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China Approves New Food-Contact Materials

June 12, 2020

On June 2, 2020, China’s National Health Commission (NHC) approved seven new food-contact materials and ten new resins and approved expanded use for eight food-contact materials and three resins. The substances and specifications are listed below.

New Food-Contact Materials and Articles

  • Zinc caprylate (CAS no. 557-09-5) for use in plastics (EVOH) at a maximum use level of 0.06%. and with a specific migration limit (SML) of 5 mg/kg.
  • Siloxanes and silicones, dimethyl, 3-hydroxypropyl group-terminated, diesters with poly(2-oxepanone), diacetates (CAS no. 116810-47-0) for use in coatings and coating layers at a maximum use level of 0.025% and with a SML of 0.05 mg/kg. The use temperature of the coatings containing this substance may not exceed 135o C.
  • Polymer of 2,2-dimethyl-1,3-propandiol, ethylene glycol, isophthalic acid, dimethyl terephthalate, dimer acid, and trimellitic anhydride (CAS no. 157479-47.5) for use in coatings and coating layers at a maximum use level of 2.5% and SMLs of 0.05 mg/kg for 2,2-dimethyl-1,3-propanediol, 30 mg/kg for glycol, 5 mg/kg for isophthalic acid, and 5 mg/kg (as trimellitic acid). The maximum permitted residual content (QM) is 0.05 mg/kg for dimeric acid.
  • Nepheline syenite (CAS no. 37244-96-5) for use in plastics at a maximum use level of 50%.
  • Copolymer of 1,2,4-benzenetricarboxylic anhydride,4,4’-diphenylmethane diisocyanate, and 3,3’-dimethyl-4,4’-biphenylene diisocyanate (CAS no. 133078-67-8) for use in coatings and coating layers at a maximum use level of 50% and with SMLs of 5 mg/kg for terephthalic acid and ND (DL = 0.01 mg/kg, as isocyanate moiety).
  • 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 paper board at a maximum use level of 0.0022% (in paper pulp).
  • Polymer of 2,2-dimethyl-1,3-propandiol, ethylene glycol, isophthalic acid, sebacic acid, terephthalic acid, and trimellitic anhydride for use in coatings and coating layers at a maximum use level of 1.8% and SMLs of 0.05 mg/kg for 2,2-dimethyl-1,3-propanediol, 30 mg/kg for ethylene glycol, 5 mg/kg for isophthalic acid, 7.5 mg/kg for terephthalic acid, and 5 mg/kg for trimellitic acid. Coatings containing this substance may not be used in contact with food that has an alcohol content higher than 8% and the use temperature may not exceed 121o C. 

Food-Contact Materials and Articles with Expanded Use

  • Wollastonite (CAS no. 13983-17-0) for use in rubber at a maximum use level of 15%. The use temperature of rubber materials containing this substance may not exceed 150o C and the contact time may not be longer than 30 minutes.
  • Erucamide; cis-13-Docosenamide (CAS no. 112-84-5) for use in PVC plastics at a maximum use level of 1%.  PVC plastics materials and products containing with substance may not contact food with an alcoholic content higher than 20% and the use temperature may not exceed 126o C.
  • 3-Aminopropyltriethoxysilane (CAS no. 919-30-2) for use in plastics (PPS) at a maximum use level of 0.35% and a SML of 0.05 mg/kg. The use temperature of materials and products containing this substance may not exceed 100o C.
  • 1,4-Benzenedicarboxylic acid, 1,4-dimethyl ester, polymer with 1,4-butanedioland α-hydro-ω-hydroxypoly (oxy-1,4-butanediyl) (CAS no. 9078-71-1) for use in plastics (PET) at a maximum use level of 18% and SMLs of 0.05 mg/kg for tetrahydrofuran, 5 mg/kg for 1,4-butanediol, and 7.5 mg/kg for terephthalic acid. PET plastic materials and products containing this substance may not contact food with an alcohol content higher than 20% and only may be used for long-term storage at room temperature.
  • Polymer sodium salts of 2-acrylic acid and 2-acrylamide (CAS no. 25987-30-8) for use in paper and paper board at a maximum use level of 0.5% and SMLs of 6 mg/kg for acrylic acid and ND (0.01mg/kg) for acrylamide.
  • 2-Propenoic acid, 2-methyl-, polymer with ethyl 2-propenoate and 2-propenoic acid (CAS no. 30351-73-6) for use in adhesives with SMLs of 6 mg/kg for both acrylic acid and for methacrylic acid. Food-contact materials containing adhesives to which this substances have been added may only be hot filled and pasteurized at a temperature up to 70o C if the time does not exceed two hours or at a temperature of 100o C if the time does not exceed 15 minutes. They may also be used for long-term storage at room temperature.
  • C.I. Disperse Violet 26; Disperse Violet H-FRL; 1,4-diamino-2,3-diphenoxyanthraquinone (CAS no. 6408-72-6) for use in plastics (AS) at a maximum use level of 0.0003%. The use temperature of plastic materials and products containing this substance may not exceed 100o C.
  • Glass fiber (CAS no. 65997-17-3) for use in plastics (PTFE) at a maximum use level of 25%. The use temperature of PTFE plastic materials and products containing this substance may not exceed 50o C and the contact time may not exceed 30 minutes. In addition, they may not contact infant formula food and breast milk.

New Resins

  • 2-Propenoic acid, 2-methyl-, methyl ester, polymer with ethenylbenzene, 2-ethylhexyl 2-propenoateandmethyl 2-propenoate (CAS no. 74082-28-3) for use in adhesives with SMLs of 0.05 mg/kg for 2-acrylic-2-ethylhexyl ester, 6 mg/kg for acrylic acid, and 6 mg/kg for methacrylic acid.
  • 2-Propenoicacid, 2-methyl-, methyl ester, polymer with butyl 2-propenoate, ethenyl acetate and 2-ethylhexyl 2-propenoate (CAS no. 193542-91-5) for use in adhesives with SMLs of 0.05 mg/kg for 2-acrylic-2-ethylhexyl ester, 6 mg/kg for acrylic acid, 6 mg/kg for methacrylic acid, and 12 mg/kg for vinyl acetate.
  • 2-Propenoic acid, 2-methyl-, methyl ester, polymer with ethenyl acetate, and 2-ethylhexyl 2-propenoate (CAS no. 26794-25-2) for use in adhesives with SMLs of 6 mg/kg for methacrylic acid, 12 mg/kg vinyl acetate, and 0.05 mg/kg for 2-acrylic acid-2-ethylhexyl ester.
  • 2-Propenoic acid, 2-ethylhexyl ester, polymer with ethenyl acetate (CAS no. 25067-02-1) for use in adhesives with SMLs of 0.05 mg/kg for 2-acrylic-2-ethylhexyl ester and 12 mg/kg for vinyl acetate.

The above four substances have the additional restrictions: Food-contact materials containing adhesives to which they have been added may only be hot filled and pasteurized at a temperature of up to 70o C if the time does not exceed two hours or at a temperature of 100o C if the time does not exceed 15 minutes. They may also be used for long-term storage at room temperature.

  • 1,3-benzenedicarboxylic acid, polymer with 1,4-benzenedicarboxylic acid, 1,4-cyclohexanedimethanol, and 2-methyl-1,3-propanediol (CAS no. 164002-50-0) for use in coatings and coating layers at a maximum use level of 85% and SMLs of 5 mg/kg for isophthalic acid, 7.5 mg/kg for terephthalic acid, 5 mg/kg for trimellitic acid, and 5 mg/kg 2-methyl-1,3-propanediol. The content of trimellitic anhydride in the resin may not exceed 2% (mass fraction).
  • 2,4-Hexadienoic acid, (2E,4E)-, polymer with 1,4-benzenediol, 2-(chloromethyl)oxirane, ethyl 2-propenoate, 4,4’-methylenebis[2,6-dimethylphenol], methyl 2-methyl-2-propenoate, 2-methyl-2-propenoic acid, and 2-propenoic acid,reaction products with 2-(dimethylamino)ethanol for use in coatings and coating layers with SMLs of 0.6 mg/kg for hydroquinone, 6 mg/kg for methacrylic acid and 6 mg/kg for acrylic acid. Other SMLs are specified. Coatings made from this material may not contact infant food and breast milk or be exposed to temperatures above 130o C.
  • 5-Isobenzofurancarboxylic acid, 1,3-dihydro-1,3-dioxo-, polymer with 1,2-ethanediol (CAS no. 43011-20-7) for use in coatings and coating layers at a maximum use level of 5% and SMLs of 5 mg/kg for trimellitic acid and 30 mg/kg for glycol. The use temperature of the coating produced with the material shall not exceed 121 ℃.
  • Formaldehyde, polymer with 4-(1,1-dimethylethyl)phenol and bisphenol A (CAS no. 54579-44-1) for use in coatings and coating layers at a maximum use level of 15% with SMLs of 0.05 mg/kg for p-tert-butylphenol, 15 mg/kg for formaldehyde, and 0.6 mg/kg for bisphenol A. Coatings containing this substance may not contact infant food and breast milk at 130o C or above.
  • 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% and SMLs of 30 mg/kg for glycol, 5 mg/kg for isophthalic acid, and 7.5 mg/kg for terephthalic acid. Coatings containing this substance may not contact food with an alcohol content higher than 8% and the use temperature may not exceed 121o C.
  • 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% with SMLs of 5 mg/kg for isophthalic acid, 7.5 mg/kg for terephthalic acid, and 5 mg/kg fpr 1,4-butanediol. Coatings containing this substance may not be used in contact with protein beverages at temperatures exceeding 121oC and may not contact other types of food at temperatures exceeding 130oC.

Resins with Expanded Usage

  • 2-Propenoic acid, 2-methyl-, oxiranylmethyl ester, polymer with chloroethene and ethenyl acetate (CAS no. 26781-49-7) may be used in adhesives, coatings and coating layers, and ink with SMLs of 0.02 mg/kg for 2-methyl-2-acrylic acid oxiranylmethyl ester, ND (0.01mg/kg) for vinyl chloride, and 12 mg/kg for vinyl acetate and a QM of 1 mg/kg for vinyl chloride. When 2-methyl-2-propenoic acid oxiranylmethyl ester can react with the food or food simulant that it contacts, the QM should be 0.02 mg/6 dm2.
  • Vinyl acetate, polymer with vinyl chloride, fumaric acid, and glycidyl methacrylate for use in adhesives, coatings and coatings layers, and ink with SMLs of 12 mg/kg for vinyl acetate, ND (0.01mg/kg) for vinyl chloride, and 0.02 for 2-methyl-2-acrylic acid ethylene oxide methyl ester and a QM of 1 mg/kg for vinyl chloride. When 2-methyl-2-propenoic acid oxiranylmethyl ester can react with the food or food simulant that it contacts, the QM should be 0.02 mg/6 dm2.
  • Styrene polymer with 1,3-butadiene, hydrogenated (CAS no. 66070-58-4) for use in plastic, rubber with a SML of ND (0.01mg/kg) for 1,3-butadiene and QMs of 1 mg/kg for 1,3-butadiene and 0.5% for styrene.