The Ministry of Health (MOH) of the People's Republic of China published, on its website on March 30, 2011, the Management Rules for the Administrative Approval of New Varieties of Food Related Products (the Rules). The Rules govern the approval of new food packaging materials, expanded uses of currently approved additives and food packaging materials, new disinfectants and detergents for food use, and substances used in tools and equipment intended for direct food contact. The Rules, which became effective June 1, 2011, finalized draft Rules published by MOH in May 2009. (For more information on the 2009 draft Rules, see the article, "Regulation of Food Packaging Materials in the People's Republic of China.")
Article 3 of the Rules specifies that food-related products should meet the following criteria:
- Have a clear intended use and be technically necessary;
- Pose no risk to human health in their intended use;
- Not cause a fundamental change in food ingredients, food structure, or a food's smell and taste; and
- Be used at the lowest possible level to achieve the desired technical effect.
Detailed data requirements, application forms, and procedures for new petitions have not been released yet. The general data requirement for petitions for the approval of new food-contact materials are similar to those for applications (due by June 1, 2010) for approval of food packaging materials that were in use in China but not yet approved under China's 2008 "Hygienic Standards for Uses of Additives in Food Containers and Packaging Materials" (amended in 2009). As noted above, one of the new data requirements is the need to demonstrate the technical necessity of new material. Another new feature of the recently published Rules is submitters are requested to mark the part of the information in the petition that is not confidential and can be made public.
The Rules impose additional requirements on new types of food-related products that are imported to China for the first time. These include certification documents issued by the exporting country (or region) showing that the new type of food-related product is permitted for production or sale in that country. Certification documents issued by relevant agencies or organizations of the countries (or regions) where the manufacturer is located are also required.
Petitions will be reviewed by MOH's National Center for Health Inspection and Supervision. The Center will have 60 days, once an application is accepted, to issue a technical review conclusion. However, the submitter may be asked to provide additional information or conduct additional tests.
Draft approvals will be published for public comments. After the comments have been received and reviewed, MOH will announce the final approvals and develop relevant Food Safety National Standards.