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§177.2420 交联聚酯树脂(Polyester resins, cross-linked)
2011-10-13 15:29  点击:3426
发布单位:FDA
发布文号: 54 FR 48858
发布日期:1989-11-28
生效日期:暂无
有效性状态:
废止日期:暂无
备注:交联聚酯树脂由本节(a)(1)中所列的一种或多种酸与本节(a)(2)中所列的一种或多种醇或环氧化物缩合,然后与本节(a)(3)中所列的一种或一种以上交联剂共聚制成。用于促进树脂生产或加入后可获得所希望的工艺或物理性质的辅料,这些物质按规定应不超过能达到所需物理或工艺效果的适宜量,并不超过本节中所规定的各项限量。本节(c)规定了交联聚酯树脂的浸提物限量。

       §177.2420 Polyester resins, cross-linked

  Cross-linked polyester resins may be safely used as articles or components of articles intended for repeated use in contact with food, in accordance with the following prescribed conditions:

  (a) The cross-linked polyester resins are produced by the condensation of one or more of the acids listed in paragraph (a)(1) of this section with one or more of the alcohols or epoxides listed in paragraph (a)(2) of this section, followed by copolymerization with one or more of the cross-linking agents listed in paragraph (a)(3) of this section:

  (1) Acids:

  Adipic.

  Fatty acids, and dimers thereof, from natural sources.

  Fumaric.

  Isophthalic.

  Maleic.

  Methacrylic.

  Orthophthalic.

  Sebacic.

  Terephthalic.

  Trimellitic.

  (2) Polyols and polyepoxides:

  Butylene glycol.

  Diethylene glycol.

  2,2-Dimethyl-1,3-propanediol.

  Dipropylene glycol.

  Ethylene glycol.

  Glycerol.

  4,4′-Isopropylidenediphenol-epi-chloro-hydrin.

  Mannitol.

  a-Methyl glucoside.

  Pentaerythritol.

  Polyoxypropylene ethers of 4,4′-isopropylide-nediphenol (containing an average of 2-7.5 moles of propylene oxide).

  Propylene glycol.

  Sorbitol.

  Trimethylol ethane.

  Trimethylol propane.

  2,2,4-Trimethyl-1,3-pentanediol.

  (3) Cross-linking agents:

  Butyl acrylate.

  Butyl methacrylate.

  Ethyl acrylate.

  Ethylhexyl acrylate.

  Methyl acrylate.

  Methyl methacrylate.

  Styrene.

  Triglycidyl isocyanurate (CAS Reg. No. 2451-62-9), for use only in coatings contacting bulk quantities of dry food of the type identified in § 176.170(c) of this chapter, table 1, under type VIII.

  Vinyl toluene.

  (b) Optional adjuvant substances employed to facilitate the production of the resins or added thereto to impart desired technical or physical properties include the following, provided that the quantity used does not exceed that reasonably required to accomplish the intended physical or technical effect and does not exceed any limitations prescribed in this section:

List of substances Limitations (limits of addition expressed as percent by weight of finished resin)
1. Inhibitors: Total not to exceed 0.08 percent.
Benzoquinone 0.01 percent.
tert-Butyl catechol  
 TBHQ  
Di-tert-butyl hydroquinone   
Hydroquinone   
2. Accelerators:  Total not to exceed 1.5 percent. 
Benzyl trimethyl ammonium chloride  0.05 percent. 
 Calcium naphthenate  
Cobalt naphthenate   
Copper naphthenate   
N, N-Diethylaniline   0.4 percent.
N, N-Dimethylaniline   Do.
Ethylene guanidine hydrochloride  0.05 percent. 
3. Catalysts:  Total not to exceed 1.5 percent, except that methyl ethyl ketone peroxide may be used as the sole catalyst at levels not to exceed 2 percent. 
Azo-bis-isobutyronitrile   
Benzoyl peroxide   
tert-Butyl perbenzoate   
Chlorbenzoyl peroxide   
Cumene hydroperoxide   
Dibutyltin oxide (CAS Reg. No. 818-08-6)   For use in the polycondensation reaction at levels not to exceed 0.2 percent of the polyester resin.
Dicumyl peroxide   
Hydroxybutyltin oxide (CAS Reg. No. 2273-43-0)   For use in the polycondensation reaction at levels not to exceed 0.2 percent of the polyester resin.
 Lauroyl peroxide  
 p-Menthane hydroperoxide  
 Methyl ethyl ketone peroxide  
 Monobutyltin tris(2-ethylhexoate) (CAS Reg. No. 23850-94-4)  For use in the polycondensation reaction at levels not to exceed 0.2 percent of the polyester resin.
 4. Solvents for inhibitors, accelerators, and catalysts:  
 Butyl benzyl phthalate (containing not more than 1.0 percent by weight of dibenzyl phthalate)  
 Dibutyl phthalate  
 Diethylene glycol  As a solvent for benzyl trimethyl ammonium chloride or ethylene guanidine hydrochloride only.
 Dimethyl phthalate  
 Methyl alcohol  
 Styrene  
 Triphenyl phosphate  
 5. Reinforcements:  
 Asbestos  
 Glass fiber  
 Polyester fiber produced by the condensation of one or more of the acids listed in paragraph (a)(1) of this section with one or more of the alcohols listed in paragraph (a)(2) of this section  
 6. Miscellaneous materials:  
 Castor oil, hydrogenated  
 α-Methylstyrene  
 Polyethylene glycol 6000  
Code of Federal Regulations 343
 Silicon dioxide  
 Wax, petroleum  Complying with § 178.3710 of this chapter.

  (c) The cross-linked polyester resins, with or without the optional substances described in paragraph (b) of this section, and in the finished form in which they are to contact food, when extracted with the solvent or solvents characterizing the type of food and under the conditions of time and temperature characterizing the conditions of their intended use, as determined from tables 1 and 2 of § 176.170(c) of this chapter, shall meet the following extractives limitations:

  (1) Net chloroform-soluble extractives not to exceed 0.1 milligram per square inch of food-contact surface tested when the prescribed food-simulating solvent is water or 8 or 50 percent alcohol.

  (2) Total nonvolatile extractives not to exceed 0.1 milligram per square inch of food-contact surface tested when the prescribed food-simulating solvent is heptane.

  (d) In accordance with good manufacturing practice, finished articles containing the cross-linked polyester resins shall be thoroughly cleansed prior to their first use in contact with food.

    [42 FR 14572, Mar. 15, 1977, as amended at 48 FR 37618, Aug. 19, 1983; 54 FR 48858, Nov. 28, 1989]
 


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