China Approves New Food-Contact Materials

On May 11, 2022, the China National Health Commission (NHC) gave final approval to four new food-contact substances, expanded use for two food-contact substances, and nine new resins. The substances and specifications are listed below.

New Food-Contact Materials and Articles

1. Phosphoric acid, zirconium(4+) salt (2:1) (CAS No. 13772-29-7) for use in polyethylene (PE), polypropylene (PP), polystyrene (PS), polylactic acid (PLA), and coatings and coating layers at a maximum use level of 1%. PP plastic materials and articles containing this substance may only be used for microwave heating. The above restrictions must be labelled according to the provisions of GB 4806.1.
2. Acids, aliphatic, monocarboxylic (C10-C22), esters with polyglycerol for use in plastics at a maximum use level of 0.35%. Plastic materials and articles containing this substance may only be used for filling and long-term storage at room temperature (including hot filling and pasteurization at T≤70°C, t ≤2h or T≤100°C, t≤15min). The above restrictions must be labelled according to the provisions of GB 4806.1.
3. 2-Propenoic acid, 2-methyl-, 1,2-ethanediyl ester, polymer with methyl 2-methyl-2-propenoate (CAS No. 25777-71-3) for use in PE and PP at a maximum use level of 1% and specific migration limits (SMLs) of 6 mg/kg (as methacrylic acid) and 0.05 mg/kg (as 2-methyl-2-acrylic acid-1,2-ethylene glycol ester).  The use temperature for PE and PP plastic materials containing this substance may not exceed 121°C and this substance may not be used for production of food-contact materials and articles for infant use. The above restrictions must be labelled according to the provisions of GB 4806.1.
4. Hexanedioic acid, polymer with N-(2-aminoethyl)-1,3-propanediamine, aziridine, (chloromethyl)oxirane, 1,2-ethanediamine, N,N''-1,2-ethanediyl bis[1,3-propanediamine], formic acid and α-hydro-ω-hydroxypoly (oxy-1,2-ethanediyl) (CAS No. 114133-44-7) for use in paper and paperboard at a maximum use level of 0.12% (on dry weight basis) and SMLs of 12 mg/kg (as 1,2-ethanediamine), non-detectable (ND) (as 1-aziridine, where DL=0.01 mg/kg), ND (for epichlorohydrin, where DL=0.01mg/kg), ND (for oxirane, where DL=0.01mg/kg), 5 mg/kg for (as N-(2-aminoethyl)-1,3-propanediamine), and 5 mg/kg (as N,N''-1,2-ethanediyl bis(1,3-propanediamine)). The maximum permitted residual content (QM) is 1 mg/kg (for epichlorohydrin) and 1 mg/kg (for ethylene oxide). Paper and paperboard materials and articles containing this substance may only be used for room temperature filling and long-term storage at room temperature (including hot filling and pasteurization at T ≤ 70°C, t ≤ 2 hours, or T ≤ 100°C, t ≤15 min). The above use restrictions must be labeled according to the provision of GB 4806.1.

Food-Contact Materials with Expanded Use

1. C.I. Solvent Red 52; 3-methyl-6-[(4-methylphenyl)amino]-3H-dibenz[f,ij]isoquinoline-2,7-dione (CAS No. 81-39-0) for use in polycyclohexylenedimethylene terephthalate (PCT) at maximum use level of 0.03%. Food-contact materials containing this substance may be used for filling and long-term storage at room temperatures (including hot filling and pasteurization at t ≤ 2 hours, T ≤ 70°C, and t ≤ 100°C, T ≤ 15 min). They may not contact food containing more than 10% ethanol or fatty food and they must comply with the purity specifications for colorants in GB 9685 Appendix A. The above restrictions must be labelled according to the provisions of GB 4806.1.
2. C.I. pigment yellow 180 (CAS No. 77804-81-0) for use in PCT at maximum use level of 0.3%. Food-contact materials containing this substance may be used in contact with aqueous food, acidic food, and food containing no more than 10% ethanol at temperatures no higher than 100°C and in contact with fatty food for filling and long-term storage at room temperatures (including hot filling and pasteurization at t ≤ 2 hours, T ≤ 70°C, and t ≤ 15 min, T ≤ 100°C). They also must comply with the purity specifications for colorants in GB 9685 Appendix A. The above restrictions must be labelled according to the provisions of GB 4806.1.

New Resins

1. Polymer of ethyl acrylate, acrylic acid, and styrene for use in coatings and coating layers at a maximum use level of 2% (on coating formula basis) with an SML of 6 mg/kg (as acrylic acid). Coating and coating layers using this substance as raw materials may not be used to produce food-contact materials and articles for infant use. The above restrictions must be labelled according to the provisions of GB 4806.1.
2. 1,3-Benzenedicarboxylic acid, polymer with 2,2-dimethyl-1,3-propanediol, 1,2-ethanediol and hexanedioic acid (CAS No. 58481-50-8) for use in coatings and coating layers at a maximum use level of 10% (on coating formula basis) with SMLs of 5 mg/kg (as 1,3-benzenedicarboxylic acid), 0.05 mg/kg (as 2,2-dimethyl-1,3-propanediol), and 30 mg/kg (as ethanediol). Coating and coating layers using this substance as raw materials may not be used to produce food-contact materials and articles for infant use. The above restrictions must be labelled according to the provisions of GB 4806.1.
3. 1-isocyanato-3-isocyanatomethyl- 3,5,5-trimethylcyclohexane homopolymer, methyl ethyl ketone oxime-blocked (CAS No. 103170-26-9) for use in coatings and coating layers at a maximum use level of 15% (on coating formula basis) with an SML of 0.05 mg/kg (as methyl ethyl ketoxime-terminated-1-isocyanato-3-isocyanatomethyl-3,5,5-trimethylcyclohexane trimer). Coating and coating layers using this substance as raw materials may not be used to produce food-contact materials and articles for infant use. The above restrictions must be labelled according to the provisions of GB 4806.1.
4. 1,4-Benzenedicarboxylic acid, 1,4-dimethyl ester, polymer with decanedioic acid, 2,2-dimethyl-1,3-propanediol, and1,2-ethanediol (CAS No. 51382-28-6) for use in coatings and coating layers at a maximum use level of 40% (on dry coating film basis) and SMLs of 7.5 mg/kg (as 1,4-benzenedicarboxylic acid), 0.05 mg/kg (as 2,2-dimethyl-1,3-propanediol), and 30 mg/kg (as ethanediol). The use temperature of coating and coating layers using this substance as raw materials may not exceed 121°C. The above restrictions must be labelled according to the provisions of GB 4806.1.
5. Polymer of 1,4-butanediol dimethacrylate, 2-hydroxyethyl methacrylate, ethyl acrylate, acrylic acid, and styrene for use in coatings and coating layers at a maximum use level of 92% (on coating formula basis) and SMLs of 0.05 mg/kg (as 1,4-butanediol dimethacrylate), 6 mg/kg (as methacrylic acid), and 6 mg/kg (as acrylic acid). Coating and coating layers using this substance as raw materials may not be used to produce food-contact materials and articles for infant use. The above restrictions must be labelled according to the provisions of GB 4806.1.
6. 1,3-Benzenedicarboxylic acid, polymer with azacyclotridecan-2-one, 1,4-benzenedicarboxylic acid, dodecanedioic acid and 4,4'-methylene bis[2-methylcyclohexanamine] (CAS No. 2080394-29-0) for use in polyamide/nylon (PA) at the level necessary with SMLs of 5 mg/kg (as 1,3-benzenedicarboxylic acid), 7.5 mg/kg (as 1,4-benzenedicarboxylic acid, 5 mg/kg (as azacyclotridecan-2-one), and 0.05 mg/kg (as 4,4'-methylenebis[2-methylcyclohexanamine]). Plastic materials and articles made from this substance may not be used in contact with food containing more than 8% ethanol. The above restrictions must be labelled according to the provisions of GB 4806.1. 
7. 1,3-Benzenedicarboxylic acid, polymer with 1,3-benzenedimethanamine and hexanedioic acid (CAS No. 28628-75-3) for use in PA at the necessary level and SMLs of 5 mg/kg (as 1,3-benzenedicarboxylic) and 0.05% (as 1,3-benzenedimethanamine). The thickness of plastic film produced with this substance may not exceed 50 µm and the use temperature may not exceed 100°C. The above restrictions must be labelled according to the provisions of GB 4806.1.
8. Propanoic acid, 3-hydroxy-2-(hydroxymethyl)-2-methyl-, polymer with 1,3-diisocyanatomethylbenzene and α-hydro-ω-hydroxypoly[oxy(methyl-1,2-ethanediyl)] (CAS No. 37273-57-7) for use in adhesives (for indirect food-contact use) at the level necessary with SMLs of 0.05 mg/kg (as 3-hydroxy-2-(hydroxymethyl)-2-methyl-propanoic acid) and ND (as isocyanate moiety, where DL=0.01mg/kg) and QM of 1 mg/kg (for isocyanate moiety). Adhesives using this substance as raw materials may only be used for filling and long-term storage at room temperature (including hot filling and pasteurization at T≤70°C, t ≤2h or T≤100°C, t≤15min). The above restrictions must be labelled according to the provisions of GB 4806.1.
9. 2-Propenoic acid, polymer with butyl 2-propenoate, ethenyl acetate and 2-ethylhexyl-2-propenoate (CAS No. 35239-19-1) for use in adhesives (for indirect food-contact use) at a maximum use level of 63% and SMLs of 6 mg/kg (as acrylic acid), 12 mg/kg (as vinyl acetate), and 0.05% (as 2-ethylhexyl-2-propenoate). Adhesives using this substance as raw materials may only be used for filling and long-term storage at room temperature (including hot filling and pasteurization at T≤70°C, t ≤2h or T≤100°C, t≤15min). The above restrictions must be labelled according to the provisions of GB 4806.1.