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Regulatory Framework

An investor can setup operations in India

01.

1. Setting up a manufacturing unit

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02.

2. Importing food products and selling it into Indian market

03.

3. Exporting food products manufactured in the country

1. Setting up a manufacturing unit

What kind of license is required for your business?

Registration

  • Manufactures or sells any article of food himself or a petty retailer, hawker, itinerant vendor or temporary stall holder; or distributes foods including in any religious or social gathering except a caterer.

  • Such other food businesses including small scale or cottage or such other industries relating to food business or tiny food businesses with an annual turnover not exceeding Rs 12 lakhs and/or whose

  • Production capacity of food (other than milk and milk products and meat and meat products) does not exceed 100 kg/ltr per day or

  • Procurement or handling and collection of milk is up to 500 litres of milk per day or

  • Slaughtering capacity is 2 large animals or 10 small animals or 50 poultry birds per day or less

Documents required while applying for a Registration: -

- Application in Schedule-1

- Address proof (Government documents like Voter ID card)

- Photograph of applicant

  • Registrations are granted by the Registering Authority who may be Designated Officer/ Food Safety Officer or any official in Panchayat, Municipal Corporation or any other local body or Panchayat in an area, notified by the State Food Safety Commissioner.

 
Central Licensing

  • Dairy units including milk chilling units equipped to handle or process morethan 50,000 litres of liquid milk/day or 2500 MT of milk solid per annum.

  • Vegetable oil processing units and units producing vegetable oil by the process of solvent extraction and refineries including oil expeller unit having installed capacity more than 2 MT per day.

  • All slaughter houses equipped to slaughter more than 50 large animals or 150 or more small animals including sheep and goats or 1000 or more poultry birds per day.

  • Meat processing units equipped to handle or process more than 500 kg of meat per day or 150 MT per annum.

  • All food processing units other than mentioned under (I) to (IV) including labellers and repackers having installed capacity more than 2 MT/day except grains, cereals and pulses milling units

  • 100 % Export Oriented Units.

  • All Importers importing food items including food ingredients and additives for commercial use.

  • All food business operators manufacturing/ processing/ importing any proprietary food for which NOC has been given by FSSAI.

  • Registered/ Head office of FBOs operating in two or more states.

  • Food catering services in establishments and units under Central government Agencies like Railways, Air and airport, Seaport, Defence etc.

  • Hotels with 5 star and above accreditation.

  • All E-commerce food businesses.

  • All grains, cereals and pulses milling units [All other food business operators which are not covered under registration and central licensing are covered under state licensing]

Documents to be enclosed with application for License (to Central / State Licensing Authority):

(The list is only indicative, not mandatory unless mentioned)

- Form-B duly completed and signed (in duplicate) by the proprietor/ partner or the authorised signatory (mandatory for all categories).

- Blueprint/layout plan of the processing unit showing the dimensions in metres/square metres and operation-wise area allocation (mandatory for manufacturing and processing units only).

- List of Directors with full address and contact details (mandatory for companies only)

- Name and List of Equipments and Machinery along with the number, installed capacity and horse power used (mandatory for manufacturing and processing units only).

- Photo ID and address proof issued by Government authority of Proprietor/Partner/Director(s)/Authorized Signatory. (optional).

- List of food categories desired to be manufactured. (In case of manufacturers).

- Authority letter with name and address of responsible person nominated by the manufacturer along with alternative responsible person indicating the powers vested with them viz, assisting the officers in inspections, collection of samples, packing & dispatch. (mandatory for manufacturing and processors).

- Analysis report (Chemical & Bacteriological) of water to be used as ingredient in food from a recognized/ public health laboratory to confirm the portability (mandatory only for manufacturing and processing units only).

- Proof of possession of premises. (Sale deed/ Rent agreement/ Electricity bill, etc.) (optional).

- Partnership Deed/Affidavit/Memorandum & Articles of Association towards the constitution of the firm. (optional).

- Copy of certificate obtained under Coop Act - 1861/Multi State Coop Act - 2002 in case of Cooperatives. (wherever applicable).

- NOC from manufacturer (mandatory for Re-labellers and Re-packers)

- Food Safety Management System plan or certificate (if any).

- Source of milk or procurement plan for milk including location of milk collection centre’s etc. in case of Milk and Milk Products processing units(wherever applicable).

- Source of raw material for meat and meat processing plants. (wherever applicable).

- Pesticide residues report of water in case of units manufacturing packaged drinking water, packaged Mineral water and/or carbonated water from a recognized/ public health

- Recall plan wherever applicable, with details on whom the product is distributed. (Optional).

- NOCs from Municipality or local body. (Optional).

 
Food products standards laid down by FSSAI needs to be followed for each product category being manufactured and sold in Indian market.

Food License and Registration System (FLRS) is an online platform where investors can apply for license/registration and can track their application during the course of processing. Registration portal - https://foodlicensing.fssai.gov.in/about_flrs.aspx

2. Importing food products and selling it into Indian market

Process followed for importing food articles in India -

  • Bill of Entry (BOE) is filed at Customs ICE GATE (https://icegate.gov.in) on Single Window Interface for Facilitating Trade (SWIFT). Risk based sampling called Risk Management System (RMS) is in operation at Customs Single Window Interface for Facilitating Trade (SWIFT)

  • Risk Management System (RMS) scrutinizes the application and if the FSSAI clearance is required; the BOE is referred to FSSAI on online Food Import Clearance System (FICS)

  • CHA/Importer needs to be registered on FICS (www.ics.fssai.gov.in)

  • FSSAI accepts the BOE and may ask for further details from CHA/Importer, if necessary

  • If all the relevant information is provided, Authorized Officer (A.O) fixes appointment for the inspection of the consignment (only two opportunities are provided to the CHA/Importer to confirm the appointment)

  • On inspection, if everything is found satisfactory including labelling and packaging requirements of the consignments, the samples are drawn (2 nos batch wise)and if not, Authorised Officer rejects the consignment and issues Non-Conforming Report.

  • Samples are then sent to FSSAI Notified NABL accredited Laboratory, if sample is found conforming then No Objection Certificate (NOC) is generated and if not conforming, then Non-Conforming Report (NCR) is generated, rejecting the clearance of food consignment/items.

  • If Importer is not agreed with the finding of the laboratory report, he may apply for retesting of second sample at the referral laboratory. Outcome of test result will determine the fate of consignment. He may present the review application in Form 6 of FSS(Import) Regulations, 2017 to the Review Officer (Director, Imports) along with the required documents at the FSSAI Headquarter

  • The order passed by the Review Officer can be challenged before the CEO, FSSAI within 15 days whose decision thereon will be final

Documents that may be required for Importing Food into India -

S.No. Document Name Type
1 Ingredient List Mandatory
2 Spicemen Copy of Label Mandatory
3 End Use Declaration Mandatory
4 Bill of Entry Mandatory
5 Country of Origin Certificate Mandatory
6 Fssai License Mandatory
Conditional Documents if Applicable
1 Product Approval from Fssai Conditional
2 Form-II of Food Safety and Standards (Approval for Non-Specified Food and Food Ingredients) Regulations, 2017 Conditional
3 Certificate of analysis from Country of Origin (required in case of proprietary food) Conditional
4 Commercial invoice cum packing list and stuffing list (required in case of consignment of food or multiple foods or food falling under different categories packed in a single container or carton or pallet or skid) Conditional
5 Declaration and undertaking from importers for imported food consignment meant for Personal Use (Form 7)/100% Export and Re-export (Form 8)/ Research & Development purposes (Form 9)/ Display Purpose in Trade Fair/Exhibition (Form 10)/ Sports Events (Form 11)/ Provisional NOC for frozen and chilled imported food consignment (Form 12)/ Provisional NOC for imported food consignment with less than 07 days shelf life (Form 13)/ Provisional NOC for imported pre-packaged retail food consignment (Form 13A)/ imported food consignment containing bulk packages and having representative samples (Form 14)/ imported food consignment containing bulk packages but not having representative samples (form 15). Conditional
6 Any other document as specified from time to time
If any investor is importing plant/plant based products, livestock/livestock based products, they have to refer to the Sanitary Import Permit System laid down by the Ministry of Agriculture & Farmers' Welfare:
 

Sanitary Import Permits

  • Directorate of Plant Protection, Quarantine & Storage, Ministry of Agriculture & Farmers Welfare looks after issues related to plant quarantine

  • Objective is inspection of imported agricultural commodities for preventing the introduction of exotic pests and diseases into India

  • The Directorate of Plant protection, Quarantine & Storage provides import permit for planting material based on a certificate from Designated Inspection Authorities of the concerned jurisdiction for import of new commodities

  • Pest Risk Analysis is mandatory and should be submitted to the Plant Protection Adviser to the Govt. of India

  • A total of 60 entry points including 34 seaports, 12 airports and 14 land custom stations are notified points of entry for import of plants and plant material. Besides, 60 Inland Container Depot/ Container Freight Station,11 Foreign Post Offices have also been notified for the entry of plants /plant material

  • Application is submitted through the single window clearance system SWIFT, and customs authorities route the documents to Plant Quarantine for necessary processing at their end

  • Import permit is generally issued for 6 months after conducting a detailed import risk analysis

List of Processed Items (Plant Products) which does not require Plant Quarantine clearance
S. No. Processed Items
1 Asafoetida (Hing) & Exudes (gum)/extracts of various trees including Gambier extract and Tea Saponin extract
2 Agar extract, ingredient for dehydrated culture media
3 Baskets, hats, mats and handicraft articles woven with less than 6mm thick sticks
4 Bleached and dried Scandinavian mosses (steam sterilized) for decorative purpose
5 Cooked Items hermetically packed
6 Fruit Crystallized, infused with sugar
7 Dead Yeast
8 Derivatives of sugarcane like sugar and molasses
9 Bleached plant fiber including waxed/bleached coir bristle fiber, processed jute products, natural waxed coconut fiber, processed cottom linter pulp
10 Extruded cereals (Flakes, Porridge) hermetically packed
11 Foods tuffs ready for consumptions - jelly, jam, marmalade, sauces, Mashed potatoes (dried), soup (dried), Papad
12 Fruits and Vegetables - Canned juice, pulp and puree
13 Fruits and Vegetables - Cooked, canned and preserved
14 Fruits, Vegetables, flowers and nuts in brine, vinegar, oil or other preservatives
15 Fruits and Vegetables - Frozen for consumption
16 fruits and Vegetables - Minced, ground or sliced ( dried or dehydrated or dried chips) including vacuum dried carrot flakes
17 Ice Cream sticks, match sticks, tooth picks, veneer peeler cores, saw dust, wood wool and shaving and thin wood pieces, wood chips (less than 6mm thickness)
18 Paper bags
19 coated nuts in hermetically packed
20 Soybean lecithin including Soya protein isolate
21 Starch hermetically packed
22 Vegetable Oils, essences
23 De-hulled oat steamed above 95°C for 10-15 minutes including processed oat flakes
24 Medium density fiber board, processed ply wood, particle board, oriental strand board, veneer
25 Dietary food health supplement in capsule form
26 Marigold pellets undergone processing
27 Malted grains hermetically packed
28 Processed Soy Fiber hermetically packed

Standard Operating Procedures for Phytosanitary Inspection and Plant Quarantine Clearance of Plants/ Plant Products & other Regulated Articles can be referred to at: https://plantquarantineindia.nic.in/PQISPub/pdffiles/SOPimpfinal25.pdf

  • Animal quarantine is under the purview of Ministry of Agriculture, Department of Animal Husbandry Dairying and Fisheries

  • Under the scheme of Animal Quarantine & Certification Services, Animal Quarantine stations are set across the country in New Delhi, Mumbai, Kolkata, Chennai, Hyderabad, and Bangalore to provide facility of Animal Quarantine and Certification services

  • The consignments containing livestock and their products are referred by the customs for Animal Quarantine Clearance in compliance to import Quarantine health rules of the Government of India. The consignments are examined along with the accompanied health certificates and other relevant papers before allowing entry into India, to prevent the entry of any Exotic Livestock Diseases

  • Livestock products are categorized under Open General License (OGL) as per EXIM Policy

  • In India the import of livestock products are allowed subject to Sanitary Import Permits(SIPs) as per the provisions of Live-stock Importation Act.,1898. It is a certificate certifying India's sanitary requirements of all live-stock products:

    • Meat and products of all kinds of including fresh, chilled and frozen meat, tissue or poultry, pig, sheep, goat
    • Egg and egg power
    • Milk and milk products
    • Bovine, caprine embryos, ova or semen; and
    • Pet food products of animal origin

  • Imports of animal and animal products are only allowed through designated seaports/airports of Bangalore, Chennai, Delhi, Hyderabad, Kolkata, and Mumbai where animal quarantine and certification services are available.

  • Imports of fish products are allowed through the seaport of Vishakhapatnam (in the State of Andhra Pradesh), Sea and airport of Kochi and the Land Custom Station at Petra pole(for imports from Bangladesh only)

Standard Operating Procedures for Animal quarantine & certification services can be referred to at: http://www.aqcsindia.gov.in/sops.html

Application for Import/Export of Pet Animals, Aquatic/Other Animals, Birds & Poultry (Chicks): http://www.aqcsindia.gov.in/pdf/livestock1.pdf

Application for Issue of Zoo Sanitary Certificate for Import/Export of Livestock Products: http://www.aqcsindia.gov.in/pdf/livestock-products1.pdf

3. Exporting food products manufactured in the country

Every person exporting any one or more of the Scheduled products shall, before the expiration of one month from the date on which he undertakes such export or before the expiration of three months from the date of coming into force of this section, whichever is later, apply to Authority to be registered as an exporter of the Scheduled product or Scheduled products.

Registration Procedure with APEDA:

  • Application form duly filled and signed by authorized signatory.

  • Self certified copy of Import-Export code issued by D.G.F.T.

  • List of Directors/Partners/Proprietor on company’s letterhead in triplicate.

  • Pvt. Ltd./Public Ltd. Co.’s/societies should forward a copy of their Memorandum and Article of Association and Partnership firms should forward a copy of partnership deed attested by notary.

  • Self certified copy of PAN issued by Income Tax Department.

  • The company should compulsorily mention their e-mail ID, phone and fax number etc. in their application.

  • In case the exporter desires to register as Manufacturer Exporter, he should furnish the copy of company’s registration with FFO, Directorate of Industries, State Dept. of Horticulture/Agmark/EIA etc.

  • Bank certificate duly signed by the Authorities.

  • Cash or DD/Pay Order of Rs. 5000/- towards registration may be made in favor of APEDA payable to Specific APEDA office where the request has been made for Seeking RCMC.

Registration portal

https://itrack.apeda.gov.in/onlineregistration/apedaonline.aspx

AGMARK

  • AGMARK is a certification mark for agricultural produce, assuring that they conform to a grade standard notified by Directorate of Marketing & Inspection (DMI), Department of Agriculture, Cooperation and Farmers Welfare, Ministry of Agriculture & Farmers Welfare under Agricultural Produce (Grading Marking) Act, 1937

  • These standards differentiate between quality and 2-3 grades are prescribed for each commodity

  • Till date, grade standards for 222 agricultural commodities have been notified. These include fruits, Vegetables, cereals, pulses, oilseeds, vegetable oils, ghee, spices, honey, creamery butter, wheat, atta, besan.

  • Food Safety and Standards(Prohibition and Restriction on Sale)Regulations 2011 have prescribed mandatory certification under AGMARK for certain products viz. Blended Edible Vegetable Oil, Fat Spread

  • In case of Til Oil, CarbiaCallosa, Honey dew, Tea and Ghee FSSAI has prescribed few conditional restrictions

  • The certification scheme is implemented through 11Regional Offices, 26 SubOffices, 11 Regional Agmark Laboratories and Central Agmark Laboratory (Apex laboratory) of the Directorate

Application forms for AGMARK can be viewed at the following link:

For detailed information refer to: https://dmi.gov.in/GradesStandard.aspx

 

Bureau of Indian Standards

  • Operates product certification schemes by which it grants licenses to manufacturers covering practically every industrial discipline from agriculture and textiles to electronics

  • It is functioning under the administrative control of Ministry of Consumer Affairs, Food & Public Distribution

  • The certification allows the licensees to use the popular ISI mark, which has become synonymous with quality products for the Indian and neighbouring markets for over 55 years

  • The Food Safety and Standards (Prohibition and Restriction on Sales) Regulations, 2011 has prescribed mandatory certification under the BIS Act for the following products:

    • Infant formula (IS14433)
    • Milk cereal based weaning food (IS1656)
    • Processed cereal based weaning food (IS11536)
    • Follow up formula(IS15757)
    • Packaged drinking water(IS14543)
    • Packaged mineral water(IS13428)
    • Milk Powder(IS1165)
    • Skimmed Milk Powder(IS13334)
    • Partly Skimmed Milk Powder(IS14542)
    • Condensed Milk, Partly Skimmed and Skimmed Condensed Milk(IS1166)

For detailed information refer to: https://bis.gov.in/

Food Safety and Standards Authority of India

Established under the Food Safety and Standards Act 2006, Food Safety and Standards Authority of India (FSSAI) is an autonomous body established under the Ministry of Health and Family Welfare, Government of India. Operating by the guidelines set across by the FSSA 2006, FSSAI is the responsible authority that safeguards public health through the regulation and supervision of food safety. FSSAI has been created for laying down regulatory standards for articles of food and to regulate their manufacture, storage, distribution, sale and import to ensure availability of safe and wholesome food for human consumption.

FSSAI has been mandated by the FSS Act, 2006 for performing the following functions:

  • Standards and Compliances: Framing of regulations to lay down standards and guidelines with respect to articles of food and specifying an appropriate system of enforcing various standards thus notified

  • FSMS: Adoption of Good Manufacturing Practices, Good Hygienic Practices, Hazard Analysis and Critical Control Point and other such practices to be followed by Food Business Operators (FBOs) to ensure food safety

  • Laboratories: Laying down procedures and guidelines for accreditation of laboratories and notification of accredited laboratories

  • Policy and Advisory Functions: To provide scientific advise and technical support to Central and State Governments in matters of framing policy and rules in areas that have a direct or indirect bearing on food safety and nutrition

  • Risk Management: Collect and collate data regarding food consumption, incidence and prevalence of biological risks, contaminants in food, residues of various contaminants in foods products, identification of emerging risks and introduction of a rapid alert system

  • Information Dissemination: Creating an information network across the country so that the public, consumers, Panchayats etc. receive rapid, reliable and objective information about food safety and issues of concern

  • Capacity Building: Provide training programmes to those involved in or intending to get involved in food businesses

  • Collaborations and Partnerships: Contribute to the development of international technical standards for food, sanitary and phyto-sanitary standards

  • Consumer Awareness: Promote general awareness about food safety and standards

 

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