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Union of India - Section

Section 37A in The Prevention of Food Adulteration Rules, 1955

37A. Manufacture of proprietary food.

(1)Proprietary food means a food which has not been standardised under the Prevention of Food Adulteration Rules, 1955.
(2)In addition to the provisions including labelling requirements specified under these rules, the proprietary foods shall also conform to the following requirements, namely:-
(a)the name of the food and category under which it falls in these rules shall be mentioned on the label;
(b)the proprietary food product shall comply with all other regulatory provisions specified in these rules and in Appendixes.
Substituted by G.S.R. 664(E), dated 19th September, 2008, for sub-rule (2) (w.e.f. 19-3-2009). Sub-rule (2), before substitution, stood as under:(2) In addition to the provisions including labelling requirements as prescribed under these rules, all proprietary foods shall also conform to the following requirements:-(a) the manufacturer of proprietary products shall obtain separate licence for manufacture of each proprietary food products:Provided thatHalwaismanufacturing traditional foods like Indian traditional snacks and sweets shall obtain a composite licence;(b) the name of the food and/or category under which it falls in these rules shall be mentioned on the label;(c) tobacco and nicotine shall not be used as ingredients in the manufacture of proprietary food products;(d) where any food contains any allergenic and/or hypersensitive ingredients as identified under the rules, or any ingredient originating from an allergenic and/or hypersensitive ingredients, such food shall bear the label declaration as provided under clause (24) of sub-rule (zzz) of rule 42.(e) the proprietary food product shall not contain food additives except as provided in the rules for that food and/or category of food."
Substituted by G.S.R. 491(E), dated 21st August, 2006 and read with corrigendum G.S.R. 518(E), dated 31st July, 2007, G.S.R. 70(E), dated 5th February, 2008, G.S.R. 383(E), dated 16th May, 2008, G.S.R. 730(E), dated 13th October, 2008, for rule 37A (w.e.f. 18-3-2009). Rule 37A, before substitution, stood as under:37A. Manufacture of proprietary foods and infant foods.- (1) An article of infant milk substitutes/infant foods whose standards are not prescribed in Appendix 'B' shall be manufactured for sale, exhibited for sale or stored for sale only after obtaining the approval of such article of food and its label from Government of India.(2) In case of proprietary foods the name of the food or category under which it falls in these rules shall be mentioned on the label.Explanation.- For the purpose of this rule -[***](b) "Proprietary food", means a food which has not been standardised under the Prevention of Food Adulteration Rules, 1955.
[37B. Labelling of infant milk substitute and infant food. - [(1) An article of infant milk substitutes/infant foods whose standards are not prescribed in Appendix B 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 Government of India.] [Substituted by G.S.R. 147(E), dated 14th March, 1997 (w.e.f. 14-9-1997) as corrected by G.S.R. 285(E), dated 29th May, 1997, for rule 37B. Earlier Rule 37B was inserted by G.S.R. 257(E), dated 3rd May, 1991 as corrected by G.S.R. 531(E), dated 14th August, 1991 (w.e.f. 3-11-1991)]
(1A)[] [Sub-rule (1) renumbered as sub-rule (1A) by G.S.R. 491(E), dated 21st August, 2006 and read with corrigendum G.S.R. 518(E), dated 31st July, 2007, G.S.R. 70(E), dated 5th February, 2008, G.S.R. 383(E), dated 16th May, 2008, G.S.R. 730(E), dated 13th October, 2008 (w.e.f. 18-3-2009)] Without prejudice to any other provisions relating to labelling requirements contained in these rules, every container of infant milk substitute or infant food or 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 thereunder the following particulars, namely:-
(a)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 or infant food or any label affixed thereto. The colour of the text printed or used shall be different from that of the background of the label, container [* * *] [The words 'or the advertisement' omitted by G.S.R. 339(E), dated 27th May, 2005 (w.e.f. 27-5-2005)], 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] [Substituted by G.S.R. 388(E), dated 25th June, 2004 (w.e.f. 25-6-2004)] shall also be given;
(b)a statement that infant milk substitute or 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;
(c)a warning that infant milk substitute or infant food is not the sole source of nourishment of an infant;
(d)a statement indicating the process of manufacture ([spray dried] [Substituted by G.S.R. 398(E), dated 3rd July, 2006 and as corrected by G.S.R. 1(E), dated 2nd January, 2007, by G.S.R. 267(E), dated 2nd April, 2007, for 'spray or roller dried' (w.e.f. 4-7-2007)]) 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";
(e)the approximate composition of nutrients per 100 gms of the product including its energy value in Kilo Calories/Joules;
(f)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] [Inserted by G.S.R. 398(E), dated 3rd July, 2006 and as corrected by G.S.R. 1(E), dated 2nd January, 2007, by G.S.R. 267(E), dated 2nd April, 2007 (w.e.f. 4-7-2007)];
(g)the feeding chart and directions for use and instruction for discarding left over feed;
(h)instruction for use of measuring scoop (level or heaped) and the quantity per scoop (scoop to be given with the pack);
(i)indicating the Batch No., Month and Year of its manufacture and [expiry date] [Substituted by G.S.R. 398(E), dated 3rd July, 2006 and as corrected by G.S.R. 1(E), dated 2nd January, 2007, by G.S.R. 267(E), dated 2nd April, 2007, for 'month and year before which it is to be consumed' (w.e.f. 4-7-2007).];
(j)the protein efficiency ratio (PER) which shall be minimum 2.5 if the product other than infant milk substitute it claimed to have higher quality protein;
(k)[ the specific name of the food additives, if permitted, shall be declared in addition to appropriate class names.] [Inserted by G.S.R. 398(E), dated 3rd July, 2006 and as corrected by G.S.R. 1(E), dated 2nd January, 2007, by G.S.R. 267(E), dated 2nd April, 2007 (w.e.f. 4-7-2007)]
(2)No containers or label referred to in sub-rule (i) relating to infant milk substitute or infant food shall have a picture of infant or women or both. It shall not have picture or other graphic materials [or] [Corrected vide G.S.R. 423(E), dated 24th June, 2005] phrases designed to increase the saleability of the infant milk substitute or infant food. The terms "Humanised" or "Maternalised" or any other similar words shall not be used. The package and/or any other label of infant milk substitute or infant food shall not exhibit the words, "Full Protein Food", "Energy Food", "Complete Food" or "Health Food" or any other similar expression.
(3)The containers of infant milk substitute meant for [premature baby (born before 37 weeks)/low birth weight infant (less than 2500 gm)] [Substitution by G.S.R. 398(E), dated 3rd July, 2006 and as corrected by G.S.R. 1(E), dated 2nd January, 2007, by G.S.R. 267(E), dated 2nd April, 2007, for 'low birth weight infant (less than 2500 gms)', (w.e.f. 4-7-2007)] or labels affixed thereto shall indicate the following additional information, namely:-
(a)the words ["PREMATURE BABY (BORN BEFORE 37 WEEKS)/LOW BIRTH WEIGHT (LESS THAN 2.5 KG)"] [Substituted by G.S.R. 398(E), dated 3rd July, 2006 and as corrected by G.S.R. 1(E), dated 2nd January, 2007, by G.S.R. 267(E), dated 2nd April, 2007, for 'LOW BIRTH WEIGHT (LESS THAN 2.5 KG)' (w.e.f. 4-7-2007)] in capital letters alongwith the product name in central panel;
(b)a statement "the low birth weight infant milk substitute shall be withdrawn under medical advice as soon as the mother's milk is sufficiently available"; and
(c)a statement "TO BE TAKEN UNDER MEDICAL ADVICE" in capital letters.
(4)The product which contains neither milk nor any milk derivatives shall be labelled "contains no milk or milk product" in conspicuous manner.
(5)[ The container of infant milk substitute for lactose or lactose and sucrose intolerant infants or label affixed thereto shall indicate conspicuously "LACTOSE-FREE or SUCROSE-FREE or LACTOSE and SUCROSE-FREE" in capital letters and statement "TO BE TAKEN UNDER MEDICAL ADVICE" and shall also bear the following statements, namely:-"Lactose free Infant Milk Substitute should only be used in case of diarrhoea due to lactose intorlerance.The lactose free/sucrose free Infant Milk Substitute should be withdrawn if there is no improvement in symptoms of intolerance.] [[Substituted by G.S.R. 398(E), dated 3rd July, 2006 and as corrected by G.S.R. 1(E), dated 2nd January, 2007, by G.S.R. 267(E), dated 2nd April, 2007, for sub-rule (5) (w.e.f. 4-7-2007). Sub-rule (5), before substitution, stood as under:'(5) The container of infant milk substitute for lactose intolerant infants or label affixed thereto shall indicate conspicuosly 'LACTOSE FREE' in capital letters and statement 'TO BE TAKEN UNDER MEDICAL ADVICE'.]] ]
(6)[ The container of infant milk substitute meant for infants with allergy to cow's/buffalo's milk protein or soy protein or label affixed thereto shall indicate conspicuously "HYPOALLERGENIC FORMULA" in capital letters and statement "TO BE TAKEN UNDER MEDICAL ADVICE".] [Substituted by G.S.R. 398(E), dated 3rd July, 2006 and as corrected by G.S.R. 1(E), dated 2nd January, 2007, by G.S.R. 267(E), dated 2nd April, 2007, for sub-rule (6) (w.e.f. 4-7-2007)]
Substituted by G.S.R. 339(E), dated 27th May, 2005 and as corrected by G.S.R. 423(E), dated 24th June, 2005, for sub-rule (2) (w.e.f. 27-5-2005). Sub-rule (2), before substitution, stood as under:(2) No container or label referred to in sub-rule (1) relating to infant milk substitute and any advertisement relating thereto shall have a picture of infant or woman or both. It shall not have picture or other graphic materials or phrases designed to increase the saleability of the infant milk substitute. The terms 'Humanised' or 'Maternalised' or any other similar words shall not be used. The package and/or the label and/or the advertisement of infant foods infant milk substitute shall not exhibit the words 'full protein food' 'energy food' 'complete food' or 'Health Food' or any other similar expression.
[37C. Labelling of irradiated food. - The labelling of prepacked irradiated food shall be in accordance with the provisions of rule 32 and rule 42 of the Prevention of Food Adulteration Rules, 1955 and the provisions of the Atomic Energy (Control of Irradiation of Food) Rules, 1991, under the Atomic Energy Act, 1962 (33 of 1962).] [Inserted by G.S.R. 614(E), dated 9th August, 1994 (w.e.f. 9-8-1994) as corrected by G.S.R. 60(E), dated 7th February, 1995][37D. Labelling of edible oils and fats. - 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" or such other expressions which are an exaggeration of the quality of the Product.] [Inserted by G.S.R. 241(E), dated 5th April, 1999]