中国农业科技导报 ›› 2024, Vol. 26 ›› Issue (12): 7-17.DOI: 10.13304/j.nykjdb.2024.0819
李京虎1(
), 张逸璇1, 高飞1, 郭静利2()
收稿日期:2024-10-09
接受日期:2024-11-09
出版日期:2024-12-15
发布日期:2024-12-17
通讯作者:
郭静利
作者简介:李京虎E-mail： lijinghu@caas.cn；
基金资助:
Jinghu LI1(), Yixuan ZHANG1, Fei GAO1, Jingli GUO2()
Received:2024-10-09
Accepted:2024-11-09
Online:2024-12-15
Published:2024-12-17
Contact:
Jingli GUO
摘要：
功能性食品与保健食品具有十分紧密的联系，但二者并不能简单地画等号。保健食品作为一个食品类别，在我国有着明确且严格的管理规定；相对应的，功能性食品有着更加广泛的范围，功能性食品更适合作为由具有某些功能特性的食品组成的综合概念，而不是特指某种特定的食品。将功能性食品定义为除了为人体提供必要的营养和满足人们对美味的需求之外，更加强调调节人体生理机能的食品。在此基础上，结合我国政策体系以及国内外现有研究成果，将功能性食品置于食品体系中，从食品的定义、食品的监管角度及食品的原料分类3个视角提出功能性食品的定位，为完善我国功能性食品政策法律法规建言献策，并向功能性食品生产者的生产经营活动提供决策依据。
中图分类号:
李京虎, 张逸璇, 高飞, 郭静利. 功能性食品在我国食品分类中的定位及思考[J]. 中国农业科技导报, 2024, 26(12): 7-17.
Jinghu LI, Yixuan ZHANG, Fei GAO, Jingli GUO. Positioning and Thinking of Functional Food in Food Classification in China[J]. Journal of Agricultural Science and Technology, 2024, 26(12): 7-17.
图1 《食品安全国家标准》中食品的分类
Fig.1 Classification of foods in National Food Safety Standard
图2 功能性食品的定位
Fig. 2 Framework for positioning functional foods
名称 Name | 定义 Define | 来源依据 Basis of source |
|---|---|---|
普通食品 General food | 一般食品，是可供人类食用或饮用的物质，包括加工食品、半成品和未加工食品，不包括烟草或只作药品用的物质 Food in general， which is a substance intended for human consumption or drinking， including processed， semi-processed and unprocessed food， and excluding tobacco or substances intended solely for medicinal purposes | GB/T 15091—1994［ |
功能性食品 Functional food | 突出第3种功能即调节人体机能的食品。（第3种功能：除了为人体提供必要的营养和满足人们对美味的需求之外，更加强调调节人体生理机能） Food that emphasizes the third function， i.e.， regulating the function of the human body. （The third function： in addition to providing the body with essential nutrients and satisfying the need for good taste， more emphasis has been placed on regulating the physiological functions of the human body） | 本文定义 This paper definition |
特殊膳食用 食品 Food for special dietary uses | 为满足特殊的身体或生理状况和（或）满足疾病、紊乱等状态下的特殊膳食需求，专门加工或配方的食品。这类食品的营养素和（或）其他营养成分的含量与可类比的普通食品有显著不同 Food specially processed or formulated to meet special physical or physiological conditions and/or to meet special dietary needs in states such as disease， disorders， etc. Such foods contain nutrients and/or other nutrients at levels significantly different from those of analogous general food | GB 13432—2013［ |
表1 从食品的定义上定位各食品的相关概念
Table 1 Relevant concepts for locating each food product from the definition of a food product
名称 Name | 定义 Define | 来源依据 Basis of source |
|---|---|---|
普通食品 General food | 一般食品，是可供人类食用或饮用的物质，包括加工食品、半成品和未加工食品，不包括烟草或只作药品用的物质 Food in general， which is a substance intended for human consumption or drinking， including processed， semi-processed and unprocessed food， and excluding tobacco or substances intended solely for medicinal purposes | GB/T 15091—1994［ |
功能性食品 Functional food | 突出第3种功能即调节人体机能的食品。（第3种功能：除了为人体提供必要的营养和满足人们对美味的需求之外，更加强调调节人体生理机能） Food that emphasizes the third function， i.e.， regulating the function of the human body. （The third function： in addition to providing the body with essential nutrients and satisfying the need for good taste， more emphasis has been placed on regulating the physiological functions of the human body） | 本文定义 This paper definition |
特殊膳食用 食品 Food for special dietary uses | 为满足特殊的身体或生理状况和（或）满足疾病、紊乱等状态下的特殊膳食需求，专门加工或配方的食品。这类食品的营养素和（或）其他营养成分的含量与可类比的普通食品有显著不同 Food specially processed or formulated to meet special physical or physiological conditions and/or to meet special dietary needs in states such as disease， disorders， etc. Such foods contain nutrients and/or other nutrients at levels significantly different from those of analogous general food | GB 13432—2013［ |
名称 Name | 定义 Define | 来源依据 Basis of source |
|---|---|---|
功能性普通 食品 Functional general food | 属于普通食品，添加或含有特定营养成分（价值），以突出某种功能的食品 Food that is general foods with specific nutrients （values） added or contained to emphasize a certain function | 本文定义 This paper definition |
保健食品 Health food | 保健食品是声称并具有特定保健功能或者以补充维生素、矿物质为目的的食品，即适用于特定人群食用，具有调节机体功能，不以治疗疾病为目的，并且对人体不产生任何急性、亚急性或慢性危害的食品 Health food is food that claims to have specific health functions or to supplement vitamins and minerals， i.e.， food that is suitable for consumption by a specific group of people， has the function of regulating the body， does not aim at treating diseases， and does not cause any acute， subacute or chronic harm to the human body | GB 16740—2014［ |
表2 从食品的监管角度定位功能性食品
Table 2 Positioning functional food from the regulatory perspective of foods
名称 Name | 定义 Define | 来源依据 Basis of source |
|---|---|---|
功能性普通 食品 Functional general food | 属于普通食品，添加或含有特定营养成分（价值），以突出某种功能的食品 Food that is general foods with specific nutrients （values） added or contained to emphasize a certain function | 本文定义 This paper definition |
保健食品 Health food | 保健食品是声称并具有特定保健功能或者以补充维生素、矿物质为目的的食品，即适用于特定人群食用，具有调节机体功能，不以治疗疾病为目的，并且对人体不产生任何急性、亚急性或慢性危害的食品 Health food is food that claims to have specific health functions or to supplement vitamins and minerals， i.e.， food that is suitable for consumption by a specific group of people， has the function of regulating the body， does not aim at treating diseases， and does not cause any acute， subacute or chronic harm to the human body | GB 16740—2014［ |
时间 Time | 管理部门 Management | 年份 Year | 标志性文件 Landmark document | 管理方式 Management approach | 保健食品标识规范 Health food labeling code |
|---|---|---|---|---|---|
| 1995—2003 | 卫生部 Ministry of Health | 1995 | 《中华人民共和国食品卫生法》（中华人民共和国主席令〔第五十九号〕） Food Hygiene Law of the People's Republic of China （Order of the President of the People's Republic of China 〔No. 59〕） | 注册管理制 Registration system | 保健食品批准文号分为上下2行，上行为“卫食健字（ ）第 号”，下行为“中华人民共和国卫生部批准” Approval number of health food is divided into 2 lines， the upper line is “Wei Shi Jian Zi （ ） No.” and the lower line is “Approved by the Ministry of Health of the People’s Republic of China” |
| 1996 | 《保健食品管理办法》（中华人民共和国卫生部令〔第46号〕） Measures for the Administration of Health Food （Order of Ministry of Health of the People's Republic of China 〔No. 46〕） | ||||
| 1996 | 《保健食品标识规定》（卫生监发〔1996〕第 38 号） Regulations on Labeling of Health Food （Issued of Ministry of Health 〔1996〕 No. 38） | ||||
| 2003—2013 | 国家食品药品监督管理局 State Food and Drug Administration | 2005 | 《保健食品注册管理办法（试行）》（中华人民共和国国家食品药品监督管理局令第19号） Measures for the Administration of Health Food Registration （for Trial Implementation） （Order of State Food and Drug Administration of the People's Republic of China No. 19） | 注册管理制 Registration system | 国产保健食品批准文号格式为：国食健字G＋4位年代号＋4位顺序号；进口保健食品批准文号格式为：国食健字J＋4位年代号＋4位顺序号 Domestic health food approval number format： National Food and Health word G + 4 years + 4 sequential number； imported health food approval number format： National Food and Health word J + 4 years + 4 sequential number |
| 2013—2020 | 国家食品药品监督管理总局 China Food and Drug Administration | 2016 | 《保健食品注册与备案管理办法》（中华人民共和国国家食品药品监督管理总局令第22号） Measures for the Administration of Health Food Registration and Filing （Order of China Food and Drug Administration of the People’s Republic of China No. 22） | 注册与 备案制 Registration and filing system | 国产保健食品注册号格式为：国食健注G+4位年代号+4位顺序号；进口保健食品注册号格式为：国食健注J+4位年代号+4位顺序号 Domestic health food registration number format： National Food and Health Note G + 4 years + 4 sequential number； imported health food registration number format： National Food and Health Note J + 4 years + 4 sequential number |
国产保健食品备案号格式为：食健备G+4位年代号+2位省级行政区域代码+6位顺序编号；进口保健食品备案号格式为：食健备J+4位年代号+00+6位顺序编号 Domestic health food filing number format： Food and Health Preparation G + 4 years + 2 provincial administrative code + 6 sequential number； imported health food filing number format： Food and Health Preparation J + 4 years + 00 + 6 sequential number | |||||
2020至今 2020 to present | 国家市场监督管理总局 State Administration for Market Regulation | 2020 | 《保健食品注册与备案管理办法（2020修订）》（国家市场监督管理总局令第31号） Measures for the Administration of Health Food Registration and Filing （Revised in 2020） （Order of State Administration for Market Regulation No. 31） | 注册与 备案制 Registration and filing system | 同2016年规定，仅更换了管理机构 Same provisions as 2016， only the governing body has been replaced |
表3 保健食品管理的变革 (续表Continued)
Table 3 Changes in health food management
时间 Time | 管理部门 Management | 年份 Year | 标志性文件 Landmark document | 管理方式 Management approach | 保健食品标识规范 Health food labeling code |
|---|---|---|---|---|---|
| 1995—2003 | 卫生部 Ministry of Health | 1995 | 《中华人民共和国食品卫生法》（中华人民共和国主席令〔第五十九号〕） Food Hygiene Law of the People's Republic of China （Order of the President of the People's Republic of China 〔No. 59〕） | 注册管理制 Registration system | 保健食品批准文号分为上下2行，上行为“卫食健字（ ）第 号”，下行为“中华人民共和国卫生部批准” Approval number of health food is divided into 2 lines， the upper line is “Wei Shi Jian Zi （ ） No.” and the lower line is “Approved by the Ministry of Health of the People’s Republic of China” |
| 1996 | 《保健食品管理办法》（中华人民共和国卫生部令〔第46号〕） Measures for the Administration of Health Food （Order of Ministry of Health of the People's Republic of China 〔No. 46〕） | ||||
| 1996 | 《保健食品标识规定》（卫生监发〔1996〕第 38 号） Regulations on Labeling of Health Food （Issued of Ministry of Health 〔1996〕 No. 38） | ||||
| 2003—2013 | 国家食品药品监督管理局 State Food and Drug Administration | 2005 | 《保健食品注册管理办法（试行）》（中华人民共和国国家食品药品监督管理局令第19号） Measures for the Administration of Health Food Registration （for Trial Implementation） （Order of State Food and Drug Administration of the People's Republic of China No. 19） | 注册管理制 Registration system | 国产保健食品批准文号格式为：国食健字G＋4位年代号＋4位顺序号；进口保健食品批准文号格式为：国食健字J＋4位年代号＋4位顺序号 Domestic health food approval number format： National Food and Health word G + 4 years + 4 sequential number； imported health food approval number format： National Food and Health word J + 4 years + 4 sequential number |
| 2013—2020 | 国家食品药品监督管理总局 China Food and Drug Administration | 2016 | 《保健食品注册与备案管理办法》（中华人民共和国国家食品药品监督管理总局令第22号） Measures for the Administration of Health Food Registration and Filing （Order of China Food and Drug Administration of the People’s Republic of China No. 22） | 注册与 备案制 Registration and filing system | 国产保健食品注册号格式为：国食健注G+4位年代号+4位顺序号；进口保健食品注册号格式为：国食健注J+4位年代号+4位顺序号 Domestic health food registration number format： National Food and Health Note G + 4 years + 4 sequential number； imported health food registration number format： National Food and Health Note J + 4 years + 4 sequential number |
国产保健食品备案号格式为：食健备G+4位年代号+2位省级行政区域代码+6位顺序编号；进口保健食品备案号格式为：食健备J+4位年代号+00+6位顺序编号 Domestic health food filing number format： Food and Health Preparation G + 4 years + 2 provincial administrative code + 6 sequential number； imported health food filing number format： Food and Health Preparation J + 4 years + 00 + 6 sequential number | |||||
2020至今 2020 to present | 国家市场监督管理总局 State Administration for Market Regulation | 2020 | 《保健食品注册与备案管理办法（2020修订）》（国家市场监督管理总局令第31号） Measures for the Administration of Health Food Registration and Filing （Revised in 2020） （Order of State Administration for Market Regulation No. 31） | 注册与 备案制 Registration and filing system | 同2016年规定，仅更换了管理机构 Same provisions as 2016， only the governing body has been replaced |
名称 Name | 定义 Define | 具体分类 Specific classification | 来源依据 Basis of source |
|---|---|---|---|
食药物质原料 Food and drug substances | 传统作为食品，且列入《中华人民共和国药典》的物质 Substances traditionally used as food and included in the Pharmacopoeia of the People's Republic of China | 按照传统既是食品又是 中药材的物质 Substances that are traditionally used as both food and herbal medicine | 《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号）》附件中《既是食品又是药品的物品名单》 List of articles that are both food and drugs in the annex to the Notice of the Ministry of Health on Further Regulating the Management of Health Food Raw Materials （Issued of Ministry of Health 〔2002〕 No. 51） 国家卫生健康委关于印发《按照传统既是食品又是中药材的物质目录管理规定》的通知（国卫食品发〔2021〕36号） Circular of the National Health and Health Commission on the Issuance of the Provisions on the Management of the Catalog of Substances That Are Both Food and Chinese Herbal Medicine According to Tradition （Issued of National Health Commission 〔2021〕 No. 36） |
普通食品原料 General food substances | 《中国食物成分表》中所涉及的食品 Foods covered by the Chinese Food Composition List （CFCL） | 常规食品，食品添加剂 Routine food，food additive | 《中国食物成分表》《食品添加剂卫生管理办法》（中华人民共和国卫生部令第26号） Chinese Food Composition Table，Measures for the Hygienic Administration of Food Additives （Order of Ministry of Health of the People's Republic of China No. 26） |
新资源食品原料 New resource food substances | 在我国新研制、新发现、新引进的无食用习惯或仅在个别地区有食用习惯的，符合食品基本要求的物品 Newly developed， newly discovered， and newly introduced in China that are not customarily consumed or are only customarily consumed in individual regions， and that meet the basic requirements for food | 动物、植物和微生物，从动物、植物和微生物中分离的成分，原有结构发生改变的食品成分，其他新研制的食品原料 Animals， plants and microorganisms， components isolated from animals， plants and microorganisms，food components whose original structure has been altered，other newly developed food ingredients | 《新食品原料安全性审查管理办法》（中华人民共和国国家卫生和计划生育委员会令 第1号） Administrative Measures for the Review of the Safety of New Food Raw Materials （Order of National Health Commission of the People's Republic of China No. 1） 《食品添加剂新品种管理办法》（卫生部令 第73号） Measures for the Administration of New Varieties of Food Additives （Order of Ministry of Health No. 73） |
中药材 物质 Chinese herbal medicines substances | 可作为保健食品原料的中药材物质（不属于食药物质，仅属于可以用于保健食品的物质，而不能作为一般食品的原料） Chinese herbal medicine substances that can be used as raw materials for health food （not food and medicine substances， but only substances that can be used for health food and not as raw materials for general food） | 共114种物质 Total 114 substances | 《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号）》附件中《保健食品禁用物品名单》 List of Banned Items for Health Food in the Annex to the Notice of the Ministry of Health on Further Regulating the Management of Health Food Raw Materials （Issued of Ministry of Health 〔2002〕 No. 51） |
表4 从食品的原料分类定位功能性食品
Table 4 Positioning of functional foods from the classification of food ingredients
名称 Name | 定义 Define | 具体分类 Specific classification | 来源依据 Basis of source |
|---|---|---|---|
食药物质原料 Food and drug substances | 传统作为食品，且列入《中华人民共和国药典》的物质 Substances traditionally used as food and included in the Pharmacopoeia of the People's Republic of China | 按照传统既是食品又是 中药材的物质 Substances that are traditionally used as both food and herbal medicine | 《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号）》附件中《既是食品又是药品的物品名单》 List of articles that are both food and drugs in the annex to the Notice of the Ministry of Health on Further Regulating the Management of Health Food Raw Materials （Issued of Ministry of Health 〔2002〕 No. 51） 国家卫生健康委关于印发《按照传统既是食品又是中药材的物质目录管理规定》的通知（国卫食品发〔2021〕36号） Circular of the National Health and Health Commission on the Issuance of the Provisions on the Management of the Catalog of Substances That Are Both Food and Chinese Herbal Medicine According to Tradition （Issued of National Health Commission 〔2021〕 No. 36） |
普通食品原料 General food substances | 《中国食物成分表》中所涉及的食品 Foods covered by the Chinese Food Composition List （CFCL） | 常规食品，食品添加剂 Routine food，food additive | 《中国食物成分表》《食品添加剂卫生管理办法》（中华人民共和国卫生部令第26号） Chinese Food Composition Table，Measures for the Hygienic Administration of Food Additives （Order of Ministry of Health of the People's Republic of China No. 26） |
新资源食品原料 New resource food substances | 在我国新研制、新发现、新引进的无食用习惯或仅在个别地区有食用习惯的，符合食品基本要求的物品 Newly developed， newly discovered， and newly introduced in China that are not customarily consumed or are only customarily consumed in individual regions， and that meet the basic requirements for food | 动物、植物和微生物，从动物、植物和微生物中分离的成分，原有结构发生改变的食品成分，其他新研制的食品原料 Animals， plants and microorganisms， components isolated from animals， plants and microorganisms，food components whose original structure has been altered，other newly developed food ingredients | 《新食品原料安全性审查管理办法》（中华人民共和国国家卫生和计划生育委员会令 第1号） Administrative Measures for the Review of the Safety of New Food Raw Materials （Order of National Health Commission of the People's Republic of China No. 1） 《食品添加剂新品种管理办法》（卫生部令 第73号） Measures for the Administration of New Varieties of Food Additives （Order of Ministry of Health No. 73） |
中药材 物质 Chinese herbal medicines substances | 可作为保健食品原料的中药材物质（不属于食药物质，仅属于可以用于保健食品的物质，而不能作为一般食品的原料） Chinese herbal medicine substances that can be used as raw materials for health food （not food and medicine substances， but only substances that can be used for health food and not as raw materials for general food） | 共114种物质 Total 114 substances | 《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号）》附件中《保健食品禁用物品名单》 List of Banned Items for Health Food in the Annex to the Notice of the Ministry of Health on Further Regulating the Management of Health Food Raw Materials （Issued of Ministry of Health 〔2002〕 No. 51） |
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