China Approves New Food-Contact Materials

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 135^o 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 121^o 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 150^o 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 126^o 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 100^o 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 70^o C if the time does not exceed two hours or at a temperature of 100^o 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 100^o 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 50^o 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 70^o C if the time does not exceed two hours or at a temperature of 100^o 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 130^o 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 130^o 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 121^o 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 121^oC and may not contact other types of food at temperatures exceeding 130^oC.

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.