MINISTRY OF HEALTHAND F AMILY WELFARE (Food Safety …

1 Hkkx III [ 4 Hkkjr dk jkti=k % OF HEALTH AND FAMILY WELFARE (Food Safety and Standards Authority of India)Notification New Delhi, dated the 1st August, 2-15015/30/2010 Whereas in exercise of the powers conferred by clause (o) of sub section (2) of section 92 read withsection 31 of food Safety and Standards Act, 2006 (34 of 2006) the food Safety and Standards Authority of Indiaproposes to make food Safety and Standards Regulations in so far as they relates to food Safety and Standards(Licensingand Registration of food Businesses) Regulations, 2011, and; Whereas these draft Regulations were published in consolidated form at pages 1 to 776 in the Gazette of IndiaExtraordinary Part III Sec. 4 dated 20th October 2010 inviting objections and suggestions from all persons likely to beaffected thereby before the expiry of the period of thirty days from the date on which the copies of the Gazette containingthe said notification were made available to the public;And whereas the copies of the Gazette were made available to the public on the 21st October 2010.]

2 And whereas objections and suggestions received from the stakeholders within the specified period on the saiddraft Regulations have been considered and finalized by the food Safety and Standards Authority of therefore, the food Safety and Standards Authority of India hereby makes the following Regulations, namely,- food Safety AND STANDARDS (LICENSING AND REGISTRATION OF food BUSINESSES),REGULATIONS 2011 CHAPTER : Short title and : These regulations may be called the food Safety and Standards (Licensing and Registration of food Businesses)Regulations, : These regulations shall come into force on or after 5th August, : : In these regulations unless the context otherwise requires:1. Central Licensing Authority means Designated officer appointed by the Chief Executive officer of theFood Safety and Standards Authority of India in his capacity of food Safety District means a revenue district in state and UTs provided that the Commisioner of food Safety may, forthe purpose of this Act declare any local area as a district on the basis of:z Concentration of specific category of food businesses which may need special Risk assessment carried out by the Authority from time to Any other specific regulatory Licensing Authority means the Designated officer appointed under section 36 (i) of the Act by theCommissioner of food Safety of the state or by the Chief Executive officer of the food Safety and StandardsAuthority of India in his capacity of food Safety Commissioner ;4.

3 Petty food Manufacturer means any food manufacturer, who(a) manufactures or sells any article of food himself or a petty retailer, hawker, itinerant vendor ortemporary stall holder; or distributes foods including in any religious or social gathering except a caterer;or66 THE GAZETTE OF INDIA : EXTRAORDINARY[PART III SEC. 4](b) such other food businesses including small scale or cottage or such other industries relating to foodbusiness or tiny food businesses with an annual turnover not exceeding Rs 12 lakhs and/or whose(i) production capacity of food (other than milk and milk products and meat and meat products)does not exceed 100 kg/ltr per day or(ii) procurement or handling and collection of milk is up to 500 litres of milk per day or(iii) slaughtering capacity is 2 large animals or 10 small animals or 50 poultry birds per day or Registering Authority means Designated officer / food Safety officer or any official in Panchayat, MunicipalCorporation or any other local body or Panchayat in an area, notified as such by the State food Safety Commissionerfor the purpose of registration as specified in these State Licensing Authority means Designated Officers appointed under Section 36(1) of the Act by theFood Safety Commissioner of a State or expressions used in these Regulations but have not been defined herein shall have the meaning ascribedto them in the Act or as provided in the regulations, chapters and AND REGISTRATION OF food BUSINESS2.

4 1 Registration and Licensing of food BusinessAll food Business Operators in the country will be registered or licensed in accordance with the procedures laiddown hereinafter; Registration of Petty food Business(1) Every petty food Business Operator shall register themselves with the Registering Authority by submittingan application for registration in Form A under Schedule 2 of these Regulations along with a fee as provided inSchedule 3.(2) The petty food manufacturer shall follow the basic hygiene and Safety requirements provided in Part I ofSchedule 4 of these Regulations and provide a self attested declaration of adherence to these requirements with theapplication 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 withreasons to be recorded in writing or issue notice for inspection, within 7 days of receipt of an application forregistration.

5 (4) In the event of an inspection being ordered, the registration shall be granted by the Registering Authorityafter being satisfied with the Safety , hygiene and sanitary conditions of the premises as contained in Part II ofSchedule 4 within a period of 30 registration is not granted, or denied, or inspection not ordered within 7 days as provided in above subregulation (3) or no decision is communicated within 30 days as provided in above sub regulation (4), the petty foodmanufacturer may start its business, provided that it will be incumbent on the food Business Operator to complywith any improvement suggested by the Registering Authority even that registration shall not be refused without giving the applicant an opportunity of being heard andfor reasons to be recorded in writing.(5) The Registering Authority shall issue a registration certificate and a photo identity card, which shall bedisplayed at a prominent place at all times within the premises or vehicle or cart or any other place where the personcarries on sale/manufacture of food in case of Petty food Business.

6 (6) The Registering Authority or any officer or agency specifically authorized for this purpose shall carry outfood Safety inspection of the registered establishments at least once in a that a producer of milk who is a registered member of a dairy Cooperative Society registered underCooperative Societies Act and supplies or sells the entire milk to the Society shall be exempted from this provisionfor registration. Hkkx III [ 4 Hkkjr dk jkti=k % License for food business(1) Subject to Regulation , no person shall commence any food business unless he possesses a valid that any person or food Business Operator carrying on food business on the date of notification ofthese Regulations, under a license, registration or permission, as the case may be, under the Acts or Ordersmentioned in the Second Schedule of the Act shall get their existing license converted into the license/registrationunder these regulations by making an application to the Licensing/Registering Authority after complying with thesafety requirements mentioned in the Schedule 4 contained under different Parts dependent on nature of business,within one year of notification of these Regulations.]

7 In case of difficulty, the licensing authority with the approvalof the food Safety Commissioner in the State will determine the advisability of applying any specific conditionkeeping in view the need to ensure Safety of food and public interest. No license fee will have to be paid for theremaining period of the validity of the earlier license or registration granted under any of the said Acts or with this provision by a food Business Operator will attract penalty under section 55 of the further that any food business operator holding Registration/License under any other Act/Order asspecified under schedule 2 of the FSS Act, 2006 with no specific validity or expiry date, and other wise entitled toobtain a license under these regulations, shall have to apply and obtain a Registration/License under theseRegulations within one year from the date of notification by paying the applicable fees.

8 (2) Notwithstanding the provisions contained in Regulation (1) above or in any of the registration orlicense certificates issued under existing Acts or Orders mentioned in the second schedule of the Act, the LicensingAuthority, if it has reason to believe that the food Business Operator has failed to comply with all or any of theconditions of the existing registration or license or the Safety requirements given in Schedule 4, may give appropriatedirection 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 bythe Central Licensing Authority, provided that food Authority may through notification make such changes ormodify 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 begranted by the concerned State/UT s Licensing Authority.

9 (5) The food Business Operator shall ensure that all conditions of license as provided in Annexure 2 of FormB in Schedule 2 and Safety , sanitary and hygienic requirements provided in the Schedule 4 contained under differentParts 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 licensedestablishments through its own or agencies authorized for this purpose by the further that no person shall manufacture, import, sell, stock, exhibit for distribution or sale any articleof food which has been subjected to the treatment of irradiation, except under a license obtained from Departmentof Atomic Energy under the Atomic Energy (Control of Irradiation of food ) Regulations, Application for license to the Licensing AuthorityAn application for the grant of a license shall be made in Form B of Schedule 2 to the concerned LicensingAuthority as specified in Regulation (3) and (4)

10 And it will be accompanied by a self-attested declarationin the format provided in the Annexure-1 and copies of documents mentioned in the Annexure 2 of Schedule-2 alongwith the applicable fees prescribed in Schedule Processing of Application for license(1) A license shall, subject to the provisions of these Regulations, be issued by the concerned LicensingAuthority within a period of 60 days from the date of issue of an application ID number as provided in subsection(3) below.(2) If, upon scrutiny of the application within 15 days from the date of receipt of the application, the concernedLicensing Authority requires any additional information with respect to an application or if the application isincomplete, the Licensing Authority shall inform the applicant in writing, to furnish such additional information orcomplete the application, as the case may be, within 30 days from such notice.