China’s legislature, the National People’s Congress (NPC), has released a draft of the revised Food Safety Law (Draft FSL) for public comment. The comments are due on July 31, 2014. The Food Safety Law was last revised in 2009, when the government changed the Law’s name from the Food Hygiene Law and altered most of its content. Since then, the Law has been one of the focal points of the increasingly intense discussion both inside of China and abroad regarding numerous incidents of misbranded, or at times dangerously adulterated human food produced by some farmers and food manufacturers in China.

The Draft FSL focuses on risk assessment and management. It requires increased attention to government monitoring of specific risks (i.e., foodborne illnesses, illegal additives, and other forms of contamination), assessment of those threats by a centralized government body, and the subsequent enactment of standards or adoption of other mitigation measures that are proportional to the size of the risk.  At the same time, the Draft FSL also requires greater responsibility on the part of manufacturers and distributors of food. For example, the draft requires self-audits by food manufacturers.

The Draft FSL imposes additional requirements on entities in various segments of the food industry and in different parts of the supply chain (manufacturing, distribution, retail) to ensure safety. For example, it requires that infant formula manufacturers implement special good manufacturing practices and that they self-audit and report on those audits to local food and drug authorities. It also prohibits contract manufacturing by infant formula manufacturers. Both of these measures are likely intended to further the government’s stated goal of more strictly supervising the infant formula industry after safety scandals damaged faith in domestic manufacturers in 2004 and 2008. The Draft FSL also imposes responsibilities on “third-party internet service providers,” which permit food distribution on their networks. It requires that these providers keep records and make food safety responsibilities clear to participating food distributors, as well as conduct a review the licenses of the food companies on their network. In addition, it establishes greater clarity about the management of testing and inspections of imports and exports. This is an area that has been developing on the regulatory level since the last revision of the FSL in 2009.

The Draft FSL also requires that the General Administration for Quality Inspection Supervision and Quarantine increase supervision of those companies manufacturing food-related products, presumably referring to packaging and containers and other food contact substances. Companies which manufacture “high risk” food contact substances must obtain a manufacturing license appropriate to their specific industry.

The Draft FSL adds additional detail on the regulation of health foods, or foods that claim a health-promoting function. CFDA already has regulations setting forth substantial requirements for health foods. However, the Draft FSL “supplements” the existing regulations on the systems for pre-marketing notification and approval, as well as promotion. It makes it clear that health food claims must be supported by “scientific evidence,” and CFDA will release a catalogue of permitted claims. It also requires that new health food ingredients and health food products imported for the first time be subject to registration (or licensure) procedures. However, if the new imported products and their ingredients may be evaluated according to national standards or guidelines, then manufacturers are only required to notify CFDA. CFDA will release and periodically amend a catalogue of these products. For all other health food products, the manufacturers need only notify the provincial-level food and drug regulatory authorities. The Draft FSL also describes the materials that manufacturers must submit when applying for registration or notifying the authorities, as the case may be.

Among the most far reaching requirements are those related to penalties. The Draft FSL increases penalties and liabilities significantly. Specifically, the draft increases administrative fines by agencies for FSL violations, the potential for civil compensatory and punitive damages in related litigation, and the potential for criminal prosecution. Perhaps more ominous is the pledge to strengthen the “link” between food safety regulation and criminal penalties. The Draft FSL calls for “prompt” reporting of suspected food safety crimes by CFDA and other administrative agencies to the Ministry of Public Security (China’s police force) for immediate investigation. China has already cracked down on violators of food safety standards through the Criminal Code over the last several years. The draft law increases the trend toward criminal prosecution in this area.

The Draft FSL, if adopted, has the potential to generate significant regulatory changes in China’s food regulatory oversight system. Stakeholders should consider submitting comments to NPC and monitor for the Law’s adoption, as well as the many implementing regulations that will follow.