The Dairy Industry (Dairy Produce Safety) Regulations

Legal Notice 22 of 2021

This is the latest version of this Legal Notice.
The Dairy Industry (Dairy Produce Safety) Regulations

LAWS OF KENYA

DAIRY INDUSTRY ACT

THE DAIRY INDUSTRY (DAIRY PRODUCE SAFETY) REGULATIONS

LEGAL NOTICE 22 OF 2021

  • Published in Kenya Gazette Vol. CXXIII—No. 51 on 12 March 2021
  • Commenced on 12 March 2021
  1. [Revised by 24th Annual Supplement (Legal Notice 221 of 2023) on 31 December 2022]

Part I – PRELIMINARY

1. Citation

These Regulations may be cited as the Dairy Industry (Dairy Produce Safety) Regulations.

2. Interpretation

In these Regulations, unless the context otherwise requires—"Act" means the Dairy Industry Act (Cap 336);"adulteration" means the addition or subtraction of any substance to or from dairy produce so that the natural composition and quality of dairy produce is negatively affected;"approved" means approved by the Board;"aseptic processing" means a process that is used to subject dairy product to a sufficient heat treatment process and packaged aseptically in a hermetically sealed container to maintain commercial sterility of the product under normal non-refrigerated conditions;"Board" means the Kenya Dairy Board;"bulk milk collection tanker" includes a truck and tank and its accessory equipment used to transport bulk raw or processed milk from a dairy farm, or a milk collection center, to a milk processing plant or retail milk shop;"Cabinet Secretary" means the Cabinet Secretary for the time being responsible for matters relating to the dairy industry;"carry" in relation to dairy produce includes—
(a)convey by hand or by any other means;
(b)drive or be in charge of any motorized or non-motorized vehicle, bicycle or animal on or in which there is dairy produce; and
(c)stock, store or in any other manner have or hold dairy produce on any premises or in any container,
"carrier" means a vehicle used to carry dairy produce"collection center" refers to a designated location or point at which milk is tested, aggregated or bulked for processing or further transfer;"container" means a device for holding milk during transportation;"cooling plant" means a facility established to bulk and cool milk;"cottage industry" means a small scale, decentralized dairy manufacturing business whose handling capacity does not exceed 500 kilograms of milk per day;"dairy produce" means any product in which milk is the main ingredient and has been prepared in accordance with the requirement of the relevant Standard;"designated laboratory" means a laboratory that is recognized by the Board to conduct chemical analysis of dairy produce;"dry milk and whey products" mean products intended for use in pasteurized or aseptically processed dairy produce and which have been manufactured in accordance with the provisions of the Act;"milk" means the normal, clean and fresh secretions, without any addition or subtraction, extracted from the udder of a healthy dairy animal and free from colostrum;"milk bar" means a dairy retail outlet where dairy produce is dispensed to a consumer for own consumption;"milk dispenser" means a vending machine approved by the Board for the purpose of dispensing dairy produce;"milk hawking" means selling of dairy produce by unregistered dairy business operator;"milk processing plant" means any place, premises or establishment where milk or dairy produce are collected, handled, stored, processed, packaged or prepared for distribution, and it includes the machinery for processing;"milk sampler" means a person who is authorized by the Board or any other relevant authority to sample dairy produce for testing;"milk transporter" means a person who transport dairy produce between a farm and a milk collection center, or between a milk processing plant, and a milk selling point;"milk transport tank" means a vehicle, including a truck and tank, used by a bulk milk transporter to transport bulk milk from a milk collection center, a dairy farm or farms, a processing plant to a retail milk shop, another milk collection center or a processing plant;"mini dairy" means a dairy processing business whose handling capacity exceeds 500 kilograms but does not exceed 10,000 kilograms per day;"official milk sampler" means a person who is employed by the Board or is authorized by the Board to collect samples of dairy produce for the purposes of these Regulations;"operator" means a person who has a permit from the Board to carry out relevant dairy activity;"pasteurization" means the process of heating every particle of milk or dairy produce in properly designed and correctly operated equipment in accordance with the relevant standard for pasteurized milk;"potable water" means water that is of a quality suitable for drinking and complies with the relevant standard for drinking water;"processor" refers to a person who handles and processes dairy produce in excess of 10,000 kilograms per day;"process" means to treat, prepare or manufacture dairy produce;"relevant Standard" means a standard relating to milk, milk produce or any other relevant standard developed pursuant to the provisions of the Standards Act (Cap. 496);"sanitize" means the application of any effective method or substance to properly clean surfaces for the destruction of pathogens, and other microorganisms as far as is practicable which method or substance shall not adversely affect the equipment, the milk or dairy produce, or the health of the consumers and which is approved by the Competent Authority;

3. Application

These Regulations apply in respect to dairy produce and the activities that affect the safety of dairy produce throughout the dairy value chain.

4. Objects of the Regulation

The objects of these Regulations are—
(a)to enhance compliance to safety standards of dairy produce
(b)to promote self-regulation in the dairy industry through adoption of global best practices.
(c)provide the mechanisms for the Board to oversight the dairy industry

Part II – SAFETY OF DAIRY PRODUCE

5. Conditions for Sale of dairy produce

(1)Primary producers may sell milk to his or her immediate neighbor provided that—
(a)the milk is obtained from a healthy animal and is, to the best of the knowledge of the seller, free from a disease, antibiotic residue, contaminant, adulterant or preservative and meets the relevant Standard for raw milk;
(b)the buyer collects the milk from where the milk is produced using a clean, hygienic food grade, container;
(c)the seller expressly communicates to the buyer that the milk is raw and the buyer commits to ensure that it is safe for domestic consumption.
(d)the milk shall not be resold;
(2)No persons shall engage in hawking of dairy produce except as provided for in this regulation.
(3)Paragraph 5(1) does not apply to sale of milk in urban centers and cities where urban centers and cities are as defined by the relevant legislation.
(4)A person who is involved in the processing of dairy produce shall ensure that—
(a)the dairy produce is sold in a container that meets the requirements set forth in these Regulations;
(b)the treatment process meets the requirements of the relevant Standard; and
(c)The dairy produce offered for sale meets the relevant standards and safety requirements.

6. Safety Practices

A person shall not trade in, sell or otherwise offer for sale any dairy produce which is not compliant with the relevant standard.

7. Conditions for sale of dairy produce

A person shall, for the purpose of destroying or deactivating microorganisms in dairy produce, only process or manipulate the produce through—
(a)pasteurization;
(b)aseptic processing;
(c)retort-sterilization, and
(d)refrigeration after pasteurization.
(e)or any other method approved by the standards

8. Requirement to impound, destroy and cancellation of permit

(1)Where, a compliance officer has reasonable ground for believing that a person produces or handles dairy produce in a way that is contrary to these Regulations, the compliance officer may impound and destroy or cause the dairy produce to be destroyed; and the compliance officer shall suspend the dairy regulatory permit;
(2)Where a regulatory permit has been suspended the Board shall notify the public in an appropriate manner.

9. Adulterated or misbranded milk

(1)A person shall not sell, attempt to sell, offer or expose for sale or have in possession with intent to provide, sell, offer or expose for sale any dairy produce which is adulterated or misbranded.
(2)For the purposes of this regulation misbranded milk means milk or dairy produce labeled with misleading information or information that is contrary to the provisions of these Regulations.

10. Offence for not meeting standards

Any person who fails to comply with any of the provisions of this Part shall be liable, on conviction, to a fine not exceeding ten thousand shillings or imprisonment for a period not exceeding twelve months, or both such fine and imprisonment.

Part III – LABELING OF DAIRY PRODUCE

11. Application

This Part applies to labeling and packaging of dairy produce in accordance with the relevant Standard.

12. Information on labeling to be clear

Information required to be shown on the label of dairy produce, container, truck or vehicle shall be in accordance to the standard.

13. Exception from labeling requirements

Regulation 10 shall not apply to a milk tank truck, milk can containing raw milk, a storage tank for raw or pasteurized milk, or a milk storage tank in a milk collection center.

14. Identification on containers to be by name or number

Every container for raw milk from individual dairy farms shall be identified by the name or number unique to each individual milk producer at the collection center or the processing plant.

15. Several plants operated by same company

Where a company operates more than one processing plant, only one common name shall be indicated on all its containers or packages in addition have a system capable of identifying where the produce was obtained or processed and packaged.

16. Contract processing

Where a person processes, purchases or distributes dairy produce at a different processing plant other than their own, the name and the address of the other corresponding plant shall be indicated on the label.

17. Duty of dairy business operator

A dairy business operator shall ensure that the labeling is done in accordance with the requirements of the relevant standard.

18. Offence to use misleading mark, words, etc.

(1)Any person who knowingly uses a misleading mark, word or endorsement on the label or superimposes any material to conceal the contents of the label commits an offence and shall be liable, on conviction to a fine not exceeding ten thousand shillings or imprisonment not exceeding three months, or both.
(2)The use of a trademark or a similar logo on a milk truck, van, tanker, bottle or other container or vehicle shall not constitute a misleading mark or word so long as the same is not used so as to obscure the required labeling.

Part IV – REQUIREMENTS FOR EXAMINING OF DAIRY PRODUCE

19. Examining, testing and disposal of dairy produce

The procedure for—
(a)collecting and handling samples;
(b)selecting and preparing apparatus and instrumental analytical equipment;
(c)media and reagents;
(d)analytical procedures;
(e)incubating;
(f)reading and recording;
(g)reporting,
shall be in accordance with the relevant standard.

20. Dairy Business Operator to sample dairy produce

(1)A dairy business operator shall examine, test and grade dairy produce before acceptance in accordance to the requirements of the relevant standard.
(2)A sample collected for the purpose of paragraph (1) shall be analyzed by the dairy business operator as a routine monitoring of its quality and safety.
(3)The quantity of the milk and the reason for the rejection shall be submitted to the Board not later than the 10th day of the succeeding month in Form A in the Schedule.
(4)In the case of a milk processing plant during any consecutive twelve months, for every batch of raw milk for processing, a sample shall be obtained by the processor and submitted to a laboratory for quality and safety analysis;
(5)Records of the tests done under regulation 4 shall be maintained and made accessible to the compliance officer when required.

21. Sampling for official control

A compliance officer, or a person duly authorized by the Board for that purpose, shall obtain representative samples of dairy produce in the presence of the dairy business operator at any point of the value chain at least quarterly or at any time prior to delivery of the dairy produce to the shop or consumer. Samples obtained shall be at the cost of dairy business operator while the collection and testing cost shall be met by the Board.

22. Collection of Samples

A sample of dairy produce from a retail shop, supermarket, grocery shop or any other place where dairy produce is sold shall be examined at least quarterly by a compliance officer or a person duly authorized by the Board for that purpose and the results of such testing shall be used to determine compliance with the relevant standard. Samples shall be obtained at the cost of the Board.

23. Recall and withdrawal of non-compliant dairy produce

(1)Where non-compliance is detected in dairy produce, the dairy business operator or the person responsible for the same shall take necessary action in accordance to the requirements of the Dairy Industry (Traceability and Recall) Regulations (sub. leg).
(2)Whenever the results of tested samples fail to meet the relevant standard, the producer or dairy business operator shall take immediate remedial action, which may include making a withdrawal, halting production, placing distribution on hold, produce recycling or initiating concessions.

24. Tests and test methods

The tests and test methods for assessing compliance by a dairy business operator shall be as per the relevant standards.

25. Breakdown during processing

Whenever a breakdown during the processing or packaging of dairy produce occurs, a likelihood of a public health risk shall be presumed and the dairy business operator shall take prompt appropriate action to avert the risk.

26. Offence to sell or offer for sale substandard dairy produce

(1)No person shall sell or offer for sale any dairy produce that does not meet the relevant standard.
(2)A person who contravenes any of the provisions of these regulations commits an offence and shall be liable on conviction to a fine not exceeding ten thousand shillings or to imprisonment for a term not exceeding twelve months or to both.

Part V – GENERAL REQUIREMENTS

27. General Requirements for Personnel

A person who is involved in collection, transportation, processing, and distribution or in any other way handles milk before it reaches the consumer shall comply with the requirements of the code of practice.

28. Qualifications of personnel

A dairy business operator shall ensure that any person handling dairy produce is qualified with relevant competencies which can be demonstrated to the satisfaction of the Board.

29. Sanitation requirements and installations

An operator of a milk collection center or dairy processing plant, shall, in addition to general hygiene and operational standards on the part of the personnel, install adequate sanitary facilities and accommodations which shall include—
(a)sufficient and suitable dressing rooms, toilet rooms and conveniently located;
(b)suitable sanitary conveniences with clean running water, soap, dispensable hand paper or towels provided and situated outside the toilet rooms or urinals and their use by the dairy staff shall be monitored;
(c)appropriate and well-designed foot baths;
(d)proper drainage from toilet rooms or urinals, where applicable;
(e)properly located facilities for cleansing and disinfecting utensils and other handheld equipment; and
(f)such other requirements as may be required or approved by the Board.

30. Water supply

(1)Premises used for dairy activities shall have adequate and clean potable water to facilitate hygienic practices.
(2)A dairy business operator shall—
(a)use clean water which is appropriate for drinking by animals, cleaning and sanitation of equipment and utensils, and for all relevant processes on the farm.
(b)where potable water is not available, ensure clean water through chlorination, sedimentation, filtration, or boiling.
(c)locate or construct the wells or boreholes such as to avoid the draining of surface water into the wells or boreholes.
(d)take precaution to ensure that dairy animals do not consume or have access to contaminated water.

31. Prohibition for Transportation on Public Service Vehicles

A person shall not transport dairy produce or cause dairy produce for sale to be transported in a passenger public service vehicle or in a vehicle whose design does not meet milk carriage requirements approved by the Board except for packaged dairy produce.

32. Prescribed container

(1)A person who handles dairy produce shall carry the dairy produce in a container as prescribed under the relevant standard.
(2)The container for transporting milk shall be—
(a)made of food grade materials or any other material that meets the relevant standard;
(b)designed so as to enable cleaning and sanitization
(c)designed and constructed to ensure drainage;
(d)properly covered during transportation;
(e)exclusively used to transport milk; and
(f)kept clean and free of contamination.

33. Prevention of Contamination of raw milk from engine and fuel emissions

A person in charge of a vehicle transporting milk shall—
(a)ensure that the engine is switched off while loading and offloading
(b)ensure that all doors and lids of the part containing milk or dairy produce are securely closed before the engine is started; and
(c)if the engine is allowed to run for unavoidable reasons, care shall be taken to control engine emissions to avoid milk contamination.

34. Requirement for loaders

(1)The person responsible for loading to, transporting or offloading milk or milk produce from, a carrier shall ensure that—
(a)loading and un-loading, wear clean protective clothing which covers the parts of the body which may come into contact with the milk;
(b)every person handling milk or dairy produce, washes their hands and other exposed parts of body with clean disinfectants and shall, during
(c)any loader or transporter of milk or dairy produce undergoes a routine medical examination at such intervals of time as may be determined by the dairy business operator and any loader found medically unfit during such examination shall not be allowed to handle milk during transportation or at all until certified otherwise by a qualified medical examiner;
(d)no person chews, smokes or eats any substance, food, or take any intoxicating drink or substance while handling milk or milk produce.
(2)In the case of milk carriers, no person is allowed to stay or travel in the compartment in which milk or dairy produce is kept or to put their personal belongings or any other things in the said compartment during milk transportation.

35. Inspection by Compliance officer

Any carrier or container may be inspected by a compliance officer at any time whenever the compliance officer considers it necessary to do so to assess compliance with these Regulations.

36. Prohibit transportation

Where a compliance officer finds that a milk carrier has not complied with the provisions of these Regulations or any other legislation, the compliance officer may in liaison with the relevant authorities, accompany the carrier to its destination, or issue such directions as he or she considers necessary or advisable to ensure compliance with the provisions of these regulations and any other written law.

37. Requirements for Dairy equipment, materials and additives

The dairy equipment, materials and additives that are used in the dairy industry shall meet the requirements of the relevant standard.

38. Offence and penalties

Any person, who violates or abates in the violation of the provisions of these regulations, commits an offence and is liable to a fine not exceeding ten thousand shillings or one-month imprisonment or to both.

Part VI – STORAGE AND DISTRIBUTION OF DAIRY PRODUCE

39. General Requirements

A primary producer or dairy business operator shall ensure that the premises where dairy produce is produced, handled, processed, stored and distributed or in which dairy produce containers, utensils, or equipment are stored, meets the requirement of the relevant standard.

40. Requirements for floor construction

The construction of the floor of a building of a room in which dairy produce is handled, packaged, or in which dairy produce containers, utensils, or equipment are stored, shall meet relevant standard.

41. Walls and ceilings: Construction

Walls and ceiling of rooms of a building in which dairy produce is handled, packaged, or stored; shall have—
(a)impervious walls which shall be at least one meter high from the floor;
(b)ceilings with a smooth, washable, light-colored surface of impervious materials; and
(c)walls, partitions and ceilings kept in good repair.

41A. Doors and windows

The doors and windows of a building used for storage of dairy produce shall have—
(a)all outer openings being fly and rodent-proofed to the extent necessary to prevent the entry of flies and rodents; and
(b)the sills sloping to prevent it from being used for storage of items.

42. Lighting and ventilation

(1)All rooms of a building used for storage of dairy produce in which dairy produce is handled, packaged, or stored, shall—
(a)allow for adequate lighting that is not colored;
(b)have sufficient ventilation;
(c)have bulbs for artificial lighting being shatter proof or suitably protected;
(d)have glass windows and other glass fittings being shatterproof; and
(e)where pressurized venting, or air conditioners are used, have a filtered air intake;
(2)Where milk plants that condense or dry milk or milk products or both are involved, ventilating systems in packaging rooms used shall be separate and where possible have the ducts installed in a vertical position.

43. Requirements for buildings used for storage of dairy produce and equipment

A building that is used for storing dairy produce shall have—
(a)distinct rooms for receiving dairy produce, packaging and storage of returned packaged dairy produce.
(b)have a toilet and other sanitary facilities located in a manner that does not lead to product contamination.
(c)have adequate running water supply that complies with relevant Standard.
(d)have adequate and conveniently located hand-washing facilities. Requirements for buildings used for storage of dairy produce and equipment
(e)be constructed in a manner to ensure that cleaned and sanitized containers and equipment are properly stored and handled to prevent product contamination.
(f)have provisions to handle and store dairy produce as required by the manufacturer specifications.

44. Vehicles

A vehicle used for distribution of dairy produce shall be constructed so as to ensure that the integrity and the quality of dairy produce is not compromised.

45. Offence under the regulation

Any person who contravenes any provisions of these regulations commits an offence and shall be liable, on conviction to a fine not exceeding ten thousand shillings or imprisonment for a term not exceeding three months or to both.

Part VII – DAIRY FARMS

46. Regulation of milk safety in dairy farms

A primary producer shall offer only good quality and safe milk for sale by ensuring that—
(a)feeds for dairy animals meet the requirements of the relevant standard.
(b)lactating animals which show evidence of production of milk with abnormalities in one or more quarters, which may include bloody, stringy, off-colored milk, or milk that is abnormal to sight or odour, shall be so handled and disposed of as to preclude the infection of other lactating animals and the contamination of milk utensils and the environment, which incident shall be immediately reported to the nearest veterinary surgeon or veterinary paraprofessional.
(c)an animal that produces milk with abnormalities shall be milked last or in separate equipment.
(d)an animal that produces contaminated milk or which may have been exposed to or treated with veterinary medicinal products, or chemical substances or are exposed to radioactive agents, which are capable of being secreted in the milk and which, in the judgment of the veterinary officer or veterinary paraprofessional, may be harmful to human health, shall be milked last or with separate equipment and the milk disposed of as the veterinary surgeon or veterinary paraprofessional may direct.
(e)Milking equipment used on animals with abnormalities in their milk shall be maintained clean to reduce the possibility of re-infecting or cross infection of the dairy animals.
(f)Equipment, utensils and containers used for the handling of milk with abnormalities are not be used for handling of milk to be offered for sale, unless they are first cleaned and effectively sanitized.

47. Milking shed design and construction

(1)A primary producer shall ensure that the milking shed is designed, sited or constructed in such a way as to minimize the risk of equipment, inputs, dairy produce and environmental contamination.
(2)Where applicable, a person operating a milking shed with milk storage rooms shall ensure that storage rooms have—
(a)impervious easily cleanable floors.
(b)adequate separation between milking areas and any premises where animals are housed.
(c)suitable milk cooling rooms or refrigeration facilities when appropriate.
(d)a sufficient supply of potable water for use in milking and in cleaning of equipment and instruments.
(e)be well ventilated. where possible, windows should be placed to provide cross ventilation.
(f)have adequate natural and or artificial light.
(g)be used for no other purpose than milk storage operations.
(h)no direct opening into milking shed or into a room used for domestic purposes, provided that a direct opening between the milk storage room and milking shade is permitted when a tight-fitting, self-closing solid door hinged to be single or double acting is provided; and
(i)be equipped with adequate facilities for cleaning and sanitizing milking equipment.

48. Toilet facilities

(1)A primary producer shall provide one or more toilets which shall be conveniently located; constructed, operated, and maintained in a sanitary manner.
(2)Human and animal waste shall be drained separately and shall comply with the relevant laws and regulations.

49. Dairy Waste management

A primary producer shall ensure that waste from the dairy farm does not pollute the soil surface or contaminate any water supply by ascertaining that—
(a)manure and other organic wastes are removed from the milking shade and milk storage rooms and disposed of in a sanitary and environmentally safe manner on land or by properly controlled composting and storage.
(b)wastewater or other effluents shall be disposed of in a drain or in such a manner as to avoid its accumulation in the milking area.
(c)Human and animal waste shall be drained separately and shall comply with the relevant laws and regulations.

50. Milking Yard

(1)A primary producer operating a dairy farm with a milking yard shall at all times ensure that—
(a)the yards are graded and drained and have no standing pools of water or accumulations of organic wastes.
(b)lactating animal-housing areas, lactating animal droppings and soiled bedding are removed, or clean bedding added, at sufficiently frequent intervals to prevent the soiling of the lactating animal's udder and flanks.
(c)waste feed shall not be allowed to accumulate.
(d)other animal species are kept out of the cow-yards.
(2)For the purposes of this regulation, "milking yard" means a structure, premises or facility in which a dairy animal is milked and housed, whether it is lactating or not.

51. Milking Equipment and Sanitation

A primary producer with milking equipment shall ensure that the equipment operate effectively and are maintained in a sanitary condition by observing the following sanitary practices—
(a)Milking equipment shall be installed and tested in accordance with manufacturer specifications;
(b)Machine milking installations, when used, shall undergo periodic inspections and maintenance to ensure it is in good working order;
(c)Equipment and instruments or their surfaces which are intended to come into contact with milk shall be easy to clean and disinfect, corrosion resistant and not capable of transferring substances to the milk in such quantities as to present a health risk to humans;
(d)Milking equipment shall be cleaned and disinfected using specified cleaning agents after each milking.

52. Milk handling and storage equipment

A primary producer shall ensure that the milk handling and storage equipment are recommended for milk handling and storage, including tanks and cans.

53. Hygienic milking methods

A primary producer shall ensure that the milking methods permit the efficient withdrawal of milk without contaminating the milk or causing injury to the udder.

54. Offence under regulation

Any primary producer who fails to comply with any of the requirements of these Regulations commits an offence and is liable, on conviction to a fine not exceeding ten thousand shillings or imprisonment for a term not exceeding one month or to both such fine and imprisonment.

Part VIII – MILK COLLECTION CENTERS

55. Design, location and construction of milk collection centers

A dairy business operator responsible for a milk collection center shall ensure that the facility is designed, located and constructed in a manner that will not contaminate the milk and the environment and shall meet the following requirements—
(a)the premises of the collection centers shall be of sufficient area to carry out work under sanitary/hygienic conditions;
(b)structure and design shall be able to allow for layout of equipment in such a way that does not impede milk and personnel flow;
(c)material used in construction shall be non-toxic to human life;
(d)the walls inside shall be smooth and cleanable;
(e)the design of floor shall be in such a way that it allows for liquid flow towards the waste drainage;
(f)the floor shall be made of water proof material that's resistant to chemical actions;
(g)drainage shall be adequate and sufficient to drain away waste water/liquids;
(h)a collection point shall have some shade to protect the milk cans from direct sunlight;
(i)the shade shall be constructed with materials that do not contaminate milk;
(j)the shade shall have raised platforms for holding milk cans to avoid contamination from dust, soil or mud;
(k)there shall be adequate bright light either of natural or artificial source; or
(l)there shall be adequate ventilation to provide sufficient air circulation.
(m)equipment and containers coming in contact with milk shall be designed and constructed to ensure that they can be adequately cleaned, sanitized and maintained to avoid contamination;
(n)all equipment surfaces that come into contact with milk shall be non-toxic, inert to milk, non-absorbent and not affected by cleaning chemicals; and
(o)equipment shall be kept in appropriate state of repair and condition to facilitate cleaning and sanitation so as to prevent possible contamination of milk.
(p)milk storage tanks is designed and constructed as to avoid any contamination of the milk and to ensure complete drainage;
(q)surfaces of milk storage tanks and associated equipment intended to come in contact with milk is easy to clean and disinfect, corrosion resistant and not capable of transferring substances to the milk in such quantities as to present a health risk to humans;
(r)adequate and appropriate means of managing waste that do not pose a risk of contamination of the milk;
(s)adequate drainage system to drain off effluent; and
(t)toilets or pit latrines with self-closing doors away from the milking collection areas and do not communicate directly into the milking collection or milk storage areas.

56. Requirement for potable water

A dairy business operator who is responsible for a milk collection center shall maintain sanitary requirements by ensuring that—
(a)adequate and potable water to facilitate cleaning and sanitation of equipment and utensils is available; or
(b)where potable water is unavailable, treatment of water shall conform to Standard for drinking water.

57. Prevention of milk contamination

An operator of a milk collection center shall ensure that—
(a)the center is designed and operated in such a manner that minimizes or prevents the contamination of milk;
(b)basic quality tests such as organoleptic to isolate obvious poor-quality milk are carried out;
(c)at the collection point, milk received is accurately weighed and recorded before bulking, where applicable.
(d)milk is checked for quality before it is received as prescribed by the relevant standards;
(e)milk with any non-conformity is not received and is disposed of in accordance with the appropriate environmental regulation;
(f)milk is collected under hygienic conditions;
(g)a milk storage tank is cleaned and sanitized using appropriate cleaning agents after each emptying and remain fully drained between uses;
(h)a milk storage tank is used to store milk only;
(i)the milk is weighed and the quantity, source and quality parameters are recorded.

58. Offence and Penalty

Any dairy business operator who contravenes any of the provisions of the requirements in this Part commits an offence and is liable on conviction to a fine not exceeding five thousand shillings or to an imprisonment not exceeding one month or both such fine and imprisonment.

Part IX – MILK BARS

59. Design, Location and construction of a milk bar

An operator of a milk bar shall ensure that the milk bar is located, designed and constructed in a manner that meets the relevant standard, including ensuring that—
(a)floors of all rooms in which milk or dairy produce are handled, converted, packaged, or stored, or in which milk containers, utensils, and or equipment are washed, is constructed of good quality concrete or equally impervious tile or brick laid closely with impervious joint material, or metal surfacing with impervious joints, or other material which is the equivalent of good quality concrete;
(b)floors of storage rooms for dry ingredients and or packaging material constructed of impervious and easy to clean material; and
(c)a floor surface which is smooth and sloped and the joints between the floor and the walls are impervious;
(d)tiled walls or any other impervious easy to clean material to a height of not less than one meter and smooth ceilings which are washable, white-colored and made of impervious materials;
(e)walls, partitions and ceilings kept in good repair;
(f)doors and windows of the milk bars with all outer openings that are fly and rodent-proofed;
(g)adequate lighting and ventilation free of odours.
(h)the premises have separate rooms or areas for handling of dairy produce, cleaning and sanitizing of dairy produce equipment; and receiving, handling and storage of returned dairy produce.
(i)the premises in which the milk bar is located have convenient hand-washing facilities kept in clean condition and in good repair.

60. Milk Storage tanks, containers and utensils

A milk bar operator shall ensure that the equipment, utensils, milk storage tanks and containers meet the following requirements—
(a)milk storage tanks and containers shall be used to store dairy produce only.
(b)are made of food grade material which is easy to clean and disinfect, corrosion resistant and not capable of transferring harmful substances to the dairy produce.

61. Milk bars to sell safe dairy produce

(1)A dairy milk bar shall—
(a)only selling pasteurized dairy produce;
(b)keep records of processed milk suppliers at all times including quality certificates; and
(c)dispense dairy produce hygienically from a labelled, tamper proof, food grade and easy to clean equipment;
(d)ensure that the equipment and utensils used in handling and storage of dairy produce in milk are made of food grade material which easy to clean and disinfect, corrosion resistant and not capable of transferring harmful substances to the dairy produce.
(2)Dairy produce in milk bars shall be protected from chemical contamination by ensuring that—
(a)the storage, handling and use of poisonous or toxic materials is performed to preclude the contamination of dairy produce, or ingredients of such dairy produce, or the product-contact surfaces of all containers, utensils and equipment;
(b)only insecticides and rodenticides approved by the competent authority shall be used for insect and rodent control. Such insecticides and rodenticides are used only in accordance with the manufacturer's label directions and is prevented from contaminating dairy produce, containers, utensils and equipment.
(c)all insecticides and rodenticides are stored in a lockable poison's cabinet.
(3)The storage of single-service bottle caps, packaging paper, containers, bags and other single-service articles for use in contact with dairy produce shall be—
(a)stored in sanitary wrappings or cartons;
(b)kept in a clean dry place until used, and shall be handled in a sanitary manner.

62. Sanitary facilities

A milk bar shall ensure that the premises in which the milk bar is located—
(a)do not open directly into a room in which milk or dairy produce is handled, converted and stored;
(b)are kept in a clean and in good repair condition, well ventilated and lit;
(c)have easily cleanable and covered waste receptacles;
(d)sewage and other liquid wastes are disposed of in a sanitary manner;
(e)have adequate and suitable bins in which to collect solid wastes;
(f)have the bins located in areas that do not pose a risk of contamination of the dairy produce;
(g)have adequate and sufficient drainage to drain off wastewater and liquids.

63. Requirements for water

A milk bar operator shall ensure that the premises in which the milk bar is located have adequate water supply that—
(a)is properly located, protected and operated;
(b)is easily accessible and of a safe, sanitary quality.

64. Cleanliness and storage of utensils

A milk bar shall ensure that the premises in which the milk bar is located has—
(a)only equipment directly related to dairy produce handling kept in dairy produce storage rooms;
(b)floors, walls, ceilings, shelves, tables and the non-product contact surfaces of other facilities and equipment kept clean;
(c)no trash, solid waste or waste dry product stored within the dairy produce handling rooms;
(d)all rooms in which dairy produce is handled, converted or stored; or in which containers, utensils, and or equipment are washed or stored, are kept clean and free of insects and rodents;
(e)cleaning and sanitizing of all multi-use containers and utensils done after each use.

65. Storage of packaging material

A milk bar operator shall ensure that—
(a)containers shall be stored inverted, on racks or in cases constructed of after cleaning and sanitizing, all the containers and equipment shall be stored on racks made of impervious food grade materials, or in clean shelves elevated above the floor;
(b)containers are relatively non-absorbent, impervious, food-grade, corrosion-resistant, non-toxic materials, or otherwise protected from contamination.

66. Capacity to assess milk quality and keeping of records

(1)operator milk bar operator shall have the capacity to conduct the basic quality assessments of milk and other relevant tests.
(2)A milk bar operator shall—
(a)employ persons who are capable of conducting the basic quality assessments tests.
(b)keep records of the quality tests.

67. Handling and storage of dairy produce

A milk bar operator shall ensure that dairy produce is handled and stored in a manner that does not compromise quality and safety and environmental standards.

68. Process milk according to Standard

A Milk bar operator shall process dairy produce in accordance with the requirements of relevant standards.

69. Offence under Regulation

Any person who violates any of the provisions of these regulations shall be guilty of an offence and is liable upon conviction to a fine not exceeding ten thousand shillings or to an imprisonment of not more than three months or both.

Part X – MILK DISPENSERS

70. Dispenser location, handling of dairy produce and storage of equipment

A milk dispenser operator shall ensure that—
(a)all equipment and utensils used in handling and storage of dairy produce are easy to clean and disinfect, corrosion resistant and not capable of transferring harmful substances to the dairy produce,
(b)milk storage tanks and cans are designed and constructed to avoid any contamination of the milk and to ensure complete drainage,
(c)milk storage tanks and cans are used to store dairy produce only
(d)milk dispensers are located in areas that do not pose any threat to milk safety and shall be protected from environmental pollution.

71. General Milk Dispensing Requirements

A milk dispenser operator shall ensure that—
(a)they obtain processed dairy produce from a registered dairy business operator;
(b)milk is transported from the source using a properly cleaned and sanitized tamper proof food grade container;
(c)transportation and storage conditions should ensure product integrity is maintained;
(d)the milk dispenser is positioned far from any potential contaminants;
(e)the milk-dispensing measuring device complies to relevant law regarding weights and measures;
(f)milk-dispensing equipment is operated only by persons trained to handle dairy produce;
(g)the dispensed produce is appropriately packaged and labelled on the container into which the milk is dispensed and shall conform to the labelling requirement as prescribed by the relevant Standard;
(h)no milk is dispensed from such device more than twenty-four hours from the time of delivery of such milk to the establishment;
(i)the milk dispensed from such dispensing device is, at the time of dispensing to the final consumer, meet the specifications in the relevant Standard;
(j)All parts of the dispensing device with which milk or dairy produces come into contact, including any measuring device, shall be made of food grade material;
(k)the product-contact surfaces of the dispenser are clean and free from external contamination and foreign matter;
(l)the delivery orifice must always be clean and protected from insects, dust, and any form of external contamination;
(m)all parts of the dispensing device with which milk or dairy produces come into contact, including any measuring device, is thoroughly cleaned and sanitized;
(n)the dispensing container is filled and sealed hygienically so that it is impossible to introduce any additional product for each batch dispensed;
(o)dairy produce is kept between 4°c to 6°c at all times and records of this maintained;
(p)the milk or dairy produce is dispensed into clean food grade container.

72. Requirement for premise

A milk dispenser operator shall, with respect to the premises housing the dispenser, ensure that—
(a)the floor where the dispenser is located is constructed of good quality concrete or equally impervious material, well drained and easy to clean;
(b)the packaging material are stored in a clean and safe environment;
(c)the walls and ceiling are made of smooth washable light-coloured impervious material and kept in good repair;
(d)the doors and windows are rodent and insect proofed;
(e)the doors and windows of the premises have all outer openings that are rodent-proofed;
(f)where necessary, install air curtains to prevent entry of insects;
(g)adequate light sources are provided
(h)ventilation in the premise is sufficient to keep it reasonably free of odours and prevent excessive condensation.

73. Toilet and waste management Facilities

A dairy business operator responsible for the milk dispenser shall ensure that the premise have access to sanitary conveniences that—
(a)are well ventilated, clean and in good repair;
(b)do not open directly into any room in which dairy produce products are handled, processed or stored;
(c)waste is disposed of in a sanitary manner;
(d)adequate and suitable bins in which to collect wastes are provided;

74. Water supply

A dairy business operator responsible for a milk dispenser shall ensure that the premises holding dairy produce and dispensing equipment have access to potable water that—
(a)is of adequate supply, properly located, protected and operated;
(b)is potable and complies with relevant Standard on specification for drinking water; and
(c)effluent discharge is handled as stipulated in the relevant laws.

75. Hand washing facilities

A dairy business operator dispensing dairy produce shall ensure that the premises holding dairy produce dispensing equipment has—
(a)convenient hand-washing facilities with running water; and
(b)is kept in clean condition and in good repair.

76. Premise and hygiene cleanliness

A dairy business operator dispensing dairy produce shall ensure that—
(a)only equipment directly related to dairy produce handling, are kept in dairy produce storage areas.
(b)floors, walls, ceilings, shelves, tables and the non-product contact surfaces of other facilities and equipment are kept clean at all times.
(c)no trash, solid waste or waste product is stored within the dairy produce handling areas.
(d)all areas in which dairy produce are handled and stored should be kept clean, neat and free of infestation of insects and rodents.

77. Cleaning and sanitizing of containers and equipment

A dairy business operator operating a dairy produce dispensing equipment shall ensure that—
(a)cleaning and sanitizing of all multi-use containers and accessories is done before dispensing;
(b)after cleaning and sanitizing, all the containers and equipment are stored on racks made of impervious food grade materials, or in clean shelves elevated above the floor;
(c)containers are stored inverted, on racks or in cases constructed of non-absorbent, impervious, corrosion-resistant, non-carcinogenic, non-toxic materials, or otherwise protected from contamination.

78. Storage of single-service containers utensils and materials

A dairy business operator operating dispensing equipment shall ensure that desired sanitary requirements are attained for the storage of single-service bottle caps, packaging paper, containers, bags and other single-service articles for use in contact with dairy produce.

79. Protection from Chemical contamination

A dairy business operator operating a milk dispensing equipment shall ensure that dairy produce in dispensing premises is protected from chemical contamination.

80. Milk reception

A dairy business operator operating a dairy produce dispensing equipment shall ensure that—
(a)they possess the capacity to assess the quality of dairy produce that they handle. Need to qualify
(b)the dairy produce is transferred and handled under hygienic conditions to avoid post pasteurization contamination, and
(c)they keep records of the quality tests results for the dairy produce that they handle.

81. Milk storage

A dairy business operator operating a dairy produce dispensing equipment shall—
(a)only receive and load dairy produce that meets the relevant Standard;
(b)ensure all processed dairy produce are cooled immediately prior to dispensing, and to a temperature of between 4 °c to 7°c;
(c)maintain milk dispensing facilities in good repair;
(d)equip milk storage containers with an indicating thermometer;
(e)maintain regular temperature monitoring records throughout the dispensing period.

82. Cleaning and calibration of equipment

A dairy business operator operating a dairy produce dispensing equipment shall ensure that—
(a)the unit is cleaned in accordance with manufacturers' instructions.
(b)all measuring devices and apparatus are calibrated and records kept.

83. Offence under Regulation

Any person who violates any of the provisions of these regulations shall be guilty of an offence and is liable upon conviction to a fine not exceeding ten thousand shillings or to an imprisonment of not more than three months or both.

Part XI – MILK PROCESSING ESTABLISHMENTS-COTTAGE INDUSTRY, MINI DAIRY AND PROCESSORS

84. Location and surrounding cleanliness

(1)Every milk processing establishment shall be located in an area that does not pose any threat to safety of the dairy produce processed therein and shall be protected from environmental pollution.
(2)The surroundings of the milk processing establishment shall be kept neat, clean and free from flies, other insects and rodents.

85. Separate rooms to be used for different activities

A milk processing establishment shall have separate designated areas or rooms sections for—
(a)milk reception, processing and packaging;
(b)the cleaning of milk cans and containers, bottles, cases and dry milk or dairy produce containers;
(c)the fabrication of containers and closures for dairy produce;
(d)cleaning and sanitizing facilities for milk tankers in a facility receiving milk;
(e)receiving cans of dairy produce; and
(f)receiving, handling and storage of returned dairy produce.

86. Toilet and Sanitary facilities

Without prejudice to provisions of Part V of this regulation, a milk processing establishment shall have toilet and sanitary facilities that meet requirements which shall include—
(a)clean toilet facilities;
(b)toilet rooms shall not open directly into any room in which milk and dairy products are handled, processed and stored;
(c)toilet rooms and fixtures that are kept in good repair, well ventilated and lit;
(d)toilet tissue and easily cleanable covered waste receptacles provided in toilet rooms;
(e)no pit latrines shall be allowed in the milk processing plant;
(f)sewage and other liquid wastes are disposed of in a sanitary manner;
(g)adequate and suitable bins in which to collect solid wastes;
(h)bins located in areas that do not pose a risk of contamination of the dairy produce; and
(i)adequate drainage to drain off liquid waste and sewage in a sanitary manner.

87. Water supply

(1)A milk processing establishment shall have water supply system that facilitates—
(a)adequate potable water supply, properly located, protected, and of a safe sanitary quality;
(b)water supply that complies with relevant Standard for drinking water; and
(c)flow without cross-connection between the safe water supply and any unsafe or questionable water supply, or any source of pollution through which the safe water supply might become contaminated;
(2)Water for different purposes shall be clearly distinguished by pipe colour coding in accordance with the provisions of the relevant Standard.

88. Hand washing facilities

(1)A dairy business operator shall ensure the plant shall have convenient hand-washing facilities that—
(a)provides clean and running water, soap and individual sanitary paper towels; and
(b)is kept in clean condition and in good repair.
(2)Hand wash facilities in the toilets and milk handling areas shall be designed to prevent after wash contamination.

89. Dairy plant cleanliness

The dairy business operator shall ensure that—
(a)all rooms in which dairy produce is handled, processed or stored or in which containers, utensils and or equipment are washed or stored, are kept clean, neat and free of pests, insects and rodents;
(b)only equipment directly related to processing operations or the handling of containers, utensils and equipment are permitted in the processing, cooling, condensing, drying, packaging, and bulk milk or dairy produce storage rooms
(c)floors, walls, ceilings, shelves, tables and the non-product-contact surfaces of other facilities and equipment are kept clean;
(d)all sanitary piping, fittings and connections which are exposed to dairy produce shall consist of smooth, impervious, corrosion-resistant, non-toxic, easily cleanable material, which is approved for dairy produce-contact surfaces in the relevant Standard;
(e)all piping is in good repair;
(f)trash, solid or dry waste product are removed promptly so as not to pose a source of contamination; and
(g)pasteurized dairy produce shall be conveyed from one piece of equipment to another in a sanitary manner.

90. Construction and repair of containers and equipment

The construction and repair of milk processing establishment containers and equipment shall be done in such a way that—
(a)all multi-use containers and equipment that dairy produce come into contact with shall be of smooth, impervious, corrosion-resistant and non-toxic material;
(b)such containers and equipment shall be constructed for ease of cleaning; and shall be kept in good repair;
(c)all single-service containers, closures, gaskets and other articles that dairy produce come in contact with shall be food grade, non-toxic and shall be manufactured, packaged, transported and handled in a sanitary manner;
(d)articles intended for single-service use shall not be reused.

91. Cleaning and sanitizing of containers and equipment

(1)The cleaning and sanitizing of equipment, surfaces and vehicles in the milk processing establishment shall be done in a manner that prevents contamination of the dairy produce.
(2)The records generated to confirm efficiency of cleaning shall be identified, dated and retained for a shelf life period of the relevant dairy produce consider one year

92. Storage of cleaned containers and equipment

A person responsible for a milk establishment shall ensure that cleaned and sanitized containers and equipment are stored in a manner that prevents contamination.

93. Protection from contamination

A person responsible of a milk processing establishment shall protect or cause the dairy produce or ingredients to be protected from contamination.

94. Processing of dairy produce

A person responsible of a milk processing establishment shall cause the dairy produce to be processed in accordance with the respective relevant Standard.

95. Maintenance of processing equipment

All equipment in a milk processing establishment that is used for processing of dairy produce shall meet the relevant Standard and shall be maintained in a manner that prevents contamination of the dairy produce.

96. Handling, storage and transportation of dairy produce

A person responsible for handling, storage or transportation of dairy produce shall ensure that the dairy produce is not contaminated.

97. Offence under regulations

Any person who contravenes any provisions of these regulations commits an offence and shall be liable, on conviction to a fine not exceeding ten thousand shillings or imprisonment for a term not exceeding three months or to both.

Part XII – CALIBRATION OF EQUIPMENT AND APPARATUS

98. Requirement for Calibration

(1)A person operating any dairy produce testing, monitoring or recording equipment shall obtain a valid calibration certificate.
(2)The requirement for calibration shall be done for each of the equipment specified in Form B in the schedule
(3)The operator shall ensure routine calibration is done as by the manufacturer or as by the relevant legislation; and
(4)The operator shall keep records of all the calibration results.

Part XIII – RECORDS

99. Requirement for maintenance of records

(1)Every dairy business operator shall ensure—
(a)all operations and activities along the milk value chain on which evidence of quality assurance is required to be observed under these regulations, have such evidence recorded and the records thereof are processed and maintained in accordance with these regulations.
(b)the records kept are submitted as may be determined by the Board.
(c)the records and data contained therein are retained for such period of time as provided in the relevant laws.
(2)a dairy business operator shall not trade in dairy produce without sufficient proof of maintenance of records as required under these regulations.

100. Offence under regulation

A person who contravenes any provisions of these regulations commits an offence and is liable upon conviction to a fine not exceeding ten thousand shillings or an imprisonment to a term not exceeding three months or both.

101. [Spent]

SCHEDULE

FORMS

FORM A(r. 20(3))
DECLARATION OF REJECTED MILK
 
(1)This form must be completed by all dairy business operators
(2)This form must be completed and sent to Kenya Dairy Board not later than the tenth (10th) day after the month of production.Name.......................... Regulatory Permit No..................... Licence No..............Milk Statistics for the month of:
Name of SupplierDateVolumes RejectedReasons for rejection
    
    
    
    
    
    
    
    
Total Volumes RejectedComments:.........................................................................................................................................................

DECLARATION

I/We declare that the above information is correctNAME................................ ADDRESS...................SIGNATURE & STAMP....................... DATE....................(if the signature is on behalf of the Limited Company or Estate, this must be stated)FOR OFFICIAL USE ONLYOfficers Name........................ Signature...............Date..........................................................Dated the............................................... 2021
FORM B(r. 98(2))
LIST OF EQUIPMENT REQUIRING CALIBRATION
 
(a)Thermometers (including Indicating and Recording)
(b)Volume determination equipment
(c)Pressure Gauges
(d)pH meters
(e)Electrical Conductivity measuring devices
(f)Time/ Frequency equipment
(g)Flow Diversion Device assembly and function
(h)Pressure switches
(i)Differential pressure controller
(j)Milk or dairy produce flow controls and temperature cut in cut out
(k)Continuous flow holding tube time
(l)Continuous flow Holding tube and alarm
(m)Weighing machines and equipment
(n)Milk testing laboratory equipment
(o)Any other equipment or apparatus the calibration of which may be required by the Board or any other competent authority from time to time.
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History of this document

31 December 2022 this version
12 March 2021