhexadecane. limitations prescribed. 176.260 Pulp from reclaimed fiber. (c) The optional substances per- 176.300 Slimicides. mitted are as follows: 176.320 Sodium nitrate-urea complex. 176.350 Tamarind seed kernel powder. List of substances Limitations AUTHORITY: 21 U.S.C. 321, 342, 346, 348, 379e. Ethylene glycol ...................... As a solvent removed by water washing. SOURCE: 42 FR 14554, Mar. 15, 1977, unless Iron oxide. otherwise noted. Lithium hydroxide .................. Removed by water washing. Methyl orange ........................ As an acid-base indicator. EDITORIAL NOTE: Nomenclature changes to Potassium dichromate ........... Removed by water washing. part 176 appear at 61 FR 14482, Apr. 2, 1996, 66 Silica gel. FR 56035, Nov. 6, 2001, and 70 FR 72074, Dec. Sodium silicate. 1, 2005. Zinc, as particulate metal. (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 Only as Components of Paper under the conditions of its intended use and Paperboard as shown in table 1 and 2 of § 175.300(d) (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 Acrylamide-acrylic acid resins may total extractives not to exceed those be safely used as components of arti- prescribed in § 175.300(c)(3); lithium ex- cles intended for use in producing, 205 VerDate Sep<11>2014 17:56 Jun 11, 2019 Jkt 247072 PO 00000 Frm 00215 Fmt 8010 Sfmt 8010 Q:\21\21V3.TXT PC31 kpayne on VMOFRWIN702 with $$_JOB § 176.120 21 CFR Ch. I (4–1–19 Edition) manufacturing, packing, processing, (b) Anti-offset powders are prepared preparing, treating, packaging, trans- from substances that are generally rec- porting, or holding food, subject to the ognized as safe in food, substances for provisions of this section. which prior sanctions or approvals (a) Acrylamide-acrylic acid resins are were granted and which are used in ac- produced by the polymerization of ac- cordance with the specific provisions of rylamide with partial hydrolysis or by such sanction or approval, and sub- the copolymerization of acrylamide stances named in paragraph (c) of this and acrylic acid. section. (b) The acrylamide-acrylic acid res- (c) The substances permitted are as ins contain less than 0.2 percent resid- follows: ual monomer. (c) The resins are used as adjuvants Substances Limitations in the manufacture of paper and paper- Carbon tetrachloride. board in amounts not to exceed that Methyl hydrogen polysiloxanes. necessary to accomplish the technical Industrial starch—modified .... Complying with § 178.3520 of effect and not to exceed 2 percent by this chapter. weight of the paper or paperboard. Stannous oleate. Zinc-2-ethyl hexoate. § 176.120 Alkyl ketene dimers. Alkyl ketene dimers may be safely § 176.150 Chelating agents used in the used as a component of articles in- manufacture of paper and paper- board. tended for use in producing, manufac- turing, packing, processing, preparing, The substances named in paragraph treating, packaging, transporting, or (a) of this section may be safely used in holding food, subject to the provisions the manufacture of paper and paper- of this section. board, in accordance with the condi- (a) The alkyl ketene dimers are man- tions prescribed in paragraphs (b) and ufactured by the dehydrohalogenation (c) of this section: of the acyl halides derived from the (a) Chelating agents: fatty acids of animal or vegetable fats List of substances Limitations and oils. (b) The alkyl ketene dimers are used Ammonium fructoheptonate. Ammonium glucoheptonate. as an adjuvant in the manufacture of Disodium ethylenediamine tetraacetate. paper and paperboard under such condi- Pentasodium salt of diethylenetriamine tions that the alkyl ketene dimers and pentaacetate. Sodium fructoheptonate. their hydrolysis products dialkyl Sodium glucoheptonate. ketones do not exceed 0.4 percent by Tetrasodium ethylenediamine tetra- weight of the paper or paperboard. acetate. (c) The alkyl ketene dimers may be Trisodium N-hydroxyethyl ethylene- diamine triacetate. used in the form of an aqueous emul- sion which may contain sodium (b) Any one or any combination of lignosulfonate as a dispersant. the substances named is used or in- tended for use as chelating agents. § 176.130 Anti-offset substances. (c) The substances are added in an Substances named in paragraphs (b) amount not greater than that required and (c) of this section may be safely to accomplish the intended technical used to prevent the transfer of inks effect nor greater than any specific employed in printing and decorating limitation, where such is provided. paper and paperboard used for food packaging in accordance with the pro- § 176.160 Chromium (Cr III) complex visions of this section: of N-ethyl-N-heptadecylfluoro-oc- (a) The substances are applied to the tane sulfonyl glycine. nonfood contact, printed side of the The chromium (Cr III) complex of N- paper or paperboard in an amount not ethyl - N -heptadecylfluoro-octane greater than that required to accom- sulfonyl glycine containing up to 20 plish the technical effect nor greater percent by weight of the chromium (Cr than any specific limitations, where III) complex of heptadecylfluoro-octane such are provided. sulfonic acid may be safely used as a 206 VerDate Sep<11>2014 17:56 Jun 11, 2019 Jkt 247072 PO 00000 Frm 00216 Fmt 8010 Sfmt 8010 Q:\21\21V3.TXT PC31 kpayne on VMOFRWIN702 with $$_JOB Food and Drug Administration, HHS § 176.170 component of paper for packaging dry 1 in paragraph (c) of this section are food when used in accordance with the subject to the provisions of § 176.180. following prescribed conditions. (a) Substances identified in para- (a) The food additive is used as a graph (a) (1) through (5) of this section component of paper in an amount not may be used as components of the food- to exceed 0.5 percent by weight of the contact surface of paper and paper- paper. board. Paper and paperboard products (b)(1) The food-contact surface of the shall be exempted from compliance paper is overcoated with a polymeric or with the extractives limitations pre- scribed in paragraph (c) of this section: resinous coating at least 1⁄3-mil in thickness, that meets the provision of Provided, That the components of the § 176.170; or food-contact surface consist entirely of one or more of the substances identi- (2) The treated paper forms one or fied in this paragraph: And provided fur- more plies of a paper in a multiwall ther, That if the paper or paperboard bag and is separated from the food by when extracted under the conditions at least one ply of packaging films or prescribed in paragraph (c) of this sec- grease-resistant papers which serves as tion exceeds the limitations on extrac- a functional barrier between the food tives contained in paragraph (c) of this additive and the food. Such packaging section, information shall be available films or grease-resistant papers con- from manufacturing records from form with appropriate food additive which it is possible to determine that regulations. only substances identified in this para- (c) The labeling of the food additive graph (a) are present in the food-con- shall contain adequate directions for tact surface of such paper or paper- its use to insure compliance with the board. requirements of paragraphs (a) and (b) (1) Substances generally recognized of this section.
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