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

02 New food-related products

SN	Date	File Number	Product Name
1	2025-11-07	衛食相進申字(2025)第0022號	C.I. Pigment Black 7
2	2025-11-07	衛食相進申字(2025)第0023號	Manganese(II) salt of C16-18 fatty acids
3	2025-11-07	衛食相申字(2025)第0008號	Phenyl bis(2,4,6-trimethylbenzoyl)phosphine oxide
4	2025-11-07	衛食相進申字(2024)第0014號	Adipic acid
5	2025-11-07	衛食相進申字(2025)第0021號	Boric acid
6	2025-11-07	衛食相進申字(2025)第0012號	Polymer of triphenyl phosphite with 1,4-cyclohexanedimethanol and polypropylene glycol, C10-16 alkyl ester
7	2025-11-07	衛食相申字(2025)第0007號	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	衛食添新申字(2025)第0069號	Monopotassium phosphate
2	2025-11-12	衛食添新申字(2025)第0070號	Monopotassium phosphate
3	2025-11-12	衛食添新申字(2025)第0050號	Lactose-N-neotetraose
4	2025-11-12	衛食添新申字(2025)第0038號	Lactase (β-galactosidase)
5	2025-11-12	衛食添新申字(2024)第0087號	Deaminase
6	2025-11-12	衛食添新申字(2025)第0089號	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	衛食相進申字(2025)第0025號	Copolymer of 2-ethylhexyl acrylate and vinyl acetate
2	2025-11-07	衛食相申字(2025)第0006號	Iron titanium oxide
3	2025-11-07	衛食相進申字(2025)第0024號	Terpene resin composed of α-pinene, β-pinene, and/or dipentene polymers

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Further Information

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