All Food Business Operators in the country will be registered or licensed in accordance with the procedures laid down hereinafter;
2.1.1 Registration of Petty Food Business. (1) Every Petty Food Business Operator shall register themselves with the Registering Authority by submitting an application for registration in Form A under Schedule 2 of these regulations along with a fee as provided in Schedule 3.
(2) The petty food manufacturer shall follow the basic hygiene and safety requirements provided in Part I of Schedule 4 of these regulations and provide a self-attested declaration of adherence to these requirements with the application in the format provided in Annexure-1 under Schedule 2.
(3) The Registering Authority shall consider the application and may either grant registration or reject it with reasons to be recorded in writing or issue notice for inspection, within 7 days of receipt of an application for registration.
(4) In the event of an inspection being ordered, the registration shall be granted by the Registering Authority after being satisfied with the safety, hygiene and sanitary conditions of the premises as contained in Part I of Schedule 4 within a period of 30 days.
If registration is not granted, or denied, or inspection not ordered within 7 days as provided in above sub-regulation (3) or no decision is communicated within 30 days as provided in above sub-regulation (4), the petty food manufacturer may start its business, provided that it will be incumbent on the Food Business Operator to comply with any improvement suggested by the Registering Authority even later:
Provided that registration shall not be refused without giving the applicant an opportunity of being heard and for reasons to be recorded in writing.
The Registering Authority shall issue a registration certificate and a photo identity card, which shall be displayed at a prominent place at all times within the premises or vehicle or cart or any other place where the person carries on sale/ manufacture of food in case of Petty Food Business.
The Registering Authority or any officer or agency specifically authorized for this purpose shall carry out food safety inspection of the registered establishments at least once in a year:
Provided that a 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 shall be exempted from this provision for registration.
2.1.2 License for food business. (1) Subject to Regulation 2.1.1, no person shall commence any food business unless he possesses a valid license:
Provided that any person or Food Business Operator carrying on food business on the date of notification of these regulations, under a license, registration or permission, as the case may be, under the Acts or Orders mentioned in the Second Schedule of the Act shall get their existing license converted into the license/ registration under these regulations 2[within 3[sixty months] from the date of commencement of these regulations] by making an application to the Licensing/ Registering Authority after complying with the safety requirements mentioned in the Schedule 4 contained under different Parts dependent on nature of business 4[* * *]. In case of difficulty, the licensing authority with the approval of the Food Safety Commissioner in the State will determine the advisability of applying any specific condition keeping in view the need to ensure safety of food and public interest. No license fee will have to be paid for the remaining period of the validity of the earlier license or registration granted under any of the said Acts or Orders. Non-compliance with this provision by a Food Business Operator will attract penalty under Section 55 of the Act:
Provided further that any food business operator holding Registration/License under any other Act/Order as specified under Schedule 2 of the FSS Act, 2006 with no specific validity or expiry date, and otherwise entitled to obtain a license under these regulations, shall have to apply and obtain a Registration/License under these Regulations within 5[6[sixty months] from the date of commencement of these regulations] by paying the applicable fees:
7[Provided also that in case of difficulty, the licensing/registration authority with the approval of the Food Safety Commissioner in the State will determine the advisability of applying any specific condition keeping in view the need to ensure safety of food and public interest. Non-compliance with above provisions by a food business operator shall attract penalty as provided under Section 55 of the Act.]
(2) Notwithstanding the provisions contained in Regulation 2.1.2(1) above or in any of the registration or license certificates issued under existing Acts or orders mentioned in the Second Schedule of the Act, the Licensing Authority, if it has reason to believe that the Food Business Operator has failed to comply with all or any of the conditions of the existing registration or license or the safety requirements given in Schedule 4, may give appropriate direction to the Food Business Operator to comply with.
(3) License for commencing or carrying on food business, which falls under Schedule 1, shall be granted by the Central Licensing Authority, provided that Food Authority may through notification make such changes or modify the list given in the Schedule I as considered necessary.
(4) License for commencing or carrying on food business, which are not covered under Schedule 1, shall be granted by the concerned State/UT's Licensing Authority.
(5) The Food Business Operator shall ensure that all conditions of license as provided in Annexure 3 of Form B in Schedule 2 and safety, sanitary and hygienic requirements provided in the Schedule 4 contained under different Parts depending on nature of business are complied with at all times:
Provided that the Licensing Authority shall ensure periodical food safety audit and inspection of the licensed establishments through its own or agencies authorized for this purpose by the FSSAI:
Provided further that no person shall manufacture, import, sell, stock, exhibit for distribution or sale any article of food which has been subjected to the treatment of irradiation, except under a license obtained from Department of Atomic Energy under the Atomic Energy (Control of Irradiation of Food) Regulations, 1996.
2.1.3 Application for license to the Licensing Authority. An application for the grant of a license shall be made in Form B of Schedule 2 to the concerned Licensing Authority as specified in Regulations 2.1.2 (3) and 2.1.2 (4) and it will be accompanied by a self-attested declaration in the format provided in the Annexure 1 and copies of documents mentioned in the Annexure 2 of Schedule 2 along with the applicable fees prescribed in Schedule 3.
2.1.4 Processing of Application for license. (1) A license shall, subject to the provisions of these regulations, be issued by the concerned Licensing Authority within a period of 60 days from the date of issue of an application ID number as provided in sub-section (3) below.
(2) If, upon scrutiny of the application within 15 days from the date of receipt of the application, the concerned Licensing Authority requires any additional information with respect to an application or if the application is incomplete, the Licensing Authority shall inform the applicant in writing, to furnish such additional information or complete the application, as the case may be, within 30 days from such notice. In case the applicant fails to furnish the required information within the stipulated time of 30 days, the application for license shall stand rejected.
(3) On the receipt of a complete application including the additional information if asked for, the Licensing Authority shall issue an Application ID number to each applicant that will be referred to in all future correspondence between the Licensing Authority and the applicant.
(4) After the issue of Application ID number the Licensing Authority may direct the Food Safety Officer or any other person or agency specially designated for such functions to inspect the premises in the manner prescribed by the Food Safety and Standard Authority of India in accordance with these regulations. Such Inspecting Officer or person may issue a notice to the applicant, if it deems fit, guiding food business operator on necessary steps to be taken or changes or alteration to be made in the premises in order to ensure general sanitary and hygienic conditions as specified in Schedule 4. The applicant shall carry out the required steps, changes or alterations and intimate the Licensing Authority within 30 days or such period as may be allowed by the Licensing Authority.
(5) Within a period of 30 days from receipt of an inspection report excluding the time taken by the applicant in complying with the advice, if any, given in the inspection report and verification thereof, the concerned Licensing Authority shall consider the application and may either grant license or reject the application:
Provided that before refusing license an applicant shall be given an opportunity of being heard and the reasons for refusal shall be recorded in writing.
(6) The Licensing Authority shall issue a License in Format C under Schedule 2 of these regulations, a true copy of which shall be displayed at a prominent place at all times within the premises where the Food Business Operator carries on the food business.
2.1.5 Procedure for License in certain local areas. (1) A single license may be issued by the Licensing Authority for one or more articles of food and also for different establishments or premises in the same local area including collection and chilling units run by milk cooperatives or its members.
(2) The Chief Executive Officer of the Food Safety and Standards Authority of India in the capacity of Food Safety Commissioner may appoint a Designated Officer or Food Safety Officer for Central Government organizations like Railways, Defence etc., which have a large number of food establishments, to ensure food safety in those establishments and to ensure that all other conditions laid down for running food business under the Act and these regulations are complied with. Provided further that the Food Authority may carry out food safety audit of these establishments once in a year through its own or accredited agencies.
2.1.6 Commencement of Business. An applicant may commence his food business and the concerned Licensing Authority shall not deny the applicant to commence such business if, from the date of making the completed application, a license is not issued within 60 days or the applicant has not received any intimation of inadequacy under Regulation 2.1.4 (2) or inspection report indicating defects from the concerned Licensing Authority under Regulation 2.1.4(4).
2.1.7 Validity and Renewal of Registration and License. (1) A Registration or license granted under these regulations shall be valid and subsisting, unless otherwise specified, for a period of 1 to 5 years as chosen by the Food Business Operator, from the date of issue of registration or license subject to remittance of fee applicable for the period and compliance with all conditions of license.
(2) Any application for the renewal of a registration or license granted under these regulations shall be made in Form A or B of Schedule 2, as the case may be, not later than 30 days prior to the expiry date indicated in the license.
(3) The Registration or License shall continue to be in force till such time that the orders are passed on the renewal application which in no case shall be beyond 30 days from the date of expiry of registration or license.
(4) Any renewal application filed beyond the period mentioned under Regulation 2.1.7 (2) above but before the expiry date, shall be accompanied by a late fee of Rs 100 per day for each day of delay:
8[Provided that in case of registration, late fee of Rs 100 per day for each day of delay shall not be applicable.]
(5) Any Registration or license for which renewal has not been applied for within the period mentioned in Regulation 2.1.7 (2) or 2.1.7 (4) above shall expire and the Food Business Operator shall stop all business activity at the premises. The Food Business Operator will have to apply for fresh Registration or license as provided in Regulations 2.1.1 and 2.1.3 as the case may be, if it wants to restart the business.
(6) Food Business Operator having valid certificate of an accredited food safety auditor or from an agency accredited by Food Authority or any other organisation notified by Food Authority for this purpose will not be normally required to be inspected before renewal of license:
Provided that Designated Officer may order an inspection before renewal if considered necessary for reasons to be recorded in writing.
2.1.8 Suspension or cancellation of Registration Certificate or license. (1) The Registering or Licensing Authority in accordance with the provisions of Section 32 of the Act may, after giving the concerned Food Business Operator a reasonable opportunity of being heard, suspend any registration or license in respect of all or any of the activities for which the registration/license has been granted under these regulations after recording a brief statement of the reasons for such suspension, if there is reason to believe that the Food Business Operator has failed to comply with the conditions within the period mentioned in any Improvement Notice served under Section 32 of the Act. A copy of such statement shall be furnished to the concerned Food Business Operator whose Registration or license has been suspended.
(2) The registering or Licensing Authority, as the case may be, may direct an inspection of the Food Business Operator's premise(s) within a reasonable period which shall not be less than 14 days from the date of order of suspension.
(3) In the event that the Registering or Licensing Authority is of the opinion, on a review of the inspection report, that the Food Business Operator has still failed to rectify the defects or omissions or comply with the conditions of the improvement notice causing the suspension, such authority may cancel the license/registration of the Food Business Operator after giving him an opportunity to show cause as provided under Section 32 (3) of the Act.
(4) Notwithstanding anything contained in these regulations, the Registering or Licensing Authority may suspend or cancel any registration or license forthwith in the interest of public health for reasons to be recorded in writing.
(5) A suspension or cancellation of registration or license under these regulations shall not entitle the Food Business Operator for any compensation or refund of fee(s) paid in respect of the registration certificate or license or renewal thereof.
(6) After a period of 3 months from the date of cancellation under Regulation 2.1.8(3) above the Food Business Operator may make fresh application for registration or license to the concerned authority if all observations made in the improvement notice have been complied with.
2.1.9 Modifications, Expansion or Changes in premise(s) after grant of license or registration. (1) Food Business Operators shall ensure that the Registering or Licensing Authority always has up-to-date information on their food business establishments and shall inform the relevant Authority of any modifications or additions or changes in product category, layout, expansion, closure, or any other material information based on which the license was granted and such information shall be conveyed before the changes occur:
Provided that any change that alters the information contained in the license certificate shall require an approval or endorsement in license prior to start of business with such changes. The Food Business Operator shall submit the original license to the Licensing Authority along with a fee equivalent to one year license fee for effecting necessary changes. The Licensing Authority may approve and issue an amended license incorporating such changes in activities within 30 days from the date of receipt of such information. While approving the aforementioned changes the concerned Registering or Licensing Authority shall take into account the feasibility of carrying on the business and the legal and other relevant aspects of the desired modifications or additions or changes in activities and, if required, may order an inspection of the premises before granting the approval.
2.1.10 Mode of payment. All fees and charges payable under these regulations shall be paid vide pay order or demand draft or any online mode of payment as may be prescribed in this regard, by the concerned Food Safety Commissioner.
2.1.11 Transfer of registration certificate or License in case of death. (1) In the event of death of the holder of a Registration Certificate or license, such certificate or license shall subsist for the benefit of the legal representative or any family member of the deceased or until the expiry of
(a) the period of 90 days from the date of death of the holder of a Registration Certificate or license; or
(b) such longer period as the Designated Officer may allow, for reasons to be recorded in writing.
(2) The legal representative or family member of the deceased holder of the registration certificate or license shall apply to the Concerned Authority for transfer of such certificate or license in his favour.
(3) The registering or Licensing Authority, as the case may be, may, after making such enquiry as it may deem fit, either approve the transfer of the Registration Certificate or license if satisfied that the applicant is the legal representative, or refuse the request:
Provided that the registering or licensing authority shall not refuse the request without giving the applicant an opportunity of being heard and for reasons to be recorded in writing.
(4) Upon filing of application for transfer and pending the decision of the authority, the registration or license shall continue to be in force.
2.1.12 Appeal. (1) A Food Business Operator aggrieved by an order of the Registering Authority or Licensing Authority, as the case may be, under these regulations may prefer an appeal to the concerned Designated Officer or the Food Safety Commissioner, as per provisions laid down under Sections 31(8) and 32(4)- (5) of the Act.
2.1.13 Return. (1) Every 9[manufacturer and importer who has been issued a license] shall on or before 31st May of each year, submit a return electronically or in physical form as may be prescribed by the concerned Food Safety Commissioner, in Form D-l provided in Schedule 2 of these regulations to the Licensing Authority in respect of each class of food products handled by him during the previous financial year:
Provided however that every licensee engaged in manufacturing of milk and/or milk products shall file half yearly returns for the periods 1st April to 30th September and 1st October to 31st March of every financial year in the form D-2, as provided in Schedule 2 of these regulations. Such returns will be filed within a month from the end of the period.
(2) A separate return shall be filed for every license issued under the regulations, irrespective of whether the same Food Business Operator holds more than one license.
(3) Any delay in filing return beyond 31st May of each year shall attract a penalty of Rs 100 per day of delay.
2.1.14 Food Business Operator to be bound by directions or order. (1) Every Food Business Operator to whom any direction or order is issued in pursuance of any provisions of this regulation shall be bound to comply with such directions or regulation and any failure on the part of the Food Business Operator to comply with such direction or order shall be deemed to be contravention of the provisions of these regulations and will attract legal action under the provisions of the Act.
(2) Guarantee. Every manufacturer, distributor or dealer selling an article of food to a vendor shall give either separately or in the bill, cash memo, or label a warranty in Form E. (Refer Form A for form of Guarantee)
2.1.15 Power of State/UT Governments to constitute Advisory Committee. The State/UT Governments, may, if required designate an existing Advisory Committee at panchayat/district/state level or where such a committee does not exist, constitute an Advisory Committee to assist, aid or advise on any matter concerning food safety.
2.1.16 Jurisdiction of Designated Officer. The Commissioner of Food Safety shall, by an order, appoint the Designated Officer, who shall not be below the rank of a Sub-Divisional Officer, to be in-charge of food safety administration for each district as defined under Regulation 1.2.1 (2).
SCHEDULE 1
[See Regulation 2.1.2(3)]
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. |
| 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. |
SCHEDULE 2
[See Regulation 2.1.1 and Regulation 2.1.7]
Form A
Application for Registration/Renewal of Registration under Food Safety and Standards Act, 2006
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Kind of business: |
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Permanent/Temporary Stall holder |
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Hawker (Itinerant/Mobile food vendor)) |
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Home based canteens/dabba wallas |
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Photograph of |
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Petty Retailer of snacks/tea shops |
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the Applicant |
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Manufacturer/Processor |
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Re Packer |
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Food stalls/arrangements in religious gatherings, fairs etc |
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Milk producers (who are not member of dairy co-operative society)/milk vendor |
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Dhaba |
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Fish/meat/poultry shop/seller |
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Other(s), please specify: |
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Name of the Applicant/Company: .. |
| (b) |
Designation |
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Individual |
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Partner |
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Proprietor |
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Secretary of dairy co-operative society |
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Others (Please specify) |
| (c) |
Proof of Identity of applicant: .. |
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[Note: Please submit a copy of photo ID like Driving License, Passport, Ration Card or Election ID card] |
| (d) |
Correspondence address: .. |
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Tel No. . Mobile No. .. |
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Fax No. . E mail .. |
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[Note: In case the number(s) are a PP or common number (s), please specify the name of the contact person as well] |
| (e) |
Area or Location where food business is to be conducted/Address of the premises: . |
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| (f) |
Description of the food items proposed to be manufactured or sold: |
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Name of Food Category |
Quantity in kg per day or M.T. per annum |
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| Please attach separate sheet if required |
| (g) |
Total Annual turnover from the food business, if existing, along with any supporting document(s) showing proof of income (*In case of renewal): |
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| (h) |
In case of new business - intended date of start: .. |
| (i) |
In case of seasonal business, state the opening and closing period of the year: . |
| (j) |
Source of water supply: |
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Public supply |
Private supply |
Any other source |
| (k) |
Whether any electric power is used in manufacture of the food items: |
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Yes |
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No |
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If yes, please state the exact HP used or sanctioned Electricity load: |
| (l) |
I/We have forwarded a sum of Rs towards registration fees according to the provision of the Food Safety and Standards (Licensing and Registration) Regulations, 2011 vide: |
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Demand Draft No. (payable to ..) |
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Cash |
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(Signature of the Applicant) |
Form B
[See Regulation 2.1.2, Regulation 2.1.3 and Regulation 2.1.7]
Application for License/Renewal of license under Food Safety and Standards Act, 2006
| Kind of business (Please tick more than one, if applicable): |
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Manufacturing/Processing including sorting, grading etc. |
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Milk Collection/chilling |
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Slaughter House |
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Solvent extracting unit |
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Solvent extracting plant equipped with pre-cleaning of oil seeds or pre-expelling of oil |
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Solvent extracting and oil refining plant |
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Packaging |
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Relabelling (manufactured by third party under own packing and labelling) |
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Importing |
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Storage/Warehouse/Cold Storage |
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Retail Trade |
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Wholesale Trade |
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Distributor/Supplier |
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Transporter of food |
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Catering |
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Dhabha or any other food vending establishment |
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Club/canteen |
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Hotel |
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Restaurant |
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Other(s), please specify: .. |
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| 1. |
Name of the Company/Organization: .. |
| 2. |
Registered Office Address: . |
| 3. |
Address of Premise for which license is being applied .. |
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| 4. |
Name and/or designation, qualification and address of technically qualified person in charge of operations as required under regulation . |
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Name: |
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Qualification: |
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Address: |
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Telephone Number(s): |
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Mobile No: |
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E mail: |
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Photo Identity Card No. and expiry date |
| 5. |
Name and/or designation, address and contact details of person responsible for complying with conditions of license (if different from 4 above): |
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Name: |
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Address: |
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Telephone Number(s): |
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Mobile No.: |
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E mail: |
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Photo Identity Card No. and expiry date |
| 6. |
Correspondence address (If different from 3 above) |
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| 7. |
Tel No.: |
Mobile No.: |
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Fax No: |
E mail: . |
| 8. |
Food items proposed to be manufactured: |
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Name of Food Item |
Quantity in kg per day or M.T. per annum |
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If required attach separate sheet |
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If already having valid license mention annual quantity of each food category manufactured during last three years |
| 9. |
Installed Capacity Food Productwise (per day) |
| 10. |
For Dairy units |
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(i) |
Location and installed capacity of Milk Chilling Centers (MCC)/Bulk Milk Cooling Centers (BMCs)/Milk Processing Unit/Milk Packaging Unit in litres owned or managed by the applicant. |
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Name of Food Item |
Quantity in kg per day or M.T. per annum |
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| If required attach separate sheet |
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(ii) |
Average quantity of milk per day to be used/handled in |
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a. |
in lean season |
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b. |
in flush season |
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(iii) |
Milk products to be manufactured and their manufacturing capacity (tonnes/year) |
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(1) |
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(2) |
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(3) |
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| 11. |
For Solvent -Extracted Oil, De-oiled meal and Edible Flour: |
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(i) |
Details of proposed business |
| Name of Oil bearing material |
From seed or nut or cake |
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Solvent-Extracted Oil, De-oiled meal and Edible Flour |
Vegetable Oil |
| Crude |
Neutralized and Bleached |
Neutralized meal |
Refined |
De-oiled |
Edible Flour |
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If already having valid license mention annual quantity of each product manufactured during last three years |
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(ii) |
Name and address of factory or factories used by the miller or solvent extractor for processing oil bearing material produced or procured by him or for refining solvent extracted oil produced by him. |
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| 12. |
Sanctioned electricity load or HP to be used .. |
| 13. |
Whether unit is equipped with an analytical laboratory . |
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If yes the details thereof: . |
| 14. |
In case of renewal or transfer of license granted under other laws as per proviso to Regulation 5(1) period for which license required ( 1 to 5 years) |
| 15. |
I/We have forwarded a sum of Rs .. towards License fees according to the provision of the Food Safety and Standards Regulations, 2011, vide: |
| Demand Draft No. (Payable to ) |
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(Signature of the applicant/authorized signatory) |
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| Annexure 1 |
| Declaration |
| I, Mr/M./Mrs .. . S/o/D/o Mr. , R/o .. do hereby solemnly affirm and declare that all information and particulars furnished here by me are true and correct to the best of my knowledge. I further declare that the food business conducted or proposed to be conducted by/through me conforms/shall conform to the Food Safety and Standards Act, Regulations/Bye-laws enacted thereunder, and specifically to the Guidelines on Hygiene and Sanitary Practices provided under Schedule 4 of the Registration and Licensing Regulations published by the Food Safety and Standards Authority of India or any person authorized on its behalf from time to time. |
| Dated: |
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(Signature) |
| Annexure 2 |
| Documents to be enclosed for new application for license to State/Central Licensing Authority |
| 1. |
Form-B duly completed and signed (in duplicate) by the proprietor/partner or the authorised signatory. |
| 2. |
Blueprint/layout plan of the processing unit showing the dimensions in metres/square metres and operationwise area allocation. |
| 3. |
List of Directors with full address and contact details. |
| 4. |
Name and List of Equipments and Machinery along with the number, installed capacity and horse power used. |
| 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 along with alternative responsible person indicating the powers vested with them viz. assisting the officers in inspections, collection of samples, packing and dispatch. |
| 8. |
Analysis Report (Chemical and Bacteriological) of water to be used as ingredient in food from a recognized/public health laboratory to confirm the portability indicating the name of authorized representative of Lab who collected the sample and date of collecting sample. |
| 9. |
Proof of possession of premises. (Sale Deed/Rent Agreement/Electricity bill, etc.) |
| 10. |
Partnership Deed/Affidavit/Memorandum and 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 from a recognised/public health laboratory indicating the name of authorised representative of Lab who collected the sample and date of collecting sample, including source of raw water and treatment plant. |
| 17. |
Recall plan wherever applicable, with details on whom the product is distributed. |
| 18. |
NOCs from Municipality or local body and from State Pollution Control Board except in case of notified industrial area. |
| Documents to be included for renewal or transfer of license given under other existing laws prior to these regulations |
| 1. |
Any change in documents or information provided during grant of previous license. |
| 2. |
Certificate or Plan of Food Safety Management System being adopted (for units under Central Licensing it has to be a certificate from accredited agencies). |
| 3. |
List of workers with their medical fitness certificates. |
| 4. |
Name, qualification and details of technical personnel in charge of operation. |
| Annexure 3 |
| Conditions of License |
| All Food Business Operators shall ensure that the following conditions are complied with at all times during the course of its food business. |
| 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 and 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. |
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Furnish periodic annual return (1st April to 31st March), within up to 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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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 and 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, licensed/registered vendors and maintain record thereof. |
| Other conditions |
| 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: |
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Provided that nothing in this sub-clause shall apply to the sale or movement of the following: |
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(i) |
karanjia oil; |
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(ii) |
kusum oil; |
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(iii) |
mahua oil; |
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(iv) |
neem oil; |
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(v) |
(vi) tamarind seed oil. |
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(vii) |
edible groundnut flour bearing the I.S.I. Certification Mark. |
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(viii) |
edible coconut flour bearing the I.S.I. Certification Mark. |
| 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 recorded in writing. |
Form C
License Format
[See Regulation 2.1.4 (6)]
Government of India
Food Safety and Standards Authority of India
License under FSS Act, 2006
| License No. . |
| 1. |
Name and Registered Office Address of licensee .. |
| 2. |
Address of authorized premises . |
| 3. |
Kind of Business . |
| 4. |
For dairy business details of location with address and capacity of Milk Chilling Centers (MCC)/Bulk Milk Cooling Centers (BMCs)/Milk Processing Unit/Milk Packaging Unit owned by the holder of licensee/RC |
| 5. |
Category of License: |
| This license is granted under and is subject to the provisions of FSS Act, 2006 all of which must be complied with by the licensee. |
| Place: |
Date: |
| Stamp and signature of Designated Officer |
| Food Safety and Standards Authority of India |
| Validation and Renewal |
| Renewal Date |
Period of validity |
License fee paid |
Items of food products with capacities authorized to Manufacture/Re-pack/Re-label |
Installed/ Handling Capacity |
Signature of Designated Officer |
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Form D-1
Annual Return
(For business other than Milk and Milk products)
(See Regulation 2.1.13)
| 1. |
Name and address of Licensee:- |
| 2. |
Address of the authorized premises for the manufacturing/10[importer] of food products: |
| 3. |
License No. |
| 4. |
Statement showing quantities of food products manufactured/11[* * *] imported 12[* * *] in tonnes |
| Name of the food product manufactured/ 13[* * *]/ imported/ 14[* * *] |
Size of can/bottle/ any other package (like PP) or bulk package |
Quantity in MT |
Sale price per kg or per unit of packing |
Value |
Quantity 15[* * *]/ imported in kg |
Name of the country 16[* * *] |
Rate per kg or per unit of packing C.I.F./F.O.B. |
Value |
Remarks |
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Form D-2
(See Regulation 2.1.13)
Half yearly return for Milk and Milk products
For the period ending
(a) 1st April to 30th September
(b) 1st October to 31st March
| 1. |
Name and address of Licensee |
| 2. |
Address of the authorized premises for the manufacturing milk and milk products: |
| 3. |
License No. .. date of issue/validity . |
| 4. |
Procurement |
| Type of milk |
Total Qty MT |
Total fat MT |
Average |
Total SNF content MT |
Price Rs/kg of milk |
Price Rs/kg of fat |
Price Rs/kg of SNF |
| 1 |
2 |
3 |
4 |
5 |
6 |
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Fat% |
SNF% |
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| (A) Own Sources |
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| Cow |
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| Buffalo |
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| Mixed |
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| (B) Milk supplied by other dairies |
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| 5. |
Purchase of Milk Products |
| Name of Milk Products |
Source of purchase (MT)* |
Total quantity purchased |
Average Fat% |
Average SNF% |
Quantity used (MT)* |
Closing balance (MT)* |
| 1. |
SMP |
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WMP |
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Butter Oil |
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White Butter |
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| *Metric Tonnes |
| Utilized for making liquid milk or milk products |
Whole milk powder (MT)* |
Skimmed milk powder (MT)* |
Butter oil (MT)* |
White butter (MT)* |
| All liquid milks for sale |
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In lean season (Apr-Sep) |
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In flush season (Oct-Mar) |
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| Other milk products |
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In lean season (Apr-Sep) |
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In flush season (Oct-Mar) |
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| Sub Total |
| Grand Total |
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| 7. |
Details of Milk products Manufactured, Sold and Stock position. |
| Product Name (Please list out the name of all products mentioned below in this form) |
Opening stock (MT) |
Production of Milk and milk products (MT) |
Average Fat% SNF% |
Sales of milk products |
Closing stock (MT) |
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2 |
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| Total |
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| 8. |
Conversion of Milk into Milk Products outsourced to other dairies |
| Type of milk |
Quantity (TLPD)* |
Average Fat % |
Average SNF% |
Name of converted products |
Quantity (MT) |
| Cow Milk |
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| Buffalo Milk |
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| Mixed Milk |
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| Concentrated Milk |
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Type of milk |
Quantity sold *(TLPD) |
Average Fat % |
Average SNF% |
Consumer price Rs per litre |
| (a) Milk sold in Retail |
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| Sub-total A |
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| (b) Milk sold I bulk to other dairies |
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| Sub-total B |
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| Grand Total A+B |
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| *TLPD Thousand liters per day |
| 10. |
Statement showing quantities of milk products manufactured and exported in tonnes with their sale value during the period .. |
| Name of the milk pro-ducts |
Size of the can/ bottle/ any other package (like PP) or bulk package |
Qty. in MT |
Avg. fat/SNF for milk products (%) |
Sale Price/ kg or per unit of packing Rs |
Val-ue in Rs |
Qty exported/imported in Kg |
Name of the country or port of export |
Rate per kg or/unit of packing C.I.F/FOB Rs |
Value in Rs |
Remarks |
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4a |
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| Date: |
| Signature of the Licensee |
| A register detailing the above information shall be maintained by each licensee for inspections. |
| Name of Milk Products required to be listed in Table 8 Column No. 1. |
| Cream |
Voghurt |
| White butter |
Buttermilk |
| Table butter |
Lassi |
| Butter oil |
Paneer |
| Ghee |
Khoa |
| Skimmed milk powder |
Khoa sweets |
| Whole milk powder |
Flavoured milk pasteurized |
| Dairy whitener |
Flavoured milk sterilized |
| Infant Milk Food |
UHT-MLK |
| Infant formula |
Ice cream |
| Malted milk food |
Casein |
| Dahi/curd |
lactose |
| Shrikhand/Amarkhand |
Whey powder |
| Buttermilk powder |
Any other milk products as lowed in license |
| Condensed milk |
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Form E
Form of Guarantee
[Refer Regulation 2.1.14(2)]
| Invoice No. |
Place: . |
| From: . |
Date: .. |
| To: |
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| Date of sale |
Nature and quality of article/brand name, if any |
Batch No. or Code No. |
Quantity |
Price |
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2 |
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4 |
5 |
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| I/We hereby certify that food/foods mentioned in this invoice is/are warranted to be of the nature and quality which it/these purports/purported to be. |
| Signature of the manufacturer/Distributor/Dealer |
| Name and address of Manufacturer/Packer |
| (In case of packed article) |
| License No. (wherever applicable) |
SCHEDULE 3
(See Regulation 2.1.3)
FEE FOR GRANT/RENEWAL OF LICENSE
REGISTRATION/LICENSE FEE PER ANNUM IN RUPEES
| 1. |
Fees for Registration |
Rs 100 |
| 2. |
Fees for License issued by Central Licensing Authority: |
Rs 7500 |
| 3. |
Fees for License issued by State Licensing Authority: |
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1. |
Manufacturer/Miller |
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(i) |
Above 1 MT per day production or 10,001 to 50,000 LPD of milk or 501 to 2500 MT of milk solids per annum |
Rs 5000 |
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(ii) |
Below 1 MT of production or 501 to 10,000 LPD of milk or 2.5 MT to 500 MT of milk solids per annum |
Rs 3000 |
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2. |
Hotels -3 Star and above |
Rs 5000 |
| 3. |
All Food Service providers including restaurants/boarding houses, clubs etc. serving food, Canteens (Schools, Colleges, Office, Institutions), Caterers, Banquet halls with food catering arrangements, food vendors like dabba-wallas etc. |
Rs 2000 |
| 4. |
Any other Food Business Operator |
Rs 2000 |
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The fees paid by any applicant for a license shall not be refundable under any circumstances. |
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Issue of Duplicate registration or License |
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(1) |
Where a registration certificate or license is lost, destroyed, torn, defaced or mutilated, the applicant may apply for a duplicate copy of the registration certificate or license during the validity period, accompanied with a fee amounting to 10% of the applicable License fee. |
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(2) |
On receipt of such an application, the Licensing Authority shall grant a duplicate copy of the registration certificate or license, as the case may be to the applicant with the word Duplicate appearing prominently thereon. |
| Mode of Payment |
| The payment shall be made by the Food Business Operator through Bank draft or online transfer or Treasury Challan or any other suitable means as specified by the Licensing Authority. |
SCHEDULE 4
(See Regulation 2.1.2)
General Hygienic and Sanitary practices to be followed by Food Business Operators
It is hereby recognized and declared as a matter of legislative determination that in the field of human nutrition, safe, clean, wholesome food is indispensable to the health and welfare of the consumer of the country; that food is a perishable commodity susceptible to contamination and adulteration; and that basic sanitary and hygienic conditions are deemed to be necessary for the production and distribution of milk Meat products, service establishments, etc.
The establishment in which food is being handled, processed, manufactured, stored, distributed by the food business operator whether holder of registration certificate or a license as per the norms laid down in these regulations and the persons handling them should conform to the sanitary and hygienic requirement, food safety measures and other standards as specified below. It shall also be deemed to be the responsibility of the food business operator to ensure adherence to necessary requirements.
These are the basic compulsory requirements for ensuring safety of the food manufactured in any premise and FBOs shall continuously try to improve the sanitary and hygienic conditions at the premises with a goal of attaining India HACCP standards within a - previously determined period.
Part I
General Hygienic and Sanitary Practices to be followed by Petty Food Business Operators applying for Registration
[See Regulation 2.1.1 (2)]
In case inspection of the units is directed by the Registering or Licensing Authority, the inspection should confirm that the following measures are adopted by the unit as far as possible:
SANITARY AND HYGIENIC REQUIREMENTS FOR FOOD MANUFACTURER/PROCESSOR/ HANDLER
The place where food is manufactured, processed or handled shall comply with the following requirements:
1. The premises shall be located in a sanitary place and free from filthy surroundings and shall maintain overall hygienic environment. All new units shall set up away from environmentally polluted areas.
2. The premises to conduct food business for manufacturing should have adequate space for manufacturing and storage to maintain overall hygienic environment.
3. The premises shall be clean, adequately lighted and ventilated and sufficient free space for movement.
4. Floors, Ceilings and walls must be maintained in a sound condition. They should be smooth and easy to clean with no flaking paint or plaster.
5. The floor and skirted walls shall be washed as per requirement with an effective disinfectant the premises shall be kept free from all insects. No spraying shall be done during the conduct of business, but instead fly swats/flaps should be used to kill spray flies getting into the premises. Windows, doors and other openings shall be fitted with net or screen, as appropriate to make the premise insect free The water used in the manufacturing shall be potable and if required chemical and bacteriological examination of the water shall be done at regular intervals at any recognized laboratory.
6. Continuous supply of potable water shall be ensured in the premises. In case of intermittent water supply, adequate storage arrangement for water used in food or washing shall be made.
7. Equipment and machinery when employed shall be of such design which will permit easy cleaning. Arrangements for cleaning of containers, tables, working parts of machinery, etc. shall be provided.
8. No vessel, container or other equipment, the use of which is likely to cause metallic contamination injurious to health shall be employed in the preparation, packing or storage of food. (Copper or brass vessels shall have proper lining).
9. All equipments shall be kept clean, washed, dried and stacked at the close of business to ensure freedom from growth of mould/fungi and infestation.
10. All equipments shall be placed well away from the walls to allow proper inspection.
11. There should be efficient drainage system and there shall be adequate provisions for disposal of refuse.
12. The workers working in processing and preparation shall use clean aprons, hand gloves, and head wears.
13. Persons suffering from infectious diseases shall not be permitted to work. Any cuts or wounds shall remain covered at all time and the person should not be allowed to come in direct contact with food.
14. All food handlers shall keep their finger nails trimmed, clean and wash their hands with soap, or detergent and water before commencing work and every time after using toilet. Scratching of body parts, hair shall be avoided during food handling processes.
15. All food handlers should avoid wearing, false nails or other items or loose jewellery that might fall into food and also avoid touching their face or hair.
16. Eating, chewing, smoking, spitting and nose blowing shall be prohibited within the premises especially while handling food.
17. All articles that are stored or are intended for sale shall be fit for consumption and have proper cover to avoid contamination.
18. The vehicles used to transport foods must be maintained in good repair and kept clean.
19. Foods while in transport in packaged form or in containers shall maintain the required temperature.
20. Insecticides/disinfectants shall be kept and stored separately and away from food manufacturing/storing/handling areas.
A. SANITARY AND HYGIENIC REQUIREMENTS FOR STREET FOOD VENDORS AND UNITS OTHER THAN MANUFACTURING/PROCESSING
1. Potential sources of contamination like rubbish, waste water, toilet facilities, open drains and stray animals shall be avoided.
2. The surfaces of the vending carts which come in contact with food or food storage utensils shall be built of solid, rust/corrosion resistant materials and kept in clean and good condition They shall be protected from sun, wind and dust. When not in use, food vending vans shall be kept in clean place and properly protected.
3. Rubbish bin with cover shall be provided by food stall or vending cart owners for any waste generated in the process of serving and eating by consumers.
4. Working surfaces of vending carts shall be clean, hygienic, impermeable and easy to clean (like stainless steel), and placed at least 60 to 70 cm from above ground.
5. Sale points, tables, awnings, benches and boxes, cupboards, glass cases, etc. shall be clean and tidy.
6. Cooking utensils and crockery shall be clean and in good condition. It should not be broken/chipped.
7. All containers shall be kept clean, washed and dried at the close of business to ensure that there is no growth of mould/fungi and infestation.
8. Water used for cleaning, washing and preparing food shall be potable in nature.
9. Transporting of drinking water (treated water like bottled water, boiled/filtered water through water purifier etc.) shall be in properly covered and protected containers and it shall be stored in clean and covered containers in a protected area away from dust and filth.
10. Cooking, storage and serving shall not be done in utensils of, cadmium, lead, non-food grade plastic and other toxic materials.
11. Utensils shall be cleaned of debris, rinsed, scrubbed with detergent and washed under running tap water after every operation. Wiping of utensils shall be done with clean cloth. Separate cloths shall be used for wiping hands and for clearing surfaces, cloth used for floor cleaning will not be used for cleaning surfaces of tables and working areas and for wiping utensils Person cooking, handling or serving food should use hand gloves and aprons, where necessary. He shall wear head gear and cover his mouth always while at work.
12. Removing dust or crumb from plates or utensils shall be done by using cloth or wiper into dustbin.
13. The person suffering from infectious disease shall not be permitted to work.
14. All food handlers shall remain clean, wear washed clothes and keep their finger nails trimmed, clean and wash their hands with soap/detergent and water before commencing work and every time after touching food or using toilet.
15. All food handlers should avoid wearing loose items that might fall into food and also avoid touching or scratching their face, head or hair.
16. All articles that are stored or intended for sale shall have proper cover to avoid contamination. Food should be stored only in food grade plastic containers as steel containers to prevent leaking.
17. Eating, chewing, smoking, spitting and nose blowing shall be prohibited within the premises.
18. Foods shall be prepared or cooked as per the day's requirement to avoid left over which might be used in the next day without ascertaining its safety for consumption or use in food. Consumables left over shall be kept in the refrigerator immediately after their intended use.
19. Adequate number of racks shall be provided for storage of articles of food, with clear identity of each commodity. Proper compartment for each class shall also be provided wherever possible so that there is no cross contamination.
20. Rubbish or garbage bin shall be with a tight cover and shall be cleaned everyday by transferring contents into designated locations.
21. Vegetarian and non-vegetarian items should be segregated.
22. Fridge should be cleaned at least once a week to remove stains, ice particles and food particles. The temperature in the fridge should be in the range of 4 C - 6 C.
23. The location of the vending unit should be in a place approved by the local authorities and not blocking traffic or pedestrians or near unhygienic locations.
Part II
[See Regulation 2.1.1 (4)]
General Requirements on Hygienic and Sanitary Practices to be followed by all Food Business Operators applying for License
The establishment in which food is being handled, processed, manufactured, packed, stored, and distributed by the food business operator and the persons handling them should conform to the sanitary and hygienic requirement, food safety measures and other standards as specified below. It shall also be deemed to be the responsibility of the food business operator to ensure adherence to necessary requirements.
In addition to the requirements specified below, the food business operator shall identify steps in the activities of food business, which are critical to ensure food safety, and ensure that safety procedures are identified, implemented, maintained and reviewed periodically.
1. LOCATION AND SURROUNDINGS
1.1 Food establishment shall ideally be located away from environmental pollution and industrial activities that produce disagreeable or obnoxious odour, fumes, excessive soot, dust, smoke, chemical or biological emissions and pollutants, and which pose a threat of contaminating food areas that are prone to infestations of pests or where wastes, either solid or liquid, cannot be removed effectively.
1.2 In case there are hazards of other environment polluting industry located nearby, appropriate measures should be taken to protect the manufacturing area from any potential contamination.
1.3 The manufacturing premise should not have direct access to any residential area.
2. LAYOUT AND DESIGN OF FOOD ESTABLISHMENT PREMISES
As far as possible, the layout of the food establishment shall be such that food preparation/ manufacturing processes are not amenable to cross-contamination from other pre and post-manufacturing operations like goods receiving, pre-processing (viz. packaging, washing/portioning of ready-to-eat food etc.).
2.1 Floors, ceilings and walls must be maintained in a sound condition to minimize the accumulation of dirt, condensation and growth of undesirable moulds. They should be made of impervious material and should be smooth and easy to clean with no flaking paint or plaster.
2.2 Doors shall also be made of smooth and non-absorbent surfaces so that they are easy to clean and wherever necessary, disinfect.
2.3 The floor of food processing/food service area shall have adequate and proper drainage and shall be easy to clean and where necessary, disinfect. Floors shall be sloped appropriately to facilitate drainage and the drainage shall flow in a direction opposite to the direction of food preparation/manufacturing process flow.
2.4 Adequate control measures should be in place to prevent insects and rodents from entering the processing area from drains.
2.5 Windows, doors and all other openings to outside environment shall be well screened with wire-mesh or insect-proof screen as applicable to protect the premise from fly and other insects/pests/animals and the doors be fitted with automatic closing springs. The mesh or the screen should be of such type which can be easily removed for cleaning.
2.6 No person shall 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.
3. EQUIPMENT AND CONTAINERS
3.1 Equipment and containers that come in contact with food and used for food handling, storage, preparation, processing, packaging and serving shall be made of corrosion free materials which do not impart any toxicity to the food material and should be easy to clean and/or disinfect (other than disposable single use types).
3.2 Equipment and utensils used in the preparation of food shall be kept at all times in good order and repair and in a clean and sanitary condition. Such utensil or container shall not be used for any other purpose.
3.3 Every utensil or container containing any food or ingredient of food intended for sale shall at all times be either provided with a properly fitted cover/lid or with a clean gauze net or other material of texture sufficiently fine to protect the food completely from dust, dirt and flies and other insects.
3.4 No utensil or container used for the manufacture or preparation of or containing any food or ingredient of food intended for sale shall be kept in any place in which such utensil or container is likely by reason of impure air or dust or any offensive, noxious or deleterious gas or substance or any noxious or injurious emanations, exhalation, or effluvium, to be contaminated and thereby render the food noxious.
3.5 Equipment shall be so located, designed and fabricated that it permits necessary maintenance and cleaning functions as per its intended use and facilitates good hygiene practices inside the premise including monitoring and audit.
3.6 Appropriate facilities for the cleaning and disinfecting of equipments and instruments and wherever possible cleaning in place (CIP) system shall be adopted.
3.7 Equipment and containers for waste, by-products and inedible or dangerous substances, shall be specifically identifiable and suitably constructed.
3.8 Containers used to hold cleaning chemicals and other dangerous substances shall be identified and stored separately to prevent malicious or accidental contamination of food.
3.9 If required, a waste water disposal system/effluent treatment plant shall be put in place.
3.10 All items, fittings and equipments that touch or come in contact with food must be:
kept in good condition in a way that enables them to be kept clean and wherever necessary, to be disinfected.
Chipped enamelled containers will not be used. Stainless stee1/aluminium/glass containers, mugs, jugs, trays etc. suitable for cooking and storing shall be used. Brass utensils shall be frequently provided with lining.
4. FACILITIES
4.1 Water supply
4.1.1 Only potable water, with appropriate facilities for its storage and distribution shall be used as an ingredient in processing and cooking.
4.1.2 Water used for food handling, washing, should be of such quality that it does not introduce any hazard or contamination to render the finished food article unsafe.
4.1.3 Water storage tanks shall be cleaned periodically and records of the same shall be maintained in a register.
4.1.4 Non-potable water can be used provided it is intended only for cleaning of equipment not coming in contact with food, which does not come into contact with food steam production, fire fighting and refrigeration equipment and provided that pipes installed for this purpose preclude the use of this water for other purposes and present no direct or indirect risk of contamination of the raw material, dairy products or food products so processed, packed and kept in the premise.
4.1.5 Non-potable water pipes shall be clearly distinguished from those in use for potable water.
4.2 For Cleaning Utensils/Equipments. Adequate facilities for cleaning, disinfecting of utensils and equipments shall be provided. The facilities must have an adequate supply of hot and cold water if required.
4.3 Washing of Raw materials. Adequate facilities for washing of raw food should be provided. Every sink (or other facilities) for washing food must have an adequate supply of hot and/or cold water. These facilities must be kept clean and, where necessary, disinfected. Preferably, sinks which are used for washing raw foods shall be kept separate and that should not be used for washing utensils or any other purposes.
4.4 Ice and Steam. Ice and steam used in direct contact with food shall be made from potable water and shall comply with requirements specified under 4.1.1. Ice and steam shall be produced, handled and stored in such a manner that no contamination can happen.
4.5 Drainage and waste disposal
4.5.1 Food waste and other waste materials shall be removed periodically from the place where food is being handled or cooked or manufactured to avoid building up. A refuse bin of adequate size with a proper cover preferably one which need not be touched for opening shall be provided in the premises for collection of waste material. This shall be emptied and washed daily with a disinfectant and dried before next use.
4.5.2 The disposal of sewage and effluents (solid, liquid and gas) shall be in conformity with requirements of Factory/Environment Pollution Control Board. Adequate drainage, waste disposal systems and facilities shall be provided and they shall be designed and constructed in such manner so that the risk of contaminating food or the potable water supply is eliminated.
4.5.3 Waste storage shall be located in such manner that it does not contaminate the food process, storage areas, the environment inside and outside the food establishment and waste shall be kept in covered containers and shall be removed at regular intervals.
4.5.4 Periodic disposal of the refuse/waste should be made compulsory. No waste shall be kept open inside the premise and shall be disposed of in an appropriate manner as per local rules and regulations including those for plastics and other non-environment friendly materials.
4.6 Personnel facilities and toilets
4.6.1 Personnel facilities shall include those for proper washing and drying of hands before touching food materials including wash basins and a supply of hot and/or cold water as appropriate; separate lavatories, of appropriate hygienic design, for males and females separately; and changing facilities for personnel and such facilities shall be suitably located so that they do not open directly into food processing, handling or storage areas.
4.6.2 Number of toilets should be adequate depending on the number of employees (male/female) in the establishment and they should be made aware of the cleanliness requirement while handling food.
4.6.3 Rest and refreshments rooms shall be separate from food process and service areas and these areas shall not lead directly to food production, service and storage areas.
4.6.4 A display board mentioning do's and don'ts for the workers shall be put up inside at a prominent place in the premise in English or in local language for everyone's understanding.
4.7 Air quality and ventilation. Ventilation systems natural and/or mechanical including air filters, exhaust fans, wherever required, shall be designed and constructed so that air does not flow from contaminated areas to clean areas.
4.8 Lighting. Natural or artificial lighting shall be provided to the food establishment, to enable the employees/workers to operate in a hygienic manner. Lighting fixtures must wherever appropriate, be protected to ensure that food is not contaminated by breakages of electrical fittings.
5. FOOD OPERATIONS AND CONTROLS
5.1 Procurement of raw materials
5.1.1 No raw material or ingredient thereof shall be accepted by an establishment if it is known to contain parasites, undesirable micro-organisms, pesticides, veterinary drugs or toxic items, decomposed or extraneous substances, which would not be reduced to an acceptable level by normal sorting and/or processing.
5.1.2 All raw materials, food additives and ingredients, wherever applicable, shall conform to all the regulations and standards laid down under the Act.
5.1.3 Records of raw materials, food additives and ingredients as well as their source of procurement shall be maintained in a register for inspection.
5.1.4 All raw materials should be checked and cleaned physically and thoroughly.
5.1.5 Raw materials should be purchased in quantities that correspond to storage/preservation capacity.
5.1.6 Packaged raw material must be checked for expiry date / best before / use by date, packaging integrity and storage conditions.
5.1.7 Receiving temperature of potentially high risk food should be at or below 5 C.
5.1.8 Receiving temperature of frozen food should be 8 C or below.
5.2 Storage of raw materials and food
5.2.1 Food storage facilities shall be designed and constructed to enable food to be effectively protected from contamination during storage; permit adequate maintenance and cleaning, to avoid pest access and accumulation.
5.2.2 Cold Storage facility, wherever required, shall be provided to raw, processed/packed food according to the type and requirement.
5.2.3 Segregation shall be provided for the storage of raw, processed, rejected, recalled or returned materials or products which will be distinguishably marked and secured. Raw materials and food shall be stored in separate areas from printed packaging materials, stationery, hardware and cleaning materials/ chemicals.
5.2.4 Raw food, particularly meat, poultry and seafood products shall be cold stored separately from the area of work-in-progress, processed, cooked and packaged products. The conditions of storage in terms of temperature and humidity requisite for enhancing the shelf life of the respective food materials/products shall be maintained.
5.2.5 Storage of raw materials, ingredients, work-in-progress and processed/cooked or packaged food products shall be subject to FIFO (First in, First Out), FEFO (First Expire First Out) stock rotation system as applicable.
5.2.6 Containers made of non-toxic materials shall be provided for storage of raw materials, work-in-progress and finished/ready to serve products. The food materials shall be stored on racks/pallets such that they are reasonably well above the floor level and away from the wall so as to facilitate effective cleaning and prevent harbouring of any pests, insects or rodents.
5.3 Food Processing/Preparation, Packaging and Distribution/Service
5.3.1. Time and temperature control.
5.3.1.1 The Food Business shall develop and maintain the systems to ensure that time and temperature are controlled effectively where it is critical to the safety and suitability of food. Such control shall include time and temperature of receiving, processing, cooking, cooling, storage, packaging, distribution and food service up to the consumer, as applicable.
5.3.1.2 Whenever frozen food/raw materials are being used/handled/transported, proper care should be taken so that defrosted/thawed material are not stored back after opening for future use.
5.3.1.3 If thawing is required then only required portion of the food should be thawed at a time.
5.3.1.4 Wherever cooking is done on open fire, proper outlets for smoke/steam etc. like chimney, exhaust fan etc. shall be provided.
5.4 Food Packaging
5.4.1 Packaging materials shall provide protection for all food products to prevent contamination, damage and shall accommodate required labelling as laid down under the FSS Act and the regulations thereunder.
5.4.2 For primary packaging (i.e. packaging in which the food or ingredient or additive comes in direct contact with the packaging material), only Food grade packaging materials are to be used. For packaging materials like aluminium plastic and tin, the standards to be followed are as mentioned under the FSS Regulations and rules framed thereunder.
5.4.3 Packaging materials or gases where used, shall be non-toxic and shall not pose a threat to the safety and suitability of food under the specified conditions of storage and use.
5.5 Food Distribution/Service
5.5.1 All critical links in the supply chain need to be identified and provided for to minimize food spoilage during transportation. Processed/packaged and/or ready-to-eat food shall be protected as per the required storage conditions during transportation and/or service.
5.5.2 Temperatures and humidity which are necessary for sustaining food safety and quality shall be maintained. The conveyances and/or containers shall be designed, constructed and maintained in such manner that they can effectively maintain the requisite temperature, humidity, atmosphere and other conditions necessary to protect food conveyances and/or containers used for transporting/serving foodstuffs shall be non-toxic, kept clean and maintained in good condition in order to protect foodstuffs from any contamination.
5.5.3 Receptacles in vehicles and/or containers shall not be used for transporting anything other than foodstuffs where this may result in contamination of foodstuffs. Where the same conveyance or container is used for transportation of different foods, or high risk foods such as fish, meat, poultry, eggs etc., effective cleaning and disinfections shall be carried out between loads to avoid the risk of cross- contamination. For bulk transport of food, containers and conveyances shall be designated and marked for food use only and be used only for that purpose.
6. MANAGEMENT AND SUPERVISION
6.1 A detailed Standard Operating Procedure (SOP) for the processing of food as well as its packing, despatch and storage will be developed for proper management which in turn would help in identifying any problem and the exact point, so that damage control would be faster.
6.2 The Food Business shall ensure that technical managers and supervisors have appropriate qualifications, knowledge and skills on food hygiene principles and practices to be able to ensure food safety and quality of its products, judge food hazards, take appropriate preventive and corrective action, and to ensure effective monitoring and supervision.
7. FOOD TESTING FACILITIES
7.1 A well equipped, laboratory for testing of food materials/food for physical, microbiological and chemical analysis in accordance with the specification/standards laid down under the rules and regulations shall be in place inside the premise for regular/periodic testing and whenever required.
7.2 In case of any suspicion or possible contamination, food materials/food shall be tested before dispatch from the factory.
7.3 If there is no in-house laboratory facility, then regular testing shall be done through an accredited lab notified by FSSAI. In case of complaints received and if so required, the company shall voluntarily do the testing either in the in-house laboratory or an accredited lab or lab notified by FSSAI.
8. AUDIT, DOCUMENTATION AND RECORDS
8.1 A periodic audit of the whole system according to the SOP shall be done to find out any fault/gap in the GMP/GHP system.
8.2 Appropriate records of food processing/preparation, production/cooking, storage, distribution, service, food quality, laboratory test results, cleaning and sanitation, pest control and product recall shall be kept and retained for a period of one year or the shelf-life of the product, whichever is more.
9. SANITATION AND MAINTENANCE OF ESTABLISHMENT PREMISES
9.1 Cleaning and Maintenance
9.1.1 A cleaning and sanitation programme shall be drawn up and observed and the record thereof shall be properly maintained, which shall indicate specific areas to be cleaned, cleaning frequency and cleaning procedure to be followed, including equipment and materials to be used for cleaning. Equipments used in manufacturing will be cleaned and sterilized at set frequencies.
9.1.2 Cleaning chemicals shall be handled and used carefully in accordance with the instructions of the manufacturer and shall be stored separately away from food materials, in clearly identified containers, to avoid any risk of contaminating food.
9.2 Pest Control Systems
9.2.1 Food establishment, including equipment and building shall be kept in good repair to prevent pest access and to eliminate potential breeding sites. Holes, drains and other places where pests are likely to gain access shall be kept in sealed condition or fitted with mesh/grills/claddings or any other suitable means as required and animals, birds and pets shall not be allowed to enter into the food establishment areas/premises.
9.2.2 Food materials shall be stored in pest-proof containers stacked above the ground and away from walls.
9.2.3 Pest infestations shall be dealt with immediately and without adversely affecting the food safety or suitability. Treatment with permissible chemical, physical or biological agents, within the appropriate limits, shall be carried out without posing a threat to the safety or suitability of food. Records of pesticides/insecticides used along with dates and frequency shall be maintained.
10. PERSONAL HYGIENE
10.1 Health Status
10.1.1 Personnel known, or believed, to be suffering from, or to be a carrier of a disease or illness likely to be transmitted through food, shall not be allowed to enter into any food handling area. The Food Business shall develop system, whereby any person so affected, shall immediately report illness or symptoms of illness to the management and medical examination of a food handler shall be carried out apart from the periodic checkups, if clinically or epidemiologically indicated.
10.1.2 Arrangements shall be made to get the food handlers/employees of the establishment medically examined once in a year to ensure that they are free from any infectious, contagious and other communicable diseases. A record of these examinations signed by a registered medical practitioner shall be maintained for inspection purpose.
10.1.3 The factory staff shall be compulsorily inoculated against the enteric group of diseases as per recommended schedule of the vaccine and a record shall be kept for inspection.
10.1.4 In case of an epidemic, all workers are to be vaccinated irrespective of the scheduled vaccination.
10.2 Personal Cleanliness
10.2.1 Food handlers shall maintain a high degree of personal cleanliness. The food business shall provide to all food handlers adequate and suitable clean protective clothing, head covering, face mask, gloves and footwear and the food business shall ensure that the food handlers at work wear only clean protective clothes, head covering and footwear every day.
10.2.2 Food handlers shall always wash their hands with soap and clean potable water, disinfect their hands and then dry with hand drier or clean cloth towel or disposable paper at the beginning of food handling activities immediately after handling raw food or any contaminated material, tools, equipment or work surface, where this could result in contamination of other food items or after using the toilet.
10.2.3 Food handlers engaged in food handling activities shall refrain from smoking, spitting, chewing, sneezing or coughing over any food whether protected or unprotected and eating in food preparation and food service areas.
10.2.4 The food handlers should trim their nails and hair periodically, do not encourage or practice unhygienic habits while handling food.
10.2.5 Persons working directly with and handling raw materials or food products shall maintain high standards of personal cleanliness at all times. In particular:
(a) they shall not smoke, spit, eat or drink in areas or rooms where raw materials and food products are handled or stored;
(b) wash their hands at least each time work is resumed and whenever contamination of their hands has occurred; e.g. after coughing/sneezing, visiting toilet, using telephone, smoking etc.
(c) avoid certain hand habits e.g. scratching nose, running finger through hair, rubbing eyes, ears and mouth, scratching beard, scratching parts of bodies etc. that are potentially hazardous when associated with handling food products, and might lead to food contamination through the transfer of bacteria from the employee to product during its preparation. When unavoidable, hands should be effectively washed before resuming work after such actions.
10.3 Visitors
10.3.1 Generally visitors should be discouraged from going inside the food handling areas. Proper care has to be taken to ensure that food safety and hygiene is not getting compromised due to visitors in the floor area.
10.3.2 The Food Business shall ensure that visitors to its food manufacturing, cooking, preparation, storage or handling areas must wherever appropriate, wear protective clothing, footwear and adhere to the other personal hygiene provisions envisaged in this section.
11. PRODUCT INFORMATION AND CONSUMER AWARENESS
All packaged food products shall carry a label and requisite information as per provisions of Food Safety and Standards Act, 2006 and regulations made thereunder so as to ensure that adequate and accessible information is available to the each person in the food chain to enable them to handle, store, process, prepare and display the food products safely and correctly and that the lot or batch can be easily traced and recalled, if necessary.
12. TRAINING
12.1 The Food Business shall ensure that all food handlers are aware of their role and responsibility in protecting food from contamination or deterioration. Food handlers shall have the necessary knowledge and skills which are relevant to food processing/manufacturing, packing, storing and serving so as to ensure the food safety and food quality.
12.2 The Food Business shall ensure that all the food handlers are instructed and trained in food hygiene and food safety aspects along with personal hygiene requirements commensurate with their work activities, the nature of food, its handling, processing, preparation, packaging, storage, service and distribution.
12.3 Periodic assessments of the effectiveness of training, awareness of safety requirements and competency level shall be made, as well as routine supervision and checks to ensure that food hygiene and food safety procedures are being carried out effectively.
12.4 Training programmes shall be routinely reviewed and updated wherever necessary.
Part III
[See Regulation 2.1.2.(1)(5)]
Specific Hygienic and Sanitary Practices to be followed by Food Business Operators engaged in manufacture, processing, storing and selling of Milk and Milk Products
In addition to Part-II, the dairy establishment in which dairy based food is being handled, processed, manufactured, stored, distributed and ultimately sold by the food business operator, and the persons handling them should conform to the sanitary and hygienic requirement, food safety measures and other standard as specified below.
I. SANITARYREQUIREMENTS
1. Dairy Establishments shall have the following:
(a) Facilities for the hygienic handling and protection of raw materials and of non-packed or non-wrapped dairy products during loading and unloading, transport and storing including Bulk Milk cooling facilities.
(b) Special watertight, non-corrodible containers to put raw materials or dairy products intended for human consumption. Where such raw materials or dairy products are removed through conduits, these shall be constructed and installed in such a way so as to avoid any risk of contamination of other raw materials or dairy products;
(c) a waste water disposal system which is hygienic and approved;
(d) facilities for cleaning and disinfecting of tanks used for transporting dairy products and raw milk. These containers have to be cleaned after every use.
2. The occupier of a dairy establishment shall take appropriate measures to avoid cross-contamination of dairy products in accordance with the cleaning program as specified in point 9.1 of Part II.
3. Where a dairy establishment produces food stuffs containing dairy products together with other ingredients, which have not undergone heat treatment or any other treatment having equivalent effect, such dairy products and ingredients shall be stored separately to prevent cross-contamination.
4. The production of heat-treated milk or the manufacture of milk-based products, which might pose a risk of contamination to other dairy products, shall be carried out in a clearly separated working area.
5. Equipment, containers and installations which come into contact with dairy products or perishable raw materials used during production shall be cleaned and if necessary disinfected according to a verified and documented cleaning programme.
6. Equipment, containers, instruments and installations which come in contact with microbiologically stable dairy products and the rooms in which they are stored shall be cleaned and disinfected according to a verified and documented Food Safety management programme drawn up by the owner/occupier of the dairy establishment.
7. Disinfectants and similar substances used shall be used in such a way that they do not have any adverse effects on the machinery, equipment, raw materials and dairy products kept at the dairy establishment. They shall be in clearly identifiable containers bearing labels with instructions for their use and their use shall be followed by thorough rinsing of such instruments and working equipment with potable water, unless supplier's instructions indicate otherwise.
II. PERSONAL HYGIENE REQUIREMENTS
1. The Food Business Operator shall employ those persons only in such an establishment to work directly with and handle raw materials or dairy products if those persons have proved to the occupier's satisfaction by means of a medical certificate, on recruitment, that there is no medical impediment to their employment in that capacity.
2. Persons working directly with and handling raw materials or dairy products shall maintain the highest standards of personal cleanliness at all times. In particular they shall
(a) wear suitable, clean working clothes and headgear which completely encloses their hair;
(b) wash their hands at least each time work is resumed and whenever contamination of their hands has occurred; e.g. after coughing/sneezing, visiting toilet, using telephone, smoking etc.;
(c) cover wounds to the skin with a suitable waterproof dressing. No person with injury on hand, even with dressing, shall be placed in any product making/handling section;
(d) avoid certain hand habits - e.g. scratching nose, running finger through hair, rubbing eyes, ears and mouth, scratching beard, scratching parts of bodies etc. that are potentially hazardous when associated with handling dairy products, and might lead to food contamination through the transfer of bacteria from the employee to product during its preparation. When unavoidable, hands should be effectively washed before resuming work after such actions.
III. SANITARYREQUIREMENTS FOR STORAGE
1. Immediately after procuring, raw milk shall be placed in a clean place, which is suitably equipped so as to prevent any kind of contamination.
2. The cans/containers made up of mild steel metal and plastic material used for storage and transportation of milk and milk products shall not be allowed.
3. If raw milk is brought to the dairy plant by a producer or farmer then it shall be ensured that he brings it within four hours of milking and it shall be cooled as soon as practicable to a temperature of 4 C or lower and maintained at that temperature until processed.
4. Where raw milk is collected daily from a producer, it shall be cooled immediately to a temperature of 4 C to 6 C or lower and maintained at that temperature until processed;
5. When the pasteurization process is completed, pasteurized milk shall be cooled immediately to a temperature of 4 C or lower.
6. Subject to Paragraph 7 below, any dairy product not intended to be stored at ambient temperature shall be cooled as quickly as possible to the temperature established by the manufacturer of that product as suitable to ensure its durability and thereafter stored at that temperature.
7. Where dairy products other than raw milk are stored under cooled conditions, their storage temperatures shall be registered and the cooling rate shall be such that the products reach the required temperature as quickly as possible.
8. The maximum temperature at which pasteurized milk may be stored until it leaves the treatment establishment shall not exceed 5 C.
IV. WRAPPING AND PACKAGING
1. The wrapping and packaging of dairy products shall take place under satisfactory hygienic conditions and in rooms provided for that purpose.
2. The manufacture of dairy products and packaging operations may take place in the same room if the following conditions are satisfied:
(a) The room shall be sufficiently large and equipped to ensure the hygiene of the operations;
(b) the wrapping and packaging shall have been brought to the treatment or processing establishment in protective cover in which they were placed immediately after manufacture and which protects the wrapping or packaging from any damage during transport to the dairy establishment, and they shall have been stored thereunder hygienic conditions in a room intended for that purpose;
(c) the rooms for storing the packaging material shall be free from vermin and from dust which could constitute an unacceptable risk of contamination of the product and shall be separated from rooms containing substances which might contaminate the products. Packaging shall not be placed directly on the floor;
(d) packaging shall be assembled under hygienic conditions before being brought into the room, except in the case of automatic assembly or packaging, provided that there is no risk of contamination of the products;
(e) packaging shall be done without delay. It shall be handled by separate group of staff having experience in handling and product wrapping, and
(f) immediately after packaging, the dairy products shall be placed in the designated rooms provided for storage under required temperature.
3. Bottling or filling of containers with heat-treated milk and milk product shall be carried out hygienically.
4. Wrapping or packaging may not be re-used for dairy products, except where the containers are of a type which may be re-used after thorough cleaning and disinfecting.
5. Sealing shall be carried out in the establishment in which the last heat-treatment of milk or liquid milk-based products have been carried out, immediately after filling, by means of a sealing device which ensures that the milk is protected from any adverse effects of external origin on its characteristic. The sealing device shall be so designed that once the container has been opened, the evidence of opening remains clear and easy to check.
Part IV
[See Regulation 2.1.2 (1)(5)]
Specific Hygienic and Sanitary Practices to be followed by Food Business Operators engaged in manufacture, processing, storing and selling of Meat and Meat Products
A. Slaughter House. Food Business Operator which slaughters large animals and small animals including sheep and goat or poultry birds within the premises of his factory for production of meat/meat products for supply/sale/distribution to the public shall comply with the following requirements:
1. General Requirements:
1.1 No Objection Certificate to be obtained from local Authority before grant of license.
2. Location of Premises:
Such establishments/Slaughter Houses should be linked to a meat market located away from vegetable, fish or other food markets and shall be free from undesirable odour, smoke, dust or other contaminants. The premises shall be located at elevated level in a sanitary place.