In December 2023, China’s National Health Commission (NHC) published on its website a batch of draft standards[1] relating to food, food additives, food-contact materials, and assorted testing methods. A draft amendment of GB 4806.10 on food-contact coatings and coating layers (“Draft Amendment”) is included. Below is a summary regarding the key changes in the Draft Amendment from the current Coatings Standard.

The current version of the Coatings Standard (GB 4806.10-2016), which was published in 2016 and became effective in October 2017, is only applicable to coatings applied to the direct food-contact side of food-contact materials and articles, and resulting coating layers. Further, the Coatings Standard explicitly excludes paper coatings and coating layers from its scope. As a result, industry may not rely upon the positive list in the Coatings Standard to establish a suitable status for coatings used on the indirect food-contact side or paper coatings. However, the Draft Amendment proposes a new definition, which covers coatings and coating layers that may directly or indirectly contact food and of which the components may transfer to food. The exclusion of paper coatings and coating layers is also removed. Accordingly, the Draft Amendment will capture the coatings and coating layers on all kinds of substrates that directly or indirectly contact food.

Compared with the current version of the Coatings Standard, which includes 105 permitted base polymers in its Appendix A, the Draft Amendment contains a positive list of 358 materials, which is a combination of base polymers and monomers. There are more than 60 non-polymeric substances that may be used as monomers and other starting materials. Polymers created by the reaction of listed materials (polymers and non-polymeric substances), with a molecular weight greater than 1,000 Daltons, are also permitted for use as the base materials. Moreover, similar to the amended Plastics Standard (GB 4806.7-2023) that will take effect on September 6, 2024, sodium, potassium, and calcium salts of acids, alcohols, and phenols, which are the starting monomers of polymers, can be used in the synthesis of corresponding polymers. As a result, the positive list in the Draft Amendment would effectively allow the use of many more substances in food-contact coatings and coating layers in China.

As we saw in the amended Plastics Standard, a new specification on the total migration of primary aromatic amines (PAAs), which should be “not detectable” at a limit of detection (LOD) of 0.01 mg/kg, is added. This specification is applicable only to coatings and coating layers that contain aromatic isocyanates and azo dyes.

All comments on the draft must be submitted to NHC before February 10, 2024.

[1] http://www.nhc.gov.cn/sps/s3594/202312/821bdcd4568b4e07834b59b3f91239fe.shtml