China has increasingly enacted laws and regulations that hold individual company employees accountable for serious food, drug, medical device, and cosmetic regulatory violations, such as those related to safety. Consistent with this trend, on September 26, 2022, the State Administration for Market Regulation (SAMR) issued the Provisions on the Supervision and Administration of Implementation of Food Safety Responsible Individuals (the “Provisions”).
These Provisions define the roles and experience requirements for managerial and lower-level food safety personnel of licensed food manufacturers and distributors in China, including the principal responsible person and the food safety director. The Provisions also define the obligations of these companies to establish internal monitoring and recordkeeping systems, and to conduct monitoring and remediate issues. Depending on the seriousness of the violation, companies and individuals can be subject to warning letters, fines, debarment, and loss of licensure for failing to monitor and address safety and other regulatory issues as they arise.
Since becoming effective in late 2022, local MSBs have taken enforcement action pursuant to the Provisions, issuing warning letters and orders to rectify for failures to have required food safety personnel, food safety monitoring systems, and related records.
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Contributors for the China & APAC Food, Drug, Device, and Cosmetics blog:
John Balzano, Julia Post, Muyun Hu, and Kaixin Fan
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