Rules for the Examination of Licensing Criteria for Enterprises Producing Formula Milk Powder for Infants and Young Children (2010 Version)1 Scope of applicationThe Rules are applicable to the examination of production conditions and inspection of production licenses applied by enterprises which are supposed to process and produce formula milk powder for infants, older infants and young children (less than 3 years old) under production conditions required by laws and standards, with cow milk or goat milk and its processed products (whey powder, whey protein, skimmed milk powder and whole milk powder, etc.) as main raw materials and with addition of appropriate amount of vitamins, minerals and other adjuvants.Formula milk powder for infants and young children has one application scope and its category number is 0502. Product names on the production license shall be marked with formula milk powder for infants and young children (wet-mix process, dry-mix process). Variety details of formula milk powder for infants and young children shall be indicated on the attached sheet of the production license.Production license examination shall be not performed for the cases of there being only packaging area, work procedures and equipment, which do not constitute complete production conditions.The Rules contain documents and standards which, through reference in this text, constitute provisions of the Rules. For dated references and standards, all the subsequent amendments to (excluding corrections), or revisions of, any of these publications are not applicable to the Rules. For undated references and standards, the latest edition (including all the amendments) is applicable to the Rules.2 Examination of production licensing 2.1 Examination of management system.The completeness of food quality and safety management system established by enterprises shall be examined according to relevant laws and regulations such as Food Safety Law of the People’s Republic of China and Regulation on the Implementation of the Food Safety Law of the People’s Republic of China and Regulation on the Supervision and Administration of the Quality and Safety of Diary Products as well as General Principles on Examination of Food Production License. The contents to be examined mainly include:2.1.1 Examination contents of main raw materials and products management system:(1) System of testing and recording inspection of incoming raw milk and raw milk powder by batches; (2) regulations on handling measures of unqualified raw materials and adjuvants such as rejection, scrapping and return; (3) regulation on judgment of unqualified semi-finished products and finished products as well as relevant treatment measures; (4) disposal measures of products being manufactured when production is interrupted due to such particular reasons as equipment fault, power failure and water failure to ensure that non-conforming products are disposed as unqualified products; and (5) recall system of unqualified outgoing products shall contain relevant contents in the national standard Good Producing Practice for Milk Products (GB12693) and shall have management regulations for implementing recall electronic information system.2.1.2 Examination contents of personnel requirements management system:(1) Job training and appraisal measures for technical and operating personnel; (2) arrangement of suitable production, quality and inspection technicians for important sections as well as post responsibilities; (3) implementation of training plans for periodical education on quality safety, processing techniques and quality management of milk products; and (4) safety protection measures for production and processing personnel and ensuring that production and processing personnel in direct contact with raw materials and products shall be transferred away from original posts in case of catching diseases affecting food safety regulated by laws and regulations.2.1.3 Examination contents of technical standards and process documents:(1) Related current texts of national standards listed in Annex 1; (2) regulations on management of technical standards, process documents, accounts, production process and critical control points, etc., and regulation of keeping records for 2 years; and (3) records of accounts and production process established by enterprises shall include incoming material acceptance records, incoming materials accounts, environment and workplace cleaning records, production equipment cleaning and disinfection records, storehouse safekeeping records, production feeding records, control records of critical control points, factory inspection records, product inspection and sample retention records, unqualified products disposal records, unqualified raw materials treatment records, product sale records, unqualified products recall records, returned goods disposal records, employee health examination records, learning and training records, custom。