Multiple HMO Substances Face Approval Delay or Recommended Non-Approval in China

Recently, China's National Health Commission (NHC) issued notifications regarding the approval and review of “Three new foods” (new food raw materials, new food additives, and new food-related products). The notifications included:

19 notifications of extension notices;
9 notifications of review opinions.

Details are as follows:

Extension notice (requires supplementary materials following the technical review by China National Center for Food Safety Risk Assessment (CFSA))

01 New food additives

SN	Date	File Number	Product Name
1	2025-11-12	卫食添新申字(2025)第0077号	Sodium 6’-Sialyllactose
2	2025-11-12	卫食添新申字(2023)第0033号	Sodium 6’-Sialyllactose
3	2025-11-12	卫食添新申字(2024)第0034号	Sodium 6’-Sialyllactose
4	2025-11-12	卫食添新申字(2025)第0091号	Sodium 6’-Sialyllactose
5	2025-11-12	卫食添新申字(2025)第0027号	Advantame
6	2025-11-12	卫食添新申字(2025)第0087号	Brazzein
7	2025-11-12	卫食添新申字(2025)第0086号	Anethole
8	2025-11-12	卫食添新申字(2025)第0075号	Steviol glycosides (enzymatic conversion method)
9	2025-11-12	卫食添新申字(2025)第0092号	Steviol glycosides (enzymatic conversion method)
10	2025-11-12	卫食添新申字(2025)第0088号	Vanillin
11	2025-11-12	卫食添新申字(2024)第0007号	Lipase
12	2025-11-12	卫食添新申字(2025)第0090号	Naringin

02 New food-related products

SN	Date	File Number	Product Name
1	2025-11-07	卫食相进申字(2025)第0022号	C.I. Pigment Black 7
2	2025-11-07	卫食相进申字(2025)第0023号	Manganese(II) salt of C16-18 fatty acids
3	2025-11-07	卫食相申字(2025)第0008号	Phenyl bis(2,4,6-trimethylbenzoyl)phosphine oxide
4	2025-11-07	卫食相进申字(2024)第0014号	Adipic acid
5	2025-11-07	卫食相进申字(2025)第0021号	Boric acid
6	2025-11-07	卫食相进申字(2025)第0012号	Polymer of triphenyl phosphite with 1,4-cyclohexanedimethanol and polypropylene glycol, C10-16 alkyl ester
7	2025-11-07	卫食相申字(2025)第0007号	Zinc oxide

Review opinions (CFSA recommends not granting approval after the technical review)

01 New food additives

SN	Date	File Number	Product Name
1	2025-11-12	卫食添新申字(2025)第0069号	Monopotassium phosphate
2	2025-11-12	卫食添新申字(2025)第0070号	Monopotassium phosphate
3	2025-11-12	卫食添新申字(2025)第0050号	Lactose-N-neotetraose
4	2025-11-12	卫食添新申字(2025)第0038号	Lactase (β-galactosidase)
5	2025-11-12	卫食添新申字(2024)第0087号	Deaminase
6	2025-11-12	卫食添新申字(2025)第0089号	Vitamin E (dl-α-tocopherol, d-α-tocopherol, mixed tocopherol concentrate)

02 New food-related products

SN	Date	File Number	Product Name
1	2025-11-07	卫食相进申字(2025)第0025号	Copolymer of 2-ethylhexyl acrylate and vinyl acetate
2	2025-11-07	卫食相申字(2025)第0006号	Iron titanium oxide
3	2025-11-07	卫食相进申字(2025)第0024号	Terpene resin composed of α-pinene, β-pinene, and/or dipentene polymers

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Further Information

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