Food additives permitted in food or in contact with food on an interim basis pending additional study (21 CFR 180.1-180.37)

462 21 CFR Ch. I (4–1–16 Edition) Pt. 180 § 177.1520(a) of this chapter. The fin ished film may contain one or more of the following added substances: Substances Limitations Amides of erucic, linoleic, oleic, palmitic, and stearic acid ......... Not to exceed 1 pct by weight of the polymer. BHA as described in § 172.110 of this chapter ........................... Do. BHT as described in § 172.115 of this chapter ........................... Do. Calcium and sodium propionates ................................................ Do. Petroleum wax as described in § 178.3710 of this chapter ........ Do. Polypropylene, noncrystalline, as described in § 177.1520(c) of this chapter. Not to exceed 2 pct by weight of the polymer. Stearates of aluminum, calcium, magnesium, potassium, and sodium as described in § 172.863(a) of this chapter. Not to exceed 1 pct by weight of the polymer. Triethylene glycol as described in § 178.3740(b) of this chapter Do. Mineral oil as described in § 178.3620 (a) or (b) of this chapter Do. (ii) Polyethylene terephthalate film prepared from the basic polymer as de scribed in § 177.1630(e)(4)(ii) of this chapter. The finished film may contain one or more of the added substances listed in paragraph (d)(2)(i) of this sec tion. (iii) Nylon 6 films prepared from the nylon 6 basic polymer as described in § 177.1500(a)(6) of this chapter and meet ing the specifications of item 6.1 of the table in § 177.1500(b) of this chapter. The finished film may contain one or more of the added substances listed in paragraph (d)(2)(i) of this section. (iv) Vinyl chloride-vinyl acetate co polymer film prepared from the basic copolymer containing 88.5 to 90.0 weight percent of vinyl chloride with 10.0 to 11.5 weight percent of vinyl ace tate and having a maximum volatility of not over 3.0 percent (1 hour at 105 °C) and viscosity not less than 0.30 deter mined by ASTM method D1243–79, ‘‘Standard Test Method for Dilute So lution Viscosity of Vinyl Chloride Polymers,’’ Method A, which is incor porated by reference. The availability of this incorporation by reference is given in paragraph (b)(9) of this sec tion. The finished film may contain one or more of the added substances listed in paragraph (d)(2)(i) of this sec tion. (e) Acrylonitrile copolymers identi fied in this section shall comply with the provisions of § 180.22 of this chap ter. [42 FR 14635, Mar. 15, 1977, as amended at 49 FR 10113, Mar. 19, 1984; 54 FR 7405, Feb. 21, 1989; 54 FR 24899, June 12, 1989; 59 FR 14551, Mar. 29, 1994; 61 FR 14246, Apr. 1, 1996; 66 FR 10575, Feb. 16, 2001] PART 180—FOOD ADDITIVES PER MITTED IN FOOD OR IN CON TACT WITH FOOD ON AN IN TERIM BASIS PENDING ADDI TIONAL STUDY Subpart A—General Provisions Sec. 180.1 General. Subpart B—Specific Requirements for Certain Food Additives 180.22 Acrylonitrile copolymers. 180.25 Mannitol. 180.30 Brominated vegetable oil. 180.37 Saccharin, ammonium saccharin, cal cium saccharin, and sodium saccharin. AUTHORITY: 21 U.S.C. 321, 342, 343, 348, 371; 42 U.S.C. 241. EDITORIAL NOTE: Nomenclature changes to part 180 appear at 61 FR 14482, Apr. 2, 1996, and 66 FR 56035, Nov. 6, 2001. Subpart A—General Provisions § 180.1 General. (a) Substances having a history of use in food for human consumption or in food contact surfaces may at any time have their safety or functionality brought into question by new informa tion that in itself is not conclusive. An interim food additive regulation for the use of any such substance may be promulgated in this subpart when new information raises a substantial ques tion about the safety or functionality of the substance but there is a reason able certainty that the substance is not harmful and that no harm to the VerDate Sep<11>2014 08:44 Jun 03, 2016 Jkt 238072 PO 00000 Frm 00472 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 463 Food and Drug Administration, HHS § 180.1 public health will result from the con tinued use of the substance for a lim ited period of time while the question raised is being resolved by further study. (b) No interim food additive regula tion may be promulgated if the new in formation is conclusive with respect to the question raised or if there is a rea sonable likelihood that the substance is harmful or that continued use of the substance will result in harm to the public health. (c) The Commissioner, on his own ini tiative or on the petition of any inter ested person, pursuant to part 10 of this chapter, may propose an interim food additive regulation. A final order pro mulgating an interim food additive regulation shall provide that continued use of the substance in food is subject to each of the following conditions: (1) Use of the substance in food or food contact surfaces must comply with whatever limitations the Commis sioner deems to be appropriate under the circumstances. (2) Within 60 days following the effec tive date of the regulation, an inter ested person shall satisfy the Commis sioner in writing that studies adequate and appropriate to resolve the ques tions raised about the substance have been undertaken, or the Food and Drug Administration may undertake the studies. The Commissioner may extend this 60-day period if necessary to re view and act on proposed protocols. If no such commitment is made, or ade quate and appropriate studies are not undertaken, an order shall imme diately be published in the FEDERAL REGISTER revoking the interim food ad ditive regulation effective upon publi cation. (3) A progress report shall be filed on the studies every January 1 and July 1 until completion. If the progress report is inadequate or if the Commissioner concludes that the studies are not being pursued promptly and diligently or if interim results indicate a reason able likelihood that a health hazard ex ists, an order will promptly be pub lished in the FEDERAL REGISTER revok ing the interim food additive regula tion effective upon publication. (4) If nonclinical laboratory studies are involved, studies filed with the Commissioner shall include, with re spect to each study, either a statement that the study has been or will be con ducted in compliance with the good laboratory practice regulations as set forth in part 58 of this chapter, or, if any such study was not conducted in compliance with such regulations, a brief statement of the reason for the noncompliance. (5) [Reserved] (6) If clinical investigations involving human subjects are involved, such in vestigations filed with the Commis sioner shall include, with respect to each investigation, a statement that the investigation either was conducted in compliance with the requirements for institutional review set forth in part 56 of this chapter, or was not sub ject to such requirements in accord ance with §§ 56.104 or 56.105, and that it has been or will be conducted in com pliance with the requirements for in formed consent set forth in part 50 of this chapter. (d) Promptly upon completion of the studies undertaken on the substance, the Commissioner will review all avail able data, will terminate the interim food additive regulation, and will ei ther issue a food additive regulation or will require elimination of the sub stance from the food supply. (e) The Commissioner may consult with advisory committees, professional organizations, or other experts in the field, in evaluating: (1) Whether an interim food additive regulation is justified, (2) The type of studies necessary and appropriate to resolve questions raised about a substance, (3) Whether interim results indicate the reasonable likelihood that a health hazard exists, or (4) Whether the data available at the conclusion of those studies justify a food additive regulation. (f) Where appropriate, an emergency action level may be issued for a sub stance subject to paragraph (a) of this section that is not an approved food ad ditive, pending the issuance of a final interim food additive regulation. Such an action level shall be issued pursuant to sections 306 and 402(a) of the act to identify, based upon available data, a safe level of use for the substance. VerDate Sep<11>2014 08:44 Jun 03, 2016 Jkt 238072 PO 00000 Frm 00473 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 464 21 CFR Ch. I (4–1–16 Edition) § 180.22 Such an action level shall be issued in a notice published in the FEDERAL REG ISTER and shall be followed as soon as practicable by a proposed interim food additive regulation. Where the avail able data do not permit establishing an action level for the safe use of a sub stance, use of the substance may be prohibited. The identification of a pro hibited substance may be made in part 189 of this chapter when appropriate. [42 FR 14636, Mar. 15, 1977, as amended at 42 FR 15674, Mar. 22, 1977; 42 FR 52821, Sept. 30, 1977; 46 FR 8952, Jan. 27, 1981; 46 FR 14340, Feb. 27, 1981; 50 FR 7492, Feb. 22, 1985; 54 FR 39634, Sept. 27, 1989] Subpart B—Specific Requirements for Certain Food Additives § 180.22 Acrylonitrile copolymers. Acrylonitrile copolymers may be safely used on an interim basis as arti cles or components of articles intended for use in contact with food, in accord ance with the following prescribed con ditions: (a) Limitations for acrylonitrile monomer extraction for finished food contact articles, determined by a method of analysis titled ‘‘Gas-Solid Chromatographic Procedure for Deter mining Acrylonitrile Monomer in Ac rylonitrile-Containing Polymers and Food Simulating Solvents,’’ which is incorporated by reference. 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 Ad ministration (NARA). For information on the availability of this material at NARA, call 202–741–6030, or go to: http:// www.archives.gov/federallregister/ codeloflfederallregulations/ ibrllocations.html. (1) In the case of single-use articles having a volume to surface ratio of 10 milliliters or more per square inch of food contact surface—0.003 milligram/ square inch when extracted to equi librium at 120 °F with food-simulating solvents appropriate to the intended conditions of use. (2) In the case of single-use articles having a volume to surface ratio of less than 10 milliliters per square inch of food contact surface—0.3 part per mil lion calculated on the basis of the vol ume of the container when extracted to equilibrium at 120 °F with food-simu lating solvents appropriate to the in tended conditions of use. (3) In the case of repeated-use arti cles—0.003 milligram/square inch when extracted at a time equivalent to ini tial batch usage utilizing food-simu lating solvents and temperatures ap propriate to the intended conditions of use. The food-simulating solvents shall in clude, where applicable, distilled water, 8 percent or 50 percent ethanol, 3 percent acetic acid, and either n heptane or an appropriate oil or fat. (b) Where necessary, current regula tions permitting the use of acrylo nitrile copolymers shall be revised to specify limitations on acrylonitrile/ mercaptan complexes utilized in the production of acrylonitrile copolymers. Such copolymers, if they contain re versible acrylonitrile/mercaptan com plexes and are used in other than re peated-use conditions, shall be tested to determine the identity of the com plex and the level of the complex present in the food-contact article. Such testing shall include determina tion of the rate of decomposition of the complex at temperatures of 100 °F, 160 °F, and 212 °F using 3 percent acetic acid as the hydrolic agent. Acrylo nitrile monomer levels, acrylonitrile/ mercaptan complex levels, acrylo nitrile oligomer levels, descriptions of the analytical methods used to deter mine the complex and the acrylonitrile migration, and validation studies of these analytical methods shall be sub mitted by June 9, 1977, to the Center for Food Safety and Applied Nutrition (HFS–200), Food and Drug Administra tion, 5100 Paint Branch Pkwy., College Park, MD 20740, unless an extension is granted by the Food and Drug Admin istration for good cause shown. Analyt ical methods for the determination of acrylonitrile complexes with n dodecyl-mercaptan, n-octyl mercaptan, and 2-mercaptoethanol, titled ‘‘Deter mination of b-Dodecyl mercaptopropionitrile in NR–16R Aque ous Extracts’’ and ‘‘Measurement of b (2-Hdroxyethylmercapto) Propionitrile in Heptane Food-Simulating Solvent,’’ VerDate Sep<11>2014 08:44 Jun 03, 2016 Jkt 238072 PO 00000 Frm 00474 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 465 Food and Drug Administration, HHS § 180.22 are incorporated by reference. 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 Ad ministration (NARA). For information on the availability of this material at NARA, call 202–741–6030, or go to: http:// www.archives.gov/federallregister/ codeloflfederallregulations/ ibrllocations.html. (c) The following data shall be pro vided for finished food-contact articles intended for repeated use: (1) Qualitative and quantitative mi gration values at a time equivalent to initial batch usage, utilizing solvents and temperatures appropriate to the intended conditions of use. (2) Qualitative and quantitative mi gration values at the time of equi librium extractions, utilizing solvents and temperatures appropriate to the intended conditions of use. (3) Data on the volume and/or weight of food handled during the initial batch time period(s), during the equilibrium test period, and over the estimated life of the food-contact surface. (d) Where acrylonitrile copolymers represent only a minor component of a polymer system, calculations based on 100 percent migration of the acrylo nitrile component may be submitted in lieu of the requirements of paragraphs (a), (b), and (c) of this section in sup port of the continued safe use of acry lonitrile copolymers. (e) On or before September 13, 1976, any interested person shall satisfy the Commissioner of Food and Drugs that toxicological feeding studies adequate and appropriate to establish safe condi tions for the use of acrylonitrile co polymers have been, or soon will be, undertaken. Toxicity studies of acrylo nitrile monomer shall include: (1) Life time feeding studies with a mamma lian species, preferably with animals exposed in utero to the chemical, (2) studies of multigeneration reproduc tion with oral administration of the test material, (3) assessment of teratogenic and mutagenic potentials, (4) subchronic oral administration in a nonrodent mammal, (5) tests to deter mine any synergistic toxic effects be tween acrylonitrile monomer and cya nide ion, and (6) a literature search on the effects of chronic ingestion of hy drogen cyanide. Data on levels of acryl amide extractable from acrylonitrile copolymers shall also be submitted. Protocols of testing should be sub mitted for review to the Center for Food Safety and Applied Nutrition (HFS–200), Food and Drug Administra tion, 5100 Paint Branch Pkwy., College Park, MD 20740. (f) Acrylonitrile copolymers may be used in contact with food only if au thorized in parts 174 through 179 or § 181.32 of this chapter, except that other uses of acrylonitrile copolymers in use prior to June 14, 1976, may con tinue under the following conditions: (1) On or before August 13, 1976, each use of acrylonitrile copolymers in a manner not authorized by § 181.32 of this chapter or parts 174 through 179 of this chapter shall be the subject of a notice to the Center for Food Safety and Applied Nutrition (HFS–200), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740. Such notice shall be accompanied by a statement of the basis, including any articles and correspondence, on which the user in good faith believed the use to be prior-sanctioned. The Commis sioner of Food and Drugs shall, by no tice in the FEDERAL REGISTER, identify any use of acrylonitrile copolymers not in accordance with this paragraph. Those uses are thereafter unapproved food additives and consequently unlaw ful. (2) Any use of acrylonitrile copoly mers subject to paragraph (f)(1) of this section shall be the subject of a peti tion submitted on or before December 13, 1976, in accordance with § 171.1 of this chapter, unless an extension of time is granted by the Food and Drug Administration for good cause shown. Any application for extension shall be by petition submitted in accordance with the requirements of part 10 of this chapter. If a petition is denied, in whole or in part, those uses subject to the denial are thereafter unapproved food additives and consequently unlaw ful. (3) Any use of acrylonitrile copoly mers subject to paragraph (f)(1) of this section shall meet the acrylonitrile VerDate Sep<11>2014 08:44 Jun 03, 2016 Jkt 238072 PO 00000 Frm 00475 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 466 21 CFR Ch. I (4–1–16 Edition) § 180.25 monomer extraction limitation set forth in paragraph (a) of this section and shall be subject to the require ments of paragraph (b) of this section. (g) In addition to the requirements of this section, the use of acrylonitrile co polymers shall comply with all applica ble requirements in other regulations in this part. [42 FR 14636, Mar. 15, 1977, as amended at 47 FR 11850, Mar. 19, 1982; 54 FR 24899, June 12, 1989; 61 FR 14246, Apr. 1, 1996] § 180.25 Mannitol. (a) Mannitol is the chemical 1,2,3,4,5,6,-hexanehexol (C6H14O6) a hexahydric alcohol, differing from sor bitol principally by having a different optical rotation. Mannitol is produced by one of the following processes: (1) The electrolytic reduction or transition metal catalytic hydro genation of sugar solutions containing glucose or fructose. (2) The fermentation of sugars or sugar alcohols such as glucose, sucrose, fructose, or sorbitol using the yeast Zygosaccharomyces rouxii. (3) A pure culture fermentation of sugars such as fructose, glucose, or maltose using the nonpathogenic, nontoxicogenic bacterium Lactobacillus intermedius (fermentum). (b) The ingredient meets the speci fications of the ‘‘Food Chemicals Codex,’’ 3d Ed. (1981), pp. 188–190, which is incorporated by reference. Copies may be obtained from the National Academy Press, 2101 Constitution Ave. NW., Washington, DC 20418, or may be examined at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202–741–6030, or go to: http://www.archives.gov/ federallregister/ codeloflfederallregulations/ ibrllocations.html. (c) The ingredient is used as an anticaking agent and free-flow agent as defined in § 170.3(o)(1) of this chapter, formulation aid as defined in § 170.3(o) (14) of this chapter, firming agent as defined in § 170.3(o)(10) of this chapter, flavoring agent and adjuvant as defined in § 170.3(o)(12) of this chapter, lubri cant and release agent as defined in § 170.3(o)(18) of this chapter, nutritive sweetener as defined in § 170.3(o)(21) of this chapter, processing aid as defined in § 170.3(o)(24) of this chapter, sta bilizer and thickener as defined in § 170.3(o)(28) of this chapter, surface-fin ishing agent as defined in § 170.3(o)(30) of this chapter, and texturizer as de fined in § 170.3(o)(32) of this chapter. (d) The ingredient is used in food at levels not to exceed 98 percent in pressed mints and 5 percent in all other hard candy and cough drops as defined in § 170.3(n)(25) of this chapter, 31 per cent in chewing gum as defined in § 170.3(n)(6) of this chapter, 40 percent in soft candy as defined in § 170.3(n)(38) of this chapter, 8 percent in confections and frostings as defined in § 170.3(n)(9) of this chapter, 15 percent in non standardized jams and jellies, commer cial, as defined in § 170.3(n)(28) of this chapter, and at levels less than 2.5 per cent in all other foods. (e) The label and labeling of food whose reasonably foreseeable consump tion may result in a daily ingestion of 20 grams of mannitol shall bear the statement ‘‘Excess consumption may have a laxative effect’’. (f) In accordance with § 180.1, ade quate and appropriate feeding studies have been undertaken for this sub stance. Continued uses of this ingre dient are contingent upon timely and adequate progress reports of such tests, and no indication of increased risk to public health during the test period. (g) Prior sanctions for this ingredient different from the uses established in this regulation do not exist or have been waived. [42 FR 14636, Mar. 15, 1977, as amended at 49 FR 5610, Feb. 14, 1984; 61 FR 7991, Mar. 1, 1996; 69 FR 65542, Nov. 15, 2004] § 180.30 Brominated vegetable oil. The food additive brominated vege table oil may be safely used in accord ance with the following prescribed con ditions: (a) The additive complies with speci fications prescribed in the ‘‘Food Chemicals Codex,’’ 3d Ed. (1981), pp. 40– 41, which is incorporated by reference, except that free fatty acids (as oleic) shall not exceed 2.5 percent and iodine value shall not exceed 16. Copies of the material incorporated by reference may be obtained from the National Academy Press, 2101 Constitution Ave. VerDate Sep<11>2014 08:44 Jun 03, 2016 Jkt 238072 PO 00000 Frm 00476 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 467 Food and Drug Administration, HHS § 180.37 NW., Washington, DC 20418, or may be examined at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202–741–6030, or go to: http://www.archives.gov/ federallregister/ codeloflfederallregulations/ ibrllocations.html. (b) The additive is used on an interim basis as a stabilizer for flavoring oils used in fruit-flavored beverages, for which any applicable standards of iden tity do not preclude such use, in an amount not to exceed 15 parts per mil lion in the finished beverage, pending the outcome of additional toxicological studies on which periodic reports at 6 month intervals are to be furnished and final results submitted to the Food and Drug Administration promptly after completion of the studies. [42 FR 14636, Mar. 15, 1977, as amended at 49 FR 5610, Feb. 14, 1984] § 180.37 Saccharin, ammonium sac charin, calcium saccharin, and so dium saccharin. The food additives saccharin, ammo nium saccharin, calcium saccharin, and sodium saccharin may be safely used as sweetening agents in food in accord ance with the following conditions, if the substitution for nutritive sweet eners is for a valid special dietary pur pose and is in accord with current spe cial dietary food regulations and poli cies or if the use or intended use is for an authorized technological purpose other than calorie reduction: (a) Saccharin is the chemical, 1,2 benzisothiazolin-3-one - 1,1 - dioxide (C7H5NO3S). The named salts of sac charin are produced by the additional neutralization of saccharin with the proper base to yield the desired salt. (b) The food additives meet the speci fications of the Food Chemicals Codex, 7th ed. (2010), pp. 52–54, 153–154, 898–899, 961–962, which is incorporated by ref erence. The Director of the Office of the Federal Register approves this in corporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You may obtain copies from the United States Pharmacopeial Convention, 12601 Twinbrook Pkwy., Rockville, MD 20852 (Internet address http:// www.usp.org). Copies may be examined at the Food and Drug Administration’s Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301–796–2039, or at the National Archives and Records Admin istration (NARA). For information on the availability of this material at NARA, call 202–741–6030 or go to: http:// www.archives.gov/federal-register/cfr/ibr locations.html. (c) Authority for such use shall ex pire when the Commissioner receives the final reports on the ongoing studies in Canada and publishes an order on the safety of saccharin and its salts based on those reports and other avail able data. (d) The additives are used or intended for use as a sweetening agent only in special dietary foods, as follows: (1) In beverages, fruit juice drinks, and bases or mixes when prepared for consumption in accordance with direc tions, in amounts not to exceed 12 mil ligrams of the additive, calculated as saccharin, per fluid ounce. (2) As a sugar substitute for cooking or table use, in amounts not to exceed 20 milligrams of the additive, cal culated as saccharin, for each ex pressed teaspoonful of sugar sweet ening equivalency. (3) In processed foods, in amounts not to exceed 30 milligrams of the additive, calculated as saccharin, per serving of designated size. (e) The additives are used or intended for use only for the following techno logical purposes: (1) To reduce bulk and enhance fla vors in chewable vitamin tablets, chewable mineral tablets, or combina tions thereof. (2) To retain flavor and physical properties of chewing gum. (3) To enhance flavor of flavor chips used in nonstandardized bakery prod ucts. (f) To assure safe use of the additives, in addition to the other information re quired by the Act: (1) The label of the additive and any intermediate mixes of the additive for manufacturing purposes shall bear: (i) The name of the additive. (ii) A statement of the concentration of the additive, expressed as saccharin, in any intermediate mix. VerDate Sep<11>2014 08:44 Jun 03, 2016 Jkt 238072 PO 00000 Frm 00477 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 468 21 CFR Ch. I (4–1–16 Edition) Pt. 181 (iii) Adequate directions for use to provide a final food product that com plies with the limitations prescribed in paragraphs (d) and (e) of this section. (2) The label of any finished food product containing the additive shall bear: (i) The name of the additive. (ii) The amount of the additive, cal culated as saccharin, as follows: (a) For beverages, in milligrams per fluid ounce; (b) For cooking or table use products, in milligrams per dispensing unit; (c) For processed foods, in terms of the weight or size of a serving which shall be that quantity of the food con taining 30 milligrams or less of the ad ditive. (iii) When the additive is used for cal orie reduction, such other labeling as is required by part 105 of this chapter. [42 FR 14636, Mar. 15, 1977, as amended at 49 FR 5610, Feb. 14, 1984; 72 FR 10357, Mar. 8, 2007; 78 FR 71467, Nov. 29, 2013] PART 181—PRIOR-SANCTIONED FOOD INGREDIENTS Subpart A—General Provisions Sec. 181.1 General. 181.5 Prior sanctions. Subpart B—Specific Prior-Sanctioned Food Ingredients 181.22 Certain substances employed in the manufacture of food-packaging mate rials. 181.23 Antimycotics. 181.24 Antioxidants. 181.25 Driers. 181.26 Drying oils as components of finished resins. 181.27 Plasticizers. 181.28 Release agents. 181.29 Stabilizers. 181.30 Substances used in the manufacture of paper and paperboard products used in food packaging. 181.32 Acrylonitrile copolymers and resins. 181.33 Sodium nitrate and potassium ni trate. 181.34 Sodium nitrite and potassium nitrite. AUTHORITY: 21 U.S.C. 321, 342, 348, 371. SOURCE: 42 FR 14638, Mar. 15, 1977, unless otherwise noted. EDITORIAL NOTE: Nomenclature changes to part 181 appear at 61 FR 14482, Apr. 2, 1996, and 66 FR 56035, Nov. 6, 2001. Subpart A—General Provisions § 181.1 General. (a) An ingredient whose use in food or food packaging is subject to a prior sanction or approval within the mean ing of section 201(s)(4) of the Act is ex empt from classification as a food addi tive. The Commissioner will publish in this part all known prior sanctions. Any interested person may submit to the Commissioner a request for publi cation of a prior sanction, supported by evidence to show that it falls within section 201(s)(4) of the Act. (b) Based upon scientific data or in formation that shows that use of a prior-sanctioned food ingredient may be injurious to health, and thus in vio lation of section 402 of the Act, the Commissioner will establish or amend an applicable prior sanction regulation to impose whatever limitations or con ditions are necessary for the safe use of the ingredient, or to prohibit use of the ingredient. (c) Where appropriate, an emergency action level may be issued for a prior sanctioned substance, pending the issuance of a final regulation in ac cordance with paragraph (b) of this sec tion. Such an action level shall be issued pursuant to section 402(a) of the Act to identify, based upon available data, conditions of use of the substance that may be injurious to health. Such an action level shall be issued in a no tice published in the FEDERAL REG ISTER and shall be followed as soon as practicable by a proposed regulation in accordance with paragraph (b) of this section. Where the available data dem onstrate that the substance may be in jurious at any level, use of the sub stance may be prohibited. The identi fication of a prohibited substance may be made in part 189 of this chapter when appropriate. [42 FR 14638, Mar. 15, 1977, as amended at 42 FR 52821, Sept. 30, 1977; 54 FR 39635, Sept. 27, 1989] § 181.5 Prior sanctions. (a) A prior sanction shall exist only for a specific use(s) of a substance in VerDate Sep<11>2014 08:44 Jun 03, 2016 Jkt 238072 PO 00000 Frm 00478 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