The Infant Milk Substitutes, Feeding Bottles and Infant Foods (Regulation of Production, Supply and Distribution) Rules, 1993

REGD. NO. D.L.-33004/93 The Gazette of India EXTRAORDINARY PUBLISHED BY AUTHORITY No. 258] NEW DELHI, SATURDAY, JULY 31, 1993/SRAVANA 9, 1915 MINISTRY OF HUMAN RESOURCE DEVELOPMENT (Department of Women and Child Development) NOTIFICATIONS New Delhi, the 31st July, 1993 G.S.R. 527(E).—In exercise of the powers conferred by sub-section (3) of section 1 of the Infant Milk Substitutes, Feeding Bottles and Infant Foods (Regulation of Production, Supply and Distribution) Act, 1992 (41 of 1992). the Central Government hereby appoints the first day of August, 1993 as the date on which the said Act shall come into force. [No. F-12-1/93-NT] MEENAXI ANAND CHAUDHRY, Jt. Secy. 1714G1/93 (1) New ueuu, me ^ist Juiy, in? 3 G.S.R. 528(E).—In exercise of the powers conferred by sub-sectioa (1) of section 26 of the Infant Milk Substitutes, Feeding Bottles and Infant Foods (Regulation of Production, Supply and Distribution) Act, 1992 (41 of 1992), the Central Government hereby makes the following rules, namely:— 1. Short title and commencement.—(1) These rules may be . called the Infant Milk Substitutes, Feeding Bottles and Infant Foods (Regulation of Production, Supply and Distribution) Rules, 1993. (2) They shall come into force on the date of commence- ment of the'Ifififtt Milk Substitutes, Feeding Buttles and Infant Foods (Regulation of Production, Supply and Distri- bution) Act, 1992 (41 of 1992). 2. Definitions.—(1) In these rules, unless fhe context other- wise requires,— (a) "Act" means the Infant Milk Substitutes, Feeding Wottles and Infant Foods (Regulation of Production, Supply and Distribution) Act, 1992 (41 of 1992); (b) "authorised officer" means an officer not below the rant of a Class I (Group A or whatever name called) officer of the Government duly authorised by the State Government under section 12; (c) "'Food inspector" means a person appointed by the Government as such under section 9 of the Preven- tion ef Foad Adulteration Act, 1954 (37 of 1954); (d) "section" mearis * section of the Act. (2) Words and expressions used in these rules and not defined but defined in the Act shall have the respective mean- ings assigned to them in the Act. 3. Local limits of jurisdiction of food inspectors The local limits of jurisdiction of food inspectors shall be the same as are assigned to them under the Prevention of Food Adulteiatitn Act, 1954 (37 of 1954). 4. Authorised officers.—(1) No officer of the Government shall be authorised by the State Government under section (a) a medical officer in charge of health administration of a local area; or (b) a graduate in medicine and has received at least one month's training in food inspection and sampling work approved for the purpose of food inspection under the Prevention of Food Adulteration Act, 1954 (37 of 1954) by the Central Government of a State Government. (2) The State Government may, by notification in the Official Gazette, define the local limits of jurisdiction of autho- rised officers. 5. Conditions and restrictions for donation and distribution of infant milk substitutes, feeding bottles or equipments and materials relating to them through health care system.—No institution, organisation or health worker in private practice, engaged in health care for mothers, infants or pregnant women, shall donate or distribute any educational or other informational or communication aids relating to infant milk substitutes or feeding bottles without complying with the following condition and restrictions, namely:— (a) the donor should be informed in writing on— (i) the need for promoting breast feeding; (ii) the nutritional superiority of mother's milk; (iii) the benefits of breast milk, that is to say that breast milk is— (A) the best natural food for infants; (C) protects the infant from infection and diseases; (E) requires no special preparation; (iv) that breast feeding helps parents to space their children. i (v) the danger of microbial contaminations involved in bottle feeding. (b) informational or educational equipment or material relating to infant milk substitutes or feeding bottles should be donated or distributed only in case it is found necessary for healthy growth of the infant by a medical practitioner. 6. Language of the notice and other particulars of declara- t i o n . ^ 1) No person shall produce, supply or distribute any infant milk substitute or, infant food unless the container thereof or any label affixed thereto indicate in a clear, cons- picuous and "in an easily readable and understandable manner the words "IMPORTANT NOTICE", in capital letters in English and its equivalent in Hindi in Devnagri script: Provided that nothing herein contained shall prevent the u»e of any local language in addition to the language re- quired to be used under this sub-rule. 6 THfc GAZETTE OF INDIA: EXTRAORDINARY [PART II—SEC. 3(i)J il) The particulars of declaration to be specified on the label under the Prevention of Food Adulteration Act, 1*»54 (37 of 1954) and the rules made thereunder shall be in English or in Hindi in Devnagri script: Provided that nothing herein cotnained shall prevent the user of any language in addition to the language lequired to be used under this sub-rule. 7. Particulars of labelling of infant foods.—In addition to the requirements specified by or under the Prevention of Food Adulteration Act, 1954 (37 of 1954) and under section « of the Act, the label or the container of every infant milk or infant food substitute or their advertisements shall conform to the following, namely :— (a) the types of letters used shall not be less than 5 millimetres in size. (b) the colour of the text printed or used shall be different from that of the background of the label, container or the advertisement, as the case may be. 'c) the text of the particulars shall be prominent and conspicuous in the central panel of the label, con- tainer or the advertisement. (d) it shall indicate— <i) that an infant milk substitute or an infant milk food should be prepared appropriately and hyfii- enically besides taking adequate care in cleaning of utensils, bottles and teats. (ii) a warning against health hazards of inappropriate preparation as under:— "Infant milk substitutes /Infant Foods ''Warning/caution—Careful and hygienic preparation of infant food is most essential for health. Do not use fewer scoops than directed, since dilute 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." (iii) the approximate composition of nutrients per 100 grams of product including its energy yalue in calories. (iv) the storage conditions specifically stating "Store in cool and dry place in. an air-tight container" or the like. (v) the feeding chart and direction for use and instruc- tion for discarding left over feed,' the batch num- ber and date of manufacture. (vi) instructions for flse of measuring stoop (level or neaped) and the quantity per scoop. (vii) the prescribed period by which the infant milk sub- stitutes or the infant food, as the case may- be, is to be consumed. (viii) the Protein Efficiency Ratio (PER) which shall be minimum of 2.5 if the product other than the infant milk substitutes and infant foods is claimed to have high quality protein. 8. Particulars which a label, container or an advertisement should not contain.—Without prejudice to the requirements under the Prevention of Food Adulteration Act, 1954 (37 of 1954) and the rules made thereunder, the following restric- tions on use of words in any language on the label, container or advertisement, as the case may be, shall be applicable:— (a) the label, container or advertisement shall not con- tain any reference to the Act or 'these rules or any comment on, or reference to, orTSqjlanation of any particulars or declaration required b>»the Act or any of these rules to be included in the .lattel which directly or by implication, contradicts, quali- fies or modifies such particulars or declaration. (b) no words implying "teconunended by the jpedical profession" or any words which imply or safest that the food is recommended, prescribed or approve ed by medical practitioners shall be used in a label, container or advertisement. (c) the label, container or advertisement shall not con- tain the terms "Humanised" or "Maternalised'' or any other similar expressions in any language. (d) No label, container or advertisement of infant food shall exhibit the words "Full Protein Food". "Energy Food", "Complete Food" or "Health Food" or any other similar expressions in any language. 9. Details of information intended to reach pregnant women or mothers of infants through education or other material.—(1) Every educational or other material, whether audio or visual, dealing with pre-natal or post-natal care or with the feeding of an infant and intended to reach preg- nant women and mothers of infante shall, besides the infor- mation specified in clauses (a) tO^^'OT^'suV^ecWfi^Tt) of section 7, shall include: (a) the following details of advantages, as also nutritio-, nal superiority of breast feeding:— (i) Immediately after delivery, breast milk is yello wish and sticky. This milk is called colostrum, Which is secreted during the first week of delivery. Colostrum is more nutritious than that of mature milk because it contains more protein, more anti- infective properties which are of great import- ance for the infant's defence against dangerous neonatal infactiong. It also contains higher levels of Vitamin 'A1. tiQ^hntot milk— (A) is a complete and balan«*d fo&d and provide* all the nutrients needed by the infant in the first 'few' months of * * birth; (B) has anti-infective properties &af protect-lSe in- fants from infection in the early months; (C) is always available; (D) needs no utensils or water (which nrifcht carry germs) or fuel for its preparation', i (iii) breast feeding is much cheaper than feeding in- fant milk substitutes as the-'cost of the extra food needed by the mother is negligible computed to the cost of feeding infant milk-sufcstkutos; (iv) mothers who breast feed usually have longer periods of infertility after child birth than non- lactators. (b) details of management of breast feeding, as under:— (i) breast feeding— (A) immediately after delivery enagles the contrac- tion of the womb and helps the mother to re- --gain her figure quickly; (B) is successful when the infant suckles frequently and the mother wanting to breast-feed is con- fident in her ability to do so. (ii) in order to promote and support breast feeding the mothers natural desire to breast feed should always be encouraged by giving, where needed, practical advice and making sure that she has the support of her relatives. (iii) adequate care for the breast and nipples should be taken during pregnancy. (iv) it is also necessary to put the infant to the breast as soon as possible after delivery. (v) let the mother and the infant stay together after the delivery, the mother and her infant should be allowed to stay together (in hospital, this is called "rooming-in"). (vi) give the infant colostrum as it is rich in many nutrients and anti-infective factors protecting the infants from infections during the few days of its birth. (vii) the practice of discarding colostrum and giving sugar water, honey water, butter or other concoc- tions instead of colostrum should be very strongly discouraged. (viii) let the infants suckle on demand. (ix) every effort should be made to breast feed the infants whenever they cry. (x) mother should keep her body and clothes and that of the infant always neat and clean. MEENAXI ANAND CHAUDHRY, Jt. Secy. Printed by the Manager, Govt. of Jndia Press, Ring Road, Maya Puri, New DeIhi-n0O64 and Published by the Ccnirolkr o< Publications, Delhi-110054. 1993