Food (Control of Quality)(Marketing of Breast-milk Substitutes and Designated Products) Regulations 1994 (G.N. No. 256 of 1994)

SUPIBment No. 25 SUBSIDIARY LEGISLAnON ISBN .. 034X .,., July, 19114 to theGuette of theUnited Republic of TanZilllia No. 26, Vol. 75, dtlted 1"/uly, 1994 Printed by !be Government Printer, Dar es Salaam, by Order of Government THE FOOD (CONTROL OF QUALITY) (MARKETING OF BREAST-MILK SUBSTITUTES AND DESIGNATED PRODUCI'S) REGULATIONS, 1994 TABLE OF CONTENTS PART I PRELIMINARY Regulation Title L Citation and Commencement. 2. Application. 3. Interpretation. PART II EDUCATION AND HEALTH CARE FACILmEs 4. Informational and Educational Materials on Infant Feeding. 5. Restrictions regarding informational and educational materials. 6. The Commission to encourage breastfeeding. 7. Restrictions regarding health care facility. 8. Donations to be approved by the Commission. 9. Distributions outside the health care facility. PART III HEALTH WORKERS, MANUFACI1JRERS AND DISTRmUTORS 10. Restrictions on the conducts of health workers. 11. Questions regarding the use of products. 12. Prohibitions of advertising of breast-milk substitutes and desig nated products. 13. Manufacturers to disclose their contributions. 14. Prohibitions regarding manufacturers and distributors. 15. Persons employed by manufacturers and distributors. 587 Food (Control of Quality) G.N. No. 256 (contd.) PART IV INFANT FORMULAE 16. Composition of Infant Formula and supplementary foods. 17. Labels and marks on infant formula and supplementary foods. PART V LICENCES, IMPORT PERMITS, OFFENCES ANn PENALTIES 18. Licences and Import permits. 19. Offences and Penalties. 20. RevocationofG.N. No. 237 of 1989. SCHEDULES FIRST SCHEDULE (LIMITS OFMICRO·ORGANISMS IN INFANTS AND SUPPLEMENTARY FOODS) SECOND SCHEDULE (COMPOSITIONS AND QUALITY FACTORS OF INFANT FORMULA THIRD SCHEDULE (COMPOSITION AND QUALITY FACTORS OF SUPPLEMENTARY FOODS) FOURTH SCHEDULE ESSENTIAL COMPOSITION AND QUALITY FACTORS OF FOLLOW-UP FORMULA 588 Food (Control of Quality) GOVERNMENT NOTICE No. 256 published on 1/7/94 THE FOOD (CONTROL OF QUALITY) ACf, 1978 (No. 10 OF 1978) REGULATIONS Made under Section 16 and 33 THE FOOD (CONTROL OF QUALITY) (MARKETING OF BREAST·MILK SUB· STITUTES AND DESIGNATED PRODUCTS) REGULATIONS 1994 PART I PRELIMINARY 1. These regulations may be cited as the Food (Control of Quality) (Marketing of Breast-milk Substitutes and Designated Products) Regu lations 1994 and shall come into operation on the 1st day of July 1994. 2. These Regulations shall apply to all areas in which the Act applies and shall affect marketing of all Breast-milk Substitutes and Designated Products whether locally made imported and practices related thereto. They shall apply to their quality, availability, and to information concern ing their use. 3. In these Regulations, unless the context otherwise requires: "Act" means the Food (Control of Quality), Act of 1978; "Breast-milk substitute" means any food marketed, used or perceived as a partial or total replacement of breast-milk whether or not suitable for that purpose; "container" means every form of packaging of breastmilk substitute and/or designated products for distribution or sale as a retail unit including wrappers; The "Commission" means The National Food Control Commission es tablished under the Act. "Distributor" means a person, a corporation or any other entity in the public or private sector either distributing or engaged in such business, whether wholesale or retail, of marketing any breast-milk substitutes and/or designated products and includes any person engaged in the business of providing information, or public relations services in rela tion to breast-milk substitutes and/or designated products. "designated products" means (a) infant formula; or (b) follow up formula; or (c) any product marketed, or otherwise represented or commonly used for feeding of infants; or 589 Citation and com mence ment Applica tion Interpre tation Food (Control of Quality) G.N. No. 256 (contd.j (d) any product to be fed by use of a feeding bottle; or (e) beverages, milks and other foods intended for use by infant and young children whether industrially made or occuring naturally; or (f) feeding bottles, teats and pacifiers; and (g) such other product as may be specified by the Minister by Notice in the Official Gazette; "exclusive breastfeeding" means giving no food or liquid other than breast-milk not even water until the infant is between 4 and 6 months of age. "follow up formula" means (a) food intended for use as a liquid part of the weaning diet for the infant from the sixth month onwards and for young children; it must conform to quality standard scheduled herein; (b) a food prepared from the milk of dairy animals and/or other constituents of animal and/or plant origin, which have been ap proved by the Commission to be suitable for infants from the sixth month onwards and for young children; (c) a food which when in liquid form, is suitable for use either directly or diluted with water before feeding as appropriate; in powdered form it requires water for preparation; the product shall be nitri tionally adequate to contribute to normal growth and develop ment when used in accordance with its directions for use; "health care facility" means governmental, non-governmental or private institutions or organizations engaged, directly or indirectly, in health care for mothers, infants, young children and pregnant women, and nurseries or child-care institutions including pharmacies. "health professional" means any technical personnel involved in matters of human health and/or nutrition and any other person as may be specified by the Minister by notice in the Official Gazette; "health worker" means a person working in a component of such a health care system, whether professional or non professional, including voluntary unpaid workers; "infant" means a person of not more than twelve months of age; "infant formula" means a breast-milk substitute formulated to Tanzania Standard 187 "Infant Formula Specification" industrially, in accor dance to herein scheduled standard to satisfy the normal nutritional requirements of infants up to between four and six months of age, and adapted to their physiological characteristics, infant formula may also be prepared at home, in which case it is described as home prepared; 590 Food (Control of Quality) G.N. No. 256 (contd.) "label" means any tag, mark, pictorial or other descriptive matter, writ ten, printed, stencilled, marked, embossed, attached or otherwise appearing on a container of breastmilk substitutes and/or designated products; "manufacturer" means a person or corporation or other entity in the public or private sector engaged in the business of manufacturing of breast-milk substitutes and or designated product whether directly, through an agent, or through a person controlled by or under an agreement; "marketing" means any method of introducing or selling breast-milk substitutes and or designated product, including promotion, distribu tion, advertising, display on shelves, production, distribution of sam ples, product public relations and product informational services; "Minister" means the Minister for the time being responsible for matters relating to Health. "prescribed" or "as prescribed" means prescribed or as prescribed by written decision made pursuant to these Regulations; "promote" includes advertising, givingof samples or gifts of breast-milk substitutes and or designated products or materials or information or decorations related thereto; "promotion" means any method of introducing, familiarizing or en couraging a person to purchase a breast-milk substitute or designated product; "Prohibited promotional practice" means and includes; (a) special displays of or concerning breast-milk substitutes and de signated products; (b) discount coupons; (c) the selling of breast-milk substitutes and designated products at a reduced price unless such reduction in price is intended to be permanent; (d) the distribution of gifts or items or little or no cost bearing the name or logo of a manufacturer or distributor; (e) the use of printed matter including books, pamplets, or posters bearing the name logo, graphic or other representation of a prop rietary product or the name or .logo of a manufacturer or dis tributor; or (f) in any other manner; "sample" means a single or small quantity of breast-milk substitutes or designated products, provided without cost: "supplementary food" means any food suitable as an addition to breast milk and/or breast-milk substitute when either becomes insufficient 591 Food (Control of Quality) G.N. No. 256 (contd.) to satisfy the nutritional requirements of an infant. Such foods are also called "complementary" or "eaning foods"; "protected persons" includes infants, young childre~, pregnant wom~n, guardians, lactatingwomen and/or members of their household family; "young children" means persons from the age of more than 12 months up to the age of five years; PART II Informa tional and Educa tional Materials on Infant Feeding EDUCATION AND HEALTH CARE FACILITIES 4.-(1) The Commissionshall have the responsibility for the scrutiny, of the production, provision, planning, design, and dissemination of Informational and Educational Materials on Infant and Young Child feeding for use by families and those involved in the field of Infant and Young Child health and nutrition; (2) Informational and Educational Materials, Whether written, audio or visual, dealing with the feeding of infants and intended to reach pregnant women, mothers of infants and young children or members of their families shall include clear and appropriate information on all the following points: (a) the benefits and superiority of breastfeeding; or (b) how to prepare for and maintain breastfeeding includingmaternal nutrition; (c) the negative effects which the introduction of artificial feeding has on lactation or how too early introduction of supplementary foods interferes with breastfeeding; and (d) the difficulty of returning to breastfeeding after a period of artifi cial feeding. (3) Informational and Educational Materials that include the topic of feeding infants with infant formula, follow up formula or any other food shall explain, in addition to the information specified in these Regula tions, the following topics: (a) the proper preparation and use of the product; (b) the approximate financial cost of feeding an infant with the pro duct; (c) the health hazards of bottle feeding and improper preparation of the product; (d) how to feed infants with a cup; and (e) the importance of feeding infants with a cup. (4) Informational and Educational Materials that include the topic of feeding infants with complementary foods shall explain in addition to the information specified in regulation 4(1) and (2), the following to pics: 592 The Com mission to encourage breast feeding Restric tions re garding health care facil ity Restric tions re garding informa tionaland educa tional materials Food (Control o/Quality) o», No. 256 (contd.) (a) the health hazards of feeding with inappropriate food, and feeding at inappropriate age of the child; and (b) how supplementary foods can easily be prepared at home. 5.-(1) Informational and Educational Materials shall contain only factual and current information and shall not use any pictures or. texts that encourage artificial feeding or use of bottles for feeding or discourage breastfeeding. (2) Informational and Educational Materials shall be written in Kis wahili and if intended for academic purposes in Kiswahili or English. (3) Informational and Educational Materials shall not make reference to any brand of breast-milk substitutes or designated product nor contain the name or logo of any manufacturer or distributor of breast-milk substitute or designated product. (4) Any materials containing information about the use of Infant Formula shall point out the risks entailed for the child's health in the unnecessary and indiscriminate use of such formulas. (5) Donations of Informational or educational materials or equipment by manufacturers or distributors shall be made through the commission and in accordance with these Regulations. 6.-(1) The Commission shall take appropriate measures to encour age, protect and promote breastfeeding and shall give appropriate feed ing practices where infant and young children are concerned. (2) The Commission shall encourage exclusive breastfeeding and ad vise health workers in regard to their responsibilities including informa tion specified in these Regulations. 7.-(1) The facility of health care system shall not be used for the purpose of promoting infant formula or other designated products, or for the display of the products or for placards or posters concerning such products or for the distribution of materials provided by a manufac turer of distributor. (2) Notwithstanding the provisions of sub-regulation (1) of this regu lation, the restrictions prescribed shall not preclude the dissemination of information to health professionals as provided for in these regula tions. (3) Feeding with infant formula or any designated products, whether manuractured or home prepared, shall be demonstrated by health work ers, or other community workers if necessary, and only to the mothers or family members who have beenprescribed to use it, and the informa tion given shall include a clear explanation of the hazards of improper use. (4) The head of a health care facility shall: (a) present to the Commission, in writing, a full disclosure of any contribution made by a distributor or manufacturers of breastmilk 593 Donation to be ap proved by the Com mission Food (Control of Quality) G,N. No. 256 (contd.) substitutes and or designated products to the health care system or health care workers therein; and (b) prohibit acceptance into the facility gifts of samples of breastmilk substitutes and/or designated product or supplies of the same or gifts of any article or utensil which may idealise or promote the use of breast-milk substitutes or bottle feeding, 8.-(1) Donation or low price sales or supplies of designated food products to health care. facilities o~ any other institutions whether for use in the facilities or institutions, or for distribution outside the facilities or institutions shall be accepted through and under the written approval of the Commission. Distribu tions out side the health care facil ity Prohibi tions on the con duc:tJ of health workers (2) Such supplies or donations made under sub-regulation (1) of this regulation, shall only be used or distributed for infaatswho have prescrip tion to be fed on breast-milk substitutes or any other designated product. 9.-(1) Where donated supplies of breast-milk substitute or other designated products within the scope of these Regulations are distributed outside the health care facility, the facility shall take such steps as to ensure that supplies can be continued as long as the infants concerned need them; (2) Subject to sub-regulation (1) of this regulation, health workers shall (i) encourage and protect breast-feeding; or (ii) where necessary, give demonstrations of feeding with infant for mula; and (iii) make a full disclosure to the Commission in writing of any con tribution made by it distributor or a manufacturer, on behalf of the health worker, for fellowships, study tours, research grants, attendance to professional conferences, or for other similar pur pose. PART III HEALTH WORKERS MAN1JF'AcruRERS AND DISTRIBUTORS 10.-(1) Under these regulations, health workers or members of their immediate families shall: (a) not be allowed to accept any financial or other benefits from a distributor or a manufacturer to promote any breastmilk substi tute and/or designated products or (b) not give samples of infant formula or other de~ig~atedprod~ct to a protected person, notwithstanding protessional e:valuatlon as referred to under regulation 15(2) of these Regulations; and 594 Food (Control of Quality) G.N. No. 256 (contd.) (C) not demonstrate prelacteal feeding to mothers or familymembers; whenever necessary it shall be only demonstrated to mothers or family members who are prescribed to use it and the information given at such demonstration shall include a clear explanation of the hazard of improper use. (2) Pursuant to Regulation 11 every health worker shall (a) observe and give effect to appropriate directions; and (b) have regard to any Informational and Educational Material, and information and advice given or disseminated under these Regulations with respect to that duty and its performance. 11.-(1) Health professional with technical questions regarding tht use of products within the scope of these Regulations may however, seek information from manufacturers in writing and manufacturers shall respond in writing specificallyto such professional enquiries; except that general promotional literature about the product or related products shall not be included unless it answers directly to the questions asked. (2) Subject to sub-regulation (1) of this regulation all copies of such correspondence between Health professionals, manufacturers and dis tributors shall be sent to the Commission for perusal. 12.-(1) Under these regulations, advertisements or any other form of promotion to the general public of any breast-milk substitutes and designated products is hereby prohibited. (2) Any manufacturer, distributor or any other person shall not pro vide directly or indirectly to pregnant women, mothers or members of their immediate families or health workers samples of products which may promote the use of breast-milk substitutes or bottle feeding. (3) A manufacturer or distributor or any other person shall not put forth any advertisement that promotes any breast-milk substitute and or designated product; to imply or create the belief that artifici~1 feeding is equivalent to or superior to breast-feeding. (4) For the purposes of the Regulation. advertisement includes every form of advertising whether (a) in a publication, or by television,radio, film, video or telephone; and traditional communication media; (b) by display or signs, bill boards, notices or goods; or (c) by exhibition of pictures or models; and (d) in any other manner. 595 Questions regarding the use of products Prohibi tion of ad· vertising of breast milk sub stitutes and desig· natedpro d1:R:ts Food (Control of Quality) G.N. No. 256 (contd.) Manufac turers to disclose their con tributions Prohibi tions re garding manufac turers and dis tributors 13.-(1) Manufacturers and distributors of products within the scope of these Regulations shall disclose to the institution to which a recipient health worker is affiliated any contribution made to him/her or on his/her behalf for fellowships, study tours, research grants, attendance at profes sional conferences, or the like. Similar disclosures shall be made by the recipient. 14.-(1) A manufacturer or distributor shall not promote breast milk substitute and or designated products, whether within a health care facility or otherwise. (2) A manufacturer or distributor shall not apply or distribute one or more samples of breast-milk substitutes and/or designated products to any person except under such conditions as may be prescribed under the approval of the Commission, or under regulation 15 (2) of these regulations. (3) No distributor or manufacturer shall donate any quantity of breast milk substitutes and/or designated/product to a health care facility or any other institution or organisation unless such facility, institution or organisation requests a donation on a form as may be prescribed by the Commission who shall approve such requests. (4) No distributor.or manufacturer shall donate equipment or R mate rials to a health care facility or health worker without the approval of the Commission. (5) No distributor or manufacturer shall offer or make to a health worker or health care facility personnel any gift or other benefit, financial or otherwise, except as provided under sub-regulation (6) of this Regu lation. (6) No manufacturer or distributor shall provide fellowships or re search grants for a health worker or shall sponsor a professional meeting or conference or fund the attendance of a health worker at such a professional meeting or conference unless such is requested on a form as may be prescribed and such request is approved by the Commission under the prescribed conditions. (7) No manufacturer or distributor of products under these Regula tions: (a) shall use a system of sales incentives for the marketing personnel which includes the volume of sales of any of the products under these Regulations for the purpose of the calculation of bonuses;' and (b) shall set quotas specifically for the sale of any of the product under these regulations. 596 Food (Control of Quality) G.N. No. 256 (contd.) 15.-(1) Persons employed in marketing products under these Regu lations shall not as part of their responsibilities, perform educational functions in relation to pregnant women or mothers of Infants and Young Children. (2) Without prejudice to the generality of Regulation 14(1) and (2) samples of breast-milk substitutes or other products or Equipment and Utensils for their preparation or use may be provided. to health workers when necessary for the purpose of professional evaluation or research at the institutional level such as government food control institutions, laboratories or universities or other recognized research institutions. PART IV INFANT FORMULA 16.-(1) The Composition of Infant Formula shall be in accordance with Tanzania Standard 187 "infant formula specification". (2) Infant formula shall be in powder form prepared by physical means excluding ionization and shall be prepared from dairy animals or other animals or other edible constituents of animal including fish or plants which are suitable for infant feeding and shall contain only oils of plant origin after satisfactory removal of fats of animal origin. (3) Infant formula shall be free from lumps, coarse particles, dirt, extraneous matter and added colouring substances and shall be free from any material, microorganisms, in amounts which are hazardous to infants as set out in the First Schedule to these Regulations. (4) Infant formula shall be clean, safe, suitable for ingestion and nutritionally adequate to promote normal growth and developments of infants and shall contain nutrients in quality and composition as set Ol~t in the second, third and fourth schedule to these Regulations. (5) Infant formula shall be packed in air tight and tamper proof con tainers approved by the Commission and they shall safeguard the hygienic and nutritional qualities of the product. (6) Subject to sub-regulation (5) of this Regulation, nitrogen or a mixture of carbon-dioxide and nitrogen may be used as packing media in the case of spray dried infant formula. (7) The Composition of supplementary foods shall be in accordance with Tanzania Standard 180 "processed cereal based weaning food." (8) S.upplementary food shall be clean, safe suitable for ingestion and nutritionally adequate to promote normal growth and development of the young child and shall contain nutrients in quality and composition as set out in Tanzania Standard 180. 597 Persons employed by man ufacturers and dis tributors Composi tion of In fant For mula and suppleme ntary foods Food (Control of Quality) 17.-(1) Labelling and marking of infant formula and supplementary foods shall be in accordance with Tanzania Standard 187 and Tanzania Standard 180 respectively. o». No. 256 (contd.) Labels and marks on Infant formula and suppleme ntary foods (2) Labels and marks on any infant formula shall include the following information in Kiswahili, English and in any other language where the product is marketed: (a) name of the product, that isinfant formula, and trade name or brand name; (b) name and address of the manufacturer and or licenced parker; (c) batch or code number; (d) net content by mass/volume; (e) list of ingredients with the average content of each nutrient indi cated in descending order of proportion; (f) protein source and the proportion of saturated and unsaturated farry acids; (g) the average content of each nutrient; (h) directions for storing the unopened container and special direc tions after the container has been opened; (i) an indication, with a print letter not less than 5mm. that infant formula is not intended to replace breastfeeding but is a comple ment where breastfeeding in insufficient; U) the words "IMPORTANT NOTICE" or their equivalent, direct ing on how to prepare and use the formula for consumption and shall include; (i) a statement of the superiority of breastfeeding; (ii) a statement that the product should be used only on the advice of a doctor or health worker; (iii) instruction and a warning against the health hazards of inappropriate preparation; (iv) a statement that infants should be fed only with cup and or spoon; (k) advisory not that infacts over 6 months of age should receive supplementary foods in addition to the formula; (I) date of manufacture and expiry to be printed in tamper proof on the container. (m) country of origin. 598 Food (Control of Quality) G.N. No. 256 (contd.) (3) The label shall not show any photographs, drawings or other graphic representations other than for illustrating methods of preparation and in no case, shall depict a feeding bottle. PART V LICENCES, IMPORT PERMITS, OFFENCES AND PENALTIES 18.-(1) Manufacturers shall obtain a licence for manufacturing .breastmilk substitutes and/or any of the designated products from the Commission. (2) All importers shall obtain import permits of breast mili substitutes and/or designated products from the Commission. (3) No person shall distribute or sell or display for sale or otherwise any breastmilk substitutes and/or designated product unless he is con vinced beyond resonable doubt and can so produce evidence that the designated product in his custody has been manufactured under licence from the Commission, and if imported has been so imported under the permission from the Commission. 19.-(1) Any manufacturer, importer, packer or distributor who con travenes or fails to comply with these Regulations or directly or indirectly aids an individual or any other person in committing an offence under these Regulations shall be guilty of an offence and shall be liable on conviction to a fine not exceeding one million shillingsor to imprisonment for a term not exceeding fiveyears or to both such fine and imprisonment. (2) Any health facility that intentionally contravenes or fails to comply with these Regulations, or directly or indirectly aids any other person in committing an offence under these Regulations shall be guilty of an offence and shall be liable on conviction to a fine not exceeding one million shillings or revocation of its operating licence or to both fine and licence revocation. (3) Any health worker who intentionally contravenes or fails to com ply with these Regulations or directly or indirectly aids another person in committing an offence under these Regulations shall be guilty of an offence and shall be liable on conviction to a fine not exceeding five thousand shillingsor to imprisonment for a term not exceeding sixmonths or to both fine and imprisonment. (4) Any person other than those mentioned under Regulation 19(1), (2) and (3) who intentionally contravenes or fails to comply with these Regulations, or directly or indirectly aids another person in committing an offence under these Regulations shall be guilty of an offence and shall be liable on conviction to a fine not exceeding five thousand shillings or to imprisonment for a term not exceeding six months or to both fine and imprisonment. 20.-(1) The Food (Control of Quality) (Infant Formula and Weaning Food) Regulations 1989 are hereby revoked. 599 Licence and im port per mits Offences and Penalties Revoca tion of GN. No. 237 of 1989 Food (Control of Quality) G.N. No. 256 (contd.) FIRST SCHEDULE LIMITS OF MICRO-ORGANISMS IN INFANTS AND SUPPLEMENTARY FOOD Type ofFood Dried biscuits type (1) Plain (2) Coated Dried and Instant products Dried products requiring heating before consumption Type ofOrganisms Maximum number of Organisms allowed n c m M Coliform bacteria 5 2 2 20 Salmonella 10 0 0 Mesophollic earobic bacteria 1 2 10 10 Coliform bacteria 5 1 2 20 Salmonella 10 0 0 Mesophollic earobic bacteria 5 3 10 10 Coliform bacteria 5 2 10 10 Salmonella 10 0 0 n = number of sample units examined. c = the maximum allowable number of positive unit (defective) m = represents dividing line between acceptable and defectives acceptable when the values aqual to or less than (m) defective when values are above (m) M Separate marginally acceptable (m) from non-acceptable. SECOND SCHEDULE COMPosmON AND QUALITY FACTORS OF INFANT FORMULA 1. Protein Not less than 4.4g and not more than 109. of protein per MJ ornot less than 85% of casein. 2. Fat Not less than O.7gm per MJ oflinoleic acid in the form of glycerides. Total fat content shall be not less than 8g and not more than 15gperMJ. 3. Carbohydrates ..Energy content not less than 2,700 KJ per litre of the product ready for consumption with between 35 to 55% of the energy originating from lactose, maltose.and dextrins. 4. Moisture Notmorethan5.0percent. 5. Tocopherol Not less than 0.7mg per gram linoleic acid but shall not be less than 1.7mg and not more than 5mg per megajoule. 6. Choline Not less than 17mg and not more than 70mg per mJ. 7. Vitamins As indicated in the following table: Min Max Retinol (Vitamin A), mcg . Ascorbic acid (Vitamin C), mg .. Thiamine (Vitamin Bl) mg . Riboflavine (Vitamin B2), mg . Nicotinamide, mg . Pyridoxine (Vitamin 1\6) mg .. Pantothemic acid, mg .. Folic acid mcg . Cynocobalamin (Vitamin B12) meg . Cholecalcifero (Vitamin D3) mcg . Biotin (Vitamin H) mcg ; . Vitamin K, meg .. 600 120 20 0.1 0.15 0.6 0.1 0.7 10 0.4 2.5 4.0 10.0 360 60 0.3 0.45 1.8 0.3 2.1 30 1.1 5.0 Not specified Not specified Food (Control of Quality) G.N. No. 256 (contd.) 8. Minerals as indicated in the following table: Minerals Sodium, mg . Potassium, mg .. Chloride, mg . Calcium, mg .. Phosphorous, mg ...............•........................................ Magnesium, mg .. Iron, mg . Zinc, meg . Iodine, mcg .. Manganese, mcg .. Copper, mcg .. 9. Food Additives .as indicated in the following table: Content permegajoule (ml} Min Max 50 150 200 500 140 350 120 360 60 300 114 45 2.5 5 1.2 Not specified 12 36 12 Not specified 140 Not specified FoodA dditive Emuslifiers Lecithin mono and diglycerides Antioxidants L·ascorby/palmitate Alpha-tocopherol Citric acid and its sodium salts pH-Adjusting Agents Sodium citrates Sodium hydrogen carbonate Potassium citrate Maximum levelofuse 0.5/1of the product consumed 0.5/1of the product consumed IOmg/1 of the product as consumed IOmg/1 of product as consumed 3g/1of the product as consumed THIRD SCHEDULE COMPOSITIONS AND QUALITY FACTORS OF SUPPLEMENTARY FOOD 1. Moisture not more than 8.0 percent 2. Crude protein ; notmorethan 14.0 percent 3. Total Fat ..................................•...................not more than 7.5 percent 4. Total carbohydrates not more than 45.0 percent 5. Bacteria count per gram not more.than 10.000 6. Coliform count per gram not more than 10 7. Urease activity test (difference in pH) not more than 0.8 8. Total ash not more than 5.0percent 9. Vitamins and minerals as indicated in the following table: Characteristics Vitamin A, IV/100g Vitamin C, mg/100g Vitamin D, IV/100g Thiamine (BI), hydrochloride mg/lOOg Riboflavin (B2), mg/100g Nicotinic acid, mg/100g Calcium, g/lOOg Iron mg/lOOg Requirements minimum 1,500 minimum 25 not less than 300, not more than 800 minimum 0.5 minimum 0.6 minimumS minimum 1.0 minimum 10 601 H.2 3.2.2.1 Amounts per 100 availablekilojoules Minimum Minimum 601.U. or 1801.U. or l8mcg 54mcg expressed expressed as retinol as retinol Food (Control of Quality) G.N. No. 256 (contd.) FOURTH SCHEDULE 3. ESSENTIAL COMPOSITION AND FACTORS OF FOLLOW UP FORMULAS 3.1 Energy Content When prepared in accordance with the instructions for use, 100ml. of the ready-for consumption product shall provide not less than 60 kcal (or 355 kJ). 3.2 Nutrient Content "Follow-up Formula" shall contain the following nutrients at minimum and maximum levels indicated below: 3.2.1 Protein per 100 Available Calories (or kilojoules) 3.2.1.1 Not less than 3.0g per 100 available calories (or 0.7g per 100 available kilojoules) of protein of nutritional quality equivalent to that of casein or greater quantity of other protein in inverse proportion to its. nutritional quality. The quality of the protein shall not be less than 85% of that of casein. The total quantity of protein shall not be more than 5.5g per 100 available calories (or 1.3 per 100 available kilojoules). 3.2.1.2 Essential amino acids may be added to follow-up formula only to Improve its nutritional value. Essential amino acids may be added to improve protein quality, only in amounts necessary for that purpose. Only L forms of amino acids shall be used. Fat per 100 Available Calories (or kilojoules) Not less than 3g and not more than 6g per 100 calories (0.7 and l.4g per 100 available kilojoules). 3.2.2.2 The level of linoleic acid (in the form of a glyceride) shall not be less than 300mg per 100 calories (or 71.7mg per 100 available kilojoules). 3.2.3 Carbohydrates The product shall contain nutritionally available carbohydrates suitable for the feeding of the older infant and the young child in such quantities as to adjust the product to the energy density in accordance with the requirements set out in section 3.1. 3.2.4 Vitamins other than Vitamin E Amounts per 100 availablecalories Vitamin A Minimum .Minimum 2501.U. 7501.U. or or 75 meg 225meg expressed expressed as retinol as retinol Amounts per 100 Amounts per 100 available calories available kilojoules Minimum Maximum Minimum Maximum VitaminD 40LVor 120LV or 10LVor 30 LV or l mcg 3mcg 0.25mcg 0.75mcg Ascorbic acid (VitaminC) 8mg N.S.I-/ 1.9mg N.S.I-/ Thiamile VitaminB RIboflavin 40 meg N.S.I-/ lOmcg N.S.l-/ VitaminB 60mcg N.S.I-/ 60mcg N.S.l-/ Nicotinamide 250mcg N.S.I-/ 60 meg N.S.l-/ Vitamin B 2-/ 25mcg N.S.I-/ llmcg N.S.I-/ Folic acid 4mcg N.S.I-/ 1meg N.S.l-/ 602 Food (Control of Quality) Pantothenic acid VitaminBI2 Vitamin Kl Biotin (Vitamin H) 3.2.5 300mcg 0.I5mcg 4mcg 1.5 meg Vitamin E (a-tocopherol compounds N.S.I-I N.S.2-1 N.S.2-1 N.S.2-1 0.7I.U/g Linoleic acid 3-1 but in no case less thanO.7 LUll00 available calories 70mcg 0.04mcg l mcg O.4mcg N.S.2-/ C.N. No. 256 (contd.) N.S.2-1 N.S.2-1 N.S.2-1 N.S.2-1 N.S.2-1 Linoleic acid 3-1 butinno case less thanO.IS LUlIOO available kilojoules 3.2.6 Minerals Amounts per 100 available calories Minimum Maximum Amounts per 100 available kilojoules Minimum Maximum 21 mg N.S.2-1 N.S.2-1 N.S.I-I N.S.2-1 N.S.2-1 0.50mg N.S.2-1 N.S.2-1 5mg 20mg 14mg 22mg I4mg 1.4mg 0.25mg 1.2mcg 0.I2mg 85mg N.S.2-1 N.S.2-1 N.S.2-1 N.S.2-1 N.S.2-1 2mg N.S.2-1 N.S.2-1 Sodium (Na) 20mg Potassium (K) 80 mg Chlorine (CI) 55mg Calcium (Ca) 1-1 90mg Phosphorous (P) 1-1 60 mg Magnesium (Mg) 6 mg Iron (Fe) 1mg Iodine (I) 5 mcg Zins (Zn) 0.5 mg 3.3 Ingredients 3.3.1 Essential Ingeredients 3.3.1.1. Follow-up formula shall be prepared from the milk of dairy animals and/or other protein products of animal and/or plant origin which have been proved suitable for infants from the 6th month on and for young children and from other suitable ingredients necessary to achieve the essential composition of the product as set out in section 3.1 and 3.2 above. 3.3.1.2. Follow-up Formula based on milk shall be prepared from ingredients as set out in section 3.3.1.1 above except that a minimum of 3 g per 100 available calories (or 0.7. g per 100 kilojoules) of protein shall be derived from whole or skimmed milk as such, or with minor modification that does not substantially impair the vitamm of mineral content ot the milk and which presents a mini mum of 90% of the total protein. . 1-1 N.S. 7" Not specified. 2-1 Formulae should contain a minimum of 15 meg vitamin B6 per gram of protein. See section 3.2.1.1. 1-1 The Ca: P ratioshall be not less than 1.0 and not more than 2.0. 2-1 N.S. = Not specified. 3-1 Or per g polyunsaturated fatty acids, expressed as linoleic acid. 3.3.2. Optional Ingredients 3.3.2.1. In addition to the vitamins and minerals listed under 3.2.4 to 3.2.6 other nutrients may be added-when required to ensure that the product is suitable to form part of a mixed feeding scheme intended for use from the 6th month on. 3.3.2.2. The unusefulness of these nutrients shall be scientifically shown. 603 3.4. 3.4.1 Food (Control of Quality) G.N. No. 256 (contd.) 3.3.2.3. When any of these nutrients is added, the IOoO sha1lCQlltain si of these nutrients, based on the requirements of infants from the 6da and young children. Purity Requirements General All ingredients shall be -clean, of goodq~e and suitable for to:'.:z infants from the 6th month on ana yoUJll cni • 'The.J IbaI COIIIOnB.... normal quality requirements, such as colour.1aYoar aDd odour. 3.4.2 Vitamin compounds and Mineral SaiU 3.4.2.1. Vitamin compounds and mineral salts usedin accordance with sec:tioa3.3.2" be selected from the Advisory Lists for Mineral Salts and Vitamin~I" for Use in Foods for Infants and Children approved by the Codex AlimobtarlQl Commission. 3.4.2.2. The amounts of sodium derived from vitalllin JIl1d mineral ingredients shall be within the limit for sodium in section 3.2.6. 3.5. 3.6. 4. Consistency-and Particles Size When prepared according to the directions for use, the product shall be free of lumps and of large, coarse particles. Specific Prohibition The product andits components shall not have been treated by ionizing radiation. FOOD ADDITIVES Maximum Level in 100 mi. ofProduct Ready-for-Consumption 4.1 4.1.1 4.1.2 4.1.3 4.1.4 4.1.5 4.1.6 4.1.7 4.1.8 4.2 4.2.1 4.2.2 4.3 4.3.1 4.3.2 4.3.3 4.3.4 4.3.5 4.3.6 4.3.7 4.3.8 4.3.9 4.3.10 4.3.11 4.3.12 Thickening Agents Guargum Locust bean gum Distarch phosphate Acetylated distarch phosphate Phosphated distarch phospate Acetylated distarch adipate Carrageenan Pectins Emnlsijiers Lecithm Mono-and Diglycerides pH-AdjustingAgents Sodium hydrogen carbonate Sodium carbonate Sodium citrate Potassium hydrogen carbonate Potassisum carbonate Potassium citrate Sodium hydroxide Potassium hydroxide Calcium hydroxide L (+)Lactic acid L (+)Lactic acid producing cultures Citric acid 604 0.1g 0.5 singly orin combination in 2.5 g singly or in combination in hydrolyzed protein and/or amino acid-based products only 0.03 g singly or in combination in milk and soy-based products only 0.1 g singly or in combination in hydrolized protein and/or amino acid - based liquid products only. 19 0.5g O.4g Limited by Good Manufacturing Practices within the limits for Na in section 3.2.6 Food (Control of Quality) G.N. No. 256 (contd.) Carry-Over Principles Section 3 of the "Principle relating to the Carry-over of Additives into Foods" asset forth In Volume I ofthe Codex Alimentarius shall apply. 4.4 4.4.1 4.4.2 4.4.3 4.4.4 4.5 4.5.1 4.5.1 4.5.3 4.5.4 4.6 Antioxidants Mixed tocopherols concentrate a-Tocopherol L-Ascorbyl palmitate L-Ascorbic acid and its Na. Casalts Flavours Natural Fruits Extracts Vanilla extract Ethyl vanillin Vanillin Maximum Level in 100 mi. ofProduct Ready-jor-Consumption 3 mg singly or in combination 5 mg singly or in combination, expressed as ascorbic acid (See section 3.2.6) GMP GMP 5mg 5mg 5. 5.1 5.2 6. 6.1 6.2 7. CONTAMINANTS PesticideResidues Theproduct shall be prepared with special care under good manufa ctunng practices, so that residues of those pesticides which may be re.quired in the production, storage or processing of the raw materials or the finished food ingredient do not remain, or, iftechnically unavoidable, are reduced to the maximum extent possible. Other Contaminants The product shall be free from residues of hormones and antibiotics, as determined by means of agreed methods of analysis, and practically free from other contaminants, especially pharmocological active substances. PACKAGING The product shall be packed in containers which will safequard the hygienic and other qualities of the food. When in liquid form, the product shall be packed in hermetically sealed containers; nitrogen and carbon dioxide may be used as packing media. The containers, including packaging materials, shall be made pnly of substances which are safe and suitable for their intended uses. Where the Codex Alimentarius Commission has established a standard for any such substance used as packaging materials, that standard shall apply. FILL OF CONTAINERS In the case of products in ready-to-eat form, the fillof container shall be: (i) not less than 80% VlVfor products weighing less than 150 g (5112 oz.);or (ii) not less than 85% v/v for products in the weight range 150-250 g (5112-9 oz.): and (iii) not less than 90% v/v for products weighing more than 250 g (9 oz) of the water capacity of the container. The water capacity of the container is the volume of distilled water at 20"C which the sealed container will hold when completely filled. Dar es Salaam, 15th June, 1994 605 A. H. MAYAGILA, Minister for Health