On May 6, 2009, China’s Ministry of Health published two draft regulations that implement new preimportation licensing requirements for imports of food and food-related products such as packaging under China’s new Food Safety Law (FSL). The FSL is the long-anticipated Chinese food safety law that went into effect on June 1, 2009.1 The final import licensing regulations will impose additional registration and data reporting requirements on importers and distributors of imported food products and new food-related products and materials. Food companies with operations in China will also be affected by the proposed food import licensing regulations.
Solicitation of Chinese domestic comments on the draft regulations ended on May 17, 2009. A revised or final version of the proposed regulations is expected to be published in coming weeks.
Unregistered Imported Foods Will Require an Advance License
The first draft regulation, “Provisional Administrative Regulations on the Administrative Licensing of the Importation of Food Without National Food Safety Standards” (Imported Food Regulations) covers imported food products that are manufactured and distributed abroad as food and for which China does not have relevant national food safety standards. These products must be licensed by the Ministry of Health prior to importation.
License applicants would be required to submit to the Ministry of Health a completed standard form (in Chinese) with detailed supporting information and documentation (most of which must also be translated into Chinese). Within 60 days after filing of the application, the Ministry of Health will initiate an investigation and approval process. The investigation process may rely on assistance from experts in a variety of fields, such as food safety, toxins, nutrition, microbiology, craftsmanship, and chemistry, to assess the application. If the assessment demonstrates that the product is subjected to similar industrial standards from relevant international organizations, other countries or China, the Minister of Health will refer to those standards for execution. The Ministry of Health will determine whether to grant the license based upon recommendations from its experts and taking into account applicable national laws and regulations.
The supporting information and documentation required to accompany the application includes a description of the origin of the food products, a statement of the reason and utilization of having such food products imported, a main ingredients list, statistical evaluation of the ingredients and the safety intake level, a description of the production process, quality standards and basis of establishment, sanitary quality inspection reports of three batch of such kind of food products, safety assessment materials, product tags and specifications, and other supporting documentation proving that the imported food products are authorized for manufacturing and sale by the governing departments or institutions from the producing country (region) or exporting country (region), and other documentary materials proving the eating of such foods in historical records. Additionally, in cases where such food products are already manufactured in accordance with relevant standards of international organizations or other countries, the application must be supported by a written description of the standards already practiced. Finally, the application must be accompanied by a sample (i.e., the smallest package of such products or 30g of the product).
New Food-Related Packaging and Other Materials Will Need to be Licensed
The second draft regulation, “Provisional Administrative Measures of Administrative Licensing of New Food Related Product Varieties” (Food-Related Products Regulations) covers a broad range of articles not currently subject to national standards or relevant agency listings. These articles include domestically produced and imported food packaging materials, food containers, food production and management tools (e.g., resins, ceramics, etc.), and food detergents and disinfectants. Specifically identified for coverage are:
- Materials or molding products used in food packaging materials, containers and food production and management tools, and equipment that directly contact food that are not currently subject to national food safety standards;
- Additives not listed in hygienic standards for uses of additives in food containers and packaging materials;
- Materials or molding products of food packaging materials, containers and food production and management tools, and equipment that directly contact the food not listed in the List of Notice of the Ministry of Health;
- The additives listed in the Hygienic standards for uses of additives in food container and packaging materials, or in the List of Notice of the Ministry of Health, but requiring expansion of the use scope or increase of the use frequency; and
- Certain new detergent and disinfectant materials used for food or for tools and equipment used in food production.
Similar to the Imported Foods Regulations, license applications for covered food-related materials would be submitted on a standard application form accompanied by supporting information and documentation. Within 60 days after receipt of the license application, a committee of experts under the direction of the Ministry of Health would review the application for new varieties of food-related products. Committee experts may recommend on-site reviews and safety verification testing. Their opinion and that of the general public would be considered by the Ministry of Health in determining whether or not to grant a license.
Supporting information required to accompany the license application includes, data concerning chemical properties (including chemical properties and constitutional formula, etc.), information on usage and conditions of use, description of the production processes, descriptions of company standards, toxicological information, information on conditions of use in other states and relevant supporting documents, and other documentation.