China Approves News and Expanded Usage for Food-Contact Materials

On October 10, 2024, National Health Commission of the People’s Republic of China (NHC) approved four additives with expanded usage, one new resin, and one resin with expanded usage. The substances and specification are listed below. 

Additives with Expanded Usage

1. C.I. Pigment black 7: Carbon black (CAS No. 1333-86-4) is to be cleared for use in PTC plastics at a maximum use level of 2.5%. The toluene extract in this substance is less than 1%, and the benzo[a]pyrene content is less than 0.25 mg/kg; The substance should meet the requirements of GB 9685-2016 for the purity of colorants. PCT plastic materials and articles containing this substance may not be used in contact with foods containing more than 50% ethanol, and the use temperature may not exceed 100°C. The above restriction of use requirements must be marked in accordance with the provisions of GB 4806.1.
2. Sodium hydroxide (CAS No. 1310-73-2) is to be cleared for use in polyvinylidene fluoride (PVDF) plastic at the necessary dosage. This substance may only used as a processing aid in the production of PVDF plastic materials and products and the amount of fluorine migration in the PVDF plastic materials and articles may not exceed 0.2 mg/kg. PVDF plastic materials and articles containing this substance may only be used under the conditions of T≤70°C and t≤24 h and may not be used in contact with food containing more than 50% ethanol and food containing fat. The above restriction of use requirements must be marked in accordance with the provisions of GB 4806.1.
3. Dibutyl sebacate (CAS No. 109-43-3) is to be cleared for use in PVDF plastic at the necessary dosage and with a specific migration level (SML) of 60 mg/kg (as the sum of No. 32 substances in Appendix B of GB 9685-2016). PVDF plastic materials and articles containing this substance may only be used under the conditions of T≤70°C and t≤24 and may not be used in contact with food containing more than 50% ethanol and food containing fat. The above restriction of use requirements must be marked in accordance with the provisions of GB 4806.1.
4. 2,4,8,10-Tetraoxa-3,9-diphosphaspiro [5.5]undecane,3,9-bis[2,4- bis(1-methyl-1-phenylethyl)phenoxy]- (CAS No. 154862-43-8) is to be cleared for use in adhesives that have direct contact with food at a maximum use level of 0.04% and a specific migration level (SML) of 5 mg/kg. Adhesives containing this substance may not be used in contact with fatty foods. The above restriction of use requirements must be marked in accordance with the provisions of GB 4806.1.

New Resins

1. Copolymer of trimethoxyphenylsilane, methyltrimethoxysilane, and silica is to be cleared for use in coatings and coating layers at the necessary dosage and with a residual content (QM) of 1 mg/kg (methyltrimethoxysilane). Coatings containing substances may only be applied to metal surfaces. The above restriction of requirements must be marked in accordance with the provisions of GB 4801.6.

Resin with Expanded Usage

1. Benzene, ethenyl-, polymer with 1,3-butadiene, hydrogenated (CAS No. 66070-58-4) is to be cleared for use in coatings and coating layers at a maximum use level of 27.5% (based on dry weight of the coating film). The SML is non-detected for 1,3-butadiene (DL=0.01mg/kg) and a QM of 1 mg/kg for 1,3-butadiene. Coatings and coating layers containing this substance are for one-time use only, may only be used for room temperature filling (including hot filling, pasteurization or other hot filling), and only stored at room temperature for a long time (t>3d). The above restriction of use requirements must be marked in accordance with the provisions of GB 4806.1.