銆€銆€§178.2650 Organotin stabilizers in vinyl chloride plastics.
銆€銆€ The organotin chemicals identified in paragraph 锛坅锛 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 § 177.1950 or § 177.1980 of this chapter and that are identified for use in contact with food of types I, II, III, IV 锛坋xcept liquid milk锛? V, VI 锛坋xcept malt beverages and carbonated nonalcoholic beverages锛? VII, VIII, and IX described in table 1 of § 176.170锛坈锛 of this chapter, except for the organotin chemical identified in paragraph 锛坅锛夛紙3锛 of this section, which may be used in contact with food of types I through IX at temperatures not exceeding 75 °C 锛?67 °F锛? and further that the organotin chemicals identified in paragraphs 锛坅锛 锛?锛 and 锛?锛 of this section may be used in contact with food of types I through IX at temperatures not exceeding 66 °C 锛?50 °F锛? conditions of use D through G described in table 2 of § 176.170锛坈锛 of this chapter, and further that dodecyltin chemicals identified in paragraph 锛坅锛夛紙7锛 of this section which may be used in contact with food of types I, II, III, IV 锛坋xcept liquid milk锛? V, VI 锛坋xcept malt beverages and carbonated nonalcoholic beverages锛? VII, VIII, and IX described in table 1 of § 176.170锛坈锛 of this chapter at temperatures not exceeding 71 °C 锛?60 °F锛? in accordance with the following prescribed conditions:
銆€銆€锛坅锛 For the purpose of this section, the organotin chemicals are those listed in paragraphs 锛坅锛 锛?锛? 锛?锛? 锛?锛? 锛?锛? 锛?锛? 锛?锛? and 锛?锛 of this section.
銆€銆€锛?锛 Di锛坣 -octyl锛塼in S,S′-bis锛坕sooctylmercaptoacetate锛 is an octyltin chemical having 15.1 to 16.4 percent by weight of tin 锛圫n锛 and having 8.1 to 8.9 percent by weight of mercapto sulfur. It is made from di锛坣 -octyl锛塼in dichloride or di锛坣 -octyl锛塼in oxide. The isooctyl radical in the mercaptoacetate is derived from oxo process isooctyl alcohol. Di锛坣 -octyl锛塼in dichloride has an organotin composition that is not less than 95 percent by weight of di锛坣 -octyl锛塼in dichloride and not more than 5 percent by weight of tri锛坣 -octyl锛塼in chloride. Di锛坣 -octyl锛塼in oxide has an organotin composition that is not less than 95 percent by weight of di锛坣 -octyl锛塼in oxide and not more than 5 percent by weight of bis[tri锛坣 -octyl锛塼in] oxide, and/or mono n -octyltin oxide.
銆€銆€锛?锛 Di锛坣- octyl锛 tin maleate polymer is an octyltin chemical having the formula [锛圕8 H17 锛? SnC4 H2 O4 ]n 锛坵here n is between 2 and 4 inclusive锛? having 25.2 to 26.6 percent by weight of tin 锛圫n锛 and having a saponification number of 225 to 255. It is made from di锛坣- octyl锛塼in dichloride or di锛坣- octyl锛塼in oxide meeting the specifications prescribed for di锛坣- octyl锛 tin dichloride or di锛坣- octyl锛 tin oxide in paragraph 锛坅锛夛紙1锛 of this section.
銆€銆€锛?锛 C10-16 -Alkyl mercaptoacetates reaction products with dichlorodioctylstannane and trichlorooctylstannane 锛圕AS Reg. No. 83447-69-2锛 is an organotin chemical mixture having 10.8 to 11.8 percent by weight of tin 锛圫n锛 and having 8.0 to 8.6 percent by weight of mercapto sulfur. It is made from a mixture of di锛坣 -octyl锛塼in dichloride and 锛坣 -octyl锛塼in trichloride which has an organotin composition that is not less than 95 percent by weight di锛坣 -octyl锛塼in dichloride/锛坣 -octyl锛塼in trichloride, and not more than 1.5 percent by weight of tri锛坣 -octyl锛塼in 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.
銆€銆€锛?锛 锛坣 -Octyl锛塼in S,S′S″ tris锛坕sooctyl-mercaptoacetate锛 is an octyltin chemical having the formula n -C8 H17 Sn锛圫CH2 CO2 C8 H17 锛? 锛圕AS Reg. No. 26401-86-5锛 having 13.4 to 14.8 percent by weight of tin 锛圫n锛 and having 10.9 to 11.9 percent by weight of mercapto sulfur. It is made from 锛坣 -octyl锛塼in trichloride. The isooctyl radical in the mercaptoacetate is derived from oxo process isooctyl alcohol. The 锛坣 -octyl锛塼in trichloride has an organotin composition that is not less than 95 percent by weight of 锛坣 -octyl锛塼in trichloride and not more than 5 percent by weight of tri锛坣 -octyl锛塼in chloride.
銆€銆€锛?锛 Bis锛坆eta -carbobutoxyethyl锛塼in bis锛坕sooctylmercaptoacetate锛 锛圕AS Reg. No. 63397-60-4锛 is an estertin chemical having 14.0 to 15.0 percent by weight of tin 锛圫n锛 and having 7.5 to 8.5 percent by weight of mercapto sulfur. It is made from bis锛坆eta -carbobutoxyethyl锛塼in dichloride. The isooctyl radical in the mercaptoacetate is derived from oxo process primary octyl alcohols. The bis锛坆eta -carbobutoxyethyl锛塼in dichloride has an organotin composition that is not less than 95 percent by weight of bis锛坆eta -carbobutoxyethyl锛塼in dichloride and not more than 5 percent by weight of bis锛坆eta -carbobutoxyethyltin trichloride. The triestertin chloride content of bis锛坆eta -carbobutoxyethyltin锛 dichloride shall not exceed 0.02 percent. p
銆€銆€锛?锛 Beta -carbobutoxyethyltin tris锛坕sooctylmercaptoacetate锛 锛圕AS Reg. No. 63438-80-2锛 is an estertin chemical having 13.0 to 14.0 percent by weight of tin 锛圫n锛 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.
銆€銆€锛?锛 The dodecyltin stabilizer is a mixture of 50 to 60 percent by weight of n -dodecyltin S,S′锛孲″-tris锛坕sooctylmercaptoacetate锛 锛圕AS Reg. No. 67649-65-4锛 and 40 to 50 percent by weight of di锛坣 -dodecyl锛塼in S,S′-di锛坕sooctylmercaptoacetate锛 锛圕AS Reg. No. 84030-61-5锛 having 13 to 14 percent by weight of tin 锛圫n锛 and having 8 to 9 percent by weight of mercapto sulfur. It is made from a mixture of dodecyltin trichloride and di锛坉odecyl锛塼in 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锛坉odecyl锛塼in chloride. The isooctyl radical in the mercaptoacetate is derived from oxo process primary octyl alcohols.
銆€銆€锛坆锛 The vinyl chloride plastic containers, film or panels in the finished form in which they are to contact food, shall meet the following limitations:
銆€銆€锛?锛 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 § 176.170锛坈锛 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 § 176.170锛坈锛 of this chapter. The extraction tests shall cover at least three equilibrium periodic determinations, as follows:
銆€銆€锛坕锛 The exposure time for the first determination shall be at least 72 hours for aqueous solvents, and at least 6 hours for heptane.
銆€銆€锛坕i锛 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 锛?977锛? which is incorporated by reference. Copies are available from the Center for Food Safety and Applied Nutrition 锛圚FS-200锛? Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, or available for inspection at the National Archives and Records Administration 锛圢ARA锛? 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.
銆€銆€锛坕ii锛 Subsequent determinations for the dodecyltin mixture described in paragraph 锛坅锛夛紙7锛 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锛坣 -octyl锛塼in S,S′-bis锛坕sooctylmercaptoacetate锛? or di锛坣 -octyl锛塼in maleate polymer, or 锛圕10 -C16 锛?alkylmercaptoacetate- reaction products with dichlorodioctylstannane and trichlorooctylstannane, or n -octyltin S,S′锛孲″-tris锛坕sooctylmercaptoacetate锛? tris锛坕sooctylmercaptoacetate锛 and di锛坣 -dodecyl锛塼in bis锛坕sooctylmercaptoacetate锛?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 锛?977锛? which is incorporated by reference in accordance with 5 U.S.C. 552锛坅锛? The availability of this incorporation by reference is given in paragraph 锛坆锛夛紙1锛夛紙ii锛 of this section.
銆€銆€锛?锛 In lieu of the tests prescribed in paragraph 锛坆锛 锛?锛 of this section, the finished plastics intended for contact with foods only of Types II, V, VI-A 锛坋xcept malt beverages锛? 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 锛坆锛夛紙1锛 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 |