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1 中国保健食品及其原料的法规监管魏明峰, CHINAGATE, March, 2017

2 1 Chapter 1 CFDA 保健食品备案与注册系统 CFDA Health Food Registration and Recording System

新的食品安全法, 于 2015 年 4 月 24 日颁布, 于 2015 年 10 月 1

2016 年 7 月 1 日正式开始实施 2017 年 3 月,CFDA 正式成立

负责保健食品的注册管理工作 New Food Safety Law was issued on

chapter 4 Food Production and Trading lay down

management system of registration & recording.

and Recording> was issued on February 26 th

In March 2017, CFDA founded Special Food

3 新的食品安全法, 于 2015 年 4 月 24 日颁布, 于 2015 年 10 月 1 日开始实施, 食安法第四章食品生产经营中的第四节特殊食品规定了保健食品相关政策, 采用注册与备案相结合的分类管理制度新的保健食品注册与备案管理办法 ( 国家食品药品监督管理总局令第 22 号 ), 于 2016 年 2 月 26 日颁布, 并于 2016 年 7 月 1 日正式开始实施 2017 年 3 月,CFDA 正式成立特殊食品注册管理司 ( 特食司 ), 下设注册一处注册二处综合处, 其中注册一处负责保健食品的注册管理工作 New Food Safety Law was issued on April 24 th 2015 and implemented on October 1 st In the Law, the section 4 Special Food of the chapter 4 Food Production and Trading lay down health food related policy and the classified management system of registration & recording. The new <Measures of Health Food Registration and Recording> was issued on February 26 th 2016, will be implemented on July 1 st In March 2017, CFDA founded Special Food Registration Management Department, which contains three branches. No.1 Registration Branch is responsible for health food registration.

4 2016 年 11 月 14 日, 国家食品药品监督管理总局印发保健食品注册审评审批工作细则 ( 食药监食监三 [2016] 139 号 ), 该细则自印发之日起实施 2016 年 12 月 19 日, 国家食品药品监督管理总局发布保健食品注册申请服务指南的通告 (2016 年第 167 号 ) 2016 年 12 月 27 日, 国家食品药品监督管理总局会同国家卫生计生委和国家中医药管理局制定的保健食品原料目录 ( 一 ) 和允许保健食品声称的保健功能目录 ( 一 ) (2016 年第 205 号公告 ) 予以发布 On November , CFDA issued and implemented the <Health Food Registration Review Rules> [2016] No.139. On December , CFDA issued the <Health Food Registration Application Service Guideline> [2016] No.167 On December , CFDA, National Health Commission and National Chinese Traditional Medicine Administration created <Health Food Raw Materials List (part 1) > and <Health Function Claims List (part 1) >.

5 2017 年 01 月 24 日, 国家食品药品监督管理总局发布关于保健食品备案管理有关事项的通告 (2017 年第 16 号 ): 自 2017 年 5 月 1 日起, 对使用列入保健食品原料目录 ( 一 ) 的原料生产和进口保健食 On January , CFDA issued [2017] No.16 announcement, which states that the health food 品的, 国内生产企业和境外生产厂商应当进行备案 recording system will be officially started from May 原注册人持有的保健食品注册证书及其附件载明内 1 st 容变更或有效期届满的, 应当按照备案程序办理 2017 年 03 月 03 日,CFDA 发布关于加快提交营 On December , CFDA health food review center issued No.184 announcement, which states 养素类产品补充资料有关事宜的公告 ( 第 184 号 ): that for any nutrients finish submitting 2017 年 3 月 30 日前, 完成补充资料提交的营养素类产品, 将按保健食品注册审评审批工作细则 supplementary materials before March , will be reviewing base on the new <Health Food Registration Review Rules>. If the supplementary (2016 版 ) 规定的程序和产品技术要求组织技术 materials haven t been submitted or are not 审评, 逾期未提交补充资料和补充资料不符合要求 qualified, the application will be automatically 产品, 按照通告要求将可能转入保健食品的备 transferred to recording system if possible. 案管理

6 2017 年 02 月 06 日, 国家食品药品监督管理总局公开征求保健食品备案工作细则 (2017 年版 )( 征求意见稿 ) 的意见 On February , CFDA issued the Exposure Draft of <Health Food Recording Rules (2017) >, which includes that <Excipients List for Health Food Recording System (part 1) >.

7 01 备案制 Recording 备案制适用于 : a. 使用已列入保健食品备案原料目录中的原料生产的保健食品 ; b. 首次进口属于补充维生素矿物质等营养物质的保健食品, 营养物质应是列入保健食品原料目录的物质 Recording applicable for: a. Health Food, which is made of the raw material listed on the Raw Material List for Health Food Recording system; b. First-time imported health food belong to Vitamins, Minerals and other nutrients. Other nutrients shall be listed on the Raw materials List. 02 注册制 Registration 注册制适用于 : a. 使用保健食品原料目录外原料的保健食品 ; b. 首次进口的功能性保健食品 Registration applicable for: a. Health food, which is made of the raw material NOT listed on the Raw Material List for Health Food Recording System; b. First-time Imported functional health food. 03 原料目录 Raw Materials a 年 12 月 27 日, 制定发布保健食品原料目录 ( 一 ); b. 名单规定了原料名称原料的标准依据用量使用范围等 ; a. Raw Materials List (part 1) has been issued on December ; b. The list stipulate the name, standard basis, usage level and usage scope of the raw materials.

8 04 备案与注册申请人资格 About the Applicant 06 省级食药监局省自治区直辖市食品药品监督管理部门负责国产保健食品备案 The provincial, autonomous regional and municipal health administrative department responsible for domestic health food recording. 05 国家食药总局 (CFDA) 国家食药总局负责 : 保健食品注册管理和首次进口的属于维生素矿物质等营养物质的保健食品备案管理 CFDA s responsibility: Health Food registration management; Health Food recording of Firsttime imported vitamins and minerals. 国产保健食品备案人应当是保健食品生产企业, 有加工厂 ; 国产保健食品注册申请人可以是工厂或公司 ; 进口保健食品备案或注册申请人, 必须是上市保健食品境外生产厂商 ( 两点区别 : 境外上市国 ) Applicant of domestic health food recording should be health food manufacturer, which has the production ability; Applicant of domestic health food registration can be manufacturer or company; Applicant of imported health food recording or registration shall be oversea manufacturer and trader of the marketed health food. (Oversea & Country of Origin)

9 保健食品注册系统相关调整 Health Food Registration System Adjustments 产品研发报告部分要求更加全面 : 原辅料安全性研究产品安全性研究功能研究生产工艺研究质量可控性研究产品技术要求研究稳定性研究等 ; 申请由国家食品药品监督管理总局受理机构承担, 以受理为注册审批的起点, 将生产现场核查和复核检验调整至技术审评环节 ; 申请资料需要补正的, 需要申请人在 3 个月内按要求一次性提交 ; Requirements for product R&D report are more comprehensive: ingredients and excipients safety research, product safety research, functional research, production process research, quality controllability research, product technical requirements research, stability research etc. CFDA Accepting Institution is responsible for the application process, start from receive the registration evaluation, plus manufacturing on-site inspection and retest adjustments, also the technical review section. If any supplementary materials are needed, the applicant should submit those within 3 months at a time.

10 2 Chapter 2 保健食品注册及备案流程时间及费用 Health Food Registration and Recording procedure, duration and costs.

11 国产保健食品注册流程时间及费用 : 费用 : 依据申报功能而定, 约 60 万 -90 万人民币时间 : 依据申报功能而定, 约 2-3 年

12 For Domestic Health Food: Determine the function Determine the formulation Product Research and Development Prepare samples Product Testing Create Application Dossier Submit the application materials to CFDA Technical Review meeting Supplement and modify materials Production on-site inspection and sampling; testing on-site inspection Evaluation Administrative Approval Get Approval Re-test Cost: Estimate 600, ,000, depends on different function claims. Duration: Estimate 2-3 years, depends on different function claims.

13 进口保健食品注册流程时间及费用 : 确定功能准备样品产品检测整理技术资料递交申请资料至国家药监局审评大会补充修改资料产品加工现场核查抽样 ; 试验现场核查评审行政审批复检获得批文费用 : 依据申报功能而定, 约 60 万 -90 万人民币时间 : 依据申报功能而定, 约 2-3 年

14 For Imported Health Food: Determine the function Prepare sample Product testing Create Application Dossier Submit the application materials to CFDA Technical Review Meeting Supplement and modify materials Production on-site inspection and sampling; testing on-site inspection Evaluation Administrative Approval Get approval Re-test Cost: Estimate 600, ,000, depends on different function claims. Duration: Estimate 2-3 years, depends on different function claims.

15 保健食品备案流程时间及费用 : 准备样品产品检测整理技术资料递交申请资料准予备案不予备案时间 : 预计 10 个月左右费用 : 预计万元人民币补充修改资料

16 Health Food Recording: Prepare Sample Product Testing Create Application Dossier Submit application materials Approval Dis-approval Supplement and modify materials Cost: Estimate 100, ,000. Duration: Estimate 10 months.

17 3 Chapter 3 保健食品原料监管 Health Food Ingredient Regulations

18 保健食品监管相关规定 : Health Food Ingredient Regulatory Related Rules: 关于加强保健食品原料监督管理有关事宜的通知国食药监许 [2011]123 号 - 由各省自治区直辖市的食品药品监督管理局进行监管 ; Announcement about strength health food ingredient regulatory works. CFDA No. [2011]123 -Regulate by provincial, autonomous and direct-controlled municipality FDA; - 严禁假冒伪劣原料, 采购时应对供应商资质质量指标等进行审核 ; 保健食品生产企业原辅料供应商审核指南 ( 食药监办保化 [2011]187 号 ) -Avoid to use fake ingredients. Should evaluate the supplier quality, quality indicators etc. 卫生部关于进一步规范保健食品原料管理的通知 ( 卫法监发 [2002] 51 when purchasing. 号 ) - 可用于保健食品的物品名单 - 既是食品又是药品的物品名单 - 保健食品禁用物品名单 Health Food Manufacturer Ingredients and Excipients Suppliers Evaluation Guide (FDA No. [2011]187) Further Standardize the health food ingredients and excipients management (Ministry of Health No. [2002] 51) - Ingredients can be used for Health Food - Ingredients can be used for both food and drugs - Banned Health Food Ingredient List

19 保健食品监管相关规定 : Health Food Ingredient Regulatory Related Rules: 涉及新食品原料的, 需要按照新食品原料申报与受理规定有关 Related with New Food Ingredients, need to follow<new Food Ingredient 规定执行 ; Declaration and Acceptance Rules>; - 已批准新原料可参考卫计委有关新食品原料普通食品名单汇 -Approved New Food Ingredients refers to <General Food and New Food 总 Ingredients List> issued by China Ministry of Health 涉及食品添加剂的, 需要按照食品添加剂新品种申报与受理规定 Related with Food Additives, need to follow <New Food Additives 有关规定执行 ; Declaration and Acceptance Rules >; - 已批准食品添加剂可参考 GB Approved Food Additives refers to GB 益生菌类保健食品申报与审评规定 ( 试行 )( 国食药监注 [2005]202 号 ) - 可用于保健食品的益生菌菌种名单 Probiotics Health Food Declaration and Acceptance Rules (Trial) (CFDA No. [2005]202) -Probiotics strains list can be used for Health Food 真菌类保健食品申报与审评规定 ( 试行 )( 国食药监注 [2005]202 号 Fungi Health Food Declaration and Acceptance Rules (Trial) (CFDA No. ) [2005]202) - 可用于保健食品的真菌菌种名单 - Fungi strains list can be used for Health Food 营养素补充剂申报与审评规定 ( 试行 )( 国食药监注 [2005]202 号 ) Nutrients Supplement Declaration and Acceptance Rules (Trial) (CFDA No. [2005]202)

20 其他特殊原料的管理规定 Other Special Ingredients Management Rules 关于限制以甘草麻黄草苁蓉和雪莲及其产品原料生产保健食品的通知 ( 卫法监发 [2001]188 号 ) 关于不再审批以熊胆粉和肌酸为原料生产的保健食品的通告 ( 卫法监发 [2001]267 号 ) 关于印发以酶制剂等为原料的保健食品评审规定的通知 ( 卫法监发 [2002]100 号 ) 核酸类保健食品申报与审评规定 ( 试行 )( 国食药监注 [2005]202 号 ) 氨基酸螯合物等保健食品申报与审评规定 ( 试行 )( 国食药监注 [2005]202 号 ) 野生动植物类保健食品申报与审评规定 ( 试行 )( 国食药监注 [2005]202 号 ) 应用大孔吸附树脂分离纯化工艺生产的保健食品申报与审评规定 ( 试行 )( 国食药监注 [2005]202 号 ) Limited licorice, ephedra herb, desert cistanche and saussurea involucrata Usage in Health Food (No.[2001]188) No longer review any health food produced with bear bile powder and creatine (No. [2001]267) Review rules of enzyme preparation for raw materials of health food (No. [2002]100) Nucleic acid Health Food Declaration and Acceptance Rules (Trial) (CFDA No. [2005]202) Amino chelate Health Food Declaration and Acceptance Rules (Trial) (CFDA No. [2005]202) Wild animals and plants Health Food Declaration and Acceptance Rules (Trial) (CFDA No. [2005]202) Health Food produced by Macroporous adsorption resin purification process Declaration and Acceptance Rules (Trial) (CFDA No. [2005]202)

21 其他特殊原料的管理规定 Other Special Ingredients Management Rules: 关于不饱和脂肪酸类保健食品审评问题的复函 ( 食药监注便函号 ) 关于含辅酶 Q10 保健食品产品注册申报与审评有关规定的通知 ( 国食药监许 [2009]566 号 ) 关于含大豆异黄酮保健食品产品注册申报与审评有关规定的通知 ( 国食药监许 [2009]567 号关于以红曲等为原料保健食品产品申报与审评有关事项的通知 ( 国食药监许 [2010]2 号 ) 保健食品中可能非法添加的物质名单 ( 第一批 )( 食药监办保化 [2012]33 号 ) 食品药品监管总局关于养殖梅花鹿及其产品作为保健食品原料有关规定的通知 ( 食药监食监三 ( 号 ) Return Letters about polyunsaturated fatty acid health food review (CFDA No. [2007] 251) Health Food (contains CoQ10) Registration Declaration and Acceptance Rules (CFDA No. [2009]566) Health Food (contains soy isoflavones) Registration Declaration and Acceptance Rules (CFDA No. [2009]567 Health Food (use red yeast rice for raw ingredient) Declaration and Acceptance Rules (CFDA No. [2010]2) Illegal additives in Health Food (First part) CFDA No. [2012]33 Breeding sika deer and their products as health food raw materials notice(cfda No.[2014]242)

22 备案原辅料相关规定 : Ingredients and Excipients regulations for Recording: 关于公开征求保健食品备案可用辅料名单 ( 第一批 ) 等意见的函食药监食监三便函号 2016 年 12 月 27 日, 国家食品药品监督管理总局会同国家卫生计生委和国家中医药管理局制定发布保健食品原料目录 ( 一 ) Ask for public comments on <Excipients List for Health Food Recording System ( Part 1> again on the CFDA announcement about <Health Food Recording Rule> (2017). Ask for public comments on Health Food Raw Ingredients List (Part 1) CFDA No

23 可用于保健食品的物品名单 : Ingredients can be used for Health Food: 人参人参叶人参果三七土茯苓大蓟女贞子山茱萸川牛膝川贝母川芎马鹿胎马鹿茸马鹿骨丹参五加皮五味子升麻天门冬天麻太子参巴戟天木香木贼牛蒡子牛蒡根车前子车前草北沙参平贝母玄参生地黄生何首乌白及白术白芍白豆蔻石决明石斛 ( 需提供可使用证明 ) 地骨皮当归竹茹红花红景天西洋参吴茱萸怀牛膝杜仲杜仲叶沙苑子牡丹皮芦荟苍术补骨脂诃子赤芍远志麦门冬龟甲佩兰侧柏叶制大黄制何首乌刺五加刺玫果泽兰泽泻玫瑰花玫瑰茄知母罗布麻苦丁茶金荞麦金樱子青皮厚朴厚朴花姜黄枳壳枳实柏子仁珍珠绞股蓝胡芦巴茜草荜茇韭菜子首乌藤香附骨碎补党参桑白皮桑枝浙贝母益母草积雪草淫羊藿菟丝子野菊花银杏叶黄芪湖北贝母番泻叶蛤蚧越橘槐实蒲黄蒺藜蜂胶酸角墨旱莲熟大黄熟地黄鳖甲

24 既是食品又是药品的物品名单 : Ingredients can be used for food and drugs: 丁香八角茴香刀豆小茴香小蓟山药山楂马齿苋乌梢蛇乌梅木瓜火麻仁代代花玉竹甘草白芷白果白扁豆白扁豆花龙眼肉 ( 桂圆 ) 决明子百合肉豆蔻肉桂余甘子佛手杏仁( 甜苦 ) 沙棘牡蛎芡实花椒赤小豆阿胶鸡内金麦芽昆布枣 ( 大枣酸枣黑枣 ) 罗汉果郁李仁金银花青果鱼腥草姜( 生姜干姜 ) 枳椇子枸杞子栀子砂仁胖大海茯苓香橼香薷桃仁桑叶桑椹桔红桔梗益智仁荷叶莱菔子莲子高良姜淡竹叶淡豆豉菊花菊苣黄芥子黄精紫苏紫苏籽葛根黑芝麻黑胡椒槐米槐花蒲公英蜂蜜榧子酸枣仁鲜白茅根鲜芦根蝮蛇橘皮薄荷薏苡仁薤白覆盆子藿香

25 保健食品禁用物品名单 : Banned Health Food Ingredients List: 八角莲八里麻千金子土青木香山莨菪川乌广防己马桑叶马钱子六角莲天仙子巴豆水银长春花甘遂生天南星生半夏生白附子生狼毒白降丹石蒜关木通农吉痢夹竹桃朱砂米壳( 罂粟壳 ) 红升丹红豆杉红茴香红粉羊角拗羊踯躅丽江山慈姑京大戟昆明山海棠河豚闹羊花青娘虫鱼藤洋地黄洋金花牵牛子砒石 ( 白砒红砒砒霜 ) 草乌香加皮( 杠柳皮 ) 骆驼蓬鬼臼莽草铁棒槌铃兰雪上一枝蒿黄花夹竹桃斑蝥硫磺雄黄雷公藤颠茄藜芦蟾酥

26 首批备案原料名单 (22 种营养素,69 个原料 ) 1. 钙 (12 种 ) 2. 镁 (5 种 ) 3. 钾 (5 种 ) 4. 锰 (2 种 ) 5. 铁 (5 种 ) 6. 锌 (6 种 ) 7. 硒 (3 种 ) 8. 铜 (2 种 ) 9. V. A(3 种 ) 10. V. D(2 种 ) 11. V. B1 (2 种 ) 16. 叶酸 (1 种 ) 12. V. B2 (2 种 ) 13. V. B6(1 种 ) 14. V. B12(1 种 ) 15. 烟酸 (2 种 ) 17. 生物素 (1 种 ) 18. 胆碱 (1 种 ) 19. V.C(4 种 ) 20. V.K(2 种 ) 21. 泛酸 (1 种 ) 22. V.E(6 种 ) 适宜人群用量, 要符合要求

27 Raw Material List of Health Food Recording Part 1 (22 nutrient, 69 raw materials) 1. Ca(12 types) 2. Mg(5) 3. Ka(5) 4. Mn(2) 5. Fe(5) 6. Zn(6) 7. Se(3) 8. Gu(2) 9. V. A(3) 10. V. D(2) 11. V. B1 (2) 12. V. B2 (2) 13. V. B6(1) 14. V. B12(1) 15. Niacin(2) 16. Folate(1) 17. Biotin(1) 18. Choline(1) 19. V.C(4) 20. V.K(2) 21. Pantothenic acid(1) 22. V.E(6) Applicable Population and usage should follow the requirements.

28 4 Chapter 4 进口无国标食品申请 Application of Food Import without National Standard

29 年 4 月, 国家卫计委颁布关于规范进口尚无食品安全国家标准审查工作的通知 ( 国卫办食品发号 ); 年 6 月 1 日, 国家食品安全风险评估中心颁布关于进口尚无食品安全国家标准食品相关标准技术审查工作的通知, 规定了进口无国标食品的范围及申请资料要求和程序 ; 3. 进口无国标食品的申请, 已经开始! 1) In April 2017, National Health Commission established Notice of Regulate the Inspection of Import without Food Safety National Standard (No.[2017] 14) 2) On June 1 st 2017, National Food Safety Risk Evaluation Center established another technical inspection notice, which stipulated the scope, requirements and procedure of Food Import without National Standard. 3) The application of Food Import without National Standard has been started.

30 1. 保健食品的注册与备案, 从此已经按照新的法规执行 ; 2. 国产营养素备案工作, 各省已纷纷开始 ; 3. 6 月开始, 延续注册制的营养素保健食品已经有批文下发 ; 4. 今年 CFDA 将逐步解决申请产品积压的问题 ; 5. 乐观预计 3 季度将有注册制功能型保健食品获批 ; 最晚 4 季度 ; 6. 进口保健食品申请人, 必须是境外厂商 ; 7. 备案制目前限于营养素补充剂 ; 其它原料名单需较长时间 ; 8. 进口无国标食品, 有利于解决了原料的进口问题

31 1. The new Health Food Registration Recording Regulation has been effective 2. Domestic Nutrients Recording has been started in many provinces; 3. Some health food registration renewal applications have been approved in June; 4. CFDA will continually solve the problem of accumulated application cases. 5. Some new health food registrations will be expected to be approved in the third quarter of this year, the latest fourth quarter; 6. The imported health food applicant shall be oversea manufacturer and trader; 7. For now, the recording system will be only applicable for nutrients supplement, other raw materials list will take a while; 8. Food Import without National Standard, which will benefit ingredient import problems.

32 Thank You for Listening! China Gate Consulting June 19, 2017

中国化妆品法规与监管

中国化妆品法规与监管中国大陆保健食品监管情况国家食品药品监督管理局保健食品化妆品监管司 2012.6 一二三保健食品原料管理保健食品监管法规保健食品注册管理 1 保健食品原料管理 1. 基本规定 2. 可作为保健食品的原料 3. 不可用于保健食品的原料 4. 保健食品原料与其他食品原料的区别和联系基本规定 1 2 3 4 5 应符合国家标准和卫生要求如无国家标准, 应当提供行业标准或自行制定的质量标准,