DRAFT KENYA STANDARD  DKS  2571 :2020  
ICS 67.120  
Second   Edition  
  
 © KEBS 2020   
 Food fortification premix and fortificants 
— Requirements for supply in Kenya   
 
  
 
 
 
 TECHNICAL COMMITTEE REPRESENTATION  
The following organizations were represented on the Technical Committee:  
University of Nairobi  
Egerton University  
Ministry of Health –Food Safety  Division   
Ministry of Health  – Division of Nutrition and Dietetics  
Kenya Industrial Research and Development Institute  
Kenya Medical Research Institute  
Ministry of Industrialization  
Directorate of Dietetics and Nutrition  
Government Chemist  
DSM Nutritional Products  
Capwell Industries Ltd  
Mühlenchemie  
Mombasa Maize Millers  
Nestle Food Kenya Limited  
Kenya Bureau of Standards — Secretariat  
REVISION OF KENYA STANDARDS  
In order to keep abreast of progress in industry, Kenya Standards shall be regularly reviewed.  Suggestions 
for im provements to published standards, addressed to the Managing Director, Kenya Bureau of Standards, 
are welcome.  
© Kenya Bureau of Standards, 2020  
Copyright. Users are reminded that by virtue of Section 25 of the Copyright Act, Cap. 130 of 2001 of  the Laws o f Kenya, copyright 
subsists in all Kenya Standards and except as provided under Section 25 of this Act, no Kenya Standard produced by Kenya Bure au of 
Standards may be reproduced, stored in a retrieval system in any form or transmitted by any means without prior permission in writing 
from the Managing Director.   DKS 2571 :2020  
ICS 67.120  
Second   Edition  
  
 
Food fortification premix and fortificants — 
Requirements for supply in Kenya   
 
 
Kenya Bureau of Standards,  Popo Road, Off Mombasa Road,  
P.O. Box 54974 - 00200,  Nairobi, Kenya  
 +254 020 6948000, + 254 722202137, + 254 734600471  
 info@kebs.org  
 @KEBS_ke  
 Kenya  bureau of standards ( KEBS )  
  
 
 Foreword  
This Kenya Standard was developed by the Technical Committee on Processed Cereals and Pulses  under 
the guidance of the Standards Projects Committ ee, and it is in accordance with the Procedures of the Kenya 
Bureau of Standards.  
The Government of Kenya through the Ministry of Health is implementing mandatory food fortification on salt, 
wheat flour, maize flour and edible fats/oils as one of the strat egies to addressing the micronutrient 
deficiencies in Kenya. This has led to increased interest in the supply of premix in the country. To ensure 
appropriate control, the Ministry of Health in Kenya is registering all suppliers of premixes and fortificants  in 
Kenya. It is on the basis of this the Ministry found the need to have standardised requirements which will be 
based for registration process which resulted to development of this standard.  
This standard , provides the minimum requirements to which suppl iers of premix both imported and locally 
produced should comply to so as to supply local industries. These requirements may also be used by local 
manufacturers of the final products for their direct procurement of their premix.  
The revision of the first ed ition was aimed at aligning these requirements to premix and fortificant specification 
standard as well as enhance clarity on handling of premixes or fortificants where a local industry opts to 
directly import.  
The edition therefore cancels and replaces fi rst edition, KS 2571:2014, of the standard  
 DRAFT KENYA STANDARD  DKS 2571 :2020  
 
 © KEBS 2020   
 Food fortification premix and fortificants — Requirements for supply in 
Kenya  
1 Scope  
1.1 This Draft Kenya Standard provides the requirements for registration of suppliers of food fortification 
premix and fortificants to industry  producing products to which  mandatory food fortification  has been declared  
in Kenya .  
1.2 The standard applies to both manufacturers and suppliers of premix as well as food industries  such as 
millers or edible oil refineries  that may seek to directly import premix for both internal use  and sale . 
2 Normative references  
The following documents ar e referred to in the text in such a way that some or all of their content constitutes 
requirements of this document. For dated references, only the edition cited applies. For undated references, 
the latest edition of the referenced document (including any amendments) applies.  
KS 2890, Food fortification premix and fortificants – Specification    
KS ISO 17025, General requirements for the competence of testing and calibration laboratories  
KS ISO 22000, Food safety management system  
3 Terms and d efinition s 
For the purposes of this document, the following term and definition apply:  
3.1  
food fortification  
practice of deliberately adding essential micronutrients in a food so as to improve the nutritional quality of the 
food and to provide a public health benefit with minimal risk to health  
3.2 
Fortificant  
a compound which contains the specified micronutrient intended to be added to a food vehicle  
3.3  
food fortification premix (premix)  
blend of fortificants and diluents formulated to provide specified and determinable amounts of micronutrients  
3.4 
food grade containers  
Containers whose food contact materials will not permit or introduce any food hazard to the premix or 
fortificant  
3.5  
supplier  
any business, person or company in the business of manufacturing, importing, storing, distributing and or 
marketing of premix  DKS 2571 :2020  
2 © KEBS: 2020 : – All rights reserved  
  
4 Requirements  
4.1 General requirements  
4.1.1 The quality and safety requirements of the premix and fortificant shall comply with the requirements 
KS 2890.  
Note:  The particle size (granule size) of the premix has a direct effect to both mixing and appearance of the final product. 
In the case of bigger granules, spots are observed in the final product while the difference in particle size between the fin al 
product and the premix may result in uneven distribution of premix in the final product. As a result, the manufacturer 
should ensure that the granules are in such a size that the premix will blend well with the final product to avoid such spots  
in the final product. The spots may al so be due to the nature of the fortificant used.  
4.1.2  The liquid form of premix shall be stable, blend well, mix homogenously and shall not separate in the 
final product.  
4.2 Specific requirements  for qualification to supply premix  and fortificants  in Kenya  
Supplier of premix  and fortificants  in Kenya shall comply with all the requirements under this clause.  
4.2.1 Registration of company or business  
A supplier shall be legally registered in accordance to the relevant laws of Kenya. Where renewal of 
registration/permit of trade is applicable, the company shall demonstrate compliance of such requirement.  
Note: Local registered firms such as millers or edible oil refineries opting to import premix or fortificant for exclusive 
internal use need not to register as a premix/fortificant supplier but should have evidence  in their possession for the 
consignment received  that their exporting supplier is reg istered at the country of origin  
4.2.2 Health clearance  
A supplier shall have a certificate of health as prescribed in the Food, Drugs and Chemicals Substances Act , 
Cap. 254 of the laws of Kenya . 
4.2.3 Conformity to quality and safety requirements  
4.2.3.1  The supplier shall demonstrate that the premix is safe and that it is in compliance KS 2890 and has 
been approved for placement in Kenyan market such as evidence of Certificate of Conformity issued in 
reference to KS 2890.  
4.2.3. 2 The supplier shall provid e material safety data sheet at registration and shall be updated on annual 
basis . 
4.2.3. 3 The supplier shall have a Certificate of A nalysis  (CoA)  indicating the composition of all the nutrients in 
the premix as required in KS 2890  for each batch imported . The CoA should be issued  by a laboratory 
accredited to ISO 17025 or as may be directed or requested by regulatory body in Kenya.  
4.2.3. 4 The supplier shall provide a copy of the certificate  of analysis (CoA) indicated  in clause  4.2.3.3  to their 
customer  before or at the time of supplying the premix . 
4.2.3. 5  In addition , where applicable,  the importing supplier shall have evidence of compliance with any other 
conformity assessment requirement set by the regulatory authorities in Kenya . 
 DKS 2571 :2020  
© KEBS 2020  – All rights reserved  3 
 4.2.4  Declaratio n of source of premix or fortificants  
4.2.4.1 The supplier shall declare in descriptive terms the source of the premix including but not limited to 
manufacturer, importer (in case where one is distributing on behalf of an importer), country of origin, physical 
address. Evidence of this informa tion shall be availed on during registration . 
4.2.4.2 Where a supplier is an appointed local agent of a firm outside the country, they shall provide a 
company sealed letter as evidence of such appointment . 
4.2.4 .3 The supplier shall declare and update the relevant division or directorate responsible for food 
fortification in the M inistry of Health either through correspondence or by uploading through the Ministry’s food 
fortification data base (or as guided by the M inistry)  the quantities for every consignment imported or 
produced in the country. On a quarterly basis , the supplier shall provide information on the distribution 
indicating the firms and quantities of premix supplied.  
4.2.5 Packaging, labe lling and stora ge of premix  
4.2.5 .1 Packaging  
The premix shall be packaged in food grade containers that shall ensure the safety and quality of the premix is 
maintained throughout the shelf life .  
4.2.5 .2 Labe lling 
The labe lling of the containers shall comply with KS 2890 .  
4.2.5 .3 Storage  
The premix shall be stored in compliance to storage instruction as provided by the manufacturer and in 
compliance to the Public Health Act,  Cap. 242 of the L aws of Kenya.  
5 Certification  
A manufacturer of premix shall possess a valid  certificate from a recognized certification body demonstrating 
that the company is implementing a food -related quality system such as ISO 22000 or HACCP. A copy of this 
certificate shall be provided to the local agents or importers.  
 
 
 
 DKS 2571 :2020    
 
© KEBS 2020 – All rights reserved