印度保健食品登記法規問題集

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各國健康食品登記法規問題集

HLF-TW-10
請問印度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 India? 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：

在印度，保健品由印度食品安全標準局(FSSAI)負責監管，上市前需在FSSAI完成註冊，確定該產品符合規定要求，且標籤應符合規範，不合格產品按照程序進行召回。

保健品定義為，用於補充5歲以上的人士的正常食品。保健品應含有一種或多種營養素的濃縮來源，即氨基酸、酶、礦物質、蛋白質、維生素、其他膳食物質、植物或植物藥、益生元、益生菌和動物源性物質或其他類似物質，單獨或組合提供已知、確定營養有益於生理作用。應以一次性包裝銷售，以保持產品的完整性和質量，或以膠囊、片劑、丸劑、小袋等劑型銷售；或以果凍或凝膠、半固體和其他類似形式的液體和粉末計量。

In India, health products are regulated by the Food Safety Standards Agency of India (FSSAI). Before listing, they must be registered with the FSSAI to confirm that the product meets the specified requirements, and the labeling should meet the specifications. Unqualified products should be recalled in accordance with the procedures.

Supplements are defined as supplements to normal foods for people over 5 years of age. Nutraceuticals shall contain a concentrated source of one or more nutrients, namely amino acids, enzymes, minerals, proteins, vitamins, other dietary substances, plants or botanicals, prebiotics, probiotics and substances of animal origin or other similar substances, either alone or The combination provides known, established nutritionally beneficial physiological effects. It should be sold in single-use packaging to preserve product integrity and quality, or in dosage forms such as capsules, tablets, pills, sachets, etc.; or in jelly or gel, semi-solid and other similar forms of liquid and powder metering.

【參考連結】

https://www.fssai.gov.in/cms/food-safety-and-standards-regulations.php

https://www.fssai.gov.in/upload/uploadfiles/files/Nutraceuticals_Regulations.pdf

HLF-TW-20
外國公司要到印度銷售保健食品，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 India, 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：

需要，須以印度當地公司名義取得食品經營者登記。
在印度，保健品屬於食品，所有食品經營者都須按照規定程序進行登記。流程：

1. 向FSSAI提交申請表及相關文件。

網頁：https://foscos.fssai.gov.in/

2. 根據申請日起60 天內頒發許可證。

3. 或者如果申請不完整，許可當局應通知申請人 在收到通知後的 30 天內，以書面形式補充或完成申請（視情況而定）。 如果申請人未能在規定的 30 天期限內提供所需資料，許可申請將被駁回。

4. 註冊有效期為1-5年，由食品經營者自行決定，到期須申請更新。

申請文件

1. 由業主/合夥人或授權簽署人填妥並簽署（一式兩份）的申請表。

2. 藍圖/佈局計劃，以米/平方米為單位的尺寸和運營區域顯示。

3. 董事名單、附有完整地址和聯繫方式。

4. 設備和機器的名稱和清單，以及數量、裝機容量和使用的馬力。

5. 由業主/合夥人/董事/授權簽字人的政府機構簽發的帶照片的身份證、地址證明。

6. 希望生產的食品類別清單。（如果是製造商）

7. 製造商指定負責人姓名和地址的授權書。

8. 來自認可/公共衛生實驗室的用於食品成分的水的分析報告（化學和細菌學），以確認可攜帶性，並註明收集的實驗室授權代表的姓名樣品和取樣日期。

9. 擁有房屋的證明。 （銷售契據/租金協議/電費單等）

10. 合夥契約/宣誓書/備忘錄和公司章程。

11. 食品安全管理體系計劃或證書（如有）

12. 召回計劃，包括產品分銷商的詳細信息。

13. 已通過的食品安全管理體系證書或計劃（中央許可單位必須是認可機構的證書）。

14. 持有健康證明的工人名單。

15. 負責操作的技術人員的姓名、資格和詳細情況。

16. 通過NABL /FSSA 認可的實驗室對食品中的相關化學和/或微生物污染物進行測試，以確保食品安全。

表格A

1. 業務種類

．永久/臨時攤位持有人

．小販（流動食品供應商）

．家庭食堂/dabba wallas

．小吃店/小零售商

．製造商/加工廠

．重新打包商

．宗教聚會、集市等的食品攤位

．牛奶供應商

．魚/肉/家禽店/賣家

．其他(說明)

2. 申請人身份：合夥商/企業/其它(說明)

3. 通訊地址、電話號碼、手機號碼、傳真號碼、電子郵件

4. 開展食品業務的區域或地點/場所地址

5. 擬製造或銷售的食品描述

6. 食品企業的年總營業額（如果有），以及任何證明文件

7. 預計開始日期

8. 如屬季節性業務，請註明一年的開閉期

9. 供水來源：公共/私人/任何其他來源(說明)

10. 製造食品時是否使用電力(如果是，請說明使用的電力負載)

11. 繳費：匯票編號/現金

表格B

1.業務種類（如適用可複選）：

．製造/加工，包括分類、分級等。

．牛奶收集/冷藏

．屠宰場

．溶劑萃取裝置

．溶劑萃取設備，配備油籽預清洗或油預排。

．溶劑提取和煉油廠。

．包裝

．重新貼標籤（由第三方根據自己的包裝和標籤製造）

．導入

．倉儲/倉庫/冷庫

．零售貿易

．批發貿易

．分銷商/供應商

．食物運輸者

．餐飲

．其他食品自動售貨機構

．俱樂部/食堂

．酒店

．餐廳

．其他(說明)

2. 公司/機構名稱：

3. 註冊辦公地址：

4. 申請執照的經營場所地址

5. 具有技術資格的運營負責人的姓名和/或職務、資格和地址

6. 每天平均使用/處理的牛奶數量

7. 使用的電力負載

8. 單位是否配備分析實驗室

9. 其他法律授予的許可證

10. 繳費：匯票編號/現金

11. 申請人/授權簽字人簽字

12. 聲明書、簽章

Yes.  A registration of food operator in the name of a local Indian company is required.

In India, health products are classified as food, and all food operators are required to follow the prescribed procedures for registration. process:

1. Submit the application form and relevant documents to FSSAI.

URL:https://foscos.fssai.gov.in/

2. Issue the license within 60 days from the filing date.

3. Or if the application is incomplete, the licensing authority shall notify the applicant within 30 days of receipt of the notification to supplement or complete the application in writing (as the case may be). If the applicant fails to provide the required information within the prescribed 30-day period, the permit application will be rejected.

4. The registration is valid for 1-5 years, which is at the discretion of the food operator, and must apply for renewal when it expires.

Application documents

1. Owner/partner or an authorized signatory.

2. Blueprint/layout plan showing dimensions and operating area in m/m².

3. List of directors, complete with addresses and contact details.

4. Name and list of equipment and machinery, as well as number, installed capacity and horsepower used.

5. Photo ID, address proof issued by the owner/partner/director/authorized signatory’s government agency.

6. A list of the food categories that you wish to produce. (if manufacturer)

7. A letter of authorization from the manufacturer specifying the name and address of the person responsible.

8. Analytical report (chemical and bacteriological) of water used for food ingredients from an accredited/public health laboratory to confirm portability, noting the name of the laboratory authorized representative who collected the sample and date of sampling.

9. Proof of ownership of the home. (Deed of sale/rent agreement/electricity bill, etc.)

10. Partnership Deed/Affidavit/Memorandum and Articles of Association.

11. Food safety management system plan or certificate (if available)

12. Recall plan, including product distributor details.

13. An approved food safety management system certificate or program (the central licensing unit must be a certificate from an accredited body).

14. List of workers holding health certificates.

15. The name, qualifications and details of the technical personnel responsible for the operation.

16. Test food for relevant chemical and/or microbial contaminants by NABL/FSSA accredited laboratories to ensure food safety.

Form A

1. Type of business

． Permanent/temporary stall holder

． Hawker (mobile food supplier)

． Family canteen/dabba wallas

． Snack Bar/Small Retailer

． Manufacturer/Processing Plant

． Repacker

． Food stalls for religious gatherings, markets, etc.

． Milk Supplier

． Fish/Meat/Poultry Store/Seller

． Other (Explanation)

2. Applicant’s identity: Partner/Enterprise/Other (Explain)

3. Mailing address, telephone number, mobile number, fax number, email

4. Address of the area or location/premises where the food business is carried out

5. Description of the food product intended for manufacture or sale

6. Gross annual turnover of the food business (if any), and any supporting documents

7. Expected Start Date

8. If it is a seasonal business, please indicate the one-year opening and closing period

9. Source of water supply: public/private/any other source (description)

10. Is electricity used in the manufacture of food (if yes, please specify the electrical load used)

11. Payment: bill of exchange number/cash

Form B

1. Type of business (check if applicable):

． Manufacturing/processing, including sorting, grading, etc.

． Milk collection/refrigeration

． Slaughterhouse

． Solvent extraction device

． Solvent extraction equipment, equipped with oilseed prewash or oil pre-drain.

． Solvent extraction and refineries.

． Package

． Relabeled (manufactured by a third party based on their own packaging and labels)

． Import

． Warehouse/Warehouse/Cold Storage

． Retail trade

． Wholesale trade

． Distributor/Supplier

． Food carrier

． Food

． Other food vending establishments

． Club/Canteen

． Hotels

． Dining room

． Other (description)

2. Company/Organization Name:

3. Registered office:

4. The address of the business premises where the license is applied for

5. Name and/or title, qualifications and address of the technically qualified operational leader

6. Average amount of milk used/handled per day

7. Electric load used

8. Does the unit have an analytical laboratory?

9. Licenses granted by other laws

10. Payment: bill of exchange number/cash

11. Applicant/Authorized Signatory Signature

12. Declaration, signature and seal

【參考連結】

https://www.fssai.gov.in/upload/uploadfiles/files/Licensing_Regulations.pdf

HLF-TW-25

HLF-TW-30
外國公司要到印度銷售保健食品，可以指派印度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 India, can it assign an India 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：

可以，須以印度當地公司名義取得食品經營者登記。

在印度，保健品屬於食品，所有食品經營者都須按照規定程序進行登記。流程：

1. 向FSSAI提交申請表及相關文件。

網頁：https://foscos.fssai.gov.in/

2. 根據申請日起60 天內頒發許可證。

3. 或者如果申請不完整，許可當局應通知申請人 在收到通知後的 30 天內，以書面形式補充或完成申請（視情況而定）。 如果申請人未能在規定的 30 天期限內提供所需資料，許可申請將被駁回。

4. 註冊有效期為1-5年，由食品經營者自行決定，到期須申請更新。

申請文件

1. 由業主/合夥人或授權簽署人填妥並簽署（一式兩份）的申請表。

2. 藍圖/佈局計劃，以米/平方米為單位的尺寸和運營區域顯示。

3. 董事名單、附有完整地址和聯繫方式。

4. 設備和機器的名稱和清單，以及數量、裝機容量和使用的馬力。

5. 由業主/合夥人/董事/授權簽字人的政府機構簽發的帶照片的身份證、地址證明。

6. 希望生產的食品類別清單。（如果是製造商）

7. 製造商指定負責人姓名和地址的授權書。

8. 來自認可/公共衛生實驗室的用於食品成分的水的分析報告（化學和細菌學），以確認可攜帶性，並註明收集的實驗室授權代表的姓名樣品和取樣日期。

9. 擁有房屋的證明。 （銷售契據/租金協議/電費單等）

10. 合夥契約/宣誓書/備忘錄和公司章程。

11. 食品安全管理體系計劃或證書（如有）

12. 召回計劃，包括產品分銷商的詳細信息。

13. 已通過的食品安全管理體系證書或計劃（中央許可單位必須是認可機構的證書）。

14. 持有健康證明的工人名單。

15. 負責操作的技術人員的姓名、資格和詳細情況。

16. 通過NABL /FSSA 認可的實驗室對食品中的相關化學和/或微生物污染物進行測試，以確保食品安全。

表格A

1. 業務種類

．永久/臨時攤位持有人

．小販（流動食品供應商）

．家庭食堂/dabba wallas

．小吃店/小零售商

．製造商/加工廠

．重新打包商

．宗教聚會、集市等的食品攤位

．牛奶供應商

．魚/肉/家禽店/賣家

．其他(說明)

2. 申請人身份：合夥商/企業/其它(說明)

3. 通訊地址、電話號碼、手機號碼、傳真號碼、電子郵件

4. 開展食品業務的區域或地點/場所地址

5. 擬製造或銷售的食品描述

6. 食品企業的年總營業額（如果有），以及任何證明文件

7. 預計開始日期

8. 如屬季節性業務，請註明一年的開閉期

9. 供水來源：公共/私人/任何其他來源(說明)

10. 製造食品時是否使用電力(如果是，請說明使用的電力負載)

11. 繳費：匯票編號/現金

表格B

1.業務種類（如適用可複選）：

．製造/加工，包括分類、分級等。

．牛奶收集/冷藏

．屠宰場

．溶劑萃取裝置

．溶劑萃取設備，配備油籽預清洗或油預排。

．溶劑提取和煉油廠。

．包裝

．重新貼標籤（由第三方根據自己的包裝和標籤製造）

．導入

．倉儲/倉庫/冷庫

．零售貿易

．批發貿易

．分銷商/供應商

．食物運輸者

．餐飲

．其他食品自動售貨機構

．俱樂部/食堂

．酒店

．餐廳

．其他(說明)

2. 公司/機構名稱：

3. 註冊辦公地址：

4. 申請執照的經營場所地址

5. 具有技術資格的運營負責人的姓名和/或職務、資格和地址

6. 每天平均使用/處理的牛奶數量

7. 使用的電力負載

8. 單位是否配備分析實驗室

9. 其他法律授予的許可證

10. 繳費：匯票編號/現金

11. 申請人/授權簽字人簽字

12. 聲明書、簽章

責任

每個食品經營者應遵循食品召回程序，包括完整的召回流程、召回後報告和後續行動，以確保召回的有效性並防止再次發生，印度食品安全和標準局的首席執行官或邦或聯邦領土的食品安全專員或兩者都可以指示食品經營者啟動召回程序。

如果任何利益相關者向食品經營者報告或投訴，並且食品經營者確定有召回的需要，也應啟動召回過程。
如果食品經營者未對投訴作出回應，投訴人或消費者可以通知印度食品安全和標準局的首席執行官或州或聯邦領土的食品安全專員或兩者，他們將採取措施確定召回的必要性，並就召回事宜向有關食品經營者提出要求，有關食品經營者應受其約束。

Yes.  A registration of food operator in the name of a local Indian company is required.

In India, health products are classified as food, and all food operators are required to follow the prescribed procedures for registration. process:

1. Submit the application form and relevant documents to FSSAI.

URL:https://foscos.fssai.gov.in/

2. Issue the license within 60 days from the filing date.

3. Or if the application is incomplete, the licensing authority shall notify the applicant within 30 days of receipt of the notification to supplement or complete the application in writing (as the case may be). If the applicant fails to provide the required information within the prescribed 30-day period, the permit application will be rejected.

4. The registration is valid for 1-5 years, which is at the discretion of the food operator, and must apply for renewal when it expires.

Application documents

1. Owner/partner or an authorized signatory.

2. Blueprint/layout plan showing dimensions and operating area in m/m².

3. List of directors, complete with addresses and contact details.

4. Name and list of equipment and machinery, as well as number, installed capacity and horsepower used.

5. Photo ID, address proof issued by the owner/partner/director/authorized signatory’s government agency.

6. A list of the food categories that you wish to produce. (if manufacturer)

7. A letter of authorization from the manufacturer specifying the name and address of the person responsible.

8. Analytical report (chemical and bacteriological) of water used for food ingredients from an accredited/public health laboratory to confirm portability, noting the name of the laboratory authorized representative who collected the sample and date of sampling.

9. Proof of ownership of the home. (Deed of sale/rent agreement/electricity bill, etc.)

10. Partnership Deed/Affidavit/Memorandum and Articles of Association.

11. Food safety management system plan or certificate (if available)

12. Recall plan, including product distributor details.

13. An approved food safety management system certificate or program (the central licensing unit must be a certificate from an accredited body).

14. List of workers holding health certificates.

15. The name, qualifications and details of the technical personnel responsible for the operation.

16. Test food for relevant chemical and/or microbial contaminants by NABL/FSSA accredited laboratories to ensure food safety.

Form A

1. Type of business

． Permanent/temporary stall holder

． Hawker (mobile food supplier)

． Family canteen/dabba wallas

． Snack Bar/Small Retailer

． Manufacturer/Processing Plant

． Repacker

． Food stalls for religious gatherings, markets, etc.

． Milk Supplier

． Fish/Meat/Poultry Store/Seller

． Other (Explanation)

2. Applicant’s identity: Partner/Enterprise/Other (Explain)

3. Mailing address, telephone number, mobile number, fax number, email

4. Address of the area or location/premises where the food business is carried out

5. Description of the food product intended for manufacture or sale

6. Gross annual turnover of the food business (if any), and any supporting documents

7. Expected Start Date

8. If it is a seasonal business, please indicate the one-year opening and closing period

9. Source of water supply: public/private/any other source (description)

10. Is electricity used in the manufacture of food (if yes, please specify the electrical load used)

11. Payment: bill of exchange number/cash

Form B

1. Type of business (check if applicable):

． Manufacturing/processing, including sorting, grading, etc.

． Milk collection/refrigeration

． Slaughterhouse

． Solvent extraction device

． Solvent extraction equipment, equipped with oilseed prewash or oil pre-drain.

． Solvent extraction and refineries.

． Package

． Relabeled (manufactured by a third party based on their own packaging and labels)

． Import

． Warehouse/Warehouse/Cold Storage

． Retail trade

． Wholesale trade

． Distributor/Supplier

． Food carrier

． Food

． Other food vending establishments

． Club/Canteen

． Hotels

． Dining room

． Other (description)

2. Company/Organization Name:

3. Registered office:

4. The address of the business premises where the license is applied for

5. Name and/or title, qualifications and address of the technically qualified operational leader

6. Average amount of milk used/handled per day

7. Electric load used

8. Does the unit have an analytical laboratory?

9. Licenses granted by other laws

10. Payment: bill of exchange number/cash

11. Applicant/Authorized Signatory Signature

12. Declaration, signature and seal

Responsibility

Every food operator should follow food recall procedures including full recall process, post-recall reporting and follow-up to ensure the effectiveness of the recall and prevent its recurrence, Chief Executive Officer, Food Safety and Standards Authority of India or state or federal territory The Food Safety Commissioner, or both, may direct food operators to initiate recall procedures.

The recall process should also be initiated if any stakeholder reports or complains to the food operator and the food operator determines that a recall is required. If the food operator fails to respond to the complaint, the complainant or the consumer may notify the Chief Executive Officer of the Food Safety and Standards Authority of India or the Food Safety Commissioner of a State or Union Territory or both and they will take steps to determine the necessity of a recall, And put forward a request to the relevant food operators on the recall, and the relevant food operators should be bound by it.

【參考連結】

https://www.fssai.gov.in/upload/uploadfiles/files/Licensing_Regulations.pdf

https://www.fssai.gov.in/upload/uploadfiles/files/Food_Recall_Regulations.pdf

HLF-TW-35

HLF-TW-40
外國公司銷售到印度保健食品本身，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？可允許的語文有哪些？網頁？

Do foreign companies need to apply for an approval before importing health food sold to India?
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? Which languages are allowed? Website?

Evershine RD：

需要，食品進口商須以印度當地公司名義取得食品經營者登記，並在對外貿易總局進行註冊並擁有有效的進出口代碼。

食品經營者登記流程：

1. 向FSSAI提交申請表及相關文件。

網頁：https://foscos.fssai.gov.in/

2. 根據申請日起60 天內頒發許可證。

3. 或者如果申請不完整，許可當局應通知申請人 在收到通知後的 30 天內，以書面形式補充或完成申請（視情況而定）。 如果申請人未能在規定的 30 天期限內提供所需資料，許可申請將被駁回。

4. 註冊有效期為1-5年，由食品經營者自行決定，到期須申請更新。

申請文件

1. 由業主/合夥人或授權簽署人填妥並簽署（一式兩份）的申請表。

2. 藍圖/佈局計劃，以米/平方米為單位的尺寸和運營區域顯示。

3. 董事名單、附有完整地址和聯繫方式。

4. 設備和機器的名稱和清單，以及數量、裝機容量和使用的馬力。

5. 由業主/合夥人/董事/授權簽字人的政府機構簽發的帶照片的身份證、地址證明。

6. 希望生產的食品類別清單。（如果是製造商）

7. 製造商指定負責人姓名和地址的授權書。

8. 來自認可/公共衛生實驗室的用於食品成分的水的分析報告（化學和細菌學），以確認可攜帶性，並註明收集的實驗室授權代表的姓名樣品和取樣日期。

9. 擁有房屋的證明。 （銷售契據/租金協議/電費單等）

10. 合夥契約/宣誓書/備忘錄和公司章程。

11. 食品安全管理體系計劃或證書（如有）

12. 召回計劃，包括產品分銷商的詳細信息。

13. 已通過的食品安全管理體系證書或計劃（中央許可單位必須是認可機構的證書）。

14. 持有健康證明的工人名單。

15. 負責操作的技術人員的姓名、資格和詳細情況。

16. 通過NABL /FSSA 認可的實驗室對食品中的相關化學和/或微生物污染物進行測試，以確保食品安全。

表格A

1. 業務種類

．永久/臨時攤位持有人

．小販（流動食品供應商）

．家庭食堂/dabba wallas

．小吃店/小零售商

．製造商/加工廠

．重新打包商

．宗教聚會、集市等的食品攤位

．牛奶供應商

．魚/肉/家禽店/賣家

．其他(說明)

2. 申請人身份：合夥商/企業/其它(說明)

3. 通訊地址、電話號碼、手機號碼、傳真號碼、電子郵件

4. 開展食品業務的區域或地點/場所地址

5. 擬製造或銷售的食品描述

6. 食品企業的年總營業額（如果有），以及任何證明文件

7. 預計開始日期

8. 如屬季節性業務，請註明一年的開閉期

9. 供水來源：公共/私人/任何其他來源(說明)

10. 製造食品時是否使用電力(如果是，請說明使用的電力負載)

11. 繳費：匯票編號/現金

表格B

1.業務種類（如適用可複選）：

．製造/加工，包括分類、分級等。

．牛奶收集/冷藏

．屠宰場

．溶劑萃取裝置

．溶劑萃取設備，配備油籽預清洗或油預排。

．溶劑提取和煉油廠。

．包裝

．重新貼標籤（由第三方根據自己的包裝和標籤製造）

．導入

．倉儲/倉庫/冷庫

．零售貿易

．批發貿易

．分銷商/供應商

．食物運輸者

．餐飲

．其他食品自動售貨機構

．俱樂部/食堂

．酒店

．餐廳

．其他(說明)

2. 公司/機構名稱：

3. 註冊辦公地址：

4. 申請執照的經營場所地址

5. 具有技術資格的運營負責人的姓名和/或職務、資格和地址

6. 每天平均使用/處理的牛奶數量

7. 使用的電力負載

8. 單位是否配備分析實驗室

9. 其他法律授予的許可證

10. 繳費：匯票編號/現金

11. 申請人/授權簽字人簽字

12. 聲明書、簽章

進出口代碼 (IEC)

IEC 編號是對外貿易總幹事頒發給印度公司的10位數代碼。每個從事進出口業務的個人或實體都必須獲得 IEC。 它具有終身有效期，大約需要 15 天才能簽發。

1.網頁註冊：https://www.dgft.gov.in/CP/

．獲得 IEC 的公司的性質可以是以下任何一種：獨資企業、合夥企業、有限責任合夥企業、有限公司、信託、HU”。引入 GST 後，IEC 編號與公司的 PAN 相同。IEC 將由 DGFT 單獨發布。

2.簽署聲明。

3.支付IEC費用。

4.簽發IEC代碼。

標籤、展示和廣告不得聲稱保健品具有預防、治療、治愈人類疾病，或提及此類特性。

保健品標籤需要包含以下內容：

1. 保健品的通用名稱，或足以表明保健品真實性質的描述，包括產品特徵的營養素或物質類別的通用名稱。

2. 成分表：除單一配料食品外，應在標籤上註明成分表。

．產品中使用的成分名稱應按其成分按重量或體積的降序排列，視其製造時的情況而定。

．一種成分本身是兩種或兩種以上複合的，應標明其具體名稱並按比例 (m/m) 降序排列。

3. 對於作為混合物或組合銷售的食品，應在製造時按適當重量或體積成分（包括複合成分或成分類別）的進料百分比：

．通過文字、圖片或圖形在標籤上強調

4. 為消費者提供信息和使用服務建議的圖形。

5. 營養信息：應以克 (g) 或毫升 (ml) 為單位標示在份量旁邊。

．能量值（千卡）

．蛋白質 (g)

．碳水化合物 (g) 和總糖 (g)，添加糖 (g)

．總脂肪 (g)、飽和脂肪 (g)、反式脂肪（天然反式脂肪除外）(g) 和膽固醇（毫克）

．鈉 (mg)

．維生素和礦物質(公制單位)

6.  營養信息可以額外以條形碼/全球貿易識別號 (GTIN) 的形式提供，營養素的數量以印度醫學研究委員會規定的每日攝入量的百分比表示，並帶有警告：不要超過推薦的每日使用量。

7. 品牌所有者的名稱、完整地址，無論是否是製造商、營銷商、包裝商或裝瓶商，均應在標籤上註明。

8. 進口到印度的包裝應帶有印度進口商的名稱、完整地址。此外，如果在印度以外製造、在印度包裝或裝瓶，則裝有此類食品的包裝還應在標籤上標明原產國名稱、進口商名稱、完整地址，以及在印度進行包裝或裝瓶的場所。

9. FSSAI 標誌和許可證號。

． FSSAI 標誌和許可證編號應顯示在食品包裝的標籤上，與背景形成對比色。

．品牌所有者的 FSSAI 標誌和許可證號應顯示在標籤上。此外，製造商/銷售商/包裝商/裝瓶商的許可證號如果與品牌所有者不同，也應顯示在標籤上。

．對於進口保健品，進口商應展示 FSSAI 標誌、許可證號以及進口商的名稱和地址。

．每個食品經營者應在其所有儲存、加工、分發或銷售食品的場所展示註冊/許可證編號或食品安全展示板。

10. 淨數量、零售價格和消費者服務細節。

11. 製造或包裝日期、有效期/使用期限。

．對於保質期不超過 3 個月的產品，使用 DD/MM/YY 格式的日、月和年；保質期超過三個月的產品的月份和年份，應以未編碼的數字順序聲明，但月份應以大寫字母和縮寫（至少月份的前三個字母）表示。

．除保質期或使用期限外，食品儲存的任何特殊條件均應在標籤上註明，如果需要，還需要標示打開包裝後的儲存條件。

12. 關於食物過敏原的聲明。

13. 保健品字樣。

14. 醒目處標示：「非藥用」的警告。

15. 關於產品中存在的營養或具有營養/生理作用物質的含量聲明。

16. 保健品不能替代多樣化飲食的聲明。

17. 食用時應採取的警告或任何其他預防措施、已知的副作用（如果有）、禁忌症以及已發布的產品或藥物相互作用（如適用）。

18. 要求將產品存放在兒童接觸不到的地方的聲明等

注意：

1. 標籤上的內容應清晰、不含糊、醒目、顯眼、不可磨滅，使消費者在正常購買和使用條件下易於辨認。

2. 在不與規定相抵觸的前提下，可以在標籤上顯示任何書寫、印刷、圖形的信息或者圖形。

3. 在標籤上註明的聲明詳情應使用英語或梵文印地語。

4. 如果包裝帶有外部容器或包裝，並且該容器或包裝用於零售展示，則還應包含所有要求的聲明，除非該容器或包裝本身是透明的，並且很容易通過這種外部容器或包裝器讀取聲明。

5. 食品經營者不得在保健品配方中使用添加劑，但已規範的添加劑除外。

Food importers must be registered as food operators in the name of a local company in India, registered with the Directorate General of Foreign Trade and have a valid import and export code.

Registration process of food business operators:

1. Submit the application form and relevant documents to FSSAI.

URL:https://foscos.fssai.gov.in/

2. Issue the license within 60 days from the filing date.

3. Or if the application is incomplete, the licensing authority shall notify the applicant within 30 days of receipt of the notification to supplement or complete the application in writing (as the case may be). If the applicant fails to provide the required information within the prescribed 30-day period, the permit application will be rejected.

4. The registration is valid for 1-5 years, which is at the discretion of the food operator, and must apply for renewal when it expires.

Application documents

1. Owner/partner or an authorized signatory.

2. Blueprint/layout plan showing dimensions and operating area in m/m².

3. List of directors, complete with addresses and contact details.

4. Name and list of equipment and machinery, as well as number, installed capacity and horsepower used.

5. Photo ID, address proof issued by the owner/partner/director/authorized signatory’s government agency.

6. A list of the food categories that you wish to produce. (if manufacturer)

7. A letter of authorization from the manufacturer specifying the name and address of the person responsible.

8. Analytical report (chemical and bacteriological) of water used for food ingredients from an accredited/public health laboratory to confirm portability, noting the name of the laboratory authorized representative who collected the sample and date of sampling.

9. Proof of ownership of the home. (Deed of sale/rent agreement/electricity bill, etc.)

10. Partnership Deed/Affidavit/Memorandum and Articles of Association.

11. Food safety management system plan or certificate (if available)

12. Recall plan, including product distributor details.

13. An approved food safety management system certificate or program (the central licensing unit must be a certificate from an accredited body).

14. List of workers holding health certificates.

15. The name, qualifications and details of the technical personnel responsible for the operation.

16. Test food for relevant chemical and/or microbial contaminants by NABL/FSSA accredited laboratories to ensure food safety.

Form A

1. Type of business

． Permanent/temporary stall holder

． Hawker (mobile food supplier)

． Family canteen/dabba wallas

． Snack Bar/Small Retailer

． Manufacturer/Processing Plant

． Repacker

． Food stalls for religious gatherings, markets, etc.

． Milk Supplier

． Fish/Meat/Poultry Store/Seller

． Other (Explanation)

2. Applicant’s identity: Partner/Enterprise/Other (Explain)

3. Mailing address, telephone number, mobile number, fax number, email

4. Address of the area or location/premises where the food business is carried out

5. Description of the food product intended for manufacture or sale

6. Gross annual turnover of the food business (if any), and any supporting documents

7. Expected Start Date

8. If it is a seasonal business, please indicate the one-year opening and closing period

9. Source of water supply: public/private/any other source (description)

10. Is electricity used in the manufacture of food (if yes, please specify the electrical load used)

11. Payment: bill of exchange number/cash

Form B

1. Type of business (check if applicable):

． Manufacturing/processing, including sorting, grading, etc.

． Milk collection/refrigeration

． Slaughterhouse

． Solvent extraction device

． Solvent extraction equipment, equipped with oilseed prewash or oil pre-drain.

． Solvent extraction and refineries.

． Package

． Relabeled (manufactured by a third party based on their own packaging and labels)

． Import

． Warehouse/Warehouse/Cold Storage

． Retail trade

． Wholesale trade

． Distributor/Supplier

． Food carrier

． Food

． Other food vending establishments

． Club/Canteen

． Hotels

． Dining room

． Other (description)

2. Company/Organization Name:

3. Registered office:

4. The address of the business premises where the license is applied for

5. Name and/or title, qualifications and address of the technically qualified operational leader

6. Average amount of milk used/handled per day

7. Electric load used

8. Does the unit have an analytical laboratory?

9. Licenses granted by other laws

10. Payment: bill of exchange number/cash

11. Applicant/Authorized Signatory Signature

12. Declaration, signature and seal

Import/Export Code (IEC)

The IEC number is a 10-digit code issued by the Director General of External Trade to Indian companies. Every person or entity engaged in importing or exporting business must obtain IEC. It has a lifetime validity and takes about 15 days to issue.

1. Web registration: https://www.dgft.gov.in/CP/

．The nature of the company that obtains the IEC can be any of the following: Sole Proprietorship, Partnership, LLP, Limited Company, Trust, HU”. With the introduction of GST, the IEC number will be the same as the company’s PAN. The IEC will be issued separately by the DGFT.

2. Sign the statement.

3. Pay the IEC fee.

4. Issue the IEC code.

Labels, displays and advertisements must not claim that nutraceuticals prevent, treat, cure human disease, or refer to such properties.

Health product labels need to include the following:

1. The generic name of the health product, or a description sufficient to indicate the true nature of the health product, including the generic name of the nutrient or substance category characteristic of the product.

2. Ingredient list: Except for single-ingredient foods, the ingredient list should be stated on the label.

．The names of the ingredients used in the product should be listed in descending order of their ingredients by weight or volume, as they were made.

．An ingredient itself is a compound of two or more, and its specific names should be identified and listed in descending order of proportion (m/m).

3. For food products sold as mixtures or combinations, at the time of manufacture, at the time of manufacture, at the time of manufacture, at the appropriate weight or volume ingredients (including compound ingredients or ingredient categories) in percentages fed:

． Emphasize on labels through text, pictures or graphics

4. Graphics that provide consumers with information and recommendations for use of the service.

5. Nutritional Information: Should be indicated in grams (g) or milliliters (ml) next to serving size.

． Energy value (kcal)

．Protein (g)

．Carbohydrates (g) and total sugars (g), added sugars (g)

．Total Fat (g), Saturated Fat (g), Trans Fat (except Natural Trans Fat) (g) and Cholesterol (mg)

．Sodium (mg)

．Vitamins and Minerals (Metric Units)

6. Nutritional information can additionally be provided in the form of a barcode/Global Trade Identification Number (GTIN), the amount of the nutrient is expressed as a percentage of the Daily Intake as prescribed by the Indian Council of Medical Research, with a warning: Do not exceed the recommended daily intake Usage amount.

7. The name, full address of the brand owner, whether the manufacturer, marketer, packer, or bottler, should be stated on the label.

8. Packages imported into India should bear the name and full address of the Indian importer. In addition, if manufactured outside India, packed or bottled in India, the package containing such food shall also be labelled with the name of the country of origin, the name of the importer, the full address, and the name of the packaging or bottling in India. place.

9. FSSAI logo and license number.

．The FSSAI logo and license number shall be displayed on the label of the food package in a contrasting color against the background.

．The brand owner’s FSSAI logo and license number shall be displayed on the label. In addition, the license number of the manufacturer/seller/packer/bottler should also be shown on the label if it is different from the brand owner.

．For imported health products, the importer should display the FSSAI logo, license number, and the name and address of the importer.

．Each food business operator shall display registration/license numbers or food safety display boards at all of its premises where food is stored, processed, distributed or sold.

10. Net quantity, retail price and consumer service details.

11. Manufacture or packaging date, expiration date/use by date.

．For products with a shelf life of 3 months or less, use the day, month, and year in DD/MM/YY format; for products with a shelf life of more than three months, the month and year should be declared in uncoded numerical order, but the month should be in uppercase Letters and abbreviations (at least the first three letters of the month) are indicated.

．Any special conditions for food storage, other than shelf life or use-by date, should be indicated on the label and, if required, the storage conditions after opening the package.

12. Statement Regarding Food Allergens.

13. The wording of health care products.

14. Prominently marked: “Non-medicinal” warning.

15. Content claims about nutrients or substances with nutritional/physiological effects present in the product.

16. Claims that supplements are not a substitute for a varied diet.

17. Warnings or any other precautions to be taken when consumed, known side effects (if any), contraindications, and published product or drug interactions (if applicable).

18. Statements, etc., requiring products to be kept out of the reach of children

Notice:

1. The content on the label should be clear, unambiguous, conspicuous, conspicuous and indelible, so that it can be easily identified by consumers under normal purchase and use conditions.

2. Any written, printed, graphic information or graphics may be displayed on the label, provided that it does not contravene the regulations.

3. The declaration details stated on the label shall be in English or Sanskrit Hindi.

4. If the package has an outer container or packaging, and the container or packaging is for retail display, it shall also contain all required declarations, unless the container or packaging itself is transparent and can easily pass through such outer container or packaging Reader statement.

5. Food operators are not allowed to use additives in the formula of health products, except for those that have been standardized.

【參考連結】

https://www.fssai.gov.in/upload/uploadfiles/files/Licensing_Regulations.pdf

https://www.fssai.gov.in/cms/food-safety-and-standards-regulations.php

HLF-TW-45

HLF-TW-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？可允許的語文有哪些？？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? Which languages are allowed?Website?

Evershine RD：

食品進口商須以印度當地公司名義取得食品經營者登記，並在對外貿易總局進行註冊並擁有有效的進出口代碼。

食品經營者登記流程：

1. 向FSSAI提交申請表及相關文件。

網頁：https://foscos.fssai.gov.in/

2. 根據申請日起60 天內頒發許可證。

3. 或者如果申請不完整，許可當局應通知申請人 在收到通知後的 30 天內，以書面形式補充或完成申請（視情況而定）。 如果申請人未能在規定的 30 天期限內提供所需資料，許可申請將被駁回。

4. 註冊有效期為1-5年，由食品經營者自行決定，到期須申請更新。

申請文件

1. 由業主/合夥人或授權簽署人填妥並簽署（一式兩份）的申請表。

2. 藍圖/佈局計劃，以米/平方米為單位的尺寸和運營區域顯示。

3. 董事名單、附有完整地址和聯繫方式。

4. 設備和機器的名稱和清單，以及數量、裝機容量和使用的馬力。

5. 由業主/合夥人/董事/授權簽字人的政府機構簽發的帶照片的身份證、地址證明。

6. 希望生產的食品類別清單。（如果是製造商）

7. 製造商指定負責人姓名和地址的授權書。

8. 來自認可/公共衛生實驗室的用於食品成分的水的分析報告（化學和細菌學），以確認可攜帶性，並註明收集的實驗室授權代表的姓名樣品和取樣日期。

9. 擁有房屋的證明。 （銷售契據/租金協議/電費單等）

10. 合夥契約/宣誓書/備忘錄和公司章程。

11. 食品安全管理體系計劃或證書（如有）

12. 召回計劃，包括產品分銷商的詳細信息。

13. 已通過的食品安全管理體系證書或計劃（中央許可單位必須是認可機構的證書）。

14. 持有健康證明的工人名單。

15. 負責操作的技術人員的姓名、資格和詳細情況。

16. 通過NABL /FSSA 認可的實驗室對食品中的相關化學和/或微生物污染物進行測試，以確保食品安全。

表格A

1. 業務種類

．永久/臨時攤位持有人

．小販（流動食品供應商）

．家庭食堂/dabba wallas

．小吃店/小零售商

．製造商/加工廠

．重新打包商

．宗教聚會、集市等的食品攤位

．牛奶供應商

．魚/肉/家禽店/賣家

．其他(說明)

2. 申請人身份：合夥商/企業/其它(說明)

3. 通訊地址、電話號碼、手機號碼、傳真號碼、電子郵件

4. 開展食品業務的區域或地點/場所地址

5. 擬製造或銷售的食品描述

6. 食品企業的年總營業額（如果有），以及任何證明文件

7. 預計開始日期

8. 如屬季節性業務，請註明一年的開閉期

9. 供水來源：公共/私人/任何其他來源(說明)

10. 製造食品時是否使用電力(如果是，請說明使用的電力負載)

11. 繳費：匯票編號/現金

表格B

1.業務種類（如適用可複選）：

．製造/加工，包括分類、分級等。

．牛奶收集/冷藏

．屠宰場

．溶劑萃取裝置

．溶劑萃取設備，配備油籽預清洗或油預排。

．溶劑提取和煉油廠。

．包裝

．重新貼標籤（由第三方根據自己的包裝和標籤製造）

．導入

．倉儲/倉庫/冷庫

．零售貿易

．批發貿易

．分銷商/供應商

．食物運輸者

．餐飲

．其他食品自動售貨機構

．俱樂部/食堂

．酒店

．餐廳

．其他(說明)

2. 公司/機構名稱：

3. 註冊辦公地址：

4. 申請執照的經營場所地址

5. 具有技術資格的運營負責人的姓名和/或職務、資格和地址

6. 每天平均使用/處理的牛奶數量

7. 使用的電力負載

8. 單位是否配備分析實驗室

9. 其他法律授予的許可證

10. 繳費：匯票編號/現金

11. 申請人/授權簽字人簽字

12. 聲明書、簽章

進出口代碼 (IEC)

IEC 編號是對外貿易總幹事頒發給印度公司的10位數代碼。每個從事進出口業務的個人或實體都必須獲得 IEC。 它具有終身有效期，大約需要 15 天才能簽發。

1.網頁註冊：https://www.dgft.gov.in/CP/

．獲得 IEC 的公司的性質可以是以下任何一種：獨資企業、合夥企業、有限責任合夥企業、有限公司、信託、HU”。引入 GST 後，IEC 編號與公司的 PAN 相同。IEC 將由 DGFT 單獨發布。

2.簽署聲明。

3.支付IEC費用。

4.簽發IEC代碼。

標籤、展示和廣告不得聲稱保健品具有預防、治療、治愈人類疾病，或提及此類特性。

保健品標籤需要包含以下內容：

1. 保健品的通用名稱，或足以表明保健品真實性質的描述，包括產品特徵的營養素或物質類別的通用名稱。

2. 成分表：除單一配料食品外，應在標籤上註明成分表。

．產品中使用的成分名稱應按其成分按重量或體積的降序排列，視其製造時的情況而定。

．一種成分本身是兩種或兩種以上複合的，應標明其具體名稱並按比例 (m/m) 降序排列。

3. 對於作為混合物或組合銷售的食品，應在製造時按適當重量或體積成分（包括複合成分或成分類別）的進料百分比：

．通過文字、圖片或圖形在標籤上強調

4. 為消費者提供信息和使用服務建議的圖形。

5. 營養信息：應以克 (g) 或毫升 (ml) 為單位標示在份量旁邊。

．能量值（千卡）

．蛋白質 (g)

．碳水化合物 (g) 和總糖 (g)，添加糖 (g)

．總脂肪 (g)、飽和脂肪 (g)、反式脂肪（天然反式脂肪除外）(g) 和膽固醇（毫克）

．鈉 (mg)

．維生素和礦物質(公制單位)

6.  營養信息可以額外以條形碼/全球貿易識別號 (GTIN) 的形式提供，營養素的數量以印度醫學研究委員會規定的每日攝入量的百分比表示，並帶有警告：不要超過推薦的每日使用量。

7. 品牌所有者的名稱、完整地址，無論是否是製造商、營銷商、包裝商或裝瓶商，均應在標籤上註明。

8. 進口到印度的包裝應帶有印度進口商的名稱、完整地址。此外，如果在印度以外製造、在印度包裝或裝瓶，則裝有此類食品的包裝還應在標籤上標明原產國名稱、進口商名稱、完整地址，以及在印度進行包裝或裝瓶的場所。

9. FSSAI 標誌和許可證號。

． FSSAI 標誌和許可證編號應顯示在食品包裝的標籤上，與背景形成對比色。

．品牌所有者的 FSSAI 標誌和許可證號應顯示在標籤上。此外，製造商/銷售商/包裝商/裝瓶商的許可證號如果與品牌所有者不同，也應顯示在標籤上。

．對於進口保健品，進口商應展示 FSSAI 標誌、許可證號以及進口商的名稱和地址。

．每個食品經營者應在其所有儲存、加工、分發或銷售食品的場所展示註冊/許可證編號或食品安全展示板。

10. 淨數量、零售價格和消費者服務細節。

11. 製造或包裝日期、有效期/使用期限。

．對於保質期不超過 3 個月的產品，使用 DD/MM/YY 格式的日、月和年；保質期超過三個月的產品的月份和年份，應以未編碼的數字順序聲明，但月份應以大寫字母和縮寫（至少月份的前三個字母）表示。

．除保質期或使用期限外，食品儲存的任何特殊條件均應在標籤上註明，如果需要，還需要標示打開包裝後的儲存條件。

12. 關於食物過敏原的聲明。

13. 保健品字樣。

14. 醒目處標示：「非藥用」的警告。

15. 關於產品中存在的營養或具有營養/生理作用物質的含量聲明。

16. 保健品不能替代多樣化飲食的聲明。

17. 食用時應採取的警告或任何其他預防措施、已知的副作用（如果有）、禁忌症以及已發布的產品或藥物相互作用（如適用）。

18. 要求將產品存放在兒童接觸不到的地方的聲明等

注意：

1. 標籤上的內容應清晰、不含糊、醒目、顯眼、不可磨滅，使消費者在正常購買和使用條件下易於辨認。

2. 在不與規定相抵觸的前提下，可以在標籤上顯示任何書寫、印刷、圖形的信息或者圖形。

3. 在標籤上註明的聲明詳情應使用英語或梵文印地語。

4. 如果包裝帶有外部容器或包裝，並且該容器或包裝用於零售展示，則還應包含所有要求的聲明，除非該容器或包裝本身是透明的，並且很容易通過這種外部容器或包裝器讀取聲明。

5. 食品經營者不得在保健品配方中使用添加劑，但已規範的添加劑除外。

Food importers must be registered as food operators in the name of a local company in India, registered with the Directorate General of Foreign Trade and have a valid import and export code.

Registration process of food business operators:

1. Submit the application form and relevant documents to FSSAI.

URL:https://foscos.fssai.gov.in/

2. Issue the license within 60 days from the filing date.

3. Or if the application is incomplete, the licensing authority shall notify the applicant within 30 days of receipt of the notification to supplement or complete the application in writing (as the case may be). If the applicant fails to provide the required information within the prescribed 30-day period, the permit application will be rejected.

4. The registration is valid for 1-5 years, which is at the discretion of the food operator, and must apply for renewal when it expires.

Application documents

1. Owner/partner or an authorized signatory.

2. Blueprint/layout plan showing dimensions and operating area in m/m².

3. List of directors, complete with addresses and contact details.

4. Name and list of equipment and machinery, as well as number, installed capacity and horsepower used.

5. Photo ID, address proof issued by the owner/partner/director/authorized signatory’s government agency.

6. A list of the food categories that you wish to produce. (if manufacturer)

7. A letter of authorization from the manufacturer specifying the name and address of the person responsible.

8. Analytical report (chemical and bacteriological) of water used for food ingredients from an accredited/public health laboratory to confirm portability, noting the name of the laboratory authorized representative who collected the sample and date of sampling.

9. Proof of ownership of the home. (Deed of sale/rent agreement/electricity bill, etc.)

10. Partnership Deed/Affidavit/Memorandum and Articles of Association.

11. Food safety management system plan or certificate (if available)

12. Recall plan, including product distributor details.

13. An approved food safety management system certificate or program (the central licensing unit must be a certificate from an accredited body).

14. List of workers holding health certificates.

15. The name, qualifications and details of the technical personnel responsible for the operation.

16. Test food for relevant chemical and/or microbial contaminants by NABL/FSSA accredited laboratories to ensure food safety.

Form A

1. Type of business

． Permanent/temporary stall holder

． Hawker (mobile food supplier)

． Family canteen/dabba wallas

． Snack Bar/Small Retailer

． Manufacturer/Processing Plant

． Repacker

． Food stalls for religious gatherings, markets, etc.

． Milk Supplier

． Fish/Meat/Poultry Store/Seller

． Other (Explanation)

2. Applicant’s identity: Partner/Enterprise/Other (Explain)

3. Mailing address, telephone number, mobile number, fax number, email

4. Address of the area or location/premises where the food business is carried out

5. Description of the food product intended for manufacture or sale

6. Gross annual turnover of the food business (if any), and any supporting documents

7. Expected Start Date

8. If it is a seasonal business, please indicate the one-year opening and closing period

9. Source of water supply: public/private/any other source (description)

10. Is electricity used in the manufacture of food (if yes, please specify the electrical load used)

11. Payment: bill of exchange number/cash

Form B

1. Type of business (check if applicable):

． Manufacturing/processing, including sorting, grading, etc.

． Milk collection/refrigeration

． Slaughterhouse

． Solvent extraction device

． Solvent extraction equipment, equipped with oilseed prewash or oil pre-drain.

． Solvent extraction and refineries.

． Package

． Relabeled (manufactured by a third party based on their own packaging and labels)

． Import

． Warehouse/Warehouse/Cold Storage

． Retail trade

． Wholesale trade

． Distributor/Supplier

． Food carrier

． Food

． Other food vending establishments

． Club/Canteen

． Hotels

． Dining room

． Other (description)

2. Company/Organization Name:

3. Registered office:

4. The address of the business premises where the license is applied for

5. Name and/or title, qualifications and address of the technically qualified operational leader

6. Average amount of milk used/handled per day

7. Electric load used

8. Does the unit have an analytical laboratory?

9. Licenses granted by other laws

10. Payment: bill of exchange number/cash

11. Applicant/Authorized Signatory Signature

12. Declaration, signature and seal

Import/Export Code (IEC)

The IEC number is a 10-digit code issued by the Director General of External Trade to Indian companies. Every person or entity engaged in importing or exporting business must obtain IEC. It has a lifetime validity and takes about 15 days to issue.

1. Web registration: https://www.dgft.gov.in/CP/

．The nature of the company that obtains the IEC can be any of the following: Sole Proprietorship, Partnership, LLP, Limited Company, Trust, HU”. With the introduction of GST, the IEC number will be the same as the company’s PAN. The IEC will be issued separately by the DGFT.

2. Sign the statement.

3. Pay the IEC fee.

4. Issue the IEC code.

Labels, displays and advertisements must not claim that nutraceuticals prevent, treat, cure human disease, or refer to such properties.

Health product labels need to include the following:

1. The generic name of the health product, or a description sufficient to indicate the true nature of the health product, including the generic name of the nutrient or substance category characteristic of the product.

2. Ingredient list: Except for single-ingredient foods, the ingredient list should be stated on the label.

．The names of the ingredients used in the product should be listed in descending order of their ingredients by weight or volume, as they were made.

．An ingredient itself is a compound of two or more, and its specific names should be identified and listed in descending order of proportion (m/m).

3. For food products sold as mixtures or combinations, at the time of manufacture, at the time of manufacture, at the time of manufacture, at the appropriate weight or volume ingredients (including compound ingredients or ingredient categories) in percentages fed:

． Emphasize on labels through text, pictures or graphics

4. Graphics that provide consumers with information and recommendations for use of the service.

5. Nutritional Information: Should be indicated in grams (g) or milliliters (ml) next to serving size.

． Energy value (kcal)

．Protein (g)

．Carbohydrates (g) and total sugars (g), added sugars (g)

．Total Fat (g), Saturated Fat (g), Trans Fat (except Natural Trans Fat) (g) and Cholesterol (mg)

．Sodium (mg)

．Vitamins and Minerals (Metric Units)

6. Nutritional information can additionally be provided in the form of a barcode/Global Trade Identification Number (GTIN), the amount of the nutrient is expressed as a percentage of the Daily Intake as prescribed by the Indian Council of Medical Research, with a warning: Do not exceed the recommended daily intake Usage amount.

7. The name, full address of the brand owner, whether the manufacturer, marketer, packer, or bottler, should be stated on the label.

8. Packages imported into India should bear the name and full address of the Indian importer. In addition, if manufactured outside India, packed or bottled in India, the package containing such food shall also be labelled with the name of the country of origin, the name of the importer, the full address, and the name of the packaging or bottling in India. place.

9. FSSAI logo and license number.

．The FSSAI logo and license number shall be displayed on the label of the food package in a contrasting color against the background.

．The brand owner’s FSSAI logo and license number shall be displayed on the label. In addition, the license number of the manufacturer/seller/packer/bottler should also be shown on the label if it is different from the brand owner.

．For imported health products, the importer should display the FSSAI logo, license number, and the name and address of the importer.

．Each food business operator shall display registration/license numbers or food safety display boards at all of its premises where food is stored, processed, distributed or sold.

10. Net quantity, retail price and consumer service details.

11. Manufacture or packaging date, expiration date/use by date.

．For products with a shelf life of 3 months or less, use the day, month, and year in DD/MM/YY format; for products with a shelf life of more than three months, the month and year should be declared in uncoded numerical order, but the month should be in uppercase Letters and abbreviations (at least the first three letters of the month) are indicated.

．Any special conditions for food storage, other than shelf life or use-by date, should be indicated on the label and, if required, the storage conditions after opening the package.

12. Statement Regarding Food Allergens.

13. The wording of health care products.

14. Prominently marked: “Non-medicinal” warning.

15. Content claims about nutrients or substances with nutritional/physiological effects present in the product.

16. Claims that supplements are not a substitute for a varied diet.

17. Warnings or any other precautions to be taken when consumed, known side effects (if any), contraindications, and published product or drug interactions (if applicable).

18. Statements, etc., requiring products to be kept out of the reach of children

Notice:

1. The content on the label should be clear, unambiguous, conspicuous, conspicuous and indelible, so that it can be easily identified by consumers under normal purchase and use conditions.

2. Any written, printed, graphic information or graphics may be displayed on the label, provided that it does not contravene the regulations.

3. The declaration details stated on the label shall be in English or Sanskrit Hindi.

4. If the package has an outer container or packaging, and the container or packaging is for retail display, it shall also contain all required declarations, unless the container or packaging itself is transparent and can easily pass through such outer container or packaging Reader statement.

5. Food operators are not allowed to use additives in the formula of health products, except for those that have been standardized.

【參考連結】

https://www.fssai.gov.in/upload/uploadfiles/files/Licensing_Regulations.pdf

https://www.fssai.gov.in/cms/food-safety-and-standards-regulations.php

HLF-TW-55

HLF-TW-60
經過核准登記的保健食品，進口到印度要檢附什麼文件？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 India? What is the procedure?
Any preparation is required to submit to the Ministry of Health and Welfare for selling products? Website?

Evershine RD：

進口流程

1.於印度海關電子網關 (ICEGATE)註冊會員

印度海關電子網關 (ICEGATE) 是印度海關中央間接稅和海關委員會 (CBIC) 的國家門戶，以電子方式向貿易、貨運承運人和其他貿易夥伴提供電子申報服務。網頁：https://www.icegate.gov.in/index.html

．申請人

．公司名稱

．地址

．城市

．密碼

．電話、傳真號碼、電子信箱

．類別：進口商/出口商等

．清關位置

．內容、發貨地、收貨地

．貨物的詳情、貨物登記

．商業發票

．合約

．提單

．成分分析報告(需提供翻譯文件)

．標籤樣本(需提供翻譯文件)

．灌裝日期

．收方公司IEC Code

．收貨人個人證件影本(PAN：永久帳戶號/TAN：收稅及減稅帳號/身份證/護照)

．通過電子現金分類賬支付和電子稅收信用分類。

2. 風險管理系統 (RMS) 將審查申請以及是否需要抽樣，並將資料轉發給印度食品安全和標準局食品進口清關系統(FICS)。

3. 進口商需要在FSSAI設立的食品進口清關系統 FICS上註冊：

網頁：www.ics.fssai.gov.in

4. 如果提供了所有相關信息，授權人員 (A.O) 會安排對貨物進行檢查的預約（僅向 CHA/進口商提供兩次確認預約的機會）。

5. 經檢查，如果一切都符合要求(括貨物的標籤和包裝要求)抽取樣品*2 個，每個樣品 5000盧比，如果不符合要求，授權人員將拒絕該貨物並出具不合格報告。

6. 授權人員將樣品送至 FSSAI 指定NABL 認可實驗室，如果發現樣品符合，則生成無異議證書 (NOC)，如果不符合，則生成不合格報告 (NCR)，拒絕食品貨物清關。

7. 如果進口商對實驗室報告的結果不同意，可以向指定實驗室申請重新檢測。

8. 進口商取得實驗室分析報告，並獲得授權官員的無異議證書 (NOC)清關後才能銷售。(准許進口食品的無異議證書收到食品進口商須從關區帶出食品的無異議證明之日起30日內有效，食品進口商應採取有效措施，在授權官員出具的無異議證書規定的有效期內，將食品從海關區域放行，否則視為未清關的食品。)

9.如果不合格，應根據實驗室分析的不合格報告確認，微生物的污染或存在可能對公眾健康構成重大風險需要銷毀該樣食品。

10. 送實驗室分析的樣品標籤封樣，應當載有下列信息：

．樣品編號

．收集日期和地點

．樣品數量

．聲明

．抽取樣品時添加的防腐劑的名稱和數量（如有）

．食品進口商或其海關代理的姓名和簽名

．寄件人姓名及簽名，加蓋公章

．一份密封並貼上標籤的食品樣品應送至指定實驗室。第二份食品樣品應儲存在適當的條件下，以便在需要時重新測試。

Import process

1. Register as a member in India Customs Electronic Gateway (ICEGATE)

The Indian Customs Electronic Gateway (ICEGATE) is the national portal of the Central Indirect Tax and Customs Board (CBIC) of Customs of India, providing electronic declaration services to trades, freight carriers and other trading partners electronically.

URL: https://www.icegate.gov.in/index.html

．Applicant

．Company Name

．Address

．City

．Password

．Telephone, fax number, e-mail

．Category: Importer/Exporter etc.

．Customs clearance location

．Contents, place of origin, place of receipt

．Details of cargo, cargo registration

．Commercial invoice

．Contract

．B/L

．Composition analysis report (translation documents are required)

．Label sample (translation file required)

．Filling date

．Receiving company IEC Code

．Photocopy of the consignee’s personal certificate (PAN: Permanent Account Number/TAN: Tax and Tax Reduction Account Number/ID Card/Passport)

．Payment via electronic cash ledger and electronic tax credit sorting.

2. The Risk Management System (RMS) will review the application and if sampling is required and forward the information to the Food Safety and Standards Authority of India Food Import Clearance System (FICS).

3. Importers need to register on FICS, the food import clearance system established by FSSAI:

URL: www.ics.fssai.gov.in

4. If all relevant information is provided, the Authorized Personnel (A.O) will schedule an appointment to inspect the shipment (only 2 chances to confirm the appointment are given to the CHA/Importer).

5. After inspection, if everything meets the requirements (including the labelling and packaging requirements of the goods), take samples*2, each sample is 5000 rupees, if it does not meet the requirements, the authorized person will reject the goods and issue a non-conformity report.

6. Authorized personnel send the samples to the FSSAI-designated NABL-accredited laboratory, and if the samples are found to be compliant, a No Objection Certificate (NOC) will be generated, if not, a Non-Conformity Report (NCR) will be generated to reject the food shipments for customs clearance.

7. If the importer does not agree with the results reported by the laboratory, he can apply to the designated laboratory for re-testing.

8. The importer obtains the laboratory analysis report and obtains the No Objection Certificate (NOC) from the authorized official before it can be sold. (The no-objection certificate for the permission to import food is valid within 30 days from the date of receipt of the no-objection certificate that the food importer must bring out the food from the customs area. The food importer should take effective measures to ensure the validity period specified in the no-objection certificate issued by the authorized official. inside, release the food from the customs area, otherwise it will be regarded as uncleared food.)

9. If unqualified, it should be confirmed according to the unqualified report of laboratory analysis that the contamination or existence of microorganisms may pose a significant risk to public health and the food should be destroyed.

10. The label seal of samples sent for laboratory analysis shall contain the following information:

．Sample serial number

．Collection date and place

．Number of samples

．Statement

．Name and amount (if any) of preservatives added when the sample was drawn

．Name and signature of the food importer or its customs agent

．Sender’s name and signature, stamped with official seal

．A sealed and labeled food sample should be sent to the designated laboratory. The second food sample should be stored under appropriate conditions for retesting if required.

【參考連結】

https://fics.fssai.gov.in/pdf/FAQs_Import.pdf

https://www.fssai.gov.in/upload/uploadfiles/files/Food_Import_Regulations.pdf

HLF-TW-70
印度保健食品審核機構，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：

實驗室檢查須包含：

1. 樣本描述

2. 物理外觀

3. 標籤

4. 質量特性

5. 保健品成品檢測

．卡路里

．總脂肪

．飽和脂肪

．膽固醇

．鈉

．總碳水化合物

．膳食纖維

．醣類

．蛋白質

．維生素A

．維生素C

．鈣等

6. 微生物檢測

．食品衛生

．食源性病原體，如：大腸桿菌、沙門氏菌、酵母和黴菌、空腸彎曲桿菌、產氣莢膜梭菌、李斯特菌、志賀氏菌、金黃色葡萄球菌、霍亂弧菌、副溶血性弧菌、創傷弧菌、小腸結腸炎耶爾森菌等

7. 抗氧化劑

8.重金屬

9. 酒精含量

10. 三聚氰胺等

Laboratory tests must include:

1. Sample description

2. Physical appearance

3. Labels

4. Quality characteristics

5. Inspection of finished health products

．Calories

．Total fat

．Saturated fat

．Cholesterol

．Na

．Total carbohydrates

．Dietary fiber

．Carbohydrates

．Protein

．Vitamin A

．Vitamin C

．Calcium, etc.

6. Microbiological testing

．Food sanitation

．Foodborne pathogens such as: Escherichia coli, Salmonella, Yeasts and Molds, Campylobacter jejuni, Clostridium perfringens, Listeria, Shigella, Staphylococcus aureus, Vibrio cholerae, Vibrio parahaemolyticus, Vibrio vulnificus, Yersinia enterocolitica, etc.

7. Antioxidants

8. Heavy Metals

9. Alcohol content

10. Melamine etc

【參考連結】

https://www.fssai.gov.in/upload/uploadfiles/files/Lab_Sample_Regulations.pdf

HLF-TW-75

HLF-TW-77

HLF-TW-80
外國子公司進口保健食品後，如果委託印度的經銷商銷售，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 India 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，須以印度當地公司名義取得食品經營者登記。

在印度，保健品屬於食品，所有食品經營者都須按照規定程序進行登記。

責任

每個食品經營者應遵循食品召回程序，包括完整的召回流程、召回後報告和後續行動，以確保召回的有效性並防止再次發生，印度食品安全和標準局的首席執行官或邦或聯邦領土的食品安全專員或兩者都可以指示食品經營者啟動召回程序。

如果任何利益相關者向食品經營者報告或投訴，並且食品經營者確定有召回的需要，也應啟動召回過程。如果食品經營者未對投訴作出回應，投訴人或消費者可以通知印度食品安全和標準局的首席執行官或州或聯邦領土的食品安全專員或兩者，他們將採取措施確定召回的必要性，並就召回事宜向有關食品經營者提出要求，有關食品經營者應受其約束。

A registration of food operator in the name of a local Indian company is required.

In India, health products are classified as food, and all food operators are required to follow the prescribed procedures for registration.

Responsibility

Every food operator should follow food recall procedures including full recall process, post-recall reporting and follow-up to ensure the effectiveness of the recall and prevent its recurrence, Chief Executive Officer, Food Safety and Standards Authority of India or state or federal territory The Food Safety Commissioner, or both, may direct food operators to initiate recall procedures.

The recall process should also be initiated if any stakeholder reports or complains to the food operator and the food operator determines that a recall is required. If the food operator fails to respond to the complaint, the complainant or the consumer may notify the Chief Executive Officer of the Food Safety and Standards Authority of India or the Food Safety Commissioner of a State or Union Territory or both and they will take steps to determine the necessity of a recall, And put forward a request to the relevant food operators on the recall, and the relevant food operators should be bound by it.

【參考連結】

https://www.fssai.gov.in/upload/uploadfiles/files/Licensing_Regulations.pdf

https://www.fssai.gov.in/upload/uploadfiles/files/Food_Recall_Regulations.pdf

HLF-TW-85

各國健康食品登記法規問題集

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