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Analysis of the Application and Approval of New Food-Related Products in the First Half of 2024

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As of the end of June 2024, the National Health Commission (NHC) has issued one announcement (No. 2 of 2024), approving a total of 23 products as “three new foods” (new food raw material, new food additive, and new food-related product). Among these, there are 5 new food-related products, including those with expanded scope of use.

CIRS Group provides you with a detailed analysis of the acceptance and approval of new food-related products in China for the first half of 2024.

Overview of the application and approval of new food-related products in the first half of 2024

In the first half of 2024, the NHC accepted the applications for 23 new food-related products. Fourteen products were issued for public comment, including those with expanded scope of use and use levels. Five products, including those with expanded scope of use and use levels, were officially approved, while non-approval decisions were issued for six products.

China,Food,Food-related,Application,Approval

New food-related products accepted in the first half of 2024 (23 types)

As of the end of June 2024, a total of 23 new food-related products (food contact additives and resins) have been reviewed and accepted by the NHC, including 10 domestic products and 13 imported ones.

S.N.

Date of acceptance

Acceptance No.

Name

Review status

(as of the end of June 2024)

1

2024.01.05

卫食相进申字(2024) No. 0001

2,6-naphthalenedicarboxylic acid 2,6-dimethyl ester, polymer with 1,4-cyclohexanedimethanol, 1,2-ethylene glycol, 2,2'-oxybis[ethanol], and β3,β3,β9,β9-tetramethyl-2,4,8,10-tetraoxaspiro[5.5]undecane-3,9-diol

Not issued for public comment yet

2

2024.01.08

卫食相申字(2024) No. 0001

Calcium sulfate dihydrate

Issued a non-approval decision

3

2024.01.15

卫食相进申字(2024) No. 0002

Copolymer of isobutylene and butene

Not issued for public comment yet

4

2024.01.15

卫食相进申字(2024) No. 0003

Polyisobutylene

Not issued for public comment yet

5

2024.03.01

卫食相进申字(2024) No. 0004

3,6,9-trimethyl-3,6,9-tri (ethyl and propyl) derivative of 1,2,4,5,7,8-hexanone

Not issued for public comment yet

6

2024.03.06

卫食相申字(2024) No. 0002

Acrylic acid (content not exceeding 2%)

modified chloride-N,N,N-trimethyl-2-[(1-oxo-2-propenyl)oxyethylammonium], polymer with and 2-propenamide

Not issued for public comment yet

7

2024.03.08

卫食相申字(2024) No. 0003

Ethoxylated hydrogenated castor oil

Not issued for public comment yet

8

2024.03.11

卫食相进申字(2024) No. 0005

Pigment Blue 29

Not issued for public comment yet

9

2024.03.14

卫食相申字(2024) No. 0004

Ethoxylated hydrogenated castor oil

Issued an opinion on the review

10

2024.03.15

卫食相进申字(2024) No. 0006

Mixture of saturated linear fatty acid esters produced from C12-C18 aliphatic alcohols and C12-C18 fatty acids

Issued an opinion on the review

11

2024.03.15

卫食相进申字(2024) No. 0007

Ammonium salt of acrylic acid and ethylene polymer

Not issued for public comment yet

12

2024.04.01

卫食相申字(2024) No. 0005

A liquid unsaturated polyester resin made from isophthalic acid, terephthalic acid, phthalic anhydride, maleic anhydride, propylene glycol, ethylene glycol, diethylene glycol, and supplemented with styrene

Issued an opinion on the review

13

2024.04.01

卫食相进申字(2024) No. 0008

AMMONIUM LAURATE

Not issued for public comment yet

14

2024.04.02

卫食相申字(2024) No. 0006

Barium sulfate

Not issued for public comment yet

15

2024.04.30

卫食相进申字(2024) No. 0009

Docosanamide

Not issued for public comment yet

16

2024.05.11

卫食相进申字(2024) No. 0010

Cobalt Blue

Not issued for public comment yet

17

2024.05.11

卫食相进申字(2024) No. 0011

Pigment Blue 29

Not issued for public comment yet

18

2024.05.13

卫食相申字(2024) No. 0007

Calcium sulfate dihydrate

Issued an opinion on the review

19

2024.05.14

卫食相申字(2024) No. 0008

Hexanedioic acid, polymer with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol

Not issued for public comment yet

20

2024.05.15

卫食相申字(2024) No. 0009

Ethoxylated hydrogenated castor oil

Issued an opinion on the review

21

2024.05.16

卫食相进申字(2024) No. 0012

Mixture of saturated linear fatty acid esters produced from C12-C18 aliphatic alcohols and C12-C18 fatty acids

Issued an opinion on the review

22

2024.05.20

卫食相申字(2024) No. 0010

3-Aminopropyltriethoxysilane

Not issued for public comment yet

23

2024.06.26

卫食相进申字(2024) No. 0013

Calcium tert-butylphosphonate

Not issued for public comment yet

New food-related products issued for public comment in the first half of 2024 (14 types)

As of the end of June 2024, a total of 14 products have been reviewed by the China National Center for Food Safety Risk Assessment (CFSA) Expert Review Committee and issued for public comment. These include two new food contact additives, five additives with an expanded scope of use and use levels, five new food contact resins, one resin with an expanded scope of use, and 1 new food contact material.

Notably, four products have been officially approved in the first half of this year. Details are as follows:

New food contact additives issued for public comment (two types)

S.N.

Product information

Acceptance information/number

Review status

(as of the end of June 2024)

1

Name: Chromium iron oxide

CAS number: 12737-27-8

Scope of use: Plastic

Maximum level/%: 2

Accepted on January 29, 2023

Acceptance No.: 卫食相进申字(2023) No. 0001

  1. Issued for public comment on January 3, 2024
  2. Officially approved on March 13, 2024, according to Announcement No. 2 of 2024

2

Name: Bicyclo[2.2.1] heptane-2,3-dicarboxylicacid, calcium salt (1:1), (1R,2R,3S,4S)-rel

CAS number: 839683-04-4

Scope of use: Plastic: PP, PE

Maximum level/%: 0.25

Accepted on January 4, 2022

Acceptance No.: 卫食相进申字(2022) No. 0001

  1. Issued for public comment on January 3, 2024
  2. Officially approved on March 13, 2024, according to Announcement No. 2 of 2024

New food contact resins issued for public comment (five types)

S.N.

Product information

Acceptance information

Review status

(as of the end of June 2024)

1

Name: Polybutylene succinate adipate

CAS number: 67423-06-7

Scope of use: Plastic

Common name: PBSA

Accepted on January 28, 2021

Acceptance No.: 卫食相进申字(2021) No. 0006

  1. Issued for public comment on January 3, 2024
  2. Officially approved on March 13, 2024, according to Announcement No. 2 of 2024

2

Name: 1,3-Benzenedicarboxylic acid, polymerwith 1,4-benzenedicarboxylic acid and1,4-cyclohexanedimethanol

CAS number: 26124-27-6

Scope of use: Plastic

Common name: PCT

Accepted on November 14, 2022

Acceptance No.: 卫食相进申字(2022) No. 0017

  1. Issued for public comment on January 3, 2024
  2. Officially approved on March 13, 2024, according to Announcement No. 2 of 2024

3

Name: Poly (neopentyl glycol-co-terephtalicacid-co-monoethylene glycol-co-isophtalicacid-co-monopropylene glycol-co-Fattyacids, C18-unsaturated, dimers, hydrogenated-co-1,6-haxanediol- co-trimethylol

CAS number: /

Scope of use: Coating and coating film

Maximum level/%: 69 (expressed as the coating formula)

Accepted on July 12, 2023

Acceptance No.: 卫食相申字(2023) No. 0007

Issued for public comment on February 26, 2024

4

Name: Copolymer of trimethoxyphenylsilane, methyltrimethoxysilane, and silica

CAS number: /

Scope of use: Coating and coating film

Maximum level/%: Appropriate level

Accepted on November 15, 2023

Acceptance No.: 卫食相申字(2023) No. 0009

Issued for public comment on May 9, 2024

5

Name: Poly(3-hydroxybutyrate-co- 3-hydroxyhexanoate)

Source: Cupriavidus necator H16

CAS number: 147398-31-0

Common name: PHA

Scope of use: Plastic

Maximum level/%: Appropriate level

Accepted on November 16, 2023

Acceptance No.: 卫食相申字(2023) No. 0010

Issued for public comment on June 24, 2024

Food contact additives with expanded scope of use and use levels (five types)

S.N.

Product information

Acceptance information

Review status

(as of the end of June 2024)

1

Name: C.I. Pigment black 7; Carbon black

CAS number: 1333-86-4

Scope of use: Plastic: PCT

Maximum level/%: 2.5

Accepted on September 7, 2023

Acceptance No.: 卫食相进申字(2023) No. 0013

Issued for public comment on May 9, 2024

2

Name: Sodium hydroxide

CAS number: 1310-73-2

Scope of use: Plastic: PVDF

Maximum level/%: Appropriate level

Accepted on September 15, 2023

Acceptance No.: 卫食相进申字(2023) No. 0015

Issued for public comment on May 9, 2024

3

Name: Dibutyl sebacate

CAS number: 109-43-3

Scope of use: Plastic: PVDF

Maximum level/%: Appropriate level

Accepted on September 15, 2023

Acceptance No.: 卫食相进申字(2023) No. 0014

Issued for public comment on May 9, 2024

4

Name: 4.2,4,8,10-Tetraoxa-3,9-diphosphaspiro[5.5]undecane,3,9-bis

[2,4-bis(1-methyl-1-phenylethyl)phenoxy]-

CAS number: 154862-43-8

Scope of use: Adhesive (in direct contact with food)

Maximum level/%: 0.04

Accepted on September 19, 2022

Acceptance No.: 卫食相进申字(2022) No. 0012

Issued for public comment on May 9, 2024

5

Name: 1,3,5-Trimethyl-2,4,6-tris (3,5-di-tert-butyl-4-hydroxytolyl)benzene

CAS number: 1709-70-2

Scope of use: Carbon monoxide-ethylene-propylene terpolymer

Maximum level/%: 0.5

Accepted on March 28, 2023

Acceptance No.: 卫食相申字(2023) No. 0004

Issued for public comment on June 24, 2024

Food contact resin with an expanded scope of use (one type)

S.N.

Product information

Acceptance information

Review status

(as of the end of June 2024)

1

Name: Benzene, ethenyl-, polymer with 1,3-butadiene, hydrogenated

CAS number: 66070-58-4

Scope of use: Coatings and coating film

Maximum level/%: 27.5 (expressed as dry weight of coating)

  1. Accepted on January 7, 2021; Acceptance No.: 卫食相进申字(2021) No. 0004l
  2. Accepted on February 9, 2023; Acceptance No.: 卫食相进申字(2023) No. 0002

Issued for public comment on May 9, 2024

New food contact material issued for public comment (one type)

S.N.

Product information

Acceptance information

Review status

(as of the end of June 2024)

1

Name: Chromium nitride coatings made from nitrogen and chromium

CAS number: 12053-27-9, 24094-93-7

Scope of use: Coatings and coating film

Maximum level/%: Appropriate level

Accepted on May 17, 2023

Acceptance No.: 卫食相申字(2023) No. 0006

Issued for public comment on May 9, 2024

New food-related products approved in the first half of 2024 (five types)

As of the end of June 2024, the NHC has approved a total of five new food-related products, including two new food contact additives, two new food contact resins, and one food contact resin with an expanded scope of use. Details are as follows:

Approved new food contact additives (two types)

S.N.

Product information

Acceptance information

Date of public consultation

Date of official approval

1

Name: Chromium iron oxide

CAS number:12737-27-8

Scope of use: Plastic

Maximum level/%: 2

Accepted on January 29, 2023

Acceptance No.: 卫食相进申字(2023) No. 0001

Issued for public comment on January 3, 2024

Officially approved on March 13, 2024, according to Announcement No. 2 of 2024

2

Name: Bicyclo[2.2.1] heptane-2,3-dicarboxylicacid, calcium salt (1:1), (1R,2R,3S,4S)-rel

CAS number: 839683-04-4

Scope of use: Plastic: PP; PE

Maximum level/%: 0.25

Accepted on January 4, 2022

Acceptance No.: 卫食相进申字(2022) No. 0001

Issued for public comment on January 3, 2024

Officially approved on March 13, 2024, according to Announcement No. 2 of 2024

Approved new food contact resins (two types)

S.N.

Product information

Acceptance information

Date of public consultation

Date of official approval

1

Name: Polybutylene succinate adipate

CAS number: 67423-06-7

Scope of use: Plastic

Maximum level/%: Appropriate level

Accepted on January 28, 2021

Acceptance No.: 卫食相进申字(2021) No. 0006

Issued for public comment on January 3, 2024

Officially approved on March 13, 2024, according to Announcement No. 2 of 2024

2

Name: 1,3-Benzenedicarboxylic acid, polymerwith 1,4-benzenedicarboxylic acid and 1,4-cyclohexanedimethanol

CAS number: 26124-27-6

Scope of use: Plastic

Maximum level/%: Appropriate level

Accepted on November 14, 2022

Acceptance No.: 卫食相进申字(2022) No. 0017

Issued for public comment on January 3, 2024

Officially approved on March 13, 2024, according to Announcement No. 2 of 2024

Approved food contact resin with an expanded scope of use (one type)

S.N.

Product information

Acceptance information

Date of public consultation

Date of official approval

1

Name: Undecanoic acid, 11-amino-, homopolymer

CAS number: 25587-80-8

Scope of use: Plastic

Common name: PA

Maximum level/%: Appropriate level

Accepted on March 17, 2023

Acceptance No.: 卫食相进申字(2023) No. 0004

Issued for public comment on November 3, 2023

Officially approved on March 13, 2024, according to Announcement No. 2 of 2024

New food-related products issued non-approval decisions in the first half of 2024 (six types)

As of the end of June 2024, six new food-related products have been issued a non-approval decision by the NHC. Details are as follows:

S.N.

Product name

Date of issue

(as of the end of June 2024)

Acceptance No.

1

Adipic acid, polymer with fumaric acid, and ethoxylated tricyclodecanedimethanol.

2024.04.07

卫食相进申字(2022) No. 0011

2

Silicon dioxide

2024.06.13

卫食相申字(2023) No. 0012

3

Bis (2-ethylhexyl) adipate

2024.06.13

卫食相进申字(2023) No. 0019

4

Calcium sulfate

2024.06.13

卫食相申字(2023) No. 0011

5

Calcium sulfate dihydrate

2024.06.13

卫食相申字(2024) No. 0001

6

Pentaerythritol tetrakis [3-(3,5-di-tert-butyl-4-hydroxyphenyl)-propionate]

2024.06.13

卫食相进申字(2023) No. 0018

Conclusion

It can be observed from the above analysis that most products undergo an application cycle ranging from 1 to 1.5 years. However, several new products took significantly longer to obtain final approval, such as polybutylene succinate adipate and Bicyclo[2.2.1] heptane-2,3-dicarboxylicacid, calcium salt (1:1), (1R,2R,3S,4S)-rel. This underscores the importance of thorough preparation of application materials, comprehensive safety studies, and precise timing to expedite the approval process. In the first half of this year, none of the products accepted were issued for public comment, highlighting the rigorous scrutiny of application materials for new food-related products in China. Companies must be fully prepared to navigate the rigorous review process successfully.

If you need any assistance or have any questions, please get in touch with us via service@cirs-group.com.

Note: The data in this article is for reference only. Please refer to the official information released by government authorities.

  

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+353 1 477 3710 (EU)
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+82 2 6347 8816 (KR)
service@cirs-group.com
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