MINISTRY OFHEALTHANDFAMILY WELFARE (Food Safety and Standards Authority of India) Notification New Delhi, dated the s August, 2011 FNo.2-150

1 · 1: Short title and commencement

1 · 1.1: These regulations may be called the Food Safety and Standards (Packaging and labelling) Regulations, 2011 1.1.2: These regulations shall come into force On Or after 5uh August, 2011 1.2: Definitions

1 · 2.1: In these regulations unless the context otherwise requires: 1. "Best before' means the date which signifies the end of the period under any stated storage conditions during which the food shall remain fully marketable and shall retain any specific qualities for which tacit O express claims have been made and beyond that date, the food may still be perfectly safe to consume, though its quality may have diminished. However the food shall not be sold if at any stage the product becomes unsafe. 2. "Date of manufacture means the date on which the food becomes the product as described; 3. "Date of packaging' means the date on which the food is placed in the immediate container in which it will be ultimately sold; 4. *Infant' means a child not more than twelve months of age; 5. ~Lot number" or "code number" or batch number' means the number either in numericals or alphabets or in combination thereof, representing the lot number or code number or batch number; being preceded by the words ~Lot No" or 'Lot" or *code number or "Code" or Batch No" or Batch or any distinguishing prefix by which the food can be traced in manufacture and identified in distribution. 6. "Multipiece package' means a package containing two O more individually packaged or labelled pieces of the same commodity of identical quantity, intended for retail either in individual pieces or packages as a whole. 7. ~Non- Vegetarian Food" means an article of food which contains whole O part of any animal including birds, fresh water or marine animals or eggs O products of any animal origin; but excluding milk Or milk products, as an ingredient; 8. "Prepackaged" or Pre-packed food" means food, which is placed in a package of any nature, in such a manner that the contents cannot be changed without tampering it and which is ready for sale to the consumer:

2 · 1: Packaging

2 · 1.1: General Requirements 1. Autensil or container made of the following materials O metals, when used in the preparation, packaging and storing of food shall be deemed to render it unfit for human consumption: containers which are rusty; b) enameled containers which have become chipped and rusty; copper or brass containers which are not properly tinned containers made of aluminium not conforming in chemical composition to IS:20 specification for Cast Aluminium & Aluminium Alloy for utensils or IS:21 specification for Wrought Aluminium and Aluminium Alloy for utensils_ 2 Containers made of plastic materials should conform to the following Indian Standards Specification; used as appliances Or receptacles for packing Or storing whether partly o wholly, food articles namely IS 10146 (Specification for Polyethylene in contact with foodstuffs); (ii) IS 10142 (Specification for Styrene Polymers in contact with foodstuffs); (iii) IS 10151 (Specification for Polyvinyl Chloride (PVC), in contact with foodstuffs); (iv) IS 10910 (Specification for Polypropylene in contact with foodstuffs); IS 11434 (Specification for Ionomer Resins in contact with foodstuffs); (vi) IS: 11704 Specification for Ethylene Acrylic Acid (EAA) copolymer (vii) IS: 12252 - Specification for Poly alkylene terephathalates (PET) (viii) IS: 12247 Specification for Nylon 6 Polymer; (ix) IS: 13601 Ethylene Vinyl Acetate (EVA); (x) IS: 13576 - Ethylene Metha Acrylic Acid (EMAA); (xi) Tin and plastic containers once used, shall not be re-used for packaging of edible oils and fats; Provided that utensils or containers made of copper though not properly tinned, may be used for the preparation of sugar confectionery Or essential oils and mere use of such utensils O containers shall not be deemed t0 render sugar confectionery Or essential oils unfit for human consumption. 3. General packaging requirements for Canned products,

2 · 1.2: Product specific requirements 1 Packaging requirements for Milk and Milk Products Bottling or filling of containers with heat-treated milk and milk product shall be carried out mechanically and the sealing of the containers shall be carried out automatically: (b) Wrapping or packaging may not be re-used for dairy products, except where the containers are of a type which may be re-used after thorough cleaning and disinfecting: (c) Sealing shall be carried out in the establishment in which the last heat-treatment of drinking milk O liquid milk-base products has been carried out, immediately after filling, by means of a sealing device which ensures that the milk is protected from any adverse effects of external origin on its characteristic. The sealing device shall be so designed that once the container has been opened, the evidence of opening remains clear and easy to check: Immediately after packaging, the dairy products shall be placed in the rooms provided for storage_ 2. Packaging requirements for Edible il/ fat: Tin Plate used for the manufacture of tin containers for packaging edible oils and fats shall conform to the standards of prime grade quality contained in B.I.S. Standards No. 1993 or 13955 or 9025 or 13954 as amended from time to time and in respect of Tin containers for packaging edible oils and fats shall conform to IS No. 10325 or 10339 as amended from time t0 time_ 3. Packaging requirements for Fruits and Vegetables Products Every container in which any fruit product is packed shall be so sealed that it cannot be opened without destroying the licensing number and the special identification mark of the manufacture to be displayed on the top Or neck of the bottle: (ii) For Canned fruits, juices and vegetables, sanitary top cans made up of suitable kind of tin plates shall be used: (iii) For Bottled fruits, juices and vegetables, only bottles/ jars capable of giving hermetic seal shall be used_ (iv) Juices, squashes, crush, cordials, syrups, barley waters and other beverages shall be packed in clean bottles securely sealed. These products when frozen and sold in the form of ice shall be packed in suitable cartons. Juices and Pulps may be packed in wooden barrels when sulphited. For packing Preserves, Jams, Jellies, and Marmalades, new cans, clean jars, new canisters, bottles chinaware jars, aluminium containers may be used and it shall be securely sealed. (vi) For Pickles, clean bottles, jars, wooden casks, tin containers covered from inside with polythene lining of 250 gauge or suitable lacquered cans shall be used. (vii) For Tomato Ketchups and Sauces, clean bottles shall be used. If acidity does not exceed 0.59 as acetic acid, open top sanitary cans may also be used. (viii) Candied fruits and peels and dried fruits and vegetables can be packed in paper bags, cardboard or wooden boxes, new tins, bottles, jars, aluminium and other suitable approved containers (ix) Fruits and Vegetable products can also be packed in aseptic and flexible packaging material having good grade quality conforming to the standards laid down by BIS. 4 Packaging requirements for Canned Meat Products (i) New sanitary top cans made from suitable kind of tin plate shall be used: The cans shall be lacquered internally; they - shall be sealed hermetically after filling: The lacquer used shall be sulphur resistant and shall not be soluble in fat or brine_ (ii) Cans used for filling pork luncheon meat shall be coated internally with edible gelatin, lard or lined with vegetable parchment paper before being filled.

2 · 2.1: General Requirements 1. Every prepackaged food shall carry a label containing information as required here under unless otherwise provided, namely; 2 The particulars of declaration required under these Regulations to be specified on the label shall be in English or Hindi in Devnagri script: Provided that nothing herein contained shall prevent the use of any other language in addition to the language required under this regulation. 3. Pre-packaged food shall not be described Or presented on any label or in any labelling manner that is false, misleading O deceptive Or is likely to create an erroneous impression regarding its character in any respect; 4. Label in pre-packaged foods shall be applied in such a manner that they will not become separated from the container; 5.Contents on the label shall be clear; prominent; indelible and readily legible by the consumer under normal conditions of purchase and use; 6. Where the container is covered by a wrapper; the wrapper shall carry the necessary information or the label on the container shall be readily legible through the outer wrapper and not obscured by it;

2 · 2.2: Labelling of Pre-packaged Foods In addition to the General Labelling requirements specified in 2.2.1 above every package of food shall carry the following information On the label, namely 1. The Name of Food: The name of the food shall include trade name or description of food contained in the package. 2. List of Ingredients: Except for single ingredient foods, a list of ingredients shall be declared on the label in the following manner: The list of ingredients shall contain an appropriate title, such as the term "Ingredients" b) The name of Ingredients used in the product shall be listed in descending order oftheir composition by weight or volume, as the case may be, at the time of its manufacture; (c)A specific name shall be used for ingredients in the list of Ingredients; Provided that for Ingredients falling in the respective classes, the following class titles may be used, namely

4 · Declaration regarding Veg - or Non veg (i) Every package of "Non Vegetarian" food shall bear a declaration to this effect made by a symbol and colour code as stipulated below to indicate that the product is Non-Vegetarian Food. The symbol shall consist of a brown colour filled circle having a diameter not less than the minimum size specified in the Table mentioned in the regulation 2.2.2 (4) (iv), inside a square with brown outline having sides double the diameter of the circle as indicated below

2 · 3: Manner of declaration

2 · 3.1: General Conditions 1.Any information Or pictorial device written, printed, Or graphic matter may be displayed in the label provided that it is not in conflict with the requirements of these Regulations. 2. Every declaration which is required to be made on package under these regulations shall be: (i) Legible and prominent, definite, plain and unambiguous (ii) Conspicuous as to size number and colour; (iii) as far as practicable, in such style or type of lettering as to be boldly, clearly and conspicuously present in distinct contrast to the other type, lettering O graphic material used on the package, and shall be printed or inscribed on the package in a colour that contrasts conspicuously with the background of the label Provided that Where any label information is blown, formed o moulded on a glass or plastic surface Or where such information is embossed or perforated on package, that information shall not be required to be presented in contrasting colours:

2 · 3.3 The height of numeral in the declaration The height of any numeral required under these regulations, on the principal display panel shall not be less than as shown in Table below, if the net quantity is declared in terms of weight O volume and as shown in Table II below, if the net quantity is declared in terms of length, area Or number: TABLE - I When net quantity is in weight or volume

4 · 6

2 · 4.1: Labelling of infant milk substitute and infant food 1. An article of infant milk substitutes /infant foods, whose standards are not prescribed under Food Safety and Standards (Food Products standards and Food Additives) Regulations, 2011 shall be manufactured for sale _ exhibited for sale or stored for sale only after obtaining the approval of such articles of food and its label from the Authority: 2 Without prejudice to any other provisions relating to labelling requirements contained in these regulations_ every container of infant milk substitute Or infant food o any label affixed thereto shall indicate in a clear; conspicuous and in an easily readable manner; the words ~IMPORTANT NOTICE" in capital letters and indicating there under the following particulars, namely: a statement "MOTHER 'S MILK IS BEST FOR YOUR BABY" in capital letters The types of letters used shall not be less than five millimeters and the text of such statement shall be in the Central Panel of every container of infant milk substitute infant food O any label affixed thereto. The colour ofthe text printed O used shall be different from that of the background of the label, container as the case may be. In case of infant food, a statement indicating "infant food shall be introduced only (after the age of six months and upto the age of two years)" shall also be given; (ii) a statement that infant milk substitute O infant food should be used only on the advice of a health worker as to the need for its use and the proper method of its use; (iii) a warning that infant milk substitute Or infant food is not the sole source of nourishment of an infant; (iv) a statement indicating the process of manufacture (e.g spray dried) except in case of infant foods_ instruction for appropriate and hygienic preparation including cleaning of utensils, bottles and teats and warning against health hazards of inappropriate preparations, as under; ~Warning/ caution-Careful and hygienic preparation of infant foods/infant milk substitute is most essential for health: Do not use fewer scoops than directed since diluted feeding will not provide adequate nutrients needed by your infant: Do not use more scoops than directed since concentrated feed will not provide the water needed by your infant" the approximate composition of nutrients per 100 gms of the product including its energy value in Kilo Calories/Joules; vi) the storage condition specifically stating store in a cool and dry place in an air tight container" or the like (after opening use the contents within the period mentioned or the expiry date whichever is earlier); (vii) the feeding chart and directions for use and instruction for discarding leftover feed;

2 · 4.2: Labelling of edible oils and fats 1. The package, label or the advertisement of edible oils and fats shall not use the expressions 'Super- Refined" "Extra-Refined"' "Micro-Refined' Double-Refined" , Ultra-Refined "_ Anti-Cholesterol" , "Cholesterol Fighter" ~Soothing to Heart" "Cholesterol Friendly" Saturated Fat Free' O1 such other expressions which are an exaggeration of the quality of the Product: 2. Every container in which solvent-extracted oil or de-oiled meal or edible flouris packed for sale shall, at the time of sale by the producer; bear the following particulars in English or Hindi (Devnagri script) the name, trade name, if any; or description of the solvent-extracted oil or de-oiled meal or edible flour; as the case may be:

7 · Every package containing an admixtu re of imported rape-seed oil with mustard oil, shall carry the following label, namely

8 · Every package of vanaspati made from more than 30 percent of Rice bran oil shall bear the following label, namely This package of vanaspati is made from more than 30 per cent Rice bran oil by weight 9.Every package containing Fat Spread shall carry the following labels namely= Milk Fat Spread Use before

10 · Apackage containing annatto colour in vegetable oils shall bear the following label namely Annatto colour in oil (Name of oilloils_ used 11. Every package containing an admixture of edible oils shall carry the following label, namely: This blended edible vegetable oil contains an admixture of =

2 · 4.3: Labelling of permitted food colours 1. No person shall sell a permitted synthetic food colours for use in O upon food unless its container carries label stating ~ the following particulars: the words Food Colours

3 · No person shall sell preparation of permitted synthetic food colours for use in Or upon food unless its container carries a label stating - the following particulars: the words "Food Colour Preparation' (ii) the name of the various ingredients used in the preparation.

2 · 4.4: Labelling of irradiated Food Irradiated foods_ The label of a food, which has been treated with ionizing radiation, shall carry a written statement indicating the treatment in close proximity to the name of the food. In addition all packages of irradiated food shall bear the following declaration and logo, namely:

2 · 4.5: Specific Labelling Requirements of other Products 1. Coffee-Chicory Mixture:- (i) Every package containing a mixture of coffee and chicory shall have affixed to ita label upon which shall be printed the following declaration:

2 · CONDENSED MILK OR DESICCATED (DRIED) MILK: Every package containing condensed milk O desiccated (dried) milk shall bear a label upon which is printed such one of the following declarations as may be applicable O such other declaration substantially to the like effect as may be allowed by the State Government, namely;

3 · The declaration shall in each case be completed by inserting at (x the appropriate number in words and in figures, for example, one and a half (1V2) any fraction being expressed as eight quarters O ahalf,as the case may be_ 4_ There shall not be placed o any package containing condensed milk O desiccated (dried) milk any comment on, explanation of,or reference to either the statement of equivalence, contained in the prescribed declaration

10 · Every package containing Cassia Bark" shall bear the following label.

11 · Every package containing CINNAMON' shall bear the following label

12 · Every package of chillies which contains added edible oil shall bear the following label:

13 · Every package of ice-cream; kulfi, kulfa and chocolate ice-cream containing starch shall have a declaration on a label as specified in regulation 2.7.1(2) 14. Masala: Every package of mixed masala fried in oil shall bear the following label:

15 · Compounded Asafoetida: Every container of compounded asafoetida shall indicate the approximate composition of edible starch or edible cereal flour used in the compound, on the label. 16.Every package containing maida treated with improver or bleaching agents shall carry the following label, namely - WHEAT FLOUR TREATED WITH IMPROVERIBLEACHINGAGENTS, TO BE USED BY BAKERIES ONLY 17. Unless otherwise provided in these regulations, every package of malted milk food which contains added natural colouring matter except caramel, shall bear the following label, namely,

18 · Every advertisement for and/or a package of food containing added Monosodium Glutamate shall carry the following declaration, namely;

19 · Every container of refined salseed fat shall bear the following label, namely,

20 · Every container or package of table iodised salt o iron fortified common salt containing permitted anticaking agent shall bear the following label, namely;- IODIZED SALT IRON FORTIFIED COMMON SALT* CONTAINS PERMITTED ANTICAKINGAGENT Strike out whichever is not applicable 21. Every container O package of iron fortified common salt shall bear the following label, namely;

22 · Every package of Dried Glucose Syrup containing sulphur dioxide exceeding 40 ppm shall bear the following label namely

23 · Apackage containing tea with added flavour shall bear the following label, namely;

24 · Every package of food which is permitted to contain artificial sweetener mentioned in table given in regulation 3.1.3 (1) of Food Safety and standards (Food Products standards and Food Additive) Regulations, 2011 and an advertisement for such food shall carry the following label, namely;

25 · In addition to the declarations under regulation 2.4.5 (24 and 26), every package of food which is permitted to contain artificial sweetener mentioned in table in regulation 3.1.3 (1)of Food Safety and Standards (Food Products standards and Food Additive) Regulations, 2011 and an advertisement for such food shall carry the following label, namely -

26 · The declaration under regulation 2.4.5 (25) shall be provided along with name O trade name of product and shall be half of the size of the name/ trade name. The declaration may be given in two sentences, but in the same box_ 27. Every package of Aspertame (Methyl ester), Acesulfame K, Sucralose and Saccharin Sodium, Neotame marketed as Table Top = Sweetener and every advertisement for such Table Top Sweetener shall carry the following label, namely -

28 · Every package of food which is permitted to contain a mixture of Aspertame (Methyl Ester) and Acesulfame Potassium Sweeteners mentioned in the Table given in regulation 3.1.3(1) of Food Safety and Standards Food Products Standards and Food Additive) Regulation,2011,shall carry the following label, namely,

29 · Every package of food which is permitted to contain mixture of Acesulfame Potassium and Sucralose sweeteners mentioned in the Table given in Regulation 3.1.2 (1) of Food Safety and Standards (Food Products Standards and FoodAdditive) Regulation,2011 shall carry the following label, namely;

30 · Every package of Pan Masala and advertisement relating thereto, shall carry the following warning; namely;

31 · Every package of supari and advertisement relating thereto shall carry the following warning in conspicuous and bold print; namely; Chewing of Supari is injurious to Health 32. Every package of fruit squash by whatever name it is sold, containing additional sodium Or potassium salt shall bear the following label, namely.

33 · Every package of Cheese (hard), surface treated with Natamycin, shall bear the following label, namely,

34 · Every package of Bakery and Industrial Margarine made from more than 30 per cent of Rice Bran Oil shall bear the following label, namely; This package of Bakery Industrial Margarine is made from more than 30 per cent of Rice Bran Oil by Wt: 35. Every container Or package of flavour emulsion and flavour paste meant for use in carbonated Or non- carbonated beverages shall carry the following declaration, in addition to the instructions for dilution, namely;

36 · Every package of drinking water shall carry the following declaration in capital letters having the size of each letter as prescribed in Regulation 2.3.3

37 · Every package of mineral water shall carry the following declaration in capital letters having the size of each letter as prescribed in regulation 2.3.3

38 · Every package of food having added caffeine, shall carry the following label, namely;

40 · Every package of Cheese(s), if coated/packed in food grade waxes polyfilm/wrapping of cloth, shall bear the following label, namely;

41 · Every package of Frozen Desert / Frozen Confection shall bear the following label, namely;

42 · Every container Or package of common salt shall bear the following label, namely;

43 · Every package of biscuits, bread and cakes containing Oligofructose shall bear the following declaration, namely;

44 · Every package of fresh fruit if coated with wax shall carry the following label, namely;

45 · Gelatin meant for human consumption should be labeled as "Gelatin Food Grade" 46. Every package of food containing Polyols shall bear the following label,

47 · Every package of food containing Polydextrose shall bear the following label: -

2 · 4.6: Specific restrictions on Product labels Labels not to contain reference to Act or rules Or regulations contradictory to required particulars The label shall not contain any reference t0 the Act o any of these regulations any comment on, O reference to, Or explanation of any particulars or declaration required by the Act O any of these regulations to be included in the label which directly o by implication, contradicts, qualifies Or modifies such particulars O declaration. (2) Labels not to use words implying recommendations by medical profession: There shall not appear in the label of any package, containing food for sale the words 'recommended by the medical profession' or any words which imply or suggest that the food is recommended, prescribed, or approved by medical practitioners or approved for medical purpose (3) Unauthorized use of words showing imitation prohibited 1_ There shall not be written in the statement or label attached to any package containing any article of food the word 'imitation' or any word, or words implying that the article is a substitute for any food, unless the use of the said word or words is specifically permitted under these regulations. 2. Any fruit syrup, fruit juice, fruit squash, fruit beverages, cordial, crush Or any other fruit products standardised under Food Safety and Standards (Food Products standards and Food Additives) Regulations, 2011 which does not contain the prescribed amount of fruit juice O fruit pulp o fruit content shall not be described as a fruit Syrup, fruit juice, fruit squash; fruit beverages, cordial, crush or any other fruit product as the case may be_ 3. Any food product which does not contain the specified amount of fruit and is likely to deceive O mislead OT give a false impression to the consumer that the product contains fruit; whetherby use of words O pictorial representation, shall be clearly and conspicuously marked on the label as 'ADDED(NAME OF THE FRUIT) FLAVOUR'. 4_ Any food product which contains only fruit flavours, whether natural flavours and natural flavouring substances or nature identical flavouring substances, artificial flavouring substances as single or in combination thereof, shall not be described as a fruit product and the word ADDED" (NAME OF FRUIT) FLAVOUR shall be used in describing such product; 5 . Carbonated water containing no fruit juice Or fruit pulp shall not have a label which may lead the consumer into believing that it is a fruit product. 6. Any fruit and vegetable product alleged to be fortified with vitamin C shall contain not less than 40 mgms. of ascorbic acid per 100 gm. of the product: (4 Imitations not to be marked "pure' The word 'pure or any word or words of the same significance shall not be included in the label ofa package that contains an imitation of any food. (5) Labelling prohibitions for Drinking Water (Both Packaged and Mineral Water) No claims concerning medicinal (preventative, alleviative Or curative) effects shall be made in respect of the properties of the product covered by the standard Claims of other beneficial effects related to the health of the consumer shall not be made

2 · 5: Restriction on advertisement

2 · 6: Exemptions from labelling requirements-

2 · 6.1

1 · Where the surface area of the package is not more than 100 square centimeters, the label of such package shall be exempted from the requirements of list of ingredients, Lot Number or Batch Number or Code Number, nutritional information and instructions for use, but these information shall be given on the wholesale packages o multi piece packages, as the case may be. 2. the 'date of manufacture' or 'best before date' or 'expiry date' may not be required to be mentioned on the package having surface area of less than 30 square centimeters but these information shall be given on the wholesale packages or multipiece packages, as the case may be; 3. in case of liquid products marketed in bottles, if such bottle is intended to be reused for refilling, the requirement of list of ingredients shall be exempted, but the nutritional information specified in regulation 2.2.2 (4) these regulations shall be given on the label. Provided that in case of such glass bottles manufactured after March 19, 2009, the list of ingredients and nutritional information shall be given on the bottle: 4_ in case of food with shelf-life of not more than seven days, the 'date of manufacture' may not be required to be mentioned on the label of packaged food articles; but the 'use by date' shall be mentioned on the label by the manufacturer or packer: 5. In case of wholesale packages the particulars regarding list of ingredients. Date of manufacturel packing, best before, expiry date labelling of irradiated food and vegetarian logolnon vegetarian logo; may not be specified: 2.7: Notice of addition, admixture O deficiency in food

2 · 7.1

1 · Every advertisement and every price Or trade list o label for an article of food which contains an addition, admixture or deficiency shall describe the food as containing such addition, admixture or deficiency and shall also specify the nature and quantity of such addition, admixture O deficiency and no such advertisement O price or trade list or label attached to the container of the food shall contain any words which might imply that the food is pure: Provided that forpurpose of this regulation the following shall not be deemed as an admixture or an addition_ namely: salt in butter Or margarine; b) vitamins in food_ 2 Every package, containing food which is not pure by reason ofany addition, admixture or deficiency shall be labelled with an adhesive label, which shall have the following declaration: Declaration This (a) contains an admixtureladdition of not more than (b) per cent of (c)_ Here insert the name of food_ b) Here insert the quantity of admixture which may be present Here insert the name of the admixture or the name of ingredient which is deficient. Where the context demands it, the words 'contains an admixture of' shall be replaced by the words 'contains an addition of' or 'is deficient in'. 3. Unless the vendor of a food containing an addition, admixture or deficiency, has reason to believe that the purchaser is able to read and understand the declaratory label, he shall give the purchaser; if asked, the information contained in the declaratory label by word of mouth at the time of sale.