日本保健食品登記法規問題集
Email：tyo4ww@evershinecpa.com
或
日本永輝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）日本籍来自台灣
王礼芳（Lily Wang）日本永居来自福建
或
林幸穗 Anny Lin 協理
手機：+886-937-606-272
skype: annylin8008
wechat: annylin8008
電話：+886-2-2717-0515 分機:110
HLF-JP-10
請問日本對於保健食品的歸類方式為何？它的正式名稱為何？
不同歸類管理強度有何差異?它的政府管轄機構為何？網頁？
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《食品衛生法》、《食品標識法》、《健康促進法》規範，由主管當局厚生勞動省 (MHLW) 監管。
健康食品沒有法律上的定義，是指除藥品外，以具有維持和改善健康的特殊功效，或具有這種功效的方式出售的食品，是指所有預期具有保健作用的食品。
健康促進法將健康食品分為三類：
1. 營養機能食品：指能提供身體健康所需的營養成分，包括 13 種維生素（維生素 A、維生素B1、維生素 B2、維生素 B6、維生素 B12、維生素 C、維生素 D、維生素 E、維生素 K、葉酸、菸酸、泛酸、生物素）、六種礦物質（ 鋅、 鈣、 鐵、 銅、 鎂、 鉀 ） 及 n-3 脂 肪酸，且須合乎政府制定之相關基準。
只需在上市販售前60天提出系統性文獻回顧或是臨床試驗，即可在產品包裝上使用機能性食品標誌。但日後若發現該宣稱有虛偽誇大或有誤導性表述，仍將依法處罰。
2. 機能性表示食品：係指具有科學文獻基礎表示機能性的食品，業者在販售前須向日本消費者廳報備，以日本消費者廳公告可宣稱之用語，且符合營養功能食品標準標準，則不需要許可申請和通知等，但需要提出針對安全性和機能性相關的科學文獻資料，且自行承擔相關責任。
3. 特定保健用食品：係指含有保健機能成分，能影響生理機能之食品，包含維持血壓、調節血中膽固醇、調節腸胃功能等特定保健用途者，須通過嚴密的試驗，經過日本消費者廳審查、取得許可證後才能販售。
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.
【參考連結】
https://www.mhlw.go.jp/stf/seisakunitsuite/bunya/kenkou_iryou/shokuhin/hokenkinou/index.html
HLF-JP-20
外國公司要到日本銷售保健食品，無論設100%子公司或分公司，需要在公司登記時取得營業特許證？
假如要，其必要條件是什麼？所需文件及申請程序為何？網頁？
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：
健康食品歸類在食品，依法販售需要取得營業執照。外資在日本子公司或分公司可以申請(Revised in 20240320)。
需要文件：
1.營業執照申請書資料
．申請人、郵政編碼、 電話號碼、傳真號碼、電子郵件地址、公司編號、出生年月日
．負責人(如果是法人)
．營業設施信息：郵編、電話號碼、傳真號碼、電子郵件地址
．設施名稱、位置、店鋪名稱或商號
．食品衛生經理姓名、參加都道府縣知事等的課程
．主要處理食品、添加劑、器具/容器和包裝
2.結構、設備、設施圖
3.食品衛生管理員資格證明(進行食品銷售時，需要指定食品衛生經理)
．定期參加都道府縣知事或都道府縣知事批准的研討會，努力學習有關食品衛生的新知識。
．按照經營者的指示管理衛生。
．採取必要的預防措施，並儘力向經營者提供必要的意見。
．必須了解最新的食品衛生信息，以便妥善管理衛生。
．要成為食品衛生經理，必須參加總共約 6 小時的培訓課程。
．具備以下資格的人員無需參加課程即可成為食品衛生管理人員：廚師、營養師、製菓衛生士、船舶料理士、《屠宰場法》規定的衛生管理人員、《屠宰場法》規定的工作衛生經理、家禽加工衛生經理、符合食品衛生經理或食品衛生觀察員資格要求的人員。
4. 水質檢驗報告（使用自來水、專用水或簡單專用水以外的水時）
5. 繳交許可證申請費
6. 如果是法人註冊需要填寫法人編號。
申請流程：
向營業所轄區的衛生所申辦許可：
在進行食品營業許可審核時，對該營業設施進行實地調查，並對該設施的牢固性和設備的耐久性進行檢驗，根據所規定的審核基準有效期最短為5年，最長為8年。
Health food is classified as food, and a business license is required to sell it in accordance with the law. Foreign owned subsidiary or Branch 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.
【參考連結】
https://www.fukushihoken.metro.tokyo.lg.jp/shokuhin/kyokatodokede/youshiki.html#kanri
HLF-JP-25
假如需要辦理，請問日本有專業服務公司可以協助辦理保健食品公司營業許可證？
HLF-JP-30
外國公司要到日本銷售保健食品，可以指派日本公司擔任營業代理人銷售嗎?
擔任營業代理人，其必要條件是什麼？所需文件及申請程序為何？外國公司與營業代理人的產品責任為何?網頁？
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：
健康食品歸類在食品，依法販售需要取得營業執照。
需要文件：
1.營業執照申請書資料
．申請人、郵政編碼、 電話號碼、傳真號碼、電子郵件地址、公司編號、出生年月日
．負責人(如果是法人)
．營業設施信息：郵編、電話號碼、傳真號碼、電子郵件地址
．設施名稱、位置、店鋪名稱或商號
．食品衛生經理姓名、參加都道府縣知事等的課程
．主要處理食品、添加劑、器具/容器和包裝
2.結構、設備、設施圖
3.食品衛生管理員資格證明(進行食品銷售時，需要指定食品衛生經理)
．定期參加都道府縣知事或都道府縣知事批准的研討會，努力學習有關食品衛生的新知識。
．按照經營者的指示管理衛生。
．採取必要的預防措施，並儘力向經營者提供必要的意見。
．必須了解最新的食品衛生信息，以便妥善管理衛生。
．要成為食品衛生經理，必須參加總共約 6 小時的培訓課程。
．具備以下資格的人員無需參加課程即可成為食品衛生管理人員：廚師、營養師、製菓衛生士、船舶料理士、《屠宰場法》規定的衛生管理人員、《屠宰場法》規定的工作衛生經理、家禽加工衛生經理、符合食品衛生經理或食品衛生觀察員資格要求的人員。
4. 水質檢驗報告（使用自來水、專用水或簡單專用水以外的水時）
5. 繳交許可證申請費
6. 如果是法人註冊需要填寫法人編號。
申請流程：
向營業所轄區的衛生所申辦許可：
在進行食品營業許可審核時，對該營業設施進行實地調查，並對該設施的牢固性和設備的耐久性進行檢驗，根據所規定的審核基準有效期最短為5年，最長為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.
【參考連結】
https://www.fukushihoken.metro.tokyo.lg.jp/shokuhin/kyokatodokede/youshiki.html#kanri
HLF-JP-35
假如需要辦理指派日本公司擔任營業代理人，請問日本有專業服務公司可以協助？
HLF-JP-40
外國公司銷售到日本保健食品本身，進口前需要辦理產品許可嗎？
如需要，哪個單位在管理？需要什麼文件？申請程序為何？保健食品包裝內容及各種標示，需要事先核准嗎？
可允許的語文除了日文外，其他哪種語文也可以？網頁？
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：
【參考連結】
需要，營養機能食品為自我認證，機能性表示食品、特定保健食品需要提出申請。
營養機能食品：具有自我認證體系，無需單獨申請許可。
機能性表示食品的申請手續(從入口網註冊、提出申請)
須具備資料
1. 註冊食品的基本信息
．公司名稱、編號、負責人、郵政編號、地址、電話號碼
．負責部門、接洽窗口、聯繫電話(分機)、電子郵件
．產品名稱、食品分類
．機能性成分名稱
．確認機能性成分是否為萃取物、安全性評價方法
．通過對食用性能進行評估、確認了足夠的安全性
．根據現有信息對飲食體驗進行評估，確認了足夠的安全性
．通過安全測試確認了足夠的安全性、功能評價方法
．功能性通過使用最終產品的人體測試評估
．功能性在最終產品的研究審查中進行評估
．檢查表、相關的材料、商業協會認可資料
2.附件資料
．產品主要目標人群
．基本安全信息(安全性評價方法)
．攝入注意事項
．有關生產/製造和質量控制的信息
說明管理體系，如果是加工食品，請描述 GMP、HACCP、ISO 22000、FSSC 22000 的分類以及每個製造工廠是否有認證。)
．功能性評價方法
．提交者對產品功能的評價
．飲食體驗評價
．使用現有信息進行評估
．安全測試評估
．通過安全測試進行評估(附體外試驗和體內試驗報告)
．與藥品相互作用的評估
．有關健康危害的信息(例如聯繫人、電話號碼、傳真、電子郵件)
．科學依據
．最終產品的人體測試、最終產品的研究回顧
．機能性成分研究綜述
．預計每日攝入量
．保存、攝取方法、攝取注意事項
．對烹調或保管方法需要特別注意的事項
．展示樣品的附件
．食品相關業務的基本信息
．製造商名稱（工廠或加工廠名稱）和位置
．消費者服務部門的聯繫方式（電話號碼、網頁等）
．預定銷售開始日期等
特定保健食品的申請手續
1. 提交許可申請和審查申請
．向營業所區域的衛生所提交許可申請。(正本1份、副本2份)
．收到許可申請的都道府縣知事等將檢查許可申請的不足之處，並將認為適當的內容提交給厚生勞動大臣。
．提交許可申請書等後，附上許可申請書複印件，將審查申請書(含附件)提交至厚生勞動省食品安全局-食品安全司標準審查處，可以寄送或親送(正本1份、副本1份)
2.具備資料
．帶有標籤和健康聲明的整個包裝樣本
．證明產品和/或其功能成分的臨床和營養證明以維持健康的文件
．證明產品和/或其功能成分攝入量的臨床和營養證明的文件
．有關產品及其功能成分安全性的文件，包括關於飲食體驗的額外人體研究
．有關產品及其功能組成穩定性的文件
．產品和功能組件的物理和生物學特性的文檔
．其功能成分的定性/定量分析測定方法及產品中成分的分析測定結果
．產品指定營養成分及熱量含量分析報告
．生產方法說明、工廠設備清單和質量控制系統說明
3.免費樣品測試檢驗請求
．申請人在產品樣品上附上檢驗申請表等複印件，請求美國國家健康與營養研究所或註冊檢測機構進行檢測檢驗。
．申請人向新發食品衛生措施辦公室提交該機構或註冊檢測機構出具的檢測報告原件。
4. 許可測試的實施機構
特殊用途食品（含特定保健用食品）許可檢測主體為美國國立衛生與營養研究所及以下註冊檢測機構。
．國立健康與營養研究所
．註冊檢測機構名單：
日本食品分析中心
食品環境檢驗協會
食品分析開發中心 SUNTEC
日本食品檢驗
大阪公共衛生研究所
保健食品的標籤必須符合食品標籤法規範，所有販售食品必需在容器包裝上以日文標示。
1. 營養機能食品標籤陳列項目顯示：
．能顯示機能的營養成分
脂肪酸（1種）：n-3脂肪酸
礦物質（6種）：鋅、鉀*、鈣、鐵、銅、鎂
維生素（13種）：菸酸、泛酸、生物素、維生素A、維生素B 1、維生素B 2、維生素B 6、維生素B 12、維生素C、維生素D、維生素E、維生素K、葉酸
(片劑、膠囊對於以製劑形式存在的加工食品不包括鉀)
．營養功能食品及營養成分的標示：顯示為營養機能食品（營養成分名稱），顯示多個設定標準的營養成分時，順序不固定。
．營養成分的作用：描述每種營養成分指定的功能，即使標籤內容相同，也不允許改變或省略指定營養成分的功能。
．預計每日攝入量：也可以在寬度的兩端顯示“請吃○粒到○粒。” （在規定的上限和下限內）。
．營養成分的量和熱量（營養成分標籤）：顯示每日攝入量指南的營養成分量和熱量。(需要用規定方法求得的數值表示)
．攝取方法
．食入注意事項
．促進和啟發均衡飲食的措辭：必須標註飲食習慣要以主食、主菜、配菜為主，均衡飲食
．必須標註該產品與特定保健食品不同，未經消費者廳長官個別審查
．營養成分量與顯示營養素等的標準值的百分比。
．營養素的標準值等有關目標年齡和標準發熱量的字樣
．烹調或保管方法上需要特別注意的事項
．特定對象需要注意的事項
．保存方法 (只限新鮮食品)
．對於因加熱等而導致營養成分發生顯著變化的食品，需要顯示保證的烹調上下限範圍內方法。(只限新鮮食品)
．即使是生鮮食品，如果要作為營養機能性食品銷售，也需要裝在容器中，並附上必要的標籤物品，不能裸賣
．當可顯示區域約為 150 ㎠ 或更小時，可以以 5.5 點或更大的大小顯示字符。
2. 機能性表示食品
具有機能性聲稱的食品在容器、包裝上註明有助於維持和促進健康的特定健康目標（不包括與降低疾病風險相關的目標）可以通過功能相關的成分來實現，必須在銷售日期前至少 60 天向消費者廳長官報告下列事項。
具有機能聲稱的食品的通知項目：
．顯示內容
．食品相關業務的基本信息
．基於安全的信息
．基於功能的信息
．有關生產/製造和質量控制的信息
．健康危害信息採集系統
．其他必要事項
具有機能聲稱的食品應標註的項目：
．是一種具有機能聲稱的食物
．具有科學證據的功能相關成分以及該成分/含有該成分食品的功能
．營養成分和卡路里的量
．每日攝入量指南中功能性成分的含量
．估計每日攝入量
．通知編號
．食品相關企業的聯繫信息．食品相關企業的名稱或名稱、地址和聯繫信息(僅限新鮮食品)
．未接受國家對功能和安全性的評估
．攝取方法
．攝入注意事項
．促進和啟發均衡飲食的措辭
．烹飪或儲存方法需要特別注意的物品的注意事項
．不適用於疾病的診斷、治療或預防
．不適用於患病者、未成年人、孕婦（包括計劃懷孕者）和哺乳期婦女(僅限加工食品)
．患病者應諮詢醫生，服用藥物者服藥前應諮詢醫生或藥劑師。
．如果感覺身體狀況有任何變化，應立即停止服用並諮詢醫生。
．保存方法(只限生鮮)
．所有需要的顯示項目將以 8 點或更大的大小顯示，如果可顯示區域約為 150 ㎠ 或更小，則可以顯示大小為 5.5 點或更大的字符。
．如果想將生鮮食品作為具有機能聲稱的食品進行銷售，需要將其放入描述了必要標籤項目的容器和包裝並通知消費者事務廳，不能裸賣。
3. 特定保健用食品
作為特定保健用食品銷售，必須對每種產品的食品有效性和安全性進行檢查，並且標籤必須得到消費者事務廳的批准。
特定保健食品和有條件的特定保健食品均附有許可證，特定保健食品分為四類。
．特定保健食品：在飲食中為特定健康目的服用者。表明可以通過攝入來達到健康目的之食物
． 特定保健食品（降低疾病風險標籤）：如果所涉及成分有降低疾病風險效果的科學依據，並在醫學和營養學上被廣泛接受，則允許使用降低疾病風險標籤。
．特定保健食品（標準型）：依據科學根據確認所涉成分和標準是否符合具有足夠的作為特定保健用途食品的批准記錄，無需消費者委員會單獨審查。
．有條件的特定保健食品：未達到特定保健食品檢驗所要求的科學證據水平，但其有效性得到一定程度證實的食品，需在標籤上標明其科學證據有限。 .
特定保健食品所需的標籤陳列項目顯示：
1.是指定保健用途的食品
2.經許可顯示的內容等
3.營養成分（包括相關成分）的量和熱量
4.估計每日攝入量
5.攝取方法
6.攝入註意事項
7.促進和啟發均衡飲食的措辭
8.如果針對所涉及的成分顯示營養素等參考值，則每日攝入量所涉及的成分與營養素等參考值的比例。
9.烹飪或儲存方法需要特別注意的物品的注意事項
10.所有需要的顯示項目均以8 點或更大的字符顯示（當可顯示區域約為 150 cm 2或更小時，字符至少 5.5 點或更多）。
標籤禁止：
健康聲稱食品以外的食品，不得使用與健康聲稱食品、營養成分的功能、可期待特定健康目的的用語混淆的名稱。
(例)特定保健食品、特定功能食品、保健XX食品、XX功能食品等名稱，尤其是包含功能和健康字樣的名稱。
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
【參考連結】
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
請問在日本有哪些專業服務機構，可以協助辦理保健食品產品許可證？
HLF-JP-50
外國公司可以用自己名義申請辦理產品許可嗎？
如需要，哪個單位在管理？需要什麼文件？申請程序為何？
保健食品包裝內容及各種標示，需要事先核准嗎？
可允許的語文除了日文外，其他哪種語文也可以？網頁？
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，進口商(公司)可以直接申請。營養機能食品為自我認證，機能性表示食品、特定保健食品需要提出申請。
營養機能食品：具有自我認證體系，無需單獨申請許可。
機能性表示食品的申請手續(從入口網註冊、提出申請)
須具備資料
1. 註冊食品的基本信息
．公司名稱、編號、負責人、郵政編號、地址、電話號碼
．負責部門、接洽窗口、聯繫電話(分機)、電子郵件
．產品名稱、食品分類
．機能性成分名稱
．確認機能性成分是否為萃取物、安全性評價方法
．通過對食用性能進行評估、確認了足夠的安全性
．根據現有信息對飲食體驗進行評估，確認了足夠的安全性
．通過安全測試確認了足夠的安全性、功能評價方法
．功能性通過使用最終產品的人體測試評估
．功能性在最終產品的研究審查中進行評估
．檢查表、相關的材料、商業協會認可資料
2.附件資料
．產品主要目標人群
．基本安全信息(安全性評價方法)
．攝入注意事項
．有關生產/製造和質量控制的信息
說明管理體系，如果是加工食品，請描述 GMP、HACCP、ISO 22000、FSSC 22000 的分類以及每個製造工廠是否有認證。)
．功能性評價方法
．提交者對產品功能的評價
．飲食體驗評價
．使用現有信息進行評估
．安全測試評估
．通過安全測試進行評估(附體外試驗和體內試驗報告)
．與藥品相互作用的評估
．有關健康危害的信息(例如聯繫人、電話號碼、傳真、電子郵件)
．科學依據
．最終產品的人體測試、最終產品的研究回顧
．機能性成分研究綜述
．預計每日攝入量
．保存、攝取方法、攝取注意事項
．對烹調或保管方法需要特別注意的事項
．展示樣品的附件
．食品相關業務的基本信息
．製造商名稱（工廠或加工廠名稱）和位置
．消費者服務部門的聯繫方式（電話號碼、網頁等）
．預定銷售開始日期等
特定保健食品的申請手續
1. 提交許可申請和審查申請
．向營業所區域的衛生所提交許可申請。(正本1份、副本2份)
．收到許可申請的都道府縣知事等將檢查許可申請的不足之處，並將認為適當的內容提交給厚生勞動大臣。
．提交許可申請書等後，附上許可申請書複印件，將審查申請書(含附件)提交至厚生勞動省食品安全局-食品安全司標準審查處，可以寄送或親送(正本1份、副本1份)
2.具備資料
．帶有標籤和健康聲明的整個包裝樣本
．證明產品和/或其功能成分的臨床和營養證明以維持健康的文件
．證明產品和/或其功能成分攝入量的臨床和營養證明的文件
．有關產品及其功能成分安全性的文件，包括關於飲食體驗的額外人體研究
．有關產品及其功能組成穩定性的文件
．產品和功能組件的物理和生物學特性的文檔
．其功能成分的定性/定量分析測定方法及產品中成分的分析測定結果
．產品指定營養成分及熱量含量分析報告
．生產方法說明、工廠設備清單和質量控制系統說明
3.免費樣品測試檢驗請求
．申請人在產品樣品上附上檢驗申請表等複印件，請求美國國家健康與營養研究所或註冊檢測機構進行檢測檢驗。
．申請人向新發食品衛生措施辦公室提交該機構或註冊檢測機構出具的檢測報告原件。
4. 許可測試的實施機構
特殊用途食品（含特定保健用食品）許可檢測主體為美國國立衛生與營養研究所及以下註冊檢測機構。
．國立健康與營養研究所
．註冊檢測機構名單：
日本食品分析中心
食品環境檢驗協會
食品分析開發中心 SUNTEC
日本食品檢驗
大阪公共衛生研究所
保健食品的標籤必須符合食品標籤法規範，所有販售食品必需在容器包裝上以日文標示。
1. 營養機能食品標籤陳列項目顯示：
．能顯示機能的營養成分
脂肪酸（1種）：n-3脂肪酸
礦物質（6種）：鋅、鉀*、鈣、鐵、銅、鎂
維生素（13種）：菸酸、泛酸、生物素、維生素A、維生素B 1、維生素B 2、維生素B 6、維生素B 12、維生素C、維生素D、維生素E、維生素K、葉酸
(片劑、膠囊對於以製劑形式存在的加工食品不包括鉀)
．營養功能食品及營養成分的標示：顯示為營養機能食品（營養成分名稱），顯示多個設定標準的營養成分時，順序不固定。
．營養成分的作用：描述每種營養成分指定的功能，即使標籤內容相同，也不允許改變或省略指定營養成分的功能。
．預計每日攝入量：也可以在寬度的兩端顯示“請吃○粒到○粒。” （在規定的上限和下限內）。
．營養成分的量和熱量（營養成分標籤）：顯示每日攝入量指南的營養成分量和熱量。(需要用規定方法求得的數值表示)
．攝取方法
．食入注意事項
．促進和啟發均衡飲食的措辭：必須標註飲食習慣要以主食、主菜、配菜為主，均衡飲食
．必須標註該產品與特定保健食品不同，未經消費者廳長官個別審查
．營養成分量與顯示營養素等的標準值的百分比。
．營養素的標準值等有關目標年齡和標準發熱量的字樣
．烹調或保管方法上需要特別注意的事項
．特定對象需要注意的事項
．保存方法 (只限新鮮食品)
．對於因加熱等而導致營養成分發生顯著變化的食品，需要顯示保證的烹調上下限範圍內方法。(只限新鮮食品)
．即使是生鮮食品，如果要作為營養機能性食品銷售，也需要裝在容器中，並附上必要的標籤物品，不能裸賣
．當可顯示區域約為 150 ㎠ 或更小時，可以以 5.5 點或更大的大小顯示字符。
2. 機能性表示食品
具有機能性聲稱的食品在容器、包裝上註明有助於維持和促進健康的特定健康目標（不包括與降低疾病風險相關的目標）可以通過功能相關的成分來實現，必須在銷售日期前至少 60 天向消費者廳長官報告下列事項。
具有機能聲稱的食品的通知項目：
．顯示內容
．食品相關業務的基本信息
．基於安全的信息
．基於功能的信息
．有關生產/製造和質量控制的信息
．健康危害信息採集系統
．其他必要事項
具有機能聲稱的食品應標註的項目：
．是一種具有機能聲稱的食物
．具有科學證據的功能相關成分以及該成分/含有該成分食品的功能
．營養成分和卡路里的量
．每日攝入量指南中功能性成分的含量
．估計每日攝入量
．通知編號
．食品相關企業的聯繫信息．食品相關企業的名稱或名稱、地址和聯繫信息(僅限新鮮食品)
．未接受國家對功能和安全性的評估
．攝取方法
．攝入注意事項
．促進和啟發均衡飲食的措辭
．烹飪或儲存方法需要特別注意的物品的注意事項
．不適用於疾病的診斷、治療或預防
．不適用於患病者、未成年人、孕婦（包括計劃懷孕者）和哺乳期婦女(僅限加工食品)
．患病者應諮詢醫生，服用藥物者服藥前應諮詢醫生或藥劑師。
．如果感覺身體狀況有任何變化，應立即停止服用並諮詢醫生。
．保存方法(只限生鮮)
．所有需要的顯示項目將以 8 點或更大的大小顯示，如果可顯示區域約為 150 ㎠ 或更小，則可以顯示大小為 5.5 點或更大的字符。
．如果想將生鮮食品作為具有機能聲稱的食品進行銷售，需要將其放入描述了必要標籤項目的容器和包裝並通知消費者事務廳，不能裸賣。
3. 特定保健用食品
作為特定保健用食品銷售，必須對每種產品的食品有效性和安全性進行檢查，並且標籤必須得到消費者事務廳的批准。特定保健食品和有條件的特定保健食品均附有許可證，特定保健食品分為四類。
．特定保健食品：在飲食中為特定健康目的服用者。表明可以通過攝入來達到健康目的之食物
． 特定保健食品（降低疾病風險標籤）：如果所涉及成分有降低疾病風險效果的科學依據，並在醫學和營養學上被廣泛接受，則允許使用降低疾病風險標籤。
．特定保健食品（標準型）：依據科學根據確認所涉成分和標準是否符合具有足夠的作為特定保健用途食品的批准記錄，無需消費者委員會單獨審查。
．有條件的特定保健食品：未達到特定保健食品檢驗所要求的科學證據水平，但其有效性得到一定程度證實的食品，需在標籤上標明其科學證據有限。 .
特定保健食品所需的標籤陳列項目顯示：
1.是指定保健用途的食品
2.經許可顯示的內容等
3.營養成分（包括相關成分）的量和熱量
4.估計每日攝入量
5.攝取方法
6.攝入註意事項
7.促進和啟發均衡飲食的措辭
8.如果針對所涉及的成分顯示營養素等參考值，則每日攝入量所涉及的成分與營養素等參考值的比例。
9.烹飪或儲存方法需要特別注意的物品的注意事項
10.所有需要的顯示項目均以8 點或更大的字符顯示（當可顯示區域約為 150 cm 2或更小時，字符至少 5.5 點或更多）。
11. 許可測試的實施機構
標籤禁止：
健康聲稱食品以外的食品，不得使用與健康聲稱食品、營養成分的功能、可期待特定健康目的的用語混淆的名稱。
(例)特定保健食品、特定功能食品、保健XX食品、XX功能食品等名稱，尤其是包含功能和健康字樣的名稱。
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.
【參考連結】
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
請問在日本有哪些專業服務機構，可以協助以外國公司名義辦理保健食品產品許可證？
HLF-JP-60
經過核准登記的保健食品，進口到日本要檢附什麼文件？經過什麼手續？
在銷售時要向各地的衛生福利部相關機構事先或事後準備嗎？網頁？
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：
根據食品衛生法的規定，進口用於銷售或經營的食品，必須提交進口申報。
當貨物從海外通過船舶或飛機抵達日本時，將被扣留在保稅區。保稅區是從外國進口的貨物可以被扣留直到清關完成的地方。
海關將根據法規進行審查和檢查，獲得進口許可證的人員可以將其從保稅區運往日本。
進口流程
準備文件：
1.食品進口申報表
．進口商的名稱和地址、代碼
．原產國、代碼
．進口食品管理員註冊號
．製造商名稱、代碼
．廠名、代碼
．出口商名稱、代碼
．包裝商名稱、代碼
．裝貨港/代號
．裝貨日期、日期、日期
．裝卸港/代碼
．到貨日期
．存儲倉庫/代碼
．交貨日期、通知日期
．貨物符號
．有無事故
．船舶或飛機的名稱或航班號
．提交者/代碼
2.其他相關文件
．原材料、製造過程等說明：
製造商、製造工廠名稱和所在地、產品編號、產品名稱等可識別為到達日本的貨物
．材料、零件清單等說明：
原材料表（必填）、製造工序表（必填）、註冊檢驗機構等的測試報告、產品彩色照片、目錄等
．衛生證明書（取決於物品和原產國）
．檢測報告（根據需要）
3. 需提交食品進口申報表及必要的附件兩份
．通知書可以在貨物到達前7天開始提交
．提交通知書的地點視貨物清關地點而定
．也可以通過郵寄方式提交通知表
．郵寄通知書時，請務必附上貼有郵票的回信信封。
4. 貨物到達
．填寫食品進口申報單上的必填項目
．向檢疫站食品監測窗口提交食品進口申報單
每次進口保健食品時，都必須通知厚生勞動大臣（檢疫所）進行初步調查，需要繳交：
1.製造商、所在地
2.工廠、所在地
3.原材料(包括食品添加劑時的物質名稱和用量)
4.製造和加工方法
5.容器和包裝材料
6.儲存方法
7.應用
8.顧問姓名、地址、聯繫信息
9.進口商名稱、地址、聯繫信息
10.容器包裝材料、內部容量
11.保存方法
12.用途
13.如何使用
14.預定自檢項目
15.預定進口港口/時間
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
【參考連結】
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
日本保健食品審核機構，需要附上的實驗室檢驗資料有哪些? 網頁？
What are the laboratory inspection materials that need to be attached for verification? Website?
Evershine RD：
1. 營養食品、機能性食品可以由海外機構檢驗，符合生產/製造和質量控制(GMP、HACCP、ISO 22000、FSSC 22000 等，不必審核，安全性及有效性皆由業者自行驗證、 自主管理。
2. 特定保健食品必須經由許可測試的實施機構認證。許可檢測主體為美國國立衛生與營養研究所及以下註冊檢測機構。
．國立健康與營養研究所
．日本食品分析中心
．食品環境檢驗協會
．食品分析開發中心 SUNTEC
．日本食品檢驗
．大阪公共衛生研究所
特定保健食品檢測內容
特定保健食品的安全性評估是根據具體情況對每種食品進行的，原則上對食品所涉及的成分的安全性進行評價，特別是片劑、膠囊等。
1.製造/加工方法、質量控制
2.作用機制(涉及成分的定量方法、吸收/代謝/排泄、積累等)
3.重金屬、殘留農藥等、致敏物質等分析值信息(如有必要)
4.使用記錄的數據和信息
5.產品所含成分或食物的每日攝入量數據。
6.關於商業食品中成分含量的數據
7.其他國家的使用記錄、食物攝入量等數據
8.食物烹飪方法的數據（需要加熱/不加熱）
9. 數據應盡可能具體地使用數值
10.使用動物進行體外和體內試驗的數據和信息
11.測試數據如下
．基因毒性測試數據
．單次口服劑量試驗數據（急性毒性）
．28 天或 90 天重複口服給藥研究數據
．根據需要參與1年長期口服給藥試驗、抗原性試驗、過敏性試驗、生殖試驗、致畸試驗、致癌試驗等數據
12.需要設定允許量（值）等資料
13.當涉及的成分是微生物時，需檢驗抗生素抗性基因的質粒轉移等，以及有關可能性的信息
13.在適當的受試者上進行的人體試驗
14.測試的測試數據、文獻等必須適當的統計方法進行處理。
．使用雙盲方法，對非攝入者和攝入者進行對照（安慰劑）
．通過無控制執行的方法攝取之前、期間和之後攝取器的狀態差異
．基於健康用途的受試者（例如，健康的成年男性和女性以及疾病儲備組）（涉及的成分相關的臨床試驗值高的人）等）數據
．連續攝入（重複攝入測試、長期攝入測試）、過量攝入的影響
15.可以評估攝入效果的數據（過量測試）
16.與藥物聯合使用時有關安全性的數據和充分考慮
17.提交的數據應保證測試的可靠性。
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.
【參考連結】
http://www.fsc.go.jp/senmon/sinkaihatu/index.html
HLF-JP-75
日本保健食品審核機構，能夠接受海外檢驗機構的檢驗資料嗎？假如是的話，有些被認可的機構？網頁？
Evershine RD：
1. 營養食品、機能性食品可以由海外機構檢驗，符合生產/製造和質量控制(GMP、HACCP、ISO 22000、FSSC 22000 等，不必審核，安全性及有效性皆由業者自行驗證、 自主管理。
2. 特定保健食品僅有日本國內檢驗機構：
．國立健康與營養研究所
．日本食品分析中心
．食品環境檢驗協會
．食品分析開發中心 SUNTEC
．日本食品檢驗
．大阪公共衛生研究所
HLF-JP-77
請問在日本有哪些保健食品檢驗機構可以提供保健食品檢驗服務？網頁？
HLF-JP-80
外國子公司進口保健食品後，如果委託日本的經銷商銷售，經銷商需要保健食品營業許可證嗎？
假如保健食品有品質瑕疵的話，外國子公司和經銷商各自的責任為何？是連帶責任嗎？還是可以規範由外國子公司負責？
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，健康食品歸類在食品，依法販售需要取得營業執照。
需要文件：
1.營業執照申請書
．申請人、郵政編碼、 電話號碼、傳真號碼、電子郵件地址、公司編號、出生年月日
．負責人(如果是法人)
．營業設施信息：郵編、電話號碼、傳真號碼、電子郵件地址
．設施名稱、位置、店鋪名稱或商號
．食品衛生經理姓名、參加都道府縣知事等的課程
．主要處理食品、添加劑、器具/容器和包裝
2.結構、設備、設施圖
3.食品衛生管理員資格證明(進行食品銷售時，需要指定食品衛生經理)
．定期參加都道府縣知事或都道府縣知事批准的研討會，努力學習有關食品衛生的新知識。
．按照經營者的指示管理衛生。
．採取必要的預防措施，並儘力向經營者提供必要的意見。
．必須了解最新的食品衛生信息，以便妥善管理衛生。
．要成為食品衛生經理，必須參加總共約 6 小時的培訓課程。
．具備以下資格的人員無需參加課程即可成為食品衛生管理人員：廚師、營養師、製菓衛生士、船舶料理士、《屠宰場法》規定的衛生管理人員、《屠宰場法》規定的工作衛生經理、家禽加工衛生經理、符合食品衛生經理或食品衛生觀察員資格要求的人員。
4. 水質檢驗報告（使用自來水、專用水或簡單專用水以外的水時）
5. 繳交許可證申請費
6. 如果是法人註冊需要填寫法人編號。
申請流程：
向營業所轄區的衛生所申辦許可：
在進行食品營業許可審核時，對該營業設施進行實地調查，並對該設施的牢固性和設備的耐久性進行檢驗，根據所規定的審核基準有效期最短為5年，最長為8年。
根據食品安全基本法，食品進口商必須
1. 對確保食品安全負有首要責任，並負責在食品供應過程的每個階段採取適當確保措施。
2. 提供與食品準確和適當的信息，或者予以規定。
根據食品衛生法規範，食品經營者必須
1. 有責任確保食品安全。
2. 需獲取與食品衛生相關的知識和技術
3. 確認所用原材料的安全。
4. 進行自我檢查
5. 需要時採取其他必要措施。
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
【參考連結】
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
請問在日本有哪些專精於保健食品銷售與消費權益相關法律服務的業者？
Email：tyo4ww@evershinecpa.com
或
日本永輝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）日本籍来自台灣
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或
林幸穗 Anny Lin 協理
手機：+886-937-606-272
skype: annylin8008
wechat: annylin8008
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