Approval Status of New Food-Related Products (including Food Contact Additives and Resins) in the First Half of 2023 - Regulatory News - Food & Food Contact Materials

As of the end of June 2023, the National Health Commission of the People’s Republic of China (NHC) has issued two announcements (No. 1 of 2023, No. 3 of 2023), with a total of 42 products approved, covering 17 new food-related products (including those for expanded use).

CIRS Group will introduce the detailed information about the acceptance and approval of new food-related products in China in the first half of 2023.

1. Overview of the application and approval status in the first half of 2023

In the first half of 2023, 13 new food-related products were accepted, and 15 food-related products (including those for expanded scope and use) were released for public comments. Additionally, 17 new food-related products (including expanded scope and use) were officially approved, while 10 received rejection decisions.

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Figure 1. Overview of the application and approval status of new food-related products in the first half of 2023

2. List of new food-related products accepted by NHC in the first half of 2023

As of the end of June 2023, 13 new food-related products (including food contact additives and resins), including 6 domestic products and 7 overseas products have passed the technical review and been accepted by NHC.

No.	Acceptance date	Acceptance code	Name of the product	Approval status (By the end of June 2023)
1	2023.01.28	衛食相申字(2023)第0001號	Pentaerythritoltetrakis (3-(3,5-di-tert-butyl-4- hydroxyphenyl)propionate)	Passed the technical review and issued for public comments on June 28, 2023
2	2023.01.29	衛食相申字(2023)第0002號	N,N'-Hexane-1,6-diylbis[3-(3,5-di-tert-butyl-4- hydroxyphenylpropionamide]	Passed the technical review and issued for public comments on June 28, 2023
3	2023.01.29	衛食相進申字(2023)第0001號	Chromium iron oxide	Has not passed the technical review yet.
4	2023.02.09	衛食相進申字(2023)第0002號	Styrene polymer with 1,3-butadiene, hydrogenated	Has not passed the technical review yet.
5	2023.03.03	衛食相進申字(2023)第0003號	Polymer of 2-methyl-1,3-propanediol with 1,4-benzoic acid and tricyclodecanedimethanol	Issued a rejection decision on June 26, 2023
6	2023.03.17	衛食相進申字(2023)第0004號	Homopolymer of 11-aminoundecanoic acid	Has not passed the technical review yet.
7	2023.03.22	衛食相進申字(2023)第0005號	Polymer of methyl methacrylate and 2-methyl-2-acrylic acid-1,2-ethanediol ester	Has not passed the technical review yet.
8	2023.03.22	衛食相申字(2023)第0003號	Copolymers of trimethoxyphenylsilane, methyltrimethoxysilane, and silica	Issued a rejection decision on June 26, 2023
9	2023.03.28	衛食相申字(2023)第0004號	1,3,5-trimethyl-2,4,6-tris (3,5-di-tert-butyl-4-hydroxybenzyl) benzene	Has not passed the technical review yet.
10	2023.03.30	衛食相進申字(2023)第0006號	3-Methoxy-3-methyl-1-butanol	Has not passed the technical review yet.
11	2023.05.12	衛食相申字(2023)第0005號	Hydrogenated C6-20 hydrocarbon polymer	Has not passed the technical review yet.
12	2023.05.12	衛食相進申字(2023)第0007號	Steam Light Cracking Debenzene Polymerization Hydrogen Fossil Naphtha	Has not passed the technical review yet.
13	2023.05.17	衛食相申字(2023)第0006號	Chromium nitride	Has not passed the technical review yet.

3. List of new food-related products released for public comments in the first half of 2023

As of the end of June 2023, 15 products, including 2 new food contact additives, 6 new food contact resins and 7 current food contact additives with expanded scope and use, have passed the technical review of CFSA Expert Review Committee and been released for public comments.

Among them, only 3 substances were officially approved by HNC. Detailed information is as follows:

3.1) New food contact additives (2 types)

No.

Basic information

Acceptance date and code

Approval status

(By the end of June 2023)

Name: Hexanedioic acid polymer with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol, 4-(1,1-dimethylethyl) benzoate

CAS number: 74564-66-2

Scope: Coating and coating film

Maximum level of use/%: 5 (count as the coating formula)

Accepted on July 27, 2022. Acceptance code: 衛食相進申字(2022)第0006號

Issued for public comments on January 16, 2023

Officially approved on May 6, 2023 according to No. 3 of 2023.

Name: Coffee grounds

CAS number: /

Scope: Plastic: PLA, PBS

Maximum level of use/%: PLA: 20; PBS: 10

Accepted on September 9, 2021. Acceptance code: 衛食相申字(2021)第0021號

Issued for public comments on June 28, 2023

3.2) New food contact resins (6 types)

No.	Basic information	Acceptance date and code	Approval status (By the end of June 2023)
1	Name: Tricyclodecanedimethanol polymer with terephtalic acid and 1,6-hexandiol CAS number: / Scope: Coating and coating film Maximum level of use/%: 60 (count as the coating formula)	Accepted on July 27, 2022. Acceptance code: 衛食相申字(2022)第0008號	Issued for public comments on January 16, 2023 Officially approved on May 6, 2023 according to No. 3 of 2023.
2	Name: Fatty acids, C18-unsatd., dimmers, hydrogenated polymers with 1,4-butanediol, ethylene glycol, terephthalic acid and trimethylolpropane, block CAS number: / Common category name: PET Scope: plastic	Accepted on May 9, 2022. Acceptance code:衛食相進申字(2022)第0005號	Issued for public comments on January 16, 2023 Officially approved on May 6, 2023 according to No. 3 of 2023.
3	Name: β-Alanine, N-(2-aminoethyl)-, monosodium salt, polymer with 1,4-butanediol, 1,6-diisocyanatohexane, 1,3-diisocyanatomethylbenzene and hexanedioic acid CAS number: 141073-56-5 Scope: Adhesive (Direct contact with food) Maximum level of use/%: 20 g/m² (count as the dry weight)	Accepted on May 10, 2021. Acceptance code:衛食相申字(2021)第0007號	Issued for public comments on March 15, 2023
4	Name: 1,4-Benzenedicarboxylic acid, polymer with decanedioic acid and 1,2-ethanediol CAS number: 25067-21-4 Scope: Coating and coating film Maximum level of use/%: Appropriate level	Accepted on January 6, 2022. Acceptance code: 衛食相申字(2022)第0001號	Issued for public comments on April 25, 2023
5	Name: 2-Propenoic acid, 2-methyl-, polymer with butyl 2-methyl-2-propenoate, ethyl 2-propenoate and methyl 2-methyl-2-propenoate, salts with 1,4-benzenediol-epichlorohydrin-4,4'-methy lenebis[2,6-dimethylphenol]polymer-2-(dim ethyulamino)ethanol reaction products CAS number: / Scope: Coating and coating film Maximum level of use/%: 20 (count as the coating formula)	Accepted on November 16, 2022. Acceptance code: 衛食相進申字(2022)第0019號	Issued for public comments on April 25, 2023
6	Name: 2-propenoic acid, 2-methyl-,1,1-(1,4-butanediyl) ester, polymer with butyl 2-methyl-2-propenoate, butyl 2-propenoate and methyl 2-methyl-2-propenoate CAS number: / Scope: Coating and coating film Maximum level of use/%: 46 (count as the coating formula)	Accepted on November 16, 2022. Acceptance code: 衛食相進申字(2022)第0020號	Issued for public comments on June 28, 2023

3.3) Food contact additives applying for expanded scope and use (7 types)

No.	Basic information	Acceptance date and code	Approval status (By the end of June 2023)
1	Name: Glass fiber CAS number: 65997-17-3 Scope: Plastic: Plastic: PEEK Maximum level of use/%: 30	Accepted on September 13, 2021. Acceptance code: 衛食相進申字(2021)第0025號	Issued for public comments on March 15, 2023
2	Name: C.I. Pigment black 28 CAS number: 68186-91-4 Scope: Coating and coating film Maximum level of use/%: 15 (count as the dry weight of coating)	Accepted on September 22, 2022. Acceptance code:衛食相進申字(2022)第0014號	Issued for public comments on March 15, 2023
3	Name: C.I. pigment black 7; Carbon black CAS number: 1333-86-4 Scope: Plastic: PEEK Maximum level of use/%: 0.5	Accepted on September 13, 2021. Acceptance code: 衛食相進申字(2021)第0024號	Issued for public comments on April 25, 2023
4	Name: Copolymer of acrylamide, 2-methacryloxyethyltrimethyl ammonium chloride, itaconic acid, and N,N’ -methylenebis acrylamide CAS number: 214495-32-6 Scope: Paper and paperboard Maximum level of use/%: 1.5 (count as the dry weight)	Accepted on October 18, 2021. Acceptance code: 衛食相申字(2021)第0023號	Issued for public comments on April 25, 2023
5	Name: 2-acetoxy-1,2,3-propanetricarboxylicacidtributylester CAS number: 77-90-7 Scope: Ink for direct contact with food Maximum level of use/%: 10	Accepted on November 11, 2022. Acceptance code: 衛食相申字(2022)第0011號	Issued for public comments on April 25, 2023
6	Name: N,N'-Hexane-1,6-diylbis[3-(3,5-di-tert-butyl-4- hydroxyphenylpropionamide] CAS number: 23128-74-7 Scope: Plastic: PUR conveyor belt Maximum level of use/%: 0.5	Accepted on January 29, 2023. Acceptance code: 衛食相申字(2023)第0002號	Issued for public comments on June 28, 2023
7	Name: Pentaerythritoltetrakis(3-(3,5-di-tert-butyl-4- hydroxyphenyl)propionate) CAS number: 6683-19-8 Scope: Plastic: PUR conveyor belt Maximum level of use/%: 0.5	Accepted on January 28, 2023. Acceptance code:衛食相申字(2023)第0001號	Issued for public comments on June 28, 2023

4. List of approved new food-related products in the first half of 2023 (17 types)

As of the end of June 2023, NHC has approved a total of 17 new food-related products, including 4 new food contact additives, 4 new food contact additives with expanded scope and use, 8 new food contact resins, and 1 new food contact resin with expanded scope and use. The acceptance date, date of issuance for public comments and date of official approval for these 17 products are as follows:

4.1) List of approved new food contact additives (4 types)

No.	Basic information	Acceptance date and code	Date of issuance for public comments	Date of official approval
1	Name: Cyclohexane, 1,1'-methylenebis[4-isocyanato-, homopolymer, cyclohexylamine-terminated CAS number: 315207-86-4 Scope: Plastic: PCN Maximum level of use/%: 0.35	Accepted on August 27, 2021. Acceptance code: 衛食相進申字(2021)第0020號	Issued for public comments on August 23, 2022	Officially approved on March 2, 2023 according to No. 1 of 2023.
2	Name: 2-[2-(2,4-diamino-6-hydroxypyrimidin-5-yl) diazenyl]-5-methylbenzenesulfonic acid CAS number: 1021701-36-9 Scope: Plastic Maximum level of use/%: 0.5	Accepted on July 8, 2021. Acceptance code: 衛食相進申字(2021)第0017號	Issued for public comments on August 23, 2022	Officially approved on March 2, 2023 according to No. 1 of 2023.
3	Name: Copolymer of acrylamide, 2-methacryloxyethyltrimethyl ammonium chloride, itaconic acid, and N,N’-methylenebis acrylamide CAS number: 214495-32-6 Scope: Paper and paperboard Maximum level of use/%: 1 (count as the dry weight)	Accepted on August 20, 2021. Acceptance code: 衛食相申字(2021)第0013號	Issued for public comments on July 1, 2022	Officially approved on March 2, 2023 according to No. 1 of 2023.
4	Name: Hexanedioic acid polymer with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol, 4-(1,1-dimethylethyl) benzoate CAS number: 74564-66-2 Scope: Coating and coating film Maximum level of use/%: 5 (count as the coating formula)	Accepted on July 27, 2022. Acceptance code: 衛食相進申字(2022)第0006號	Issued for public comments on January 16, 2023	Officially approved on May 6, 2023 according to No. 3 of 2023.

4.2) List of new food contact resins (8 types)

No.	Basic information	Acceptance date and code	Date of issuance for public comments	Date of official approval
1	Name: Carbon monoxide-ethylene-propylene terpolymera CAS number: 88995-51-1 Scope: Plastic Maximum level of use/%: Appropriate level	Accepted on September 23, 2021. Acceptance code: 衛食相進申字(2021)第0026號	Issued for public comments on August 23, 2022	Officially approved on March 2, 2023 according to No. 1 of 2023.
2	Name: 4-ethylphenol, m-cresol, p-cresol and 4-tert-Butylphenol polymers with formaldehyde CAS number: 68957-28-8 Scope: Coating and coating film Maximum level of use/%: 62 (count as the coating formula)	Accepted on March 21, 2022. Acceptance code: 衛食相申字(2022)第0004號	Issued for public comments on August 23, 2022	Officially approved on March 2, 2023 according to No. 1 of 2023.
3	Name: Polymer of ethylene glycol, 2,2-dimethyl1,3-propandiol, terephthalic acid, isophthalic acid, adipic acid and itaconic acid CAS number: 1041633-99-1 Scope: Coating and coating film Adhesive (Direct contact with food) Maximum level of use/%: 20 (count as the dry weight)	Accepted on March 5, 2021. Acceptance code: 衛食相進申字(2021)第0007號	Issued for public comments on August 23, 2022	Officially approved on March 2, 2023 according to No. 1 of 2023.
4	Name: Tricyclodecanedimethanol polymer with terephtalic acid and 1,6-hexandiol CAS number: / Scope: Coating and coating film Maximum level of use/%: 60 (count as the coating formula)	Accepted on July 27, 2022. Acceptance code: 衛食相申字(2022)第0008號	Issued for public comments on January 16, 2023	Officially approved on May 6, 2023 according to No. 3 of 2023.
5	Name: Fatty acids, C18-unsatd., dimmers, hydrogenated polymers with 1,4-butanediol, ethylene glycol, terephthalic acid and trimethylolpropane, block CAS number: / Common category name: PET Scope: Plastic	Accepted on May 9, 2022. Acceptance code: 衛食相進申字(2022)第0005號	Issued for public comments on January 16, 2023	Officially approved on May 6, 2023 according to No. 3 of 2023.
6	Name: 1,6-Hexanedioic acid, polymer with (E)-2-butenedioic acid and tricyclodecanedimethanol CAS number: 58891-19-3 Scope: Coating and coating film Maximum level of use/%: 18 (count as the dry weight of coating)	Accepted on September 13, 2022. Acceptance code: 衛食相進申字(2022)第0011號	Issued for public comments on October 28, 2022	Officially approved on May 6, 2023 according to No. 3 of 2023.
7	Name: Polymer of 1,4-butanediol, 2,2-dimethyl-1,3-propanediol, 1,4-cyclohexanedicarboxylic acid and m-phthalic acid CAS number: / Scope: Coating and coating film Maximum level of use/%: 30 (count as the dry weight of coating)	Accepted on November 9, 2021. Acceptance code: 衛食相申字(2021)第0025號	Issued for public comments on October 28, 2022	Officially approved on May 6, 2023 according to No. 3 of 2023.
8	Name: Polymer of butanediol-1,4, tricyclodecanedimethanol and dimethyl terephthalate CAS number: 490017-22-6 Scope: Coating and coating film Maximum level of use/%: 59 (count as the coating formula)	Accepted on March 11, 2022. Acceptance code: 衛食相進申字(2022)第0004號	Issued for public comments on October 28, 2022	Officially approved on May 6, 2023 according to No. 3 of 2023.

4.3) List of food contact additives with expanded scope and use (4 types)

No.	Basic information	Acceptance date and code	Date of issuance for public comments	Date of official approval
1	Name: Octadecyl 3-(3,5-di-tert-butyl-4-hydroxyphenyl) propionate CAS number: 2082-79-3 Scope: Coating and coating film Maximum level of use/%: 0.5	Accepted on November 1, 2021. Acceptance code: 衛食相進申字(2021)第0027號	Issued for public comments on August 23, 2022	Officially approved on March 2, 2023 according to No. 1 of 2023.
2	Name: Napthalensulfonic acid, polymer with formaldehyde, sodium salt CAS number: 9084-06-4; 36290-04-7 Scope: Plastic: ABS Maximum level of use/%: 0.12	Accepted on May 7, 2021. Acceptance code: 衛食相申字(2021)第0004號	Issued for public comments on August 23, 2022	Officially approved on March 2, 2023 according to No. 1 of 2023.
3	Name: Fatty acid esters of C1~C18 mono- and poly-fatty alcohols CAS number: / Scope: Plastic Maximum level of use/%: 0.1	Accepted on September 6, 2021. Acceptance code: 衛食相申字(2021)第0019號	Issued for public comments on August 23, 2022	Officially approved on March 2, 2023 according to No. 1 of 2023.
4	Name: Silane, dichlorodimethyl-, reaction products with silica CAS number: 68611-44-9 Scope: Adhesive (Direct contact with food)；Ink (Indirect contact with food) Maximum level of use/%: Adhesive: 0.002% (Count as the dry weight)； Ink: 4 (Count as the dry weight)	Accepted on March 11, 2022. Acceptance code: 衛食相申字(2022)第0002號	Issued for public comments on August 23, 2022	Officially approved on March 2, 2023 according to No. 1 of 2023.

4.4) List of food contact resin (1 type)

No.

Basic information

Acceptance date and code

Date of issuance for public comments

Date of official approval

Name: Isophthalic acid, polymer with 1,3-benzenedimethanamine and hexanedioic acid

CAS number: 28628-75-3

Scope: Plastic

Common category name: PA

Maximum level of use/%: Appropriate level

Accepted on July 29, 2022. Acceptance code: 衛食相進申字(2022)第0007號

Issued for public comments on August 23, 2022

Officially approved on March 2, 2023 according to No. 1 of 2023.

5. List of new food-related products that have been rejected in the first half of 2023 (10 types)

As of the end of June 2023, 10 new food-related products have been rejected by NHC. The name of the products, date of delivery and acceptance code are as follows.

No.	Name of the product	Date of delivery (By the end of June 2023)	Acceptance code
1	1,3-Benzenedicarboxylic acid, polymer with 1,4-benzenedicarboxylic acid, 1,4-cyclohexanedimethanol, sebacic acid, 2,2-dimethyl-1,3-propanediol	2023-01-28	衛食相進申字(2022)第0009號
2	Bis(2-ethylhexyl) cyclohexane-1,4-dicarboxylate	2023-01-28	衛食相進申字(2022)第0013號
3	1,4-Benzenedicarboxylic acid, polymer with 2-methyl-1,3-propanediol, tricyclodecane dimethanol	2023-01-28	衛食相進申字(2022)第0010號
4	Phenyltrimethoxysilane, copolymer with methyltrimethoxysilane, silicon oxide	2023-01-28	衛食相申字(2022)第0010號
5	Ammonium laurate	2023-01-28	衛食相進申字(2022)第0008號
6	Dimethyl-3-hydroxypropyl-methyl ethyl oxidation, polymer with propyl oxidation (siloxane and polysiloxane) and 1,6-diisocyanyl hexane, allyloxypolyethyleneglycol and Poly(propylene glycol) monoallyl ether terminated	2023-03-09	衛食相進申字(2021)第0029號
7	1,3-benzenedicarboxylic acid, polymer with 1,4-benzenedicarboxylic acid, butyl methacrylate, 2,2-dimethyl-1,3-propanediol, 1,2-ethanediol, adipic acid, methylene succinic acid and methyl methacrylate	2023-03-17	衛食相進申字(2021)第0018號
8	11-amino-undecanoicacidpolymer	2023-03-17	衛食相進申字(2022)第0015號
9	2-Propenoic acid, 2-methyl-, alkyl diethyl ester, polymer with 2-methyl-2-propenoate aryl ester	2023-03-17	衛食相進申字(2022)第0018號
10	Chromium dinitrogen	2023-03-17	衛食相申字(2022)第0009號

Conclusion

On May 10, 2023, the National Health Commission (NHC) in China issued the Announcement No. 4 of 2023 , which introduce the inventories of “Three New Food” in China as well as the food safety standards applicable to these products. The applicable standard for 235 new food-related products announced in former Announcements also became clear.

Generally, it takes about 1-1.5 years to complete the registration. But a number of new food-related products, such as hexanedioic acid polymer with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol, 4-(1,1-dimethylethyl) benzoate, 1,6-Hexanedioic acid, polymer with (E)-2-butenedioic acid and tricyclodecanedimethanol, and isophthalic acid, polymer with 1,3-benzenedimethanamine and hexanedioicacid, only spent about 8 months to complete entire approval process. Therefore, the time required from acceptance to final approval will be significantly reduced if applicants carefully prepare the required files, conduct thorough research on the safety of the substances, and fully understand the application stages and suitable scheduling.

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Note: The data in this article is for reference only, please refer to the official information published by government departments.