[Updated] China Food Contact Materials Updates in 2024: NHC Approved Two New FCM Substances

Editor's Note: This article tracks and collects the updates on China FCM substances in 2024. Previous contents can be seen at the bottom of the article.

Ensuring the safety of food contact materials (FCM) plays a key part in China's efforts on achieving a food-safety society, 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 the current standards, China National Center for Food Safety Risk Assessment (CFSA) and 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, including newly proposed and approved substances:

December 13, 2024 [Approved]

On December 13, 2024, China National Health Commission (NHC) approved two new FCM substances, including a FCM additive with expanded usage scope and a new FCM resin. Details are as follows:

One FCM additive with expanded usage scope

Name

CAS no.

Use scope

Maximum usage/%

SML/(mg/kg)

Notes

1,3,5-Trimethyl-2,4,6-tris

(3,5-di-tert-butyl-4-hydroxytolyl)

benzene

1709-70-2

Plastic: carbon monoxide-ethylene-propylene terpolymer

0.5

One new FCM resin

Name

CAS no.

Use scope

Maximum usage/%

SML/(mg/kg)

Notes

Poly(3-hydroxybutyrate-co-3-hydroxyhexanoate); (PHA)

147398-31-0

Plastic

As necessary

0.05 (Butene acid)

Source: Cupriavidus necator H16. The PHA plastic materials and products made from this substance should not be used at temperatures exceeding 100°C, and should not be used in the production of materials and products specifically intended for contact with food for infants and young children The above limited use requirements should be labeled in accordance with the provisions of GB 4806.1.

October 25, 2024 [Proposed]

On October 25, 2024, China CFSA consulted on three new FCM substances, including one FCM additive with expanded usage scope and two FCM resins. Comments can be sent to [email protected] before November 23, 2024.

One FCM additive with expanded usage scope

Name

CAS no.

Use scope

Maximum usage/%

SML/(mg/kg)

Notes

Behenamide

3061-75-4

Plastics: PBT; PLA

0.4

Materials and products made of PBT and PLA plastics are limited to single-use only; they are intended for room temperature filling (including hot filling, pasteurization, or other heat treatments) and long-term storage at room temperature (t > 3 days). The aforementioned usage restrictions should be indicated in accordance with the provisions of GB 4806.1.

Two FCM resins

Name

CAS no.

Use scope

Maximum usage/%

SML/(mg/kg)

Notes

1,4-Benzenedicarboxylic acid, polymer with

2-methyl-1,3-propanediol andtricyclodecanedimethanol

1699749-26-2

Paints and coats9

25 (calculate by dry film weight)

7.5 (calculated as phthalic acid);

5 (2-methyl-1,3-propanediol);

0.05 (4,8-trioxa-3,7,9-tricyclo[5.2.1.0^2,7]decane-2,6-diol)

Coatings and films produced with this substance as a raw material shall not be used in the production of materials and products intended for contact with infant and baby food, with a maximum use temperature not exceeding 131°C. The above usage restrictions should be indicated in accordance with the provisions of GB 4806.1.

Polymer of 1,3-phthalic acid, 1,4-phthalic acid, phthalic anhydride, maleic anhydride and1,2-propylene glycol, 1,2-ethyleneglycol, diethylene glycol, copolymer of styrene; (UP)

1253842-93-1

Plastic

As necessary

5 (calculated as isophthalic acid);

7.5 (calculated as phthalic acid);

30 (calculated as maleic acid);

30 (calculated as ethylene glycol)

Products and materials made from this substance for the production of UP plastics are not permitted for use in manufacturing materials and products intended for contact with infant and baby food. The maximum temperature of use should not exceed 70°C, and they should not be used for contact with food containing ethanol content higher than 20%. The S/V should not exceed 2 dm²/L (kg). These usage restrictions must be indicated in accordance with the provisions of GB 4806.1.

October 10, 2024 [Approved]

On October 10, 2024, China National Health Commission (NHC) approved six new FCM substances, including four FCM additives with expanded use scope, one FCM resins and one FCM resin with expanded use scope. Details are as follows:

Four FCM additives with expanded use scope

Name	CAS no.	Use scope	Maximum usage/%	SML/(mg/kg)	Notes
C.I. Pigment black 7; Carbon black	1333-86-4	Plastic: PCT	2.5	/	The toluene extract in this substance is less than 1%, and the benzo[a]pyrene content is less than 0.25 mg/kg; it should comply with the colorant purity requirements in Appendix A of GB 9685-2016. Plastic materials and products containing this substance shall not be used for food contact with ethanol content higher than 50%, and the usage temperature should not exceed 100°C. The above use restrictions should be labeled in accordance with the provisions of GB 4806.1.
Sodium hydroxide	1310-73-2	Plastic: PVDF	As necessary	/	The substance is only used as a processing aid in the production process of PVDF plastic materials and products. The fluorine migration in the produced PVDF plastic materials and products shall not exceed 0.2 mg/kg. PVDF plastic materials and products containing this substance should only be used under conditions where T ≤ 70°C and t ≤ 24 hours and shall not be used for food contact with ethanol content higher than 50% or oily foods. The above userestrictions should be labeled in accordance with the provisions of GB 4806.1.
Dibutyl sebacate	109-43-3	Plastic: PVDF	As necessary	60 (calculated as the sum of substances in Group 32 in Appendix B of GB 9685-2016)	PVDF plastic materials and products containing this substance should only be used under conditions where T ≤ 70°C and t ≤ 24 hours and shall not be used for food contact with ethanol content higher than 50% or oily foods. The above use restrictions should be labeled in accordance with the provisions of GB 4806.1.
2,4,8,10-Tetraoxa-3,9-diphosphaspiro[5.5]undecane,3,9-bis[2,4- bis(1-methyl-1-phenylethyl)phenoxy]-	154862-43-8	Adhesive (direct contact with food)	0.04	5	Adhesives containing this substance shall not be used for food contact with oily foods. The above use restrictions should be labeled in accordance with the provisions of GB 4806.1.

One FCM resin

Name

CAS no.

Use scope

Maximum usage/%

SML/(mg/kg)

QM/(mg/kg)

Notes

Copolymer of trimethoxyphenylsilane, methyltrimethoxysilane, and silica

Paints and coats

As necessary

1 (Methyltrimethoxysilane)

Coatings produced using this substance as a raw material should only be applied to metal surfaces. The above use restrictions should be labeled in accordance with the provisions of GB 4806.1.

One FCM resin with expanded use scope

Name	CAS no.	Use scope	Maximum usage/%	SML/(mg/kg)	QM/(mg/kg)	Notes
Benzene, ethenyl-, polymer with1,3-butadiene, hydrogenated	66070-58-4	Paints and coats	27.5 (calculated based on the dry weight of the coating)	ND (1,3-butadiene, DL=0.01 mg/kg)	1 (1,3-butadiene)	Coatings produced using this substance as a raw material are for one-time use only, intended for room temperature filling (including hot filling, pasteurization, or other heat treatment) followed by long-term storage at room temperature (t > 3 days). The above use restrictions should be labeled in accordance with the provisions of GB 4806.1.

September 2, 2024 [Proposed]

On September 2, 2024, China CFSA consulted on six new FCM substances, including four FCM additives with expanded usage scope, one FCM resin and one FCM resin with expanded usage scope. Comments can be sent to [email protected] before October 2, 2024.

Four FCM additives with expanded usage scope

Name	CAS no.	Use scope	Maximum usage/%	SML/(mg/kg)	Notes
Polyisobutylene	1709-70-2	Adhesive (for direct/indirect contact with food)	35	/	The adhesive containing this substance is only to be used for contacting aqueous foods, liquid milk, and foods with an ethanol content not exceeding 50%. When in contact with food indirectly, it should be filled at room temperature and stored long term at room temperature (including hot filling under conditions of T≤70℃, t≤2h or T≤100℃, t≤15min, and pasteurization), and when in direct contact with food, it should be used under refrigeration conditions. The aforementioned restrictions on usage should be labeled according to the regulations of GB4806.1.
Butene, polymer with 2-methyl-1-propene	9044-17-1	Adhesive (for direct/indirect contact with food)	35	/	The adhesive containing this substance is only to be used for contacting aqueous foods, liquid milk, and foods with an ethanol content not exceeding 50%. When in contact with food indirectly, it should be filled at room temperature and stored long term at room temperature (including hot filling under conditions of T≤70℃, t≤2h or T≤100℃, t≤15min, and pasteurization), and when in direct contact with food, it should be used under refrigeration conditions. The aforementioned restrictions on usage should be labeled according to the regulations of GB4806.1.
2-Propenoic acid polymer withethene, ammoniumsalt	25212-83-3	Paper and paperboard	16.7(calculated as product formula)	6 (calculated as propenoic acid)	Paper and paperboard materials and products containing this substance shall not be used in the production of materials and products intended for contact with infant and baby food. They should be filled at room temperature and stored long term at room temperature (including hot filling under conditions of T≤70℃, t≤2h, or T≤100℃, t≤15min, and pasteurization). The aforementioned restrictions on usage should be labeled according to the regulations of GB4806.1.
Ethanaminium, N,N,N-trimethyl-2- [(1-oxo-2-propen-1-yl)oxy]-, chloride (1:1), polymer with 2-propenamide modified withpropenoic acid	69418-26-4	Paper and paperboard	0.6 (calculated on the dry weight of the paper)	ND (acrylamide, DL=0.01mg/kg)	The content of propenoic acid in this substance shall not exceed 2%. Paper and paperboard materials and products containing this substance shall not be used for irradiation. The aforementioned restrictions on usage should be labeled according to the regulations of GB 4806.1.

One FCM resin

Name

CAS no.

Use scope

Maximum usage/%

SML/(mg/kg)

Notes

2-Propenoic acid, 2-methyl-, phenylmethyl ester, polymer with2-propenoic acid, 2-methyl-, 1,2-ethanediyl ester (PAcr)

126969-53-7

Plastic

As necessary

6 (calculated as methacrylic acid); 0.05 (2-methyl-2-propenoic acid-1,2-ethanediyl ester)

Quality specifications:

Particle size: uniformity coefficient ≤2.0; 200-600 μm: ≥85% (by volume); >600 μm (600-1000 μm): ≤10% (by volume);<200 μm: ≤5% (by volume).

PAcr plastic materials and products produced with this substance as a raw material shall not exceed 70°C in temperature and 2 hours in contact time when in contact with food. The aforementioned restrictions on usage should be labeled according to the regulations of GB4806.1.

One FCM resin with expanded usage scope

Name

CAS no.

Use scope

Maximum usage/%

SML/(mg/kg)

Notes

2,6-Naphthalenedicarboxylic acid, 2,6-dimethyl ester, polymer with 1,4-cyclohexanedimethanol, 1,2-ethanediol, 2,2’-oxybis[ethanol] and β³, β³, β⁹, β⁹-tetramethyl-2,4,8,10- tetraoxaspiro[5.5]undecane-3,9-diethanol (PCN)

2146168-28-5

Plastic

0.05 (2,6-naphthalene dimethyl dicarboxylate); 30 (calculated as ethylene glycol); 5 (β³, β³, β⁹, β⁹-tetramethyl-2,4,8,10-tetraoxa-spiro[5.5]undecane-3,9-diethanol)

PCN plastic materials and products produced with this substance as a raw material shall not exceed 100°C in usage temperature. The aforementioned restrictions on usage should be labeled according to the regulations of GB 4806.1.

August 5, 2024 [Approved]

June 24, 2024 [Proposed]

May 9, 2024 [Proposed]

On May 9, 2024, China CFSA consulted on seven new FCM substances, including one new food contact material, four new FCM additives with expanded usage scope, one FCM resin and one FCM resin with expanded usage scope. Comments can be sent to [email protected] before May 27, 2024.

one new food contact material

Name

CAS no.

Use scope

Maximum usage/%

SML/(mg/kg)

Notes

Chromium nitride coatings made from nitrogen and chromium

12053-27-9, 24094-93-7

Paintings and coatings

As necessary

ND (calculated as VI, DL=0.01mg/kg)

Using nitrogen and metallic chromium as raw materials, the Physical Vapor Deposition (PVD) technology is adopted to create a coating on the surface of the metal substrate. In the coating, the atomic percentage of nitrogen elements is 18%-40%, and the atomic percentage of chromium elements is 60%-82%.

Four new FCM additives with expanded usage scope

Name	CAS no.	Use scope	Maximum usage/%	SML/(mg/kg)	Notes
C.I. Pigment black 7; Carbonblack	1333-86-4	Plastic: PCT	2.5	/	In this substance, the toluene extractables are less than 1%, and the content of benzo[a]pyrene is less than 0.25mg/kg; it should meet the purity requirements for colorants in Appendix A of GB 9685-2016. PCT plastics and articles containing this substance must not be used in contact with foods containing more than 50% ethanol, and the temperature during use must not exceed 100℃. The above limited use requirements should be labeled in accordance with the provisions of GB 4806.1.
Sodium hydroxide	1310-73-2	Plastic: PVDF	As necessary	/	This substance is solely used as a processing aid in the production process of PVDF plastic materials and products. The fluorine migration in the resulting PVDF plastic materials and products must not exceed 0.2 mg/kg; PVDF plastic materials and products containing this substance can only be used under conditions where T≤70℃ and t≤24h, and must not be used in contact with foods containing more than 50% ethanol and oily foods. The above limited use requirements should be labeled in accordance with the provisions of GB 4806.1.
Dibutyl sebacate	109-43-3	Plastic: PVDF	As necessary	/	This substance is solely used as a processing aid in the production process of PVDF plastic materials and products; PVDF plastic materials and products containing this substance can only be used under conditions where T≤70℃ and t≤24h, and must not be used in contact with foods containing more than 50% ethanol and oily foods. The above limited use requirements should be labeled in accordance with the provisions of GB 4806.1.
2,4,8,10-Tetraoxa-3,9-diphosphaspiro[5.5]undecane,3,9-bis[2,4- bis(1-methyl-1-phenylethyl)phenoxy]-	154862-43-8	Adhesives (direct contact with food)	0.04	/	Adhesives containing this substance are used for room temperature filling and long-term storage at room temperature (including hot filling and pasteurization under conditions of T≤70℃, t≤2h or T≤100℃, t≤15min), and must not be used in contact with oily foods. The above limited use requirements should be labeled in accordance with the provisions of GB 4806.1.

One FCM resin

Name

CAS no.

Use scope

Maximum usage/%

SML/(mg/kg)

QM / (mg/kg)

Notes

Copolymer of

trimethoxyphenylsilane, methyltrimethoxysilane, and silica

Paintings and coatings

As necessary

1 (Methyltrimethoxysilane)

Paintings and coatings produced from this material are only coated on metal surfaces. The above limited use requirements should be labeled in accordance with the provisions of GB 4806.1.

One FCM resin with expanded usage scope

Name

CAS no.

Use scope

Maximum usage/%

SML/(mg/kg)

QM / (mg/kg)

Notes

Benzene, ethenyl-, polymer with1,3-butadiene, hydrogenated

66070-58-4

Paintings and coatings

27.5 (calculated based on the dry weight of the coating film)

ND (1,3-butadiene, DL=0.01mg/kg)

1 (1,3-butadiene)

Paints and coatings produced with this substance as a raw material are limited to single-use, and are used for room temperature filling and long-term storage at room temperature (including hot filling at T≤70°C, t≤2h or T≤100°C, t≤15min conditions and Pasteurization disinfection).The above limited use requirements should be labeled in accordance with the provisions of GB 4806.1.

March 13, 2024 [Approved]

On March 13, 2024, China National Health Commission (NHC) approved five new food related products, including two new FCM additives, two new FCM resins, and one FCM resin with expanded usage scope. Details are as follows:

Two new FCM additives

Name	CAS no.	Use scope	Maximum usage/%	SML/(mg/kg)	Notes
Chromium iron oxide	12737-27-8	Plastic	2	/	Plastic materials and articles that contain this substance shall not be used in contact with food specifically for infants and young children; This substance must meet the purity requirements for colorants specified in GB 9685-2016; It should comply with the requirements for indicating the use restrictions in GB 4806.1.
Bicyclo[2.2.1] heptane-2,3-dicarboxylic acid, calcium salt (1:1), (1R,2R,3S,4S)-rel-	839683-04-4	Plastic: PP, PE	0.25	5	PP and PE plastic materials and articles that contain this substance shall not be used in contact with food specifically for infants and young children; The temperature of use shall not exceed 100 ℃; It should comply with the requirements for indicating the use restrictions in GB 4806.1.

Two new FCM resins

Name	CAS no.	Use scope	Maximum usage/%	SML/(mg/kg)	Notes
Polybutylene succinate adipate (Generic name: PBSA)	67423-06-7	Plastic	As necessary	5 (calculated as 1,4-butanediol); 0.05 (tetrahydrofuran)	It cannot be used for the production of food contact materials and articles for infant and young children; PBSA plastics and articles containing this substance cannot be used in contact with acidic foods or foods with an ethanol content higher than 10%;They shall be used only for one-time use, filled at room temperature, and stored for a long time at room temperature (including hot filling in the condition of T≤70°C, t≤2h or T≤100°C, t≤15min, and pasteurization); It should comply with the requirements for indicating the use restrictions in GB 4806.1.
1,3-Benzenedicarboxylic acid, polymer with 1,4-benzenedicarboxylic acidand1,4-cyclohexanedimethanol (Generic name: PCT)	26124-27-6	Plastic	As necessary	5 (as 1,3-Benzenedicarboxylic acid); 7.5 (as 1,4-benzenedicarboxylic acid)	It cannot be used for the production of food contact materials and articles for infant and young children; PCT plastics and articles containing this substance 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); It should comply with the requirements for indicating the use restrictions in GB 4806.1.

One FCM resin with expanded usage scope

Name	CAS no.	Use scope	Maximum usage/%	SML/(mg/kg)	Notes
Undecanoic acid, 11-amino-, homopolymer (Generic name: PA)	25587-80-8	Plastic	As necessary	5 (11-Aminoundecanoic acid）	PA plastics and articles containing this substance shall not be used in contact with foods with an ethanol content higher than 50%; The temperature of use shall not exceed 100℃; Usage time must not exceed 1 hour; It should comply with the requirements for indicating the use restrictions in GB 4806.1.

February 26, 2024 [Proposed]

January 3, 2024 [Proposed]

On January 3, 2024, China CFSA consulted on four new FCM substances, including two new FCM additives and two new FCM resins. Comments can be sent to [email protected] before January 21.

Two new FCM additives

Name	CAS no.	Use scope	Maximum usage/%	SML/(mg/kg)	Notes
Chromium iron oxide	12737-27-8	Plastic	2	/	Plastics and articles containing this substance cannot be used for the production of food contact materials and articles for infant and young children; It should comply with the requirements for the purity of colorants in GB 9685-2016.
Bicyclo[2.2.1] heptane-2,3-dicarboxylic acid, calcium salt (1:1), (1R,2R,3S,4S) -rel	839683-04-4	Plastic: PP, PE	0.25	/	PP and PE plastic materials and articles containing this substance cannot be used for the production of food contact materials and articles for infant and young children; The temperature of use shall not exceed 100℃.

Two new FCM resins

Name	CAS no.	Use scope	Maximum usage/%	SML/(mg/kg)	Notes
Polybutylene succinate adipate (Generic name: PBSA)	67423-06-7	Plastic	As necessary	5 (as 1,4-butanediol); 0.05 (tetrahydrofuran)	It cannot be used for the production of food contact materials and articles for infant and young children; PBSA plastics and articles containing this substance shall not be used in contact with acidic foods or foods with an ethanol content higher than 10%. They shall be used only for one-time use, filled at room temperature, and stored for a long time at room temperature (including hot filling in the condition of T≤70°C, t≤2h or T≤100°C, t≤15min, and pasteurization).
1,3-Benzenedicarboxylic acid, polymer with 1,4-benzenedicarboxylic acid and 1,4-cyclohexanedimethanol (Generic name: PCT)	26124-27-6	Plastic	As necessary	5 (as 1,3-Benzenedicarboxylic acid); 7.5 (as 1,4-benzenedicarboxylic acid)	It cannot be used for the production of food contact materials and articles for infant and young children; PCT plastics and articles containing this substance 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).

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