【作者】 何翔；

【导师】 孙振球； 严卫星；

【作者基本信息】 中南大学 ， 公共管理， 2013， 博士

【摘要】 目的通过分析研究我国食品标准体系的现状和存在问题,借鉴国际组织和发达国家食品安全技术法规标准体系的特点,结合我国食品工业发展水平和食品安全监管工作实际需要,提出我国食品安全标准体系建设基本原则和体系框架的建议,为政府主管部门开展食品标准清理工作,健全完善我国食品安全标准体系提供理论依据和参考。方法1.文献分析和比较研究：系统查阅国内外食品安全法规标准和技术文件,研究分析我国与国际组织和主要发达国家食品安全法规标准体系的各自特点,找出我国标准体系的不足和差距。2.问卷调查和专家咨询：以食品安全国家标准审评委员会秘书处名义设计发放《食品安全国家标准体系建设咨询问卷》,对415名分别来自政府监管部门、专业技术机构和食品行业／企业的专家开展问卷调查,对咨询结果进行量化分析。3.深度访谈：根据专家咨询的结果,设计访谈提纲,选取25位从事食品安全标准相关工作且熟悉我国食品标准体系的权威专家,针对食品安全国家标准体系建设的基本原则和框架结构等重点内容进行深度访谈。4.数据处理和统计分析方法：调查问卷均录入到问卷星系统进行数据核查。对问卷结果进行统计描述和统计推断,并分析专家的权威程度、专家意见的协调系数以及咨询问卷的信度和效度分析、量化指标的归一化权重排序等。结果1.对我国现行有效的食品标准进行梳理,总共有各类食品标准5264项。按照标准性质分主要有：①国家标准2248项(占42.71%),其中强制性国家标准722项,推荐性国家标准1521项,指导性国家标准5项；②行业标准2931项(占55.68%),其中强制性行业标准781项,推荐性行业标准2150项；③另有由卫生部发布的针对食品添加剂的指定标准85项。按照标准归属分主要有：由卫生部归属管理标准688项(占13.07%),国家质量监督检验检疫总局归属管理标准1308项(占24.85%),农业部归属管理标准1307项(占24.83%)。按照标准内容分主要有：理化检验方法标准2443项,食品产品标准1208项,食品添加剂标准523项,生产经营规范401项,食品相关产品标准399项,微生物检验方法标准215项。通过全面梳理发现我国食品标准数量众多,基本涵盖各相关领域,无重要标准缺失。但是由于标准的管理部门多,标准的种类和层级多,导致我国现有食品标准体系较混乱,以卫生标准、质量标准、食用农产品质量标准和行业标准为主的标准之间存在交叉、重复和矛盾的问题。2.通过对国际组织和发达国家食品安全标准体系的研究可知,各国食品安全标准均为强制性技术法规,且均由政府部门组织制定和发布,同时各国组织制定食品安全标准均建立在风险评估的基础上。我国与国际组织和主要发达国家的食品安全标准体系所涵盖的内容是基本一致的,均包括对食品生产过程的控制、食品中微生物、污染物、农兽药残留的控制,以及食品添加剂、营养强化剂、新资源食品、辐照食品等方面的管理。但是,国际食品法典委员会和发达国家对食品中有害物质的控制并不主要依赖食品终产品限量标准,而是更注重食品生产过程的控制规范,所以制定的食品产品标准数量较少,这与我国有很大差异；对于检验方法,国际食品法典委员会并不制定具体食品的检验方法,仅是制定食品检验方法的通用原则,各主要发达国家也均没有制定强制性的检验方法标准,只是推荐或认可国际组织制定的检验方法,而我国《食品安全法》规定食品检验方法应是强制性食品安全标准。3.通过专家咨询和深度访谈确定构建食品安全国家标准体系时应优先考虑污染物限量、真菌毒素限量、致病性微生物限量、兽药残留限量、农药残留限量,以及食品添加剂、营养强化剂的使用品种、范围和限量等标准。本研究提出的食品安全国家标准体系框架的一级类别包括：基础(通用)标准、食品产品标准、食品添加剂产品标准、食品相关产品标准、生产经营规范、检验方法与规程和其他。4.对于食品产品标准的制定,应注重其与基础(通用)标准的衔接和产品标准的覆盖面,除非安全性要求较高,不对食品大类下的具体产品类别制定安全标准,制定食品产品标准时应尽可能引用基础(通用)标准的内容。5.对于食品添加剂产品标准,目前来说针对每个添加剂品种制定产品标准更符合实际需要,而如果在食品添加剂产品的类别和工艺要求可以合并的情况下,则按照食品添加剂的类别制定添加剂产品通用标准更为合理。6.对于食品相关产品标准,应根据食品相关产品大类制定安全标准,同时在特殊情况下,允许针对小类制定安全标准。7.对于生产经营规范类标准,首先应完善通用生产经营规范,再根据产品的安全要求和污染情况确定是否需要制定专项规范和控制导则。制定生产经营规范标准时,还应充分考虑规范类标准与食品产品标准的配套,以及与农产品质量安全过程管理相关法规标准的衔接。8.对于检验方法标准,既可以根据食品产品、食品相关产品的分类来制定,也可以根据检测项目来制定,或者根据食品产品、食品相关产品分类和检测项目相结合来制定。结论1.我国现行的各类食品标准之间存在重复、交叉和矛盾等问题,给食品安全监管工作造成影响,且部分类别标准的制定原则意见分歧较大,因此迫切需要构建一套科学、合理、可行的食品安全国家标准体系框架,以此指导食品安全标准的清理工作和制修订工作。2.国际组织和各发达国家地区的食品安全法规标准体系的构建原则基本一致,标准的制定均是以风险评估为依据。他们的体系框架内容都涵盖基础(通用)标准、产品标准和过程控制规范三个主要方面,这与我国食品安全国家标准体系所涵盖的内容是基本一致的,但其更注重食品生产过程控制规范的建设,值得我国借鉴。3.本研究构建的食品安全国家标准体系框架包括：①基础(通用)标准、②食品产品标准、③食品添加剂产品标准、④食品相关产品标准、⑤生产经营规范、⑥检验方法与规程以及⑦其他,并结合实际需要提出了各类别标准的基本原则,既涵盖了食品从农田到餐桌的整个食物链过程,又符合我国国情,基本能够满足我国食品安全工作的需要。本研究创新点1.首次全面系统分析我国与国际组织、主要发达国家的食品安全法规标准体系及建立过程,对比分析国内外体系框架的共性和个性,为我国食品安全国家标准体系建设提供参考借鉴；2.首次提出了食品安全国家标准体系框架的建议,包括七部分内容：基础标准(通用标准)、食品产品标准、食品相关产品标准、食品添加剂产品标准、生产经营规范、检验方法与规程、以及其他,并提出了各类别标准制定基本原则的建议；3.首次采用文献分析、比较研究、专家咨询、深度访谈四种方法相结合深入探讨我国食品安全国家标准体系框架建设,研究采用定性研究和定量研究,为开创食品安全标准体系的研究提供了新的思路；咨询专家数量较大,且专家来源覆盖政府监管部门、专业技术机构、食品行业／企业等几个主要领域,兼顾食品安全标准的管理方和使用方,专家的代表性和权威度较高。更多还原

【Abstract】 ObjectiveThis study puts forward suggestions on basic principles and system framework in construction of China’s food safety standard system, by analyzing the current status and existing problems of food standard system in China, gaining experience from food safety technical regulations and standard systems within international organizations and developed countries, and taking the development level of China’s food industry and the actual needs of food safety supervision into consideration. It provides theoretical basis and reference for government departments to carry out the food standards clean-up projects and improve China’s food safety standard system.Methods1. Literature Analysis and Comparative Study:A comprehensive literature review on domestic and international food safety laws, regulations, standards and technical documents was conducted and the specific characteristics of food safety regulations and standard systems among China, international organizations and developed countries were analysed in order to find out the areas for improvement in China’s food safety standard system.2. Questionnaire Survey and Expert Consultation:A survey was carried out among415experts from government, professional institutions and the food industry/enterprises using the National Food Safety StandardSystem Construction Consultation Questionnaire designed and published in the name of the Secritariat of National Food Safety Standard Committee. The results of this survey were analysed quantificationally.3. In-depth Interviews:The interview topics were developed specificallybased on the results of expert consultation and then the In-depth Interviews were carried out among25authorities who were engaged in the food safety standard related affairs and familiar with the food standard system in China to learn their opinions on the basic principles, framework structure and other important issues during the construction of national food safety standard system.4. Data Handling and Statistical Analysis Methodologies:SO JUMP, a questionnaire survey system,was used to collect and verify the data of questionnaire. Descriptive statistics and statistical inference were used in the analysis of questionnaire results, in order to examine the authorities of experts, coordination coefficient of expert advices, as well as the reliability and validity of the questionnaire, and sort quantitative indicators by their normalized weights, etc.Results1. Among the current food standards,5264were effective. Classified according to the properties of the standard, there were2248(42.71%) national standards, including722mandatory national standards,1521recommended national standards,5directive standards, and2931(55.68%) industry standards (among which781were mandatory industry standards and2150were recommended industry standards); classified according toadministration of standards,688(13.07%) standards were administered by the Ministry of Health,1308(24.85%) were administered by the General Administration of Quality Supervision, Inspection and Quarantine,1307(24.83%) were administered by the Ministry of Agriculture; classified according to the standard contents,2443were standards for physical and chemical testing methods,1208for food product,523for food additive,401for food production and operation specification,399for food related products, and215for microbial test methods. Numerous food standards which almost covered all food related areas in China were found during our comprehensive evaluation, with low possibility of missing important food related standards. However, the current food standard system was sometimes in disorder due to the multi-sector management and numerous types and levels existed in the system. As a result of which, crossover, duplicationand contradiction among food hygiene standards, food quality standards, edible agricultural products qualitystandards, and food industry standards might occur.2. Under the research on food safety standard systems of international organizations and developed countries, we understood that all food safety standards in developed countries were mandatory technical regulations developed and published by government. Meanwhile, all food safety standard published by international organizations were developed on the basis of food safety risk assessment results. The contents of the food safety standard system of China was basically consistent with that of international organizations and the main developed countries, which all contained the controls of food production process, pathogens, contaminants, pesticide/veterinary drug residues in food, as well as the management of food additives, nutrient supplements, novel food, and irradiated food, etc. Whereas in Codex Alimentarius Commission and developed countries, the control of hazardous substances in food were more relied on the standards for food production processes control, instead of the standards for food final product limit standards, resulting in fewer food production standards needed, which was a big difference from China. With respect to the food test methods, instead of developing specific methods, the Codex only developed the general principles for food test methods. No mandatory standards for food test methods were set up in major developed countries, they only recommended or recognized the use of food test methods published by international organizations. While in China, the Food Safety Law states that food test methods should be mandatory food safety standards.3. Based on the results of expert consultations and in-depth interviews, we recommended that limits of contaminants, mycotoxins,pathogenic microorganisms, veterinary drug residues, pesticide residues, as well as the types, ranges and limits of food additives and nutrient supplements used in food should be preferablyconsidered in the construction of national food safety standards system. This study proposed the primary categories of the national food safety standard system framework, including the basic (general) standards, food product standards, food additive product standards, food related product standards, code of practice, test methods and procedures, etc.4. For the development of food product standards, more attention should be paied to theirconnection with the basic (general) standards, as well as to the coverages of product standards. No food safety standards specific to products under main food categories should be developed unless safety requirements for these foods are higher. Food product standards should be developedby quoting the contents of basic (general) standards as much as possible.5. For food additive product standards, it was more practical to develop product standards for each type of food additive, while development of general standards based on the categories of food additives was more reasonable when the product categories and process requirements could be integrated. 6. With respect to food related product, safety standards should be developed according to the main categories of food related products. Meanwhile, under certain circumstances, developing safety standards based on lower categories was also accepted.7. For production and operation specification standards, the most important task was to improve the general production and operation specification, after which the need of developing specific standards and guidelines should be considered in the context of safety requirements and contaminants. During the development of production operation specification standards, harmonization with food production standards, and consistency with relevantlaws and regulations on quality and safety of agricultural products, should also be evaluated.8. The test method standardscould be developed according to the classification of food products, food related products, test projects, aswell as by integrally taking the classification of food products, food related products and the test items into consideration.Conclusions1. Food safety supervision in China was impacted by the crossover, duplicationand contradiction existed among current food related standards, and different principles followed in developing standards for differentfood products. It is urgent to establish a scientific, reasonable and feasible framework for national food safety standardsystems, in order to guide the clean-up projects, developments and revisions for the food safety standards.2. The principles for food safety regulation and standard system constructions of international organizations and developed countries were basically the same and developed based on the risk assessment. The contents of their frameworks covered three main aspects, including basic (general) standards, product standards and process control specifications, which were basically the same with that of China’s national food safety standard system. However, they paid more attention to the construction of food production process control specification, from which we could gain experience.3. The framework for China’s national food safety standard system proposed in our research includedbasic (general) standards, food product standards, food additives product standards, food-related product standards, food production and operation specifications, test methods and procedures, and so on. The study presented the basic principles for each food category, which not only covered the whole process of the food chain from farmtotable, but also was consistent with China’s situations, meeting the basic needs of China’s food safety supervision.Innovations of this research1.This research comprehensively and systematically analyzed the food safety regulation standard systems and construction processes among China, international organizations, and major developed countries for the first time, by comparing the generality and individuality of the domestic and international food safety system frameworks, which will provide a reference for construction of national food safety standard system in China;2.Also, this research firstly proposed seven aspects of recommendations on framework construction of national food safety standard system, includingbasic (general) standards, food product standards, food-related product standards, food additives product standards, food production and operation specifications, test methods and procedures, etc., as well as the suggestionson basic principles for standard development of each food category;3.Third, it’s the first time that one research has explored the construction of national food safety standard system framework quantitatively and qualitatively by incorporating four study methods (literature analysis, comparative study, expert consultation, in-depth interview), which proposed a new approach for studies of food safety standard system. A number of experts from different fields, involving government supervision departments, professional technical institutions, the food industry/enterprises, were enrolled in this study, representing the administration departments and users of food safety standards.According to the study results, these experts represented their fields well and had high authority.更多还原