Department of Legal Affairs of China Food and Drug Administration

Reply to the Letter on Asking for Reply Statements for
EU  Comments on Chinese Notification

China WTO/TBT National Notification & Enquiry Center:

  We have received the Letter on Asking for Reply Statements for the Letter on Asking for Reply Statements for EU and Australian Comments on Chinese CHN1165 (WTO/TBT letter No. (2016) 15). After research, the following relevant conditions regarding to the preparation of Formula Registration Regulation for Infant and Follow-Up Formula and Registration Regulation for Food for Special Medical Purpose are provided just for reference.

I. About Formula Registration for Infant and Follow-Up Formula

   China has always attached great importance to the quality of infant and follow-up formula, on which the strictest supervision is imposed among all food in China. To ensure that infant and follow-up formula provide sufficient, scientific and safe nutrition for the growth and development of infants and follow-ups, in regard to problems including excessive amount and low quality of formulas of infant and follow-up formulas, insufficient research arguments regarding to the establishment of formulas, lack of scientific evidences between different formulas, obstacles imposed on consumer choice due to confusions in brands and formulas, hidden dangers for product quality due to frequent change of formulas, etc., Food Safety Law of the People’s Republic of China specifies that the food materials (such as the raw milk and supplementary substances) and food additives used for infant and follow-up formula production shall comply with laws, regulations and provisions, as well as national food safety standards; they shall guarantee sufficient nutritional content for infant growth and development; the product formula of infant and follow-up formula shall get registered with CFDA authority; the same company is not allowed to produce infant and follow-up formula of different brands by using the same formula. According to the Food Safety Law of the People’s Republic of China, CFDA has enhanced the management of product formula of infant and follow-up formula, drafted the Formula Registration Regulation for Infant and Follow-Up Formula, urged companies to improve their R&D, manufacture and test abilities so as to research and develop product formula for infant and follow-up formula scientifically as well as prohibited to conduct exaggerated propaganda and mislead consumers with the formula.