The Breast Milk Substitutes Act, no. 6 of 2020

ii THE BREAST-MILK SUBSTITUTES ACT, 2021 ARRANGEMENT OF SECTIONS Sections PART I- PRELIMINARY 1. Interpretation. PART II- ESTABLISHMENT OF THE NATIONAL BREAST FEEDING ADVISORY AND PROMOTION COMMITTEE 2. Establishment of Advisory and Promotion Committee. 3. Disclosure of interest. PART III - OBJECTS, POWERS AND FUNCTIONS OF THE ADVISORY COMMITTEE 4. Objects, Powers and functions of Committee. PART IV - ADMINISTRATIVE PROVISIONS 5. Secretariat of Committee. 6. Secondment of public officers. 7. Protection of officers. PART V- FUNDS AND ACCOUNTS OF THE NATIONAL BREAST FEEDING ADVISORY AND PROMOTION COMMITTEE 8. Funds of Committee. 9. Accounts and audit of Committee. 10. Internal auditor. 11. Financial year of Committee. 12. Annual report. PART VI - PROHIBITIONS 13. Sale of designated product. 14. Promotion of designated product. 15. Prohibition related to labelling of designated product. 16. Prohibition related to labelling of infant formula, follow-up formula and young child formula. 17. Prohibition related to labelling of ready-to-feed therapeutic food and complementary product. 18. Prohibition related to labelling of skimmed or condensed milk. 19. Prohibition related to labelling of low-fat and standard milk. 20. Prohibition related to labelling of feeding bottles and teats. 21. Prohibition related to labelling of pacifiers. PART VII - INFORMATION AND EDUCATION 22. Information and education materials about infant and young child feeding. 23. Information and education materials about artificial feeding or feeding bottles. 24. Product information for health professionals. PART VIII - ENFORCEMENT 25. Inspectors. 26. Powers of Inspectors. 27. Authority to issue warrant. 28. Improvement notices, cease and desist orders, etc. 29. Forfeiture of products. 30. Liability of directors, partners and owners. 31. Regulations. ACT Supplement to the Sierra Leone Gazette Vol. CXLXII, No. 55 dated 16th September, 2021 Short title. No. 6 2020 Sierra Leone The Breast Milk Substitutes Act, 2021. Being an Act to provide for safe and adequate nutrition for infants and young children by promoting breast-feeding and regulating the marketing of breast-milk substitutes and for other related matters. [ ] ENACTED by the President and Members of Parliament in this present Parliament assembled. Date of com mencement. SIGNED this 23rd day of August , 2021. DR. JULIUS MAADA BIO, President. LS No. 6 The Breast Milk Substitutes Act 2021 No. 6 The Breast Milk Substitutes Act 2021 PART I-PRELIMINARY 1. In this Act, unless the context otherwise requires "advertising" means to make a representation by any means for the purpose of directly or indirectly promoting the sale or use of a designated product, by (a) written publication, television, radio, film, electronic transmission including the internet, social media, video, telephone or mobile application; (b) display of signs, bill or notices; or (c) exhibition of pictures or models; "artificial feeding" means feeding with a food product which replaces breast milk; "breast-milk substitute" includes milk or product that could be used to replace milk, such as fortified soy milk, in either liquid or powdered form, that are specifically marketed for feeding infants and young children up to the age of 3 years, including follow up formula and growing-up milk; "brand name'' means a name given by the manufacturer to a product or range of products; "bottle feeding" means feeding liquid or semi-solid food from a bottle with a nipple; "Committee" means the Breast-milk SubstitutesAdvisory Committee established under subsection (1) of section 2; "complementary food" means food that is suitable or represented as suitable as an addition to breast milk, infant formula or follow-up formula; "complementary food product" means food that is commercially processed; "container" means a form of packaging of a designated product for sale as a retail unit including wrappers; "cross-promotion'' means the use of similar brand names packaging designs, labels, texts, images, colour schemes, symbols or slogans; "designated product" means (a) infant formula; (b) any other product marketed or otherwise represented as suitable for feeding infants up to the age of 6 months; (c) follow up formula; (d) young child formula; (e) ready-to use therapeutic food; (f) complementary food product; (g) feeding bottles, pacifiers and teats; (h) such other product as the Minister may, by notice in the Gazette, declare to be a "designated product" for the purposes of this Act; 2 3 Interpretation. No. 6 The Breast Milk Substitutes Act 2021 No. 6 The Breast Milk Substitutes Act 2021 "distributor" means a person, corporation or other entity engaged in the business of marketing a designated product, whether wholesale or retail; "Executive Secretary" means the head to the Breast-milk Substitutes Secretariat appointed under subsection (3) of section 6; "Food and feed Safety Act, 2017" means the Food and Feed Safety Authority established under section 3 of the Food and feed Safety Act, 2018 (Act No. 7 of 2018); "follow-up formula" means a food intended for use as the liquid part of (a) the diet for older infants when complementary feeding is introduced; and (b) the progressively diversified diet of young children; "health" means a state of complete physical, mental and social wellbeing and not merely the absence of disease or infirmity in an infant or young child; "health-care facility" means a public or private institution or organisation engaged directly or indirectly in the provision of health care, health care education, day care center, nursery or other infant or young child-care facility; "health claim" means a representation that states, suggests or implies that a relationship exists between a food or a constituent of that food and health including (a) a nutrient function claim that describes the physiological role of the nutrient in growth development and normal function of the body; (b) a function claim concerning specific beneficial effects of the consumption of foods or their constituents that relate to a positive contribution to health or to the improvement of a function or to modifying or preserving health; and (c) a reduction of disease risk claim relating to the consumption of a food or food constituent, in the context of the total diet, to the reduced risk of developing a disease or health-related condition; "health professional" means a health worker with a professional degree, diploma or licence, such as a medical practitioner, a registered nurse or midwife or such other person as may be specified by the Minister by notice in the Gazette; "health worker" means a person providing or in training to provide health care services in a health care facility or community, whether professional or non professional, including voluntary unpaid worker; "infant" means a child from birth up to the age of 12 months; "infant formula"means a breast-milk sub stitutespecially manufactured to satisfy, by itself, thenutritional requirements of infants from birth or during the first months of life up to the introduction of complementary feeding; 4 5 No. 6 The Breast Milk Substitutes Act 2021 No. 6 The Breast Milk Substitutes Act 2021 "Inspector" means a person, appointed under subsection (2) of section 5 or deemed, under subsection (2) of section 26, to be an Inspector for the purposes of this Act; "label" means a tag, mark, insert, pictorial or other descriptive matter, written, printed, stenciled, marked, embossed, attached or otherwise appearing on a container of a designated product; "labelling" includes a written, printed or graphic matter that is present on the label, accompaning the food, or is displayed near the food, including that for the purpose of promoting its sale or disposal; "logo" means an emblem ,picture or symbol by means of which a company or a product is identified; "manufacturer" means a person, corporation or other entity, engaged in the business of manufacturing a designated product, whether directly, through an agent, or through a person controlled by or under an agreement with it; "market" means a method of introducing or selling of a designated or complementary product, and includes promotion, distribution, advertising, public relations, information services and distribution of samples; "Minister" means the Minister responsible for health and sanitation and "ministry" shall be construed accordingly; "nutrition claim" means a representation which states, suggests or implies that a food has particular nutritional properties including, energy value and content of protein, fat, carbohydrates, vitamins or minerals but does not include (a) a reference to substances in a list of ingredients; (b) a reference to nutrients as a mandatory part of nutrition labelling; (c) quantitative or qualitative declaration of certain nutrients or ingredients as a mandatory part of nutrition labelling; "package" means a box, carton, tin or a wrapping of any kind, in which a designated product is customarily sold by a wholesale or retail unit; "publish" means to show, broadcast, televise, display, exhibit or distribute a designated product; "social welfare institution" means a public or private organisation engaged, directly or indirectly, in providing social welfare for infants or young children, but does not include a healthcare facility; "sample" means a single or any quantity of a designated product provided at no cost; "young child" means a child between the age of 12 months to 36 months; and "young child formula" means a milk or product that can be used to replace milk, manufactured for use as a liquid part of the diet of young children. PART II-ESTABLISHMENT OF THE NATIONAL BREAST FEEDING ADIVISORY PROMOTION COMMITTEE. 2. (1) There is hereby established a body to be known as the Breast-milk Substitutes Advisory Committee. 6 7 Establishment of Advisory and Promotion Committee. No. 6 The Breast Milk Substitutes Act 2021 No. 6 The Breast Milk Substitutes Act 2021 (2) The Committee shall comprise the Director of Food and Nutrition, Ministry of Health and Sanitation, who shall be Chairman and the following other members (a) the Director, Sierra Leone Standards Bureau; (b) the Director of Research and training, Ministry of Health and Sanitation; (c) the Registrar, Nurses and Midwives Board; (d) the Permanent Secretary, Ministry of Trade and Industry; (e) the Permanent Secretary, the Ministry responsible for Children’s Affairs. (f) the Chairman, Sierra Leone Association of Nutritionists; (g) the President, Sierra Leone Medical and dental Association; (h) one person representing a nutrition related non-governmental organisation nominated by that organisation, appointed by the Minister; (i) 1 person with relevant technicial expertise in infant and young child feeding and 1 person from the Scaling up Nutrition Secretariat appointed by the Minister. (3) A person shall cease to be a member of the Committee on any of the following grounds (a) for his inability to perform the functions of his office by reason of infirmity of mind or body; (b) for proven misconduct; (c) if he becomes bankrupt or insolvent; (d) if he is convicted and sentenced for an offence involving fraud or dishonesty; (e) if he fails to attend 3 consecutive meetings of the Committee without reasonable cause; (f) if he resigns his office by written notice to the Minister. (4) The Committee shall meet for the dispatch of its business at least once every 3 months and at such times as the Chairman may determine. (5) The quorum at any meeting of the Committee shall be 6. (6) The Committee may co-opt any person to attend and participate in its deliberations on any matter but such person shall not vote on any issue for the decision by the Committee. (7) Subject to this Act, the Committee shall report on its activities to the Board of the Food and feed Safety Authority and shall regulate the procedure of its own meeting. 3. (1) A member of the Committee who has any interest, whether direct or indirect in any matter being considered or to be considered by the Committee, shall disclose the nature of his interest to the Committee and the disclosure shall be recorded in the minutes of the Committee and such member shall not take part in any deliberation or decision of the Committee relating to that matter. (2) Notwithstanding subsection (1), a person with a family, professional or business association with a person or entity involved in the manufacturing or distribution of a designated product shall not be a member of the Committee. 8 9 Disclosure of interest. No. 6 The Breast Milk Substitutes Act 2021 No. 6 The Breast Milk Substitutes Act 2021 PART III - OBJECTS, POWERS AND FUNCTIONS OF THE ADVISORY COMMITTEE 4. (1) The object for which the Committee is established is to facilitate the implementation and enforcement of this Act. (2) Without prejudice to the generality of subsection (1), the Committee shall have the following powers and functions (a) review educational materials submitted under section 23; (b) create regional Committees to carry out the functions of the Committee at the regional level; (c) ensure widespread distribution of and publicity of this Act to persons and entities that may be subject to or affected by its provisions, including (i) Inspectors designated under this Act; (ii) relevant health workers and their professional associations; (iii) owners and operators of establishments that import, sell, distribute, promote or otherwise market designated products; (iv) owners and operators of media outlets including television and radio stations, websites, and advertising agencies; (v) manufacturers and distributors of designated products (vi) relevant civil society organisations and associations; (vii) relevant government departments. (d) develop materials and procedures necessary for monitoring compliance with this Act; (e) build capacity of Inspectors and other monitors to be able to effectively enforce this Act; (f) develop a procedure for accepting and responding to complaints of suspected violations of this Act; (g) review and evaluate reports of violations or other matters relating to this Act; and (h) issue instructions to Inspectors as to action to be taken against persons believed to be in violation of this Act or the regulations made under it. (i) promote exclusive breast feeding for lactating mothers and providing baby friendly work places. (j) Advocate for 6 months maternity leave (k) the committee shall appoint other staff as may be required for the efficient performance of the functions of the committee. PART IV - ADMINISTRATIVE PROVISIONS 5. (1) The Committee shall have a Secretariat which shall be responsible for the day-to-day administration of the affairs of the Committee. 10 11 Objects, Powers and functions of Committee. Secretariat of Committee. No. 6 The Breast Milk Substitutes Act 2021 No. 6 The Breast Milk Substitutes Act 2021 (2) There shall be an Executive Secretary who shall be a person with proven knowledge and experience in the promotion of breast-feeding and the regulation of the marketing of food products manufactured for infants and young children and the head of the Secretariat and such other staff, including Finance Officer, Administrative officer, Inspectors and other administrative and technical staff as may be required for its efficient performance of the functions of the Committee. (3) The Executive Secretary and other staff of the Secretariat shall be appointed by the Committee upon such terms and conditions as the Committee shall, after consultation with the Minister, determine. 6. Public officers may be seconded or otherwise render assistance to the Secretariat but the Committee may request the withdrawal of any such seconded staff who is unable to carry out assigned functions in a manner satisfactory to the Committee. 7. An officer or employee of the Secretariat or a person acting on the directions of a senior officer or employee of the Secretariat shall not be liable in respect of any matter or thing done by him in good faith under this Act. PART V- FUNDS AND ACCOUNTS OF THE NATIONAL BREAST FEEDING ADVISORY AND PROMOTION COMMITTEE 8. (1) The activities of the Committee shall be financed by funds consisting of (a) moneys appropriated from time to time by Parliament for the purposes of the Committee; (b) moneys given to the Committee by way of gifts, bequests, grants or other contributions: Provided contributions shall not beaccepted from manufacturers or distributors of designated products. (c) all other moneys which may, from time to time, accrue to the Committee. (2) The funds of the Committee shall be applied only for the purposes of the approved budget of the Committee. 9. (1) The Committee shall keep proper books of account and other records in relation to the activities, approved by the Auditor-General and shall prepare in respect of each financial year, a financial statement which shall include (a) balance sheet accounts; (b) income and expenditure accounts; and (c) source and application of funds. (2) The accounts of the Committee kept under subsection (1) shall, not later than 2 months after the end of each financial year, be audited by the Auditor-General or an auditor appointed by him. (3) For the purposes of subsection (2), the Auditor General or the auditor appointed by him shall be entitled to have access to all the books of account, vouchers and other financial records of the Committee and to require such information and explanation thereon as he may think fit. (4) The Committee shall provide the Auditor-General or the auditor appointed by him with all the necessary and appropriate facilities for the examination of the accounts and records of the Committee. 12 13 Secondment of public officers. Protection of officers. Funds of Committee. Accounts and audit of Committee. No. 6 The Breast Milk Substitutes Act 2021 No. 6 The Breast Milk Substitutes Act 2021 (5) The Auditor- General or auditor appointed by him shall submit to the Committee a report on the audited accounts and the financial statements referred to in subsection (1) and shall, in his report draw attention to (a) irregularities in the accounts; (b) matters that are likely to adversely affect the operations of the Committee; and (c) any other matter which, in his opinion, ought to be brought to the notice of the Committee. 10. (1) There shall be an internal auditor appointed by the Committee who shall be responsible for the internal audit of the Committee. (2) The Internal Auditor shall submit quarterly reports of the audit carried out by him to the Committee. 11. The financial year of the Committee shall be the same as the financial year of the government. 12. (1) The Committee shall, within 3 months after the end of the financial year submit to the Minister a report on the performance of its functions during that year and on its policies and programmes. (2) The annual report shall include the accounts and annual financial statement prepared under section 9 and the report of the audit thereon. (3) The Minister shall lay copies of the annual report before Parliament within 2 months after he has received the report. (4) The Committee shall make copies of the report available to all stakeholders once it has been laid before Parliament. PART VI - PROHIBITIONS 13. (1) A person shall not manufacture and or distribute a designated product for sale, stock or exhibit for sale, unless the designated product (a) is registered for sale in accordance with such conditions and procedures as the Minister may by statutory instrument prescribe; and (b) has not exceeded its date of minimum durability. (2) A person who wishes to register a designated product for sale under paragraph (a) of subsection (1) shall, submit to the Secretariat, an application for registration accompanied by such information and samples as may be prescribed. (3) An application for registration under subsection (2) shall not be approved unless the designated product is in accordance with the applicable standards and has a label which is in accordance with the applicable requirements contained in sections 15 to 21. (4) A person whose application for registration under subsection (2) is approved shall be issued a Certificate of Registration. (5) A person who contravenes subsection (1) commits an offence and is liable on conviction to a fine not exceeding 50,000,000.00 Leones or to a term of imprisonment not exceeding 2 years. Financial year of Committee. Annual report. 14 15 Internal auditor. Sale of designated product. No. 6 The Breast Milk Substitutes Act 2021 No. 6 The Breast Milk Substitutes Act 2021 14. (1) A manufacturer or distributor shall not, directly or indirectly, do anything to promote a designated product including (a) advertising; (b) using sales devices such as special displays, discount coupons, premiums, rebates, special sales, loss-leaders, tie-in sales, prizes or gifts. (c) giving samples of a designated product to any person; (d) distribution of information, donation of educational materials, performance of educational functions relating to infant or young child feeding, except in the case of product information for health professionals under section 24; (e) cross-promotion of a designated product. (2) A manufacturer or distributor shall not directly or indirectly (a) donate, waive payment, provide at lower than the wholesale price or lower than 80 percent of the retail price, a designated product to a health worker or a health care facility; (b) donate or distribute equipment, services or materials to a health care facility; (c) offer or give a gift, contribution, sponsorship, benefit, financial or otherwise, of whatevervalue to a health worker or to an association of health workers engaged in maternal, infant and child health; (d) sponsor events, telephone counseling lines, campaigns or programmes related to reproductive health, pregnancy, childbirth, infant or young child feeding; (e) establish relationships with parents and other caregivers through baby clubs, social media groups, child care classes, contests and any other means; or (f) include the volume of sales of designated products in the calculation of its employee remuneration or bonuses or set quotas for sales of designated products. (3) A health worker or an association of health workers engaged in maternal and child health shall not directly or indirectly (a) accept a gift, contribution, sponsorship, benefit, financial or otherwise, of whatever value, from a manufacturer or distributor; (b) accept or give samples of designated products to a person ;or (c) demonstrate the use of infant formula, except to individual mothers or members of their families in very special cases of need, and in such cases, shall give a clear explanation of other information or educational materials required for infant and young child feeding under section 23. (4) Notwithstanding subsection (1) a manufacturer or distributor may promote a complementary food product provided that 16 17 Promotion of designated product. No. 6 The Breast Milk Substitutes Act 2021 No. 6 The Breast Milk Substitutes Act 2021 (a) the promotional practice does not take place in a health care facility; (b) the material promoting a complementary food product shall include a statement 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" expressing (i) the importance of exclusive breastfeeding for the first 6 months and of continued breastfeeding up to 2 years or beyond; and (ii) the recommended age of introduction which is not less than 6 months and a statement that early introduction of complementary foods negatively affects breastfeeding. (c) the material promoting a complementary food product does not contain a text, image or other representation that (i) suggests the suitability of the product for infants under 6 months including references to development milestones clearly reached before 6 months or the use of pictures of infants appearing to be younger than 6 months; (ii) idealises the product or is likely to undermine or discourage breastfeeding or create a belief that the product is equivalent or superior to breastmilk; (iii) undermines or discourages appropriate complementary feeding or that may suggest that the product is inherently superior to home-prepared com plementary foods (d) the material promoting a complementary food does not contain (i) a recommendation to feed the product in a bottle or anything that otherwise promotes the use of bottle feeding; (ii) an endorsement, or anything that may be conveyed or construed as an endorsement by a health professional, an association of health professional or other body; or (iii) any element that allows for cross promotion of any other designated product. (5) (a) A person who contravenes subsection (1) (2) or (4) commits an offence and is liable on conviction to a fine not exceeding 50,000,000.00 Leones or to a term of imprisonment not exceeding 2 years. (b) A health worker or an association of workers who contravenes sub-section (3)commits an offence and is liable on conviction to a fine not exceeding 10,000,000 Leones or to a term of imprisonment not exceeding 12 months. 15. (1) A manufacturer or distributor shall not sell or offer for sale, a designated product (a) other than a complementary food product or ready-to-feed therapeutic food, if the container or label affixed thereto includes a photograph, drawing or other graphic representation other than for illustrating methods of preparation; Prohibition related to labelling of designated product. 18 19 No. 6 The Breast Milk Substitutes Act 2021 No. 6 The Breast Milk Substitutes Act 2021 (b) other than a feeding bottle, teat or pacifier unless the container or label affixed thereto indicates in a clear, conspicuous and easily readable manner in English the following particulars (i) instructions in words and in easily understood graphics appropriate for preparation and use; (ii) the age, in numbers, for which the product is recommended; (iii) a warning about the health risks of improper use, preparation or storage and of introducing the product prior to the recommended age; (iv) the list of ingredients and declaration of nutritional value in accordance with such national standards as may be prescribed by the Sierra Leone Standards Bureau or, in the absence of such standard, with the relevant Codex Alimentarius Standard; (v) the required storage conditions both before and after opening, taking into account climatic conditions; (vi) the batch number, date of manufacture and date before which the product is to be consumed, taking into account climatic and storage conditions; (vii) the name and national address of the manufacturer or distributor; and (viii) such other particulars as prescribed by the Food and Feed Safety Act, 2017; (c) if the labelling thereto contains a health or nutrition claim or a representation that states or suggests that a relationship exists between the product or its composition and health, including the physiological role of a nutrient in growth, development and normal functions of the body; (d) if the labelling thereto recommends or promotes bottle feeding. (2) A person who contravenes subsection (1) commits an offence and is liable on conviction to a fine not exceeding 50,000,000.00 Leones or to a term of imprisonment not exceeding 2 years. 16. (1) In addition to the requirements of sections 24 a manufacturer or distributor shall not sell or offer for sale (a) infant formula or follow-up formula unless the container or label affixed thereto, conforms to the following (i) contains the words, "IMPORTANT NOTICE" in capital letters and indicated thereunder, the statement primarily in English "Breastfeeding is the normal and optimal way to feed infants and young children. Breast milk is important for the healthy growth and development of infants and young children. It protects against diarrhoea and other illnesses" or similar statement as to the superiority of breastfeeding or breastmilk; Prohibition related to labelling of infant formula, follow-up formula and young child formula. 20 21 No. 6 The Breast Milk Substitutes Act 2021 No. 6 The Breast Milk Substitutes Act 2021 (ii) contains a statement that the product should only be used on advice of a health worker as to the need for its use and the proper method of use; (iii) has preparation instructions for infant or follow-up formula in powdered form that state that (aa) powdered formula is not sterile and may be contaminated with pathogenic microorganisms during the manufacturing process or may become contaminated during preparation; (bb) it is necessary for formula to be prepared one feed at a time using water first boiled and then cooled to not less than 70 °C; and (cc) unused milk shall be discarded immediately after every feed; (b) infant formula, follow-up formula or young child formula unless the container or label affixed thereto, conforms to the following (i) includes a feeding chart in the storage or preparation instructions; (ii) does not use the terms "maternalised", "humanised" or terms similar thereto or any comparison with breast milk; (iii) does not use text that may tend to discourage breastfeeding; (iv) specifies the source of the protein; (v) does not contain an element that allows for cross-promotion of any other designated product; (vi) in the case of follow-up formula, states in a clear, conspicuous and easily readable manner primarily in English; that the product shall (aa) not be used for infants less than 6 months old (bb) not be used as the sole source of nutrition of infants and that o l d e r infants should receive complementary foods in addition to the product; and (cc) not lead to cessation of breastfeeding; (c) young child formula unless the container or label affixed thereto, states in a clear, conspicuous and easily readable manner primarily in English; that (i) breast-feeding is recommended up to 2 years and beyond; (ii) the mother or caregiver should seek advice of a health worker on proper feeding of young children; (iii) that the product should not be used to feed infants below 12 months or be used as the sole source of nutrition for young children. 22 23 No. 6 The Breast Milk Substitutes Act 2021 No. 6 The Breast Milk Substitutes Act 2021 (2) A person who contravenes subsection (1) commits an offence and is liable on conviction to a fine not exceeding 50,000,000.00 Leones or to a term of imprisonment not exceeding 2 years. 17. (1) In addition to the requirements of section 16 a manufacturer or distributor shall not sell or offer for sale, a ready-to feed therapeutic food product or a complementary food product if the container or label affixed thereto contains (a) a text, image or other representation that (i) suggests the suitability of the product for infants under 6 months including references to development milestones clearly reached before 6 months or the use of pictures of infants appearing to be younger than 6 months; (ii) idealises the product or is likely to undermine or discourage breast feeding or create a belief that the product is equivalent or superior to breast milk; (iii) undermines or discourages appropriate complementary feeding or that may suggest that the product is inherently superior to home prepared complementary foods; (b) a recommendation to feed the product in a bottle or otherwise promote the use of bottle feeding; (c) an endorsement, or anything that may be conveyed or construed as an endorsement by a health professional, an association of health professional or other body; and (d) an element that allows for cross-promotion of any other designated product. (2) In addition to the requirements of Subsection (1), the label of a ready-to-feed therapeutic food or a complementary food product shall include (a) a statement in characters in a clear, conspicuous and easily readable manner, in English on (i) the importance of exclusive breastfeeding for the first 6 months and of continued breastfeeding up to 2 years or beyond; and (ii) the recommended age of introduction which is not less than 6 months and a statement of that early introduction of complementary foods negatively affects breastfeeding; (b) instructions for preparation, storage, handling and use; and (c) a feeding chart showing the appropriate ration or serving size consistent with guiding principles issued by the World Health Organisation. (3) A person who contravenes subsection (1) commits an offence and is liable on conviction to a fine not exceeding 50,000,000.00 Leones or to a term of imprisonment not exceeding 2 years. 24 25 Prohibition related to labelling of ready-to- feed therapeutic food and complementary product. No. 6 The Breast Milk Substitutes Act 2021 No. 6 The Breast Milk Substitutes Act 2021 18. (1) A manufacturer or distributor shall not sell or offer for sale, skimmed or condensed milk in powder or liquid form, unless the container or label affixed thereto contains the words, in a clear, conspicuous and easily readable manner, in English "This product should not be used to feed infants" (2) A person who contravenes subsection (1) commits an offence and is liable on conviction to a fine not exceeding 50,000,000.00 Leones or to a term of imprisonment not exceeding 2 years. 19. (1) A manufacturer or distributor shall not sell or offer for sale, low-fat or standard milk in powder or liquid form, unless the container or label affixed thereto contains the words, in a clear, conspicuous and easily readable manner, in English "This product shall not be used to feed infants". (2) A person who contravenes subsection (1) commits an offence and is liable on conviction to a fine not exceeding 50,000,000.00 Leones or to a term of imprisonment not exceeding 2 years. 20. (1) In addition to the requirements of section 24, a manufacturer or distributor shall not sell or offer for sale a bottle or teat unless the package or label affixed thereto indicates in a clear, conspicuous and easily readable manner, primarily in English, indicating (a) the words, "IMPORTANT NOTICE" in capital statement "Breastfeeding is best. Breast milk is the ideal food for the healthy growthand development of infants and young children. It protects against diarrhea and other illnesses;" (b) the statement in a clear, conspicuous and easily readable manner primarily in English indicating "WARNING: It is important for your baby's health that you follow the cleaning and sterilisation instructions very carefully. If you use a feeding bottle, your baby may no longer want to feed from the breast" (c) instructions for cleaning and sterilisation in words and graphics; (d) a statement explaining that feeding with a cup is more hygienic than bottle feeding; (e) a warning that children should not be left to self-feed and that extended contact with sweetened liquids, including infant formula may cause severe tooth decay; and (f) the name and national address of the manufacturer or the distributor. (2) A person who contravenes subsection (1) commits an offence and is liable on conviction to a fine not exceeding 50,000,000.00 Leones or to a term of imprisonment not exceeding 2 years. 21. (1) In addition to the requirements of section 24 a manufacturer or distributor shall not sell or offer for sale a pacifier unless it is labeled with the words "WARNING: use of a pacifier can interfere with breastfeeding." Prohibition related to labelling of pacifiers. 26 27 Prohibition related to labeling of skimmed or condensed milk. Prohibition related to labeling of low-fat and standard milk. Prohibition related to labelling of feeding bottles and teats. No. 6 The Breast Milk Substitutes Act 2021 No. 6 The Breast Milk Substitutes Act 2021 (2) A person who contravenes subsection (1) commits an offence and is liable on conviction to a fine not exceeding 50,000,000.00 Leones or to a term of imprisonment not exceeding 2 years. PART VII - INFORMATION AND EDUCATION 22. (1) Information or educational materials, whether written, audio or visual, which refer to infant and young child feeding shall (a) contain only correct and current information and shall not use any pictures or text that encourage artificial feeding, the use of feeding bottles or that discourage breast feeding; (b) be written in English; (c) not give an impression or create a belief that a designated product is equivalent to, comparable with or superior to breast milk or to breast-feeding; (d) not contain the brand name or logo of a designated product, manufacturer or distributor of a designated product, except in the case of designated products intended for health professionals under section 24; and (e) clearly explain (i) the benefits and superiority of breastfeeding; (ii) the value of exclusive breastfeeding for 6 months followed by sustained breast feeding for 2 years or beyond; (iii) how to initiate and 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 6 months; (vi) how and why an introduction of artificial feeding, the use of a feeding bottle or the early introduction of complementary foods negatively affectsbreastfeeding; and (vii) that complementary foods can easily be prepared at home using local ingredients. (2) A person who contravenes subsection (1) commits an offence and is liable on conviction to a fine not exceeding 10,000,000.00 Leones or to a term of imprisonment not exceeding 12 months. 23. (1) Where information or educational material in section 22 deals with artificial feeding or the use of a feeding bottle, it shall also contain (a) instructions for the proper preparation, storage and use of the product including cleaning and sterilisation of feeding utensils; (b) instructions on how to feed infants with a cup; Information and education materials for feeding or feeding bottles. 28 29 Information and education materials about infant and young child feeding. No. 6 The Breast Milk Substitutes Act 2021 No. 6 The Breast Milk Substitutes Act 2021 (c) information on the health risks of artificial feeding, the use of a feeding bottle and improper preparation of the product; (d) statement that (i) powdered formula is not sterile and may be contaminated with pathogenic microorganisms during the manufacturing process or may become contaminated during storage or preparation; (ii) it is necessary for powdered formula to be prepared one feed at a time usingwater first boiled and then cooled to not less than 70 °C; and (iii) an unused milk must be discarded immediately after every feed; (e) the approximate financial cost of feeding an infant or a young child with such a product in the recommended quantities; and (f) that the practice of providing follow-up formula and young child formula is not necessary. (2) Except as provided in section 24 concerning product information for health professionals, materials that include the topic of artificial feeding shall not contain any health or nutrition claims or other representation that states or suggests that a 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. (3) A person who contravenes subsection (1) commits an offence and is liable on conviction to a fine not exceeding 10,000,000.00 Leones or to a term of imprisonment not exceeding 12 months. 24. (1) A manufacturer or distributor may give or provide information materials relating to a designated product to a health professional if such information or material (a) is restricted to scientific and factual matters regarding the technical aspects and methods of use of a product; or (b) provides references to published and peer reviewed studies to support a representation or claim that states or suggests that a relationship exists between a product or a constituent of that product and health, growth or development. (2) A manufacturer or distributor who gives or provides information or material relating to a designated product to a health professional under subsection (1), shall submit copies to the Committee in such form as the Minister may by statutory instrument prescribe. (3) A person who contravenes subsection (1) commits an offence and is liable on conviction to a fine not exceeding 50,000,000.00 Leones or to a term of imprisonment not exceeding 12 months. Product information for health professionals. 30 31 No. 6 The Breast Milk Substitutes Act 2021 No. 6 The Breast Milk Substitutes Act 2021 PART VIII - ENFORCEMENT 25. (1) In addition to Inspectors appointed under subsection (2) of section 5, public health officers appointed under the Public Health Act and any other person upon whom the functions of maintenance of law and order is vested by law shall be deemed to be an Inspector for the purposes of this Act. (2) An inspector may, for the purpose of enforcing this Act, at all reasonable times, enter and inspect a place in which he believes, on reasonable grounds that (a) a designated product is or has been produced, manufactured stored, packaged, sold or used; (b) there is anything used in the production, manufacture, testing, packaging, promotion or sale of a designated product; (c) there is information relating to the production, manufacture, testing, packaging, promotion or sale of a designated product; (d) a person is, in any way, contravening this Act. (3) An Inspector shall, after each inspection, submit a report including any finding of a violation of this Act to the Committee. 26. In carrying out an inspection under subsection (2) of section 25, an Inspector may (a) with the consent of the occupant or under authority of a warrant issued under section 27, enter a place in which a designated food product is or has been produced, manufactured stored, packaged, sold or used. (b) examine a designated food product or document relating thereto; (c) require a person in charge of a place in which a designated food product is or has been produced, manufactured stored, packaged, sold or used, to (i) produce for inspection, written or electronic information that is relevant to the administration or enforcement of this Act; (ii) open a container or package which the inspector believes, on reasonable grounds, contains a designated product; (iii) take or require a person to produce samples of a designated product; Powers of Inspectors. Inspectors. 32 33 No. 6 The Breast Milk Substitutes Act 2021 No. 6 The Breast Milk Substitutes Act 2021 (iv) seize a designated product or thing by means of which or in relation to which the inspector believes, on reasonable grounds, that this Act has been contravened and take full inventory of all the items seized; (v) direct that any designated product or thing seized be kept or stored in the place where it was seized or that it be removed to another place; or (vi) conduct test, analysis or examination of a designated product. 27. Upon an ex-parte application, a judge of the High Court may issue a warrant authorising an inspector named in the warrant to enter and inspect a place in which a designated product is or has been produced, manufactured stored, packaged, sold or used, subject to such conditions as may be specified in the warrant. 28. (1) On the receipt of a report from an inspector of a violation of this Act under subsection (3) of section 25 the Committee shall, by an improvement notice served on a person who is deemed to be in contravention of this Act, (a) state the grounds for believing that the person is failing to comply with this Act; (b) specify the matters which constitute the person's failure so to comply; (c) specify the measures which the person shall take in order to secure compliance; and (d) require the person to take those measures within such period as may be specified in the notice. (2) In addition to the powers conferred under Subsection (1), the Committee may, upon receiving a report from an inspector or other report of a violation of this Act, make a cease and desist order directing a person who is deemed to be in contravention of this Act to stop a particular activity or practice. (3) A person who fails to comply with an improvement notice or cease and desist order under subsection (1) or (2) commits an offence and is liable on conviction to a fine not exceeding 10,000,000.00 Leones or to a term of imprisonment not exceeding 12 months. 29. Where (a) a person has been convicted of an offence under this Act in respect of which a designated product or a thing has been seized under this Act; Forfeiture of products. Authority to issue warrant. Improvement notices, cease and desist orders, etc. 34 35 No. 6 The Breast Milk Substitutes Act 2021 No. 6 The Breast Milk Substitutes Act 2021 Passed in Parliament this 21st day of July, in the year of our Lord two thousand and Twenty One. UMAR PARAN TARAWALLY, Clerk of Parliament. THIS PRINTED IMPRESSION has been carefully compared by me with the Bill which has passed Parliament and found by me to be a true and correct printed copy of the said Bill. UMAR PARAN TARAWALLY, Clerk of Parliament. PRINTED AND PUBLISHED BY THE GOVERNMENT PRINTING DEPARTMENT, SIERRA LEONE. GAZETTE NO. 55 OF 16TH SEPTEMBER, 2021. (b) an inspector has seized a designated or complementary food product or a thing and the owner or the person in whose possession it was, at the time of seizure, consents in writing to its forfeiture, a designated or complementary food product or a thing shall be forfeited to the State and may be destroyed or disposed of in such manner as the Minister may direct. 30. When a person guilty of an offence under this Act is a corporation, company, partnership, firm or other association, every director, partner and owners of the corporation, company, partnership, firm or other association, shall also be liable for that offence unless he proves that the offence was committed without his knowledge or consent. 31. (1) The Minister may, by statutory instrument make regulations for carrying out the purposes of this Act. (2) Notwithstanding the generality of subsection (1) the Minister may make regulations to prescribe (a) conditions and procedures for the registration of designated product; (b) qualifications and powers of and procedures for Inspectors appointed pursuant to this Act; and (c) procedures for submitting educational or informational materials to the Committee. 36 37 Liability of directors, partners and owners. Regulations.