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China NHC Approves 8 New Varieties of Food Related Products

Some new food related products approved this time are subject to application scope restrictions in food contact materials and articles for infant and young children food. The application scope of “Terephthalic acid, polymer with 1,4:3,6-dianhydro-D-glucitol, 4-cyclohexanedimethanol and 1,2-ethanediol” has been extended to FCM contacting infant and young children food.

On Dec. 12, 2018, China NHC announced the approval of 8 new food related products, including 5 new varieties of FCM additives, 2 novel resins, and 1 resin with expanded application scope.

5 new FCM additives

S/N.NameCASScopeMaximum usage/%SML/(mg/kg)Notes
1Rosin, polymer with formaldehyde and phenol67700-45-2Paints and coating515 (calculated as formaldehyde)Maximum usage temperature for paints and coating containing this ingredient is 121℃
2Copolymer of 2-(dimethylamino) ethyl methacrylate with 3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl methacrylate, N-oxide, acetate1440528-04-0Paper and paperboard4 mg/dm2/Fluorine content: ≤ 45%
Maximum usage temperature for paper and paperboard containing this ingredient: 100℃;
No contact with baby food and breast milk
3C.I. Pigment orange 79; Benzoic acid, 4-[(2-hydroxy-6-sulfo-1-naphthalenyl)azo]-, strontium salt (2:1)250640-08-5Plastic1/Conform to colorant purity requirements in GB 9685-2016;
Maximum usage temperature for plastic containing this substance: 121℃
4Formaldehyde, polymer with 2-methylphenol, Bu ether118685-25-9Paints and coating115  (calculated as formaldehyde)Maximum usage temperature for paints and coating containing this ingredient: 121℃
51,3-Benzenedicarboxamide,N,N'-bis(2,2,6,6-tetramethyl-4-piperdinyl)42774-15-2Plastics: PET, EVOH, PAPET: 0.5
EVOH, PA: 0.2
5EVOH containing this ingredient: it can only be used as interlayer that does not directly contact with food and the maximum thickness is 12μm.
PA containing this ingredient: the maximum thickness is 50μm
All FCM products containing this ingredient cannot contact with baby food and breast milk.

2 new resins for food contact use

S/N.NameCASScopeMaximum usage/%SML/(mg/kg)Notes
12-Propenoic acid, 2-methyl-, polymer with 1,4-benzenediol, 2-(chloromethyl)oxirane, ethenylbenzene, ethyl 2-propenoate and 4,4enoate and 4,4,4and 4,44hylphenol], reaction products with 2-(dimethylamino)ethanol/Paints and coating405 (calculated as 1,3-benzenedicarboxylic acid);
7.5 (calculated as 1,4-benzenedicarboxylic acid);
5 (calculated as 1,4-butanediol)
30 (calculated as ethylene glycol)
The maximum usage temperature of paints and coating produced from this ingredient is 121℃, and it can only contact with food whose alcoholic content is less than 20%.
22-Propenoic acid, 2-methyl-, polymer with 1,4-benzenediol, 2-(chloromethyl)oxirane, ethenylbenzene, ethyl 2-propenoate and 4,4enoate and 4,4,4and 4,44hylphenol], reaction products with 2-(dimethylamino)ethanol/Paints and coating750.6 (hydroquinone)
18 (2-(dimethylamino)ethanol)
6 (acrylic acid)
0.2 (calculated as the amount of 4, 4-methylene bis (2, 6-dimethylphenol), TMBPF-DGE, TMBPF-DGE∙H20 and TMBPF-DGE∙2H20)
0.05 (calculated as the amount of TMBPF-DGE∙HCl, TMBPF-DGE∙2HCl and TMBPF-DGE∙HCl∙H20)
Paints and coating produced from this ingredient cannot contact fatty food, baby food and breast milk.

The resin with enlarged application scope

The application scope of “Terephthalic acid, polymer with 1,4:3,6-dianhydro-D-glucitol, 4-cyclohexanedimethanol and 1,2-ethanediol” has been expanded to food contact materials and articles used for infant and young children food (previously it is prohibited). The detailed information of this substance is listed below.

S/N.NameCASScopeGeneric category nameSML/(mg/kg)Notes
1Terephthalic acid, polymer with 1,4:3,6-dianhydro-D-glucitol, 4-cyclohexanedimethanol and 1,2-ethanediol1038843-64-9PlasticsPET30 (calculated as 1,2-ethanediol);
7.5 (calculated as 1,4-phthalicacid)
5 (1,4:3,6-dianhydro-D-glucitol)
Maximum usage temperature of plastics produced from this substance: 100℃.


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