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

Names the instrument as the Breast Milk Substitutes (General) Regulations and states they come into force on 30th May 2022.

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Jurisdiction: Kenya
Instrument: Notice
Citation: Legal Notice 184 of 2021
Version: Undated source snapshot
Language: en

Source attribution: Source: Kenya Law

Statute overview

About this statute

Names the instrument as the Breast Milk Substitutes (General) Regulations and states they come into force on 30th May 2022. Provides definitions for terms used in the Regulations, e.g. "Act", "cross-promotion", "donation", "donee", "donor", standards abbreviations, "public analyst" and "public venue". Guiding principles: protect the best interest of infants and young children; initiate breastfeeding within an hour of delivery and exclusively breastfeed for the first six months; introduce appropriate complementary foods with continued breastfeeding for twenty-four months or beyond; ensure breastmilk substitutes and pre-packaged complementary food are safe where appropriate; make adequate and accurate information on breastfeeding and infant and young child feeding available to the public; and conduct interaction with manufacturers and distributors in the manner prescribed under the Act and these Regulations. The objects of the Regulations are to guide all persons who use, manufacture, sell and market breast milk substitutes and to ensure that all persons understand that breast milk substitutes undermine breastfeeding and that suboptimal breastfeeding is a leading but preventable cause of death and serious illness in infants and young children. Anyone who stocks, distributes, sells or exhibits a designated product or pre-packaged complementary food in an alternative container must hermetically seal and label the alternative container in accordance with the Act and any other written law.

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

Showing 45 of 45

Part I

PRELIMINARY

1
PRELIMINARY - 1. Citation

AI-assisted research summary: Names the instrument as the Breast Milk Substitutes (General) Regulations and states they come into force on 30th May 2022.

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.]
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PRELIMINARY - 2. Interpretation

AI-assisted research summary: Provides definitions for terms used in the Regulations, e.g. "Act", "cross-promotion", "donation", "donee", "donor", standards abbreviations, "public analyst" and "public venue".

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 being, the public or any section of the public are entitled or permitted to have access whether on payment or otherwise, and in relation to any meeting to be held in future, includes any venue which will, on the occasion and for the purpose of such a meeting, be a public venue. [L.N. 80/2022, r. 3.]
3
PRELIMINARY - 3. Guiding principles

AI-assisted research summary: Guiding principles: protect the best interest of infants and young children; initiate breastfeeding within an hour of delivery and exclusively breastfeed for the first six months; introduce appropriate complementary foods with continued breastfeeding for twenty-four months or beyond; ensure breastmilk substitutes and pre-packaged complementary food are safe where appropriate; make adequate and accurate information on breastfeeding and infant and young child feeding available to the public; and conduct interaction with manufacturers and distributors in the manner prescribed under the Act and these Regulations.

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 prescribed under the Act and these Regulations.
4
PRELIMINARY - 4. Objects

AI-assisted research summary: The objects of the Regulations are to guide all persons who use, manufacture, sell and market breast milk substitutes and to ensure that all persons understand that breast milk substitutes undermine breastfeeding and that suboptimal breastfeeding is a leading but preventable cause of death and serious illness in infants and young children.

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.

Part II

PROCEDURES RELATING TO THE USE OF DESIGNATED PRODUCTS AND PRE-PACKAGED COMPLEMENTARY FOOD

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PROCEDURES RELATING TO THE USE OF DESIGNATED PRODUCTS AND PRE-PACKAGED COMPLEMENTARY FOOD - 10. Use of alternative containers from the original

AI-assisted research summary: Anyone who stocks, distributes, sells or exhibits a designated product or pre-packaged complementary food in an alternative container must hermetically seal and label the alternative container in accordance with the Act and any other written law.

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.
11
PROCEDURES RELATING TO THE USE OF DESIGNATED PRODUCTS AND PRE-PACKAGED COMPLEMENTARY FOOD - 11. Certificate of analysis

AI-assisted research summary: An authorised officer may collect and submit samples of designated or pre-packaged complementary food products for analysis; the public analyst must issue a certificate of analysis upon analysing the product.

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.
5
PROCEDURES RELATING TO THE USE OF DESIGNATED PRODUCTS AND PRE-PACKAGED COMPLEMENTARY FOOD - 5. Production and packaging of designated and complementary food products

AI-assisted research summary: Section 5. Production and packaging of designated and complementary food products

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
6
PROCEDURES RELATING TO THE USE OF DESIGNATED PRODUCTS AND PRE-PACKAGED COMPLEMENTARY FOOD - 6. Registration

AI-assisted research summary: Manufacturers or importers of designated products must register with the Ministry office in charge of nutrition and dietetics and provide contact details and a declaration; they must update that information within 30 days of changes.

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.
7
PROCEDURES RELATING TO THE USE OF DESIGNATED PRODUCTS AND PRE-PACKAGED COMPLEMENTARY FOOD - 7. Sampling and testing

AI-assisted research summary: Sampling and testing of the designated products and pre-packaged complementary food must be in accordance with the Act, the Food, Drugs and Chemical Substances Act (Cap. 254), the Public Health Act (Cap. 242), the Standards Act (Cap. 496) and any other written law.

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.
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PROCEDURES RELATING TO THE USE OF DESIGNATED PRODUCTS AND PRE-PACKAGED COMPLEMENTARY FOOD - 8. Complying with Regulations

AI-assisted research summary: Manufacturers, traders, importers and distributors must not import, offer for sale, or sell designated products or pre-packaged complementary food that do not comply with these Regulations, the Act or any other relevant 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.
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PROCEDURES RELATING TO THE USE OF DESIGNATED PRODUCTS AND PRE-PACKAGED COMPLEMENTARY FOOD - 9. Manufacturing, sell and expiry date

AI-assisted research summary: No person must not stock, distribute, sell or exhibit any infant and young child food that lacks a manufacturing date and an expiry date.

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.

Part III

DONATIONS OF DESIGNATED PRODUCTS AND PRE-PACKAGED COMPLEMENTARY FOOD

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DONATIONS OF DESIGNATED PRODUCTS AND PRE-PACKAGED COMPLEMENTARY FOOD - 12. Application to donate

AI-assisted research summary: People or institutions intending to donate designated products or pre-packaged complementary food to charitable children's or social welfare institutions must apply in writing to the Committee for approval.

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.
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DONATIONS OF DESIGNATED PRODUCTS AND PRE-PACKAGED COMPLEMENTARY FOOD - 13. Restrictions to donations

AI-assisted research summary: Donations of designated or pre-packaged complementary food products must meet standards, have at least 50% shelf life, be labelled "Not for Sale", not be publicised, be used for their donated purpose within recipient institutions, and not be distributed outside those institutions except with the Committee's prior written consent.

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.
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DONATIONS OF DESIGNATED PRODUCTS AND PRE-PACKAGED COMPLEMENTARY FOOD - 14. Filing of returns

AI-assisted research summary: Donors and donees must file specified returns (Forms BMS 2, BMS 3, BMS 4) with the Committee (and Director of Children Services for donors) within two weeks or upon utilisation, and donee returns must report numbers of children benefiting and health outcomes.

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.
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DONATIONS OF DESIGNATED PRODUCTS AND PRE-PACKAGED COMPLEMENTARY FOOD - 15. Application by charitable and social institutions

AI-assisted research summary: A person or institution wishing to apply for a donation of a designated product or a pre‑packaged complementary food must apply in writing to the committee for directions.

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.
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DONATIONS OF DESIGNATED PRODUCTS AND PRE-PACKAGED COMPLEMENTARY FOOD - 16. Use of donations

AI-assisted research summary: Donations of designated products and pre-packaged complementary foods must be used only to benefit infants and young children; and no person may donate such products without the Committee's written approval by directly giving them to any person, institution or health facility.

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.

Part IV

LABELLING OF DESIGNATED PRODUCTS AND PRE-PACKAGED COMPLEMENTARY FOOD

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LABELLING OF DESIGNATED PRODUCTS AND PRE-PACKAGED COMPLEMENTARY FOOD - 17. Labelling of designated products and pre-packaged complementary food product

AI-assisted research summary: Labels must include the name, physical address, website address, email address and telephone number of the manufacturer and seller; if imported, include contact information of the responsible importer.

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.
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LABELLING OF DESIGNATED PRODUCTS AND PRE-PACKAGED COMPLEMENTARY FOOD - 18. Prohibitions on labelling

AI-assisted research summary: Labels or containers of designated products or pre-packaged complementary foods must not contain photographs, drawings or other graphic representations except to show how the product is used.

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.
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LABELLING OF DESIGNATED PRODUCTS AND PRE-PACKAGED COMPLEMENTARY FOOD - 19. Labelling of infant formula and follow-up formula

AI-assisted research summary: A person must not offer for sale or sell infant formula and follow-up formula except where the container and label display a specified WARNING statement in English or Kiswahili with particular formatting requirements.

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 to discourage breastfeeding; Section 19(2)(c) specify the source of protein; and Section 19(2)(d) in case of follow up formula, state that the product shall not be used for infants who are less than six months old.
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LABELLING OF DESIGNATED PRODUCTS AND PRE-PACKAGED COMPLEMENTARY FOOD - 20. Containers of designated pre-packaged complementary food

AI-assisted research summary: Containers of designated pre-packaged complementary food: Section instructions for appropriate preparation and use

Section 20. Containers of designated pre-packaged complementary food Section instructions for appropriate preparation and use;
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LABELLING OF DESIGNATED PRODUCTS AND PRE-PACKAGED COMPLEMENTARY FOOD - 21. Labelling of formula in powdered form

AI-assisted research summary: Powdered formula may be contaminated during manufacturing or during preparation.

Section 21. Labelling of formula in powdered form Section powdered formula may be contaminated during the manufacturing process or may become contaminated during preparation;
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LABELLING OF DESIGNATED PRODUCTS AND PRE-PACKAGED COMPLEMENTARY FOOD - 22. Labelling requirements for feeding bottles

AI-assisted research summary: Labels, packages or containers of feeding bottles and the bottle itself must display the specified WARNING message in English or Kiswahili, with the warning word in capital letters and the text at least 50% of the size of the largest words on the label and not less than 3 mm in height based on the lower case "o".

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".
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LABELLING OF DESIGNATED PRODUCTS AND PRE-PACKAGED COMPLEMENTARY FOOD - 23. Labelling requirements for teats

AI-assisted research summary: Labels, packages or containers of pacifiers and the surface of the pacifier itself must display a WARNING and the words "Use of teats can interfere with breastfeeding." in English or Kiswahili, with specified size requirements.

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."
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LABELLING OF DESIGNATED PRODUCTS AND PRE-PACKAGED COMPLEMENTARY FOOD - 24. Labelling requirements for pacifiers

AI-assisted research summary: Section 24 sets labelling requirements for pacifiers, including prohibitions on certain graphics, words or images idealizing teats and comparisons to breastfeeding, and a mandated warning statement in English or Kiswahili with specified size and style.

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".
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LABELLING OF DESIGNATED PRODUCTS AND PRE-PACKAGED COMPLEMENTARY FOOD - 25. Particulars to be inscribed on container

AI-assisted research summary: Labels on containers of designated products and pre-packaged complementary foods must include specified particulars (ingredients, storage conditions, manufacture date, batch number, expiry date), bear directions for use in English or Kiswahili and adequate warnings, and have legible, conspicuous, permanent labeling that specifies a name and contact details for the manufacturer/distributor/packer/labeler.

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 publications used by such person in connection with his business as dealer in the designated product or a pre-packaged complementary food product.

Part V

INTERACTIONS BETWEEN MANUFACTURERS, DISTRIBUTORS AND HEALTH WORKERS

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INTERACTIONS BETWEEN MANUFACTURERS, DISTRIBUTORS AND HEALTH WORKERS - 26. Interactions

AI-assisted research summary: Manufacturers or distributors must hold interactions with health workers (referred to in subregulation (1)) in a public venue approved by the Committee under a decision-making process consistent with the Fair Administrative Action Act (Cap. 7L).

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).
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INTERACTIONS BETWEEN MANUFACTURERS, DISTRIBUTORS AND HEALTH WORKERS - 27. Creating awareness

AI-assisted research summary: Manufacturers or distributors must apply in writing to the Committee for approval before commencing interactions with any health worker; the application must include the documents listed in Section 27(2)(a)–(j); the Committee must respond within fourteen days; applicants must supply any additional information requested under (j) within 30 days.

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; Section 27(2)(g) a detailed report on scientific findings and evidence based research on the benefits of the product; Section 27(2)(h) a peer-reviewed scientific information of the product; Section 27(2)(i) proof that the designated product or pre-packaged complementary food to be used during the interaction meets the national and international standards; and Section 27(2)(j) any other relevant document requested by the Committee. Section 27(3) An applicant who is required to supply additional information under paragraph (j), shall do so within a period of 30 days from the date of the request. [L.N. 80/2022, r. 4.]
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INTERACTIONS BETWEEN MANUFACTURERS, DISTRIBUTORS AND HEALTH WORKERS - 28. Professional evaluation

AI-assisted research summary: Interactions between a manufacturer or distributor and a health worker for professional evaluation may only start after Committee approval; written approval and explicit written statements are required, and certain supporting documents must be provided.

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) any other document the Committee may require.
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INTERACTIONS BETWEEN MANUFACTURERS, DISTRIBUTORS AND HEALTH WORKERS - 29. Formal record

AI-assisted research summary: Health workers who take part in interactions with manufacturers or distributors for evaluation or research must prepare and submit a formal record to the Committee within thirty days.

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.
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INTERACTIONS BETWEEN MANUFACTURERS, DISTRIBUTORS AND HEALTH WORKERS - 30. Restrictions to interactions

AI-assisted research summary: Prohibits distribution of promotional material or items.

Section 30. Restrictions to interactions Section distribute any promotional material or items;
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INTERACTIONS BETWEEN MANUFACTURERS, DISTRIBUTORS AND HEALTH WORKERS - 31. Cross-promotion

AI-assisted research summary: Manufacturers or distributors of a designated product or a pre‑packaged complementary food must not engage in cross‑promotion.

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.
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INTERACTIONS BETWEEN MANUFACTURERS, DISTRIBUTORS AND HEALTH WORKERS - 32. Advertisement

AI-assisted research summary: Lists types of advertisement media: written publication; television or radio broadcast; film; or electronic transmission including the Internet, video or telephone.

Section 32. Advertisement Section written publication, television or radio broadcast, film or electronic transmission, including the Internet, video or telephone;
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INTERACTIONS BETWEEN MANUFACTURERS, DISTRIBUTORS AND HEALTH WORKERS - 33. Demonstration for use of a pre-packaged complementary food product

AI-assisted research summary: Allows demonstration for the use of a pre-packaged complementary food product and mentions the benefits and superiority of breastfeeding.

Section 33. Demonstration for use of a pre-packaged complementary food product Section the benefits and superiority of breastfeeding;
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INTERACTIONS BETWEEN MANUFACTURERS, DISTRIBUTORS AND HEALTH WORKERS - 34. Procedure for demonstration for use of infant and follow-up formula

AI-assisted research summary: Section 34 lists procedural requirements for demonstrations of use of infant and follow‑up formula (34(1)(a)–(f)) and specifies topics that must be covered during demonstrations (34(2)(a)–(n)).

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) the difficulty of returning to breastfeeding after a period of artificial feeding; Section 34(2)(g) the approximate financial cost of adequate feeding of an infant with breastmilk substitutes during the first six months of life; Section 34(2)(h) why it is difficult to return to breastfeeding after starting to feed babies on breastmilk substitutes; Section 34(2)(i) the importance of not introducing complementary foods until after six months of life; Section 34(2)(j) the negative effects of artificial feeding on lactation and how early introduction of complementary food interferes with breastfeeding; Section 34(2)(k) instructions on proper preparation and use of the product; Section 34(2)(l) the potential health hazards of feeding bottles and cups with spouts; Section 34(2)(m) the importance of feeding an infant with an open cup and spoon; and Section 34(2)(n) how to feed an infant with an open cup and spoon.
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INTERACTIONS BETWEEN MANUFACTURERS, DISTRIBUTORS AND HEALTH WORKERS - 35. Procedure for demonstrating proper complementary feeding

AI-assisted research summary: Requires concealment of product brand names, maintaining hygiene, following the manufacturer's preparation instructions, and provision of breastfeeding and nutrition information including exclusive breastfeeding for the first six months, continued breastfeeding with complementary foods up to two years or beyond, maternal nutrition, harms of artificial and mixed feeding, and instructions emphasizing home-prepared, locally available, nutrient-dense, safe preparation and feeding.

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.

Part VI

INFORMATION, EDUCATION AND COMMUNICATION MATERIALS

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INFORMATION, EDUCATION AND COMMUNICATION MATERIALS - 36. Publication of information, education and communication materials

AI-assisted research summary: Persons must not publish or distribute informational, educational or communication materials about infant and young child feeding unless the Committee approves them; persons must submit an application letter and sample for approval; the Committee must respond in writing within twenty-one days and may approve if satisfied under regulation 37.

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.
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INFORMATION, EDUCATION AND COMMUNICATION MATERIALS - 37. Contents of information, education and communication materials

AI-assisted research summary: Information, education and communication materials must be written in easily readable and understandable English or Kiswahili.

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

Part VII

ENFORCEMENT

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ENFORCEMENT - 38. Authorised persons

AI-assisted research summary: An authorised officer may include specified personnel such as a health worker, custom officer, police officer or officers from the body responsible for Standards.

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.
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ENFORCEMENT - 39. Access to breast milk substitutes

AI-assisted research summary: Manufacturers or distributors must, upon request, produce prescribed designated products or pre-packaged complementary food to an authorised officer.

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.
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ENFORCEMENT - 40. Seizures

AI-assisted research summary: Authorized officers must effect seizures of goods under these Regulations and the Act in accordance with Form A and B in the Schedule.

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.
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ENFORCEMENT - 41. Conflict of interest

AI-assisted research summary: Health workers must disclose any pecuniary or business interest in designated products or pre‑packaged complementary food to the Committee when starting employment and as soon as they learn the facts; the Committee must record such disclosures; a health worker who has disclosed must not be present during interactions under the Act.

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.
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ENFORCEMENT - 42. General penalty

AI-assisted research summary: A person who contravenes any of the provisions of these Regulations shall be liable on conviction in accordance to 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.
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ENFORCEMENT - 43. Spot fines

AI-assisted research summary: A person who breaches the Regulations may be fined up to 20,000 Kenya Shillings following inspection.

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.
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ENFORCEMENT - 44. Subsequent offences

AI-assisted research summary: If someone breaches these Regulations two or more times, the Cabinet Secretary responsible for public health may order a penalty for each violation, calculated per unit sold for labelling/distribution offences or per person reached by advertising/promotional campaigns.

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.
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ENFORCEMENT - 45. Review

AI-assisted research summary: The Cabinet Secretary may from time to time review these Regulations to better implement the Act.

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

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