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China Approves New and Expanded Usage for Food-Contact Materials

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On October 7, 2023, China’s National Health Commission (NHC) approved expanded usage for three food-contact materials and two new resins. The substances and specifications are listed below.

Expanded Usage Food-Contact Materials

  1. C.I. pigment black 7; Carbon black (CAS No. 1333-86-4) is to be cleared for use in polyetheretherketone (PEEK) at a maximum use level of 0.5%. The toluene extract of this substance is less than 1%, and the benzo[a]pyrene content is less than 0.25 mg/kg. It should comply with the purity requirements for colorants in Appendix A of GB 9685-2016; and the above restricted use requirements must be labeled in accordance with the provisions of GB 4806.1.
  2. Copolymer of acrylamide, 2-methacryloxyethyltrimethyl ammonium chloride, itaconic acid, and N,N’ -methylenebis acrylamide (CAS No. 214495-32-6) is to be cleared for use in paper and paperboard at a maximum use level of 1.5% (on dry weight basis). The specific migration level (SML) is non-detectable (ND) for acrylamide, where the detection limit (DL) is 0.01 mg/kg. Paper and paperboard materials and articles containing this substance may not be used for irradiation, and the use temperature may not exceed 121°C. The above restricted use requirements must be labeled in accordance with the provisions of GB 4806.1.
  3. 2-acetoxy-1,2,3-propanetricarboxylicacid[1]tributylester (CAS No. 77-90-7) is to be cleared for use in printing ink in indirect contact with food at a maximum use level of 10%. The SML is 60 mg/kg (calculated based on the sum of SMT (T) Group 32 substances). Inks containing this substance may not be used to produce food-contact materials and products specifically for infants and young children. The food-contact materials and products produced are limited to room temperature filling and long-term storage at room temperature (including T ≤ 70℃, t ≤ 2 h or hot filling and pasteurization under the conditions of T ≤ 100℃, t ≤ 15 min). The above restricted use requirements must be labeled in accordance with the provisions of GB 4806.1.


New Resins

  1. Polymer from 1,4-terephthalic acid, sebacic acid and 1,2-ethylene glycol (CAS No. 25067-21-4) is to be cleared for use in coatings and coating layers at the necessary use level. The SMLs are 7.5 mg/kg (as 1,4-terephthalic acid) and 30 mg/kg (as 1,2-ethylene glycol). This substance may only be used for surface coating of PET films. The food-contact materials and products produced are limited to room temperature filling and long-term storage at room temperature and below (including T≤70℃, t≤2h or T≤100℃, hot filling and pasteurization under the condition of t≤15 min), and microwave heating. The above restricted use requirements must be labeled in accordance with the provisions of GB4806.1.
  2. 2-Propenoic acid, 2-methyl-,polymer with butyl 2-methyl-2-propenoate, ethyl 2-propenoate and methyl 2-methyl-2-propenoate, salts with 1,4-benzenediol-epichlorohydrin-4,4'- methylenebis[2,6-dimethylphenol]poly mer-2-(dimethyulamino)ethanol reaction products is to be cleared for use in coatings and coating layers at a maximum use level of 20% (as painting formula). The SMLs are 6 mg/kg (as 2-Propenoic acid); 0.6 mg/kg (Quinol); 18 mg/kg (N,N-dimethylethanolamine); 0.2 mg/kg [calculated based on the sum of the polymer of 4,4-methylenebis(2,6-dimethylphenol), 4,4-methylenebis(2,6-dimethyl91phenol), and epichlorohydrin (TMBPF- DGE), TMBPF-DGE∙H2O, and TMBPF-DGE∙2H2O]; and 0.05 mg/kg (calculated based on the sum of TMBPF-DGE∙HCl, TMBPF-DGE∙2HCl, and TMBPF-DGE∙HCl∙H2O). Food-contact paints and coatings containing this substance may not contact oily foods or be used to produce food-contact materials and products for infants and young children. The above restricted use requirements must be labeled in accordance with the provisions of GB 4806.1.