This article tracks and collects the updates on China FCM substances in 2023.
Latest update: On November 30, 2023, China National Health Commission (NHC) approved four new food related products, including one new FCM resin, one new FCM additive, and two FCM additives with expanded usage scope.
Ensuring the safety of food contact materials (FCM) plays a key part in China's efforts towards food safety, as some hazardous substances are likely to migrate from food packaging and containers to food products and pose potential risks to human health.
China adopts the positive list system for FCM substances. In addition to the FCM substances included in current standards, the National Health Commission (NHC) proposes and approves new FCM substances from time to time. This article tracks and collects the updates on China FCM substances in 2023, including newly approved and newly proposed substances.
Latest Update: November 30, 2023 [Official Approval]
On November 30, 2023, China National Health Commission (NHC) approved four new food related products, including one new FCM resin, one new FCM additive, and two FCM additives with expanded usage scope. Details are as follows:
One new FCM resin
Name | Use scope | Maximum usage/% | SML/(mg/kg) | Notes |
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 | Paintings and coatings | 46 (as painting formula) | 6 (as methacrylic acid); 6 (as acrylic acid); 0.05 (1,4-butanediol dimethyl acrylate) | It cannot be used for the production of food contact materials and articles for infant and young children, and cannot be used in contact with oil food. |
One new FCM additive
Name | Use scope | Maximum usage/% | Notes |
Coffee grounds | Plastic: PLA, PBS | PLA: 20; PBS: 10 | 1. It cannot be used for the production of food contact materials and articles for infant and young children, and the temperature of use shall not exceed 100℃. 2. Quality specification requirements: particle size ≥ 90% (0.3mm/mass fraction of passing rate), water content<2g/100g, fat content<12g/100g, lead ≤ 0.5mg/kg, arsenic ≤ 0.5mg/kg, Ochratoxin A ≤ 5.0µg/kg, mold ≤ 50CFU/g. 3. Coffee beans and roasted coffee beans used for the production of coffee grounds shall comply with GB 2761 and GB 2763. The collection, production, processing, storage and transportation of coffee grounds shall comply with GB 14881. |
Two FCM additives with expanded usage scope
Name | CAS no. | Use scope | Maximum usage/% | SML/(mg/kg) | Notes |
N,N'-Hexane-1,6-diylbis[3-(3,5-di-tert-butyl-4- hydroxyphenylpropionamide] | 23128-74-7 | Plastic: PUR conveyor belt | 0.5 | 45 | It is limited in the use of PUR conveyor belt. PUR conveyor belt added with this substance shall only be used for the convey of food in the condition of T≤70°C, t≤2h or T≤100°C, t≤15min, and cannot be in contact with foods for infant and young children. |
Pentaerythritoltetrakis(3-(3,5-di-tert-butyl-4- hydroxyphenyl)propionate) | 6683-19-8 | Plastic: PUR conveyor belt | 0.5 | / | It is limited in the use of PUR conveyor belt. PUR conveyor belt added with this substance shall only be used for the convey of food in the condition of T≤70°C, t≤2h or T≤100°C, t≤15min, and cannot be in contact with foods for infant and young children. |
November 3, 2023 [Consultation Draft]
On November 3, 2023, China CFSA opened a FCM resin with expanded usage scope for public comments. Comments can be sent to [email protected] before December 1. Notably, as per GB 9685-2016, this substance has been approved as an additive to be used in rubber, paintings and coatings.
Name | CAS no. | Generic name | Use scope | Maximum usage/% | SML/(mg/kg) | Notes |
Undecanoic acid, 11-amino-, homopolymer | 25587-80-8
| Polyamide (PA) | Plastics | As necessary | 5 (11-aminoundecanoic acid) | Plastic materials and articles produced from this substance as raw materials shall not be used in contact with food with an ethanol content exceeding 50%, the temperature of use shall not exceed 100 ℃, and the contact time with food shall not exceed 1 hour. |
October 7, 2023 [Official Approval]
On October 7, 2023, China National Health Commission (NHC) approves five new food related products, including two new FCM resins and three FCM additives with expanded usage scope. Details are as follows:
Two new FCM resins
Name | CAS no. | Use scope | Maximum usage/% | SML/(mg/kg) | QM/(mg/kg) | Notes |
Polymer from 1,4-terephthalic acid, sebacic acid and 1,2-ethylene glycol | 25067-21-4 | Paintings and coatings | As necessary | 7.5 (as terephthalic acid); 30 (as ethylene glycol) | / | This substance is only used for PET film surface coating, and shall only be used for filling or long-term storage in the condition of room temperature (including hot filling in the condition of T≤70°C, t≤2h or T≤100°C, t≤15min, and pasteurization), as well as microwave heating. |
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 | / | Paintings and coatings | 20 (as painting formula) | 6 (as methacrylic acid); 0.6 (hydroquinone); 18 (N, N-dimethylethanolamine); 0.2 [as the sum of 2,6-dimethylphenol, 2,6-dimethylphenol and TMBPF-DGE, TMBPF-DGE ∙ H2O, and TMBPF-DGE ∙ 2H2O]; 0.05 (as the sum of TMBPF-DGE ∙ HCl, TMBPF-DGE ∙ 2HCl, and TMBPF-DGE ∙ HCl ∙ H2O) | / | Paintings and coatings added with substance shall not contact with oil foods, nor shall they be used for the production of food contact materials and articles for infants and young children. |
Three FCM additives with expanded application scope
Name | CAS no. | Use scope | Maximum usage/% | SML/(mg/kg) | QM/(mg/kg) | Notes |
C.I. pigment black 7; Carbon black | 1333-86-4 | Plastic: PEEK | 0.5 | / | / | The toluene extract of this substance is less than 1%, and the content of benzo [a] pyrene is less than 0.25 mg/kg; It should comply with the requirements for the purity of colorants in Appendix A of GB 9685-2016. |
Copolymer of acrylamide, 2-methacryloxyethyltrimethyl ammonium chloride, itaconic acid, and N,N’ -methylenebis acrylamide | 214495-32-6 | Paper and paperboard | 1.5 (as dry weight) | ND (acrylamide, DL=0.01mg/kg) | / | The paper and cardboard materials and products added with this substance shall not be used for irradiation, and the temperature of use shall not exceed 121 ℃. |
2-acetoxy-1,2,3-propanetricarboxylicacid-tributylester | 77-90-7 | Ink (indirect contact with food) | 10 | 60 [as the sum of substances in the 32nd group of SMT (T)] | / | Ink added with this substance cannot be used for the production of food contact materials and articles for infant and young children, and shall only be used for filling or long-term storage in the condition of room temperature (including hot filling in the condition of T≤70°C, t≤2h or T≤100°C, t≤15min, and pasteurization). |
August 1, 2023 [Official Approval]
On August 1, 2023, China National Health Commission (NHC) approves three new food related products, including one new FCM resin, and two FCM additives with expanded usage scope. Details are as follows:
One new FCM resin
Name | CAS no. | Use scope | Maximum usage/% | SML/(mg/kg) | QM/(mg/kg) | Notes |
β-Alanine, N-(2-aminoethyl)-, monosodium salt, polymer with 1,4-butanediol, 1,6-diisocyanatohexane, 1,3-diisocyanatomethylbenzene and hexanedioic acid | 141073-56-5 | Adhesive (direct contact with food) | 20g/m² (as dry weight) | 5 (as 1,4-butanediol); ND (as isocyanate, DL=0.01 mg/kg); 0.05 [β-Alanine, N-(2-aminoethyl)-, monosodium salt] | 1 (as isocyanate) | For more detailed requirements for these new FCM resins, please look up the names in Chinese Mainland: Permitted Resins. |
Two FCM additives with expanded usage scope
Name | CAS no. | Use scope | Maximum usage/% | SML/(mg/kg) | QM/(mg/kg) | Notes |
Glass fiber | 65997-17-3 | Plastic: PEEK | 30 | / | / | For more detailed requirements for these new FCM additives, please look up the names in Chinese Mainland: Food Contact Materials Additives. |
C.I. pigment black 28 | 68186-91-4 | Paintings and coatings | 15 (by dry weight of coating film) | / | / |
June 28, 2023 [Consultation Draft]
On June 28, 2023, China NHC opened four new FCM substances for public comments, including one new FCM additive, one new FCM resin, and two FCM additives with expanded application scope. Comments can be sent to [email protected] before July 24.
One new FCM additive
Name | Use scope | Maximum usage/% | Notes |
Coffee grounds | Plastic: PLA, PBS | PLA: 20; PBS: 10 | 1. Quality specification requirements: particle size (mass fraction of passing rate of 50 mesh sieve) ≥ 90%, water content<2%, fat content<12%, lead ≤ 0.5mg/kg, arsenic ≤ 0.5mg/kg, Ochratoxin A ≤ 5.0µg/kg, mold ≤ 50CFU/g. 2. Coffee beans and roasted coffee beans used for the production of coffee grounds shall comply with GB 2761 and GB 2763. 3. The collection, production, processing, storage and transportation of coffee grounds shall comply with GB 14881. 4. It cannot be used for the production of food contact materials and articles for infant and young children, and the temperature of use shall not exceed 100℃. |
One new FCM resin
Name | Use scope | Maximum usage/% | SML/(mg/kg) | Notes |
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 | Paintings and coatings | 46 (as painting formula) | 6 (as methacrylic acid); 0.05 (1,4-butanediol dimethyl acrylate) | It cannot be used for the production of food contact materials and articles for infant and young children, and cannot be used in contact with oil food. |
Two FCM additives with expanded application scope
Name | CAS no. | Use scope | Maximum usage/% | SML/(mg/kg) | Notes |
N,N'-Hexane-1,6-diylbis[3-(3,5-di-tert-butyl-4- hydroxyphenylpropionamide] | 23128-74-7 | Plastic: PUR conveyor belt | 0.5 | 45 | It is limited in the use of PUR conveyor belt. PUR conveyor belt added with this substance shall only be used for the convey of food in the condition of T≤70°C, t≤2h or T≤100°C, t≤15min, and cannot be in contact with foods for infant and young children. |
Pentaerythritoltetrakis(3-(3,5-di-tert-butyl-4- hydroxyphenyl)propionate) | 6683-19-8 | Plastic: PUR conveyor belt | 0.5 | ND (acrylamide, DL=0.01mg/kg) | It is limited in the use of PUR conveyor belt. PUR conveyor belt added with this substance shall only be used for the convey of food in the condition of T≤70°C, t≤2h or T≤100°C, t≤15min, and cannot be in contact with foods for infant and young children. |
May 6, 2023 [Official Approval]
On May 6, 2023, China National Health Commission (NHC) announced to approve the use of six new FCM substances, including one new FCM additive and five new FCM resins.
One new FCM additive
Name | CAS no. | Use scope | Maximum usage/% | SML/(mg/kg) | Notes |
Hexanedioic acid polymer with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol, 4-tert-butylbenzoic acid | 74564-66-2 | Paintings and coatings | 5 (as painting formula) | 6 (trimethylolpropane) | For more detailed requirements, please look up the name in Chinese Mainland: Food Contact Materials Additives. |
Five new FCM resins
Name | CAS no. | Use scope | Maximum usage/% | SML/(mg/kg) | Notes |
Tricyclodecanedimethanol polymer with terephtalic acid and 1,6-hexandiol | / | Paintings and coatings | 60 (as painting formula) | 0.05 (Tricyclodecanedimethanol); 7.5 (as terephtalic acid); 0.05 (1,6-hexandiol) | For more detailed requirements for these new FCM resins, please look up the names in Chinese Mainland: Permitted Resins. |
Fatty acids, C18-unsatd., dimmers, hydrogenated polymers with 1,4-butanediol, ethylene glycol, terephthalic acid and trimethylolpropane, block Generic alias: PET | / | Plastic | / | 0.05 (as the sum of fatty acids, C18-unsatd., dimers, hydrogenated and fatty acids, C18-unsatd., dimers, unhydrogenated); 5 (as1,4-butanediol); 30 (as ethylene glycol); 7.5 (as terephthalic acid); 6 (trimethylolpropane) |
1,6-Hexanedioic acid, polymer with (E)-2-butenedioic acid and tricyclodecanedimethanol | 58891-19-3 | Paints and coatings | 18 (as dry weight of paint film) | 0.05 (tricyclodecanedimethanol) |
Polymer of 1,4-butanediol, 2,2-dimethyl-1,3-propanediol, 1,4-cyclohexanedicarboxylic acid and m-phthalic acid | / | Paints and coatings | 30 (as dry weight of paint film) | 5 (as 1,4-butanediol); 0.05 (2,2-dimethyl-1,3-propanediol); 5 (1,4-cyclohexanedicarboxylic acid); 5 (as m-phthalic acid) |
Polymer of butanediol-1,4, tricyclodecanedimethanol and dimethyl terephthalate | 490017-22-6 | Paints and coatings | 59 (as coating formula) | 7.5 (as terephthalic acid); 5 (as 1,4-butanediol); 0.05 (tricyclodecanedimethanol) |
April 25, 2023 [Consultation Draft]
On April 25, 2023, China NHC opened five new FCM substances for public comments, including three FCM additives with expanded application scope, and two new FCM resins. Comments can be sent to [email protected] before May 24.
Three FCM additives with expanded application scope
Name | CAS no. | Use scope | Maximum usage/% | SML/(mg/kg) | QM/(mg/kg) | Notes |
C.I. pigment black 7; Carbon black | 1333-86-4 | Plastic: PEEK | 0.5 | / | / | The toluene extract of this substance is less than 1%, and the content of benzo [a] pyrene is less than 0.25 mg/kg; It should comply with the requirements for the purity of colorants in Appendix A of GB 9685-2016. |
Copolymer of acrylamide, 2-methacryloxyethyltrimethyl ammonium chloride, itaconic acid, and N,N’ -methylenebis acrylamide | 214495-32-6 | Paper and paperboard | 1.5 (as dry weight) | ND (acrylamide, DL=0.01mg/kg) | / | The paper and cardboard materials and products added with this substance shall not be used for irradiation, and the temperature of use shall not exceed 121 ℃. |
2-acetoxy-1,2,3-propanetricarboxylicacid-tributylester | 77-90-7 | Ink (indirect contact with food) | 10 | 60 [as the sum of substances in the 32nd group of SMT (T)] | / | Ink added with this substance cannot be used for the production of food contact materials and articles for infant and young children, and shall only be used for filling or long-term storage in the condition of room temperature (including hot filling in the condition of T≤70°C, t≤2h or T≤100°C, t≤15min, and pasteurization). |
Two new FCM resins
Name | CAS no. | Use scope | Maximum usage/% | SML/(mg/kg) | QM/(mg/kg) | Notes |
Polymer from 1,4-terephthalic acid, sebacic acid and 1,2-ethylene glycol | 25067-21-4 | Paintings and coatings | As necessary | 7.5 (as terephthalic acid); 30 (as ethylene glycol) | / | This substance is only used for PET film surface coating, and shall only be used for filling or long-term storage in the condition of room temperature (including hot filling in the condition of T≤70°C, t≤2h or T≤100°C, t≤15min, and pasteurization), as well as microwave heating. |
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 | / | Paintings and coatings | 20 (as painting formula) | 6 (as methacrylic acid); 0.6 (hydroquinone); 18 (N, N-dimethylethanolamine); 0.2 [as the sum of 2,6-dimethylphenol, 2,6-dimethylphenol and TMBPF-DGE, TMBPF-DGE ∙ H2O, and TMBPF-DGE ∙ 2H2O]; 0.05 (as the sum of TMBPF-DGE ∙ HCl, TMBPF-DGE ∙ 2HCl, and TMBPF-DGE ∙ HCl ∙ H2O) | / | Paintings and coatings added with substance shall not contact with oil foods, nor shall they be used for the production of food contact materials and articles for infants and young children. |
March 15, 2023 [Consultation Draft]
On March 15, 2023, China National Health Commission (NHC) opened three new FCM substances for public comments, including two FCM additives with expanded application scope, and one new FCM resin. Comments can be sent to [email protected] before April 10.
Two FCM additives with expanded application scope
Name | CAS no. | Use scope | Maximum usage/% | SML/ (mg/kg) | QM/ (mg/kg) | Notes |
Glass fiber | 65997-17-3 | Plastic: PEEK | 30 | / | / | / |
C.I. pigment black 28 | 68186-91-4 | Paintings and coatings | 15 (by dry weight of coating film) | / | / | This substance shall comply with the requirements for the purity of colorant in Appendix A of GB 9685-2016, and the content of manganese shall not exceed 100 mg/kg; The SML of copper and manganese shall comply with the provisions of Appendix C of GB 9685-2016. |
One new FCM resin
Name | CAS no. | Use scope | Maximum usage/% | SML/ (mg/kg) | QM/ (mg/kg) | Notes |
β-Alanine, N-(2-aminoethyl)-, monosodium salt, polymer with 1,4-butanediol, 1,6-diisocyanatohexane, 1,3-diisocyanatomethylbenzene and hexanedioic acid | 141073-56-5 | Adhesive (direct contact with food) | 20 g/m² (as dry weight) | 5 (as 1,4-butanediol); ND (as isocyanate, DL=0.01 mg/kg); 0.05 [β-Alanine, N-(2-aminoethyl)-, monosodium salt] | 1 (as isocyanate) | The shelf life of this substance is 6 months under the storage environment of 10~30 ℃. Adhesive produced with this substance as raw materials should only be used for filling or long-term storage in the condition of room temperature (including hot filling in the condition of T≤70°C, t≤2h or T≤100°C, t≤15min, and pasteurization). |
March 2, 2023 [Official Approval]
On March 2, 2023, China National Health Commission (NHC) announced to approve the use of 11 new FCM substances, including three new FCM additives, four FCM additives with expanded use scope, three new FCM resins, and one FCM resin with expanded use scope.
Three new FCM additives
Name | CAS no. | Use scope | Maximum usage/% | SML/(mg/kg) | QM/(mg/kg) | Notes |
Cyclohexane, 1,1'-methylenebis[4-isocyanato-, homopolymer, cyclohexylamine-terminated | 315207-86-4 | Plastic: PCN | 0.35 | ND [1,1'- methylenebis (4-isocyanate cyclohexane), as isocyanate: DL=0.01 mg/kg]; 0.05 (4,4 '- subunit dicyclohexylamine) | 1 [1,1'- methylenebis (4-isocyanate cyclohexane), as isocyanate] | For more detailed requirements for these new FCM additives, please look up the names in Chinese Mainland: Food Contact Materials Additives. |
2-[2-(2,4-diamino-6-hydroxypyrimidin-5-yl)diazenyl]-5-methylbenzenesulfonic acid | 1021701-36-9 | Plastic | 0.5 | 0.05 | / |
Copolymer of acrylamide, 2-methacryloxyethyltrimethyl ammoniumchloride, itaconic acid, and N,N’-methylenebis acrylamide | 214495-32-6 | Paper and paperboard | 1 (as dried paper) | ND (acrylamide, dl=0.01mg/kg) | / |
Four FCM additives with expanded use scope
Name | CAS no. | Use scope | Maximum usage/% | SML/(mg/kg) | QM/(mg/kg) | Notes |
Octadecyl 3-(3,5-di-tert-butyl-4-hydroxyphenyl) propionate | 2082-79-3 | Paints and coatings | 0.5 | 6 | / | For more detailed requirements for these new FCM additives, please look up the names in Chinese Mainland: Food Contact Materials Additives. |
Napthalensulfonic acid, polymer with formaldehyde, sodium salt | 9084-06-4；36290-04-7 | Plastic: ABS | 0.12 | 15 (as formaldehyde) | / |
Fatty acid esters of C1~C18 mono- andpoly-fatty alcohols | / | Plastics | 0.1 | / | / |
Silane, dichlorodimethyl-, reaction products with silica | 68611-44-9 | Adhesive (direct contact with food); Ink (indirect contact with food) | Adhesive: 0.002 (as dry weight); Ink: 4 (as dry weight) | / | / |
Three new FCM resins
Name | CAS no. | Use scope | Maximum usage/% | SML/(mg/kg) | QM/(mg/kg) | Notes |
Carbon monoxide-ethylene-propylene terpolymer | 88995-51-1 | Plastic | As necessary | / | / | For more detailed requirements for these new FCM resins, please look up the names in Chinese Mainland: Permitted Resins. |
4-Ethylphenol, m-cresol, p-cresol and4-tert-butylphenol polymers with formaldehyde | 68957-28-8 | Paints and coatings | 62 (as coating formula) | 0.05 (p-tert-butylphenol); 15 (as formaldehyde) | / |
Polymer of ethylene glycol, 2,2-dimethyl1,3-propandiol, terephthalic acid, isophthalic acid, adipic acid and itaconic acid | 1041633-9-1 | Paints and coatings; Adhesive (direct contact with food) | 20 (as dry weight) | 30 (as ethylene glycol); 0.05 (2,2-dimethyl-1,3-propanediol); 7.5 (as terephthalic acid); 5 (as isophthalic acid) | / |
One FCM resin with expanded use scope
Name | CAS no. | Use scope | Maximum usage/% | SML/(mg/kg) | QM/(mg/kg) | Notes |
Isophthalic acid, polymer with 1,3-benzenedimethanamine and hexanedioic acid (Generic name: PA) | 28628-75-3 | Plastic | As necessary | 5 (as isophthalic acid); 0.05 (m-phenylenediamine) | / | For more detailed requirements for the new FCM resin, please look up the name in Chinese Mainland: Permitted Resins. |
January 16, 2023 [Consultation Draft]
On January 16, 2023, China National Center for Food Safety Risk Assessment (CFSA) opened three new food-related products for public comments. Any comments can be sent to [email protected] before February 10, 2023.
One new FCM additive
Name | CAS no. | Application scope | Maximum usage/% | SML (mg/kg) | Notes |
Hexanedioic acid polymer with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol, 4-(1,1-dimethylethyl) benzoate | 74564-66-2 | Paints and coatings | 5 (as coating formula) | 6 (Trimethylolpropane) | Paints and coatings produced with this substance as raw materials cannot be used for the production of plastic and articles for infant and young children. All the restricted use requirements shall be indicated in accordance with the provisions in GB 4806.1. |
Two new FCM resins
Name | Application scope | Maximum usage/% | SML (mg/kg) | Notes |
Tricyclodecanedimethanol polymer with terephtalic acid and 1,6-hexandiol | Paints and coatings | 60 (as coating formula) | 0.05 (Tricyclodecanedimethanol); 7.5 (as terephtalic acid); 0.05 (1,6-hexandiol) | Paints and coatings produced with this substance as raw materials cannot be used for the production of plastic and articles for infant and young children. All the restricted use requirements shall be indicated in accordance with the provisions in GB 4806.1. |
Fatty acids, C18-unsatd., dimmers, hydrogenated polymers with 1,4-butanediol, ethylene glycol, terephthalic acid and trimethylolpropane, block
Generic alias: PET | Plastic | / | 0.05 (as the sum of fatty acids, C18-unsatd., dimers, hydrogenated and fatty acids, C18-unsatd., dimers, unhydrogenated); 5 (as1,4-butanediol); 30 (as ethylene glycol); 7.5 (as terephthalic acid); 6 (trimethylolpropane) | Plastic film made of this substance shall not be in direct contact with food, and the thickness shall not exceed 10μm. The use temperature shall not exceed 130 ℃ and shall not be used in the production of food contact materials and articles for infant and young children. All the restricted use requirements shall be indicated in accordance with the provisions in GB 4806.1. |
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