FOOD SAFETY AND STANDARDS(LICENSING AND REGISTRATION OF FOOD BUSINESSES),REGULATIONS 2011 PDF/PPT

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FOOD SAFETY AND
STANDARDS(LICENSING
AND REGISTRATION OF

FOOD BUSINESSES),
REGULATIONS 2011

These regulations shall come into force on or after 5th August, 2011

 

IMP Definitions
 “Central Licensing Authority” means Designated Officer appointed by the Chief

Executive Officer of the Food Safety and Standards Authority of India in his
capacity of Food Safety Commissioner

 “Licensing Authority” means the Designated Officer appointed under section 36
(i) of the Act by the Commissioner of Food Safety of the state or by the Chief
Executive Officer of the Food Safety and Standards Authority of India in his
capacity of Food Safety Commissioner ;

 “Petty Food Manufacturer” means any food manufacturer, who (a) 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; or (b) 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 (i) production
capacity of food (other than milk and milk products and meat and meat products)
does not exceed 100 kg/ltr per day or (ii) procurement or handling and collection
of milk is up to 500 litres of milk per day or (iii) slaughtering capacity is 2 large
animals or 10 small animals or 50 poultry birds per day or less.

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Definitions

 Registering Authority” means Designated Officer/ Food Safety Officer or any
official in Panchayat, Municipal Corporation or any other local body or
Panchayat in an area, notified as such by the State Food Safety Commissioner
for the purpose of registration as specified in these Regulations.

 “State Licensing Authority” means Designated Officers appointed under
Section 36(1) of the Act by the Food Safety Commissioner of a State or UT.

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List of food business falling under the
purview of Central Licensing Authority

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

 II. 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.

 III. 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.

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

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

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List of food business falling under the
purview of Central Licensing Authority

 VI. 100 % Export Oriented Units.

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

 VIII. All food business operators manufacturing any article of food containing
ingredients or substances or using technologies or processes or combination thereof
whose safety has not been established through these regulations or which do not have
a history of safe use or food containing ingredients which are being introduced for the
first time into the country.

 IX. Food Business Operator operating in two or more states.

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

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LICENSING AND REGISTRATION OF FOOD
BUSINESS

 Registration of Petty Food Business:

 application for registration in Form A

 fee

 follow the basic hygiene and safety requirements provided in Part I of
Schedule 4

 provide a self attested declaration of adherence to these requirements
with the application in the format provided in Annexure-1 under Schedule
2.

 RA to grant or reject application or issue notice for inspection within 7
days.

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..

 If inspection ordered, Registering Authority after being satisfied with the
safety, hygiene and sanitary conditions of the premises, grant registration
within a period of 30 days.

 If registration not granted within 30 days, FBO can start business.

 Registration and photo ID card shall be displayed in premises.

 The Registering Authority or any officer shall carry out food safety inspection
of the registered establishments at least once in a year.

 Exemptions from Registration: producer of milk who is a registered member
of a dairy Cooperative Society registered under Cooperative Societies Act and
supplies or sells the entire milk to the Society

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License for food business

 No person shall commence any food business unless he possesses a valid license.

 Licenses for FBO following under business category specified under schedule I issued by
CLA.

 Other FBO licenses by State/UT LA

 Application Form B

 FBO shall comply all conditions of license as provided in Annexure 2 of Form B in Schedule
2 and safety, sanitary and hygienic requirements provided in the Schedule 4

 Periodic food safety audit by LA by its own or by agency authorized

 For food subjected to the treatment of irradiation, a license from Department of Atomic
Energy under the Atomic Energy (Control of Irradiation of Food) Regulations, 1996.

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Application Process
 Application in Form B

 Self attested declaration in format provided in annex 1 of sch 2

 Copies of documents as specified in Annexure 2 of schedule 2

 Fee as prescribed in schedule 3.

 Processing – 1.Issue of application ID

 2.License shall be granted within 60 days. If not granted and if no any notice, applicant may commence
business.

 3.To issue compliance notice if any additional information / documents required within 15 days.

 Applicant to submit compliance within 30 days from issuing notice.

 If applicant fails to comply within 30 days from notice, application stands rejected.

 LA may direct food safety officer or authorized agency to inspect premises- inspecting authority issue
notice for compliance if any- compliance within 30 days by applicant- recommendation by inspecting
authority to LA to grant or reject application.

 LA authority within 30 days from recommendation by inspecting authority either grant or reject
application after due compliance.

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 License issued in form ‘C’ of schedule 2.

 

Process of Renewal of licenses
 Application in form A or B to be made before expiry.

 Can be made within 30 days from date of expiry with late fee Rs.100 per day.

 After 30 days FBO has to stop business and obtain fresh license.

 Suspension or cancellation of Registration Certificate or license

 Inspection – improvement notice- no compliance- hearing – suspension- compliance
inspection- no compliance – lic/reg cancellation.

 Appeal to Designated officer or Food Safety Commissioner

 Returns- Every year before 31st may in Form D1.If not filed before 31st may, to pay penalty
of Rs.100 per day.

 For milk and milk products 6 monthly in form D2

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Documents to be enclosed for new application for license to
State/Central Licensing Authority
 1. Form-B duly completed and signed (in duplicate)

 2. Blueprint/layout plan of the processing unit

 3. List of Directors with full address and contact details

 4. Name and List of Equipments and Machinery

 5. Photo I.D and address proof issued by Government authority of Proprietor/Partner/Director(s)/Authorised Signatory.

 6. List of food category desired to be manufactured. ( In case of manufacturers).

 7. Authority letter with name and address of responsible person nominated by the manufacturer.

 8. Analysis report (Chemical & Bacteriological) of water to be used as ingredient in food.

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

 10. Partnership Deed/Affidavit/Memorandum & Articles of Association towards the constitution of the firm.

 11. Copy of certificate obtained under Coop Act – 1861/Multi State Coop Act – 2002 in case of Cooperatives.

 12. NOC from manufacturer in case of Re-labellers

 13. Food Safety Management System plan or certificate if any,

 14. Source of milk or procurement plan for milk including location of milk collection centres etc in case of Milk and Milk
Products processing units.

 15. Source of raw material for meat and meat processing plants.

 16. Pesticide residues report of water to be used as ingredient in case of units manufacturing Packaged drinking water,
packaged Mineral water and/or carbonated water.

 17. Recall plan wherever applicable, with details on whom the product is distributed.
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 1ul8oM. ixN.cOomCs from Municipality or local body and from State Pollution Control Board except in case of n1o1tified industrial area.

 

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Conditions of License

 Food Business Operators shall:

 1. Display a true copy of the license granted in Form C shall at all times at a prominent
place in the premises.

 2. Give necessary access to Licensing Authorities or their authorised personnel to the
premises

 3. Inform Authorities about any change or modifications in activities /content of license.

 4. Employ at least one technical person to supervise the production process. The person
supervising the production process shall possess at least a degree in Science with
Chemistry/Bio Chemistry/Food and Nutrition/ Microbiology or a degree or diploma in food
technology/ Dairy technology/ dairy microbiology/ dairy chemistry/ dairy engineering/ oil
technology /veterinary science /hotel management & catering technology or any degree
or diploma in any other discipline related to the specific requirements of the business
from a recognized university or institute or equivalent.

 5. Furnish periodic annual return (1st April to 31st March), within upto 31st May of each
year. For collection/ handling/ manufacturing of Milk and Milk Products half yearly returns
also to be furnished as specified (1st April to 31st September before 30th November and
1st October to 31st March).

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Conditions of License
 6. Ensure that no product other than the product indicated in the license/ registration is produced

in the unit.

 7. Maintain factory’s sanitary and hygienic standards and worker’s Hygiene as specified in the
Schedule – 4 according to the category of food business.

 8. Maintain daily records of production, raw materials utilization and sales separately.

 9. Ensure that the source and standards of raw material used are of optimum quality.

 10. Food Business Operator shall not manufacture, store or expose for sale or permit the sale of any
article of food in any premises not effectively separated to the satisfaction of the licensing
authority from any privy, urinal, sullage, drain or place of storage of foul and waste matter.

 11. Ensure Clean-In-Place systems (wherever necessary) for regular cleaning of the machine &
equipments.

 12. Ensure testing of relevant chemical and/or microbiological contaminants in food products in
accordance with these regulations as frequently as required on the basis of historical data and risk
assessment to ensure production and delivery of safe food through own or NABL accredited /FSSA
notified labs at least once in six months.

 13. Ensure that as much as possible the required temperature shall be maintained throughout the
supply chain from the place of procurement or sourcing till it reaches the end consumer including
chilling, transportation, storage etc.

 14. The manufacturer/importer/distributor shall buy and sell food products only from, or to,
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licensed/registered vendors and maintain record thereof.

 

Other Conditions of License
 1. Proprietors of hotels, restaurants and other food stalls who sell or expose for sale savouries, sweets or other

articles of food shall put up a notice board containing separate lists of the articles which have been cooked in ghee,
edible oil, vanaspati and other fats for the information of the intending purchasers.

 2. Food Business Operator selling cooked or prepared food shall display a notice board containing the nature of
articles being exposed for sale

 3. Every manufacturer [including ghani operator] or wholesale dealer in butter, ghee, vanaspati, edible oils, Solvent
extracted oil, de oiled meal, edible flour and any other fats shall maintain a register showing the quantity of
manufactured, received or sold, nature of oil seed used and quantity of de-oiled meal and edible flour used etc. as
applicable and the destination of each consignment of the substances sent out from his factory or place of
business, and shall present such register for inspection whenever required to do so by the Licensing Authority.

 4. No producer or manufacturer of vegetable oil, edible oil and their products shall be eligible for license under this
Act, unless he has own laboratory facility for analytical testing of samples.

 5. Every sale or movement of stocks of solvent-extracted oil, ‘semi refined’ or ‘raw grade I’, edible groundnut flour
or edible coconut flour, or both by the producer shall be a sale or movement of stocks directly to a registered user
and not to any other person, and no such sale or movement shall be effected through any third party.

 6. Every quantity of solvent-extracted oil, edible groundnut flour or edible coconut flour, or both purchased by a
registered user shall be used by him in his own factory entirely for the purpose intended and shall not be re-sold or
otherwise transferred to any other person.

 7. No Food Business Operator shall sell or distribute or offer for sale or dispatch or deliver to any person for
purpose of sale any edible oil which is not packed, marked and labelled in the manner specified in the regulations
unless specifically exempted from this condition vide notification in the official Gazette issued in the public
interest by Food Safety Commissioners in specific circumstances and for a specific period and for reasons to be

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