¡ì178.2650 Organotin stabilizers in vinyl chloride plastics.
　　 The organotin chemicals identified in paragraph （aï¼ of this section may be safety used alone or in combination, at levels not to exceed a total of 3 parts per hundred of resin, as stabilizers in vinyl chloride homopolymers and copolymers complying with the provisions of ¡ì 177.1950 or ¡ì 177.1980 of this chapter and that are identified for use in contact with food of types I, II, III, IV （except liquid milkï¼? V, VI （except malt beverages and carbonated nonalcoholic beveragesï¼? VII, VIII, and IX described in table 1 of ¡ì 176.170（cï¼ of this chapter, except for the organotin chemical identified in paragraph （a）（3ï¼ of this section, which may be used in contact with food of types I through IX at temperatures not exceeding 75 ¡ãC ï¼?67 ¡ãFï¼? and further that the organotin chemicals identified in paragraphs （aï¼ ï¼?ï¼ and ï¼?ï¼ of this section may be used in contact with food of types I through IX at temperatures not exceeding 66 ¡ãC ï¼?50 ¡ãFï¼? conditions of use D through G described in table 2 of ¡ì 176.170（cï¼ of this chapter, and further that dodecyltin chemicals identified in paragraph （a）（7ï¼ of this section which may be used in contact with food of types I, II, III, IV （except liquid milkï¼? V, VI （except malt beverages and carbonated nonalcoholic beveragesï¼? VII, VIII, and IX described in table 1 of ¡ì 176.170（cï¼ of this chapter at temperatures not exceeding 71 ¡ãC ï¼?60 ¡ãFï¼? in accordance with the following prescribed conditions:
　　（aï¼ For the purpose of this section, the organotin chemicals are those listed in paragraphs （aï¼ ï¼?ï¼? ï¼?ï¼? ï¼?ï¼? ï¼?ï¼? ï¼?ï¼? ï¼?ï¼? and ï¼?ï¼ of this section.
　　ï¼?ï¼ Di（n -octyl）tin S,S¡ä-bis（isooctylmercaptoacetateï¼ is an octyltin chemical having 15.1 to 16.4 percent by weight of tin （Snï¼ and having 8.1 to 8.9 percent by weight of mercapto sulfur. It is made from di（n -octyl）tin dichloride or di（n -octyl）tin oxide. The isooctyl radical in the mercaptoacetate is derived from oxo process isooctyl alcohol. Di（n -octyl）tin dichloride has an organotin composition that is not less than 95 percent by weight of di（n -octyl）tin dichloride and not more than 5 percent by weight of tri（n -octyl）tin chloride. Di（n -octyl）tin oxide has an organotin composition that is not less than 95 percent by weight of di（n -octyl）tin oxide and not more than 5 percent by weight of bis[tri（n -octyl）tin] oxide, and/or mono n -octyltin oxide.
　　ï¼?ï¼ Di（n- octylï¼ tin maleate polymer is an octyltin chemical having the formula [（C8 H17 ï¼? SnC4 H2 O4 ]n （where n is between 2 and 4 inclusiveï¼? having 25.2 to 26.6 percent by weight of tin （Snï¼ and having a saponification number of 225 to 255. It is made from di（n- octyl）tin dichloride or di（n- octyl）tin oxide meeting the specifications prescribed for di（n- octylï¼ tin dichloride or di（n- octylï¼ tin oxide in paragraph （a）（1ï¼ of this section.
　　ï¼?ï¼ C10-16 -Alkyl mercaptoacetates reaction products with dichlorodioctylstannane and trichlorooctylstannane （CAS Reg. No. 83447-69-2ï¼ is an organotin chemical mixture having 10.8 to 11.8 percent by weight of tin （Snï¼ and having 8.0 to 8.6 percent by weight of mercapto sulfur. It is made from a mixture of di（n -octyl）tin dichloride and （n -octyl）tin trichloride which has an organotin composition that is not less than 95 percent by weight di（n -octyl）tin dichloride/（n -octyl）tin trichloride, and not more than 1.5 percent by weight of tri（n -octyl）tin chloride. The alkyl radical in the mercaptoacetate is derived from a mixture of saturated n -alcohols which has a composition that is not less than 50 percent by weight tetradecyl alcohol, and that is not more than 50 percent by weight total of decyl alcohol and/or dodecyl alcohol, and/or hexadecyl alcohol.
　　ï¼?ï¼ ï¼ˆn -Octyl）tin S,S¡äS¡å tris（isooctyl-mercaptoacetateï¼ is an octyltin chemical having the formula n -C8 H17 Sn（SCH2 CO2 C8 H17 ï¼? （CAS Reg. No. 26401-86-5ï¼ having 13.4 to 14.8 percent by weight of tin （Snï¼ and having 10.9 to 11.9 percent by weight of mercapto sulfur. It is made from （n -octyl）tin trichloride. The isooctyl radical in the mercaptoacetate is derived from oxo process isooctyl alcohol. The （n -octyl）tin trichloride has an organotin composition that is not less than 95 percent by weight of （n -octyl）tin trichloride and not more than 5 percent by weight of tri（n -octyl）tin chloride.
　　ï¼?ï¼ Bis（beta -carbobutoxyethyl）tin bis（isooctylmercaptoacetateï¼ ï¼ˆCAS Reg. No. 63397-60-4ï¼ is an estertin chemical having 14.0 to 15.0 percent by weight of tin （Snï¼ and having 7.5 to 8.5 percent by weight of mercapto sulfur. It is made from bis（beta -carbobutoxyethyl）tin dichloride. The isooctyl radical in the mercaptoacetate is derived from oxo process primary octyl alcohols. The bis（beta -carbobutoxyethyl）tin dichloride has an organotin composition that is not less than 95 percent by weight of bis（beta -carbobutoxyethyl）tin dichloride and not more than 5 percent by weight of bis（beta -carbobutoxyethyltin trichloride. The triestertin chloride content of bis（beta -carbobutoxyethyltinï¼ dichloride shall not exceed 0.02 percent. p
　　ï¼?ï¼ Beta -carbobutoxyethyltin tris（isooctylmercaptoacetateï¼ ï¼ˆCAS Reg. No. 63438-80-2ï¼ is an estertin chemical having 13.0 to 14.0 percent by weight of tin （Snï¼ and having 10.5 to 11.5 percent by weight of mercapto sulfur. It is made from beta -carbobutoxyethyltin trichloride. The isooctyl radical in the mercaptoacetate is derived from oxo process primary octyl alcohol. The beta -carbobutoxyethyltin trichloride has an organotin composition that is not less than 95 percent by weight of beta- carbobutoxyethyltin trichloride and not more than 5 percent total of triestertin chloride and diestertin chloride.
　　ï¼?ï¼ The dodecyltin stabilizer is a mixture of 50 to 60 percent by weight of n -dodecyltin S,S¡ä，S¡å-tris（isooctylmercaptoacetateï¼ ï¼ˆCAS Reg. No. 67649-65-4ï¼ and 40 to 50 percent by weight of di（n -dodecyl）tin S,S¡ä-di（isooctylmercaptoacetateï¼ ï¼ˆCAS Reg. No. 84030-61-5ï¼ having 13 to 14 percent by weight of tin （Snï¼ and having 8 to 9 percent by weight of mercapto sulfur. It is made from a mixture of dodecyltin trichloride and di（dodecyl）tin dichloride which has not more than 0.2 percent by weight of dodecyltin trichloride, not more than 2 percent by weight of dodecylbutyltin dichloride and not more than 3 percent by weight of tri（dodecyl）tin chloride. The isooctyl radical in the mercaptoacetate is derived from oxo process primary octyl alcohols.
　　（bï¼ The vinyl chloride plastic containers, film or panels in the finished form in which they are to contact food, shall meet the following limitations:
　　ï¼?ï¼ The finished plastics intended for contact with foods of the types listed in this section shall be extracted with the solvent or solvents characterizing those types of foods as determined from table 2 of ¡ì 176.170（cï¼ of this chapter at the temperature reflecting the conditions of intended use as determined therein. Additionally, extraction tests for acidic foods shall be included and simulated by 3-percent acetic acid at temperatures specified for water in table 2 of ¡ì 176.170（cï¼ of this chapter. The extraction tests shall cover at least three equilibrium periodic determinations, as follows:
　　（iï¼ The exposure time for the first determination shall be at least 72 hours for aqueous solvents, and at least 6 hours for heptane.
　　（iiï¼ Subsequent determinations shall be at a minimum of 24-hour intervals for aqueous solvents, and 2-hour intervals for heptane. These tests shall yield total octylin stabilizers not to exceed 0.5 parts per million as determined by analytical method entitled ¡°Atomic Absorption Spectrometric Determination of Sub-part-per-Million Quantities of Tin in Extracts and Biological Materials with Graphite Furnace,¡± Analytical Chemistry, Vol. 49, p. 1090-1093 ï¼?977ï¼? which is incorporated by reference. Copies are available from the Center for Food Safety and Applied Nutrition （HFS-200ï¼? Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, or available for inspection at the National Archives and Records Administration （NARAï¼? For information on the availability of this material at NARA, call 202-741-6030, or go to:http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.
　　（iiiï¼ Subsequent determinations for the dodecyltin mixture described in paragraph （a）（7ï¼ of this section shall be at a minimum of 24-hour intervals for aqueous solvents and 2-hour intervals for heptane. These tests shall yield di（n -octyl）tin S,S¡ä-bis（isooctylmercaptoacetateï¼? or di（n -octyl）tin maleate polymer, or （C10 -C16 ï¼?alkylmercaptoacetate- reaction products with dichlorodioctylstannane and trichlorooctylstannane, or n -octyltin S,S¡ä，S¡å-tris（isooctylmercaptoacetateï¼? tris（isooctylmercaptoacetateï¼ and di（n -dodecyl）tin bis（isooctylmercaptoacetateï¼?nbsp;or any combination thereof, not to exceed 0.5 parts per million as determined by an analytical method entitled ¡°Atomic Absorption Spectrophotometric Determination of Sub-part-per-Million Quantities of Tin in Extracts and Biological Materials with Graphite Furnace,¡± Analytical Chemistry, Vol. 49, pp. 1090-1093 ï¼?977ï¼? which is incorporated by reference in accordance with 5 U.S.C. 552（aï¼? The availability of this incorporation by reference is given in paragraph （b）（1）（iiï¼ of this section.
　　ï¼?ï¼ In lieu of the tests prescribed in paragraph （bï¼ ï¼?ï¼ of this section, the finished plastics intended for contact with foods only of Types II, V, VI-A （except malt beveragesï¼? and VI-C may be end-tested with food-simulating solvents, under conditions of time and temperature, as specified below, whereby such tests shall yield the octyltin residues cited in paragraph （b）（1ï¼ of this section not in excess of 0.5 ppm:
| Food-simulating solvent | Time (hours) | Temperature (degrees Fahrenheit) | |
| Type II | Acetic acid, 3 pct | 48 | 135 |
| Type V | Heptane | 2 | 100 |
| Type VI-A | Ethyl alcohol, 8 pct | 24 | 120 |
| Type VI-C | Ethyl alcohol, 50 percent | 24 | 120 |