Health Food in China: Regulatory Overview

Recent estimates indicate that there are over 3,000 health food products sold on the market in China, including nutraceuticals, functional foods, and products based on Traditional Chinese Medicine (TCM). At least one source reports that total sales volume in China’s health food market for 2000 was about RMB50 billion (US$6 billion) and will reach RMB80 billion (US$9.7 billion) by 2010. Health food products with beautifying, blood nourishing, or aging prevention properties and products high in calcium are increasingly popular. Foods enhanced with functional ingredients such as probiotics also see increased sales. Slimming and weight loss products are also becoming popular. Although these products are more common in the West, where obesity is a greater problem, demand is rising in this segment.

China’s Ministry of Health (MOH) regulates China’s burgeoning health food industry. MOH brought health food under its supervision in 1996. Depending on the product, health food or health food supplements may be registered as health food supplements, ethical products, TCM, or as consumer products. If registered as a health food supplement, basic procedures and regulations must be followed. An application for import and marketing approval usually takes between 12-18 months, including testing. Required testing may be performed by any of 31 testing institutions recognized by the MOH. Testing institutions include medical institutions, comprehensive testing centers, and medical colleges and universities. Home-country test results may be used only as a reference — they may not be substituted for local testing. Products are tested for functionality, toxicology, and food hygiene, among other things, depending on the product and its uses. Testing costs will vary from RMB100,000 to RMB200,000 (US$12,000-24,000), depending on the product and the amount of testing required.

Once testing has been successfully completed, an import registration application must be submitted. The fee is RMB8,000 (US$968). The application includes the product’s name, manufacturer’s name, address, and contact information, and a description of the product’s function. An original application and 13 copies must be submitted, in both English and Chinese. The product’s composition, functional (active) ingredients, a flow chart of the manufacturing process, and quality control information must also be provided, along with packaging and labeling samples, product samples, insert data sheet samples, and related documents and information.