The regulatory situation in China

Based on the concept of traditional Chinese medicine (TCM), foods have the following functions: to maintain and improve health status; to prevent disease and help in treating disease; and to facilitate rehabilitation. In TCM, food and drug are from the same sources, are based on the same theories and the same uses. Regulatory control of Functional Foods in China The legal status of functional food (named health food min China) was first defined in the Food Hygiene Law of PRC (1995). It is stipulated in Article 22 that : with regard to the food claimed to have specific health functions, the products and its description material must be submitted to the administrative department of public health under the State Council for review and approval; and its hygienic standards and regulations for the control of its manufacturing and marketing shall be formulated by the administrative department of public health under the State Council. The Regulation for the Control of Health Food was promulgated by the Ministry of Health on March 15, 1996, in which health food is defined as a food that has special health functions, it is suitable for the consumption by special groups of people, and has the function of regulating human body functions but is not used for therapeutic purposes. Food products which claim health function shall be reviewed and approved by the Ministry of Health. The Ministry of Health shall issue a Health Food Certificate for the qualified and approved health food with a code number. Food given the Health Food Certificate can be labelled with the special symbol stipulated by the Ministry of Health (Article 5). When applying for the Healthy Food Certificate, the following information should be submitted (Article 6): Healthy food product application form. Formula, manufacturing technology and specifications of the product. Toxicological safety evaluation reports. Health function evaluation reports. List of functional ingredients and their qualitative and/or quantitative test methods, as well as reports on the stability tests of functional ingredients. Samples of the product and its laboratory test reports. Label and use instruction (draft for review). Relevant domestic and international information. Other necessary information based on the requirements of relevant regulations and characteristics of the product. The Ministry of Health has issued two lists of health functions that could be applied and approved. Other function claims may be approved if the functional tests are conducted by MOH designated institutions and detail test procedures and methods are submitted to and approved by the Ministry of Health before the testing. Established in 1978 the International Life Sciences Institute (ILSI) is a worldwide foundation that aims to help public health by advancing the understanding of scientific issues related to nutrition, food safety, toxicology, and the environment. The Institute brings together scientists from academia, government, industry, and the public sector to seek solutions for public health issues.