婴幼儿配方乳粉生产许可审查细则（2022 版）
Review Regulations for Production Licensing of Infant Formula Milk Powder (2022) English
This is a draft translation for reference among interesting stakeholders. The finalized translation (passing through draft translation, self-check, revision and verification) will be delivered upon being ordered.
Chapter I General Provisions
Article 1 This set of detailed rules is formulated in accordance with the provisions of laws, regulations, and rules such as the Food Safety Law of the People's Republic of China and its implementation regulations, and the Measures for the Administration of Food Production Licensing, with the aim of further tightening the licensing conditions for the production of infant formula milk powder, strengthening the primary responsibility of enterprises for food safety, and promoting high-quality industrial development.
Article 2 These detailed rules apply to the review work conducted by market supervision and administration departments for the production licensing, modification of licenses, and renewal of licenses for infant formula milk powder.
Article 3 Infant formula milk powder, as referred to in these detailed rules, refers to powdered infant formula food suitable for infants aged 0 to 36 months. It is produced using only physical methods, with cow's (or goat's) milk and/or its milk protein products as the main protein source, supplemented with appropriate amounts of vitamins, minerals, and/or other raw materials. Infant formula milk powder is categorized into infant formula milk powder (0–6 months, Stage 1), older infant formula milk powder (6–12 months, Stage 2), and toddler formula milk powder (12–36 months, Stage 3).
Article 4 The licensing category for infant formula milk powder is infant formula food, with the category name being infant formula milk powder and the category number 2901. The food category, category name, and detailed varieties for the production licensing of infant formula milk powder are listed in Table 1.
Table 1 Directory of Food Categories for Infant Formula Milk Powder Production Licensing
Article 5 Infant formula milk powder production enterprises (hereinafter referred to as "enterprises") shall comply with the good manufacturing practice requirements for powdered infant formula food and implement the Hazard Analysis and Critical Control Point (HACCP) system. Production licenses shall not be granted to those with only packaging facilities, processes, or equipment but lacking complete production process conditions. Composite ingredients that already comply with the national food safety standards for infant formula shall not be used as raw materials for producing infant formula milk powder.
Article 6 The term "base powder," as used in these detailed rules, refers to composite ingredients used by other enterprises for producing infant formula milk powder. It is mainly made from cow's or goat's milk and their milk protein products (such as whey powder, whey protein powder, whole milk powder, skimmed milk powder, etc.), with added nutrients and/or other auxiliary materials, processed through wet-mix technology.
Article 7 The documents and standards cited in these detailed rules are incorporated by reference and form part of these rules. The latest versions of the cited documents and standards (including all amendments) shall apply to these detailed rules.
Chapter II Production Premises
Article 8 The site selection, factory environment, workshops, and production areas shall comply with the relevant requirements of the General Rules for Food Production Licensing Review and the National Food Safety Standard: Good Manufacturing Practice for Powdered Infant Formula (GB 23790).
Article 9 Enterprises shall have production workshops and auxiliary production facilities commensurate with their production capacity. The design of production workshops and auxiliary production facilities shall follow the needs of the process flow and hygiene requirements, ensuring an orderly and rational layout. Testing rooms located within the factory premises shall be separated from production areas. In-process testing rooms set up within workshops shall meet the hygiene requirements of the relevant areas and include measures to prevent contamination.
Article 10 Based on the process flow and requirements for preventing cross-contamination, the production operation area shall be divided into clean operation areas, quasi-clean operation areas, and general operation areas according to their respective cleanliness levels. Effective physical isolation shall be implemented between operation areas of different cleanliness levels, as well as between wet and dry areas, to prevent cross-contamination. The specific divisions of operation areas by cleanliness level are provided in Table 2.
Table 2 Division of Production Operation Areas for Infant Formula Milk Powder
