Analysis of Application Approval of New Food-Related Products in the First Half of 2022 - Regulatory News - Food & Food Contact Materials

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As of the end of June 2022, the National Health Commission of the People's Republic of China (NHC) issued 2 announcements (No. 1, 2022, and No. 2, 2022) for the approval of food-related products. Totally, 34 new food-related products (herein "new food contact additives and resins") are approved. Besides, from the website of NHC and China National Center for Food Safety Risk Assessment (CFSA), a total of 10 new food contact additives and resins application were officially accepted and 5 food contact additives and resins (including expanded use) were issued for public comments.

CIRS Group will take you to detailed information about the acceptance and approval of new food contact additives and resins in China in the first half of 2022.

1. List of new food contact additives and resins application acceptance in the first half of 2022 (10 types)

In the first half of 2022, a total of 10 new food contact additives and resins (including expanded use) applications were accepted by NHC, including 5 of domestic products and 5 of overseas products. Among them, one product (衛食相進申字(2022)第0002號) has been reviewed and issued a disapproval decision on April 20, 2022.

S.N.	Acceptance date	Acceptance code	Name of the new food contact additive or resin	Approval status (By the end of June 2022)
1	2022.01.04	衛食相進申字(2022)第0001號	bicyclo[2.2.1]heptane-2,3-dicarboxylicacid, Calcium salt (1:1), (1R,2R,3S,4S)-rel-	Has not passed the technical review yet.
2	2022.01.06	衛食相申字(2022)第0001號	Terephthalic acid, polymer with sebacic acid, ethylene glycol	Has not passed the technical review yet.
3	2022.01.10	衛食相進申字(2022)第0002號	1,1-methylenebis4-isocyanatocyclohexane homopolymer, methoxypolyethylene glycols-blocked	Issued for a disapproval decision on April 20, 2022.
4	2022.03.08	衛食相進申字(2022)第0003號	1,6-adipic acid, polymer with fumaric acid and tricyclodecanedimethano	Has not passed the technical review yet.
5	2022.03.11	衛食相進申字(2022)第0004號	Dimethyl terephthalate, polymer with 1,4-butanediol and 4,8-bis(hydroxymethyl)tricyclo[5.2.1.0(2,6)]decane	Has not passed the technical review yet.
6	2022.03.11	衛食相申字(2022)第0002號	Dichlorodimethylsilane reaction products with silica	Has not passed the technical review yet.
7	2022.03.14	衛食相申字(2022)第0003號	Carbon fiber	Has not passed the technical review yet.
8	2022.03.21	衛食相申字(2022)第0004號	4-ethylphenol, polymer with m-cresol, p-cresol, 4-tert-butylphenol and formaldehyde	Has not passed the technical review yet.
9	2022.05.09	衛食相進申字(2022)第0005號	Fatty acids, C₁₈-unsaturated, dimers hydrogenated, polymer with 1,4-butanediol, ethylene glycol, terephthalic acid and trimethylolpropane, hydrogenated	Has not passed the technical review yet.
10	2022.05.12	衛食相申字(2022)第0005號	Copolymer precondensed particles containing polysilsesquioxane and silicon dioxide with methyl and/or phenyl attached to the silicon atom	Has not passed the technical review yet.

2. List of drafted approved new food contact additives and resins in the first half of 2022 (5 types)

In the first half of 2022, 5 of new food contact additives and resins have passed the technical review of the CFSA Expert Review Committee and have been open for public comments, including 3 of new food contact resins, 1 of expanded use of current food contact additive and 1 of expanded use of current food contact resin. Among them, one new food contact resin issued on 8 February was officially approved in 11^th May of this year.

2.1 List of drafted approved new food contact resins (3 types)

S.N.	Basic information	Acceptance date	Approval status (By the end of June 2022)
1	Name: 1,3-Benzenedicarboxylic acid, polymer with 1,3-benzenedimethanamine and hexanedioic acid CAS No.: 28628-75-3 Scope: Plastic Maximum level of use: Appropriate level	Accepted on September 3, 2021. The Acceptance code is衛食相進申字(2021)第0022號.	Issued for public comments on February 8, 2022, and officially approved on May 11, 2022 according to Notice No. 2, 2022.
2	Name: Hexane, 1,6-diisocyanato-, polymer with poly (oxy-1,2-ethanediyl), α-methyl-ω-hydroxy- CAS No.: 143472-08-6; 160994-68-3 Scope: Adhesive (Indirect contact with food) Maximum level of use: Appropriate level	Accepted on July 12, 2021. The Acceptance code is衛食相申字(2021)第0012號.	Issued for public comments on April 22, 2022, but has not officially approved.
3	Name: 1,4-benzenedicarboxylic acid, polymer with 1,3-benzenedicarboxylic acid, 2,2,4,4-tetramethyl-1,3-cyclobutanediol, 1,4-cyclohexanedimethanol, 1,3-propanediol, 2-methyl-, and adipic acid CAS No.: / Scope: Coating and coating film Maximum level of use: 80% (count as the dry weight of coating)	Accepted on September 6, 2021. The Acceptance code is衛食相進申字(2021)第0023號.	Issued for public comments on April 22, 2022, but has not officially approved.

2.2 List of drafted approvals of expanded use of current food contact additive (1 type)

S.N.

Basic information

Acceptance date

Approval status

(By the end of June 2022)

Name: 2-(5-Chloro-2H-benzotriazol-2-yl)-6- (1,1-dimethylethyl)-4-methylphenol

CAS No.: 3896-11-5

Scope: Plastic: Plastic: PS

Maximum level of use: 0.5%

The Acceptance code is衛食相申字(2020)第0020號.

(Note: The accepted time was not retrieved.)

Issued for public comments on April 22, 2022, but has not officially approved.

2.3 List of drafted approvals of expanded use of current food contact resin (1 type)

S.N.

Basic information

Acceptance date

Approval status

(By the end of June 2022)

Name: Poly[imino-1,4-butanediylimino (1,10-dioxo-1,10-decanediyl)]

CAS No.: 26247-06-3

Scope: Plastic

Maximum level of use: Appropriate level

Accepted on November 8, 2021. The Acceptance code is衛食相進申字(2021)第0031號.

Issued for public comments on February 8, 2022, but has not officially approved.

3. List of officially approved new food contact additives and resins in the first half of 2022 (34 types)

In the first half of 2022, there were totally 34 of new food contact additives and resins officially approved by NHC, including 10 new food contact additives, 11 of expanded use of current food contact additives, 11 of new food contact resins, 1 new food contact material and article and 1 new disinfectant raw material. The detailed information of those 34 products are listed as follows:

3.1 List of approvals of new food contact additives (10 types)

S.N.	Basic information	Acceptance date	Date for comments	Approval date
1	Name: 2-Propenoic acid, polymer with 2,5-furandione and 2-propenamide, sodium salt CAS No.: 1630821-33-8 Scope: Paper and paperboard Maximum level of use: 0.041% (count as the dry weight)	Accepted on November 6, 2020. The Acceptance code is衛食相進申字(2020)第0019號.	Issued for public comments on June 29, 2021.	Approved on March 1, 2022 according to Notice No. 1, 2022.
2	Name: 1,3,5-Triallyl-1,3,5-triazine-2,4,6 (1H,3H,5H)-trione CAS No.: 1025-15-6 Scope: Fluororubber Maximum level of use: 4%	/ (Note: The acceptance information cannot be found.)	Issued for public comments on August 20, 2021.
3	Name: C_16~18-Fatty acids, esters with pentaerythritol CAS No.: 85116-93-4 Scope: Plastic: PBT Maximum level of use: 1%	Accepted on November 6, 2020. The Acceptance code is衛食相進申字(2020)第0021號.	Issued for public comments on August 20, 2021.
4	Name: Vitamin E (dl-α-Tocopherol acetate) CAS No.: 7695-91-2 Scope: Plastic: PE, PP Maximum level of use: Appropriate level	Accepted on April 28, 2019. The Acceptance code is衛食相申字(2019)第0006號.	Issued for public comments on August 20, 2021.
5	Name: 1-Decene, homopolymer, hydrogeneated CAS No.: 68037-01-4 Scope: Coating and coating film Maximum level of use: 1% (count as the coating formula)	Accepted on January 5, 2021. The Acceptance code is衛食相申字(2021)第0001號.	Issued for public comments on August 20, 2021.
6	Name: Hexanedioic acid, polymer with 1,2-propanediol CAS No.: 25101-03-5 Scope: Coating and coating film Maximum level of use: 5% (count as the coating formula)	Accepted on January 5, 2021. The Acceptance code is衛食相進申字(2021)第0001號.	Issued for public comments on August 20, 2021.
7	Name: Acids, aliphatic, monocarboxylic (C₁₀-C₂₂), esters with polyglycerol CAS No.: / Scope: Plastic Maximum level of use: 0.35%	Accepted on March 9, 2021. The Acceptance code is衛食相進申字(2021)第0008號.	Issued for public comments on October 27, 2021.	Approved on May 11, 2022 according to Notice No. 2, 2022.
8	Name: 2-Propenoic acid, 2-methyl-, 1,2-ethanediyl ester, polymer with methyl 2-methyl-2-propenoate CAS No.: 25777-71-3 Scope: Plastic: PE, PP Maximum level of use: 1%	Accepted on October 26, 2020. The Acceptance code is衛食相進申字(2020)第0018號.	Issued for public comments on October 27, 2021.
9	Name: Hexanedioic acid, polymer with N-(2-aminoethyl)-1,3-propanediamine, aziridine, (chloromethyl)oxirane, 1,2-ethanediamine, N,N''-1,2-ethanediylbis[1,3-propanediamine], formic acid and α-hydro-ω-hydroxypoly (oxy-1,2-ethanediyl) CAS No.: 114133-44-7 Scope: Paper and paperboard Maximum level of use: 0.12% (count as the dry weight)	Accepted on May 10, 2021. The Acceptance code is衛食相申字(2021)第0008號.	Issued for public comments on October 27, 2021.
10	Name: Phosphoric acid, zirconium(4⁺) salt (2:1) CAS No.: 13772-29-7 Scope: Plastic: PE, PP, PS, PLA; Coating and coating film Maximum level of use: PE, PP, PS, PLA: 1%; For coating and coating film, 1% (count as the coating formula).	Accepted on July 7, 2021. The Acceptance code is衛食相申字(2021)第0011號.	Issued for public comments on December 9, 2021.

3.2 List of approvals of expanded use of current food contact additives (11 types)

S.N.	Basic information	Acceptance date	Date for comments	Approval date
1	Name: Maltodextin CAS No.: 9050-36-6 Scope: Adhesives Maximum level of use: Appropriate level	Accepted on January 8, 2021. The Acceptance code is 衛食相申字(2021)第0002號.	Issued for public comments on June 29, 2021.	Approved on March 1, 2022 according to Notice No. 1, 2022.
2	Name: C.I. pigment blue 15 CAS No.: 147-14-8 Scope: Plastic: PLA Maximum level of use: 0.7%	Accepted on November 2, 2020. The Acceptance code is衛食相申字(2020)第0017號.	Issued for public comments on June 29, 2021.
3	Name: C.I. pigment red 254 CAS No.: 84632-65-5 Scope: Plastic: PLA Maximum level of use: 1.4%	Accepted on November 2, 2020. The Acceptance code is衛食相申字(2020)第0016號.	Issued for public comments on June 29, 2021.
4	Name: Carbon black CAS No.: 1333-86-4 Scope: Plastic: PLA Maximum level of use: 1.5%	Accepted on November 2, 2020. The Acceptance code is衛食相申字(2020)第0015號.	Issued for public comments on June 29, 2021.
5	Name: C.I. pigment yellow 180 CAS No.: 77804-81-0 Scope: Plastic: PLA Maximum level of use: 0.5%	Accepted on November 2, 2020. The Acceptance code. is衛食相申字(2020)第0014號.	Issued for public comments on June 29, 2021.
6	Name: Hydroxyethyl cellulose CAS No.: 9004-62-0 Scope: Rubber Maximum level of use: 1%	Accepted on May 17, 2021. The Acceptance code is衛食相申字(2021)第0009號.	Issued for public comments on August 20, 2021.
7	Name: 2-Propenoic acid, polymer with styrene CAS No.: 25085-34-1 Scope: Rubber Maximum level of use: 30%	Accepted on May 17, 2021. The Acceptance code is衛食相申字(2021)第0010號.	Issued for public comments on August 20, 2021.
8	Name: 2-Propenoic acid, polymer with sodium phosphinate, sodium salt CAS No.: 129898-01-7 Scope: Paper and paperboard Maximum level of use: Appropriate level	Accepted on July 9, 2020. The Acceptance code is衛食相申字(2020)第0010號.	Issued for public comments on August 20, 2021.
9	Name: Rosin, ester with glycerol CAS No.: 8050-31-5 Scope: Paper and paperboard Maximum level of use: 0.25%	Accepted on November 18, 2020. The Acceptance code is衛食相申字(2020)第0019號.	Issued for public comments on August 20, 2021.
10	Name: C.I. solvent red 52 CAS No.: 80-39-0 Scope: Plastic: PCT Maximum level of use: 0.03%	Accepted on October 28, 2019. The Acceptance code is衛食相申字(2019)第0015號.	Issued for public comments on October 27, 2021.	Approved on May 11, 2022 according to Notice No. 2, 2022.
11	Name: C.I. pigment yellow 180 CAS No.: 77804-81-0 Scope: Plastic: PCT Maximum level of use: 0.3%	Accepted on March 9, 2021. The Acceptance code is衛食相進申字(2021)第0009號.	Issued for public comments on October 27, 2021.	Approved on May 11, 2022 according to Notice No. 2, 2022.

3.3 List of approvals of new food contact resins (11 types)

S.N.	Basic information	Acceptance date	Date for comments	Approval date
1	Name: Copolymer of acrylic acid, styrene, acrylic acid ethyl ester, acrylic acid 2-ethylhexylester, methacrylic acid methyl ester CAS No.: 25585-76-6 Scope: Adhesive (Indirect contact with food) Maximum level of use: Appropriate level	Accepted on April 8, 2020. The Acceptance code is衛食相申字(2020)第0004號.	Issued for public comments on August 20, 2021.	Approved on March 1, 2022 according to Notice No. 1, 2022.
2	Name: Polymer of cyclohexanedimethanol-1,4, ethylene glycol, 2,2-dimethyl-1,3-propanediol, isophthalic acid, dimethyl terephthalate and trimellitic anhydride CAS No.: 74239-60-4 Scope: Coating and coating film Maximum level of use: 30% (count as the coating formula)	Accepted on January 5, 2021. The Acceptance code is衛食相進申字(2021)第0002號.	Issued for public comments on August 20, 2021.	Approved on March 1, 2022 according to Notice No. 1, 2022.
3	Name: Polymer of ethyl acrylate, acrylic acid, and styrene CAS No.: / Scope: Coating and coating film Maximum level of use: 2% (count as the coating formula)	Accepted on May 14, 2021. The Acceptance code is衛食相進申字(2021)第0013號.	Issued for public comments on October 27, 2021.	Approved on May 11, 2022 according to Notice No. 2, 2022.
4	Name: 1,3-Benzenedicarboxylic acid, polymer with 2,2-dimethyl-1,3-propanediol, 1,2-ethanediol and hexanedioic acid CAS No.: 58481-50-8 Scope: Coating and coating film Maximum level of use: 10% (count as the coating formula)	Accepted on May 14, 2021. The Acceptance code is衛食相進申字(2021)第0011號.	Issued for public comments on October 27, 2021.
5	Name: 1-isocyanato-3-isocyanatomethyl- 3,5,5,-trimethylcyclohexane homopolymer, methyl ethyl ketone oxime-blocked CAS No.: 103170-26-9 Scope: Coating and coating film Maximum level of use: 15% (count as the coating formula)	Accepted on January 5, 2021. The Acceptance code is衛食相進申字(2021)第0003號.	Issued for public comments on October 27, 2021.
6	Name: 1,3-Benzenedicarboxylic acid, polymer with azacyclotridecan-2-one, 1,4-benzenedicarboxylic acid, dodecanedioic acid and 4,4'-methylenebis [2-methylcyclohexanamine] CAS No.: 2080394-29-0 Scope: Plastic Maximum level of use: Appropriate level	Accepted on December 24, 2019. The Acceptance code is衛食相申字(2019)第0021號.	Issued for public comments on October 27, 2021.
7	Name: Propanoic acid, 3-hydroxy-2-(hydroxymethyl)-2-methyl-, polymer with 1,3-diisocyanatomethylbenzene and α-hydro-ω-hydroxypoly [oxy(methyl-1,2-ethanediyl)] CAS No.: 37273-57-7 Scope: Adhesive (Indirect contact with food) Maximum level of use: Appropriate level	Accepted on May 10, 2021. The Acceptance code is衛食相申字(2021)第0006號.	Issued for public comments on October 27, 2021.
8	Name: 1,4-Benzenedicarboxylic acid, 1,4-dimethyl ester, polymer with decanedioic acid, 2,2-dimethyl-1,3-propanediol, and 1,2-ethanediol CAS No.: 51382-28-6 Scope: Coating and coating film Maximum level of use: 40% (count as the dry weight of coating)	Accepted on May 18, 2020. The Acceptance code is衛食相申字(2020)第0007號.	Issued for public comments on December 9, 2021.
9	Name: Polymer of 1,4-butanediol dimethacrylate, 2-hydroxyethyl methacrylate, ethyl acrylate, acrylic acid, and styrene CAS No.: / Scope: Coating and coating film Maximum level of use: 92% (count as the coating formula)	Accepted on May 14, 2021. The Acceptance code is衛食相進申字(2021)第0012號.	Issued for public comments on December 9, 2021.
10	Name: 2-Propenoic acid, polymer with butyl 2-propenoate, ethenyl acetate and 2-ethylhexyl-2-propenoate CAS No.: 35239-19-1 Scope: Adhesive (Indirect contact with food) Maximum level of use: 63%	Accepted on May 10, 2021. The Acceptance code is衛食相申字(2021)第0005號.	Issued for public comments on December 9, 2021.
11	Name: 1,3-Benzenedicarboxylic acid, polymer with 1,3-benzenedimethanamine and hexanedioic acid CAS No.: 28628-75-3 Scope: Plastic Maximum level of use: Appropriate level	Accepted on September 3, 2021. The Acceptance code is衛食相進申字(2021)第0022號.	Issued for public comments on February 8, 2022.

3.4 List of approvals of new food contact material and article (1 type)

S.N.

Basic information

Acceptance date

Date for comments

Approval date

Name: Silicon dioxide coatings made from the monomers hexamethyldisiloxane and hexamethyldisilazane

CAS No.: /

Scope: PET Coating

Maximum level of use: Appropriate level

Accepted on May 8, 2020. The Acceptance code. is衛食相進申字(2020)第0007號.

Issued for public comments on June 29, 2021.

Approved on March 1, 2022 according to Notice No. 1, 2022.

3.5 List of approvals of new disinfectant raw material (1 type)

S.N.

Basic information

Acceptance date

Date for comments

Approval date

Name: Peroxyoctanoic acid

CAS No.: 33734-57-5

Scope: 1) Tools and equipment that come into direct contact with food or the surfaces of food packaging materials; 2) Tableware, drinkware.

Maximum level of use: /

Accepted on April 29, 2020. The Acceptance code. is衛食相申字(2020)第0006號.

Issued for public comments on June 29, 2021.

Approved on March 1, 2022 according to Notice No. 1, 2022.

Summary:

Through above analysis, it can be seen that compared with the previous two years (in the first half of 2020: 18 types and 12 types, respectively; in the first half of 2021: 23 types and 21 types, respectively), the number of accepted products (10) and the number of the products for public comment (5) in the first half of 2022 decreased significantly. On the other hand, the first new disinfectant raw material was approved in the first half of 2022, which is a new breakthrough in China.

The declaration period of most new food contact additives and resins are between one and one and a half years. One of the fastest product, 1,3-benzenedicarboxylic acid, polymer with 1,3-benzenedimethanamine and hexanedioic acid, took about eight months from its acceptance to final approval. Therefore, if the application dossiers are fully prepared, the safety are thoroughly studied, the registration period could be shortened. Enterprises who want to carry out the application are suggested to strengthen the feasibility analysis of product registration, and make adequate preparations for product technical review.

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Note: there may be omissions and errors in the data statistics process because of the change of official websites. The data in this article is for reference only, please refer to the official information published by government departments.

Further Information

Analysis of Application Approval of New Food-Related Products (Food Contact Additives and Resins) in 2021

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