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.
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 | 衛食相進申字(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 | 衛食相申字(2024) No. 0001 | Calcium sulfate dihydrate | Issued a non-approval decision |
3 | 2024.01.15 | 衛食相進申字(2024) No. 0002 | Copolymer of isobutylene and butene | Not issued for public comment yet |
4 | 2024.01.15 | 衛食相進申字(2024) No. 0003 | Polyisobutylene | Not issued for public comment yet |
5 | 2024.03.01 | 衛食相進申字(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 | 衛食相申字(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 | 衛食相申字(2024) No. 0003 | Ethoxylated hydrogenated castor oil | Not issued for public comment yet |
8 | 2024.03.11 | 衛食相進申字(2024) No. 0005 | Pigment Blue 29 | Not issued for public comment yet |
9 | 2024.03.14 | 衛食相申字(2024) No. 0004 | Ethoxylated hydrogenated castor oil | Issued an opinion on the review |
10 | 2024.03.15 | 衛食相進申字(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 | 衛食相進申字(2024) No. 0007 | Ammonium salt of acrylic acid and ethylene polymer | Not issued for public comment yet |
12 | 2024.04.01 | 衛食相申字(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 | 衛食相進申字(2024) No. 0008 | AMMONIUM LAURATE | Not issued for public comment yet |
14 | 2024.04.02 | 衛食相申字(2024) No. 0006 | Barium sulfate | Not issued for public comment yet |
15 | 2024.04.30 | 衛食相進申字(2024) No. 0009 | Docosanamide | Not issued for public comment yet |
16 | 2024.05.11 | 衛食相進申字(2024) No. 0010 | Cobalt Blue | Not issued for public comment yet |
17 | 2024.05.11 | 衛食相進申字(2024) No. 0011 | Pigment Blue 29 | Not issued for public comment yet |
18 | 2024.05.13 | 衛食相申字(2024) No. 0007 | Calcium sulfate dihydrate | Issued an opinion on the review |
19 | 2024.05.14 | 衛食相申字(2024) No. 0008 | Hexanedioic acid, polymer with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol | Not issued for public comment yet |
20 | 2024.05.15 | 衛食相申字(2024) No. 0009 | Ethoxylated hydrogenated castor oil | Issued an opinion on the review |
21 | 2024.05.16 | 衛食相進申字(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 | 衛食相申字(2024) No. 0010 | 3-Aminopropyltriethoxysilane | Not issued for public comment yet |
23 | 2024.06.26 | 衛食相進申字(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) |
1 | Name: Chromium iron oxide CAS number: 12737-27-8 Scope of use: Plastic Maximum level/%: 2 | Accepted on January 29, 2023 Acceptance No.: 衛食相進申字(2023) No. 0001 |
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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.: 衛食相進申字(2022) No. 0001 |
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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.: 衛食相進申字(2021) No. 0006 |
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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.: 衛食相進申字(2022) No. 0017 |
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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.: 衛食相申字(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.: 衛食相申字(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.: 衛食相申字(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.: 衛食相進申字(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.: 衛食相進申字(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.: 衛食相進申字(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.: 衛食相進申字(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.: 衛食相申字(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) |
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) |
| 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) |
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.: 衛食相申字(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 |
1 | Name: Chromium iron oxide CAS number:12737-27-8 Scope of use: Plastic Maximum level/%: 2 | Accepted on January 29, 2023 Acceptance No.: 衛食相進申字(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.: 衛食相進申字(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.: 衛食相進申字(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.: 衛食相進申字(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 |
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.: 衛食相進申字(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 | 衛食相進申字(2022) No. 0011 |
2 | Silicon dioxide | 2024.06.13 | 衛食相申字(2023) No. 0012 |
3 | Bis (2-ethylhexyl) adipate | 2024.06.13 | 衛食相進申字(2023) No. 0019 |
4 | Calcium sulfate | 2024.06.13 | 衛食相申字(2023) No. 0011 |
5 | Calcium sulfate dihydrate | 2024.06.13 | 衛食相申字(2024) No. 0001 |
6 | Pentaerythritol tetrakis [3-(3,5-di-tert-butyl-4-hydroxyphenyl)-propionate] | 2024.06.13 | 衛食相進申字(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.