Recently, the State Administration for Market Regulation (SAMR) has issued the Detailed Rules for the Review of Production Licensing for Infant Formula Liquid Milk (the "Rules"), which will take effect on the date of issuance.
The Rules set out requirements in terms of production premises, equipment and facilities, equipment layout and production processes, personnel management, and management systems. According to the Rules, manufacturers of infant formula liquid milk shall comply with the Good Manufacturing Practice (GMP) requirements for infant formula food and implement a hazard analysis and critical control point (HACCP) system. If an enterprise has only packaging sites, processes, or equipment, but lacks complete production process conditions, a production license shall not be granted. The Rules prohibit the production of infant formula liquid milk through contract manufacturing or repackaging. An enterprise shall not use the same formula to produce infant formula liquid milk under different brands. In addition, infant formula liquid milk shall not be produced by reconstituting milk powder, nor shall infant formula milk powder or base powder be used as the primary raw material for the production of infant formula liquid milk.