Weekly Summary – Updates on the Approval and Review of “Three New Foods” - Regulatory News - Food & Food Contact Materials

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).

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The notifications included:

16 notifications of approval of review findings
40 notifications of extension notice;
12 notifications of review opinions.

Details are as follows:

Notifications of approval of review findings (“Notice of Approval” issued after NHC's formal announcement)

New food raw materials

SN	Received time	Acceptance No.	Product name
1	2025-12-11	衛食新進申字(2021)第0005號	Elderberry anthocyanins
2	2025-12-11	衛食新申字(2025)第0022號	Venetian Fusarium protein
3	2025-12-11	衛食新申字(2025)第0010號	Venetian Fusarium protein
4	2025-12-11	衛食新進申字(2021)第0010號	Olive fruit polyphenols

New food additives

SN	Received time	Acceptance No.	Product name
1	2025-12-01	衛食添新申字(2024)第0088號	2’-FL
2	2025-12-01	衛食添新申字(2025)第0024號	6S-5-Methyltetrahydrofolate calcium
3	2025-12-01	衛食添新申字(2025)第0028號	(6S)-5-Methyltetrahydrofolate, glucosamine salt
4	2025-12-01	衛食添新申字(2024)第0017號	β-Alanine
5	2025-12-01	衛食添新申字(2024)第0028號	β-Alanine
6	2025-12-01	衛食添新申字(2024)第0065號	Branching enzyme
7	2025-12-01	衛食添新申字(2024)第0023號	Rebaudioside M (enzymatic conversion method)
8	2025-12-01	衛食添新申字(2023)第0073號	Calcium carbonate (algae-derived)
9	2025-12-01	衛食添新申字(2024)第0031號	Steviol glycosides

New food-related products

SN	Received time	Acceptance No.	Product name
1	2025-12-01	衛食相進申字(2024)第0019號	2,2-Bis[[3-[3,5-bis(1,1-dimethylethyl)-4-hydroxyphenyl]-1-oxopropoxy]methyl]-1,3-propanediyl 3,5-bis(1,1-dimethylethyl)-4-hydroxyphenylpropionate; Pentaerythritol tetrakis[3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate]
2	2025-12-01	衛食相申字(2024)第0020號	C.I. Pigment White 21; barium sulfate
3	2025-12-01	衛食相申字(2024)第0014號	Talc

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

New food raw materials

SN	Received time	Acceptance No.	Product name
1	2025-12-02	衛食新申字(2025)第0028號	L-Ergothioneine
2	2025-12-02	衛食新申字(2025)第0032號	L-Ergothioneine
3	2025-12-02	衛食新申字(2025)第0033號	L-Ergothioneine
4	2025-12-02	衛食新申字(2025)第0035號	γ-Polyglutamic acid
5	2025-12-02	衛食新進申字(2024)第0006號	Bifidobacterium animalis subsp. lactis CBS-118529
6	2025-12-02	衛食新申字(2022)第0014號	Bifidobacterium animalis subsp. lactis CP-9
7	2025-12-02	衛食新申字(2025)第0037號	Ergothioneine
8	2025-12-02	衛食新申字(2025)第0038號	Ergothioneine
9	2025-12-02	衛食新申字(2025)第0040號	Ginseng cell culture
10	2025-12-02	衛食新進申字(2025)第0009號	Bilberry extract
11	2025-12-11	衛食新申字(2021)第0010號	D-Allulose
12	2025-12-11	衛食新申字(2025)第0036號	Pueraria lobata polysaccharides
13	2025-12-11	衛食新申字(2025)第0042號	Firethorn fruit (dried)
14	2025-12-11	衛食新進申字(2025)第0010號	Pichia kluyveri
15	2025-12-11	衛食新申字(2025)第0015號	Green coffee bean extract
16	2025-12-11	衛食新進申字(2025)第0003號	Glucosyl hesperidin
17	2025-12-11	衛食新進申字(2025)第0008號	Milk osteopontin
18	2025-12-11	衛食新申字(2024)第0016號	Nervonic acid oil
19	2025-12-11	衛食新申字(2023)第0017號	Garlic pear seed oil

New food additives

SN	Received time	Acceptance No.	Product name
1	2025-12-08	衛食添新申字(2025)第0095號	1-(tert-Butyl)-N-(4-methoxyphenyl)cyclohexane-1-carboxamide
2	2025-12-08	衛食添新申字(2025)第0019號	2′-FL
3	2025-12-08	衛食添新申字(2023)第0074號	3-FL
4	2025-12-08	衛食添新申字(2024)第0046號	3-FL
5	2025-12-08	衛食添新申字(2024)第0089號	3-FL
6	2025-12-08	衛食添新申字(2025)第0011號	Inositol
7	2025-12-08	衛食添新申字(2025)第0013號	Casein phosphopeptides
8	2025-12-08	衛食添新申字(2025)第0096號	Ammonium sulfate
9	2025-12-08	衛食添新申字(2024)第0003號	LNT
10	2025-12-08	衛食添新申字(2024)第0029號	LNT
11	2025-12-08	衛食添新申字(2024)第0064號	LNT
12	2025-12-08	衛食添新申字(2025)第0098號	Thaumatin (fermentation-derived)
13	2025-12-11	衛食添新申字(2024)第0062號	2-Methyl-1-(2-(5-(p-tolyl)-1H-imidazol-2-yl)piperidin-1-yl)butan-1-one
14	2025-12-12	衛食添新申字(2024)第0083號	6′-SL
15	2025-12-12	衛食添新申字(2025)第0099號	Neohesperidin dihydrochalcone

New food-related products

SN	Received time	Acceptance No.	Product name
1	2025-12-18	衛食相進申字(2025)第0027號	Polymer of isophthalic acid and terephthalic acid with 1,4-butanediol, 1,4-cyclohexanedimethanol, trimellitic anhydride, and ethylene glycol
2	2025-12-18	衛食相進申字(2025)第0019號	1,4-Bis[(2,6-diethyl-4-methylphenyl)amino]-9,10-anthraquinone; C.I. Solvent Blue 97
3	2025-12-18	衛食相進申字(2025)第0018號	1,8-Bis(p-toluidino)-9,10-anthraquinone; C.I. Solvent Violet 36
4	2025-12-18	衛食相申字(2025)第0004號	Polymer of methacrylic acid with n-butyl acrylate, cyclohexyl methacrylate, methyl methacrylate, 2-(methacryloyloxy)ethyl methacrylate, propylene glycol mono(methacrylate), and allyl methacrylate
5	2025-12-18	衛食相進申字(2025)第0029號	Reaction products of N,N′-distearyl ethylenediamine and azacyclotridecan-2-one homopolymer with octadecyl isocyanate
6	2025-12-18	衛食相進申字(2025)第0031號	Polymer of isophthalic acid and terephthalic acid with dimerized non-hydrogenated unsaturated fatty acids (C18), 2-methyl-1,3-propanediol, diethylene glycol, and trimethylolpropane

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

New food additives

SN	Received time	Acceptance No.	Product name
1	2025-12-08	衛食添新申字(2025)第0094號	2-Oxoglutaric acid
2	2025-12-08	衛食添新申字(2025)第0012號	Steviol glycosides (enzymatic conversion method)
3	2025-12-12	衛食添新申字(2025)第0100號	3-FL
4	2025-12-12	衛食添新申字(2025)第0091號	6′-SL
5	2025-12-12	衛食添新申字(2025)第0097號	(6S)-5-Methyltetrahydrofolate, monosodium salt
6	2025-12-12	衛食添新申字(2025)第0101號	Mannanase

New food-related products

SN	Received time	Acceptance No.	Product name
1	2025-12-18	衛食相申字(2025)第0005號	4,4′-Methylenebis(cyclohexylamine)
2	2025-12-18	衛食相進申字(2025)第0026號	Dimethyl diphenyl methyl hydrogen siloxane and polysiloxane
3	2025-12-18	衛食相進申字(2025)第0033號	Acetate of a polymer of 2-(dimethylamino)ethyl methacrylate with 2-(C16–18 acylamino)ethyl acrylate and 4-hydroxybutyl acrylate
4	2025-12-18	衛食相進申字(2025)第0032號	Hydrogenated polymer of styrene and 1,3-butadiene
5	2025-12-18	衛食相進申字(2025)第0028號	Hydrogenated aromatic petroleum hydrocarbon resin
6	2025-12-18	衛食相進申字(2025)第0030號	Reaction products of tall oil fatty acids, dimer acids, m-xylylenediamine, bisphenol A, and epichlorohydrin

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