November 19, 2019

November 18, 2019

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CFSA Solicited Comments on 9 Food Additives and 5 Food-related Products

On October 15, 2019, China National Center for Food Safety Risk Assessment (CFSA) solicited comments on five food-contact substances. The substances and specifications are listed below:

  • Glass fiber (CAS no. 65997-17-3) for use in polytetrafluoroethylene (PTFE) plastic at a maximum use level of 25 %. The use temperature for products added with PTFE may not exceed 50℃ and the contact time may not exceed 30 minutes. In addition, it may not be used on products that contact infant formula and breast milk.

  • Siloxanes and silicones, di-me, me hydrogen, reaction products with vinyl group terminated di-me siloxanes (CAS no. 156065-02-0) for use in paper and paperboard at a maximum use level of 0.0022 % (calculated as paper pulp).

  • Polymer of 2,2-dimethyl-1,3-propandiol, ethylene glycol, isophthalic acid, sebacic acidterephthalic acid and trimellitic anhydride for use in coatings and coating layers at a maximum use level of 1.8 %. Single migration limits (SML) are: 0.05 mg/kg for 2,2-dimethyl-1,3-propanediol, 30 mg/kg for Ethylene glycol, 5 mg/kg for 1,3-phthalic acid, 7.5 mg/kg 1,4-phthalic acid, and 5 mg/kg for trimellitic acid. Additional restrictions are these substances may not contact food with ethanol above 8 % and the use temperature may not exceed 121℃.

  • Polymer of ethylene glycol, isophthalic acid, terephthalic acid, dimethyl ester and adipic acid (CAS no. 82076-71-9) for use in coatings and coating layers at a maximum use level of 30% (calculated as coating formula). SMLs are: 30 mg/kg for ethylene glycol, 5 mg.kg for 1,3-phthalic acid, and 7.5 mg/kg for 1,4-phthalic acid. Additional restrictions are these substances may not contact food with ethanol above 8 % and the use temperature may not exceed 121℃.

  • 1,3-Benzenedicarboxylic acid, polymer with 1,4-butanediol, terephthalic acid, dimethyl ester and hexanedioic acid (CAS no. 82076-69-5) for use in coatings and coating layers at a maximum use level of 80 % (calculated as file dry weight). SMLs are: 5 mg/kg for 1,3-phthalic acid, 7.5 mg/kg for 1,4-phthalic acid, and 5 mg/kg for 1,4-butanediol. Other restrictions are: the use temperature for food with this substance as raw material when contacting protein beverages may not exceed 121℃ and the use temperature when contacting with other foods may not exceed 130℃.

The comment period on these substances will close on November 12, 2019.

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Keller and Heckman offers global food and drug services to its clients. Our comprehensive and extensive food and drug practice is one of the largest in the world. We promote, protect, and defend products made by the spectrum of industries regulated by the U.S. Food and Drug Administration (FDA), the European Commission and Member States authorities in the European Union (EU) and similar authorities throughout the world. The products we help get to market include foods, pharmaceuticals, medical devices, veterinary products, dietary supplements, and cosmetics. In addition...

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