Marketing Controls (Foods for Infants and Young Children) Regulations 2010 (L.N. No. 54 of 2010)

135 [LEGAL NOTICE No. 54] FOOD SAFETY ACT 2003 MARKETING CONTROLS (FOODS FOR INFANTS AND YOUNG CHILDREN) REGULATIONS 2010 TABLE OF PROVISIONS PART I - PRELIMINARY 1, Citation andCommencement 2. Purpose 3. Interpretation PART II - INFORMATION AND EDUCATION 4. Information and educational about infant and young child feeding 5. Information and educational materials about infant formula, follow-up formula, feeding bottles and other appliances. 6. Product information for health professionals PART III - PROHIBITIONS 7. Promotion PART IV -LABELLING l: 8. 9. II 10. 11. I 12. "j! Prohibitions related to labels of all designated products Prohibitions related to labels of infant 'formula and follow-up formula Prohibitions related to labels of full cream milk powder Prohibition related to labels of feeding bottles and teats Prohibition related to lahels of pacifiers PART V - CONSISTENCY WITH NATIONAL NUTRITION POLICY 13. Special Committee 14. Functions of the Special Committee PART VI - AUTHORISED OFFICERS AND INSPECTION IS. Qualifications of authorised officers and inspection in compliance. PART VII - OFFENCES AND PENALTIES 16. Sanctions 136 FOOD SAFETY ACT 2003 Marketing Controls (Foods for Infants and Young Children) Regulations 2010 IN exercise of the powers conferred upon the Board by sections I3(4), 14(3) and 70 of the Food Safety Act 2003, the Board hereby makes these Regulations. PART I - PRELIMINARY Citation and Commencement 1.-(I) These Regulations may be cited asthe Marketing Controls (Foods for Infants and Young Children) Regulations 2010. (2) These Regulations is deemed to have come into force on 1st May 2010. Purpose 2. The purpose of these Regulations is to ensure safe and adequate nutrition for infants and young children by promoting and protecting breastfeeding and by regulating the marketing of designated products intended for use by infants and young children. These Regulations apply to designated products imported into, packed in, or produced and processed in Fiji for domestic distribution andconsumption or export/re-export. Interpretation 3.-(1) In these Regulations, unless the context indicates otherwise "Act" means the Food Safety Act 2003; "Advertise" shall meanto make anyrepresentation by anymeanswhatsoever for the purpose of promoting the sale or use of a designated product, including but not limited to (aJ written or spoken publication in any manner including on or by television, radio, film, electronictransmission includingthe internet, video or telephone; (h) display of signs, billboards, or notices; or (c) exhibition of pictures or models; The word "advertisement" has a corresponding meaning in addition to the interpretation assigned to it underthe Act. "Artificial feeding" means feeding with any food which replaces breast milk; "Authorised officers" mean persons appointed by the Board constituted under section 33 of the Act; "Brand name" means a name given by the manufacturer, importer or distributor to a product or range of products; "Claim" means any representation which states, suggests or implies thata food has particular qualities whether relating to its origin, nutritional properties, nature, processing, composition or any otherquality; "Complementary food" means any food suitable or represented as suitable as an addition to breast milk, infant formula or follow-up formula for infants 137 from the age of 6 months up to the age of 24 months. For the purposes of Regulations 4, 6, 7 and 8, the term 'complementary food' includes any ready-to-use therapeutic food used inthemanagement of acutemalnutrition in children; "Container" means any packaging of food for delivery as a single item, whether by completely or partially enclosing the food and includes wrappers. A container may enclose several units or types of packages when offered to the consumer; "Designated product" rneans (a) infant formula; (b) follow-up formula; (c) any other food marketed or otherwise represented assuitable for feeding children up to the age of 5 years; (d) any appliauce that replaces breastfeeding, including but not limited to a feeding bottle, cup with spout or pacifier; and (e) such other food or appliance as the Minister of Health may, hy notice in the Gazette, declare to be a"designated product" for the purposes of these Regulations; "Distributor" means aperson,corporation orother entityengaged inthebusiness, whether wholesale or retail, of importing or marketing any designated product; "Feedingbottle" means an appliancewith an artificial teat,which is used to feed infants or young children; "Follow-up formula" means, in the absence of a Standard under the Act and its regulations, a milk or milk-like product of animal or vegetable origin formulated industrially in accordance with the Codex Alimentarius Standard for Follow-up Formula and marketed or otherwise represented as suitable for feediug infants above 6 months of age and young children. For the purposes of Regulations 4, 5, 6, 7 and 8, the term "follow-up formula" includes any formula for special medical purposes or dietary requirements for children ahove 6 months, therapeutic milk for acutely malnourished children, and milk for children between I to 3 years and older; "Gift" means something given free of charge and includes, but is not limited to, samples of a designatedproduct,mealsor refreshments, diaries,stationery, calendars, clocks, cot tags, stickers, growth charts, prescription pads, tongue depressorsor any other promotional item of whatever value: "Health care facility" means a public or private institution or organisation or private medical practitioner engaged directly or indirectly in the provision of healthcare or in healthcare education. It also includes day-care centres, nurseries,-infant or child-care facilities otherthan orphanages; "Health professional" means a health worker with a professional degree, diploma or licence, such as a medical practitioner, dietician, registered nurse, midwives or such other person as may he specified by the Minister of Health by a notice in the Gazette; 138 "Health worker" means a person providing or in training to providehealth care services in a health care facility, whether professional or non-professional including voluntary unpaidworkers; "Infant" means a child from birth up to the age of 12 months; "Infant formula" means a milk or milk-like product of animal or vegetable origin formulated industrially in accordance with the Standard on Infant Formula in the Twenty-third Schedule of the Food and Safety Regulations 2009 and for the purposes of Regulations 4, 5, 6, 7 and 8, includes any formula for special medical purposes or dietary requirements andany therapeutic milk for acutely malnourished children; "Logo"means an emblem, pictureorsymbol by means of which a manufacturer, distributor or a product is identified; "Manufacturer" includes a person engaged in the business of manufacturing a designated product whether directly, through an agent, or through a person controlled by or underan agreement with such person; "Market" meansto promote, distribute, sell, oradvertise a designated product and includes product public relations andinformation services; "Pacifier" means an artificial teat forbabies to suck; "Promote" means to employ any method of directly or indirectly encouraging a personto purchase or use a designated product; "Sample" shall, in addition to the meaning assigned in theAct, mean a single or small quantity of a designated product provided without cost; "Sponsorship" meansany financial orin-kind assistance to aperson, group, activity or programme and the word"sponsor" has a corresponding meaning; "Young child" means a child from the age of 12 months up to the age of five years. PART II-INFORMATION AND EDUCATION Information and educational materials about infant and youngfeeding 4. In accordance with section 14 sub-section (3) of the Act, information and educational materials, whether written, audio or visual, which refer to infant and young child feeding shall (a) contain only correct andcurrent information andshall not use any pictures or text that encourage artificial feeding, or the use offeeding bottles or that discourage breastfeeding; (b) not give an impression or createa belief that a designated product is equivalent to, comparablewith or superior to breastmilk or to breastfeeding; (e) not contain the brand name or logo of any designated product nor of any manufacturer ordistributor of adesignated product; provided that thisclause shall not be applicable to information about designated products intended for health professionals as authorised by Regulation 6; (d) not contain any claim or representation that states or suggests that a particular relationship exists between the product or constituent thereof and health, including the physiological role of a nutrient in growth, development or normal functions of the body of an infant or young child; and 139 (e) clearly and conspicuously explain each of the following points (i) the benefits and superiority of breast feeding; (ii) the value of exclusive breastfeeding for six months followed by sustained breastfeeding for two years or beyond; (iii) how to initiateand maintain exclusive and sustained breastfeeding; (iv) why it is difficult to reverse a decision not to breastfeed; (v) the importance of introducing complementary foods from the age of six months; (vi) how and why any early introduction of artificial feeding, the use of a feeding bottle or the early introduction of complementary foods negatively affects breastfeeding; and; (vii) that complementary food and other foods for young children can easily be prepared at home using local ingredients. Information and educational materials about infantformula, follow-up formula.feeding bottles and other appliances. 5. If the material referred to in Regulation 4 includes the topic of artificial feeding or the use of a feeding bottle or other appliances, it must also include the following points (a) instructions for the proper preparation and use of the product including cleaning and sterilisation of feeding appliances; (b) how to feed infants with a cup; (c) the health risks of artificial feeding, the use of a feeding bottle and improper preparation of the product; (d) explanations that powdered formula milk is not sterile and that to minimise the risk of serious illness, formula must be prepared using boiled water that has been cooled to no less than 70"C. Only one feed at a time must be prepared and any unused milk must be discarded; and (e) the approximate financial cost of feeding an infant with such a product in the recommended quantities. Information for health professionals 6. Manufacturers or distributors may only give materials aboutdesignated products to healthprofessionals, if such materials (a) are restricted to scientific and factual matters regarding the technical aspects and methods of use of the product; (b) provide references to independent, published and peer-reviewed studies to support any representation or claim that states or suggests that a particular relationship exists between the product or a constituent thereofandhealth, growth or development; and (c) are otherwise in accordance with Regulations 4 and 5. PART III - PROHIBITIONS Promotion 7.-(1) Notwithstanding the prohibition in section 15 of the Act, no manufacturer or distributor or any other person shall promote any designated product whether or not 140 there is reference to a brand name. Prohibited promotional practices include but are not limited to (a) advertising; (b) sales devices suchas specialdisplays, discount coupons,premiums, rebates, special sales, loss-leaders, tie-in sales, prizes or gifts; (c) giving of one or more samples of a designated product to anyperson; and (d) donation or distribution of information or education material referring to infant oryoungchild feeding orperformance of educational functions related to infantor young child fceding except as provided in Regulation 6. (2) No manufacturer or distributor orany otherpersonshaU (a) donate or provide at lower than the published wholesale price where one exists, and in its absence, lower than 80 percent of the retail price, any quantity of a designated product to a health worker or a health care facility; (b) donateto ordistribute within a health care facilitygifts, equipment, services or anyothermaterials whichreferto or maypromote the useof a designated product; (c) offer or give any gift, contribution or benefit to a health worker or to associations of health workers engaged inmaternal andchildhealth, including but not limited to sponsorship, fellowships, research grants or funding for meetings, seminars,continuing education courses or conferences; (d) sponsor events, contests, telephone counselling lines Or campaigns related to reproductive health, pregnancy, childbirth, infant or youngchild feeding or relatedtopics; or (e) include the volume of sales of designated products when calculating employee remuneration or bonuses, nor set quotas for sales of designated products. . (3) No health worker engaged in maternal and child health shalI (a) accept any gift, contribution or benefit, financial or otherwise,of whatever value from a manufacturer ordistributor; (h) accept or give samples of designated products to any person; or (e) demonstrate the use of infant formula or folIow-up formula except to individual mothers or members of their families in very special cases of need, andin such cases, shall give a clearexplanation of the risksof the use of the products as well as the other information required by Part II. PART IV - LABELLING Prohibitions related to labels ofall designated products 8.-(1) No manufacturer or distributor or any other person shan offer for sale or selI a designated product if the container or label affixed thereto includes (a) auy photograph, drawing or other graphic representation other than for illustrating methods of preparation; and (h) any nutrition, health or functional claim notwithstanding the generality of Regulation 25 of the Food and Safety Regulations 2009. ]41 (2) In addition to the requirements under section 13of the Act and Part V of the Food and Safety Regulations 2009, no manufacturer or distributor or any other person shall offer for sale or sell a designated product, other than a feeding bottle, teat, cup with spout or pacifier unless the containeror label affixed thereto indicates in a clear,conspicuous and easily readable manner, the following particulars (a) instructions for appropriate preparation anduse, in words and/or in easily understood graphics; (h) the age after which the product is recommended in numeric figures which, in the case of a complementary food, shall not be less than six months; (c) a warning aboutthehealthrisksof improper preparation andof introducing the product prior to the recommended age; Protubitions related to labels (!! infant formula (/Ildjollo\l-'-llpformu/u 9.-(1) No manufacturer or distributor or any otherperson shall offer forsale or sell infantformula or follow-up formula unless the container orlabelaffixedthereto, in addition to the requirements of Regulation 8, conforms to the following: (a) contains the words, "IMPORTANT NOTICE" in capital letter' and indicated thereunder, the statement "Breastfceding is best. Breast milk is the ideal food for the healthy growth and development of infants and young children. It protects against diarrhoea and otherillnesses" in characters no less than one-third the size of the characters in the product name, and in no case less than 2mm in height; (b) contains the word, "Warning" and indicated thereunder, the statement, "Before deciding to supplement or replace breastfeeding with this product, seek the advice of a health professional. It is important for your baby's health that you follow all preparation instructions carefully. If you use a feeding bottle, your baby may refuse to feed from the breast. It is more hygienic to feed from a cup." in characters no less than one-third the size of the characters in the product name, and in no case less than 1.5mm in height; (c) states under preparation instructions for infant or follow-up formula in powdered form that (i) powderedformula may be contaminated with microorganisms during the manufacturing process or may become contaminated during preparation; (ii) powdered formula milk is not sterile andthat to minimise the risk of serious illness, formula must be prepared using boiled water that has been cooled to no less than 70°C; or (iii) only one feed at a time must be prepared and any unused milk must be discarded. (d) includes a feeding chart in the preparation instructions; (e) does not use the terms "maternalised", "humanised" or other terms of like effect or any comparison with breast milk; (j) does not use text that may tend to discourage breastfeeding; and /42 (g) specifies the source ofthe nrotein and in the case of follow-up formula, states that the product shall Hot be used for infants less than six months old. Prohibitions related to labels offull cream milk in powder or liquid form 10. No manufacturer or distributor or any other person shall offer for sale or sell any full cream milk in powder or in liquid milk form unless the container or label affixed thereto contains the words, "This product should not be used as an infant's sole source of nourishment" in characters no less than one-third the size of the characters in theproduct name, andin no case less than 2mm in height. Prohibitions related fa labels offeeding bottles and teats II. No manufacturer or distributor or any other person shall offer for sale or sell a feeding bottle or teat unless the package or label affixed thereto, in addition to the requirements of Regulation 8, indicatesinaclear, conspicuous andeasily readable manner, the following particulars (a) the words, "IMPORTANT NOTICE" in capital letters and indicate thereunder, the statement, "Breast milk is the ideal food for the healthy growth and development of infants. If you use a feeding bottle, your baby may refuse to feed from thebreast." in characters no less than one-third the size of the characters in theproduct name, andin no case less than 2mm in height; (b) the statement, "Warning: It is important for your baby's health that you follow the cleaning and sterilisation instructions very carefully. It is more hygienic to feed from a cup." in characters no less than one-third the size of the characters in the product name, and in no case less than 2mm in height; (c) instructions for cleaning and sterilisation in words and graphics; (d) a warning that children should not be left to self-feed for long periods oftime becauseextended contactwithsweetened liquids, includinginfantformula, may cause severe tooth decay; and (e) the name and national address of the manufacturer, the distributor or both as the case may be. Prohibitions related to labels ojpacifiers 12. No manufacturer or distributor or any other person shall offer for sale or sell a pacifier unless, in addition to the requirements ofRegulation 8, itis labelled with the words, "Warning: Use of a pacifier can interfere with breastfeeding" in characters no less than one-third the size of the characters in the product name, and in no case less than 2mm in height. PART V -CONSISTENCY WITH FOOD AND NUTRITION POLICY Special Committee 13. - (I) Pursuant to section 30 of theAet, the Food and Safety Advisory Committee shall within 90 days from the date of commencement of these Regulations appoint a special committee to ensure that the administration and enforcement of these Regulations are consistent with the Food and Nutrition Policy. 143 (2) The Special Committee shall consist of (a) The Chairperson shall be the Deputy Secretary of Public Health or his representative; (h) The Secretary shall be the Chief Dietician; (c) The Committee Members shall consist of (i) the National Advisor, Non Communicable Diseases; (ii) the Manager, National Food and Nutrition Centre; (iii) the Chief Health Inspector; (iv) a representative from the Environmental Health Unit; (v) the Consultant Paediatrician; and (vi) the Director of Nursing Services; (d) The Co-opted members shall consist of a representative from Consumer Council of Fiji (by invitation) and such other persons from other Ministries, agencies, or organisations as the Food Safety Advisory Committee may appoint provided that no person shall be appointed who has any direct or indirectfinancial interest in any designated product. (3) The Committee Members shall hold office for a term of three years and shall be eligible for re-nomination. (4) Any member of the Special Committee may, at any time, resign from his or her office by writing to the Food Safety Advisory Committee or shall vacate his or her office if the Food Safety Advisory Committee so directs. A vacancy shall be filled by a replacement in office other than in the case of a Co-opted member, who may be replaced as provided in sub-section (2) (d). Functions of the Special Committee 14.-(1) The Special Committee has the following functions (a) to advise the Food Safety Advisory Committee on matters relating to the Fiji Food and Nutrition Policy, in particular, on marketing practices which may undermine the promotion, protection and support of breastfeeding; (b) to monitor orcausethemonitoring ofcompliance including administration and enforcement by Authorised officers of these Regulations by manufacturers, distributors and health workers; (c) to coordinate monitoringactivitiesandto implementa systemforreceiving complaints relatingto contraventions of these Regulations; (d) to review reports of contraventions or other matters concerning these Regulations; (e) to recommend appropriate actions to be taken against any person found to have contravened the provisions of the Act or these Regulations; and (j) such other powers and functions as may be prescribed. PART VI-AUTHORISED OFFICERS AND INSPECTIONS Qualifications of authorised officersand inspection on compliance IS. In accordance with section 33 of the Act, the provisions of Regulations 48, 49 and 50 of the Food and Safety Regulations 2009 shall apply mutatis mutandis for the administration andenforcementof these Regulations. 144 PART VII-OFFENCES AND PENALTIES Sanctions 16. In accordance with section 66(3) of the Act and except as otherwise specifically provided for in Schedule 2 thereof for an offence under sections 13 and 15 of the Act, any personwhocontravenes theseRegulations commits anoffenceand is liableupon conviction to a maximum fine of $2,000 or to imprisonment for 12 months or both. DATED this 26th day of January 2010. S. T.SAKETA Chairman Central Health Board N.SHARMA Minister for Health