Food Safety And Standards Regulations, 2010

Regulation 5.10.1Regulation 5.10.2Regulation 5.10.3Regulation 5.10.4Regulation 5.10.5Part 5.11Part 5.12Baking PowderCatechuGelatinSilver LeafPan MasalaProprietary FoodsIrradiation of FoodRegulation 5.12.1Regulation 5.12.2Regulation 5.12.3Regulation 5.12.4Regulation 5.12.5Regulation 5.12.6Regulation 5.12.7Regulation 5.12.8DefinitionsChapter 6Substances added to FoodPart 6.1Food AdditivesRegulation 6.1.1Regulation 6.1.2Regulation 6.1.3Regulation 6.1.4Regulation 6.1.5Regulation 6.1.6Regulation 6.1.7Regulation 6.1.8Regulation 6.1.9Regulation 6.1.10DefinitionsDose of IrradiationRequirement for the process of IrradiationRestrictions on Irradiation of FoodRecord of Irradiation of FoodStandards of Irradiated FoodStorage, Package and Sale of Irradiated FoodRestrictions on sale of Irradiated FoodRegulation 6.1.11Regulation 6.1.12Regulation 6.1.13Regulation 6.1.14Regulation 6.1.15Regulation 6.1.16Regulation 6.1.17Part 6.2Regulation 6.2.1Colouring MatterArtificial SweetenersPreservativesAnti-OxidantsEmulsifying and Stabilising AgentsAnticaking AgentsAntifoaming agents in edible oils and fatsUse of release agentsFlavouring agents and related substancesUse of Flavours EnhancersSequestering and buffering agents (acids, bases, and salts)Use of Glycerol Esters of Wood ResinsUse of Sucrose Acetate IsobutyrateUse of Lactulose Syrup in foodsOther substances to be used in Specified limitsCarry over of Food AdditivesStandards of AdditivesFood ColoursChapter 7Prohibition and Regulation of SalesPart 7.1Part 7.2Part 7.3Regulation 7.3.1Regulation 7.3.2Regulation 7.3.3Sale of certain admixtures prohibitedRestriction on use of certain ingredientsProhibition and Restriction on sale of certain productsProhibition on sale of food articles coated with Mineral oilRestriction on sale of Carbia Callosa and Honey dewFood resembling but not pure Honey not be marketed as HoneyProduct not to contain any substance which may be injurious toHealthProhibition of use of Carbide gas in ripening of fruitsSale of fresh Fruits and VegetablesSale or use for sale of admixtures of Ghee or Butter prohibitedRegulation 7.3.4Regulation 7.3.5Regulation 7.3.6Regulation 7.3.7- vi -454509

Regulation 7.3.9Regulation 7.3.10Regulation 7.3.11Regulation 7.3.12Regulation 7.3.13Regulation 7.3.14Regulation 7.3.15Regulation 7.3.16Restriction on sale of Ghee having less Reichert value than thatspecified for the area where such ghee is soldRestriction on sale of Til oil produced in Tripura, Assam and WestBengalSpecial provisions relating to Vegetable Oil and fatRestriction on sale of Kangra TeaCondition for sale of Flavoured TeaRestriction on sale of Common SaltUse of flesh of naturally dead animals or fowls prohibitedSpecial provisions relating to MilkRestrictions relating to conditions for saleChapter 8Contaminants, Toxins and ResiduesPart 8.1Part 8.2Part 8.3Metal ContaminantsCrop Contaminants and Naturally Occuring Toxic SubstancesResiduesRegulation 8.3.1Regulation 8.3.2Restriction on the use of InsecticidesAntibiotic and other pharma-cologically active substancesChapter 9Laboratory and Sample AnalysisPart 9.1Referral LaboratoryRegulation 9.1.1Regulation 9.1.2Regulation 9.1.3FunctionsReferral laboratory for State/UT/Local areaNotified Laboratories for ImportPart 9.2Procedure of SamplingRegulation 9.2.1Quantity of sample to be sent to the Food analystChapter 10OthersPart 10.1GuaranteeAPPENDIXAppendix ARegulation 7.3.8525549558Limits of Food AdditivesAppendix BMicrobiological RequirementsAppendix CFormsForm A - Form of GuaranteeForm B - DeclarationForm C - Certificate of Analysis by the Referral Food LaboratoryForm D - Report of the Food Analyst- vii -

Food Safety and Standards Regulations, 2010In exercise of the powers under section 92 of the Food Safety andStandards Act, 2006 (34 of 2006), the Food Safety and StandardsAuthority hereby makes the following RegulationsCHAPTER 1 – GENERALPart 1.1: Title and commencementRegulation 1.1.1:These regulations may be called the Food Safetyand Standards Regulations, 2010.Regulation 1.1.2: They shall extend to the whole of India.Part 1.2: DefinitionsRegulation 1.2.1:In these regulations unless the context otherwiserequires:1.“Act” means the Food Safety and Standards Act, 2006 (Act 34 of2006);2.“Best before” means the date which signifies the end of the periodunder any stated storage conditions during which the product shallremain fully marketable and shall retain any specific qualities forwhich tacit or express claims have been made and beyond that datethe food may still be perfectly satisfactory;3. “Date of manufacture” means the date on which the foodbecomes the product as described;--1--

4. “Date of packaging” means the date on which the food is placedin the immediate container in which it will be ultimately sold;5. "District" means a local area as defined by the Authority for thepurpose of the Food safety and Standards Act, 2006. The districtcan be categorized on the basis of: Concentration of specific category of food businesses whichmay need special attention Specific risk assessment Any other specific regulatory requirements6. “Health claims” means any representation that states, suggestsor implies that a relationship exists between a food or a constituentof that food and health and include nutrition claims which describethe physiological role of the nutrient in growth, development andnormal functions of the body, other functional claims concerningspecific beneficial effect of the consumption of food or itsconstituents, in the context of the total diet, on normal functions orbiological activities of the body and such claims relate to a positivecontribution to health or to the improvement of function or tomodifying or preserving health, or disease risk reduction claimrelating to the consumption of a food or food constituents, in thecontext of the total diet, to the reduced risk of developing a diseaseor health related condition;7. "Infant" means a child not more than twelve months of age;8. "Licensing Authority” means the Designated Officer appointed--2--

under section 36 (i) of the Act by the food safety commissioner ofthe state for the local area and includes an officer to whom powersof issue of a licence has been delegated by the Designated Officer;9. "Label” means any tag, brand, mark, pictorial or other descriptivematter, written, printed, stenciled, marked, embossed graphic,perforated, stamped or impressed on or attached to container,cover, lid or crown of any food package. For the purpose ofdeclaration of month and year of manufacture, the provisions underrule 6(B) of Standards of Weights and Measures (PackagedCommodities) Rules, 1977 shall apply.10. “Lot number” or “code number” or “batch number” meansthe number either in numericals or alphabets or in combinationthereof, representing the lot number or code number or batchnumber, being preceded by the words “Lot No” or “Lot” or “codenumber” or “Code” or Batch No” or “Batch” or any distinguishingprefix by which the food can be traced in manufacture andidentified in distribution.11. "Multipiece package" means a package containing two or moreindividually packaged or labelled pieces of the same commodity ofidentical quantity, intended for retail either in individual pieces orpackages as a whole.12. “Nutrition claim” means any representation which states,suggests or implies that a food has particular nutritional propertieswhich are not limited to the energy value but include the protein,fat and carbohydrates, vitamins and minerals;--3--

13. "Non- Vegetarian Food” means an article of food whichcontains whole or part of any animal including birds, fresh water ormarine animalsor eggs or products of any animal origin, but notincluding milk or milk products, as an ingredient;14. "Nutritional food" means the food claimed to be enriched withnutrients, such as, minerals, proteins or vitamins15. “Prepackaged” or “Pre-packed food”, means food, which isplaced in a package of any nature, in such a manner that thecontents cannot be changed without tampering it and which isready for sale to the consumer.Note: The expression “package” wherever it occurs in theseRegulations, shall be construed as package containing prepackedfood articles.16. /package which is intended or likely to be displayed orpresented or shown or examined by the customer under normal andcustomary conditions of display, sale or purchase of the commoditycontained therein.17. “Risk reduction"in thecontextof health claimsmeanssignificantly reducing a major risk factor for a disease or healthrelated condition;'18. “Use – by date” or “Recommended last consumption date”or “Expiry date” means the date which signifies the end of the--4--

estimated period under any stated storage conditions, after whichproduct probably will not have the quality attributes normallyexpected by the consumers and the food shall not be marketable;19. “Vegetarian Food” means any article of Food other than NonVegetarian Food as defined above of this article.20. “Wholesale package” means a package containing a. a number of retail packages, where such first mentionedpackage is intended for sale, distribution ordeliverytoanintermediary and is not intended for sale direct to a singleconsumer; orb. a commodity of food sold to an intermediary in bulk to chcommodity of food to the consumer in smaller quantities.The expressions used in these Regulations but have not beendefined herein shall have the meaning ascribed to them in the Actor as provided in the regulations, chapters and Appendices.--5--

CHAPTER 2 – Food Authority and Transaction of BusinessPart 2.1: Food AuthorityRegulation 2.1.1: Salaries and terms and conditions of service ofemployees of Food Authority of IndiaRegulation 2.1.2: Procedure for transaction of businessPart 2.2: Central Advisory CommitteeRegulation 2.2.1: Procedure for transaction of businessPart 2.3: Scientific Committee and PanelsRegulation 2.3.1: Procedure for establishment and operations of theScientific CommitteeRegulation 2.3.2:Procedure for establishment and operations of theScientific PanelsPart 2.4: Jurisdiction of Designated officerRegulation 2.4.1 The commissioner of Food Safety shall, by order,appoint the Designated officer, who shall not be below the rank of a SubDivisional Officer, to be in-charge of food safety administration for eachdistrict--6--

CHAPTER 3 – Licensing and Registration of Food BusinessesPart 3.1 DefinitionsIn these Regulations, unless the context otherwise requires,Regulation 3.1.1 “Central Licensing Authority” means DesignatedOfficer appointed by the Chief Executive Officer of the Food Authority ofIndia in his capacity of Food Safety Commissioner.Regulation 3.1.2“Petty Food Manufacturer”meansany foodmanufacturer, whoa. manufactures or sells any article of food himself or a pettyretailer, hawker, itinerant vendor or temporary stall holder;orb. such other food businesses including small scale or cottage orsuch other industries relating to food business or tiny foodbusinesses with an annual turnover not exceeding Rs 12 lakhsand/or whosei. production capacity of food (other than milk and milkproducts and meat and meat products) does not exceed100 kg/ltr per day orii. production or procurement or collection of milk is up to500 litres of milk per day oriii. slaughtering capacity is 2 large animals or 10 smallanimals or 50 poultry birds per day or lessRegulation 3.1.4 “Registering Authority” means Food Safety Officeror any official in Panchayat, Municipal Corporation or any other local bodyin an area, notified as such by the State Food Safety Commissioner forthe purpose of registration as specified in these Regulations.--7--

Regulation 3.1.5 “State Licensing Authority” means DesignatedOfficers appointed under Section 36(1) of the Act by the Food SafetyCommissioner of a State or UT.1. Words and expressions used herein and not defined, but definedunder the Act or in any other regulations under the Act, shall havethe meaning respectively assigned to them therein.Part 3.2 Registration and License for Food BusinessAll Food Business Operators in the country will be registered or licensed inaccordance with the procedures laid down hereinafter without prejudice tothe availability of safe and wholesome food for human consumption.Regulation 3.2.1 Registration of petty food business(1).Every petty food manufacturer shall register themselve with theRegistering Authority by submitting an application for registration inForm A under Schedule 2 of these Regulations along with a fee asprovided in Schedule 3.(2).The Food Business Operator shall follow the basic hygiene andsafety requirements provided in Schedule 4 (Part I) of theseRegulations and provide a self attested declaration of adherence tothese requirements with the application in the format provided inAnnexure-1 under Schedule 2(3).The Registering Authority shall consider the application and mayeither grant registration or reject it with reasons to be recorded in--8--

writing or issue notice for inspection, within 7 days of receipt of anapplication for registration(4).In the event of an inspection being ordered, the registration shallbe granted by the Registering Authority after being satisfied withthe safety, hygiene and sanitary conditions of the premises within aperiod of 30 days.(5).If registration is not granted, or denied, or inspection not orderedwithin 7 days as provided in above sub regulation (3) or no decisionis communicated within 30 days as provided in above subregulation (4), the Food Business Operator may start its business,provided that it will be incumbent on the Food Business operator tocomply with any improvement suggested by the RegisteringAuthority at any later time.Provided that registration shall not be refused without giving theapplicant an opportunity of being heard and for reasons to berecorded in writing.(6).The Registering Authority shall issue a registration certificate anda photo identity card, which shall be displayed at a prominent placeat all times within the premises or vehicle or cart or any other placewhere the person carries on the Petty Food Business.(7).The Registering Authority or any officer or agency specificallyauthorized for this purpose shall carry out food safety inspection ofthe registered establishments at least once in a year.--9--

Regulation 3.2.2 License for food business(1).Subject to Regulation 3.2.1, no person shall commence any seRegulations.Provided that any person or Food Business Operator carrying onfood business on the date of notification of these Regulations, undera license, registration or permission, as the case may be, under theActs or Orders mentioned in the Second Schedule of the Act shallget their existing license converted into the license/registrationunder these regulations following an application made by the FoodBusiness Operator to the Licensing/Registering Authority within oneyear of notification of these Regulations. No license fee will have tobe paid for the remaining period of the validity of the earlier licenseor registration granted under any of the said Acts or Orders Noncompliance with this provision by a Food Business Operator willattract penalty under section 55 of the ingRegistration/License under any other Act/Order as specified underschedule 2 of the FSS Act, 2006 with no specific validity or expirydate, and other wise entitiled to obtain a license under theseregulations, shall have to apply and obtain a Registration/Licenseunder these Regulations within one year from the date ofnotification by paying the applicable fees.(2).Notwithstanding the provisions contained in Regulation 3.2.2(1)above or in any of the registration or license certificates issuedunder existing Acts or Orders mentioned in the second schedule of- - 10 - -

the Act, the Licensing Authority, if it has reason to believe that theFood Business Operator has failed to comply with all or some of theconditions of the existingregistration or licenseor the safetyrequirements given in Schedule 4, may give appropriate directionto the Food Business Operator to comply with.(3).License for commencing or carrying on food business, which fallsunder Schedule 1, shall be granted by the Central LicensingAuthority. For importing any type of food items including foodingredients and additives a food business Operator shall have toobtain a license from the Central Licensing Authority,Provided that Food Authority may through notification make suchchanges or modify the list given in the Schedule I as considerednecessary.(4).License for commencing or carrying on food business, which are notcovered under Schedule 1, shall be granted by the concernedState Licensing Authority.(5).TheFood Business Operatorshall ensure that all conditions oflicense as provided in Annexure 2 of Form B in Schedule 2 andsafety, sanitary and hygienic requirementsprovided in theSchedule 4 are complied with at all times .Provided that no person shall manufacture, import, sell, stock,exhibit for distribution or sale any article of food which has beensubjected to the treatment of irradiation, except under a licenseobtained from Department of Atomic Energy under the AtomicEnergy (Control of Irradiation of Food) Regulations, 1996.- - 11 - -

Provided further that the Licensing Authority shall ensure periodicalfood safety audit and inspection of the licensed establishmentsthrough its own or authorised agencies.Regulation 3.2.3 Application for license to the Licensing AuthorityAn application for the grant of a license shall be made in Form B ofSchedule 2 to the concerned Licensing Authority as specified inRegulation 3.2.2 (3) and 3.2.2 (4) and it will be accompanied by aself-attested declaration in the format provided in the Annexure-1and copies of documents mentioned in the Annexure 2 of Schedule2 along with the applicable fees prescribed in Schedule 3.Regulation 3.2.4 Processing of Application for license(1).A license shall, subject to the provisions of these Regulations, beissued by the concerned Licensing Authority within a period of 60days from the date of receipt of the completed application alongwith all required documents and fees.(2).On the receipt of the completed application along with all requireddocuments and fees, the concerned Licensing Authority shall issue aunique application number to each applicant that will be referred toin all future correspondence between the Licensing Authority andthe applicant.(3).If, upon scrutiny of the application within 15 days from the date ofreceipt of the application, the concerned Licensing Authorityrequires any additional information with respect to an application orif the application is incomplete, the Licensing Authority may inform- - 12 - -

the applicant in writing, to furnish such additional information orcomplete the application, as the case may be, within 30 days fromsuch notice.(4).On receiving the complete information and documents the LicensingAuthority shall direct the Food Safety Officer or any other personspecially designated for such functions to inspect the premises in amanner and according to Regulations as laid down by the FoodAuthority.The Licensing Authority may issue a notice to theapplicant, if it deems fit, guiding food business Operator onnecessary steps to be taken or changes or alteration to be made inthe premises in order to ensure general sanitary and hygienicconditions as specified in Schedule 4.(5).Within a period of 30 days from receipt of an inspection report theconcerned Licensing Authority shall consider the application andmay either grant or reject the license.Provided that no applicant shall be refused a license without beinggiven an opportunity of being heard and for reasons to be recordedin writing.(6).The Licensing Authority shall issue a License in Format C underSchedule 2 of these Regulations, a true copy of which shall bedisplayed at a prominent place at all tim

Regulation 5.3.18 Tamarind Pulp/Puree And Concentrate Regulation 5.3.19 Fruit Bar/ Toffee Regulation 5.3.20 Fruit/Vegetable, Cereal Flakes Regulation 5.3.21 Squashes, Crushes, Fruit Syrups/Fruit Sharbats and Barley Water Regulation 5.3.22 Ginger Cocktail Regulation 5.3.23 S