日本保健食品登记法规问题集
Email：tyo4ww@evershinecpa.com
或
日本永辉BPO有限公司Onarimon Yusen Building 7F,Nishi-Shinbashi 3-23-5,Minato-ku, Tokyo 105-0003, Japan
接洽人:
丘玲恵（Kyu Reike）日本籍来自台湾
王礼芳（Lily Wang）日本永居来自福建
或
林幸穗 Anny Lin 协理
手机：+886-937-606-272
skype: annylin8008
wechat: annylin8008
电话：+886-2-2717-0515 分机:110
HLF-JP-10
请问日本对于保健食品的归类方式为何？它的正式名称为何？
不同归类管理强度有何差异?它的政府管辖机构为何？网页？
What are the categories of health food in Japan? What is its official name?
What is the intensity of management of different categories?
What is the governmental authority of health food? Website?
Evershine RD：
在日本，健康食品受《食品卫生法》、《食品标识法》、《健康促进法》规范，由主管当局厚生劳动省 (MHLW) 监管。
健康食品没有法律上的定义，是指除药品外，以具有维持和改善健康的特殊功效，或具有这种功效的方式出售的食品，是指所有预期具有保健作用的食品。
健康促进法将健康食品分为三类：
1. 营养机能食品：指能提供身体健康所需的营养成分，包括 13 种维生素（维生素 A、维生素B1、维生素 B2、维生素 B6、维生素 B12、维生素 C、维生素 D、维生素 E、维生素 K、叶酸、菸酸、泛酸、生物素）、六种矿物质（ 锌、 钙、 铁、 铜、 镁、 钾 ） 及 n-3 脂 肪酸，且须合乎政府制定之相关基准。
只需在上市贩售前60天提出系统性文献回顾或是临床试验，即可在产品包装上使用机能性食品标誌。但日后若发现该宣称有虚伪夸大或有误导性表述，仍将依法处罚。
2. 机能性表示食品：係指具有科学文献基础表示机能性的食品，业者在贩售前须向日本消费者厅报备，以日本消费者厅公告可宣称之用语，且符合营养功能食品标准标准，则不需要许可申请和通知等，但需要提出针对安全性和机能性相关的科学文献资料，且自行承担相关责任。
3. 特定保健用食品：係指含有保健机能成分，能影响生理机能之食品，包含维持血压、调节血中胆固醇、调节肠胃功能等特定保健用途者，须通过严密的试验，经过日本消费者厅审查、取得许可证后才能贩售。
In Japan, healthy food is regulated by the Food Sanitation Law, the Food Labeling Law, and the Health Promotion Law, and is regulated by the competent authority, the Ministry of Health, Labour and Welfare (MHLW). There is no legal definition of health food, and it refers to food, other than medicines, that have special effects of maintaining and improving health or that are sold in such a way as to have such effects, and refers to all foods that are expected to have health-care effects.
The Health Promotion Act categorizes healthy foods into three categories:
1. Nutritious functional food: refers to the nutrients that can provide the health of the body, including 13 vitamins (vitamin A, vitamin B1, vitamin B2, vitamin B6, vitamin B12, vitamin C, vitamin D, vitamin E, vitamin K, folic acid , niacin, pantothenic acid, biotin), six minerals (zinc, calcium, iron, copper, magnesium, potassium) and n-3 fatty acids, and must meet the relevant benchmarks set by the government. The functional food logo can be used on product packaging as long as a systematic literature review or clinical trial is submitted 60 days prior to the launch. However, if the claim is found to be false, exaggerated or misleading in the future, it will still be punished in accordance with the law.
2. Functional food: refers to the food that has the basis of scientific literature to show the function, the industry must report to the Japan Consumer Agency before selling, use the terms that can be declared in the Japan Consumer Agency announcement, and meet the nutritional functional food standards. , the license application and notification are not required, but the scientific literature related to safety and function needs to be submitted, and the relevant responsibilities shall be borne by yourself.
3. Specific health food: refers to food containing health-care functional ingredients that can affect physiological functions, including those with specific health-care purposes such as maintaining blood pressure, regulating blood cholesterol, and regulating gastrointestinal function, which must pass strict tests and be reviewed by the Japan Consumer Affairs Agency. , Only after obtaining a license can it be sold.
【参考连结】
https://www.mhlw.go.jp/stf/seisakunitsuite/bunya/kenkou_iryou/shokuhin/hokenkinou/index.html
HLF-JP-20
外国公司要到日本销售保健食品，无论设100%子公司或分公司，需要在公司登记时取得营业特许证？
假如要，其必要条件是什麽？所需文件及申请程序为何？网页？
If a foreign company wants to sell health food in Japan, no matter if it sets up a 100% subsidiary or branch, does it need to obtain an approval from local health bureau before the company’s registration?
If so, what are the requests? What are the required documents and application procedures? Website?
Evershine RD：
健康食品归类在食品，依法贩售需要取得营业执照。外国公司可以申请。
需要文件：
1.营业执照申请书资料
．申请人、邮政编码、 电话号码、传真号码、电子邮件地址、公司编号、出生年月日
．负责人(如果是法人)
．营业设施信息：邮编、电话号码、传真号码、电子邮件地址
．设施名称、位置、店铺名称或商号
．食品卫生经理姓名、参加都道府县知事等的课程
．主要处理食品、添加剂、器具/容器和包装
2.结构、设备、设施图
3.食品卫生管理员资格证明(进行食品销售时，需要指定食品卫生经理)
．定期参加都道府县知事或都道府县知事批准的研讨会，努力学习有关食品卫生的新知识。
．按照经营者的指示管理卫生。
．採取必要的预防措施，并儘力向经营者提供必要的意见。
．必须了解最新的食品卫生信息，以便妥善管理卫生。
．要成为食品卫生经理，必须参加总共约 6 小时的培训课程。
．具备以下资格的人员无需参加课程即可成为食品卫生管理人员：厨师、营养师、製菓卫生士、船舶料理士、《屠宰场法》规定的卫生管理人员、《屠宰场法》规定的工作卫生经理、家禽加工卫生经理、符合食品卫生经理或食品卫生观察员资格要求的人员。
4. 水质检验报告（使用自来水、专用水或简单专用水以外的水时）
5. 缴交许可证申请费
6. 如果是法人註册需要填写法人编号。
申请流程：
向营业所辖区的卫生所申办许可：
在进行食品营业许可审核时，对该营业设施进行实地调查，并对该设施的牢固性和设备的耐久性进行检验，根据所规定的审核基准有效期最短为5年，最长为8年。
Health food is classified as food, and a business license is required to sell it in accordance with the law. Foreign companies can apply.
Required documents:
1. Application for business license
．Applicant, zip code, phone number, fax number, email address, company number, date of birth
．Responsible person (if legal person)
．Business Facility Information: Postal Code, Phone Number, Fax Number, Email Address
．Facility name, location, store name or business name
．Name of the food hygiene manager, participation in the prefectural governor’s courses, etc.
．Handles primarily food, additives, utensils/containers and packaging
2. Structure, equipment and facility drawings
3. Qualification certificate of food sanitation manager (when selling food, a food sanitation manager needs to be designated)
．Regularly attend seminars approved by the prefectural governor or prefectural governor, and strive to learn new knowledge about food hygiene.
．Manage hygiene according to the operator’s instructions.
．Take the necessary precautions and try to provide the necessary advice to the operator.
．Up-to-date food hygiene information is essential in order to manage hygiene properly.
．To become a Food Hygiene Manager, one must attend a total of approximately 6 hours of training sessions.
．Persons with the following qualifications can become food hygiene managers without taking courses: cooks, nutritionists, fruit hygienists, ship cooks, hygiene managers under the Slaughterhouse Act, work hygiene managers under the Slaughterhouse Act , Poultry Processing Hygiene Managers, Persons who meet the qualification requirements for Food Hygiene Managers or Food Hygiene Observers.
4. Water quality inspection report (when using water other than tap water, special water, or simple special water)
5. Pay the permit application fee
6. If it is a legal person registration, the legal person number needs to be filled in.
Application process:
Apply to the health center in the jurisdiction of the business office license:
When conducting food business license audits, conduct on-the-spot investigation of the business facility, and test the firmness of the facility and the durability of the equipment. The validity period is 5 years at the shortest and 8 years at the longest according to the specified audit criteria.
【参考连结】
https://www.fukushihoken.metro.tokyo.lg.jp/shokuhin/kyokatodokede/youshiki.html#kanri
HLF-JP-25
假如需要办理，请问日本有专业服务公司可以协助办理保健食品公司营业许可证？
东京のまどか法务行政书士事务所
日佳
HLF-JP-30
外国公司要到日本销售保健食品，可以指派日本公司担任营业代理人销售吗?
担任营业代理人，其必要条件是什麽？所需文件及申请程序为何？外国公司与营业代理人的产品责任为何?网页？
If a foreign company wants to sell health food in Japan, can it assign a Japan company to act as a business agent?
What are the requests for acting as a business agent? What are the required documents and application procedures?
What is the product liability of foreign companies and the business agents? Website?
Evershine RD：
健康食品归类在食品，依法贩售需要取得营业执照。
需要文件：
1.营业执照申请书资料
．申请人、邮政编码、 电话号码、传真号码、电子邮件地址、公司编号、出生年月日
．负责人(如果是法人)
．营业设施信息：邮编、电话号码、传真号码、电子邮件地址
．设施名称、位置、店铺名称或商号
．食品卫生经理姓名、参加都道府县知事等的课程
．主要处理食品、添加剂、器具/容器和包装
2.结构、设备、设施图
3.食品卫生管理员资格证明(进行食品销售时，需要指定食品卫生经理)
．定期参加都道府县知事或都道府县知事批准的研讨会，努力学习有关食品卫生的新知识。
．按照经营者的指示管理卫生。
．採取必要的预防措施，并儘力向经营者提供必要的意见。
．必须了解最新的食品卫生信息，以便妥善管理卫生。
．要成为食品卫生经理，必须参加总共约 6 小时的培训课程。
．具备以下资格的人员无需参加课程即可成为食品卫生管理人员：厨师、营养师、製菓卫生士、船舶料理士、《屠宰场法》规定的卫生管理人员、《屠宰场法》规定的工作卫生经理、家禽加工卫生经理、符合食品卫生经理或食品卫生观察员资格要求的人员。
4. 水质检验报告（使用自来水、专用水或简单专用水以外的水时）
5. 缴交许可证申请费
6. 如果是法人註册需要填写法人编号。
申请流程：
向营业所辖区的卫生所申办许可：
在进行食品营业许可审核时，对该营业设施进行实地调查，并对该设施的牢固性和设备的耐久性进行检验，根据所规定的审核基准有效期最短为5年，最长为8年。
Health food is classified as food, and a business license is required to sell it in accordance with the law..
Required documents:
1. Application for business license
．Applicant, zip code, phone number, fax number, email address, company number, date of birth
．Responsible person (if legal person)
．Business Facility Information: Postal Code, Phone Number, Fax Number, Email Address
．Facility name, location, store name or business name
．Name of the food hygiene manager, participation in the prefectural governor’s courses, etc.
．Handles primarily food, additives, utensils/containers and packaging
2. Structure, equipment and facility drawings
3. Qualification certificate of food sanitation manager (when selling food, a food sanitation manager needs to be designated)
．Regularly attend seminars approved by the prefectural governor or prefectural governor, and strive to learn new knowledge about food hygiene.
．Manage hygiene according to the operator’s instructions.
．Take the necessary precautions and try to provide the necessary advice to the operator.
．Up-to-date food hygiene information is essential in order to manage hygiene properly.
．To become a Food Hygiene Manager, one must attend a total of approximately 6 hours of training sessions.
．Persons with the following qualifications can become food hygiene managers without taking courses: cooks, nutritionists, fruit hygienists, ship cooks, hygiene managers under the Slaughterhouse Act, work hygiene managers under the Slaughterhouse Act , Poultry Processing Hygiene Managers, Persons who meet the qualification requirements for Food Hygiene Managers or Food Hygiene Observers.
4. Water quality inspection report (when using water other than tap water, special water, or simple special water)
5. Pay the permit application fee
6. If it is a legal person registration, the legal person number needs to be filled in.
Application process:
Apply to the health center in the jurisdiction of the business office
license:
When conducting food business license audits, conduct on-the-spot investigation of the business facility, and test the firmness of the facility and the durability of the equipment.
The validity period is 5 years at the shortest and 8 years at the longest according to the specified audit criteria.
【参考连结】
https://www.fukushihoken.metro.tokyo.lg.jp/shokuhin/kyokatodokede/youshiki.html#kanri
HLF-JP-35
假如需要办理指派日本公司担任营业代理人，请问日本有专业服务公司可以协助？
Evershine RD：
Healthy-food
https://www.healthy-food-gr.jp/index.html
森下
HLF-JP-40
外国公司销售到日本保健食品本身，进口前需要办理产品许可吗？
如需要，哪个单位在管理？需要什麽文件？申请程序为何？保健食品包装内容及各种标示，需要事先核准吗？
可允许的语文除了日文外，其他哪种语文也可以？网页？
Do foreign companies need to apply for an approval before importing health food sold to Japan?
If yes, which authority is in charge? What documents are required? What is the application process?
Do health food packaging and labeling require prior approval? In addition to Japanese, which other languages are allowed? Website?
Evershine RD：
【参考连结】
需要，营养机能食品为自我认证，机能性表示食品、特定保健食品需要提出申请。
营养机能食品：具有自我认证体系，无需单独申请许可。
机能性表示食品的申请手续(从入口网註册、提出申请)
须具备资料
1. 註册食品的基本信息
．公司名称、编号、负责人、邮政编号、地址、电话号码
．负责部门、接洽窗口、联繫电话(分机)、电子邮件
．产品名称、食品分类
．机能性成分名称
．确认机能性成分是否为萃取物、安全性评价方法
．通过对食用性能进行评估、确认了足够的安全性
．根据现有信息对饮食体验进行评估，确认了足够的安全性
．通过安全测试确认了足够的安全性、功能评价方法
．功能性通过使用最终产品的人体测试评估
．功能性在最终产品的研究审查中进行评估
．检查表、相关的材料、商业协会认可资料
2.附件资料
．产品主要目标人群
．基本安全信息(安全性评价方法)
．摄入注意事项
．有关生产/製造和质量控制的信息
说明管理体系，如果是加工食品，请描述 GMP、HACCP、ISO 22000、FSSC 22000 的分类以及每个製造工厂是否有认证。)
．功能性评价方法
．提交者对产品功能的评价
．饮食体验评价
．使用现有信息进行评估
．安全测试评估
．通过安全测试进行评估(附体外试验和体内试验报告)
．与药品相互作用的评估
．有关健康危害的信息(例如联繫人、电话号码、传真、电子邮件)
．科学依据
．最终产品的人体测试、最终产品的研究回顾
．机能性成分研究综述
．预计每日摄入量
．保存、摄取方法、摄取注意事项
．对烹调或保管方法需要特别注意的事项
．展示样品的附件
．食品相关业务的基本信息
．製造商名称（工厂或加工厂名称）和位置
．消费者服务部门的联繫方式（电话号码、网页等）
．预定销售开始日期等
特定保健食品的申请手续
1. 提交许可申请和审查申请
．向营业所区域的卫生所提交许可申请。(正本1份、副本2份)
．收到许可申请的都道府县知事等将检查许可申请的不足之处，并将认为适当的内容提交给厚生劳动大臣。
．提交许可申请书等后，附上许可申请书複印件，将审查申请书(含附件)提交至厚生劳动省食品安全局-食品安全司标准审查处，可以寄送或亲送(正本1份、副本1份)
2.具备资料
．带有标籤和健康声明的整个包装样本
．证明产品和/或其功能成分的临床和营养证明以维持健康的文件
．证明产品和/或其功能成分摄入量的临床和营养证明的文件
．有关产品及其功能成分安全性的文件，包括关于饮食体验的额外人体研究
．有关产品及其功能组成稳定性的文件
．产品和功能组件的物理和生物学特性的文档
．其功能成分的定性/定量分析测定方法及产品中成分的分析测定结果
．产品指定营养成分及热量含量分析报告
．生产方法说明、工厂设备清单和质量控制系统说明
3.免费样品测试检验请求
．申请人在产品样品上附上检验申请表等複印件，请求美国国家健康与营养研究所或註册检测机构进行检测检验。
．申请人向新发食品卫生措施办公室提交该机构或註册检测机构出具的检测报告原件。
4. 许可测试的实施机构
特殊用途食品（含特定保健用食品）许可检测主体为美国国立卫生与营养研究所及以下註册检测机构。
．国立健康与营养研究所
．註册检测机构名单：
日本食品分析中心
食品环境检验协会
食品分析开发中心 SUNTEC
日本食品检验
大坂公共卫生研究所
保健食品的标籤必须符合食品标籤法规范，所有贩售食品必需在容器包装上以日文标示。
1. 营养机能食品标籤陈列项目显示：
．能显示机能的营养成分
脂肪酸（1种）：n-3脂肪酸
矿物质（6种）：锌、钾*、钙、铁、铜、镁
维生素（13种）：菸酸、泛酸、生物素、维生素A、维生素B 1、维生素B 2、维生素B 6、维生素B 12、维生素C、维生素D、维生素E、维生素K、叶酸
(片剂、胶囊对于以製剂形式存在的加工食品不包括钾)
．营养功能食品及营养成分的标示：显示为营养机能食品（营养成分名称），显示多个设定标准的营养成分时，顺序不固定。
．营养成分的作用：描述每种营养成分指定的功能，即使标籤内容相同，也不允许改变或省略指定营养成分的功能。
．预计每日摄入量：也可以在宽度的两端显示“请吃○粒到○粒。” （在规定的上限和下限内）。
．营养成分的量和热量（营养成分标籤）：显示每日摄入量指南的营养成分量和热量。(需要用规定方法求得的数值表示)
．摄取方法
．食入注意事项
．促进和启发均衡饮食的措辞：必须标註饮食习惯要以主食、主菜、配菜为主，均衡饮食
．必须标註该产品与特定保健食品不同，未经消费者厅长官个别审查
．营养成分量与显示营养素等的标准值的百分比。
．营养素的标准值等有关目标年龄和标准发热量的字样
．烹调或保管方法上需要特别注意的事项
．特定对象需要注意的事项
．保存方法 (只限新鲜食品)
．对于因加热等而导致营养成分发生显着变化的食品，需要显示保证的烹调上下限范围内方法。(只限新鲜食品)
．即使是生鲜食品，如果要作为营养机能性食品销售，也需要装在容器中，并附上必要的标籤物品，不能裸卖
．当可显示区域约为 150 ㎠ 或更小时，可以以 5.5 点或更大的大小显示字符。
2. 机能性表示食品
具有机能性声称的食品在容器、包装上註明有助于维持和促进健康的特定健康目标（不包括与降低疾病风险相关的目标）可以通过功能相关的成分来实现，必须在销售日期前至少 60 天向消费者厅长官报告下列事项。
具有机能声称的食品的通知项目：
．显示内容
．食品相关业务的基本信息
．基于安全的信息
．基于功能的信息
．有关生产/製造和质量控制的信息
．健康危害信息採集系统
．其他必要事项
具有机能声称的食品应标註的项目：
．是一种具有机能声称的食物
．具有科学证据的功能相关成分以及该成分/含有该成分食品的功能
．营养成分和卡路里的量
．每日摄入量指南中功能性成分的含量
．估计每日摄入量
．通知编号
．食品相关企业的联繫信息．食品相关企业的名称或名称、地址和联繫信息(仅限新鲜食品)
．未接受国家对功能和安全性的评估
．摄取方法
．摄入注意事项
．促进和启发均衡饮食的措辞
．烹饪或储存方法需要特别注意的物品的注意事项
．不适用于疾病的诊断、治疗或预防
．不适用于患病者、未成年人、孕妇（包括计划怀孕者）和哺乳期妇女(仅限加工食品)
．患病者应谘询医生，服用药物者服药前应谘询医生或药剂师。
．如果感觉身体状况有任何变化，应立即停止服用并谘询医生。
．保存方法(只限生鲜)
．所有需要的显示项目将以 8 点或更大的大小显示，如果可显示区域约为 150 ㎠ 或更小，则可以显示大小为 5.5 点或更大的字符。
．如果想将生鲜食品作为具有机能声称的食品进行销售，需要将其放入描述了必要标籤项目的容器和包装并通知消费者事务厅，不能裸卖。
3. 特定保健用食品
作为特定保健用食品销售，必须对每种产品的食品有效性和安全性进行检查，并且标籤必须得到消费者事务厅的批准。
特定保健食品和有条件的特定保健食品均附有许可证，特定保健食品分为四类。
．特定保健食品：在饮食中为特定健康目的服用者。表明可以通过摄入来达到健康目的之食物
． 特定保健食品（降低疾病风险标籤）：如果所涉及成分有降低疾病风险效果的科学依据，并在医学和营养学上被广泛接受，则允许使用降低疾病风险标籤。
．特定保健食品（标准型）：依据科学根据确认所涉成分和标准是否符合具有足够的作为特定保健用途食品的批准记录，无需消费者委员会单独审查。
．有条件的特定保健食品：未达到特定保健食品检验所要求的科学证据水平，但其有效性得到一定程度证实的食品，需在标籤上标明其科学证据有限。 .
特定保健食品所需的标籤陈列项目显示：
1.是指定保健用途的食品
2.经许可显示的内容等
3.营养成分（包括相关成分）的量和热量
4.估计每日摄入量
5.摄取方法
6.摄入註意事项
7.促进和启发均衡饮食的措辞
8.如果针对所涉及的成分显示营养素等参考值，则每日摄入量所涉及的成分与营养素等参考值的比例。
9.烹饪或储存方法需要特别注意的物品的注意事项
10.所有需要的显示项目均以8 点或更大的字符显示（当可显示区域约为 150 cm 2或更小时，字符至少 5.5 点或更多）。
标籤禁止：
健康声称食品以外的食品，不得使用与健康声称食品、营养成分的功能、可期待特定健康目的的用语混淆的名称。
(例)特定保健食品、特定功能食品、保健XX食品、XX功能食品等名称，尤其是包含功能和健康字样的名称。
Nutritious functional foods are self-certified, and functional foods and specific health foods need to be submitted for application.
Nutritious functional food: It has a self-certification system and does not need to apply for a license separately.Application procedure for functional indication food (registration and application from portal)
Required information:
1. Basic Information of Registered Food
．Company name, number, person in charge, postal code, address, phone number
．Department in charge, contact window, contact number (extension), email
．Product name, food classification
．Functional component name
．Confirmation of functional ingredients as extracts, safety evaluation method
．Adequate safety confirmed by evaluation of edible performance
．Eating experience was assessed based on available information, confirming adequate safety
．Adequate safety and functional evaluation methods confirmed through safety testing
．Functionality assessed by human testing using the final product
．Functionality is assessed in research review of final product
．Checklists, related materials, business association endorsements
2. Attachment data
．Main target audience of the product
．Basic safety information (safety assessment method)
．Ingestion precautions
．Information about production/manufacturing and quality control
Describe the management system, and if it is a processed food, describe the classification of GMP, HACCP, ISO 22000, FSSC 22000 and whether each manufacturing facility has certification． )
．Functional evaluation method
．Submitter comments on product features
．Eating experience evaluation
．Use existing information for assessment
．Security Test Evaluation
．Evaluate through safety testing (with in vitro and in vivo test reports)
．Evaluation of Interactions with Drugs
．Information about health hazards (e．g． contact person, telephone number, fax, email)
．Scientific evidence
．Human testing of the final product, review of the research on the final product
．Summary of Research on Functional Components
．Expected daily intake
．Storage, ingestion method, and precautions for ingestion
．Precautions for cooking or storage methods
．Accessories for showing samples
．Basic information on food-related businesses
．Manufacturer’s name (factory or processing facility name) and location
．Contact details for Consumer Services (phone number, webpage, etc．)
．Scheduled sales start date etc．
Application procedure for specified health food
1. Submit license application and review application
．Submit a permit application to the health center in the business area． (1 original, 2 copies)
．The prefectural governors, etc．, who have received the permission application, will examine the deficiencies of the permission application and submit the content deemed appropriate to the Minister of Health, Labour and Welfare．
．After submitting the permit application, attach a copy of the permit application, and submit the review application (including attachments) to the Ministry of Health, Labour and Welfare Food Safety Bureau – Food Safety Division Standards Review Division, which can be sent by mail or in person (1 original, 1 copy)
2. Information
．Whole package samples for labels and health claims
．Documents demonstrating clinical and nutritional certification of the product and/or its functional ingredients to maintain health
．Documentation of clinical and nutritional proof of intake of the product and/or its functional ingredients
．Documentation on the safety of the product and its functional ingredients, including additional human studies on eating experience
．Documents about the stability of the product and its functional composition
．Documentation of physical and biological properties of products and functional components
．Qualitative/quantitative analysis and determination methods of its functional ingredients and analysis and determination results of ingredients in products
．Product Specified Nutrients and Calorie Content Analysis Report
．Description of production method, list of plant equipment and description of quality control system
3. Free sample test inspection request
． The applicant should attach a copy of the inspection application form to the product sample, and request the National Institute of Health and Nutrition or a registered testing agency to conduct testing and testing．
． The applicant submits the original test report issued by the agency or a registered testing agency to the Office of New Food Sanitation Measures．
4. The implementing agency of the license test
Special purpose food (including food for specific health use) is licensed by the National Institute of Health and Nutrition in the United States and the following registered testing institutions.
．National Institute of Health and Nutrition
．List of registered testing institutions:
Japan Food Analysis Center
Food Environmental Inspection Association
Food Analysis Development Center SUNTEC
Japanese food inspection
Osaka Institute of Public Health
The labels of health food must comply with the Food Labeling Law, and all food for sale must be marked in Japanese on the container and packaging.
1. The display items of the nutrition and functional food label display:
．Nutrients that show function
Fatty acids (1 type): n-3 fatty acids
Minerals (6): Zinc, Potassium*, Calcium, Iron, Copper, Magnesium
Vitamins (13 types): niacin, pantothenic acid, biotin, vitamin A, vitamin
B1, vitamin B2, vitamin B6, vitamin B12, vitamin C, vitamin D,
vitamin E, vitamin K, folic acid
(Tablets, capsules do not include potassium for processed foods in the form of preparations)
．Labeling of nutritional functional foods and nutritional ingredients: It is displayed as nutritional functional food (name of nutritional ingredients)
．When multiple nutritional ingredients with set standards are displayed, the order is not fixed．
．Role of nutrition facts: Describe the function specified for each nutritional ingredient, even if the label content is the same, it is not allowed to change or omit the function of the designated nutritional ingredient．
．Estimated daily intake: “Please take ○ grains to ○ grains．” can also be displayed at both ends of the width (within the specified upper and lower limits)．
．Nutrient amounts and calories (Nutrition Facts Label): Displays the nutrient amounts and calories for the Daily Intake Guidelines． (It needs to be represented by a numerical value obtained by a prescribed method)
．Intake method
．Ingestion precautions
．Phrasing to promote and inspire a balanced diet: It must be marked that eating habits should be based on staple food, main dishes, and side dishes, and a balanced diet
．It must be marked that the product is different from a specific health food and has not been individually reviewed by the Director of the Consumer Affairs Agency
．The percentage of the amount of nutrients and the standard value showing nutrients, etc．
．Words about target age and standard calorific value, such as standard values of nutrients
．Precautions for cooking or storage
．Matters needing attention for specific objects
．Preservation method (Fresh food only)
．For foods whose nutrient content changes significantly due to heating, etc．, it is necessary to show the method within the guaranteed upper and lower limits of cooking． (Fresh food only)
．Even fresh food, if it is to be sold as a nutritious functional food, needs to be packed in a container with the necessary label items attached, and cannot be sold naked
．When the displayable area is about 150 ㎠ or less, characters can be displayed in 5．5 dots or more．
2. Foods that express functionality
Foods with functional claims state on the container, packaging that specific health goals (excluding goals related to reducing disease risk) that help maintain and promote health can be achieved through functionally related ingredients, and must be at least 60 years before the date of sale.
Report the following matters to the Commissioner of the Consumer Affairs Agency.
Notification Items for Food Products with Functional Claims:
．Display content
．Basic information on food-related business
．Security-Based Information
．Feature-Based Information
．Information about production/manufacturing and quality control
．Health Hazard Information Collection System
．Other necessary matters
Items that should be marked on foods with functional claims:
．Food with functional claims
．Functionally relevant ingredients with scientific evidence and the function of the ingredient/food containing the ingredient
．Nutrition facts and calorie amounts
．Content of functional ingredients in daily intake guidelines
．Estimated daily intake
． Notification number
．Contact information for food-related businesses. Food related business name or name, address and contact information (fresh food only)
．Not subject to national assessment of functionality and safety
．Intake method
．Ingestion precautions
．Words to promote and inspire a balanced diet
．Precautions for items that require special attention in cooking or storage methods
．Not suitable for diagnosis, treatment or prevention of disease
Not suitable for ill persons, minors, pregnant women (including those planning pregnancy) and lactating women (processed foods only)
．Those who are ill should consult their doctor, and those taking medication should consult their doctor or pharmacist before taking the medicine.
．If you feel any change in your physical condition, you should stop taking it immediately and consult your doctor.
．Preservation method (only fresh)
．All required display items will be displayed in a size of 8 dots or more, and characters of a size of 5.5 dots or more can be displayed if the displayable area is about 150 ㎠ or less.
．If you want to sell fresh food as a food with a functional claim, you need to put it in a container and packaging that describes the necessary labeling items and notify the Consumer Affairs Department, and cannot be sold naked.
3. Foods for Specified Health Uses
For sale as a food for specified health use, each product must be checked for food effectiveness and safety, and the label must be approved by the Department of Consumer Affairs. Licenses are attached to specific health foods and conditional specific health foods, and specific health foods are divided into four categories.
． Specified health food: Those who take it in their diet for a specific health purpose. Foods that show that they can be consumed for healthful purposes
． Specified Health Foods (Disease Risk Reduction Labels): Disease Risk Reduction Labels are permitted if the ingredients involved have scientific evidence for their disease risk reduction effect and are widely accepted in medicine and nutrition.
． Specified Health Foods (Standard Type): Confirmation on a scientific basis whether the ingredients and criteria in question are adequately documented as a food for specified health uses without the need for a separate review by the Consumer Council.
． Conditional specific health food: Foods that do not meet the level of scientific evidence required for the inspection of specific health food, but whose effectiveness has been confirmed to a certain extent, need to be marked on the label that the scientific evidence is limited. .
The label display items required for specific health foods show:
1. It is a food for designated health purpose
2. Content displayed with permission, etc.
3. Amounts and calories of nutrients (including related ingredients)
4. Estimated Daily Intake
5. Intake method
6. Ingestion Precautions
7. Words that promote and inspire a balanced diet
8. If reference values such as nutrients are shown for the components involved, the ratio of the components involved in the daily intake to the reference values such as nutrients.
9. Precautions for items that require special attention in cooking or storage methods
10. All required display items are displayed in 8-dot or larger characters (at least 5.5 dots or more in characters when the displayable area is about 150 cm 2 or less).
Labels:
Foods other than health claim foods shall not use names that are confused with health claim foods, functions of nutritional ingredients, and terms that can expect specific health purposes. (Example) Names of specific health food, specific functional food, health XX food, XX functional food, etc., especially the names containing the words function and health.
URL: https://www.fukushihoken.metro.tokyo.lg.jp/shokuhin/hyouji/shokuhyouhou_eiyou.html
https://www.caa.go.jp/policies/policy/food_labeling/#m02
【参考连结】
https://www.fukushihoken.metro.tokyo.lg.jp/shokuhin/hyouji/shokuhyouhou_eiyou.html
https://www.caa.go.jp/policies/policy/food_labeling/#m02
https://www.caa.go.jp/policies/policy/food_labeling/foods_with_nutrient_function_claims/
HLF-JP-45
请问在日本有哪些专业服务机构，可以协助办理保健食品产品许可证？
Evershine RD：
Jhnfa
https://www.jhnfa.org/index.html
Credevo
HLF-JP-50
外国公司可以用自己名义申请办理产品许可吗？
如需要，哪个单位在管理？需要什麽文件？申请程序为何？
保健食品包装内容及各种标示，需要事先核准吗？
可允许的语文除了日文外，其他哪种语文也可以？网页？
Can a foreign company apply for a product license by its own name? If yes, which authority is in charge?
What documents are required? What is the application process?
Do health food packaging and labeling require prior approval?
In addition to Japanese, which other languages are allowed? Website?
Evershine RD：
可以，进口商(公司)可以直接申请。营养机能食品为自我认证，机能性表示食品、特定保健食品需要提出申请。
营养机能食品：具有自我认证体系，无需单独申请许可。
机能性表示食品的申请手续(从入口网註册、提出申请)
须具备资料
1. 註册食品的基本信息
．公司名称、编号、负责人、邮政编号、地址、电话号码
．负责部门、接洽窗口、联繫电话(分机)、电子邮件
．产品名称、食品分类
．机能性成分名称
．确认机能性成分是否为萃取物、安全性评价方法
．通过对食用性能进行评估、确认了足够的安全性
．根据现有信息对饮食体验进行评估，确认了足够的安全性
．通过安全测试确认了足够的安全性、功能评价方法
．功能性通过使用最终产品的人体测试评估
．功能性在最终产品的研究审查中进行评估
．检查表、相关的材料、商业协会认可资料
2.附件资料
．产品主要目标人群
．基本安全信息(安全性评价方法)
．摄入注意事项
．有关生产/製造和质量控制的信息
说明管理体系，如果是加工食品，请描述 GMP、HACCP、ISO 22000、FSSC 22000 的分类以及每个製造工厂是否有认证。)
．功能性评价方法
．提交者对产品功能的评价
．饮食体验评价
．使用现有信息进行评估
．安全测试评估
．通过安全测试进行评估(附体外试验和体内试验报告)
．与药品相互作用的评估
．有关健康危害的信息(例如联繫人、电话号码、传真、电子邮件)
．科学依据
．最终产品的人体测试、最终产品的研究回顾
．机能性成分研究综述
．预计每日摄入量
．保存、摄取方法、摄取注意事项
．对烹调或保管方法需要特别注意的事项
．展示样品的附件
．食品相关业务的基本信息
．製造商名称（工厂或加工厂名称）和位置
．消费者服务部门的联繫方式（电话号码、网页等）
．预定销售开始日期等
特定保健食品的申请手续
1. 提交许可申请和审查申请
．向营业所区域的卫生所提交许可申请。(正本1份、副本2份)
．收到许可申请的都道府县知事等将检查许可申请的不足之处，并将认为适当的内容提交给厚生劳动大臣。
．提交许可申请书等后，附上许可申请书複印件，将审查申请书(含附件)提交至厚生劳动省食品安全局-食品安全司标准审查处，可以寄送或亲送(正本1份、副本1份)
2.具备资料
．带有标籤和健康声明的整个包装样本
．证明产品和/或其功能成分的临床和营养证明以维持健康的文件
．证明产品和/或其功能成分摄入量的临床和营养证明的文件
．有关产品及其功能成分安全性的文件，包括关于饮食体验的额外人体研究
．有关产品及其功能组成稳定性的文件
．产品和功能组件的物理和生物学特性的文档
．其功能成分的定性/定量分析测定方法及产品中成分的分析测定结果
．产品指定营养成分及热量含量分析报告
．生产方法说明、工厂设备清单和质量控制系统说明
3.免费样品测试检验请求
．申请人在产品样品上附上检验申请表等複印件，请求美国国家健康与营养研究所或註册检测机构进行检测检验。
．申请人向新发食品卫生措施办公室提交该机构或註册检测机构出具的检测报告原件。
4. 许可测试的实施机构
特殊用途食品（含特定保健用食品）许可检测主体为美国国立卫生与营养研究所及以下註册检测机构。
．国立健康与营养研究所
．註册检测机构名单：
日本食品分析中心
食品环境检验协会
食品分析开发中心 SUNTEC
日本食品检验
大坂公共卫生研究所
保健食品的标籤必须符合食品标籤法规范，所有贩售食品必需在容器包装上以日文标示。
1. 营养机能食品标籤陈列项目显示：
．能显示机能的营养成分
脂肪酸（1种）：n-3脂肪酸
矿物质（6种）：锌、钾*、钙、铁、铜、镁
维生素（13种）：菸酸、泛酸、生物素、维生素A、维生素B 1、维生素B 2、维生素B 6、维生素B 12、维生素C、维生素D、维生素E、维生素K、叶酸
(片剂、胶囊对于以製剂形式存在的加工食品不包括钾)
．营养功能食品及营养成分的标示：显示为营养机能食品（营养成分名称），显示多个设定标准的营养成分时，顺序不固定。
．营养成分的作用：描述每种营养成分指定的功能，即使标籤内容相同，也不允许改变或省略指定营养成分的功能。
．预计每日摄入量：也可以在宽度的两端显示“请吃○粒到○粒。” （在规定的上限和下限内）。
．营养成分的量和热量（营养成分标籤）：显示每日摄入量指南的营养成分量和热量。(需要用规定方法求得的数值表示)
．摄取方法
．食入注意事项
．促进和启发均衡饮食的措辞：必须标註饮食习惯要以主食、主菜、配菜为主，均衡饮食
．必须标註该产品与特定保健食品不同，未经消费者厅长官个别审查
．营养成分量与显示营养素等的标准值的百分比。
．营养素的标准值等有关目标年龄和标准发热量的字样
．烹调或保管方法上需要特别注意的事项
．特定对象需要注意的事项
．保存方法 (只限新鲜食品)
．对于因加热等而导致营养成分发生显着变化的食品，需要显示保证的烹调上下限范围内方法。(只限新鲜食品)
．即使是生鲜食品，如果要作为营养机能性食品销售，也需要装在容器中，并附上必要的标籤物品，不能裸卖
．当可显示区域约为 150 ㎠ 或更小时，可以以 5.5 点或更大的大小显示字符。
2. 机能性表示食品
具有机能性声称的食品在容器、包装上註明有助于维持和促进健康的特定健康目标（不包括与降低疾病风险相关的目标）可以通过功能相关的成分来实现，必须在销售日期前至少 60 天向消费者厅长官报告下列事项。
具有机能声称的食品的通知项目：
．显示内容
．食品相关业务的基本信息
．基于安全的信息
．基于功能的信息
．有关生产/製造和质量控制的信息
．健康危害信息採集系统
．其他必要事项
具有机能声称的食品应标註的项目：
．是一种具有机能声称的食物
．具有科学证据的功能相关成分以及该成分/含有该成分食品的功能
．营养成分和卡路里的量
．每日摄入量指南中功能性成分的含量
．估计每日摄入量
．通知编号
．食品相关企业的联繫信息．食品相关企业的名称或名称、地址和联繫信息(仅限新鲜食品)
．未接受国家对功能和安全性的评估
．摄取方法
．摄入注意事项
．促进和启发均衡饮食的措辞
．烹饪或储存方法需要特别注意的物品的注意事项
．不适用于疾病的诊断、治疗或预防
．不适用于患病者、未成年人、孕妇（包括计划怀孕者）和哺乳期妇女(仅限加工食品)
．患病者应谘询医生，服用药物者服药前应谘询医生或药剂师。
．如果感觉身体状况有任何变化，应立即停止服用并谘询医生。
．保存方法(只限生鲜)
．所有需要的显示项目将以 8 点或更大的大小显示，如果可显示区域约为 150 ㎠ 或更小，则可以显示大小为 5.5 点或更大的字符。
．如果想将生鲜食品作为具有机能声称的食品进行销售，需要将其放入描述了必要标籤项目的容器和包装并通知消费者事务厅，不能裸卖。
3. 特定保健用食品
作为特定保健用食品销售，必须对每种产品的食品有效性和安全性进行检查，并且标籤必须得到消费者事务厅的批准。特定保健食品和有条件的特定保健食品均附有许可证，特定保健食品分为四类。
．特定保健食品：在饮食中为特定健康目的服用者。表明可以通过摄入来达到健康目的之食物
． 特定保健食品（降低疾病风险标籤）：如果所涉及成分有降低疾病风险效果的科学依据，并在医学和营养学上被广泛接受，则允许使用降低疾病风险标籤。
．特定保健食品（标准型）：依据科学根据确认所涉成分和标准是否符合具有足够的作为特定保健用途食品的批准记录，无需消费者委员会单独审查。
．有条件的特定保健食品：未达到特定保健食品检验所要求的科学证据水平，但其有效性得到一定程度证实的食品，需在标籤上标明其科学证据有限。 .
特定保健食品所需的标籤陈列项目显示：
1.是指定保健用途的食品
2.经许可显示的内容等
3.营养成分（包括相关成分）的量和热量
4.估计每日摄入量
5.摄取方法
6.摄入註意事项
7.促进和启发均衡饮食的措辞
8.如果针对所涉及的成分显示营养素等参考值，则每日摄入量所涉及的成分与营养素等参考值的比例。
9.烹饪或储存方法需要特别注意的物品的注意事项
10.所有需要的显示项目均以8 点或更大的字符显示（当可显示区域约为 150 cm 2或更小时，字符至少 5.5 点或更多）。
11. 许可测试的实施机构
标籤禁止：
健康声称食品以外的食品，不得使用与健康声称食品、营养成分的功能、可期待特定健康目的的用语混淆的名称。
(例)特定保健食品、特定功能食品、保健XX食品、XX功能食品等名称，尤其是包含功能和健康字样的名称。
Importers (companies) can apply directlyNutritious functional foods are self-certified, and functional foods and specific health foods need to be submitted for application.
Nutritious functional food: It has a self-certification system and does not need to apply for a license separately.
Application procedure for functional indication food (registration and application from portal)
Required information:
1. Basic Information of Registered Food
．Company name, number, person in charge, postal code, address, phone number
．Department in charge, contact window, contact number (extension), email
．Product name, food classification
．Functional component name
．Confirmation of functional ingredients as extracts, safety evaluation method
．Adequate safety confirmed by evaluation of edible performance
．Eating experience was assessed based on available information, confirming adequate safety
．Adequate safety and functional evaluation methods confirmed through safety testing
．Functionality assessed by human testing using the final product
．Functionality is assessed in research review of final product
．Checklists, related materials, business association endorsements
2. Attachment data
．Main target audience of the product
．Basic safety information (safety assessment method)
．Ingestion precautions
．Information about production/manufacturing and quality control
Describe the management system, and if it is a processed food, describe the classification of GMP, HACCP, ISO 22000, FSSC 22000 and whether each manufacturing facility has certification． )
．Functional evaluation method
．Submitter comments on product features
．Eating experience evaluation
．Use existing information for assessment
．Security Test Evaluation
．Evaluate through safety testing (with in vitro and in vivo test reports)
．Evaluation of Interactions with Drugs
．Information about health hazards (e．g． contact person, telephone number, fax, email)
．Scientific evidence
．Human testing of the final product, review of the research on the final product
．Summary of Research on Functional Components
．Expected daily intake
．Storage, ingestion method, and precautions for ingestion
．Precautions for cooking or storage methods
．Accessories for showing samples
．Basic information on food-related businesses
．Manufacturer’s name (factory or processing facility name) and location
．Contact details for Consumer Services (phone number, webpage, etc．)
．Scheduled sales start date etc．
Application procedure for specified health food
1. Submit license application and review application
．Submit a permit application to the health center in the business area． (1 original, 2 copies)
．The prefectural governors, etc．, who have received the permission application, will examine the deficiencies of the permission application and submit the content deemed appropriate to the Minister of Health, Labour and Welfare．
．After submitting the permit application, attach a copy of the permit application, and submit the review application (including attachments) to the Ministry of Health, Labour and Welfare Food Safety Bureau – Food Safety Division Standards Review Division, which can be sent by mail or in person (1 original, 1 copy)
2. Information
．Whole package samples for labels and health claims
．Documents demonstrating clinical and nutritional certification of the product and/or its functional ingredients to maintain health
．Documentation of clinical and nutritional proof of intake of the product and/or its functional ingredients
．Documentation on the safety of the product and its functional ingredients, including additional human studies on eating experience
．Documents about the stability of the product and its functional composition
．Documentation of physical and biological properties of products and functional components
．Qualitative/quantitative analysis and determination methods of its functional ingredients and analysis and determination results of ingredients in products
．Product Specified Nutrients and Calorie Content Analysis Report
．Description of production method, list of plant equipment and description of quality control system
3. Free sample test inspection request
． The applicant should attach a copy of the inspection application form to the product sample, and request the National Institute of Health and Nutrition or a registered testing agency to conduct testing and testing．
． The applicant submits the original test report issued by the agency or a registered testing agency to the Office of New Food Sanitation Measures．
4. The implementing agency of the license test
Special purpose food (including food for specific health use) is licensed by the National Institute of Health and Nutrition in the United States and the following registered testing institutions.
．National Institute of Health and Nutrition
．List of registered testing institutions:
Japan Food Analysis Center
Food Environmental Inspection Association
Food Analysis Development Center SUNTEC
Japanese food inspection
Osaka Institute of Public Health
The labels of health food must comply with the Food Labeling Law, and all food for sale must be marked in Japanese on the container and packaging.
1. The display items of the nutrition and functional food label display:
．Nutrients that show function
Fatty acids (1 type): n-3 fatty acids
Minerals (6): Zinc, Potassium*, Calcium, Iron, Copper, Magnesium
Vitamins (13 types): niacin, pantothenic acid, biotin, vitamin A, vitamin
B1, vitamin B2, vitamin B6, vitamin B12, vitamin C, vitamin D,
vitamin E, vitamin K, folic acid
(Tablets, capsules do not include potassium for processed foods in the form of preparations)
．Labeling of nutritional functional foods and nutritional ingredients: It is displayed as nutritional functional food (name of nutritional ingredients)
．When multiple nutritional ingredients with set standards are displayed, the order is not fixed．
．Role of nutrition facts: Describe the function specified for each nutritional ingredient, even if the label content is the same, it is not allowed to change or omit the function of the designated nutritional ingredient．
．Estimated daily intake: “Please take ○ grains to ○ grains．” can also be displayed at both ends of the width (within the specified upper and lower limits)．
．Nutrient amounts and calories (Nutrition Facts Label): Displays the nutrient amounts and calories for the Daily Intake Guidelines． (It needs to be represented by a numerical value obtained by a prescribed method)
．Intake method
．Ingestion precautions
．Phrasing to promote and inspire a balanced diet: It must be marked that eating habits should be based on staple food, main dishes, and side dishes, and a balanced diet
．It must be marked that the product is different from a specific health food and has not been individually reviewed by the Director of the Consumer Affairs Agency
．The percentage of the amount of nutrients and the standard value showing nutrients, etc．
．Words about target age and standard calorific value, such as standard values of nutrients
．Precautions for cooking or storage
．Matters needing attention for specific objects
．Preservation method (Fresh food only)
．For foods whose nutrient content changes significantly due to heating, etc．, it is necessary to show the method within the guaranteed upper and lower limits of cooking． (Fresh food only)
．Even fresh food, if it is to be sold as a nutritious functional food, needs to be packed in a container with the necessary label items attached, and cannot be sold naked
．When the displayable area is about 150 ㎠ or less, characters can be displayed in 5．5 dots or more．
2. Foods that express functionality
Foods with functional claims state on the container, packaging that specific health goals (excluding goals related to reducing disease risk) that help maintain and promote health can be achieved through functionally related ingredients, and must be at least 60 years before the date of sale.
Report the following matters to the Commissioner of the Consumer Affairs Agency.
Notification Items for Food Products with Functional Claims:
．Display content
．Basic information on food-related business
．Security-Based Information
．Feature-Based Information
．Information about production/manufacturing and quality control
．Health Hazard Information Collection System
．Other necessary matters
Items that should be marked on foods with functional claims:
．Food with functional claims
．Functionally relevant ingredients with scientific evidence and the function of the ingredient/food containing the ingredient
．Nutrition facts and calorie amounts
．Content of functional ingredients in daily intake guidelines
．Estimated daily intake
． Notification number
．Contact information for food-related businesses. Food related business name or name, address and contact information (fresh food only)
．Not subject to national assessment of functionality and safety
．Intake method
．Ingestion precautions
．Words to promote and inspire a balanced diet
．Precautions for items that require special attention in cooking or storage methods
．Not suitable for diagnosis, treatment or prevention of disease
Not suitable for ill persons, minors, pregnant women (including those planning pregnancy) and lactating women (processed foods only)
．Those who are ill should consult their doctor, and those taking medication should consult their doctor or pharmacist before taking the medicine.
．If you feel any change in your physical condition, you should stop taking it immediately and consult your doctor.
．Preservation method (only fresh)
．All required display items will be displayed in a size of 8 dots or more, and characters of a size of 5.5 dots or more can be displayed if the displayable area is about 150 ㎠ or less.
．If you want to sell fresh food as a food with a functional claim, you need to put it in a container and packaging that describes the necessary labeling items and notify the Consumer Affairs Department, and cannot be sold naked.
3. Foods for Specified Health Uses
For sale as a food for specified health use, each product must be checked for food effectiveness and safety, and the label must be approved by the Department of Consumer Affairs. Licenses are attached to specific health foods and conditional specific health foods, and specific health foods are divided into four categories.
． Specified health food: Those who take it in their diet for a specific health purpose. Foods that show that they can be consumed for healthful purposes
． Specified Health Foods (Disease Risk Reduction Labels): Disease Risk Reduction Labels are permitted if the ingredients involved have scientific evidence for their disease risk reduction effect and are widely accepted in medicine and nutrition.
． Specified Health Foods (Standard Type): Confirmation on a scientific basis whether the ingredients and criteria in question are adequately documented as a food for specified health uses without the need for a separate review by the Consumer Council.
． Conditional specific health food: Foods that do not meet the level of scientific evidence required for the inspection of specific health food, but whose effectiveness has been confirmed to a certain extent, need to be marked on the label that the scientific evidence is limited. .
The label display items required for specific health foods show:
1. It is a food for designated health purpose
2. Content displayed with permission, etc.
3. Amounts and calories of nutrients (including related ingredients)
4. Estimated Daily Intake
5. Intake method
6. Ingestion Precautions
7. Words that promote and inspire a balanced diet
8. If reference values such as nutrients are shown for the components involved, the ratio of the components involved in the daily intake to the reference values such as nutrients.
9. Precautions for items that require special attention in cooking or storage methods
10. All required display items are displayed in 8-dot or larger characters (at least 5.5 dots or more in characters when the displayable area is about 150 cm 2 or less).
Labels:
Foods other than health claim foods shall not use names that are confused with health claim foods, functions of nutritional ingredients, and terms that can expect specific health purposes.
(Example) Names of specific health food, specific functional food, health XX food, XX functional food, etc., especially the names containing the words function and health.
【参考连结】
https://www.fukushihoken.metro.tokyo.lg.jp/shokuhin/hyouji/shokuhyouhou_eiyou.html
https://www.caa.go.jp/policies/policy/food_labeling/#m02
https://www.caa.go.jp/policies/policy/food_labeling/foods_with_nutrient_function_claims/
HLF-JP-55
请问在日本有哪些专业服务机构，可以协助以外国公司名义办理保健食品产品许可证？
Jhnfa
https://www.jhnfa.org/index.html
Yakujihou
https://www.yakujihou.com/globalconsulting/
HLF-JP-60
经过核准登记的保健食品，进口到日本要检附什麽文件？经过什麽手续？
在销售时要向各地的卫生福利部相关机构事先或事后准备吗？网页？
What documents are required when importing approved health food into Japan? What is the procedure?
Any preparation is required to submit to the Ministry of Health and Welfare for selling products? Website?
Evershine RD：
根据食品卫生法的规定，进口用于销售或经营的食品，必须提交进口申报。
当货物从海外通过船舶或飞机抵达日本时，将被扣留在保税区。保税区是从外国进口的货物可以被扣留直到清关完成的地方。
海关将根据法规进行审查和检查，获得进口许可证的人员可以将其从保税区运往日本。
进口流程
准备文件：
1.食品进口申报表
．进口商的名称和地址、代码
．原产国、代码
．进口食品管理员註册号
．製造商名称、代码
．厂名、代码
．出口商名称、代码
．包装商名称、代码
．装货港/代号
．装货日期、日期、日期
．装卸港/代码
．到货日期
．存储仓库/代码
．交货日期、通知日期
．货物符号
．有无事故
．船舶或飞机的名称或航班号
．提交者/代码
2.其他相关文件
．原材料、製造过程等说明：
製造商、製造工厂名称和所在地、产品编号、产品名称等可识别为到达日本的货物
．材料、零件清单等说明：
原材料表（必填）、製造工序表（必填）、註册检验机构等的测试报告、产品彩色照片、目录等
．卫生证明书（取决于物品和原产国）
．检测报告（根据需要）
3. 需提交食品进口申报表及必要的附件两份
．通知书可以在货物到达前7天开始提交
．提交通知书的地点视货物清关地点而定
．也可以通过邮寄方式提交通知表
．邮寄通知书时，请务必附上贴有邮票的回信信封。
4. 货物到达
．填写食品进口申报单上的必填项目
．向检疫站食品监测窗口提交食品进口申报单
每次进口保健食品时，都必须通知厚生劳动大臣（检疫所）进行初步调查，需要缴交：
1.製造商、所在地
2.工厂、所在地
3.原材料(包括食品添加剂时的物质名称和用量)
4.製造和加工方法
5.容器和包装材料
6.储存方法
7.应用
8.顾问姓名、地址、联繫信息
9.进口商名称、地址、联繫信息
10.容器包装材料、内部容量
11.保存方法
12.用途
13.如何使用
14.预定自检项目
15.预定进口港口/时间
According to the provisions of the Food Sanitation Law, import declarations must be submitted for food imported for sale or business. When goods arrive in Japan by ship or plane from overseas, they will be detained in the bonded area.
A bonded area is a place where goods imported from a foreign country can be held until customs clearance is completed.
Customs will review and inspect according to regulations, and those who have obtained an import license can ship it to Japan from the bonded area.
Import procedure
Prepare documents:
1. Food import declaration form
． Importer’s name and address, code
． Country of origin, code
． Imported food manager registration number
． Manufacturer’s name, code
． Factory name and code
． Exporter name, code
． Packer name, code
． Port of Loading/code
． Date of shipment, date, date
． Loading port /code
． Arrival date
． Repository/code
． Delivery date, notification date
． cargo symbol
． whether there is an accident
． The name or flight number of the ship or aircraft
． Submitter/Code
2. Other relevant documents
． Description of raw materials, manufacturing process, etc.:
Manufacturer, name and location of manufacturing plant, product number, product name, etc. can be identified as goods arriving in Japan
． Description of materials, parts list, etc.:
Raw material table (required), manufacturing process table (required), test reports of registered inspection agencies, etc., product color photos, catalogs, etc.
． Hygiene certificate (depending on item and country of origin)
． Test report (as needed)
3. It is necessary to submit two copies of the food import declaration form and the necessary annexes
． Notifications can be submitted up to 7 days before the arrival of the goods
． The place to submit the notice depends on the place of customs clearance of the goods
． Notification forms can also be submitted by post
． When mailing notices, be sure to include a stamped return envelope.
4. The arrival of the goods
． Fill in the required items on the food import declaration form
． Submit the food import declaration form to the food monitoring window of the quarantine station
Every time you import health food, you must notify the Minister of Health, Labour and Welfare (Quarantine Office) to conduct a preliminary investigation, and you need to pay:
1. Manufacturer, location
2. Factory, location
3. Raw materials (substance name and dosage including food additives)
4. Manufacturing and processing methods
5. Containers and Packaging Materials
6. Storage method
7. Application
8. Consultant name, address, contact information
9. Importer’s name, address, contact information
10. Container packaging materials, internal capacity
11. Save
12. Purpose
13. Use
14. Schedule self-check items
15. Scheduled import port/time
【参考连结】
https://www.mhlw.go.jp/stf/seisakunitsuite/bunya/0000144562.html
https://www.mhlw.go.jp/topics/yunyu/soudan/index.html
https://www.mhlw.go.jp/stf/seisakunitsuite/bunya/kenkou_iryou/shokuhin/jigyousya/index.html
HLF-JP-70
日本保健食品审核机构，需要附上的实验室检验资料有哪些? 网页？
What are the laboratory inspection materials that need to be attached for verification? Website?
Evershine RD：
1. 营养食品、机能性食品可以由海外机构检验，符合生产/製造和质量控制(GMP、HACCP、ISO 22000、FSSC 22000 等，不必审核，安全性及有效性皆由业者自行验证、 自主管理。
2. 特定保健食品必须经由许可测试的实施机构认证。许可检测主体为美国国立卫生与营养研究所及以下註册检测机构。
．国立健康与营养研究所
．日本食品分析中心
．食品环境检验协会
．食品分析开发中心 SUNTEC
．日本食品检验
．大坂公共卫生研究所
特定保健食品检测内容
特定保健食品的安全性评估是根据具体情况对每种食品进行的，原则上对食品所涉及的成分的安全性进行评价，特别是片剂、胶囊等。
1.製造/加工方法、质量控制
2.作用机制(涉及成分的定量方法、吸收/代谢/排泄、积累等)
3.重金属、残留农药等、致敏物质等分析值信息(如有必要)
4.使用记录的数据和信息
5.产品所含成分或食物的每日摄入量数据。
6.关于商业食品中成分含量的数据
7.其他国家的使用记录、食物摄入量等数据
8.食物烹饪方法的数据（需要加热/不加热）
9. 数据应尽可能具体地使用数值
10.使用动物进行体外和体内试验的数据和信息
11.测试数据如下
．基因毒性测试数据
．单次口服剂量试验数据（急性毒性）
．28 天或 90 天重複口服给药研究数据
．根据需要参与1年长期口服给药试验、抗原性试验、过敏性试验、生殖试验、致畸试验、致癌试验等数据
12.需要设定允许量（值）等资料
13.当涉及的成分是微生物时，需检验抗生素抗性基因的质粒转移等，以及有关可能性的信息
13.在适当的受试者上进行的人体试验
14.测试的测试数据、文献等必须适当的统计方法进行处理。
．使用双盲方法，对非摄入者和摄入者进行对照（安慰剂）
．通过无控制执行的方法摄取之前、期间和之后摄取器的状态差异
．基于健康用途的受试者（例如，健康的成年男性和女性以及疾病储备组）（涉及的成分相关的临床试验值高的人）等）数据
．连续摄入（重複摄入测试、长期摄入测试）、过量摄入的影响
15.可以评估摄入效果的数据（过量测试）
16.与药物联合使用时有关安全性的数据和充分考虑
17.提交的数据应保证测试的可靠性。
1. Nutritious foods and functional foods can be inspected by overseas institutions and comply with production/manufacturing and quality control (GMP, HACCP, ISO 22000, FSSC 22000, etc.), and do not need to be audited.
The safety and effectiveness are verified and managed by the operators themselves.
2. The specified health food must be certified by the performing agency that is licensed to test. Licensed testing subjects are the National Institutes of Health and Nutrition and the following registered testing institutions.
． National Institute of Health and Nutrition
． Japan Food Analysis Center
． Food Environmental Inspection Association
． Food Analysis Development Center SUNTEC
． Japanese food inspection
． Osaka Institute of Public Health
Specific health food testing content
The safety assessment of specific health food is carried out for each food according to the specific situation. In principle, the safety of the ingredients involved in the food, especially tablets and capsules, is evaluated.
1. Manufacturing/processing methods, quality control
2. Mechanism of action (quantitative methods involving components, absorption/metabolism/excretion, accumulation, etc.)
3. Information on analytical values of heavy metals, residual pesticides, etc., allergenic substances (if necessary)
4. Use of recorded data and information
5. Daily intake data for ingredients or foods contained in the product.
6. Data on Ingredient Content in Commercial Foods
7. Data on usage records, food intake, etc. in other countries
8. Data on how the food is cooked (requires heat/no heat)
9. Data should be as specific as possible using numerical values
10. Data and Information on In Vitro and In Vivo Tests Using Animals
11. The test data is as follows
． Genotoxicity test data
． Single Oral Dose Test Data (Acute Toxicity)
． 28-day or 90-day repeat oral dosing study data
． Participate in 1-year long-term oral administration test, antigenic test, allergy test, reproductive test, teratogenicity test, carcinogenicity test and other data as needed
12. It is necessary to set the allowable amount (value) and other data
13. When the components involved are microorganisms, it is necessary to check the plasmid transfer of antibiotic resistance genes, etc., and information on the possibility
13. Human trials on appropriate subjects
14. The test data, literature, etc. of the test must be processed by appropriate statistical methods.
． Using a double-blind approach, a control (placebo) between non-ingestors and ingestors
． Differences in the state of the ingestor before, during, and after ingestion by methods executed without control
． Data on subjects based on health use (e.g., healthy adult males and females and disease reserve groups) (people with high clinical trial values related to the components involved), etc.)
． Continuous intake (repeated intake test, long-term intake test), effects of excessive intake
15. Data that can assess the effect of intake (excess test)
16. Data and adequate considerations for safety when used in combination with drugs
17. The submitted data should guarantee the reliability of the test.
【参考连结】
http://www.fsc.go.jp/senmon/sinkaihatu/index.html
HLF-JP-75
日本保健食品审核机构，能够接受海外检验机构的检验资料吗？假如是的话，有些被认可的机构？网页？
Evershine RD：
1. 营养食品、机能性食品可以由海外机构检验，符合生产/製造和质量控制(GMP、HACCP、ISO 22000、FSSC 22000 等，不必审核，安全性及有效性皆由业者自行验证、 自主管理。
2. 特定保健食品仅有日本国内检验机构：
．国立健康与营养研究所
．日本食品分析中心
．食品环境检验协会
．食品分析开发中心 SUNTEC
．日本食品检验
．大坂公共卫生研究所
HLF-JP-77
请问在日本有哪些保健食品检验机构可以提供保健食品检验服务？网页？
Jhnfa
https://www.jhnfa.org/index.html
SGS
HLF-JP-80
外国子公司进口保健食品后，如果委託日本的经销商销售，经销商需要保健食品营业许可证吗？
假如保健食品有品质瑕疵的话，外国子公司和经销商各自的责任为何？是连带责任吗？还是可以规范由外国子公司负责？
After a foreign subsidiary imports health food and entrusts a distributor in Japan to sell it, does the distributor need a health food business license? What are the respective responsibilities of foreign subsidiaries and distributors if cosmetic products have quality defects? Is it joint liability? Or can the responsibility of the foreign subsidiary be regulated?
Evershine RD：
需要，健康食品归类在食品，依法贩售需要取得营业执照。
需要文件：
1.营业执照申请书
．申请人、邮政编码、 电话号码、传真号码、电子邮件地址、公司编号、出生年月日
．负责人(如果是法人)
．营业设施信息：邮编、电话号码、传真号码、电子邮件地址
．设施名称、位置、店铺名称或商号
．食品卫生经理姓名、参加都道府县知事等的课程
．主要处理食品、添加剂、器具/容器和包装
2.结构、设备、设施图
3.食品卫生管理员资格证明(进行食品销售时，需要指定食品卫生经理)
．定期参加都道府县知事或都道府县知事批准的研讨会，努力学习有关食品卫生的新知识。
．按照经营者的指示管理卫生。
．採取必要的预防措施，并儘力向经营者提供必要的意见。
．必须了解最新的食品卫生信息，以便妥善管理卫生。
．要成为食品卫生经理，必须参加总共约 6 小时的培训课程。
．具备以下资格的人员无需参加课程即可成为食品卫生管理人员：厨师、营养师、製菓卫生士、船舶料理士、《屠宰场法》规定的卫生管理人员、《屠宰场法》规定的工作卫生经理、家禽加工卫生经理、符合食品卫生经理或食品卫生观察员资格要求的人员。
4. 水质检验报告（使用自来水、专用水或简单专用水以外的水时）
5. 缴交许可证申请费
6. 如果是法人註册需要填写法人编号。
申请流程：
向营业所辖区的卫生所申办许可：
在进行食品营业许可审核时，对该营业设施进行实地调查，并对该设施的牢固性和设备的耐久性进行检验，根据所规定的审核基准有效期最短为5年，最长为8年。
根据食品安全基本法，食品进口商必须
1. 对确保食品安全负有首要责任，并负责在食品供应过程的每个阶段採取适当确保措施。
2. 提供与食品准确和适当的信息，或者予以规定。
根据食品卫生法规范，食品经营者必须
1. 有责任确保食品安全。
2. 需获取与食品卫生相关的知识和技术
3. 确认所用原材料的安全。
4. 进行自我检查
5. 需要时採取其他必要措施。
Health food is classified as food, and a business license is required to sell it in accordance with the law..
Required documents:
1. Application for business license
．Applicant, zip code, phone number, fax number, email address, company number, date of birth
．Responsible person (if legal person)
．Business Facility Information: Postal Code, Phone Number, Fax Number, Email Address
．Facility name, location, store name or business name
．Name of the food hygiene manager, participation in the prefectural governor’s courses, etc.
．Handles primarily food, additives, utensils/containers and packaging
2. Structure, equipment and facility drawings
3. Qualification certificate of food sanitation manager (when selling food, a food sanitation manager needs to be designated)
．Regularly attend seminars approved by the prefectural governor or prefectural governor, and strive to learn new knowledge about food hygiene.
．Manage hygiene according to the operator’s instructions.
．Take the necessary precautions and try to provide the necessary advice to the operator.
．Up-to-date food hygiene information is essential in order to manage hygiene properly.
．To become a Food Hygiene Manager, one must attend a total of approximately 6 hours of training sessions.
．Persons with the following qualifications can become food hygiene managers without taking courses: cooks, nutritionists, fruit hygienists, ship cooks, hygiene managers under the Slaughterhouse Act, work hygiene managers under the Slaughterhouse Act , Poultry Processing Hygiene Managers, Persons who meet the qualification requirements for Food Hygiene Managers or Food Hygiene Observers.
4. Water quality inspection report (when using water other than tap water, special water, or simple special water)
5. Pay the permit application fee
6. If it is a legal person registration, the legal person number needs to be filled in.
Application process:
Apply to the health center in the jurisdiction of the business office license:
When conducting food business license audits, conduct on-the-spot investigation of the business facility, and test the firmness of the facility and the durability of the equipment.
The validity period is 5 years at the shortest and 8 years at the longest according to the specified audit criteria.
According to the Food Safety Basic Law, food importers must
1. Has primary responsibility for ensuring food safety and is responsible for taking appropriate measures to ensure food safety at every stage of the food supply process.
2. Provide accurate and appropriate information on food, or provide for it.
According to the Food Sanitation Law, food operators must
1. Responsibility to ensure food safety.
2. Need to acquire knowledge and technology related to food hygiene
3. Confirm the safety of the raw materials used.
4. Self-check
5. Take other necessary measures if necessary.
URL: https://www.mhlw.go.jp/stf/seisakunitsuite/bunya/kenkou_iryou/shokuhin/hokenkinou/index.html
【参考连结】
https://www.mhlw.go.jp/stf/seisakunitsuite/bunya/kenkou_iryou/shokuhin/hokenkinou/index.html
https://www.fukushihoken.metro.tokyo.lg.jp/shokuhin/kyokatodokede/youshiki.html#kanri
HLF-JP-85
请问在日本有哪些专精于保健食品销售与消费权益相关法律服务的业者？
Atsumi & Sakai
Support Gyoseishoshi Law Firm
Foley & Lardner LLP
Email：tyo4ww@evershinecpa.com
或
日本永辉BPO有限公司 -Evershine.jp
Onarimon Yusen Building 7F,Nishi-Shinbashi 3-23-5,Minato-ku, Tokyo 105-0003, Japan
丘玲恵（Kyu Reike）日本籍来自台湾
王礼芳（Lily Wang）日本永居来自福建
或
林幸穗 Anny Lin 协理
手机：+886-937-606-272
skype: annylin8008
wechat: annylin8008
电话：+886-2-2717-0515 分机:110
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