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

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 2 new food contact additives, 5 additives with expanded scope of use and use levels, 5 new food contact resins, 1 resin with 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 (2 types)

S.N.

Product information

Acceptance information/number

Review status

(as of the end of June 2024)

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

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

New food contact resins issued for public comment (5 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	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 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	Issued for public comment on January 3, 2024 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 (5 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 expanded scope of use (1 type)

S.N.

Product information

Acceptance information

Review status

(as of the end of June 2024)

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)

Accepted on January 7, 2021; Acceptance No.: 卫食相进申字(2021) No. 0004l
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 (1 type)

S.N.

Product information

Acceptance information

Review status

(as of the end of June 2024)

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 (5 types)

As of the end of June 2024, the NHC has approved a total of 5 new food-related products, including 2 new food contact additives, 2 new food contact resins, and 1 food contact resin with expanded scope of use. Details are as follows:

Approved new food contact additives (2 types)

S.N.

Product information

Acceptance information

Date of public consultation

Date of official approval

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

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 (2 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

S.N.

Product information

Acceptance information

Date of public consultation

Date of official approval

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

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 expanded scope of use (1 type)

S.N.

Product information

Acceptance information

Date of public consultation

Date of official approval

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 (6 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 the 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.

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

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