The Breast Milk Substitutes (Regulation and Control) (General) Regulations

Section 1. Citation Section These Regulations may be cited as the Breast Milk Substitutes (General) Regulations and shall come into force on the 30th of May, 2022. [L.N. 80/2022, r. 2.]

Section 2. Interpretation Section In these Regulations, unless the context otherwise requires— "Act" means the Breast Milk Substitutes (Regulation and Control) Act (Cap. 262); "cross-promotion" means a form of marketing promotion where customers of one product or service are targeted with the promotion of a related product using symbols, colouring, naming, shelf placement or any other means that implies benefit or suitability; "donation" means a designated product or pre-packaged complementary food offered for charity or humanitarian aid; "donee" means the person or institution receiving the donation; "donor" means the person or institution making the donation; "KS CODEX STAN" means any Codex Standard that has been approved as the Kenya standards under the Standards Act (Cap. 496); "KS EAS" means an East African Standard that has been approved as a Kenya standard under the Standards Act (Cap. 496); "KS" means a Kenya Standard approved under the Standards Act (Cap. 496); and "public analyst" means a health officer who examines, reviews, evaluates, or conducts research of designated products and pre-packaged complementary food. "public venue" means any venue to which, for the time be...

Section 3. Guiding principles Section 3(1)(a) applies or interprets any provision of these Regulations; Section 3(1)(b) are involved in the manufacture, distribution, study, or advising about the use of designated products or complementary foods or about breastfeeding; and Section 3(1)(c) makes or implements public policy decisions. Section 3(2)(a) in the provision of nutrition services, the best interest of an infant and young child is protected; Section 3(2)(b) initiation of breastfeeding of the infant is done within an hour of delivery and exclusive breastfeeding for the first six (6) months of life; Section 3(2)(c) timely introduction of appropriate, adequate and safe complementary food with continued breastfeeding for a period of twenty-four (24) months or beyond; Section 3(2)(d) where appropriate, breastmilk substitutes and pre-packaged complementary food shall be safe for the consumption of an infant and young child; Section 3(2)(e) adequate and accurate information on breastfeeding and infant and young child feeding shall be available to the general public; and Section 3(2)(f) interaction with manufacturers and distributors of designated products shall be done in the manner...

Section 4. Objects Section The objects of these Regulations is to guide all persons that use, manufacture, sell and market breast milk substitutes and to ensure that all persons understand that breast milk substitutes undermines breastfeeding and suboptimal breastfeeding is a leading but preventable cause of death and serious illness in infants and young children.

Section 5. Production and packaging of designated and complementary food products Section the provisions of the Act, the Food, Drugs and Chemical Substances Act (Cap. 254), the Public Health Act ( Cap. 242 ), the Standards Act ( Cap. 496 ) and the Kenya Standards KSEAS 39 and any other written law; and

Section 6. Registration Section Every manufacturer or importer of designated products shall register with the office in charge of nutrition and dietetics in the Ministry responsible for matters relating to public health, by providing its physical address, telephone, website, and email contact information and declaring that the products it imports or distributes are subject to this Act and shall provide updated information within 30 days of these declared information changing.

Section 7. Sampling and testing Section Sampling and testing of the designated products and pre-packaged complementary food shall be in accordance with the provisions of the Act, the Food, Drugs and Chemical Substances Act (Cap. 254), the Public Health Act (Cap. 242) and the Standards Act (Cap. 496) and any other written law.

Section 8. Complying with Regulations Section A manufacturer, trader, importer and distributor shall not import, offer for sale or sell any designated product or pre-packaged complementary food if it does not comply with these Regulations, the Act and any other relevant written law.

Section 9. Manufacturing, sell and expiry date Section No person shall stock, distribute, sell or exhibit any food for infant and young child which does not have a manufacturing date and an expiry date.

Section 10. Use of alternative containers from the original Section Any person who stocks, distributes, sells or exhibits a designated product or pre-packaged complementary food for use by infants or young children in an alternative container from the original containers shall hermetically seal and label the alternative container in accordance to the Act and any other written law.

Section 11. Certificate of analysis Section 11(1) An authorised officer may at any time, collect and submit to a public analyst a sample of a designated product or a pre-packaged complementary food product for analysis. Section 11(2) The public analyst referred to under subregulation (1), shall upon analysis of the product, issue a certificate of analysis.

Section 12. Application to donate Section 12(1) A person or institution who undertakes to make a donation of a designated product or pre-packaged complementary food product to a charitable children institution or social welfare institution under the Act or these Regulations shall make an application, in writing, to the Committee for approval. Section 12(2) An application made under subregulation (1), shall be accompanied by a duly completed Form BMS 1 in the Schedule to these Regulations.

Section 13. Restrictions to donations Section 13(1) A person making a donation under the Act or these Regulations shall not advertise or publicize the making of such donation. Section 13(2) The product being donated under subregulation (1), shall meet all the requirements of both the Kenyan and applicable international standard as prescribed in law and have at least fifty percent (50%) shelf life before expiry. Section 13(3) The product being donated under subregulation (1), shall be in the original container with a clear label marked "Not for Sale". Section 13(4) Donations of designated or pre-packaged complementary food products to charitable children institutions or social welfare institution, made under the Act and these Regulations shall be for the purpose for which they were donated. Section 13(5) Without prejudice to the generality of subregulation (3), donations made to a charitable children institution or social welfare institution shall be used within the institution to which they are donated and shall not be distributed outside that institution unless further donated to another charitable children or social welfare institution with prior written consent of the Committee.

Section 14. Filing of returns Section 14(1) A person or institution making a donation under the Act and these Regulations shall within two weeks of making such donations, file returns with the Committee and the Director of Children Services, in Form BMS 2 in the Schedule to these Regulations. Section 14(2) A donee upon receipt of the donations under the Act and these Regulations, shall within two weeks, file returns for use to the Committee in Form BMS 3 in the Schedule to these Regulations. Section 14(3) A donee shall upon utilization of the donations under subregulation (1), file returns with the Committee in Form BMS 4 in Schedule to these Regulations indicating details of the number of children benefiting from the donations and the health outcomes of those recipients.

Section 15. Application by charitable and social institutions Section A person of institution that wishes to apply for donation of a designated product or a pre-packaged complementary food product shall apply in writing to the committee for directions.

Section 16. Use of donations Section 16(1) Donations of a designated product or a pre-packaged complementary food product shall be used only for purposes of benefiting infant and young children to optimal health outcomes of all recipients. Section 16(2) No person shall, for the purpose of donating any designated product or a pre-packaged complementary food product, without the written approval of the Committee, directly donate or give to any person, institution or health facility any designated product or a pre-packaged complementary food product thereof.

Section 17. Labelling of designated products and pre-packaged complementary food product Section 17(1) The label of a designated product or complementary food product, shall in addition to the provisions of the relevant written legislation or Kenya standard, contain the name, physical address, website address, email address and telephone number of the manufacturer, seller and, if imported to Kenya, contact information of the responsible importer. Section 17(2) Not withstanding subregulation (1), the label of a designated product or pre-packaged complementary food shall not refer to, promote or advertise any other designated product.

Section 18. Prohibitions on labelling Section A label or a container of a designated product or a pre-packaged complementary food shall not contain a photograph, drawing or other graphic representation other than for illustrating how the product is to be used.

Section 19. Labelling of infant formula and follow-up formula Section 19(1) A person shall not offer for sale or sell infant formula and follow-up formula unless the container and the label affixed thereto, contains the following words expressed in English or Kiswahili language in bold and conspicuous characters in a prominent position and in not less than fifty percent (50%) of the size of the largest words on the label in red lettering on white background and not less than 3 mm in height based on the lower case "o" preceded by the word "WARNING" in capital letters: "Breast milk is best. Breast milk is ideal for the healthy growth and development of infants and young children. It protects against potentially fatal diarrhea, lung infections and other illness. It is often difficult to resume breastfeeding after beginning to feed your baby breast milk substitutes." Section 19(2)(a) not include words such as "maternalised" or "humanised" or images, symbols or words that glorify or otherwise imply that feeding infants breast milk substitutes is natural or promotes cognitive, growth or other developmental goals; Section 19(2)(b) not contain any text, graphics or pictures that may tend t...

Section 20. Containers of designated pre-packaged complementary food Section instructions for appropriate preparation and use;

Section 21. Labelling of formula in powdered form Section powdered formula may be contaminated during the manufacturing process or may become contaminated during preparation;

Section 22. Labelling requirements for feeding bottles Section A label, package or a container of a feeding bottle and the bottle itself shall indicate in a clear, conspicuous and easily readable manner in English or Kiswahili language the following words in not less than 50% of the size of the largest words on the label not less than 3 mm in height based on the lower case "o" preceded by the word "WARNING" in capital letters: "Breastfeeding is best. Breastfeeding is ideal for the healthy growth and development of infants and young children. It protects against potentially fatal diarrhea, lung infections, and other illness".

Section 23. Labelling requirements for teats Section 23(1)(a) show any graphic representation other than for illustrating cleaning, the logo of manufacturer or distributer; Section 23(1)(b) contain words or images idealizing the use of teats; and Section 23(1)(c) compare the act of suckling the teat to the action, motion or benefits of suckling human breast or physical properties of such human breast. Section 23(2) A label, package or a container of a pacifier and the surface of the pacifier itself shall indicate in a clear, conspicuous and easily readable manner in English or Kiswahili language the following words in not less than 50% of the size of the largest words on the label not less than 3 mm in height preceded by the word "WARNING" in capital letters: "Use of teats can interfere with breastfeeding."

Section 24. Labelling requirements for pacifiers Section 24(1)(a) show any graphic representation other than for illustrating cleaning, the logo of manufacturer or distributer; Section 24(1)(b) contain words or images idealizing the use of teats; Section 24(1)(c) compare the act of suckling the teat to the action, motion or benefits of suckling human breast or physical properties of such human breast. Section 24(2) A label, package or a container of a pacifier and the surface of the pacifier itself shall indicate in a clear, conspicuous and easily readable manner in English or Kiswahili language the following words in not less than 50% of the size of the largest words on the label not less than 3 mm based in height based on the lower case "o" in red lettering on white background preceded by the word "WARNING" in capital letter: "Use of pacifier can interfere with breastfeeding".

Section 25. Particulars to be inscribed on container Section 25(1)(a) ingredients; Section 25(1)(a)(i) ingredients; Section 25(1)(a)(ii) required storage condition; Section 25(1)(a)(iii) date of manufacture; Section 25(1)(a)(iv) batch number; and Section 25(1)(a)(v) expiry date. Section 25(1)(b) on a label marked on or securely attached to the container the following statement in red bold text against a white background; Section 25(2) Any label affixed to any container of a designated product or a pre-packaged complementary food product as required under subregulation (1), shall bear directions for use in English or Kiswahili language and such adequate warnings against the health hazards of inappropriate preparation or use. Section 25(3)(a) be clearly legible and shall appear conspicuously and in a permanent position on the label; Section 25(3)(b) specify the name of either the manufacturer, distributor, packer or labeler of the breast milk substitute or infant formula; and Section 25(3)(c) bear a physical address, website address, telephone number, and email address at which such person carries on business which shall be clearly shown in all notices, advertisements and other publi...

Section 26. Interactions Section 26(1)(a) to creating awareness about scientific and factual matters on designated products and pre-packaged complementary food; Section 26(1)(b) to providing samples of designated products and pre-packaged complementary food for professional evaluation; and Section 26(1)(c) to providing samples of designated products and complementary foods for research on the product. Section 26(2) The interactions between a manufacturer or distributor with any health worker referred to under subregulation (1), shall take place in a public venue approved by the Committee pursuant to a decision-making process consistent with the Fair Administrative Action Act (Cap. 7L).

Section 27. Creating awareness Section 27(1) Subject to section 6(3) of the Act, a manufacturer or distributor who wishes to create awareness about the scientific and factual matters of the breast milk substitute or complementary food product, shall before commencing interactions with any health worker apply in writing to the Committee for approval. Section 27(1A) The Committee shall, upon receiving an application under this regulation, consider the application and respond to the applicant within fourteen days from the day of making the decision. Section 27(2)(a) a sworn statement that the interaction does not imply an endorsement of the designated product or pre-packaged complementary food; Section 27(2)(b) a sworn statement that there is no existing relationship, collaboration or partnership or intended relationship, collaboration or partnership with the health worker; Section 27(2)(c) particulars of the health workers targeted for awareness; Section 27(2)(d) proposed public venue; Section 27(2)(e) sample of the designated product or pre-packaged complementary food to be used during the interaction; Section 27(2)(f) a certificate of analysis from a public analyst in Kenya; Sectio...

Section 28. Professional evaluation Section 28(1) Any interactions between a manufacturer or distributor and a health worker for the purposes of professional evaluation of a designated product or pre-packaged complementary food shall commence only after approval by the Committee. Section 28(2)(a) before commencing the interaction, seek written approval from the Committee; and Section 28(2)(b) state in writing that the interaction does not imply an endorsement of the designated product or pre-packaged complementary food and that there is no existing relationship, collaboration or partnership or intended relationship, collaboration or partnership with the manufacturer or distributor. Section 28(3)(a) an approved research protocol; Section 28(3)(b) an ethics approval from a competent and recognised authority responsible for research and innovation in Kenya issued pursuant to the Science, Technology and Innovation Act (Cap. 511); Section 28(3)(c) a certificate of analysis; Section 28(3)(d) proof of use in country of origin if the product is not made in Kenya; Section 28(3)(e) ethics approval from a competent authority if the product is originating outside of Kenya; and Section 28(3)(f)...

Section 29. Formal record Section Any health worker who wishes to participate in any interaction with a manufacturer or distributor, for the purposes of professional evaluation, or research on a designated product or pre-packaged complementary food, shall prepare a formal record of the interaction and submit it to the Committee, within thirty days following the interaction.

Section 30. Restrictions to interactions Section distribute any promotional material or items;

Section 31. Cross-promotion Section A manufacturer or distributor of a designated product or a pre-packaged complementary food shall not engage in cross-promotion.

Section 32. Advertisement Section written publication, television or radio broadcast, film or electronic transmission, including the Internet, video or telephone;

Section 33. Demonstration for use of a pre-packaged complementary food product Section the benefits and superiority of breastfeeding;

Section 34. Procedure for demonstration for use of infant and follow-up formula Section 34(1)(a) be in the original container of manufacture; Section 34(1)(b) maintain hygiene; Section 34(1)(c) follow the manufacturer's instruction for preparation; Section 34(1)(d) issue the supplies in a plain packaging that conceals the brand name; Section 34(1)(e) declare whether the health facility is baby friendly; and Section 34(1)(f) make available the most recent document on demonstrations and their source. Section 34(2)(a) the benefits and superiority of breastfeeding; Section 34(2)(b) how to initiate and sustain breastfeeding; Section 34(2)(c) the importance of periodic HIV/AIDS testing of parents, adherence to maternal Anti-Retroviral treatment and infant prophylaxis, early infant diagnosis, continued Anti-Retroviral treatment, and continued breastfeeding by mothers who are infected with HIV/AIDS; Section 34(2)(d) the value of exclusive breastfeeding for the first six month of life and continued breastfeeding with introduction of nutritionally adequate and safe complementary foods for up to 2 years or beyond; Section 34(2)(e) the importance of optimal maternal nutrition; Section 34(2)(f)...

Section 35. Procedure for demonstrating proper complementary feeding Section 35(1)(a) shall conceal brand name of the product; Section 35(1)(b) shall maintain hygiene; and Section 35(1)(c) follow the manufacturer's instruction for preparation. Section 35(2)(a) the value of exclusive breastfeeding for the first six months of life and continued breastfeeding with introduction of nutritionally adequate and safe complementary foods for up to two years or beyond; Section 35(2)(b) the importance of optimal maternal nutrition; Section 35(2)(c) the negative effects of artificial feeding on lactation and how mixed feeding interferes with breastfeeding; Section 35(2)(d) instructions on proper preparation and use of the product that emphasize home-prepared, use of locally available foods, suitability of the foods, nutrient-density, safe preparation, and safe feeding.

Section 36. Publication of information, education and communication materials Section 36(1) Notwithstanding any other provision of these Regulations, no person shall publish or cause or permit to be published or distributed any informational or educational or communication material that relates to infant and young children feeding unless approved by the Committee. Section 36(2) For the purposes of approval under subregulation (1), a person shall submit an application letter, together with a sample of the proposed material to be published or distributed containing any informational or educational or communication material that relates to infant and young children feeding. Section 36(3) The Committee shall respond, in writing, to the application made under subregulation (1) within twenty-one days of the receipt of the application, and may approve upon satisfaction that the information, education and communication materials comply with the provisions of regulation 37 of these Regulations.

Section 37. Contents of information, education and communication materials Section be written in easily readable and understandable English or Kiswahili;

Section 38. Authorised persons Section An authorised officer may, in addition to the provisions of section 11 of the Act, include a health worker, custom officer, police officer or officers from the body responsible for Standards.

Section 39. Access to breast milk substitutes Section A manufacturer or distributor, upon request, shall produce any prescribed designated product or pre-packaged complementary food to an authorised officer.

Section 40. Seizures Section 40(1)(a) prohibited goods; or Section 40(1)(b) not being sold by an authorised manufacturer, wholesaler, distributor or retailer of goods, Section 40(2) Seizure of goods under these Regulations and Act by an authorized officer shall be in accordance to Form A and B provided for in the Schedule to these Regulations.

Section 41. Conflict of interest Section 41(1) A health worker who has any pecuniary or business interest, in any designated product or pre-packaged complementary food shall disclose the nature of the interest to the Committee, on commencement of employment and as soon as the relevant facts have come to his or her knowledge. Section 41(2) A disclosure of interest under subregulation (1), shall be recorded by the Committee. Section 41(3) A health worker having made such a disclosure shall not be present during any interactions under the Act.

Section 42. General penalty Section A person who contravenes any of the provisions of these Regulations, shall be liable on to conviction, in accordance to the Act.

Section 43. Spot fines Section A person who without lawful excuse the proof of which shall lie with him or her breaches any of these Regulations shall be liable, upon an inspection, by an inspector who attests to an honest belief and the balance of probability that such breach has been committed of an administrative monetary penalty of no more than 20,000 Kenya Shillings.

Section 44. Subsequent offences Section If a person is found to breach any provisions of these Regulations two or more times, the Cabinet Secretary responsible for public health may issue an order for a penalty to be issued in relation to each violation of the Regulations in respect of each unit sold in the case of labelling or distribution offenses or each person estimated to have been reached by advertising or promotional campaigns.

Section 45. Review Section The Cabinet Secretary may from time to time review these Regulations for the better implementation of the Act.