China Approves New Food-Contact Materials

On July 26, 2021, the China National Health Commission (NHC) approved 3 new food-contact materials, 9 food-contact materials with expanded usage, and 7 new resins. The substances and specifications are listed below.

New Food-Contact Materials and Articles

1. Silicic acid, sodium salt, reaction product with chlorotrimethylsilane and isopropyl alcohol (CAS No. 68988-56-7) for use in paper and paperboard at a maximum use level of 0.00585% (as dry weight). The paper and paperboard materials containing this substance may not contact infant food or breast milk.
2. Dodecylguanidine hydrochloride (CAS No. 13590-97-1) for use in paper and paperboard at a maximum use level of 0.02% (as dry weight).
3. Poly(1,4-butylene adipate) (CAS No. 25103-87-1) for use in plastics at a maximum use level of 0.09% and a specific migration limit (SML) of 5 mg/kg (1,4-butanediol). The plastic materials containing this substance may not contact infant food or breast milk.

Food-Contact materials and Articles with Expanded Usage

1. Talc (CAS No. 14807-96-6) for use in polylactic acid (PLA) plastics at a maximum use level of 30%. The talc may not contain asbestos and the PLA plastics containing talc may not contact infant food or breast milk.
2. Phosphorous trichloride, reaction products with 1,1’-biphenyl and 2,4-bis(1,1-dimethylethyl)phenol (CAS No. 119345-01-6) for use in  polyphenylsulfone (PPSU) and polyethersulfone (PESU) polymers at a maximum use level of 0.15% for PPSU and 0.115% for PESU and with an SML of 18 mg/kg.
3. C.I. solvent red 135; C.I. oil solvent red 135; 8,9,10,11-Tetrachloro-12-phthaloperinone (CAS No. 20749-68-2) for use in polycyclohexylenedimethylene terephthalate (PCT) plastics at a maximum use level of 0.03%. PCT containing this substance may not be used to contact food and fatty food with an ethanol content of more than 10% and may only be used for room temperature filling and long-term storage at room temperature (including hot filling and pasteurization under the conditions of T≤70 °C, t≤2 h or T≤100 °C, t≤15 min). In addition, the substance should meet the purity requirements for colorants in GB 9685-2016.
4. C.I. pigment violet 15; Sodium aluminosilicate violet (CAS No. 12769-96-9) for use in polystyrene (PS) plastic at a maximum use level of 3%. This substance should meet the purity requirements for colorants in GB 9685-2016 Appendix A.
5. Zinc phosphate (CAS No. 7779-90-0) for use in coatings and coating layers at a maximum use level of 12% (based on the dry weight of film) and with an SML of 25 mg/kg (as zinc).
6. Ethanol, 2-amino- (CAS No. 141-43-5) for use in paper and paperboard at a maximum use level of 0.041% (as dry weight) in paper and paperboard and 0.01% (as dry weight) in paper coatings with an SML of 0.05 mg/kg. Paper and paperboard materials and articles containing this substance may only contact fatty foods when filling at room temperature and long-term storage at room temperature (including T≤70 °C, t≤2 h or T≤100 °C, t≤15 min under hot-filling and pasteurization conditions). In addition, these substances may not contact infant food or breast milk.
7. 2,4-Bis(2,4-dimethylphenyl)-6-(2-hydroxy-4-n-octyloxyphenyl)-1,3,5-triazine (CAS No. 2725-22-6) for use in polypropylene (PP) and polyethylene (PE) plastics at a maximum use level of 0.03% (except when in contact with aquatic food) and with an SML of 5 mg/kg. PP and PE plastics containing this substance may not contact infant food or breast milk.
8. 2-Methyl-2-propenoic acid 2-ethyl-2-[[(2-methyl-1-oxo-2-propenyl) oxy] methyl]-1,3-propanediyl ester (CAS No. 3290-92-4) for use in rubber at a maximum use level of 1.2% and with an SML of 0.05 mg/kg. The use temperature for rubber materials and articles containing this substance may not exceed 150 °C.
9. 2-Propenoic acid, polymer with 2-ethylhexyl 2-propenoate (CAS No. 25134-51-4) for use in Acrylonitrile Butadiene Styrene (ABS) plastic at a maximum use level of 0.036% and with an SML of 6 mg/kg (as acrylic acid) and 0.05 mg/kg (2-ethylhexyl-2-acrylate).

New Resins

1. 2-Butenedioic acid (E)-, polymer with 1,3-isobenzofurandione and tricyclodecanedimethanol (CAS No. 68784-89-4) for use in coatings and coating layers at a maximum use level of 15% (based on the dry weight of film) and with an SML of 0.05 mg/kg (tricyclodercane dimethanol). The use temperature of coatings and coating layers containing this substance may not exceed 121°C.
2. 1,4-Benzenedicarboxylic acid, polymer with 1,3-benzenedicarboxylic acid, 2,2,4,4-tetramethyl-1,3-cyclobutanediol, 1,4-cyclohexanedimethanol, and 1,6-hexanediol for use in coatings and coating layers at a maximum use level of 80% (based on the dry weight of film) and with an SML of 7.5 mg/kg (as 1,4-phthalic acid), 5 mg/kg (as 1,3-phthalic acid), 5 mg/kg (as 2,2,4,4-Tetramethyl-1,3-cyclobutanediol), and 0.05 mg/kg (as 1,6-hexanediol).
3. 2-Propenoic acid, 2-methyl-, polymer with N-(butoxymethyl)-2-propenamide, ethenylbenzene and ethyl 2-propenoate (CAS No. 26589-46-8) for use in coatings and coating layers at dosage as necessary and with SMLs of 6 mg/kg (as methacrylate); 6 mg/kg (as acrylic acid); and non-detect (N-(butoxymethyl)-2-acrylamide), where the detection limit is 0.01 mg/kg.
4. 2,6-Naphthalenedicarboxylic acid, 2,6-dimethyl ester, polymer with 1,4-cyclohexanedimethanol, 1,2-ethanediol, 2,2’-oxybis[ethanol] and β3,β3,β9,β9-tetramethyl-2,4,8,10-tetraoxaspiro[5.5]undecane-3,9-diethanol (CAS No. 2146168-28-5) for use at dosage as necessary in plastics and SMLs of 0.05 mg/kg (2,6-Dimethyl 2,6-naphthalenedicarboxylate), 30 mg/kg (as ethylene glycol), and 5 mg/kg (β3,β3,β9,β9-tetramethyl-2,4,8,10-tetraoxaspiro[5.5]undecane-3,9-diethanol). Plastics materials and articles containing this substance may only be used in contact with liquid milk under the conditions of 70 °C≤T≤100 °C, t≤1 h and T＜70 °C, t≤2 h.
5. Poly[imino-1,4-butanediylimino(1,10-dioxo-1,10-decanediyl)] (CAS No. 26247-06-3) for use in plastics at dosage as necessary. The thickness of the plastic film containing this substance as raw materials may not exceed 50 μm and it may not contact infant food or breast milk.
6. 2-Propenoic acid, polymer with butyl 2-propenoate, ethenyl acetate, 2-ethylhexyl 2-propenoate and ethyl 2-propenoate (CAS No. 68698-72-6) for use in adhesives at a maximum use level of 20 g/m2 (as dry weight) and with SMLs of 6 mg/kg (as acrylic acid), 12 mg/kg (vinyl acetate), and 0.05 mg/kg (2-ethylhexyl acrylate). The use conditions for adhesives containing this substance are filling at room temperature and long-term storage at room temperature (including T≤70 °C, t≤2 h or T≤100 °C, t≤15 min. under hot-filling and pasteurization conditions).
7. 2,5-Furandione, polymer with ethene, ester with ethenol homopolymer; Maleic anhydride, polymer with ethene, ester with ethenol homopolymer (CAS No. 76930-37-5) for use in coatings and coating layers at dosage as necessary and with SMLs of 12 mg/kg (vinyl acetate) and 30 mg/kg (as maleic acid). Coatings and coating layers using this substance as raw materials may only be used for nylon 6 and used under or at room temperature (including high temperature heat sterilization under the conditions of T≤121 °C and t≤0.5 h). In addition, the coatings and coating layers may not contact infant food or breast milk.