Indirect food additives: general (21 CFR 174.5-174.6)

157 Food and Drug Administration, HHS § 174.5 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 National Archives 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. (d) To assure safe use of the additive, the label and labeling of the additive shall bear, in addition to other infor mation required by the Federal Food, Drug, and Cosmetic Act, adequate di rections to assure use in compliance with paragraph (c) of this section. [56 FR 42686, Aug. 29, 1991] § 173.405 Sodium dodecylbenzenesulfonate. Sodium dodecylbenzenesulfonate (CAS No. 25155–30–0) may be safely used in accordance with the following pre scribed conditions: (a) The additive is an antimicrobial agent used in wash water for fruits and vegetables. The additive may be used at a level not to exceed 111 milligrams per kilogram in the wash water. Fruits and vegetables treated by the additive do not require a potable water rinse. (b) The additive is limited to use in commissaries, cafeterias, restaurants, retail food establishments, nonprofit food establishments, and other food service operations in which food is pre pared for or served directly to the con sumer. (c) To assure safe use of the additive, the label or labeling of the additive container shall bear, in addition to the other information required by the Fed eral Food, Drug, and Cosmetic Act, adequate directions to assure use in compliance with the provisions of this section. [77 FR 71697, Dec. 4, 2012] PART 174—INDIRECT FOOD ADDITIVES: GENERAL Sec. 174.5 General provisions applicable to indi rect 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 condi tions under which food additive sub stances may be safely used predicate usage under conditions of good manu facturing practice. For the purpose of this part and parts 175, 176, and 177 of this chapter, good manufacturing prac tice shall be defined to include the fol lowing 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 ac complish the intended physical or tech nical effect in the food-contact article; shall not exceed any prescribed limita tions; and shall not be intended to ac complish any physical or technical ef fect 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 compo nent 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 condi tions 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 ar ticle 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 im part odor or taste to a specific food product such as to render it unfit with in 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). VerDate Sep<11>2014 08:44 Jun 03, 2016 Jkt 238072 PO 00000 Frm 00167 Fmt 8010 Sfmt 8010 Y:\SGML\238072.XXX 238072js ta llw o rt h o n D S K 7 T P T V N 1 P R O D w ith C F R 158 21 CFR Ch. I (4–1–16 Edition) § 174.6 (c) The existence in this subchapter B of a regulation prescribing safe condi tions 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 fol lowing, subject to any prescribed limi tations: (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. (5) Food contact substances used in accordance with an effective pre market notification for a food contact substance (FCN) submitted under sec tion 409(h) of the act. [42 FR 14534, Mar. 15, 1977, as amended at 67 FR 35731, May 21, 2002] § 174.6 Threshold of regulation for substances used in food-contact ar ticles. Substances used in food-contact arti cles (e.g., food-packaging or food-proc essing equipment) that migrate, or that may be expected to migrate, into food at negligible levels may be re viewed 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 addi tive petition will not be required for the exempted use. [60 FR 36596, July 17, 1995] PART 175—INDIRECT FOOD ADDI TIVES: ADHESIVES AND COMPO NENTS 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. 175.230 Hot-melt strippable food coatings. 175.250 Paraffin (synthetic). 175.260 Partial phosphoric acid esters of pol yester resins. 175.270 Poly(vinyl fluoride) resins. 175.300 Resinous and polymeric coatings. 175.320 Resinous and polymeric coatings for polyolefin films. 175.350 Vinyl acetate/crotonic acid copoly mer. 175.360 Vinylidene chloride copolymer coat ings for nylon film. 175.365 Vinylidene chloride copolymer coat ings for polycarbonate film. 175.380 Xylene-formaldehyde resins con densed with 4,4′-isopropylidenediphenol epichlorohydrin 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, 66 FR 56035, Nov. 6, 2001, and 70 FR 72074, Dec. 1, 2005. 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: (1) The adhesive is prepared from one or 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 adhe sive 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 VerDate Sep<11>2014 08:44 Jun 03, 2016 Jkt 238072 PO 00000 Frm 00168 Fmt 8010 Sfmt 8010 Y:\SGML\238072.XXX 238072js ta llw o rt h o n D S K 7 T P T V N 1 P R O D w ith C F R