China Food and Drug Administration raises infant milk powder production standards

On the 6th, the Food and Drug Administration announced on the official website the “Detailed Review Rules for the Production of Infant Formula Milk Powder Approval Conditions (2013 Edition) (Draft for Soliciting Opinions)” (hereinafter referred to as the “Draft for Comment”), soliciting opinions from all sectors of society.

The “Draft for Soliciting Opinions” has improved the production and management requirements for infant formula milk powder production enterprises with reference to pharmaceutical management. The “Draft for Soliciting Comments” clarified that production enterprises using raw milk as raw materials should have their own farms to ensure the quality and safety of raw milk. Manufacturers that use full-fat, skimmed milk powder as raw materials should control their milk sources. Only the packaging site, process, and equipment, without complete production conditions, are not subject to production license review; infant formula milk powder or base powder is used as the main raw material to produce infant formula milk powder. There is no complete dry process and no production is allowed. Licensing review; production water (including cleaning water) should be purified to meet the "Chinese Pharmacopoeia" purified water quality standards. (Purified water is generally used for pharmaceutical production) Other water should meet the drinking water hygiene standards.

The “Draft for Soliciting Comments” clearly states that the procurement system includes at least: material supplier evaluation methods, raw material and auxiliary acceptance rules, and unqualified raw and auxiliary materials rejected, scrapped, and returned to the factory. The use of imported raw materials shall review the qualification certificates of the imported material suppliers and traders, the quality standards of each batch of raw materials, the inspection data and reports of the products shipped, and the sanitary certificates (test reports) issued by the import and export inspection and quarantine authorities.