China Publishes Draft Amendment to Standard on Additives for FCMs
On July 3, 2025, the China National Center for Food Safety Risk Assessment (CFSA) published a draft amendment of China’s GB 9685 standard on additives for food-contact materials and articles on its website. The draft is a preliminary version that does not contain a full positive list of cleared substances as more substances may yet be added.
The draft amendment would narrow the scope of GB 9685, revise/add specific migration limits (SMLs) for various substances, and remove certain “high-risk” substances, among other changes. For example, monomers of some base polymers or other starting materials of polymerization that are used during the processing of food-contact materials and articles would no longer be included in the scope of the standard since monomers and other starting materials for coatings, adhesives, and rubbers have been or will be moved to the corresponding materials standards.
In recent years, China’s National Health Commission (NHC) has published the amended Food Safety Standards for plastics (GB 4806.7) and rubber (GB 4806.9), as well as new Standards for adhesives (GB 4806.15) and printing inks (GB 4806.14). An amendment to the Coating Standard (GB 4806.10) is ongoing. Given that certain polymers and/or monomers are regulated by these materials standards, CFSA proposes to remove these substances from the listings in GB 9685. In the draft revision, the numbers of substances that are going to be removed from the tables for additives in plastics, coatings, rubbers, printing inks, and adhesives are 3, 105, 12, 62, and 219, respectively.
Revisions of SMLs in the draft amendment include a new SML of 1 mg/kg for aluminum and a revised SML of 5 mg/kg for zinc (lowered from the current 25 mg/kg SML), which would be consistent with the EU Plastics Regulation. In addition, the SMLs for six substances would be amended in the revised GB 9685, which also align with the SMLs contained in the EU Plastics Regulation, as currently amended. Notably, the SML for bisphenol A (BPA) would be lowered from the current 0.6 mg/kg to 0.05 mg/kg.
In addition, a total of 13 substances that are deemed to have “high risk” and/or have been eliminated by industry would be deleted from the revised GB 9685 standard. These substances include four perfluorinated substances, two nonylphenol derivatives, six phthalates, and sodium perchlorate.
Other changes in the draft revision to GB 9685 include a new “carry-over principle” allowing a food-contact additive to be carried over to the food-contact materials and articles via the raw materials, if certain conditions are met, and the addition of magnesium and zinc salts to the list of salts of cleared acids, alcohols, and phenols that are permitted for use in food-contact materials and articles.
The comment period ended on July 15. It is expected that a new draft will later be published by NHC for another round of comment solicitation, but it is unclear now when that will happen.