褰撳墠浣嶇疆: 棣栭〉 » 鏀跨瓥娉曡 » 鍥藉娉曡 »搂177.1585 鑱氶叝纰抽吀閰爲鑴�(Polyestercarbonate resins)

搂177.1585 鑱氶叝纰抽吀閰爲鑴�(Polyestercarbonate resins)

鎵弿浜岀淮鐮� 鍒嗕韩濂藉弸鍜屾湅鍙嬪湀
鏀惧ぇ瀛椾綋  缂╁皬瀛椾綋 2011-10-06 21:33:14  鏉ユ簮锛�GPO  娴忚娆℃暟锛�2601
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鍙戝竷鍗曚綅
FDA
FDA
鍙戝竷鏂囧彿 64 FR 27178
鍙戝竷鏃ユ湡 1999-03-19 鐢熸晥鏃ユ湡 鏆傛棤
鏈夋晥鎬х姸鎬� 搴熸鏃ユ湡 鏆傛棤
澶囨敞 鑱氶叝纰抽吀閰爲鑴傜敱4,,4鈥�-寮備簹涓欏熀浜岄厷銆佺⒊閰版隘銆佸鑲介叞姘拰寮傝偨閰版隘缂╁悎鑰屾垚锛屾爲鑴傜敱70%-85%鐨勯叝缁勬垚锛屽叾涓墍鍚鑲介叞寮傛瀯浣撳彲楂樿揪55%銆傛湰鑺傦紙a锛夋墍鎸囩殑鏍戣剛鐢熶骇涓墍闇€鐨勮緟鏂欏彲鍖呮嫭鏈珷174.5涓敤鐨勭墿璐紝177.1580锛坆锛変腑鎵€鍒楃殑鐗╄川銆傛湰绔�178.2010锛坆锛変腑鎵€瑙勫畾鐨勭敤浜庣鍚�177.1780鐨勮仛纰抽吀閰爲鑴傜殑鐗╄川銆傝仛閰⒊閰搁叝鏍戣剛搴旂鍚堟湰鑺傦紙c锛夛紙1锛変腑瑙勫畾鐨勮川閲忔寚鏍囷紝骞剁鍚堟湰鑺傦紙c锛夛紙2锛変腑鎵€瑙勫畾鐨勬蹈鎻愮墿闄愰噺銆�

 §177.1585 Polyestercarbonate resins


銆€銆€Polyestercarbonate resins may be safely used as articles or components of articles intended for use in producing, manufacturing, packing, processing, preparing, treating, packaging, or holding food, in accordance with the following prescribed conditions:

銆€銆€锛坅锛� Polyestercarbonate resins 锛圕AS Reg. No. 71519-80-7锛� are produced by the condensation of 4,4′-isopropylidenediphenol, carbonyl chloride, terephthaloyl chloride, and isophthaloyl chloride such that the finished resins are composed of 45 to 85 molepercent ester, of which up to 55 mole-percent is the terephthaloyl isomer. The resins are manufactured using a phthaloyl chloride/carbonyl chloride mole ratio of 0.81 to 5.7/1 and isophthaloyl chloride/terephthaloyl chloride mole ratio of 0.81/1 or greater. The resins are also properly identified by CAS Reg. No. 114096-64-9 when produced with the use of greater than 2 but not greater than 5 weight percent p -cumylphenol 锛圕AS Reg. No. 599-64-4锛�, as an optional adjuvant substance in accordance with paragraph 锛坆锛夛紙2锛� of this section.

銆€銆€锛坆锛� Optional adjuvants. The optional adjuvant substances required in the production of resins identified in paragraph 锛坅锛� of this section may include:

銆€銆€锛�1锛� Substances used in accordance with § 174.5 of this chapter.

銆€銆€锛�2锛� Substances identified in § 177.1580锛坆锛�.

銆€銆€锛�3锛� Substances regulated in § 178.2010锛坆锛� of this chapter for use in polycarbonate resins complying with § 177.1580 :

銆€銆€Code of Federal Regulations

銆€銆€Provided, That the substances are used in accordance with any limitation on concentration, conditions of use, and food types specified in § 178.2010锛坆锛� of this chapter.

銆€銆€銆€銆€锛坈锛� Polyestercarbonate resins shall conform to the specifications prescribed in paragraph 锛坈锛夛紙1锛� of this section and shall meet the extractive limitations prescribed in paragraph 锛坈锛夛紙2锛� of this section.

銆€銆€锛�1锛� Specifications. Polyestercarbonate resins identified in paragraph 锛坅锛� of this section can be identified by their characteristic infrared spectrum. The resins shall comply with either or both of the following specifications:

銆€銆€锛坕锛� The solution intrinsic viscosity of the polyestercarbonate resins shall be a minimum of 0.44 deciliter per gram, as determined by a method entitled “Intrinsic Viscosity 锛圛V锛� of Lexan ? Polyestercarbonate Resin by a Single Point Method Using Dichloromethane as the Solvent,” developed by the General Electric Co., September 20, 1985, which is incorporated by reference in accordance with 5 U.S.C. 552锛坅锛� and 1 CFR part 51. Copies are available from the Office of Premarket Approval, Center for Food Safety and Applied Nutrition 锛圚FS-215锛�, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, or may be examined at the Center for Food Safety and Applied Nutrition's Library, Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, or 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i锛� A minimum weight-average molecular weight of 27,000, as determined by gel permeation chromatography using polystyrene standards.

銆€銆€锛�2锛� Extractives limitations. The polyestercarbonate resins to be tested shall be ground or cut into small particles that will pass through a U.S. standard sieve No. 6 and that will be held on U.S. standard sieve No. 10.

銆€銆€锛坕锛� Polyestercarbonate resins, when extracted with distilled water at reflux temperature for 6 hours, shall yield total nonvolatile extractives not to exceed 0.005 percent by weight of the resins.

銆€銆€锛坕i锛� Polyestercarbonate resins, when extracted with 50 percent 锛坆y volume锛� ethyl alcohol in distilled water at reflux temperature for 6 hours, shall yield total nonvolatile extractives not to exceed 0.005 percent by weight of the resins.

銆€銆€锛坕ii锛� Polyestercarbonate resins, when extracted with n -heptane at reflux temperature for 6 hours, shall yield total nonvolatile extractives not to exceed 0.002 percent by weight of the resins.

銆€銆€锛�3锛� Residual methylene chloride levels in poly-ester-carbonate resins. Poly-ester-carbonate resin articles in the finished form shall not contain residual methylene chloride in excess of 5 parts per million as determined by a method titled “Analytical Method for Determination of Residual Methylene Chloride in Polyestercarbonate Resin,” developed by the General Electric Co., July 23, 1991, which is incorporated by reference in accordance with 5 U.S.C. 552锛坅锛� and 1 CFR part 51. 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 may be examined 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€銆€銆€[57 FR 3940, Feb. 3, 1992, as amended at 64 FR 27178, May 19, 1999]

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