Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011

MINISTRYOFHEALTHAND FAMILYWELFARE (Food Safety and Standards Authority of India)
Notification
F.No. 2-15015/30/2010 New Delhi, dated the 1st August, 2011

Whereas in exercise of the powers conferred by section clause (e) of sub section (2) of section 92 read 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 (Food Products 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 India Extraordinary Part III – Sec. 4 dated 20th October 2010 inviting objections and suggestions from all persons likely to be affected thereby before the expiry of the period of thirty days from the date on which the copies of the Gazette containing the 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;
And whereas objections and suggestions received from the stakeholders within the specified period on the said draft 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 SAFETYAND STANDARDS (FOOD PRODUCTS STANDARDS AND FOOD ADDITIVES) REGULATIONS, 2011

CHAPTER 1
GENERAL


1.1: Title and commencement
1.1.1: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 5th 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 force after six months from that date.
Provided that wherever the standards given in these regulations are at variance with any of the provisions of the licenses already granted, Food Business Operator shall comply with the provisions of these regulations within six months from the date of commencement of the regulations.
1.2: Definitions
In 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-bearing material;
3. “DOUBLE TONED MILK” means the product prepared by admixture of cow or buffalo milk or both with fresh skimmed milk, or by admixture of cow or buffalo milk orboth 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 a negative Phosphatase Test. When fat or dry non-fat milk solids are used, it shall be ensured that the product remains 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, sterilised or boiled. The type of milk shall be mentioned on the label.
6. Full Cream Milk means milk or a combination of buffalo or cow milk or a product prepared by combination of both that has been standardised to fat and solids-not-fat percentage, given in the table below in 2.1.1:1, by adjustment/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 electron volts; and
(iii) Sub-atomic particles, namely, electrons generated from machine sources operated at or below an energy 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 without either addition thereto or extraction therefrom unless otherwise provided in these Regulations. It shall be free from colostrum. Milk of different classes and of different desmgnations shall conform to the standards laid down in the Table below in 2.1.1:1
Total urea content in the milk shall not be more than 700 ppm;
11. 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 below in 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 and unsweetened, condensed skimmed milk-sweetened and unsweetened, milk powder, skimmed milk powder, partly skimmed 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 the qualifications and requirements as for training specified in Schedule II of the Atomic Energy (Control of Irradiation of Food) Rules, 1991.
15. 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 630 C and holding at such temperature continuously for at least 30 minutes or heating it to at least 71.50C and holding at such temperature continuously for at least.
15 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 100 C, or less
16. RECOMBINED MILK means the homogenised product prepared from milk fat, non-fat-milk solids and water. 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 activated carbon and deodorized with steam without using any other chemical agents
18. “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 earth and/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.
19. SKIMMED MILK means the product prepared from milk from which almost all the milk fat has been removed mechanically.
20. STERILISATION :The term “sterilisation when used in association with milk, means heating milk in sealed container continuously to a temperature of either 1150 C for 15 minutes or at least 1300 C for a period of one second or 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 any of these milk that has been standardised to fat and solids-not-fat percentage given in the table below in 2.1.1:1 by the 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 skimmed 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 a negative Phosphatase Test. When fat or dry non-fat-milk solids are used, it shall be ensured that the product remains homogeneous 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 ormgin and containing glycerides;
26. “Vegetable oil product” means any product obtained for edible purposes by subjecting one or more edible oils 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), and includes any other process which may be notified by the Central Government in the official Gazette;

CHAPTER 2
FOOD PRODUCT STANDARDS

2.1: DAIRY PRODUCTS AND ANALOGUES
2.1.1: MILK
1. The standards of different classes and desmgnations of milk shall be as given in the table below. Milk shall conform to both the parameters for milk fat and milk solids not fat, independently, as prescribed in columns (4) and (5) of the said table:
Table

 

Class of Milk Desmgnation Locality Milk Fat Minimum percent
Milk solids not fat

 

(1) (2) (3) (4) (5)

Buffalo Milk
Uttar Pradesh

 (1) (2) (3) (4) (5)

 Note : sale without indication of the class, the standards prescribed for buffalo milk shall apply.

(ii) The heat treatment for the various desmgnaed milk shall be as follows.—

Desmgnation Heart treatment
Raw Nil
Pasteurised Pasteurisation.
Boiled Boiling
Flavoured Pasteurisation or Sterilisation
Sterilised Sterilisation

2.1.2 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 foremgn 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. Hmgh 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 hmgh fat cream.
2. Cream Powder means the product obtained by partial removal of water from cream obtained from milk of cow and / 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 from vegetable oil/ fat, mineral oil, added flavour and any substance foremgn to milk.
The product may contain food additives permitted in these regulations including Appendix A. It shall conform to the microbiological requirements prescribed in Appendix B. It shall conform to the following requirements:—
(i) Moisture Not more than 5.0 percent
(ii) Milk fat Not less than 42.0 percent
(iii) Milk protein in Milk solid not fat Not less than 34.0 percent
2.1.3: MALAI
1. Malai means the product rich in butter fat prepared by boiling and cooling cow or buffalo milk or a combination thereof. It shall contain not less than 25.0 per cent milk fat.
2.1.4: DAHI OR CURD
1. 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.
Where dahi or curd is sold or offered for sale without any indication of class of milk, the standards prescribed for 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 following requirements:—
(i) Moisture Not more than 70.0 percent
(ii) Milk fat Not 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: CHEESE
1. Cheese means the ripened or unripened soft or semihard, hard and extra hard product, which may be coated with food grade waxes or polyfilm, and in which the whey protein / casein ratio does not exceed that of milk. Cheese is 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 coagulation and/ 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 cultures of harmless lactic acid and / or flavour producing bacteria and cultures of other harmless microorganisms, safe and suitable 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 which must 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 by the 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 the microbiological requirements prescribed in Appendix B:
Provided that cheese or varieties of cheeses coated with food grade waxes/ or polyfilm / or wrapping of cloth shall bear proper label declaration as provided in regulation 2.4.5 (44) of Food Safety and Standards (Packaging and Labeling) Regulations, 2011. It shall conform to the following requirements:—
Product Moisture Milk Fat on Dry basis
(1) (2) (3)
(i) Hard Pressed Cheese Not more than 39.0 percent Not less than 48.0
(ii) Semi Hard Cheese Not more than 45.0 percent Not less than 40.0 percent
(iii) Semi Soft Cheese Not more than 52.0 percent Not less than 45.0 percent
(iv) Soft Cheese Not more than 80.0 percent Not less than 20.0 percent
(v) Extra Hard Cheese Not more than 36.0 percent Not less than 32.0 percent
(vi) Mozzarella Cheese Not more than 60.0 percent Not less than 35.0 percent
(vii) Pizza Cheese Not more than 54.0 percent Not less than 35.0 percent
2. “ Processed Cheese” means the product obtained by grinding, mixing, melting and emulsifying one or more varieties of cheeses with the aid of heat and emulsifying agents. It may contain cream, butter, butter oil and other milk products subject to maximum 5.0 percent lactose content in the final product and edible common salt, vinegar/ acetic acid, spices and other vegetable seasoning and foods other than sugars properly cooked or prepared for flavouring and characterization of the product provided these additions do not exceed one sixth of the weight of the total solids of the final product on dry matter basis and cultures of harmless bacteria and enzymes. It shall have pleasant taste and smell free from off flavour and rancidity. It may contain food additives permitted in these regulation including Appendix A. It shall conform to the microbiological requirements prescribed in Appendix B. It shall conform to the following requirements:—
(i) Moisture - Not more than 47.0 percent
(ii) Milk fat on dry basis - Not less than 40.0 percent.
Provided that processed cheese chiplets (packed sliced cheese) when sold in a package other than tin, shall not contain more than 50.0 percent moisture.
3. “ Processed Cheese Spread means the product obtained by grinding, mixing, melting and emulsifying one or more varieties of cheese with emulsifying agents with the aid of heat. It may contain Cream, Butter oil and other dairy products, subject to a maximum limit of 5.0 percent lactose in the final product, salt, vinegar, spices, condiments and seasonings, natural carbohydrate sweetening agents namely sucrose, dextrose, corn syrup, corn syrup solids, honey, maltose, malt syrup and hydrolysed lactose and food properly cooked or otherwise prepared for flavouring and characterization of the product provided these additions do not exceed one sixth of the weight of total solids of the final product on dry weight basis and cultures of harmless bacteria and enzymes. It 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 the microbiological requirements prescribed in Appendix B. It shall conform to the following requirements:—
(i) Moisture - Not more than 60.0 percent
(ii) Milk fat on dry basis - Not less than 40.0 percent.
4. Cheddar Cheese means ripened hard cheese obtained by coagulating heated/pasteurised milk of Cow and/ or Buffalo or mixtures thereof with cultures of harmless lactic acid producing bacteria, non-animal rennet or other suitable coagulating enzymes. It shall be in the form of hard pressed block with a coating of food grade waxes or wrapping of cloth or polyfilm. It shall have firm, smooth and waxy texture with a pale straw to orange colour without any gas holes. It may contain food additives permitted in these Regulations and Appendices including Appendix A. It shall conform to the microbiological requirements prescribed in Appendix B. It shall conform to the following requirements:—
(i) Moisture - Not more than 39.0 percent
(ii) Milk Fat on Dry Basis - Not less than 48.0 percent
5. Danbo Cheese means ripened semi hard cheese obtained by coagulating heated /pasteurised milk of cow and/ or Buffalo and mixtures thereof with cultures of harmless lactic acid producing bacteria, non-animal rennet or other suitable coagulating enzymes. It shall be smooth in appearance with firm texture and uniform yellow colour and may be coated with food grade waxes or wrapping of cloth or polyfilm. It may contain food additives permitted in these Regulations including Appendix A. It shall conform to the microbiological requirements prescribed in. Appendix B. It shall conform to the following requirements:—
(i) Moisture - Not more than 39.0 percent. (ii) Milk Fat on Dry Basis - Not less than 45.0 percent
6. Edam Cheese means the ripened semi hard cheese obtained by coagulating heated / pasteurised milk of Cow and / or Buffalo or mixtures thereof with cultures of harmless lactic acid producing bacteria non-animal rennet or other suitable coagulating enzymes. It shall have a firm texture suitable for cutting with a yellowish colour and a hard rind which may be coated with food grade waxes, wrapping of cloth, polyfilm or vegetable oil. It may contain food additives permitted in these regulations including Appendix A. It shall conform to the microbiological requirements prescribed in Appendix B. It shall conform to the following requirements:—
(i) Moisture - Not more than 46.0 percent. (ii) Milk Fat on Dry basis - Not less than 40.0 percent.
7. Gouda Cheese means ripened semi hard cheese obtained by coagulating milk of Cow and/ or Buffalo or mixtures thereof with cultures of harmless lactic acid producing bacteria non-animal / rennet or other suitable coagulating enzymes. It shall have firm texture suitable for cutting, straw to yellowish colour and a hard rind which may be coated with food grade waxes, wrapping of cloth, or vegetable oil. It may contain food additives permitted in these Regulations including Appendix “A”. It shall conform to the microbiological requirements prescribed in Appendix B. It shall conform to the following requirements:—

(i) Moisture - Not more than 43.0 percent
(ii) Milk Fat on Dry Basis - Not less than 48.0 percent.
8. Havarti Cheese means ripened semi hard cheese obtained by coagulating milk of cow and / or Buffalo or mixtures thereof with cultures of harmless lactic acid producing bacteria, non-animal rennet or other suitable coagulating enzymes. It shall have firm texture suitable for cutting, a Light yellow colour and may have a semi soft slmghtly greasy rind. It may contain food additives permitted in these regulations including Appendix A. It shall conform to the microbiological requirements prescribed in Appendix B. It shall conform to the following requirements:—

Requirements Havarti 30 percent Havarti 60 percent Havarti
Moisture Not more than Not more than53.0 Not more than 60.0
Milk Fat on Not less than 45.0 percent Not less than 30.0 percent Notlessthan60.0 percent.
Dry basis
9. Tilsiter means ripened semi hard cheese obtained by coagulating milk of Cow and/ or Buffalo or mixtures thereof with cultures of harmless lactic acid producing bacteria and cultures of Bacterium linens, non-animal rennet or other suitable coagulating enzymes. It shall have firm texture suitable for cutting with a ivory to yellow colour with a firm rind which may show red and yellow smear producing bacteria or coated with food grade waxes or wrapping of cloth or polyfilm after removal of the smear. It may contain food additives permitted in these regulations including Appendix A. It shall conform to the microbiological requirements prescribed in Appendix B. It shall conform to the following requirements:–

Requirement Tilsiter 30 percent Tilsiter 60 percent Tilsiter
(1) (2) (3) (4)
Moisture Not more than 47.0 percent Not more than 53.0 percent Not more than 39.0 percent
Milk fat on Dry Basis Not less than 45.0 percent Not less than 30.0 percent Not less than 60.0 percent
10. Cottage Cheese and Creamed Cottage Cheese means soft unripened cheese obtained by coagulation of pasteurised skimmed milk of Cow and/ or Buffalo or mixtures thereof with cultures of harmless lactic acid bacteria with or without the addition of other suitable coagulating enzymes. Creamed Cottage Cheese is cottage cheese to which a pasteurised creaming mixture of cream, skimmed milk, condensed milk, non fat dry milk, dry milk protein, Sodium/ Potassium/ Calcium/ Ammonium caseinate is added. It shall have a soft texture with a natural white colour. It may contain spices, condiments, seasonings and fruits pulp. It may contain food additives permitted in these regulations including Appendix A. It shall conform to the microbiological requirements prescribed in Appendix B. It shall conform to the following requirements:—
(i) Moisture Not more than 80.0 percent
(ii) Milk Fat(in Creamed Cottage Cheese) Not less than 4.0 percent
11. Cream Cheese (Rahmfrischkase) means soft unripened cheese obtained by coagulation of pasteurised milk of cow and / or buffalo or mixtures thereof and pasteurised cream with cultures of harmless lactic acid producing bacteria with or without the addition of suitable coagulating enzymes. It shall have a soft smooth texture with a white to Light cream colour. It may contain spices, condiments, seasonings and fruits pulp. The product may contain food additives permitted in these regulations including Appendix A. It shall conform to the microbiological requirements prescribed in Appendix B. It shall conform to the following requirements:—
(i) Moisture Not more than 55.0 percent. (ii) Milk Fat on Dry Basis Not less than 70.0 percent.
12. Coulommiers Cheese means soft unripened cheese obtained by coagulation of milk of cow and /or buffalo or mixtures thereof with cultures of harmless lactic acid producing bacteria and non-animal rennet or other suitable coagulating enzymes and moulds characteristic of the variety. It shall have soft texture and white to cream yellow colour and may show presence of white mould including orange or red spots on the surface. It may contain food additives permitted in these regulations including Appendix A. It shall conform to the microbiological requirements prescribed in Appendix B. It shall conform to the following requirements:—
(i) Moisture Not more than 56.0 percent
(ii) Milk Fat on Dry Basis Not less than 46.0 percent
13. Camembert Cheese means ripened soft cheese obtained by coagulating milk of Cow and/ or Buffalo or mixtures thereof with cultures of harmless lactic acid producing bacteria and cultures of Penicillium caseicolum and Bacterium linens non-animal rennet or other suitable coagulating enzymes. It may be in the form of flat cylindrical shaped cheese covered with white mould (Penicillum caseicolum) with occasional orange coloured spots (Bacterium linens). It may contain food additives permitted in these regulations including Appendix A. It shall conform to the microbiological requirements prescribed in Appendix B. It shall conform to the following requirements:—

Requirements 30.0 percent 40.0 percent 45.0 percent 50.0 percent
Camembert Camembert Camembert Camembert cheese cheese cheese cheese

Moisture Not more than Not more than Not more than Not more than
62.0 percent 56.0 percent 56.0 percent 56.0 percent
Milk fat on Not more than Not more than Not more than Not more than
Dry Basis 30.0 percent 40.0 percent 45.0 percent 50.0 percent

14. Brie Cheese means soft ripened cheese obtained by coagulating milk of Cow and/ or Buffalo or mixtures thereof with cultures of harmless lactic acid producing bacteria and cultures of Penicillium caseicolum and Bacterium linens, non-animal rennet and other suitable enzymes. It shall be white to creamy yellow in colour with a smooth texture showing presence of white mould (Penicillium caseicolum) with occasional orange coloured spots (Bacterium linens) on the rind. It may contain food additives permitted in these regulation including Appendix A. It shall conform to the microbiological requirements prescribed in Appendix B.

It shall conform to the following requirements:—
(i) Moisture Not more than 56.0 percent
(ii) Milk Fat on Dry basis Not less than 40.0 percent

15. Saint Paulin - means ripened semi hard cheese obtained by coagulating milk of Cow and / or Buffalo or mixtures thereof with non-animal rennet, cultures of harmless lactic acid producing bacteria or other suitable enzymes. It shall have white to yellow colour with a firm and flexible texture and a hard rind which may be coated with food grade waxes or polyfilm. It may contain food additives permitted in these regulations including Appendix A. It shall conform to the microbiological requirements prescribed in Appendix B. It shall conform to the following requirements:—
(i) Moisture Not more than 56.0 percent
(ii) Milk Fat on Dry Basis Not less than 40.0 percent
16. Samsoe means hard ripened cheese obtained by coagulating milk of Cow and /or Buffalo or combination there of with non-animal rennet and cultures of harmless lactic acid producing bacteria or suitable coagulating enzymes. It shall be yellow in colour with a firm texture suitable for cutting and may have a rind with or without food grade waxes or polyfilm coating. It may contain food additives permitted in these regulations including Appendix A. It shall conform to the microbiological requirements prescribed in Appendix B. It shall conform to the following requirements:—

Requirements Samsoe 30 percent Samsoe
(i) Moisture Not more than 44.0 percent Not more than 50.0 percent
(ii) Milk Fat on Dry Basis Not less than 45.0 percent Not less than 30.0 percent

17. Emmentaler means hard ripened cheese with round holes obtained by coagulating milk of Cow and/ or Buffalo or mixtures thereof with non-animal rennet, cultures of harmless lactic acid producing bacteria or other suitable coagulating enzymes. It may contain Cupric Sulphate not exceeding 15 mgm/Kg expressed as Copper. It shall have a Light Yellow colour and a firm texture suitable for cutting and may have a hard rind. It may contain food additives permitted in these regulations including Appendix A. It shall conform to the microbiological requirements prescribed in Appendix B.
It shall conform to the following requirements:—
(i) Moisture Not more than 40.0 percent. (ii) Milk Fat on Dry Basis Not less than 45.0 percent
18. Provolone means pasta filata cheese obtained by coagulating milk of Cow and/ or Buffalo or mixtures thereof with cultures of harmless lactic acid producing bacteria, non-animal rennet or other suitable coagulating enzymes. It may be smoked. It shall be white to yellow straw in colour with a fibrous or smooth body and rind which may be covered with vegetable fat/ oil, food grade waxes or polyfilm. It may contain food additives permitted in these regulations including Appendix A. It shall conform to the microbiological requirements prescribed in Appendix B.
It shall conform to the following requirements:—
(i) Moisture —
(a) Unsmoked Cheese Not more than 47.0 percent
(b) Smoked Cheese Not more than 45.0 percent
(ii) Milk Fat on Dry Basis Not less than 45.0 percent

19. Extra Hard Grating Cheese means ripened cheese obtained by coagulating milk of Cow and/ or Buffalo, goat/ sheep milk or mixtures thereof with cultures of harmless lactic acid producing bacteria, non-animal rennet, or other suitable coagulating enzymes. It may be white to Light cream in colour with a slmghtly brittle texture and an extra hard rind which may be coated with vegetable oil, food grade waxes or polyfilm. It may contain food additives permitted in these regulations including Appendix A. It shall conform to the microbiological requirements prescribed in Appendix B. It shall conform to the following requirements:—

(i) Moisture Not more than 36.0 percent
(ii) Milk Fat on Dry Basis Not less than 32.0 percent

2.1.7: DAIRY BASED DESSERTS/ CONFECTIONS
1. Ice Cream, Kulfi, Chocolate Ice Cream or Softy Ice Cream(hereafter referred to as the said product) means the product obtained by freezing a pasteurized mix prepared from milk and /or other products derived from milk with or without the addition of nutritive sweetening agents, fruit and fruit products, eggs and egg products, coffee, cocoa, chocolate, condiments, spices, ginger and nuts and it may also contain bakery products such as cake or cookies as a separate layer and/or coating. The said product may be frozen hard or frozen to a soft consistency; the said product shall have pleasant taste and smell free from off flavour and rancidity; the said product may contain food additives permitted in these regulation including Appendix A; the said product shall conform to the microbiological requirements specified in Appendix B; the said product shall conform to the following requirements, namely:—

Requirement Ice Cream Medium Fat Ice Cream Low Fat Ice Cream

Total Solid Not less than Not less than 30.0 Not less than 26.0
36.0 percent percent percent
Wt/Vol (gms/l) Not less than Not less than 475 Not less than 475
Milk Fat 525 Not less More than 2.5 percent Not more than 2.5
10.0 percent but less than 10.0 percent percent

Milk Protein Not less than Not less than Not less than
(Nx6.38) 3.5 percent 3.5 percent 3.0 percent

Note:— In case where Chocolate, Cake or similar food coating, base or layer forms a separate part of the product only the Ice Cream portion shall conform to the requirements given above. The type of ice-cream shall be clearly indicated on the label otherwise standard for ice-cream shall apply.
2. Dried Ice Cream Mix/ Dried Frozen Dessert/ Confection(hereafter referred to as the said product) means the product in a powder form which on addition of prescribed amount of water shall give a product conforming to the requirements of the respective products, namely - ice cream, medium fat ice-cream, low fat ice-cream as prescribed under regulation 2.1.7 (1) and frozen confection, medium fat frozen confection and low fat frozen confection as prescribed under regulation 2.1.7 (3) of these regulations except the requirement of weight /volume for both the products. The moisture content of the product shall not be more than 4.0 percent. It may contain food additives permitted in these regulation including Appendix A. It shall conform to the microbiological requirements prescribed in Appendix B.
3. Frozen Dessert / Frozen Confection(hereafter referred to as the said product) means the product obtained by freezing a pasteurised mix prepared with milk fat and / or edible vegetable oils and fat having a melting point of not more than 37.0 degree C in combination and milk protein alone or in combination / or vegetable protein products singly or in combination with the addition of nutritive sweetening agents e.g. sugar, dextrose, fructose, liquid glucose, dried liquid glucose, maltodextrin, hmgh maltose corn syrup, honey, fruit and fruit products, eggs and egg products coffee, cocoa, chocolate, condiments, spices,ginger, and nuts. The said product may also contain bakery products such as cake or cookies as a separate layer/or coating, it may be frozen hard or frozen to a soft consistency. It shall have pleasant taste and flavour free from off flavour and rancidityand may contain food additives permitted in Appendix A. It shall conform to the microbiological requirements prescribed in Appendix B. It shall conform to thefollowing requirements:—


Requirement Frozen Dessert/ Medium Fat Frozen Low Fat Frozen
Frozen Desert/ Frozen Desert/ Frozen Confection Confection Confection
(1) (2) (3) (4)
Total Solid Not less than Not less than 30.0 Not less than 26.0
36.0 percent percent percent
Wt/Vol (gms/l) Not less than Not less than 475 Not less than 475
Total Fat 525 Not less More than 2.5 percent Not more than 2.5
10.0 percent but less than 10.0 percent percent

Total Protein Not less than Not less than Not less than
(N x 6.25) 3.5 percent 3.5 percent 3.0 percent

Note: In case where Chocolate, Cake or similar food coating, base or layer forms a separate part of the product only the frozen dessert/ confection portion shall conform to the requirements given above. The type of frozen confection shall be clearly indicated on the label otherwise, standards of frozen dessert / frozen confection shall apply and every package of Frozen Dessert / Frozen Confection shall bear proper label declaration under regulation 2.4.5 (41) of Food Safety and Standards (Packaging and Labeling) Regulations, 2011 .
4. Milk Ice or Milk Lolly (hereafter referred to as the said product) means the product obtained by freezing a pasteurized mix prepared from milk and/or other products derived from milk with or without the addition of nutritive sweetening agents, fruit and fruit products, eggs and egg products, coffee, cocoa, chocolate, condiments, spices, ginger and nuts; the said product may also contain bakery products such as cake or cookies as a separate layer and/ or coating; the said product shall have pleasant taste and smell free from off flavour and rancidity. It may contain food additives permitted in Appendix A; the said product shall conform to the microbiological requirements prescribed in Appendix B; the said product shall also conform to the following requirements, namely :—

(1) Total solids (m/m) Not less than 20.0 percent (2) Milk Fat (m/m) Not more than 2.0 percent (3) Milk Protein (Nx6.38) Not less than 3.5 percent

5. Khoya by whatever variety of names it is sold such as Pindi, Danedar, Dhap, Mawa or Kava means the product obtained from cow or buffalo or goat or sheep milk or milk solids or a combination thereof by rapid drying. The milk fat content shall not be less than 30 percent on dry weight basis of finished product. It may contain citric acid not more than 0.1 per cent by weight. It shall be free from added starch, added sugar and added colouring matter.
2.1.8: EVAPORATED/ CONDENSED MILK & MILK PRODUCTS
1. Evaporated Milk means the product obtained by partial removal of water from milk of cow and/ or buffalo by heat or any other process which leads to a product of the same composition and characteristics. The fat and protein content of the milk 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 have pleasant taste and flavour free from off flavour and rancidity. It shall be free from any substance foremgn to milk. It may contain food additives permitted in these regulation including Appendix A. It shall conform to the microbiological requirements prescribed in Appendix
B. It shall conform to the following requirements:—

Product Milk Fat Milk Solids Milk Protein in milk not fat

(1) (2) (3) (4)
(i) Evaporated milk Not less than 8.0 Not less than 26.0 Not less than 34.0 percent m/m 8.0 percent m/m percent m/m percent m/m
(ii) Evaporated partly Not less than 1.0 Not less than 20.0 skimmed milk percent and not percent m/m than 34.0 percent m/m
more than 8.0 percent m/m
(iii) Evaporated
skimmed milk Not more than 1.0 percent m/m Not less than 20.0 percent m/m Not less than 34.0 percent m/m
(iv) Evaporated hmgh Not less than 15.0 percent Not less than 27.0 percent Not less than 34.0 percent m/m
fat milk m/m m/m
2. Sweetened Condensed Milk means the product obtained by partial removal of water from milk of Cow and/ or Buffalo with the addition of sugar or a combination of sucrose with other sugars or by any other process which leads to a product of the same composition and characteristics. The fat and/ or protein content of the milk 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 have pleasant taste and flavour free from off flavour and rancidity. It shall be free from any substance foremgn to milk. It may contain food additives permitted in these regulations including Appendix A. It shall conform to the microbiological requirements prescribed in Appendix B. It shall conform to the
following requirements:—

Product Milk Fat Milk Solids Milk Protein in milk solids not fat

(i) Sweetened condensed Not less than 9.0 Not less than 31.0 Not less than 34.0
milk percent m/m percent m/m percent milk m/m
(ii) Sweetened condensed Not more than 1.0 Not less than 26.0 Not less than
skimmed milk percent m/m percent m/m 34.0 percent m/m

ii) Sweetened condensed Not less than 3.0 Not less than 9.0 Not less than
partly skimmed milk percent m/m percent m/m 34.0 percent m/m

ii) Sweetened condensed Not less than 16.0 Not less than 30.0 Not less than
hmgh fat milk percent m/m percent m/m 34.0 percent m/m

3. Milk Powder - means the product obtained by partial removal of water from milk of Cow and / or Buffalo. The fat and / or protein content of the milk 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 from vegetable oil/ fat, mineral oil, thickening agents, added flavour and sweetening agent. It may contain food additives permitted in these regulations including Appendix A. It shall conform to the microbiological requirements prescribed in Appendix B. It shall conform to the following requirements:—


Product Moisture Milk Fat Milk protein Titrable acidity solubility Total ash
in milk solids (ml 0.1N Present on dry NAOH /10 gm weight
solid not fat) basis

(i) Whole milk Not more than Not less than Not less than Not more than 18.0
power 4.0 per cent

 2.1.9: FOODS FOR INFANT NUTRITION

1. Infant Milk Food means the product prepared by spray drying of the milk of cow or buffalo or a mixture thereof. The milk may be modified by the partial removal/substitution of different milk solids; carbohydrates, such as sucrose, dextrose and dextrins/maltodextrin, maltose and lactose; salts like phosphates and citrates; vitamins A, D, E, B Group, Vitamin C and other vitamins; and minerals like iron, copper, zinc and iodine. The source of Mineral Salts and Vitamin Compounds may be used from:—
1. Calcium (Ca) - Calcium carbonate, Calcium chloride, Calcium citrate, Calcium phos phate monobasic, Calcium phosphate dibasic, Calcium phosphate tribasic;
2. Phosphorous (P) - Calcium phosphate monobasic, Calcium phosphate dibasic, Calcium phosphate tribasic, Magnesium phosphate dibasic, Potassium phosphate dibasic;
3. Chloride (Cl) - Calcium chloride, Choline chloride, Magnesium chloride, Manganese chloride, Sodium chloride, Sodium chloride iodized;
4. Iron (Fe) - Ferrous citrate, Ferrous lactate, Ferrous sulphate, Ferric pyrophosphate;
5. Magnesium (Mg) - Magnesium chloride, Magnesium oxide, Magnesium phosphate dibasic;
6. Sodium (Na) - Sodium bicarbonate, Sodium chloride, Sodium chloride iodized, Sodium citrate, Sodium phosphate monobasic;
7. Potassium (K) - Potassium phosphate dibasic;
8. Copper (Cu) - Cupric citrate, Cupric sulphate;
9. Iodine (I) - Potassium iodide, Sodium iodide;
10. Zinc (Zn) - Zinc sulphate;
11. Manganese (Mn) - Manganese chloride, Manganese sulphate;
12. Vitamin A - Retinyl acetate, Retinyl palmitate, Retinyl propionate;
13. Provitamin A - Beta-carotene;
14. Vitamin D - Vitamin D2 - Ergocalciferol, Vitamin D3 - Cholecalciferol, Cholecalciferol- cholesterol;
15. Vitamin E - d-alpha-tocopherol, dl-alpha-tocopherol, d-alpha-tocopheryl acetate, dl- alpha-tocopheryl acetate, d-alpha-tocopheryl succinate, dl-alpha-tocopheryl succinate;
16. Thiamine (Vitamin B1) - Thiamine chloride hydrochloride, Thiamine mononitrate;
17. Riboflavin (Vitamin B2) - Riboflavin, Riboflavin 5' -phosphate sodium;
18. Niacin - Nicotinamide, Nicotinic acid;
19. Vitamin B6 - Pyridoxine hydrochloride;
20. Biotin (Vitamin H) - d-biotin;
21. Folacin - Folic acid;
22. Pantothenic acid - Calcium pantothenate, Panthenol;
23. Vitamin B12 - Cyanocobalamin, Hydroxycobalamin;
24. Vitamin K - Phytylmenaquinone;
25. Vitamin C - Ascorbic acid, Sodium ascorbate, Calcium ascorbate, Ascorbyl-6-palmitate;
26. Choline - Choline bitartrate, Choline chloride;
27. Inositol;
28. Selenium - Sodium selenite.
The product shall be free of lumps and shall be uniform in appearance. It shall be free from starch and added antioxidants. It shall also be free from dirt, extraneous matter, preservatives and added colour and flavour and from any material which is harmful to human health. It shall not have rancid taste or musty odour. It shall not contain food additives.
It shall conform to the following requirements, namely:—
1. Moisture, per cent by weight (not more than) 4.5
2. Total milk protein, per cent by weight (not less than) 12.0
3. Milk fat, per cent by weight (not less than) 18.0
4. Total ash, per cent by weight (not more than) 8.5
5. Ash insoluble in dilute Hydrochloric acid, per cent by
weight (not more than) 0.1
6. Solubility:
Solubility Index maximum 2.0 ml
Solubility per cent by weight (not less than) 98.5
7. Vitamin A (as retinol) ìg. per 100 g. (not less than) 350 mg
8. Added Vitamin D (expressed as Cholecalciferol or Ergocalciferol)
ìg per 100g.(not less than) 4.5 ìg
9. Vitamin C, mg per 100 g. (not less than) 35 ìg
10. Thiamine, ìg per 100 g. (not less than) 185 ìg
11. Riboflavin, ìg per 100 g. (not less than) 275 ìg
12. Niacin, ìg per 100 g. (not less than) 1160 ìg
13. Pyridoxine ìg per 100 g. (not less than) 160 ìg
14. Folic acid, ìg per 100 g. (not less than) 20 ìg
15. Pantothenic acid, mg per 100 g. (not less than) 1.4 mg
16 Vitamin B12, ìg per 100 g. (not less than) 0.7 ìg
17 Choline, mg per 100 g. (not less than) 32 mg
18 Vitamin K ìg per 100 g. (not less than) 18 ìg
19 Biotin, ìg per 100 g. (not less than) 7.0 ìg
20 Sodium mg per 100 g. (not less than) 90 mg
21 Potassium, mg per 100 g. (not less than) 370 mg
22 Chloride, mg per 100 g. (not less than) 250 mg
23 Calcium, mg per 100 g. (not less than) 230 mg
24 Phosphorous, mg per 100 g. (not less than) 115 mg
25 Magnesium, mg per 100 g. (not less than) 22 mg
26 Iron, mg per 100 g. (not less than) 5.0 mg
27 Iodine, ìg per 100 g. (not less than) 20 ìg
28 Copper, ìg per 100 g. (not less than) 280 ìg
29 Zinc, mg per 100 g. (not less than) and 2.5 mg not more than 5.0 mg
30 Manganese, ìg per 100g. (not less than) 20 ìg
31 Selenium, ìg per 100 g. (not less than) 14 ìg
32. Bacterial count, per g. (not more than) 10,000
33 Coliform count absent in 0.1 gram
34 Yeast and mould count absent in 0.1 gram
35 Salmonella and Shmgella absent in 25 gram
36 E. coli absent in 0.1 gram
37 Staphylococcus aureas absent in 0.1 gram
It shall be packed in hermetically sealed, clean and sound containers or in flexible pack made from film or combination or any of the substrate made of Board paper, polyethylene, polyester metallised film or in such a way to protect from deterioration.
It may be packed in nitrogen or a mixture of nitrogen and carbon dioxide.
2. Infant formula means the product prepared by spray drying of the milk of cow or buffalo or mixture thereof. The milk may be modified by partial removal/substitution of milk fat with vegetable oils rich in polyunsaturated fatty acids and/or by different milk solids; carbohydrates such as sucrose, dextrose and dextrins/ maltodextrin, maltose and lactose; salts such as phosphates and citrates; vitamins A, D, E, B and C group and other vitamins; minerals such as iron, copper, zinc and iodine and others. Vegetables oils rich in polyunsaturated fatty acids shall be added to partially substitute milk fat to an extent that the product shall contain a minimum of 12 per cent by weight of milk fat and a minimum of linoleate content of 1.398 g per 100 g. of the product.
The products shall also contain a minimum of 0.70 I.U. of vitamin E per 100 kcal. It may contain in addition to the vitamins and minerals listed, other nutrients may be added when required in order to provide nutrients ordinarily found in human milk such as,—
1. Carotenes Not less than 0.25 mg/L
2. Fluorine Not less than 0.107 mg/L
3. Amino acids Not less than 9 mg/L (only L forms of amino acids should be used)
4. Non-protein nitrogen Not less than 173 mg/L
5. Nucleotides Not less than 11.7 mg/L
6. Carnitine Not less than 11.27 ìg/L
7. Lactalbumin Not less than 1.4 g/L
8. Lactoferrin Not less than 0.27 g/L
9. Lysozyme Not less than 0.8 g/L
10.Fucose Not less than 1.3 g/L
11. GlucosamineNot less than 0.7 g/L
12. Inositol Not less than 0.39 g/L
13. Citric acid Not less than 0.35 g/L
14. Cholesterol Not less than 88 mg/L
15. Lipid Phosphorus Not less than 7 mg/L
16. Prostaglandins Not less than PGE 150 mg/L Not less than PGF 400 mg/L
When any of these nutrients is added, the amount of these added nutrients shall be declared on the label, which should be not less than mentioned. It may contain medium chain trmglycerides, taurine, molybdenum and chromium.
The source of Mineral Salts and Vitamin Compounds may be used from:—
(1) Calcium (Ca) - Calcium carbonate, Calcium chloride, Calcium citrate, Calcium phosphate monobasic, Calcium phosphate dibasic, Calcium phosphate tribasic;
(2) Phosphorous (P) - Calcium phosphate monobasic, Calcium phosphate dibasic, Calcium phosphate tribasic, Magnesium phosphate dibasic, Potassium phosphate dibasic;
(3) Chloride (Cl) - Calcium chloride, Choline chloride, M