Irradiation in the production, processing and handling of food (21 CFR 179.21-179.45)

456 21 CFR Ch. I (4–1–16 Edition) § 178.3940 scale as measured in 50 percent mineral spirits solution. § 178.3940 Tetraethylene glycol di-(2 ethylhexoate). Tetraethylene glycol di-(2 ethylhexoate) containing not more than 22 parts per million ethylene and/ or diethylene glycols may be used at a level not to exceed 0.7 percent by weight of twine as a finish on twine to be used for tying meat provided the twine fibers are produced from nylon resins complying with § 177.1500 of this chapter. § 178.3950 Tetrahydrofuran. Tetrahydrofuran may be safely used in the fabrication of articles intended for packaging, transporting, or storing foods, subject to the provisions of this section. (a) It is used as a solvent in the cast ing of film from a solution of poly meric resins of vinyl chloride, vinyl ac etate, or vinylidene chloride that have been polymerized singly or copolym erized with one another in any com bination, or it may be used as a solvent in the casting of film prepared from vinyl chloride copolymers complying with § 177.1980 of this chapter. (b) The residual amount of tetra hydrofuran in the film does not exceed 1.5 percent by weight of film. PART 179—IRRADIATION IN THE PRODUCTION, PROCESSING AND HANDLING OF FOOD Subpart A [Reserved] Subpart B—Radiation and Radiation Sources Sec. 179.21 Sources of radiation used for inspec tion of food, for inspection of packaged food, and for controlling food processing. 179.25 General provisions for food irradia tion. 179.26 Ionizing radiation for the treatment of food. 179.30 Radiofrequency radiation for the heating of food, including microwave fre quencies. 179.39 Ultraviolet radiation for the proc essing and treatment of food. 179.41 Pulsed light for the treatment of food. 179.43 Carbon dioxide laser for etching food. Subpart C—Packaging Materials for Irradiated Foods 179.45 Packaging materials for use during the irradiation of prepackaged foods. AUTHORITY: 21 U.S.C. 321, 342, 343, 348, 373, 374. SOURCE: 42 FR 14635, Mar. 15, 1977, unless otherwise noted. EDITORIAL NOTE: Nomenclature changes to part 179 appear at 70 FR 72074, Dec. 1, 2005. Subpart A [Reserved] Subpart B—Radiation and Radiation Sources § 179.21 Sources of radiation used for inspection of food, for inspection of packaged food, and for controlling food processing. Sources of radiation for the purposes of inspection of foods, for inspection of packaged food, and for controlling food processing may be safely used under the following conditions: (a) The radiation source is one of the following: (1) X-ray tubes producing X-radiation from operation of the tube source at a voltage of 500 kilovolt peak or lower. (2) Sealed units producing radiations at energy levels of not more than 2.2 million electron volts from one of the following isotopes: Americium-241, ce sium-137, cobalt-60, iodine-125, krypton 85, radium-226, and strontium-90. (3) Sealed units producing neutron radiation from the isotope Califor nium-252 (CAS Reg. No. 13981–17–4) to measure moisture in food. (4) Machine sources producing X-radi ation at energies no greater than 10 million electron volts (MeV). (5) Monoenergetic neutron sources producing neutrons at energies not less than 1 MeV but no greater than 14 MeV. (b) To assure safe use of these radi ation sources: (1) The label of the sources shall bear, in addition to the other informa tion required by the Act: (i) Appropriate and accurate informa tion identifying the source of radi ation. (ii) The maximum energy of radi ation emitted by X-ray tube sources. VerDate Sep<11>2014 08:44 Jun 03, 2016 Jkt 238072 PO 00000 Frm 00466 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 457 Food and Drug Administration, HHS § 179.26 (iii) The maximum energy of X-radi ation emitted by machine source. (iv) The minimum and maximum en ergy of radiation emitted by neutron source. (2) The label or accompanying label ing shall bear: (i) Adequate directions for installa tion and use. (ii) A statement that no food shall be exposed to radiation sources listed in paragraph (a) (1) and (2) of this section so as to receive an absorbed dose in ex cess of 10 grays. (iii) A statement that no food shall be exposed to a radiation source listed in paragraph (a)(3) of this section so as to receive an absorbed dose in excess of 2 milligrays. (iv) A statement that no food shall be exposed to a radiation source listed in paragraph (a)(4) of this section so as to receive a dose in excess of 0.5 gray (Gy). (v) A statement that no food shall be exposed to a radiation source listed in paragraph (a)(5) of this section so as to receive a dose in excess of 0.01 gray (Gy). [42 FR 14635, Mar. 15, 1977, as amended at 48 FR 46022, Oct. 11, 1983; 61 FR 14246, Apr. 1, 1996; 64 FR 69191, Dec. 10, 1999; 66 FR 18539, Apr. 10, 2001; 69 FR 76404, Dec. 21, 2004] § 179.25 General provisions for food ir radiation. For the purposes of § 179.26, current good manufacturing practice is defined to include the following restrictions: (a) Any firm that treats foods with ionizing radiation shall comply with the requirements of parts 110 and 117 of this chapter and other applicable regu lations. (b) Food treated with ionizing radi ation shall receive the minimum radi ation dose reasonably required to ac complish its intended technical effect and not more than the maximum dose specified by the applicable regulation for that use. (c) Packaging materials subjected to irradiation incidental to the radiation treatment and processing of pre packaged food shall be in compliance with § 179.45, shall be the subject of an exemption for such use under § 170.39 of this chapter, or shall be the subject of an effective premarket notification for a food contact substance for such use submitted under § 170.100 of this chap ter. (d) Radiation treatment of food shall conform to a scheduled process. A scheduled process for food irradiation is a written procedure that ensures that the radiation dose range selected by the food irradiation processor is adequate under commercial processing conditions (including atmosphere and temperature) for the radiation to achieve its intended effect on a specific product and in a specific facility. A food irradiation processor shall operate with a scheduled process established by qualified persons having expert knowl edge in radiation processing require ments of food and specific for that food and for that irradiation processor’s treatment facility. (e) A food irradiation processor shall maintain records as specified in this section for a period of time that ex ceeds the shelf life of the irradiated food product by 1 year, up to a max imum of 3 years, whichever period is shorter, and shall make these records available for inspection and copy by authorized employees of the Food and Drug Administration. Such records shall include the food treated, lot iden tification, scheduled process, evidence of compliance with the scheduled proc ess, ionizing energy source, source cali bration, dosimetry, dose distribution in the product, and the date of irradia tion. [51 FR 13399, Apr. 18, 1986, as amended at 67 FR 9585, Mar. 4, 2002; 67 FR 35731, May 21, 2002; 80 FR 56168, Sept. 17, 2015] § 179.26 Ionizing radiation for the treatment of food. Ionizing radiation for treatment of foods may be safely used under the fol lowing conditions: (a) Energy sources. Ionizing radiation is limited to: (1) Gamma rays from sealed units of the radionuclides cobalt-60 or cesium 137. (2) Electrons generated from machine sources at energies not to exceed 10 million electron volts. (3) X rays generated from machine sources at energies not to exceed 5 mil lion electron volts (MeV), except as VerDate Sep<11>2014 08:44 Jun 03, 2016 Jkt 238072 PO 00000 Frm 00467 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 458 21 CFR Ch. I (4–1–16 Edition) § 179.26 permitted by paragraph (a)(4) of this section. (4) X rays generated from machine sources using tantalum or gold as the target material and using energies not to exceed 7.5 (MeV). (b) Limitations. Use Limitations 1. For control of Trichinella spiralis in pork carcasses or fresh, non-heat processed cuts of pork carcasses. Minimum dose 0.3 kiloGray (kGy) (30 kilorad (krad)); maximum dose not to ex ceed 1 kGy (100 krad). 2. For growth and maturation inhibition of fresh foods. Not to exceed 1 kGy (100 krad). 3. For disinfestation of arthropod pests in food. Do. 4. For microbial disinfection of dry or dehydrated enzyme preparations (in cluding immobilized enzymes). Not to exceed 10 kGy (1 megarad (Mrad)). 5. For microbial disinfection of the fol lowing dry or dehydrated aromatic vegetable substances when used as ingredients in small amounts solely for flavoring or aroma: culinary herbs, seeds, spices, vegetable seasonings that are used to impart flavor but that are not either represented as, or ap pear to be, a vegetable that is eaten for its own sake, and blends of these aromatic vegetable substances. Tur meric and paprika may also be irradi ated when they are to be used as color additives. The blends may con tain sodium chloride and minor amounts of dry food ingredients ordi narily used in such blends. Not to exceed 30 kGy (3 Mrad). 6. For control of food-borne pathogens in fresh (refrigerated or unrefrigerated) or frozen, uncooked poultry products that are: (1) Whole carcasses or disjointed portions (or other parts) of such carcasses that are ‘‘ready-to-cook poultry’’ within the meaning of 9 CFR 381.l(b) (with or without nonfluid seasoning; includes, e.g., ground poultry), or (2) mechani cally separated poultry product (a finely comminuted ingredient pro duced by the mechanical deboning of poultry carcasses or parts of car casses). Not to exceed 4.5 kGy for non-fro zen products; not to exceed 7.0 kGy for frozen products. Use Limitations 7. For the sterilization of frozen, pack aged meats used solely in the Na tional Aeronautics and Space Admin istration space flight programs. Minimum dose 44 kGy (4.4 Mrad). Packaging mate rials used need not comply with § 179.25(c) pro vided that their use is otherwise permitted by ap plicable regula tions in parts 174 through 186 of this chapter. 8. For control of foodborne pathogens in, and extension of the shelf-life of, refrigerated or frozen, uncooked products that are meat within the meaning of 9 CFR 301.2(rr), meat byproducts within the meaning of 9 CFR 301.2(tt), or meat food products within the meaning of 9 CFR 301.2(uu), with or without nonfluid seasoning, that are otherwise com posed solely of intact or ground meat, meat byproducts, or both meat and meat byproducts. Not to exceed 4.5 kGy maximum for refrigerated products; not to exceed 7.0 kGy maximum for fro zen products. 9. For control of Salmonella in fresh shell eggs.. Not to exceed 3.0 kGy. 10. For control of microbial pathogens on seeds for sprouting.. Not to exceed 8.0 kGy. 11. For the control of Vibrio bacteria and other foodborne microorganisms in or on fresh or frozen molluscan shellfish.. Not to exceed 5.5 kGy. 12. For control of food-borne pathogens and extension of shelf-life in fresh iceberg lettuce and fresh spinach.. Not to exceed 4.0 kGy. 13. For control of foodborne pathogens, and extension of shelf-life, in unrefrigerated (as well as refrig erated) uncooked meat, meat byprod ucts, and certain meat food products. Not to exceed 4.5 kGy. 14. For control of food-borne pathogens in, and extension of the shelf-life of, chilled or frozen raw, cooked, or par tially cooked crustaceans or dried crustaceans (water activity less than 0.85), with or without spices, min erals, inorganic salts, citrates, citric acid, and/or calcium disodium EDTA. Not to exceed 6.0 kGy. (c) Labeling. (1) The label and label ing of retail packages of foods irradi ated in conformance with paragraph (b) of this section shall bear the following logo along with either the statement VerDate Sep<11>2014 08:44 Jun 03, 2016 Jkt 238072 PO 00000 Frm 00468 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 459 Food and Drug Administration, HHS § 179.39 ‘‘Treated with radiation’’ or the statement ‘‘Treated by irradiation’’ in addition to information required by other regulations. The logo shall be placed prominently and conspicuously in conjunction with the required state ment. The radiation disclosure state ment is not required to be more promi nent than the declaration of ingredi ents required under § 101.4 of this chap ter. As used in this provision, the term ‘‘radiation disclosure statement’’ means the written statement that dis closes that a food has been inten tionally subject to irradiation. (2) For irradiated foods not in pack age form, the required logo and phrase ‘‘Treated with radiation’’ or ‘‘Treated by irradiation’’ shall be displayed to the purchaser with either (i) the label ing of the bulk container plainly in view or (ii) a counter sign, card, or other appropriate device bearing the information that the product has been treated with radiation. As an alter native, each item of food may be indi vidually labeled. In either case, the in formation must be prominently and conspicuously displayed to purchasers. The labeling requirement applies only to a food that has been irradiated, not to a food that merely contains an irra diated ingredient but that has not itself been irradiated. (3) For a food, any portion of which is irradiated in conformance with para graph (b) of this section, the label and labeling and invoices or bills of lading shall bear either the statement ‘‘Treated with radiation—do not irra diate again’’ or the statement ‘‘Treated by irradiation—do not irradiate again’’ when shipped to a food manufacturer or processor for further processing, la beling, or packing. [51 FR 13399, Apr. 18, 1986, as amended at 53 FR 12757, Apr. 18, 1988; 53 FR 53209, Dec. 30, 1988; 54 FR 32335, Aug. 7, 1989; 55 FR 14415, Apr. 18, 1990; 55 FR 18544, May 2, 1990; 60 FR 12670, Mar. 8, 1995; 62 FR 64121, Dec. 3, 1997; 63 FR 43876, Aug. 17, 1998; 65 FR 45282, July 21, 2000; 65 FR 64607, Oct. 30, 2000; 69 FR 76846, Dec. 23, 2004; 70 FR 48072, Aug. 16, 2005; 73 FR 49603, Aug. 22, 2008; 77 FR 71316, 71321, Nov. 30, 2012; 79 FR 20779, Apr. 14, 2014] § 179.30 Radiofrequency radiation for the heating of food, including microwave frequencies. Radiofrequency radiation, including microwave frequencies, may be safely used for heating food under the fol lowing conditions: (a) The radiation source consists of electronic equipment producing radio waves with specific frequencies for this purpose authorized by the Federal Communications Commission. (b) The radiation is used or intended for use in the production of heat in food wherever heat is necessary and ef fective in the treatment or processing of food. § 179.39 Ultraviolet radiation for the processing and treatment of food. Ultraviolet radiation for the proc essing and treatment of food may be safely used under the following condi tions: (a) The radiation sources consist of low pressure mercury lamps emitting VerDate Sep<11>2014 08:44 Jun 03, 2016 Jkt 238072 PO 00000 Frm 00469 Fmt 8010 Sfmt 8010 Y:\SGML\238072.XXX 238072 ER 0 1 F E 9 3 .0 0 0 < /G P H > js 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 460 21 CFR Ch. I (4–1–16 Edition) § 179.41 90 percent of the emission at a wave length of 253.7 nanometers (2,537 Angstroms). (b) The ultraviolet radiation is used or intended for use as follows: Irradiated food Limitations Use Food and food products ................. Without ozone production: high fat-content food irradiated in vacuum or in an inert atmosphere; intensity of radi ation, 1 W (of 2,537 A. radiation) per 5 to 10 ft.2. Surface microorganism con trol. Potable water .................................. Without ozone production; coefficient of absorption, 0.19 per cm or less; flow rate, 100 gal/h per watt of 2,537 A. radiation; water depth, 1 cm or less; lamp-operating temperature, 36 to 46 °C.. Sterilization of water used in food production. Juice products ................................. Turbulent flow through tubes with a minimum Reynolds number of 2,200.. Reduction of human patho gens and other microorga nisms. [42 FR 14635, Mar. 15, 1977, as amended at 65 FR 71057, Nov. 29, 2000] § 179.41 Pulsed light for the treatment of food. Pulsed light may be safely used for treatment of foods under the following conditions: (a) The radiation sources consist of xenon flashlamps designed to emit broadband radiation consisting of wavelengths covering the range of 200 to 1,100 nanometers (nm), and operated so that the pulse duration is no longer than 2 milliseconds (msec); (b) The treatment is used for surface microorganism control; (c) Foods treated with pulsed light shall receive the minimum treatment reasonably required to accomplish the intended technical effect; and (d) The total cumulative treatment shall not exceed 12.0 Joules/square cen timeter (J/cm2.) [61 FR 42383, Aug. 15, 1996] § 179.43 Carbon dioxide laser for etch ing food. Carbon dioxide laser light may be safely used for etching information on the surface of food under the following conditions: (a) The radiation source consists of a carbon dioxide laser designed to emit pulsed infrared radiation with a wave length of 10.6 micrometers such that the maximum energy output of the laser does not exceed 9.8 × 10¥3 joules per square centimeter (J/cm2); (b) The carbon dioxide laser shall be used only for etching information on the skin of fresh, intact citrus fruit, providing the fruit has been adequately washed and waxed prior to laser etch ing, and the etched area is imme diately rewaxed after treatment; and (c) The maximum total energy to which the etched citrus fruit is exposed from the use of the carbon dioxide laser shall not exceed 1.5 × 10¥3 J, and the maximum total etched surface area of the citrus fruit shall not exceed 0.122 cm2. [77 FR 34215, June 11, 2012] Subpart C—Packaging Materials for Irradiated Foods § 179.45 Packaging materials for use during the irradiation of pre packaged foods. The packaging materials identified in this section may be safely subjected to irradiation incidental to the radi ation treatment and processing of pre packaged foods, subject to the provi sions of this section and to the require ment that no induced radioactivity is detectable in the packaging material itself: (a) The radiation of the food itself shall comply with regulations in this part. (b) The following packaging mate rials may be subjected to a dose of ra diation, not to exceed 10 kilograys, un less otherwise indicated, incidental to the use of gamma, electron beam, or X radiation in the radiation treatment of prepackaged foods: (1) Nitrocellulose-coated or vinyli dene chloride copolymer-coated cello phane complying with § 177.1200 of this chapter. VerDate Sep<11>2014 08:44 Jun 03, 2016 Jkt 238072 PO 00000 Frm 00470 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 461 Food and Drug Administration, HHS § 179.45 (2) Glassine paper complying with § 176.170 of this chapter. (3) Wax-coated paperboard complying with § 176.170 of this chapter. (4) Polyolefin film prepared from one or more of the basic olefin polymers complying with § 177.1520 of this chap ter. The finished film may contain: (i) Adjuvant substances used in com pliance with §§ 178.3740 and 181.22 through 181.30 of this chapter, sodium citrate, sodium lauryl sulfate, poly vinyl chloride, and materials as listed in paragraph (d)(2)(i) of this section. (ii) Coatings comprising a vinylidene chloride copolymer containing a min imum of 85 percent vinylidene chloride with one or more of the following co monomers: Acrylic acid, acrylonitrile, itaconic acid, methyl acrylate, and methyl methacrylate. (5) Kraft paper prepared from un bleached sulfate pulp to which rosin, complying with § 178.3870 of this chap ter, and alum may be added. The kraft paper is used only as a container for flour and is irradiated with a dose not exceeding 500 grays. (6) Polyethylene terephthalate film prepared from the basic polymer as de scribed in § 177.1630(e)(4)(i) and (ii) of this chapter. The finished film may contain: (i) Adjuvant substances used in com pliance with §§ 178.3740 and 181.22 through 181.30 of this chapter, sodium citrate, sodium lauryl sulfate, poly vinyl chloride, and materials as listed in paragraph (d)(2)(i) of this section. (ii) Coatings comprising a vinylidene chloride copolymer containing a min imum of 85 percent vinylidene chloride with one or more of the following co monomers: Acrylic acid, acrylonitrile, itaconic acid, methyl acrylate, and methyl methacrylate. (iii) Coatings consisting of poly ethylene conforming to § 177.1520 of this chapter. (7) Polystyrene film prepared from styrene basic polymer. The finished film may contain adjuvant substances used in compliance with §§ 178.3740 and 181.22 through 181.30 of this chapter. (8) Rubber hydrochloride film pre pared from rubber hydrochloride basic polymer having a chlorine content of 30–32 weight percent and having a max imum extractable fraction of 2 weight percent when extracted with n-hexane at reflux temperature for 2 hours. The finished film may contain adjuvant substances used in compliance with §§ 178.3740 and 181.22 through 181.30 of this chapter. (9) Vinylidene chloride-vinyl chloride copolymer film prepared from vinyli dene chloride-vinyl chloride basic co polymers containing not less than 70 weight percent of vinylidene chloride and having a viscosity of 0.50–1.50 cen tipoises as determined by ASTM meth od D729–81, ‘‘Standard Specification for Vinylidene Chloride Molding Com pounds,’’ which is incorporated by ref erence. Copies may be obtained from the American Society for Testing Ma terials, 100 Barr Harbor Dr., West Conshohocken, Philadelphia, PA 19428 2959, or may be examined at the Na tional Archives and Records Adminis tration (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. The finished film may contain adjuvant substances used in compliance with §§ 178.3740 and 181.22 through 181.30 of this chapter. (10) Nylon 11 conforming to § 177.1500 of this chapter. (c) Ethylene-vinyl acetate copoly mers complying with § 177.1350 of this chapter. The ethylene-vinyl acetate packaging materials may be subjected to a dose of radiation, not to exceed 30 kilogray (3 megarads), incidental to the use of gamma, electron beam, or X radiation in the radiation treatment of packaged foods. (d) The following packaging mate rials may be subjected to a dose of ra diation, not to exceed 60 kilograys inci dental to the use of gamma, electron beam, or X-radiation in the radiation processing of prepackaged foods: (1) Vegetable parchments, consisting of a cellulose material made from waterleaf paper (unsized) treated with concentrated sulfuric acid, neutralized, and thoroughly washed with distilled water. (2) Films prepared from basic poly mers and with or without adjuvants, as follows: (i) Polyethylene film prepared from the basic polymer as described in VerDate Sep<11>2014 08:44 Jun 03, 2016 Jkt 238072 PO 00000 Frm 00471 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 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