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Food Safety and Standards (Food Product Standards and Food Additives) Regulation, 2011

Food Safety and Standards (Food Product Standards and Food Additives) Regulation, 2011

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Published by Bar & Bench
Food Safety and Standards (Food Product Standards and Food Additives) Regulation, 2011
Food Safety and Standards (Food Product Standards and Food Additives) Regulation, 2011

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Published by: Bar & Bench on Jun 07, 2015
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06/09/2015

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MINISTRY OF HEALTH AND FAMILY WELFARE(Food Safety and Standards Authority of India)
 Notification New Delhi, dated the 1
st
 August, 2011F.No. 2-15015/30/2010 Whereas in exercise of the powers conferred by section clause (e) of sub section (2) of section 92read with 16 of Food Safety and Standards Act, 2006 (34 of 2006) the Food Safety and Standards Authority of India proposes to make Food Safety and Standards Regulations in so far they relates to Food Safety and Standards (FoodProducts Standards and Food Additives) 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 20
th
 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 21
st
 October 2010;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 India. Now therefore, the Food Safety and Standards Authority of India hereby makes the following Regulations, namely,— FOOD SAFETY AND STANDARDS (FOOD PRODUCTS STANDARDS AND FOOD ADDITIVES) REGULATIONS, 2011CHAPTER 1 G
ENERAL
1.1: Title and commencement1.1.1:These regulations may be called the Food Safety and Standards (Food Products Standards and Food Additives)Regulations, 2011.1.1.2: These regulatiions shall come into force on or after 5
th
 August, 2011, except the regulations 2.1.7.(1)(2)(3)(4),2.1.8 (1)(3), 2.1.11 (1)(2), 2.1.12(1), including table 14 of Appendix A and table 2 of Appendix B which shall come in to forceafter six months from that date.Provided that wherever the standards given in these regulations are at variance with any of the provisions of thelicenses already granted, Food Business Operator shall comply with the provisions of these regulations within six monthsfrom the date of commencement of the regulations.1.2: DefinitionsIn these regulations unless the context otherwise requires:1. BOILED MILK means milk which has been brought to boil.2. “De-oiled meal” means the residual material left over when oil is extracted by a solvent from any oil-bearingmaterial;3. DOUBLE TONED MILK means the product prepared by admixture of cow or buffalo milk or both with freshskimmed milk, or by admixture of cow or buffalo milk or both that has been standardised to fat and solids-not-fat percentage given in the table below in 2.1.1:1 by adjustment of milk solids. It shall be pasteurised and shall show anegative Phosphatase Test. When fat or dry non-fat milk solids are used, it shall be ensured that the productremains homogeneous and no deposition of solids takes place on standing.4. “Hydrogenation” means the process of addition of hydrogen to an edible vegetable oil using a catalyst to produce a fat with semi-solid consistency;5. Flavoured Milk, by whatever name called, may contain nuts (whole, fragmented or ground) chocolate,coffee or any other edible flavour, edible food colours and cane sugar. Flavoured milk shall be pasteurised, sterilisedor boiled. The type of milk shall be mentioned on the label.
 
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THE GAZETTE OF INDIA : EXTRAORDINARY[P
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 III—S
EC
. 4]6. Full Cream Milk means milk or a combination of buffalo or cow milk or a product prepared by combinationof both that has been standardised to fat and solids-not-fat percentage, given in the table below in 2.1.1:1, byadjustment/addition of milk solids, Full Cream Milk shall be pasteurised. It shall show a negative phosphatase test.It shall be packed in clean, sound and sanitary containers properly sealed so as to prevent contamination.7. ‘Irradiation’ means any physical procedure, involving the intentional exposure of food to ionizing radiations.8. ‘Irradiation facility’ means any facility which is capable of being utilized for treatment of food by irradiation.9. ‘Irradiated food’ means articles of food subjected to radiation by :— (i) Gamma Rays;(ii) X-rays generated from machine sources operated at or below an energy level of 5 million electronvolts; and(iii) Sub-atomic particles, namely, electrons generated from machine sources operated at or below anenergy level of 10 million electron volts, to dose levels as specified in Schedule I of the Atomic Energy(Control of Irradiation of Food) Rules 1991.10. MILK is the normal mammary secretion derived from complete milking of healthy milch animal withouteither addition thereto or extraction therefrom unless otherwise provided in these Regulations. It shall be free fromcolostrum. Milk of different classes and of different designations shall conform to the standards laid down in theTable below in 2.1.1:1Total urea content in the milk shall not be more than 700 ppm11. MIXED MILK means a combination of milk of cow, buffalo, sheep, goat or any other milch animal and may be a combination of any of these milk which has been made and conforms to the standards given in the table belowin 2.1.1:1.12. MILK PRODUCTS means the products obtained from milk such as cream, malai, curd, skimmed milk curd,chhanna, skimmed-milk chhanna, cheese, processed cheese, ice-cream, milk ices, condensed milk-sweetened andunsweetened, condensed skimmed milk-sweetened and unsweetened, milk powder, skimmed milk powder, partlyskimmed milk powder, khoa, infant milk food, table butter and desi butter.Milk products shall not contain any substance not found in milk unless specified in the standards.13. “Margarine” means an emulsion of edible oils and fats with water;14. ‘Operator of irradiation facility’ means any person appointed as such by licensee who satisfies thequalifications and requirements as for training specified in Schedule II of the Atomic Energy (Control of Irradiationof Food) Rules, 199115. PASTEURISATION— The terms “Pasteurisation”, “Pasteurised” and similar terms shall be taken to refer to the process of heating every particle of milk of different classes to at least 63
0
 C and holding at such temperature continuouslyfor at least 30 minutes or heating it to at least 71.5
0
C and holding at such temperature continuously for at least15 seconds or an approved temperature time combination that will serve to give a negative Phosphatase Test.All pasteurised milk of different classes shall be cooled immediately to a temperature of 10
0
 C, or less16. RECOMBINED MILK means the homogenised product prepared from milk fat, non-fat-milk solids andwater. Recombined milk shall be pasteurised and shall show a negative Phosphatase test.17. “Refined vegetable oil” means any vegetable oil which is obtained by expression or solvent extraction of vegetable oil bearing materials, deacidified with alkali and/or by physical refining and/or by miscella refining using permitted food grade solvents and/or degumming followed by bleaching with absorbent earth and/or activatedcarbon and deodorized with steam without using any other chemical agents18. “Refining” means a process by which an expressed vegetable oil or a solvent-extracted oil is deacidified— (i) With alkali, or (ii) by physical refining, or both, or (iii) By miscella refining using permitted food grade solvent, followed by bleaching with absorbent earthand/or activated carbon or both of them and deodorized with steam without using any other chemical agent;(iv) refining if required may include the process of degumming using phosphoric/citric acid.
 
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19. SKIMMED MILK means the product prepared from milk from which almost all the milk fat has beenremoved mechanically.20. STERILISATION :The term “sterilisation when used in association with milk, means heating milk in sealedcontainer continuously to a temperature of either 115
0
 C for 15 minutes or at least 130
0
 C for a period of one secondor more in a continuous flow and then packed under aseptic condition in hermatically sealed containers to ensure preservation at room temperature for a period not less than 15 days from the date of manufacture;21. STANDARDISED MILK means cow milk or buffalo milk or sheep milk or goat milk or a combination of anyof these milk that has been standardised to fat and solids-not-fat percentage given in the table below in 2.1.1:1 bythe adjustment of milk solids. Standardised milk shall be pasteurised and shall show a negative Phosphatase Test.22. “Solvent-extracted oil” means any vegetable oil obtained from oil-bearing material by the process of extraction by a solvent;23. “Solvent-extracted edible flour” means the ground material obtained from specially prepared deoiled meal,that is, the residual material left over when oil is extracted by a solvent from oil cake immediately following the single- pressing of good quality edible oilseeds;24. TONED MILK means the product prepared by admixture of cow or buffalo milk or both with fresh skimmedmilk; or by admixture of cow or buffalo milk or both that has been standardised to fat and solids-not-fat percentagegiven in the table below in 2.1.1:1 by adjustment of milk solids. It shall be pasteurised and shall show a negativePhosphatase Test. When fat or dry non-fat-milk solids are used, it shall be ensured that the product remainshomogeneous and no deposition of solids takes place on standing.25. “Vegetable oils” means oils produced from oilcakes or oilseeds or oil-bearing materials of plant origin andcontaining glycerides;26. “Vegetable oil product” means any product obtained for edible purposes by subjecting one or more edibleoils to any or a combination of any of the processes or operations, namely, refining, blending, hydrogenation or interesterification and winterization (process by which edible fats and oils are fractioned through cooling), andincludes any other process which may be notified by the Central Government in the official Gazette;CHAPTER 2F
OOD
 P
RODUCT
 S
TANDARDS
2.1: DAIRY PRODUCTS AND ANALOGUES2.1.1: MILK 1. The standards of different classes and designations of milk shall be as given in the table below. Milk shallconform to both the parameters for milk fat and milk solids not fat, independently, as prescribed in columns (4) and(5) of the said table:TableMinimum percentClass of MilkDesignationLocalityMilk FatMilk solidsnot fat(1)(2)(3)(4)(5)Buffalo MilkRaw,Assam,6.09.0 pasteurized,Bihar, boiled,Chandigarhflavoured,DelhisterlizedGujaratHaryanaJharkhandMaharashtraMeghalayaPunjabSikkimUttar Pradesh
 
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THE GAZETTE OF INDIA : EXTRAORDINARY[P
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. 4]UttarakhandWest BengalBuffalo MilkRaw,Andaman and Nicobar5.09.0 pasteurized,Andhra Pradesh boiled,Arunachal Pradeshflavoured,ChhatisgarhsterlizedDadra & Nagar haveliGoa, Daman & DiuHimachal PradeshJammu& Kashmir & KarnatakaKeralaLakshadweep,Minicoy & Amindivi IslandMadhya PradeshManipur Mizoram NagalandOrissaPuducherryRajasthanTamil NaduTripuraCow MilkRaw,Chandigarh4.08.5 pasteurized,Haryana boiled,Punjabflavoured,sterlizedCow MilkRaw, boiled,Andaman & Nicobar Islands3.58.5 pasteurized,Andhra Pradeshflavoured andArunachal PradeshsterlizedAssamBihaChhatisgarhDadra & Nagar haveliDelhiGoa,Daman & DiuGujaratHimachal PradeshJammu & Kashmir JharkhandKarnatakaKeralaLakshadweep,Minicoy & Adminidive IslandsMadhya PradeshMaharashtraManipur Meghalaya NagalandPuducherryRajasthanSikkimTamil NaduTripura(1)(2)(3)(4)(5)
 
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Uttar PradeshUttarakh andWest BengalCow MilkRaw, boiled,Mizoram3.08.5 pasteurized,Orissaflavoured andsterlizedGoat or Sheep MilkRaw, boiled,Chandigarh3.59.0 pasteurized,Chhatisgarhflavoured andHaryanasterlizedKeralaMadhya PradeshMaharashtraPunjabUttar PradeshUttarakhandGoat or Sheep MilkRaw, boiled,Andaman & Nicobar Islands3.09.0 pasteurized,Andhra Pradeshflavoured andArunachal PradeshsterlizedAssamBihar ChhatisgarhDadra and Nagar haveliDelhiGoa,Daman & DiuGujaratHimachal PradeshJammu & Kashmir JharkhandKarnatakaLakshadweep,Minicoy & Amindive IslandsManipur Meghalaya’Mizoram NagalandOrissaPuducherryRajasthanSikkim,Tamil NaduTripuraWest BengalMixed MilkRaw,All India4.58.5 pasteurised, boiled,flavoured and sterilisedStandardized milkPasteurised,All India4.58.5flavoured andsterilizedRecombined MilkPasteurised,All India3.08.5flavoured andsterilized(1)(2)(3)(4)(5)
 
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THE GAZETTE OF INDIA : EXTRAORDINARY[P
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. 4]Toned MilkPasteurised,All India3.08.5flavoured andsterilizedDouble Toned milkPasteurised,All India1.59.0flavoured andsterilizedSkimmed MilkRaw, boiled,All IndiaNot8.7 pasteurised,moreflavoured andthansterilized0.5 percentFull Cream MilkPasteurised andAll India6.09.0sterilized NOTE :-(i) When milk is offered for sale without indication of the class, the standards prescribed for buffalo milk shallapply.(ii) The heat treatment for the various designated milk shall be as follows:DesignationHeat treatmentRawNil.PasteurisedPasteurisation.BoiledBoilingFlavouredPasteurisation or SterilisationSterilisedSterilisation2.1.2 Cream:1. Cream including sterilised cream means the product of cow or buffalo milk or a combination thereof. It shall be free from starch and other ingredients foreign to milk. It may be of following three categories, namely:— 1. Low fat cream—containing milk fat not less than 25.0 percent by weight.2. Medium fat cream—containing milk fat not less than 40.0 percent by weight.3. High fat cream—containing milk fat not less than 60.0 percent by weight. Note:- Cream sold without any indication about milk fat content shall be treated as high fat cream.2. Cream Powder means the product obtained by partial removal of water from cream obtained from milk of cowand / or buffalo. The fat and / or protein content of the cream may be adjusted by addition and/ or withdrawal of milk constituents in such a way as not to alter the whey protein to casein ratio of the milk being adjusted. It shall be of uniform colour and shall have pleasant taste and flavour free from off flavour and rancidity. It shall also be free fromvegetable oil/ fat, mineral oil, added flavour and any substance foreign to milk.The product may contain food additives permitted in these regulations including Appendix A. It shall conformto the microbiological requirements prescribed in Appendix B. It shall conform to the following requirements:— (i) MoistureNot more than 5.0 percent(ii)Milk fatNot less than 42.0 percent(iii) Milk protein in Milk solid not fatNot less than 34.0 percent2.1.3: MALAI1. Malai means the product rich in butter fat prepared by boiling and cooling cow or buffalo milk or acombination thereof. It shall contain not less than 25.0 per cent milk fat.2.1.4: DAHI OR CURD1. Dahi or curd means the product obtained from pasteurised or boiled milk by souring, natural or otherwise, by a harmless lactic acid culture or other harmless bacterial culture may also be used in conjunction with lactic acid bacteria cultures for souring. Dahi may contain added cane sugar. Dahi shall have the same minimum percentage of milk fat and milk solids-not-fat as the milk from which it is prepared.(1)(2)(3)(4)(5)
 
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Where dahi or curd is sold or offered for sale without any indication of class of milk, the standards prescribedfor dahi prepared from buffalo milk shall apply.Milk solids may also be used in preparation of this product.2.1.5: CHHANA OR PANEER 1. Chhana or paneer means the product obtained from the cow or buffalo milk or a combination thereof by precipitation with sour milk, lactic acid or citric acid. It shall not contain more than 70.0 per cent moisture and the milk fat content shall not be less than 50.0 per cent of the dry matter.Milk solids may also be used in preparation of this product.Provided that paneer or chhana when sold as low fat paneer or chhana, it shall conform to the followingrequirements:— (i) MoistureNot more than 70.0 percent(ii) Milk fatNot more than 15.0 percent of dry matter:Provided further that such low fat paneer/chhana shall be sold in sealed package only and shall bear proper label declaration as provided in regulation 2.4.5 (39) of Food Safety and Standards (Packaging and Labeling)Regulations, 2011.2.1.6: CHEESE1. Cheese means the ripened or unripened soft or semihard, hard and extra hard product, which may be coatedwith food grade waxes or polyfilm, and in which the whey protein / casein ratio does not exceed that of milk. Cheeseis obtained by coagulating wholly or partly milk and/ or products obtained from milk through the action of non-animal rennet or other suitable coagulating agents and by partially draining the whey resulting from such coagulationand/ or processing techniques involving coagulation of milk and/ or products obtained from milk which give a final product with similar physical, chemical and organoleptic characteristics. The product may contain starter culturesof harmless lactic acid and / or flavour producing bacteria and cultures of other harmless microorganisms, safe andsuitable enzymes and sodium chloride. It may be in the form of blocks, slices, cut, shredded or grated cheese.(i) Ripened Cheese is cheese which is not ready for consumption shortly after manufacture but whichmust be held for some time at such temperature and under such other conditions as will result in necessary biochemical and physical changes characterizing the cheese in question.(ii) Mould Ripened cheese is a ripened cheese in which the ripening has been accomplished primarily bythe development of characteristic mould growth through the interior and/ or on the surface of the cheese.(iii) Unripened cheese including fresh cheese is cheese which is ready for consumption shortly after manufacture.Cheese or varieties of cheeses shall have pleasant taste and flavour free from off flavour and rancidity.It may contain food additives permitted in these regulation including Appendix A. It shall conform to themicrobiological requirements prescribed in Appendix B:Provided that cheese or varieties of cheeses coated with food grade waxes/ or polyfilm / or wrapping of clothshall bear proper label declaration as provided in regulation 2.4.5 (44) of Food Safety and Standards (Packaging andLabeling) Regulations, 2011. It shall conform to the following requirements:— ProductMoistureMilk Fat on Dry basis(1)(2)(3)(i) Hard Pressed CheeseNot more than 39.0 percentNot less than 48.0(ii) Semi Hard CheeseNot more than 45.0 percentNot less than 40.0 percent(iii) Semi Soft CheeseNot more than 52.0 percentNot less than 45.0 percent(iv) Soft CheeseNot more than 80.0 percentNot less than 20.0 percent(v) Extra Hard CheeseNot more than 36.0 percentNot less than 32.0 percent(vi) Mozzarella CheeseNot more than 60.0 percentNot less than 35.0 percent(vii) Pizza CheeseNot more than 54.0 percentNot less than 35.0 percent

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