China's Food Safety Law Takes Effect Today: Are You Ready?

Today, October 1st, is an important day for any company in the food industry doing business in China. More specifically, the Food Safety Law^[1] (FSL) is now in effect. As you may recall, on April 24, 2015, in response to several high-profile food safety scandals and the need to harmonize with the global practice of food safety management, China passed sweeping amendments to its FSL. We reported on this in our "China Regulatory Matters!" alert, dated April 28, 2015. The effective date has now arrived and, therefore, it is important to be aware that a number of significant changes have been made to China's food regulations and new mechanisms have been established to deepen the reforms. 

As the fundamental law regulating food safety in China, the revised FSL builds up the basic legal framework for food safety supervision and management; however, like most framework documents, it is short on detail. To put some meat on its bones, in the past few months, the National Health and Family Planning Commission (NHFPC), China Food and Drug Administration (CFDA) and General Administration of Quality Supervision, Inspection and Quarantine (AQSIQ), along with other administrative agencies, published several important regulations and national food safety standards. The purpose of this article is to alert you to what has transpired since the FSL was passed, what we can expect to see in the future, and what the prospects are for several key food industries under China's new food regulatory regime.

All Food Business

• Management Regulations for Food Operation License (Draft for comment)^[2] & Food Production License (Draft for comment^[3] were issued by the CFDA to manage the licensing regime for food production and restaurant service. For the first time, the production license for food additives is explicitly incorporated into the scope of the food production license. Furthermore, the current food distribution license and restaurant service license will be combined and subject to one food operation license which will be issued by food and drug administration. 
• Measures for the Administration of Supervision and Inspection of Food Production and Operation (Draft for comment^[4] regulate the supervision and inspection of food producers and operators per corresponding requirements mandated by the new FSL. The appendix section of the Measures attaches compliance check-lists for a) producers of foods/food additives, b) producers of health foods, c) food distributors, and d) restaurant service providers, respectively, for the enforcement officers at the local level to examine compliance. 
• Interim Regulations on Food Advertisements Publication (Amended) (Draft for comment),^[5] issued by the State Administration of Industry and Commerce (SAIC), provides detailed guidance on regulation of food advertising, capturing not only conventional foods (e.g., dairy products for infants) but also health foods. This draft is based on the currently effective version which was issued in 1998. 
• Measures for the Administration of Food Recalls^[6] which were issued by CFDA and became effective on September 1 of 2015, provide the food recall requirements for regular foods, food additives and health foods. Food recalls were previously administered by the Management Regulations of Food Recalls,^[7]    which were announced in 2007 by AQSIQ. Further coordination and implementation on food recalls between the government bodies remains to be seen. 
• Administrative Measures for the Audit and Inspection of Overseas Companies by Food Product Importers (Draft for comment)^[9] impose heavy responsibilities on the local importer to ensure the safety of food products that they plan to distribute in China. According to the Measures, at least once in every three years, domestic food importers are obliged to conduct on-site audit of facilities outside of China that produce, for example, infant formula, formulation food for special medical purposes, health foods, and meat products. Such on-site inspection can be authorized to accredited third party.^[10] Annex 1 of the Measures contains a voluntary Guideline for Risk Control and Protection Plan for the Safety of Foods Imported to China ("Guideline"). 
• Administrative Measures for the Supervision of Imported Food Inspection at Port (Draft for comment)^[11] were released by AQSIQ on September 28, 2015, to guide local ports of China on their inspection of imported food products. A categorization system per risk level and risk assessment result will be established under the Measures to manage the inspection. The Measures reinforce the legal obligations under the FSL on oversea food producers and exporters as well as those on the local importers. Detailed conditions for imposing/lifting a temporary ban on food import are also specified in the Measures. All interested stakeholders should submit their comments by October 29, 2015.
• General Code of Hygienic Practice for Food Additives (Draft for Comment)^[12] incorporates requirements on food additive production and applies to all domestic production of food additives. The Code sets forth the requirements and management code for production sites, facilities and personnel in raw material procurement, processing, packaging, storage and transportation of food additives. Reference must be given to this general Code in the future establishment of specifications for any individual food additive.
• In the past few months, several national food safety standards of great importance entered into force or were published for public comments. ^[13] Given their compulsory nature, they should be closely examined and strictly followed by relevant participants in the food industry. In particular, starting from May 24, 2015, the use of food additives in food products to be distributed in China must follow the amended General Standards for the Use of Food Additives (GB 2760-2014). Products labeled with food additive names no longer valid under the amended GB 2760 can be continued to be sold through June 30, 2016, prior to their expiration date.