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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 2023No. 3 of 2023), with a total of 42 products 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

    衛食相申字(2023)第0001號

    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

    衛食相申字(2023)第0002號

    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

    衛食相進申字(2023)第0001號

    Chromium iron oxide

    Has not passed the technical review yet.

    4

    2023.02.09

    衛食相進申字(2023)第0002號

    Styrene polymer with 1,3-butadiene, hydrogenated

    Has not passed the technical review yet.

    5

    2023.03.03

    衛食相進申字(2023)第0003號

    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

    衛食相進申字(2023)第0004號

    Homopolymer of 11-aminoundecanoic acid

    Has not passed the technical review yet.

    7

    2023.03.22

    衛食相進申字(2023)第0005號

    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

    衛食相申字(2023)第0003號

    Copolymers of trimethoxyphenylsilane, methyltrimethoxysilane, and silica

    Issued a rejection decision on June 26, 2023

    9

    2023.03.28

    衛食相申字(2023)第0004號

    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

    衛食相進申字(2023)第0006號

    3-Methoxy-3-methyl-1-butanol

    Has not passed the technical review yet.

    11

    2023.05.12

    衛食相申字(2023)第0005號

    Hydrogenated C6-20 hydrocarbon polymer

    Has not passed the technical review yet.

    12

    2023.05.12

    衛食相進申字(2023)第0007號

    Steam Light Cracking Debenzene Polymerization Hydrogen Fossil Naphtha

    Has not passed the technical review yet.

    13

    2023.05.17

    衛食相申字(2023)第0006號

    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: 衛食相進申字(2022)第0006號

    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: 衛食相申字(2021)第0021號

    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: 衛食相申字(2022)第0008號

    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:衛食相進申字(2022)第0005號

    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:衛食相申字(2021)第0007號

    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: 衛食相申字(2022)第0001號

    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: 衛食相進申字(2022)第0019號

    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: 衛食相進申字(2022)第0020號

    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: 衛食相進申字(2021)第0025號

    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:衛食相進申字(2022)第0014號

    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: 衛食相進申字(2021)第0024號

    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: 衛食相申字(2021)第0023號

    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: 衛食相申字(2022)第0011號

    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: 衛食相申字(2023)第0002號

    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:衛食相申字(2023)第0001號

    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: 衛食相進申字(2021)第0020號

    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: 衛食相進申字(2021)第0017號

    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: 衛食相申字(2021)第0013號

    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: 衛食相進申字(2022)第0006號

    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: 衛食相進申字(2021)第0026號

    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: 衛食相申字(2022)第0004號

    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: 衛食相進申字(2021)第0007號

    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: 衛食相申字(2022)第0008號

    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: 衛食相進申字(2022)第0005號

    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: 衛食相進申字(2022)第0011號

    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: 衛食相申字(2021)第0025號

    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: 衛食相進申字(2022)第0004號

    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: 衛食相進申字(2021)第0027號

    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: 衛食相申字(2021)第0004號

    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: 衛食相申字(2021)第0019號

    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: 衛食相申字(2022)第0002號

    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: 衛食相進申字(2022)第0007號

    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

    衛食相進申字(2022)第0009號

    2

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

    2023-01-28

    衛食相進申字(2022)第0013號

    3

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

    2023-01-28

    衛食相進申字(2022)第0010號

    4

    Phenyltrimethoxysilane, copolymer with methyltrimethoxysilane, silicon oxide

    2023-01-28

    衛食相申字(2022)第0010號

    5

    Ammonium laurate

    2023-01-28

    衛食相進申字(2022)第0008號

    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

    衛食相進申字(2021)第0029號

    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

    衛食相進申字(2021)第0018號

    8

    11-amino-undecanoicacidpolymer

    2023-03-17

    衛食相進申字(2022)第0015號

    9

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

    2023-03-17

    衛食相進申字(2022)第0018號

    10

    Chromium dinitrogen

    2023-03-17

    衛食相申字(2022)第0009號

    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.

    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 published by government departments.

      

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