China’s State Administration for Market Regulation (SAMR) released the new draft Food Labeling Supervision and Administrative Measures (the “Draft Measures”) for comment on June 28, 2024.  The last draft food labeling measures were publicly released in 2020, but were never finalized.  The Draft Measures provide requirements on font, size, manufacture date, and net content, as well as set restrictions on claims.  The Draft Measures also consolidate labeling rules for various special foods, including health foods, infant formula, and foods formulated for special medical use. 

As compared to the SAMR Notice on manufacturing date released on March 2024 (see here), the requirements for a manufacture date and expiration date have been changed from “encouraged” to “mandatory” in the Draft Measures.  The Draft Measures also stipulate that food cannot claim to be “for minors” or “special supply for government/armies,” and they clarify that the product standard code—which has always been required on the label—can refer to a group standard.  A group standard is issued by an industry association and can be opted into by food producers on a voluntary basis.   

The Drafting Explanation accompanying the Draft Measures states that a two-year grace period for compliance is expected once the Draft Measures are finalized.  The due date for comments on the Draft Measures is July 27, 2024.

For further information or inquiries relating to this post, please email APACRegBlog@cov.com.

Contributors for the China & APAC Food, Drug, Device, and Cosmetics blog:

John Balzano, Julia Post, Muyun Hu, Kaixin Fan, and Kexin Yang.

Photo of Muyun Hu Muyun Hu

Muyun Hu advises multinational and Chinese companies on a range of regulatory, policy, transactional, and litigation matters. Her work focuses on the life science industry, particularly with regard to food, drug, medical device, cosmetic, and other regulated products.

Photo of John Balzano John Balzano

John Balzano represents companies and business associations on U.S. and China regulatory and policy matters related to food, drugs, medical devices, cosmetics, and other regulated products.

John has over a decade of experience with legal and regulatory issues related to China, particularly with…

John Balzano represents companies and business associations on U.S. and China regulatory and policy matters related to food, drugs, medical devices, cosmetics, and other regulated products.

John has over a decade of experience with legal and regulatory issues related to China, particularly with regard to products regulated by the State Administration for Market Regulation, the National Medical Products Administration (NMPA), and other agriculture, animal and healthcare (including digital health) products and services. He assists clients with developing strategies to obtain pre-market approvals for these products in China, including clinical development, understanding relevant pricing and reimbursement policies, and reviewing distribution and promotional plans.

He also advises on regulatory compliance, due diligence, and enforcement matters for China operations, including drafting and revising and integrating China and global standard operating procedures, assessing the functions of regulatory departments in China, responding to inspection results and enforcement inquiries, and implementing product recalls. John also has significant experience designing strategies to handle professional consumer litigation for food and cosmetic companies operating in China and working with local counsel.

He advises companies and industry associations on their advocacy strategies, including the notice and comment process before NMPA and other regulatory agencies.

John has particular experience in the U.S. advising on the requirements for the acquisition and transfer of biospecimens for research purposes.