我国保健食品行业发展及监管现状、问题和对策研究
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摘要
近年来,随着经济社会的发展,人们保健需求和消费能力逐步提高,促进了保健食品市场的繁荣和产业的快速发展,保健食品的监管体制和法律法规体系也逐步建立和健全,政府监管工作不断深入。与食品安全整体情况类似,保健食品安全形势总体趋向稳定,但也发生了一些安全事件,危害了消费者的健康利益,降低了大众的消费信心,影响了产业快速发展的势头,给监管工作带来巨大挑战。
本研究主要从加强政府监管和促进行业自律的角度出发,以蜂胶类保健食品生产企业和药店经营保健食品为切入点,讨论如何对保健食品监管的体制机制进行完善,提高科学监管和依法监管能力,落实长效的监管措施,形成高效的监管体系。同时,针对企业生产经营过程中存在的问题,研究如何促进生产经营单位和人员提高保健食品安全意识,切实落实企业是第一责任人的意识,完善和落实内部管理和自我约束机制,自觉自律进行生产经营活动,从源头把好保健食品安全关。
本文通过问卷调查、实地调研、资料查阅、访谈等方法,对保健食品的监管体系和产业发展的历史及现状进行梳理,对存在的问题进行深入剖析。结果显示当前保健食品的法律法规和标准体系还不尽完善,监管责任尚未完全理顺,技术支撑能力亟待加强；生产经营单位的保健食品基本知识匮乏,安全意识淡薄,依法生产经营的能力亟待提升,甚至有部分业者为追求高额利润,铤而走险、掺杂使假,违法生产经营。
本文在分析借鉴国内外保健食品监管政策及实践经验基础上,结合蜂胶类保健食品监管特点及存在问题,在监管层面提出加快法规体系建设,理顺监管责任,加强技术保障能力,完善诚信体系等监管建议；在企业管理层面,提出加强原料采购管理、落实良好生产规范、规范委托加工管理及规范经营秩序的建议。
In recent years, with the development of society and economy, people's health demand and consumption ability are increasing gradually, which brings prosperity to the market of health food and brings rapid development to the industry. According to the development situation of industry, health food regulatory system and legal system are also gradually established and become perfect, and the work of government supervision is deepening. In recent years, similar to the overall situation of food safety, health and food security situation overall stability is going well. However some security events still happened, which are not only harmful to the consumers' health and reduce the confidence of the consumers, but also affect the industry momentum of rapid development and bring great challenges to the supervision work.
This research mainly from the perspective of strengthening government supervision and promoting self-regulation of the industry, put the propolis health food production enterprises and the management of health food stores as a breakthrough point, discusses how to perfect the system and mechanism of health food supervision, improve the scientific supervision and supervision according to law, the implementation of effective regulatory measures, the formation of efficient supervision system. At the same time, in view of the existing problems in the process of enterprise production and management, studied how to promote the production and operation units and personnel to improve health awareness of food safety, the practical implementation of enterprise is the first responsibility consciousness, apply the internal management and self restraint mechanism, self-discipline is the production and operation activities, from the source of the good health and food safety.
By the method of questionnaire, on-the-spot investigation, material collecting, interviews, this paper reviews the history and current situation of supervision system of health food and industrial development, analyze the existing problems in depth. The results show, the current health food laws and regulations and standard system are not perfect, the regulatory responsibility has not completely straighten out, the technical support ability should be strengthened; production and operation units lack basic knowledge of the health food and safety awareness the ability of engaging in production and business operation according the law needs to improve. Some manufacturers even rush into danger, doping the false, illegal production and operation in pursuit of high profits,
Based on the analysis of the domestic and foreign health food regulatory policy and practical experience, combined with propolis health food regulatory features and existing problems in the supervision level, this paper puts forward the advice of accelerating the construction of legal system, straightening out the regulatory responsibility, strengthening the technical support ability, perfecting the credit system and other regulatory advice; in the aspect of enterprise management, puts forward the advice of strengthening the purchasing management of the raw material, implementing good manufacturing practices, standardizing management and standardizing the operational order processing.
本研究主要从加强政府监管和促进行业自律的角度出发,以蜂胶类保健食品生产企业和药店经营保健食品为切入点,讨论如何对保健食品监管的体制机制进行完善,提高科学监管和依法监管能力,落实长效的监管措施,形成高效的监管体系。同时,针对企业生产经营过程中存在的问题,研究如何促进生产经营单位和人员提高保健食品安全意识,切实落实企业是第一责任人的意识,完善和落实内部管理和自我约束机制,自觉自律进行生产经营活动,从源头把好保健食品安全关。
本文通过问卷调查、实地调研、资料查阅、访谈等方法,对保健食品的监管体系和产业发展的历史及现状进行梳理,对存在的问题进行深入剖析。结果显示当前保健食品的法律法规和标准体系还不尽完善,监管责任尚未完全理顺,技术支撑能力亟待加强；生产经营单位的保健食品基本知识匮乏,安全意识淡薄,依法生产经营的能力亟待提升,甚至有部分业者为追求高额利润,铤而走险、掺杂使假,违法生产经营。
本文在分析借鉴国内外保健食品监管政策及实践经验基础上,结合蜂胶类保健食品监管特点及存在问题,在监管层面提出加快法规体系建设,理顺监管责任,加强技术保障能力,完善诚信体系等监管建议；在企业管理层面,提出加强原料采购管理、落实良好生产规范、规范委托加工管理及规范经营秩序的建议。
In recent years, with the development of society and economy, people's health demand and consumption ability are increasing gradually, which brings prosperity to the market of health food and brings rapid development to the industry. According to the development situation of industry, health food regulatory system and legal system are also gradually established and become perfect, and the work of government supervision is deepening. In recent years, similar to the overall situation of food safety, health and food security situation overall stability is going well. However some security events still happened, which are not only harmful to the consumers' health and reduce the confidence of the consumers, but also affect the industry momentum of rapid development and bring great challenges to the supervision work.
This research mainly from the perspective of strengthening government supervision and promoting self-regulation of the industry, put the propolis health food production enterprises and the management of health food stores as a breakthrough point, discusses how to perfect the system and mechanism of health food supervision, improve the scientific supervision and supervision according to law, the implementation of effective regulatory measures, the formation of efficient supervision system. At the same time, in view of the existing problems in the process of enterprise production and management, studied how to promote the production and operation units and personnel to improve health awareness of food safety, the practical implementation of enterprise is the first responsibility consciousness, apply the internal management and self restraint mechanism, self-discipline is the production and operation activities, from the source of the good health and food safety.
By the method of questionnaire, on-the-spot investigation, material collecting, interviews, this paper reviews the history and current situation of supervision system of health food and industrial development, analyze the existing problems in depth. The results show, the current health food laws and regulations and standard system are not perfect, the regulatory responsibility has not completely straighten out, the technical support ability should be strengthened; production and operation units lack basic knowledge of the health food and safety awareness the ability of engaging in production and business operation according the law needs to improve. Some manufacturers even rush into danger, doping the false, illegal production and operation in pursuit of high profits,
Based on the analysis of the domestic and foreign health food regulatory policy and practical experience, combined with propolis health food regulatory features and existing problems in the supervision level, this paper puts forward the advice of accelerating the construction of legal system, straightening out the regulatory responsibility, strengthening the technical support ability, perfecting the credit system and other regulatory advice; in the aspect of enterprise management, puts forward the advice of strengthening the purchasing management of the raw material, implementing good manufacturing practices, standardizing management and standardizing the operational order processing.
引文
[1]陈卫东,李旭才.中华人民共和国食品安全法(草案)存在问题分析[J].中国食品卫生杂志,2009,21(2)：124-125.
[2]《中国保健食品产业发展蓝皮书》在京发布[J].中国食品,2012(3)：37.
[3]金宗濂.我国保健食品研发趋势及其产业发展走向[J].农产品加工·综合刊,2012(12)：4-5.
[4]发改产业[2011]3229号,国家发展改革委工业和信息化部《关于印发食品工业“十二五”发展规划的通知》[S].2011.
[5]卫药字第70号,中药保健药品的管理规定[S].1987.
[6]中华人民共和国主席令[第五十九号],中华人民共和国食品卫生法[S].1995.
[7]卫生部令第46号,保健食品管理办法[S].1996.
[8]国家食品药品监督管理局令第19号,保健食品注册管理办法(试行)[S],2005.
[9]李江华,李丹.我国保健食品法律法规体系与标准体系现状[J].食品科学,2011,32(21）：318-323.
[10]张李伟,赵洪静,白鸿.中国保健食品法律法规体系发展与现状研究[J].中国食品卫生杂志,2008,20(3)：232-235.
[11]百度文库.保健食品监督管理条例(送审稿)[DB/OL]. 2010-07-26[2013-04-10]. http://wenku.baidu.com/view/f946aa00bed5b9f3f90f Ic59.html.
[12]吴悦,吴昊.蜂胶的功效研究[J].科技与生活,2012(18)：239.
[13]徐华锋.中国保健食品行业状况和发展趋势[J].食品工业科技,2004(12)：6-9.
[14]庄元忠.宣传蜂胶功效保护蜂胶市场[J].蜜蜂杂志,2006,26(8)：20-21.
[15]束云,刘长喜,李连达.中国已获批准的保健食品现状分析[J].中国食品卫生杂志,2006,18(5)：401-405.
[16]李锐,于春媛,刘东红,等.我国保健食品研发现状与产品准入机制关系的研究［J].首都医药,2013(2)：8-9.
[17]潘晔.江苏抽检15个品牌蜂胶半数掺有杨树胶[EB／OL].2013-03-17[2013-04-12].http://news.xinhuanet.com/local/2013-03/17/c_11505 4933.htm.
[18]GB 17405-1998,保健食品良好生产规范[S].1998.
(?)[19]卢华明.谈保健食品企业实施”良好生产规范"(GMP)[J].广西轻工业,2003(6)：32-33.
[20]徐贵福,常良才,王学慧.保健食品委托加工生产方式亟待规范[J].首都医药,2011(5)：62-63.
[21]樊迪,朱功春.浅析基本药物政策对零售药店的影响及建议[J].齐鲁药事,2010,29(10)：626-627.
[22]齐东梅.保健食品监管现状与对策探讨[J].首都医药,2011(04)：14-15.
[23]赵兴健,王志刚.我国保健食品安全监管现存问题及对策建议——基于框架分析理论的案例研究[J］.中国食物与营养,2012,18(10)：8-10.
[24]刘泽龙,刘东红,于春媛,等.国产保健食品实行备案管理的分析与思考[J].首都医药,2011(05)：59-60.
[25]张斌,卫玮,温禄云.国外及天津市保健(功能)食品现状及发展建议[J].食品研究与开发,2012,33(7)：234-235.
[26]郝同战,黄武卫,武爱香,等.保健食品科学监管的制度设计研究[J].首都医药,2009,16(10)：11-12.
[2]《中国保健食品产业发展蓝皮书》在京发布[J].中国食品,2012(3)：37.
[3]金宗濂.我国保健食品研发趋势及其产业发展走向[J].农产品加工·综合刊,2012(12)：4-5.
[4]发改产业[2011]3229号,国家发展改革委工业和信息化部《关于印发食品工业“十二五”发展规划的通知》[S].2011.
[5]卫药字第70号,中药保健药品的管理规定[S].1987.
[6]中华人民共和国主席令[第五十九号],中华人民共和国食品卫生法[S].1995.
[7]卫生部令第46号,保健食品管理办法[S].1996.
[8]国家食品药品监督管理局令第19号,保健食品注册管理办法(试行)[S],2005.
[9]李江华,李丹.我国保健食品法律法规体系与标准体系现状[J].食品科学,2011,32(21）：318-323.
[10]张李伟,赵洪静,白鸿.中国保健食品法律法规体系发展与现状研究[J].中国食品卫生杂志,2008,20(3)：232-235.
[11]百度文库.保健食品监督管理条例(送审稿)[DB/OL]. 2010-07-26[2013-04-10]. http://wenku.baidu.com/view/f946aa00bed5b9f3f90f Ic59.html.
[12]吴悦,吴昊.蜂胶的功效研究[J].科技与生活,2012(18)：239.
[13]徐华锋.中国保健食品行业状况和发展趋势[J].食品工业科技,2004(12)：6-9.
[14]庄元忠.宣传蜂胶功效保护蜂胶市场[J].蜜蜂杂志,2006,26(8)：20-21.
[15]束云,刘长喜,李连达.中国已获批准的保健食品现状分析[J].中国食品卫生杂志,2006,18(5)：401-405.
[16]李锐,于春媛,刘东红,等.我国保健食品研发现状与产品准入机制关系的研究［J].首都医药,2013(2)：8-9.
[17]潘晔.江苏抽检15个品牌蜂胶半数掺有杨树胶[EB／OL].2013-03-17[2013-04-12].http://news.xinhuanet.com/local/2013-03/17/c_11505 4933.htm.
[18]GB 17405-1998,保健食品良好生产规范[S].1998.
(?)[19]卢华明.谈保健食品企业实施”良好生产规范"(GMP)[J].广西轻工业,2003(6)：32-33.
[20]徐贵福,常良才,王学慧.保健食品委托加工生产方式亟待规范[J].首都医药,2011(5)：62-63.
[21]樊迪,朱功春.浅析基本药物政策对零售药店的影响及建议[J].齐鲁药事,2010,29(10)：626-627.
[22]齐东梅.保健食品监管现状与对策探讨[J].首都医药,2011(04)：14-15.
[23]赵兴健,王志刚.我国保健食品安全监管现存问题及对策建议——基于框架分析理论的案例研究[J］.中国食物与营养,2012,18(10)：8-10.
[24]刘泽龙,刘东红,于春媛,等.国产保健食品实行备案管理的分析与思考[J].首都医药,2011(05)：59-60.
[25]张斌,卫玮,温禄云.国外及天津市保健(功能)食品现状及发展建议[J].食品研究与开发,2012,33(7)：234-235.
[26]郝同战,黄武卫,武爱香,等.保健食品科学监管的制度设计研究[J].首都医药,2009,16(10)：11-12.