中新网8月20日电 国家食品药品监督管理局今日在其官方网站发布关于印发冬虫夏草用于保健食品试点工作方案 。方案指出，加强冬虫夏草资源使用的可控性，严格监控冬虫夏草原料来源，加强对加工、使用全过程的监管，保护冬虫夏草资源和草原生态环境。以下是全文：

Beijing, aug. 20 state food and drug administration today in its official website about print and distribute cordyceps used in health food pilot work plan 。Scheme pointed out that，Strengthen Chinese caterpillar fungus resources use of controllability，Strict monitoring cordyceps the sources of the raw materials，Strengthen the processing、Use of the whole process of the supervision，To protect Chinese caterpillar fungus resources and ecological environment on grasslands。The following is the full text：

　　各省、自治区、直辖市食品药品监督管理局(药品监督管理局)，国家食品药品监督管理局保健食品审评中心：

provinces、Autonomous region、Municipalities directly under the food and drug administration(Drug administration)，State food and drug administration health food evaluation center：

　　为在合理保护冬虫夏草资源的前提下，高效开发利用冬虫夏草资源，推动高端科技含量保健食品的研发，研究建立珍稀原料用于保健食品的有效监管办法，依据《中华人民共和国食品安全法》、《中华人民共和国野生植物保护条例》等法律法规，国家食品药品监督管理局组织制定了《冬虫夏草用于保健食品试点工作方案》。请各省(区、市)食品药品监督管理部门根据本行政区域内保健食品生产企业的实际，按照试点工作方案的要求，组织做好试点相关工作。

In the reasonable protection under the premise of Chinese caterpillar fungus resources，Effective development and utilization of Chinese caterpillar fungus resources，Promote high technology content health food products research and development，Study and establish the rare raw materials used in health food of effective supervision measures，According to the《Food security law of the People's Republic of China》、《The territory of the People's Republic of regulations on the protection of wild plants》And other laws and regulations，State food and drug administration organization established《Chinese caterpillar fungus used in health food pilot work plan》。Please provinces(area、city)The food and drug supervision and administration departments within their respective administrative areas according to the health food production enterprise's actual，According to the requirements of the pilot work plan，Organization do pilot related work。

　　国家食品药品监督管理局

State food and drug administration

　　2012年8月15日

August 15, 2012

　　冬虫夏草用于保健食品试点工作方案 Chinese caterpillar fungus used in health food pilot work plan

　　为妥善开展冬虫夏草用于保健食品试点工作，研究建立珍稀资源用于保健食品的有效监管办法，制定本试点工作方案。

For the proper development Chinese caterpillar fungus used in health food pilot work，Study and establish the rare resources used in health food of effective supervision measures，For this trial work plan。

　　一、工作目的 a、Work purpose

　　通过本试点工作，科学、严格设置准入门槛，积极引导符合条件的保健食品生产企业在冬虫夏草资源得到合理保护的前提下，高效开发利用冬虫夏草资源，推动高端科技含量保健食品的研发，促进保健食品质量安全控制水平的提高。同时，为建立珍稀资源用于保健食品的监管模式奠定基础。

Through the trial work，science、Strict admittance threshold Settings，Actively guide qualified health care food production enterprises in the Chinese caterpillar fungus resources get reasonable under the premise of protection，Effective development and utilization of Chinese caterpillar fungus resources，Promote high technology content health food products research and development，Promote health food quality and safety to raise the level of control。At the same time，For the building of rare resources used in health food regulatory model to lay the foundation。

　　二、工作原则 two、Working principle

　　(一)依法开展工作。严格按照国务院发布的《中华人民共和国野生植物保护条例》、农业部《甘草和麻黄草采集管理办法》等有关法规规章和《卫生部办公厅关于冬虫夏草作为保健食品原料有关问题的复函》(卫办监督函〔2012〕39号)要求开展相关工作。

(a)Work in accordance with the。In strict accordance with the promulgated by the state council《The territory of the People's Republic of regulations on the protection of wild plants》、The ministry of agriculture《Licorice and MaHuangCao acquisition management measures》And other relevant laws and regulations and rules《General office of the ministry of health on cordyceps as the raw materials of health food of the relevant questions of the reply》(Who do supervision letter [2012] no. 39)Requirements to carry out related work。

　　(二)合理利用珍稀资源。加强冬虫夏草资源使用的可控性，严格监控冬虫夏草原料来源，加强对加工、使用全过程的监管，保护冬虫夏草资源和草原生态环境。

(two)Reasonable utilization of rare resources。Strengthen Chinese caterpillar fungus resources use of controllability，Strict monitoring cordyceps the sources of the raw materials，Strengthen the processing、Use of the whole process of the supervision，To protect Chinese caterpillar fungus resources and ecological environment on grasslands。

　　(三)严格准入标准。制定严格的试点企业准入条件，明确相关要求，注重冬虫夏草的高水平研发和深加工，实现冬虫夏草有限资源的科学合理开发利用。

(three)Strict access standard。Formulate strict pilot enterprises access conditions，Clear requirements，Pay attention to Chinese caterpillar fungus high level of development and deep processing，To realize Chinese caterpillar fungus co., LTD., the scientific and reasonable exploitation and utilization of resources。

　　三、试点企业基本条件 three、Pilot enterprise basic conditions

　　(一)具有稳定合法的冬虫夏草来源。能够提供与资源省份有关单位签定合法且能够保障规模生产的购销合同，产品生产规模与获得的冬虫夏草资源相适应，能够保障生产可持续性。

(a)Has the stable legal source of Chinese caterpillar fungus。Can provide and resources provinces signed the relevant units legitimate and can ensure a scale production sales contract，Product production scale and acquisition adapt to Chinese caterpillar fungus resources，To ensure production sustainability。

　　(二)具有良好的保健食品研发能力。试点企业近两年曾承担食品药品领域国家级技术研究或者国家级重大科技创新项目，具有明确的创新发展战略和研发团队，具备良好的研发设备、实验室等条件和能力，获得国家技术专利。

(two)Has a good health food research and development ability。Pilot enterprises have nearly two years for food and drug field state-level technology research or national major scientific and technological innovation project，Have definite innovation development strategy and research and development team，Have good research and development equipment、The laboratory conditions and ability，Access to the national patent technology。

　　(三)具有显著技术优势。围绕以冬虫夏草为原料试点生产的产品，已开展大量基础性研究验证工作，有充分的科学依据支撑(文献依据、权威专家认可)，研发的产品具有市场发展潜力。

(three)Has significant technical advantage。On the Chinese caterpillar fungus as raw material to pilot the production of products，Has carried out a large number of basic research verification work，Have sufficient scientific basis for support(Literature basis、Authoritative experts recognized)，Research and development products have market development potential。

　　(四)具有良好的保健食品生产能力。试点企业保健食品工业产品年销售额10亿元以上(原产地保健食品生产企业可适当放宽)。具有先进的生产水平和完备的检验检测能力，拥有良好的产品质量安全过程控制能力。

(four)Has a good health food production capacity。Pilot enterprises health food industrial products with annual sales of 1 billion yuan of above(Country of origin health food production enterprise can relax appropriately)。With advanced production level and complete inspection detection ability，Have a good product quality and safety process control ability。

　　(五)具有行业带动性。试点企业有关产品市场占有率在全国位居前列，具有较大的影响力，拥有中国驰名商标。试点企业应具备良好的社会认可度和影响力，诚实守信，社会责任感强，两年内无质量安全等相关负面报道，无重大质量安全责任事故，无制假售假记录，经营状况良好。

(five)Has the profession DaiDongXing。Pilot enterprises related products market share in the national high achievers，Has greater impact，Has the Chinese famous trademark。Pilot enterprises should have good social approval and influence，Honest and trustworthy，Social sense of responsibility strong，Two years without quality safety and other related negative reports，No major quality safety accident，No counterfeit record，Operating in good condition。

　　四、试点内容 four、Pilot content

　　(一)规范冬虫夏草原料采购管理。研究冬虫夏草采购管理办法，严格控制冬虫夏草来源；研究冬虫夏草原料技术要求和相应检测方法，严格控制冬虫夏草原料质量。

(a)Standard Chinese caterpillar fungus raw material purchasing management。Study Chinese caterpillar fungus purchasing management measures，Strictly control the source of Chinese caterpillar fungus；Study Chinese caterpillar fungus raw materials technical requirements and corresponding test method，Strictly control the quality of raw material cordyceps sinensis。

　　(二)提高产品质量安全控制水平。加强高科技手段应用，严格产品质量安全保障措施，强化全过程管理，探索建立产品质量安全过程控制的有效途径。建立保障产品质量安全的生产经营全过程追溯体系，覆盖原料采购、投料、中间体控制、成品检验、销售全过程。

(two)To improve product quality and safety control level。To strengthen the application of high-tech means，Strict product quality security measures，Strengthen the management of the whole process，Establish product quality and safety to explore the effective way of process control。Establish guarantee product quality and safety production and operation process tracing system，Covering raw material purchase、feeding、Intermediate control、Finished goods inspection、Sales process。

　　(三)开展上市后产品功效性监测和验证工作。制定售出产品功效性跟踪监测的措施，积累评价数据，完成评价报告，研究建立产品功效性验证的有效办法。

(three)Listed in the product efficiency to monitoring and verification work。Formulate sold product efficiency tracking monitoring measures，Accumulation evaluation data，Complete evaluation report，Study and establish the product efficiency to the effective way to verify。

　　五、试点工作步骤 five、Pilot work steps

　　(一)企业在国家食品药品监督管理局相关通知发布之日起1年内，根据试点企业基本条件，在规定时间内到生产企业所在地省级食品药品监管部门提出试点申请，并提交相关资料。

(a)Enterprises in the state food and drug administration related notice issued within 1 year as of the date，According to the pilot enterprise basic conditions，Within the prescribed time to production enterprise the local provincial food and drug regulatory department pilot application is put forward，And submit relevant information。

　　(二)省级食品药品监管部门受理企业申请后，对相关资料进行审核，提出审核意见。符合要求的，报送国家食品药品监督管理局。

(two)Provincial food and drug supervision department accepts the enterprise application，The relevant material audit，Put forward the examination opinions。To meet the requirements of，The state food and drug administration。

　　(三)国家食品药品监督管理局组织对省级食品药品监管部门报送的相关资料进行审核，符合要求的，同意企业参加试点工作并反馈相关省级食品药品监管部门。

(three)State food and drug administration organization for the provincial food and drug regulatory department of the relevant material audit，To meet the requirements of，Agree to enterprises to participate in the pilot work and feedback related provincial food and drug regulatory department。

　　(四)相关企业按照产品注册申报程序及有关要求开展产品研发和相关试验验证等工作，准备相关申报资料，提出产品注册申请。国家食品药品监督管理局按照“程序不减、标准不降”的原则，加快开展产品审评审批工作。符合要求的，准予注册，发给保健食品批准证书。具有以冬虫夏草替代品为原料的保健食品批准证书的，申请人可以按照变更程序及有关要求开展相关申报工作。

(four)In accordance with the relevant enterprise product registration notification procedure and the requirements in product research and development and related experiments, etc，Prepare the declaration material，This paper put forward produce an application for registration。According to the state food and drug administration“Procedure does not reduce、Standard does not drop”principle，To carry out the work of examination and approval to speed up product evaluation。To meet the requirements of，Granting the registration，Issue the approval certificate of health food。With Chinese caterpillar fungus substitutes for raw materials of the approval certificate of the health food，The applicant may according to the change process and the relevant requirements to carry out relevant application。

　　(五)相关企业按照国家食品药品监督管理局批准的内容组织产品生产，并于产品批准每届满1年，按照试点内容向国家食品药品监督管理局提交试点工作报告。同时，还应提交冬虫夏草原料采购的证明文件、冬虫夏草的使用流向及相关产品销售额等资料。

(five)Related enterprises in accordance with the state food and drug administration approved content organization product production，And in the product approval each expires 1 year，According to the pilot content to the state food and drug administration, submit pilot work report。At the same time，They should submit cordyceps raw material purchase document、The use of cordyceps sinensis flow and related products sales data。

　　(六)国家食品药品监督管理局组织对企业提供的试点工作报告进行审核。符合要求的，相关企业继续开展试点工作。不符合要求的，国家食品药品监督管理局可要求相关企业停止试点工作，注销相关保健食品批准文号。

(six)State food and drug administration organization for the pilot enterprises to provide audit work report。To meet the requirements of，Related enterprises continue to carry out pilot work。Do not conform to the requirements，State food and drug administration may require related enterprise stop pilot work，The cancellation of related health food approval number。

　　(七)试点期间，对于试点企业出现产品质量安全等相关负面报道、发生重大质量安全责任事故或者出现制假售假行为的，一经查实，国家食品药品监督管理局将责令相关企业停止试点工作，注销相关保健食品批准文号并依法严肃处理。

(seven)During the pilot，Pilot enterprises appear for product quality and safety related negative reports、An important quality safety accident or appear counterfeit behavior，Once identified，State food and drug administration shall be ordered to stop the relevant enterprises pilot work，The cancellation of related health food in accordance with the approval document number and serious processing。

　

　六、试点期限 six、Pilot period

　　试点时限为国家食品药品监督管理局批准试点企业相关产品之日起5年。

Pilot time limit state food and drug administration for approval of the pilot enterprises related products within 5 years。