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Notice of the State Administration of Quality Supervision, Inspection and Quarantine on Issuing the “General Principles for the Examination of Food Quality Safety for Market Access (2004)”
(No. 558 [2004] of SAQSIQ; Date of Promulgation: December 23, 2004)
The quality and technical supervision bureaus of all provinces, autonomous regions, and municipalities directly under the Central Government:
In order to meet the demand for performing the duties of supervising the quality and sanitation in food production and processing, improve and deepen the work on food quality safety for market access, the State Administration of Quality Supervision, Inspection and Quarantine (SAQSIQ) has amended the “General Principles for the Examination of Food Quality Safety for Market Access”, which shall come into force on January 1, 2005. The General Principles are hereby printed and distributed to you. Please implement them carefully and earnestly. The Letter No. 515 [2003] of the SAQSIQ shall be repealed simultaneously.
Annex:
General Principles for the Examination of Food Quality Safety for Market Access (2004)
| | 国家质量监督检验检疫总局关于印发《食品质量安全市场准入审查通则(2004版)》的通知
（2004年12月23日 国质检监[2004]558号）
各省、自治区、直辖市质量技术监督局：
为适应履行食品生产加工环节质量卫生监管职责的需要，完善深化食品质量安全市场准入工作，总局对《食品质量安全市场准入审查通则》进行了修订，自2005年1月1日起施行。现印发给你们，请认真贯彻落实。总局“国质检监函[2003]515号”文件同时作废。
附件：食品质量安全市场准入审查通则(2004版)
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I.These General Principles are formulated in accordance with the “Product Quality Law of the People's Republic of China”, the “Food Sanitation Law of the People's Republic of China”, the “Regulation on Production Permits for Industrial Products (for Trial Implementation)”, other relevant laws and regulations, and relevant provisions on market access systems on food quality safety, so as to earnestly strengthen the supervision and administration of food quality safety from the source, regulate food enterprises' production and processing, and improve the level of food quality safety in China.
| | 一、为切实从源头加强食品质量安全的监督管理，规范食品企业生产加工过程，提高我国食品质量安全水平，依据《中华人民共和国产品质量法》、《中华人民共和国食品卫生法》、《工业产品生产许可证试行条例》等有关法律法规和食品质量安全市场准入制度的有关规定，制定本通则。
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II.A “food production or processing enterprise” mentioned in these General Principles shall mean an enterprise that has its fixed production or processing place, corresponding production or processing equipment and process flows, and makes or sells food products, excluding the food processing sites making on the spot or making in a mobile way, etc. These General Principles shall apply to the verification of the indispensable conditions for food production or processing enterprises to guarantee the product quality and to the inspections of food quality safety, etc. The application of these General Principles shall be combined with the Detailed Rules for Examination of Corresponding Food Production Permits (hereinafter referred to as Detailed Rules for Examination).
| | 二、本通则所称食品生产加工企业，是指有固定的生产加工场所、相应的生产加工设备和工艺流程，制作、销售食品的企业，不包括现做现卖、流动制作等形式的食品加工场点。本通则适用于对食品生产加工企业进行保证产品质量必备条件的核查和食品质量安全检验等工作，本通则应当与相应的食品生产许可证审查细则(以下简称审查细则)结合使用。
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III.A food production or processing enterprise shall be established in accordance with the law, conform to the industrial policies of the State, and meet the following indispensable conditions for guaranteeing product quality safety (hereinafter referred to as indispensable conditions):
| | 三、食品生产加工企业应当依法设立，符合国家产业政策，并具备以下保证产品质量安全的必备条件(以下简称必备条件)：
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(1) Environment sanitation requirements. There shall be no harmful gas, soot, dust, radioactive substances or other diffusible sources of pollution around the enterprise. The sanitary conditions of the enterprise's factory area, production and processing workshops, raw materials and auxiliary ones, storerooms for finished products, means of storage and transport, as well as the enterprise's environmental protection measures shall all meet the requirements as prescribed by the State.
| | (一)环境卫生要求。企业周围应无有害气体、烟尘、灰尘、放射性物质及其他扩散性污染源。企业厂区、生产加工车间、原辅材料与成品库房、贮运工具的卫生条件和企业环保措施应当符合国家规定的要求。
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(2) Production resource requirements. A food production or processing enterprise must have the production facilities and equipment suitable for guaranteeing the product quality safety, and the places for treatment of raw materials, for production and processing, for storage of raw materials and finished products. If it uses any special equipment to produce or process food, it shall meet the requirements of relevant laws and regulations, in addition.
| | (二)生产资源要求。食品生产加工企业必须具备与保证产品质量安全相适应的生产设施、生产设备以及原料处理、生产加工、原料与成品贮存等场所。使用特殊设备生产加工食品的，还应当符合相关的法律法规规定要求。
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(3) Requirements on raw materials and auxiliary ones. The raw materials and auxiliary ones used in food production or processing must meet corresponding national standards, trade standards and other relevant provisions. No non-food-purpose raw materials or auxiliary ones shall be used to produce food. The water directly used for food production and processing must meet the requirements in GB 5749 “Sanitary Standards for Drinking Water”. The enterprise shall, when purchasing any product under production permit administration and using it as production raw materials or auxiliary ones, ask for a photocopy of the production permit for this product and verify its validity.
| | (三)原辅材料要求。食品生产加工所用的原辅材料必须符合相应的国家标准、行业标准及有关规定，不得使用非食品用原辅料生产食品。直接用于食品生产加工的水必须符合GB 5749《生活饮用水卫生标准》的要求。采购已实施生产许可证管理的产品作为生产原辅材料时，企业应当索取该产品的生产许可证复印件并查验其有效性。
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(4) Production and processing requirements. The food processing flows should be scientific and reasonable. The course of production and processing shall be controlled strictly so as to prevent biotic, chemical or physical pollution or cross pollution between raw materials and semi-finished products or finished products. It is strictly prohibited to use the production techniques or equipments banned by the State from use or explicitly ordered by the State to be eliminated.
| | (四)生产加工要求。食品加工工艺流程应当科学、合理。生产加工过程应当严格控制，防止生物性、化学性、物理性污染及原料与半成品、成品的交叉污染。严禁使用国家禁止使用或明令淘汰的生产工艺和设备。
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(5) Product requirements. The enterprise must arrange for production according to the effective product standards. The enterprise's products must meet the national standards, trade standards, the compulsory provisions in the Detailed Rules for Examination, and the quality requirements explicitly indicated by the enterprise itself. The food additives and nutrition enhancers must meet the GB 2760 “Sanitary Standards on the Use of Food Additives” and the GB 14880 “Sanitary Standards on the Use of Food Nutrition Enhancers”. It is strictly prohibited to use excessive food additives or nutrition enhancers in food.
| | (五)产品要求。企业必须按照有效的产品标准组织生产。企业生产的产品必须符合国家标准、行业标准和审查细则的强制性规定以及企业明示的质量要求。使用食品添加剂和营养强化剂必须符合GB 2760《食品添加剂使用卫生标准》和GB 14880《食品营养强化剂使用卫生标准》，严禁在食品中超量或超范围使用食品添加剂和营养强化剂。
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(6) Staff requirements. The enterprise's person-in-charge shall have good knowledge of the product quality laws and regulations, and the enterprise's product quality responsibilities and obligations. The enterprise's production technicians shall have relevant professional knowledge. The enterprise's production operators and inspectors shall, before taking their posts, accept trainings and examination. Each inspector shall have acquired a corresponding certificate before taking. The staff engaging in food production and processing shall be healthy, and have no infectious disease. The various employees of a food production or processing enterprise shall have necessary knowledge on food quality safety.
．．．．．． | | (六)人员要求。企业负责人应当了解产品质量法律法规和企业的产品质量责任、义务。企业生产技术人员应当具有相关的专业知识。企业的生产操作人员和检验人员上岗前应当经过培训考核，检验人员应持证上岗。从事食品生产加工的人员应当身体健康，无传染性疾病。食品生产加工企业各类人员应当具有必要的食品质量安全知识。
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