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

from CIRS by

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 of42products 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.

China,Food,Products,Registration,Resin,Additive,FCM,

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

卫食相申字(2023)第0001号

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

卫食相申字(2023)第0002号

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

卫食相进申字(2023)第0001号

Chromium iron oxide

Has not passed the technical review yet.

4

2023.02.09

卫食相进申字(2023)第0002号

Styrene polymer with 1,3-butadiene, hydrogenated

Has not passed the technical review yet.

5

2023.03.03

卫食相进申字(2023)第0003号

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

卫食相进申字(2023)第0004号

Homopolymer of 11-aminoundecanoic acid

Has not passed the technical review yet.

7

2023.03.22

卫食相进申字(2023)第0005号

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

卫食相申字(2023)第0003号

Copolymers of trimethoxyphenylsilane, methyltrimethoxysilane, and silica

Issued a rejection decision on June 26, 2023

9

2023.03.28

卫食相申字(2023)第0004号

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

卫食相进申字(2023)第0006号

3-Methoxy-3-methyl-1-butanol

Has not passed the technical review yet.

11

2023.05.12

卫食相申字(2023)第0005号

Hydrogenated C6-20 hydrocarbon polymer

Has not passed the technical review yet.

12

2023.05.12

卫食相进申字(2023)第0007号

Steam Light Cracking Debenzene Polymerization Hydrogen Fossil Naphtha

Has not passed the technical review yet.

13

2023.05.17

卫食相申字(2023)第0006号

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)

1

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: 卫食相进申字(2022)第0006号

Issued for public comments on January 16, 2023

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

2

Name: Coffee grounds

CAS number: /

Scope: Plastic: PLA, PBS

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

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

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: 卫食相申字(2022)第0008号

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:卫食相进申字(2022)第0005号

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:卫食相申字(2021)第0007号

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: 卫食相申字(2022)第0001号

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: 卫食相进申字(2022)第0019号

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: 卫食相进申字(2022)第0020号

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: 卫食相进申字(2021)第0025号

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:卫食相进申字(2022)第0014号

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: 卫食相进申字(2021)第0024号

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: 卫食相申字(2021)第0023号

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: 卫食相申字(2022)第0011号

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: 卫食相申字(2023)第0002号

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:卫食相申字(2023)第0001号

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: 卫食相进申字(2021)第0020号

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: 卫食相进申字(2021)第0017号

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: 卫食相申字(2021)第0013号

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: 卫食相进申字(2022)第0006号

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: 卫食相进申字(2021)第0026号

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: 卫食相申字(2022)第0004号

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: 卫食相进申字(2021)第0007号

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: 卫食相申字(2022)第0008号

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: 卫食相进申字(2022)第0005号

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: 卫食相进申字(2022)第0011号

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: 卫食相申字(2021)第0025号

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: 卫食相进申字(2022)第0004号

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: 卫食相进申字(2021)第0027号

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: 卫食相申字(2021)第0004号

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: 卫食相申字(2021)第0019号

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: 卫食相申字(2022)第0002号

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

1

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: 卫食相进申字(2022)第0007号

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

卫食相进申字(2022)第0009号

2

Bis(2-ethylhexyl) cyclohexane-1,4-dicarboxylate

2023-01-28

卫食相进申字(2022)第0013号

3

1,4-Benzenedicarboxylic acid, polymer with 2-methyl-1,3-propanediol, tricyclodecane dimethanol

2023-01-28

卫食相进申字(2022)第0010号

4

Phenyltrimethoxysilane, copolymer with methyltrimethoxysilane, silicon oxide

2023-01-28

卫食相申字(2022)第0010号

5

Ammonium laurate

2023-01-28

卫食相进申字(2022)第0008号

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

卫食相进申字(2021)第0029号

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

卫食相进申字(2021)第0018号

8

11-amino-undecanoicacidpolymer

2023-03-17

卫食相进申字(2022)第0015号

9

2-Propenoic acid, 2-methyl-, alkyl diethyl ester, polymer with 2-methyl-2-propenoate aryl ester

2023-03-17

卫食相进申字(2022)第0018号

10

Chromium dinitrogen

2023-03-17

卫食相申字(2022)第0009号

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.

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