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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:
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. |
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