China Solicits Comments on 10 Food-Contact Materials

On August 23, 2022, China’s National Center for Food Safety Risk Assessment (CFSA) requested comments on two new food-contact materials, expanded use for four food-contact materials, three new resins, and expanded use for one resin. Comments shall be submitted by September 16, 2022. The substances and specifications are listed below.

New Food-Contact Materials

1. Cyclohexane, 1,1'-methylenebis[4-isocyanato-, homopolymer, cyclohexylamine-terminated (CAS No. 315207-86-4) is to be cleared for use in Polycyclohexanedimethylene naphthalenedicarboxylate (PCN) plastics at a maximum use level of 0.35%. The specific migration levels (SMLs) are non-detectable for 1,1'-methylenebis(4-isocyanatecyclohexane), where the detection limit is 0.01 mg/kg (as isocyanate moiety); and 0.05 mg/kg for 4,4'-methylenebis(cyclohexylamine). The maximum permitted residual content (QM) is 1 mg/kg for 1,1'-methylenebis(4-isocyanatecyclohexane), (as isocyanate moiety). 
2. 2-[2-(2,4-Diamino-6-hydroxypyrimidin-5-yl) diazenyl]-5-methylbenzenesulfonic acid (CAS No. 1021701-36-9) is to be cleared for use in plastics at a maximum use level of 0.5%. The SML is 0.05 mg/kg. The use temperature for plastic materials and articles containing this substance may not exceed 100oC and this substance may not be used in food-contact materials and articles for infant foods. These restrictions must be labeled in accordance with the provisions of GB 4806.1.

Food-Contact Materials with Expanded Use

1. Octadecyl 3-(3,5-di-tert-butyl-4-hydroxyphenyl) propionate (CAS No. 2082-79-3) is to be cleared for use in coatings and coating layers at a maximum use level of 0.5%. The SML is 6 mg/kg. Coating and coating layers containing this substance may not exceed 10 g/m². These restrictions must be labeled in accordance with the provisions of GB 4806.1. 
2. Napthalensulfonic acid, polymer with formaldehyde, sodium salt (CAS No. 9084-06-4 and 36290-04-7) is to be cleared for use in acrylonitrile butadiene styrene (ABS) plastic at a maximum use level of 0.12%. The SML is 15 mg/kg (as formaldehyde).
3. Fatty acid esters of C1~C18 mono- and poly-fatty alcohols is to be cleared for use in plastics at a maximum use level of 0.1%. This substance may not be used in food-contact materials and articles for infant foods. These restrictions must be labeled in accordance with the provisions of GB 4806.1.
4. Silane, dichlorodimethyl-, reaction products with silica (CAS No. 68611-44-9) for use in adhesives (for direct food contact) and ink (for indirect food contact) at maximum use levels of 0.002% in adhesives (on a dry weight basis) and 4% in inks (on a dry weight basis). Adhesives and ink containing this substance may not be used in food-contact materials and articles for infant foods. These restrictions must be labeled in accordance with GB 4806.1. 

New Resins

1. Carbon monoxide-ethylene-propylene terpolymer (CAS NO. 88995-51-1) is to be cleared for use in plastics at dosage as necessary. This substance may not be used in food-contact materials and articles for infant foods. These restrictions must be labeled in accordance with the provisions of GB 4806.1.
2. 4-Ethylphenol, m-cresol, p-cresol and 4-tert-butylphenol polymers with formaldehyde (CAS No. 68957-28-8) is to be cleared for use in coatings and coating layers at a maximum use level of 62% (on coating formula basis). The SMLs are 0.05 mg/kg for 4-tert-butylphenol and 15 mg/kg (as formaldehyde). The use temperature for coating and coating layers containing this substance as a raw material may not exceed 130°C. This substance may not be used in food-contact materials and articles for infant foods. These restrictions must be labeled in accordance with GB 4806.1.  
3. Polymer of ethylene glycol, 2,2-dimethyl1,3-propandiol, terephthalic acid, isophthalic acid, adipic acid and itaconic acid (CAS No. 1041633-9-1) is to be cleared for use in coatings and coating layers and adhesives (for direct food contact) at a maximum use level of 20% (on a dry weight basis). The SMLs are 30 mg/kg (as ethylene glycol); 0.05 mg/kg for 2,2-dimethyl1,3-propandiol; 7.5 mg/kg (as terepththalic acid); and 5 mg/kg (as isophthalic acid). Coatings and adhesives containing this substance may only be used for filling and long-term storage at room temperature (including hot filling and pasteurization under the conditions of T≤70°C, t ≤2h or T≤100°C, t≤15min). These restrictions must be labeled in accordance with GB 4806.1.  

Resins with Expanded Use

1. Isophthalic acid, polymer with 1,3-benzenedimethanamine and hexanedioic acid (CAS No. 28628-75-3) is to be cleared for use in plastics at dosage as necessary. The SMLs are 5 mg/kg (as isophthalic acid) and 0.05 mg/kg for 1,3-benzenedimethanamine. The thickness of plastic film containing this substance may not exceed 50μm and the use temperature may not exceed 121°C. These restrictions must be labeled in accordance with GB 4806.1.