India Health Food Regulation QA
Email: bom4ww@evershinecpa.com
A-16, 1st Floor, Aruna Asaf Ali Marg, Qutub Institutional Area, New Delhi, 110067, India
Manager Punit Singh Negi , speak in Indian and English.
Skype: cspunitnegi
HLF-TW-10
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：
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
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：
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
假如需要辦理，請問印度有專業服務公司可以協助辦理保健食品公司營業許可證？
Evershine RD：
Ebizfiling
Wwbridge
HLF-TW-30
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：
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
假如需要辦理指派印度公司擔任營業代理人，請問印度有專業服務公司可以協助？
Evershine RD：
Olcarelaboratories
https://www.olcarelaboratories.com/
Prince Care Pharma Pvt. Ltd.
https://www.princecareindia.com/
HLF-TW-40
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：
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
請問在印度有哪些專業服務機構，可以協助辦理保健食品產品許可證？
Evershine RD：
Freyr
https://foodsupplements.freyrsolutions.com/
Ebizfiling
HLF-TW-50
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：
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
請問在印度有哪些專業服務機構，可以協助以外國公司名義辦理保健食品產品許可證？
Evershine RD：
Regask
Legal
HLF-TW-60
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：
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:
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
What are the laboratory inspection materials that need to be attached for verification? Website?
Evershine RD：
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
印度保健食品審核機構，能夠接受海外檢驗機構的檢驗資料嗎？假如是的話，有些被認可的機構？網頁？
Evershine RD：
TÜV
Microbac
Dyad Labs
HLF-TW-77
請問在印度有哪些保健食品檢驗機構可以提供保健食品檢驗服務？網頁？
Evershine RD：
Eurofins
Dalpl
JK
HLF-TW-80
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：
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
請問在印度有哪些專精於保健食品銷售與消費權益相關法律服務的業者？
Evershine RD：
Arogya Legal
Krishnamurthy & Co.
Kochhar & Co.
Contact Us
Email: bom4ww@evershinecpa.com
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or
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