印度保健食品登记法规问题集

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各国健康食品登记法规问题集

HLF-TW-10
请问印度对于保健食品的归类方式为何？它的正式名称为何？不同归类管理强度有何差异?它的政府管辖机构为何？网页？

What are the categories of health food in 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标准局(FSSAI)负责监管，上市前需在FSSAI完成註册，确定该产品符合规定要求，且标籤应符合规范，不合格产品按照程序进行召回。

保健品定义为，用于补充5岁以上的人士的正常食品。保健品应含有一种或多种营养素的浓缩来源，即氨基酸、酶、矿物质、蛋白质、维生素、其他膳食物质、植物或植物药、益生元、益生菌和动物源性物质或其他类似物质，单独或组合提供已知、确定营养有益于生理作用。应以一次性包装销售，以保持产品的完整性和质量，或以胶囊、片剂、丸剂、小袋等剂型销售；或以果冻或凝胶、半固体和其他类似形式的液体和粉末计量。

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.

【参考连结】

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
外国公司要到印度销售保健食品，无论设100%子公司或分公司，需要在公司登记时取得营业特许证？
假如要，其必要条件是什麽？所需文件及申请程序为何？网页？

If a foreign company wants to sell health food in 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，须以印度当地公司名义取得食品经营者登记。
在印度，保健品属于食品，所有食品经营者都须按照规定程序进行登记。流程：

1. 向FSSAI提交申请表及相关文件。

网页：https://foscos.fssai.gov.in/

2. 根据申请日起60 天内颁发许可证。

3. 或者如果申请不完整，许可当局应通知申请人 在收到通知后的 30 天内，以书面形式补充或完成申请（视情况而定）。 如果申请人未能在规定的 30 天期限内提供所需资料，许可申请将被驳回。

4. 註册有效期为1-5年，由食品经营者自行决定，到期须申请更新。

申请文件

1. 由业主/合伙人或授权签署人填妥并签署（一式两份）的申请表。

2. 蓝图/佈局计划，以米/平方米为单位的尺寸和运营区域显示。

3. 董事名单、附有完整地址和联繫方式。

4. 设备和机器的名称和清单，以及数量、装机容量和使用的马力。

5. 由业主/合伙人/董事/授权签字人的政府机构签发的带照片的身份证、地址证明。

6. 希望生产的食品类别清单。（如果是製造商）

7. 製造商指定负责人姓名和地址的授权书。

8. 来自认可/公共卫生实验室的用于食品成分的水的分析报告（化学和细菌学），以确认可携带性，并註明收集的实验室授权代表的姓名样品和取样日期。

9. 拥有房屋的证明。 （销售契据/租金协议/电费单等）

10. 合伙契约/宣誓书/备忘录和公司章程。

11. 食品安全管理体系计划或证书（如有）

12. 召回计划，包括产品分销商的详细信息。

13. 已通过的食品安全管理体系证书或计划（中央许可单位必须是认可机构的证书）。

14. 持有健康证明的工人名单。

15. 负责操作的技术人员的姓名、资格和详细情况。

16. 通过NABL /FSSA 认可的实验室对食品中的相关化学和/或微生物汙染物进行测试，以确保食品安全。

表格A

1. 业务种类

．永久/临时摊位持有人

．小贩（流动食品供应商）

．家庭食堂/dabba wallas

．小吃店/小零售商

．製造商/加工厂

．重新打包商

．宗教聚会、集市等的食品摊位

．牛奶供应商

．鱼/肉/家禽店/卖家

．其他(说明)

2. 申请人身份：合伙商/企业/其它(说明)

3. 通讯地址、电话号码、手机号码、传真号码、电子邮件

4. 开展食品业务的区域或地点/场所地址

5. 拟製造或销售的食品描述

6. 食品企业的年总营业额（如果有），以及任何证明文件

7. 预计开始日期

8. 如属季节性业务，请註明一年的开闭期

9. 供水来源：公共/私人/任何其他来源(说明)

10. 製造食品时是否使用电力(如果是，请说明使用的电力负载)

11. 缴费：汇票编号/现金

表格B

1.业务种类（如适用可複选）：

．製造/加工，包括分类、分级等。

．牛奶收集/冷藏

．屠宰场

．溶剂萃取装置

．溶剂萃取设备，配备油籽预清洗或油预排。

．溶剂提取和炼油厂。

．包装

．重新贴标籤（由第三方根据自己的包装和标籤製造）

．导入

．仓储/仓库/冷库

．零售贸易

．批发贸易

．分销商/供应商

．食物运输者

．餐饮

．其他食品自动售货机构

．俱乐部/食堂

．酒店

．餐厅

．其他(说明)

2. 公司/机构名称：

3. 註册办公地址：

4. 申请执照的经营场所地址

5. 具有技术资格的运营负责人的姓名和/或职务、资格和地址

6. 每天平均使用/处理的牛奶数量

7. 使用的电力负载

8. 单位是否配备分析实验室

9. 其他法律授予的许可证

10. 缴费：汇票编号/现金

11. 申请人/授权签字人签字

12. 声明书、签章

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

【参考连结】

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

HLF-TW-25

HLF-TW-30
外国公司要到印度销售保健食品，可以指派印度公司担任营业代理人销售吗? 担任营业代理人，其必要条件是什麽？所需文件及申请程序为何？外国公司与营业代理人的产品责任为何?网页？

If a foreign company wants to sell health food in 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，须以印度当地公司名义取得食品经营者登记。

在印度，保健品属于食品，所有食品经营者都须按照规定程序进行登记。流程：

1. 向FSSAI提交申请表及相关文件。

网页：https://foscos.fssai.gov.in/

2. 根据申请日起60 天内颁发许可证。

3. 或者如果申请不完整，许可当局应通知申请人 在收到通知后的 30 天内，以书面形式补充或完成申请（视情况而定）。 如果申请人未能在规定的 30 天期限内提供所需资料，许可申请将被驳回。

4. 註册有效期为1-5年，由食品经营者自行决定，到期须申请更新。

申请文件

1. 由业主/合伙人或授权签署人填妥并签署（一式两份）的申请表。

2. 蓝图/佈局计划，以米/平方米为单位的尺寸和运营区域显示。

3. 董事名单、附有完整地址和联繫方式。

4. 设备和机器的名称和清单，以及数量、装机容量和使用的马力。

5. 由业主/合伙人/董事/授权签字人的政府机构签发的带照片的身份证、地址证明。

6. 希望生产的食品类别清单。（如果是製造商）

7. 製造商指定负责人姓名和地址的授权书。

8. 来自认可/公共卫生实验室的用于食品成分的水的分析报告（化学和细菌学），以确认可携带性，并註明收集的实验室授权代表的姓名样品和取样日期。

9. 拥有房屋的证明。 （销售契据/租金协议/电费单等）

10. 合伙契约/宣誓书/备忘录和公司章程。

11. 食品安全管理体系计划或证书（如有）

12. 召回计划，包括产品分销商的详细信息。

13. 已通过的食品安全管理体系证书或计划（中央许可单位必须是认可机构的证书）。

14. 持有健康证明的工人名单。

15. 负责操作的技术人员的姓名、资格和详细情况。

16. 通过NABL /FSSA 认可的实验室对食品中的相关化学和/或微生物汙染物进行测试，以确保食品安全。

表格A

1. 业务种类

．永久/临时摊位持有人

．小贩（流动食品供应商）

．家庭食堂/dabba wallas

．小吃店/小零售商

．製造商/加工厂

．重新打包商

．宗教聚会、集市等的食品摊位

．牛奶供应商

．鱼/肉/家禽店/卖家

．其他(说明)

2. 申请人身份：合伙商/企业/其它(说明)

3. 通讯地址、电话号码、手机号码、传真号码、电子邮件

4. 开展食品业务的区域或地点/场所地址

5. 拟製造或销售的食品描述

6. 食品企业的年总营业额（如果有），以及任何证明文件

7. 预计开始日期

8. 如属季节性业务，请註明一年的开闭期

9. 供水来源：公共/私人/任何其他来源(说明)

10. 製造食品时是否使用电力(如果是，请说明使用的电力负载)

11. 缴费：汇票编号/现金

表格B

1.业务种类（如适用可複选）：

．製造/加工，包括分类、分级等。

．牛奶收集/冷藏

．屠宰场

．溶剂萃取装置

．溶剂萃取设备，配备油籽预清洗或油预排。

．溶剂提取和炼油厂。

．包装

．重新贴标籤（由第三方根据自己的包装和标籤製造）

．导入

．仓储/仓库/冷库

．零售贸易

．批发贸易

．分销商/供应商

．食物运输者

．餐饮

．其他食品自动售货机构

．俱乐部/食堂

．酒店

．餐厅

．其他(说明)

2. 公司/机构名称：

3. 註册办公地址：

4. 申请执照的经营场所地址

5. 具有技术资格的运营负责人的姓名和/或职务、资格和地址

6. 每天平均使用/处理的牛奶数量

7. 使用的电力负载

8. 单位是否配备分析实验室

9. 其他法律授予的许可证

10. 缴费：汇票编号/现金

11. 申请人/授权签字人签字

12. 声明书、签章

责任

每个食品经营者应遵循食品召回程序，包括完整的召回流程、召回后报告和后续行动，以确保召回的有效性并防止再次发生，印度食品安全和标准局的首席执行官或邦或联邦领土的食品安全专员或两者都可以指示食品经营者启动召回程序。

如果任何利益相关者向食品经营者报告或投诉，并且食品经营者确定有召回的需要，也应启动召回过程。
如果食品经营者未对投诉作出回应，投诉人或消费者可以通知印度食品安全和标准局的首席执行官或州或联邦领土的食品安全专员或两者，他们将採取措施确定召回的必要性，并就召回事宜向有关食品经营者提出要求，有关食品经营者应受其约束。

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.

【参考连结】

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
外国公司销售到印度保健食品本身，进口前需要办理产品许可吗？
如需要，哪个单位在管理？需要什麽文件？申请程序为何？
保健食品包装内容及各种标示，需要事先核准吗？可允许的语文有哪些？网页？

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，食品进口商须以印度当地公司名义取得食品经营者登记，并在对外贸易总局进行註册并拥有有效的进出口代码。

食品经营者登记流程：

1. 向FSSAI提交申请表及相关文件。

网页：https://foscos.fssai.gov.in/

2. 根据申请日起60 天内颁发许可证。

3. 或者如果申请不完整，许可当局应通知申请人 在收到通知后的 30 天内，以书面形式补充或完成申请（视情况而定）。 如果申请人未能在规定的 30 天期限内提供所需资料，许可申请将被驳回。

4. 註册有效期为1-5年，由食品经营者自行决定，到期须申请更新。

申请文件

1. 由业主/合伙人或授权签署人填妥并签署（一式两份）的申请表。

2. 蓝图/佈局计划，以米/平方米为单位的尺寸和运营区域显示。

3. 董事名单、附有完整地址和联繫方式。

4. 设备和机器的名称和清单，以及数量、装机容量和使用的马力。

5. 由业主/合伙人/董事/授权签字人的政府机构签发的带照片的身份证、地址证明。

6. 希望生产的食品类别清单。（如果是製造商）

7. 製造商指定负责人姓名和地址的授权书。

8. 来自认可/公共卫生实验室的用于食品成分的水的分析报告（化学和细菌学），以确认可携带性，并註明收集的实验室授权代表的姓名样品和取样日期。

9. 拥有房屋的证明。 （销售契据/租金协议/电费单等）

10. 合伙契约/宣誓书/备忘录和公司章程。

11. 食品安全管理体系计划或证书（如有）

12. 召回计划，包括产品分销商的详细信息。

13. 已通过的食品安全管理体系证书或计划（中央许可单位必须是认可机构的证书）。

14. 持有健康证明的工人名单。

15. 负责操作的技术人员的姓名、资格和详细情况。

16. 通过NABL /FSSA 认可的实验室对食品中的相关化学和/或微生物汙染物进行测试，以确保食品安全。

表格A

1. 业务种类

．永久/临时摊位持有人

．小贩（流动食品供应商）

．家庭食堂/dabba wallas

．小吃店/小零售商

．製造商/加工厂

．重新打包商

．宗教聚会、集市等的食品摊位

．牛奶供应商

．鱼/肉/家禽店/卖家

．其他(说明)

2. 申请人身份：合伙商/企业/其它(说明)

3. 通讯地址、电话号码、手机号码、传真号码、电子邮件

4. 开展食品业务的区域或地点/场所地址

5. 拟製造或销售的食品描述

6. 食品企业的年总营业额（如果有），以及任何证明文件

7. 预计开始日期

8. 如属季节性业务，请註明一年的开闭期

9. 供水来源：公共/私人/任何其他来源(说明)

10. 製造食品时是否使用电力(如果是，请说明使用的电力负载)

11. 缴费：汇票编号/现金

表格B

1.业务种类（如适用可複选）：

．製造/加工，包括分类、分级等。

．牛奶收集/冷藏

．屠宰场

．溶剂萃取装置

．溶剂萃取设备，配备油籽预清洗或油预排。

．溶剂提取和炼油厂。

．包装

．重新贴标籤（由第三方根据自己的包装和标籤製造）

．导入

．仓储/仓库/冷库

．零售贸易

．批发贸易

．分销商/供应商

．食物运输者

．餐饮

．其他食品自动售货机构

．俱乐部/食堂

．酒店

．餐厅

．其他(说明)

2. 公司/机构名称：

3. 註册办公地址：

4. 申请执照的经营场所地址

5. 具有技术资格的运营负责人的姓名和/或职务、资格和地址

6. 每天平均使用/处理的牛奶数量

7. 使用的电力负载

8. 单位是否配备分析实验室

9. 其他法律授予的许可证

10. 缴费：汇票编号/现金

11. 申请人/授权签字人签字

12. 声明书、签章

进出口代码 (IEC)

IEC 编号是对外贸易总干事颁发给印度公司的10位数代码。每个从事进出口业务的个人或实体都必须获得 IEC。 它具有终身有效期，大约需要 15 天才能签发。

1.网页註册：https://www.dgft.gov.in/CP/

．获得 IEC 的公司的性质可以是以下任何一种：独资企业、合伙企业、有限责任合伙企业、有限公司、信託、HU”。引入 GST 后，IEC 编号与公司的 PAN 相同。IEC 将由 DGFT 单独发布。

2.签署声明。

3.支付IEC费用。

4.签发IEC代码。

标籤、展示和广告不得声称保健品具有预防、治疗、治愈人类疾病，或提及此类特性。

保健品标籤需要包含以下内容：

1. 保健品的通用名称，或足以表明保健品真实性质的描述，包括产品特徵的营养素或物质类别的通用名称。

2. 成分表：除单一配料食品外，应在标籤上註明成分表。

．产品中使用的成分名称应按其成分按重量或体积的降序排列，视其製造时的情况而定。

．一种成分本身是两种或两种以上複合的，应标明其具体名称并按比例 (m/m) 降序排列。

3. 对于作为混合物或组合销售的食品，应在製造时按适当重量或体积成分（包括複合成分或成分类别）的进料百分比：

．通过文字、图片或图形在标籤上强调

4. 为消费者提供信息和使用服务建议的图形。

5. 营养信息：应以克 (g) 或毫升 (ml) 为单位标示在份量旁边。

．能量值（千卡）

．蛋白质 (g)

．碳水化合物 (g) 和总糖 (g)，添加糖 (g)

．总脂肪 (g)、饱和脂肪 (g)、反式脂肪（天然反式脂肪除外）(g) 和胆固醇（毫克）

．钠 (mg)

．维生素和矿物质(公制单位)

6.  营养信息可以额外以条形码/全球贸易识别号 (GTIN) 的形式提供，营养素的数量以印度医学研究委员会规定的每日摄入量的百分比表示，并带有警告：不要超过推荐的每日使用量。

7. 品牌所有者的名称、完整地址，无论是否是製造商、营销商、包装商或装瓶商，均应在标籤上註明。

8. 进口到印度的包装应带有印度进口商的名称、完整地址。此外，如果在印度以外製造、在印度包装或装瓶，则装有此类食品的包装还应在标籤上标明原产国名称、进口商名称、完整地址，以及在印度进行包装或装瓶的场所。

9. FSSAI 标誌和许可证号。

． FSSAI 标誌和许可证编号应显示在食品包装的标籤上，与背景形成对比色。

．品牌所有者的 FSSAI 标誌和许可证号应显示在标籤上。此外，製造商/销售商/包装商/装瓶商的许可证号如果与品牌所有者不同，也应显示在标籤上。

．对于进口保健品，进口商应展示 FSSAI 标誌、许可证号以及进口商的名称和地址。

．每个食品经营者应在其所有储存、加工、分发或销售食品的场所展示註册/许可证编号或食品安全展示板。

10. 淨数量、零售价格和消费者服务细节。

11. 製造或包装日期、有效期/使用期限。

．对于保质期不超过 3 个月的产品，使用 DD/MM/YY 格式的日、月和年；保质期超过三个月的产品的月份和年份，应以未编码的数字顺序声明，但月份应以大写字母和缩写（至少月份的前三个字母）表示。

．除保质期或使用期限外，食品储存的任何特殊条件均应在标籤上註明，如果需要，还需要标示打开包装后的储存条件。

12. 关于食物过敏原的声明。

13. 保健品字样。

14. 醒目处标示：「非药用」的警告。

15. 关于产品中存在的营养或具有营养/生理作用物质的含量声明。

16. 保健品不能替代多样化饮食的声明。

17. 食用时应採取的警告或任何其他预防措施、已知的副作用（如果有）、禁忌症以及已发布的产品或药物相互作用（如适用）。

18. 要求将产品存放在儿童接触不到的地方的声明等

注意：

1. 标籤上的内容应清晰、不含糊、醒目、显眼、不可磨灭，使消费者在正常购买和使用条件下易于辨认。

2. 在不与规定相抵触的前提下，可以在标籤上显示任何书写、印刷、图形的信息或者图形。

3. 在标籤上註明的声明详情应使用英语或梵文印地语。

4. 如果包装带有外部容器或包装，并且该容器或包装用于零售展示，则还应包含所有要求的声明，除非该容器或包装本身是透明的，并且很容易通过这种外部容器或包装器读取声明。

5. 食品经营者不得在保健品配方中使用添加剂，但已规范的添加剂除外。

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.

【参考连结】

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
外国公司可以用自己名义申请办理产品许可吗？如需要，哪个单位在管理？需要什麽文件？申请程序为何？保健食品包装内容及各种标示，需要事先核准吗？可允许的语文有哪些？？网页？

Can a foreign company apply for a product license by its own name? If yes, which authority is in charge? What documents are required? What is the application process? Do health food packaging and labeling require prior approval? Which languages are allowed?Website?

Evershine RD：

食品进口商须以印度当地公司名义取得食品经营者登记，并在对外贸易总局进行註册并拥有有效的进出口代码。

食品经营者登记流程：

1. 向FSSAI提交申请表及相关文件。

网页：https://foscos.fssai.gov.in/

2. 根据申请日起60 天内颁发许可证。

3. 或者如果申请不完整，许可当局应通知申请人 在收到通知后的 30 天内，以书面形式补充或完成申请（视情况而定）。 如果申请人未能在规定的 30 天期限内提供所需资料，许可申请将被驳回。

4. 註册有效期为1-5年，由食品经营者自行决定，到期须申请更新。

申请文件

1. 由业主/合伙人或授权签署人填妥并签署（一式两份）的申请表。

2. 蓝图/佈局计划，以米/平方米为单位的尺寸和运营区域显示。

3. 董事名单、附有完整地址和联繫方式。

4. 设备和机器的名称和清单，以及数量、装机容量和使用的马力。

5. 由业主/合伙人/董事/授权签字人的政府机构签发的带照片的身份证、地址证明。

6. 希望生产的食品类别清单。（如果是製造商）

7. 製造商指定负责人姓名和地址的授权书。

8. 来自认可/公共卫生实验室的用于食品成分的水的分析报告（化学和细菌学），以确认可携带性，并註明收集的实验室授权代表的姓名样品和取样日期。

9. 拥有房屋的证明。 （销售契据/租金协议/电费单等）

10. 合伙契约/宣誓书/备忘录和公司章程。

11. 食品安全管理体系计划或证书（如有）

12. 召回计划，包括产品分销商的详细信息。

13. 已通过的食品安全管理体系证书或计划（中央许可单位必须是认可机构的证书）。

14. 持有健康证明的工人名单。

15. 负责操作的技术人员的姓名、资格和详细情况。

16. 通过NABL /FSSA 认可的实验室对食品中的相关化学和/或微生物汙染物进行测试，以确保食品安全。

表格A

1. 业务种类

．永久/临时摊位持有人

．小贩（流动食品供应商）

．家庭食堂/dabba wallas

．小吃店/小零售商

．製造商/加工厂

．重新打包商

．宗教聚会、集市等的食品摊位

．牛奶供应商

．鱼/肉/家禽店/卖家

．其他(说明)

2. 申请人身份：合伙商/企业/其它(说明)

3. 通讯地址、电话号码、手机号码、传真号码、电子邮件

4. 开展食品业务的区域或地点/场所地址

5. 拟製造或销售的食品描述

6. 食品企业的年总营业额（如果有），以及任何证明文件

7. 预计开始日期

8. 如属季节性业务，请註明一年的开闭期

9. 供水来源：公共/私人/任何其他来源(说明)

10. 製造食品时是否使用电力(如果是，请说明使用的电力负载)

11. 缴费：汇票编号/现金

表格B

1.业务种类（如适用可複选）：

．製造/加工，包括分类、分级等。

．牛奶收集/冷藏

．屠宰场

．溶剂萃取装置

．溶剂萃取设备，配备油籽预清洗或油预排。

．溶剂提取和炼油厂。

．包装

．重新贴标籤（由第三方根据自己的包装和标籤製造）

．导入

．仓储/仓库/冷库

．零售贸易

．批发贸易

．分销商/供应商

．食物运输者

．餐饮

．其他食品自动售货机构

．俱乐部/食堂

．酒店

．餐厅

．其他(说明)

2. 公司/机构名称：

3. 註册办公地址：

4. 申请执照的经营场所地址

5. 具有技术资格的运营负责人的姓名和/或职务、资格和地址

6. 每天平均使用/处理的牛奶数量

7. 使用的电力负载

8. 单位是否配备分析实验室

9. 其他法律授予的许可证

10. 缴费：汇票编号/现金

11. 申请人/授权签字人签字

12. 声明书、签章

进出口代码 (IEC)

IEC 编号是对外贸易总干事颁发给印度公司的10位数代码。每个从事进出口业务的个人或实体都必须获得 IEC。 它具有终身有效期，大约需要 15 天才能签发。

1.网页註册：https://www.dgft.gov.in/CP/

．获得 IEC 的公司的性质可以是以下任何一种：独资企业、合伙企业、有限责任合伙企业、有限公司、信託、HU”。引入 GST 后，IEC 编号与公司的 PAN 相同。IEC 将由 DGFT 单独发布。

2.签署声明。

3.支付IEC费用。

4.签发IEC代码。

标籤、展示和广告不得声称保健品具有预防、治疗、治愈人类疾病，或提及此类特性。

保健品标籤需要包含以下内容：

1. 保健品的通用名称，或足以表明保健品真实性质的描述，包括产品特徵的营养素或物质类别的通用名称。

2. 成分表：除单一配料食品外，应在标籤上註明成分表。

．产品中使用的成分名称应按其成分按重量或体积的降序排列，视其製造时的情况而定。

．一种成分本身是两种或两种以上複合的，应标明其具体名称并按比例 (m/m) 降序排列。

3. 对于作为混合物或组合销售的食品，应在製造时按适当重量或体积成分（包括複合成分或成分类别）的进料百分比：

．通过文字、图片或图形在标籤上强调

4. 为消费者提供信息和使用服务建议的图形。

5. 营养信息：应以克 (g) 或毫升 (ml) 为单位标示在份量旁边。

．能量值（千卡）

．蛋白质 (g)

．碳水化合物 (g) 和总糖 (g)，添加糖 (g)

．总脂肪 (g)、饱和脂肪 (g)、反式脂肪（天然反式脂肪除外）(g) 和胆固醇（毫克）

．钠 (mg)

．维生素和矿物质(公制单位)

6.  营养信息可以额外以条形码/全球贸易识别号 (GTIN) 的形式提供，营养素的数量以印度医学研究委员会规定的每日摄入量的百分比表示，并带有警告：不要超过推荐的每日使用量。

7. 品牌所有者的名称、完整地址，无论是否是製造商、营销商、包装商或装瓶商，均应在标籤上註明。

8. 进口到印度的包装应带有印度进口商的名称、完整地址。此外，如果在印度以外製造、在印度包装或装瓶，则装有此类食品的包装还应在标籤上标明原产国名称、进口商名称、完整地址，以及在印度进行包装或装瓶的场所。

9. FSSAI 标誌和许可证号。

． FSSAI 标誌和许可证编号应显示在食品包装的标籤上，与背景形成对比色。

．品牌所有者的 FSSAI 标誌和许可证号应显示在标籤上。此外，製造商/销售商/包装商/装瓶商的许可证号如果与品牌所有者不同，也应显示在标籤上。

．对于进口保健品，进口商应展示 FSSAI 标誌、许可证号以及进口商的名称和地址。

．每个食品经营者应在其所有储存、加工、分发或销售食品的场所展示註册/许可证编号或食品安全展示板。

10. 淨数量、零售价格和消费者服务细节。

11. 製造或包装日期、有效期/使用期限。

．对于保质期不超过 3 个月的产品，使用 DD/MM/YY 格式的日、月和年；保质期超过三个月的产品的月份和年份，应以未编码的数字顺序声明，但月份应以大写字母和缩写（至少月份的前三个字母）表示。

．除保质期或使用期限外，食品储存的任何特殊条件均应在标籤上註明，如果需要，还需要标示打开包装后的储存条件。

12. 关于食物过敏原的声明。

13. 保健品字样。

14. 醒目处标示：「非药用」的警告。

15. 关于产品中存在的营养或具有营养/生理作用物质的含量声明。

16. 保健品不能替代多样化饮食的声明。

17. 食用时应採取的警告或任何其他预防措施、已知的副作用（如果有）、禁忌症以及已发布的产品或药物相互作用（如适用）。

18. 要求将产品存放在儿童接触不到的地方的声明等

注意：

1. 标籤上的内容应清晰、不含糊、醒目、显眼、不可磨灭，使消费者在正常购买和使用条件下易于辨认。

2. 在不与规定相抵触的前提下，可以在标籤上显示任何书写、印刷、图形的信息或者图形。

3. 在标籤上註明的声明详情应使用英语或梵文印地语。

4. 如果包装带有外部容器或包装，并且该容器或包装用于零售展示，则还应包含所有要求的声明，除非该容器或包装本身是透明的，并且很容易通过这种外部容器或包装器读取声明。

5. 食品经营者不得在保健品配方中使用添加剂，但已规范的添加剂除外。

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.

【参考连结】

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
经过核准登记的保健食品，进口到印度要检附什麽文件？经过什麽手续？
在销售时要向各地的卫生福利部相关机构事先或事后准备吗？网页？

What documents are required when importing approved health food into India? What is the procedure?
Any preparation is required to submit to the Ministry of Health and Welfare for selling products? Website?

Evershine RD：

进口流程

1.于印度海关电子网关 (ICEGATE)註册会员

印度海关电子网关 (ICEGATE) 是印度海关中央间接税和海关委员会 (CBIC) 的国家门户，以电子方式向贸易、货运承运人和其他贸易伙伴提供电子申报服务。网页：https://www.icegate.gov.in/index.html

．申请人

．公司名称

．地址

．城市

．密码

．电话、传真号码、电子信箱

．类别：进口商/出口商等

．清关位置

．内容、发货地、收货地

．货物的详情、货物登记

．商业发票

．合约

．提单

．成分分析报告(需提供翻译文件)

．标籤样本(需提供翻译文件)

．灌装日期

．收方公司IEC Code

．收货人个人证件影本(PAN：永久帐户号/TAN：收税及减税帐号/身份证/护照)

．通过电子现金分类账支付和电子税收信用分类。

2. 风险管理系统 (RMS) 将审查申请以及是否需要抽样，并将资料转发给印度食品安全和标准局食品进口清关系统(FICS)。

3. 进口商需要在FSSAI设立的食品进口清关系统 FICS上註册：

网页：www.ics.fssai.gov.in

4. 如果提供了所有相关信息，授权人员 (A.O) 会安排对货物进行检查的预约（仅向 CHA/进口商提供两次确认预约的机会）。

5. 经检查，如果一切都符合要求(括货物的标籤和包装要求)抽取样品*2 个，每个样品 5000卢比，如果不符合要求，授权人员将拒绝该货物并出具不合格报告。

6. 授权人员将样品送至 FSSAI 指定NABL 认可实验室，如果发现样品符合，则生成无异议证书 (NOC)，如果不符合，则生成不合格报告 (NCR)，拒绝食品货物清关。

7. 如果进口商对实验室报告的结果不同意，可以向指定实验室申请重新检测。

8. 进口商取得实验室分析报告，并获得授权官员的无异议证书 (NOC)清关后才能销售。(准许进口食品的无异议证书收到食品进口商须从关区带出食品的无异议证明之日起30日内有效，食品进口商应採取有效措施，在授权官员出具的无异议证书规定的有效期内，将食品从海关区域放行，否则视为未清关的食品。)

9.如果不合格，应根据实验室分析的不合格报告确认，微生物的汙染或存在可能对公众健康构成重大风险需要销毁该样食品。

10. 送实验室分析的样品标籤封样，应当载有下列信息：

．样品编号

．收集日期和地点

．样品数量

．声明

．抽取样品时添加的防腐剂的名称和数量（如有）

．食品进口商或其海关代理的姓名和签名

．寄件人姓名及签名，加盖公章

．一份密封并贴上标籤的食品样品应送至指定实验室。第二份食品样品应储存在适当的条件下，以便在需要时重新测试。

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.

【参考连结】

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

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

HLF-TW-70
印度保健食品审核机构，需要附上的实验室检验资料有哪些? 网页？

What are the laboratory inspection materials that need to be attached for verification? Website?

Evershine RD：

实验室检查须包含：

1. 样本描述

2. 物理外观

3. 标籤

4. 质量特性

5. 保健品成品检测

．卡路里

．总脂肪

．饱和脂肪

．胆固醇

．钠

．总碳水化合物

．膳食纤维

．醣类

．蛋白质

．维生素A

．维生素C

．钙等

6. 微生物检测

．食品卫生

．食源性病原体，如：大肠杆菌、沙门氏菌、酵母和霉菌、空肠弯曲杆菌、产气荚膜梭菌、李斯特菌、志贺氏菌、金黄色葡萄球菌、霍乱弧菌、副溶血性弧菌、创伤弧菌、小肠结肠炎耶尔森菌等

7. 抗氧化剂

8.重金属

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

【参考连结】

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

HLF-TW-75

HLF-TW-77

HLF-TW-80
外国子公司进口保健食品后，如果委託印度的经销商销售，经销商需要保健食品营业许可证吗？假如保健食品有品质瑕疵的话，外国子公司和经销商各自的责任为何？是连带责任吗？还是可以规范由外国子公司负责？

After a foreign subsidiary imports health food and entrusts a distributor in 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，须以印度当地公司名义取得食品经营者登记。

在印度，保健品属于食品，所有食品经营者都须按照规定程序进行登记。

责任

每个食品经营者应遵循食品召回程序，包括完整的召回流程、召回后报告和后续行动，以确保召回的有效性并防止再次发生，印度食品安全和标准局的首席执行官或邦或联邦领土的食品安全专员或两者都可以指示食品经营者启动召回程序。

如果任何利益相关者向食品经营者报告或投诉，并且食品经营者确定有召回的需要，也应启动召回过程。如果食品经营者未对投诉作出回应，投诉人或消费者可以通知印度食品安全和标准局的首席执行官或州或联邦领土的食品安全专员或两者，他们将採取措施确定召回的必要性，并就召回事宜向有关食品经营者提出要求，有关食品经营者应受其约束。

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.

【参考连结】

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

各国健康食品登记法规问题集

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