DRAFT KENYA STANDARDS        DKS 2765:2017 
            I C S  6 7 . 0 2 0  
   
 
 
 
 
 
 
  
 
 
 
  
Monitoring and sampling of fortified foods - 
guidelines 
  
  
 
 
 
  
 
  
 
 
 
 
© KEBS 2017          First Edition 2017  DKS 2765:2017 
ii                           © KEBS 2017 — All rights reserved  DRAFT KENYA STANDARD         DKS 2765:2017 
ICS 67.020  
© KEBS 2017 — All rights reserved                           iii  TECHNICAL COMMITTEE REPRESENTATION 
The following organizations were r epresented on the Technical Committee: 
Egerton University – Depart ment of Human Nutrition 
Jomo Kenyatta University of Science & Technol ogy – Department of Food Science and Technology 
Ministry of Health – Nu trition and Dietetics Unit 
Ministry of Health – Food Safety Unit Government Chemist 
Kenya Medical Research Institute 
Kapa Oil Refineries 
Bidco Africa Ltd 
Golden Kenya Ltd Rafiki Millers Ltd 
Baraka Millers Ltd 
Pembe Flour Mills 
Unga Limited 
Proctar and Allan Capwell Industries Ltd 
Mombasa Maize Millers 
Osho Grain Ltd 
BASF  
Kenya Bureau of Standards ― Secretariat 
 
 
 
 
  
REVISION OF KENYA STANDARDS 
In order to keep abreast of  progress in industry, Keny a standards shall be regularly reviewed. Suggestion for 
improvements to published standards addressed to the Managing Director, Kenya Bu reau of Standards, are 
welcome. 
 
 
  DKS 2765:2017 
iv                           © KEBS 2017 — All rights reserved   
© Kenya Bureau of Standards, 2012 
 
Copyright. Users are reminded that by virtue of Section 25 of the Copyright Act, Cap. 12 of 2001  of the Laws of Kenya, copyrig ht subsists in 
all Kenya Standards and except as provi ded under Section 26 of this Act, no Kenya Standard produced by Kenya Bureau of Standard s may 
be reproduced, stored in a retrieval system in any form or trans mitted by any means without prior permission in writing from th e Managing 
Director.  
 DRAFT KENYA STANDARD         DKS 2765:2017 
ICS 67.020  
© KEBS 2017 — All rights reserved                           v  
 
 
 
 
  
 
 
 
  
Monitoring and sampling of fortified foods - 
guidelines  
 
 
 
 
 
 
  
 
KENYA BUREAU OF ST ANDARDS (KEBS) 
 
Head Office:  P.O. Box 54974, Nairobi-00200, Tel.: (+254 020) 605490, 602350, Fax: (+254 020) 604031 
E-Mail: info@kebs.org,  Web:http://www.kebs.org   
 
Coast Region    Lake Region       North Rift Region  
P.O. Box 99376, Mombasa-80100  P.O. Box 2949, Kisumu-40100   P.O. Box 2138, Nakuru-20100 
Tel.: (+254 041) 229563, 230939/40               Tel.: (+254 057) 23549, 22396   Tel.: (+254 051) 210553, 210555  
Fax: (+254 041) 229448                                 Fax: (+254 057) 21814  DKS 2765:2017 
vi                           © KEBS 2017 — All rights reserved  Foreword 
This Kenya Standard was prepared by the Processed Cereals and Pulses TC under the guidance of the 
Standards Project Committee, and it is in accordance with the procedures of the Kenya Bureau of Standards. 
These guideline are primarily intended to ensure uniform application of monitoring by both internal and external 
quality control players in food fortification. The guide lines are expected to produce a homogeneous sample for 
laboratory testing to reduce the variations in results usually associated with sampling. The guidelines will also 
assist the industries to establish and maintain a quality infrastructure for fortified food products. They may also 
be used in other food products whose nutrition quality has been enhanced by addition of vitamins and minerals.  
During the preparation of this standard, reference was made to the following documents 
 
Guidelines on food fortification with micronutrients, 2006, WHO/FAO. 
CAC/GL 09 – 1987: General principles for the addition of essential nutrients to foods. 
ECSA manuals for internal and extern al monitoring of fortified foods. 
KS ISO 22000: 2005 Food Safety Management System.  
Vitamin and Mineral requirements in Human Nutrition, WHO/FAO, 2004, 2nd Edition.  
Acknowledgement is hereby made for the as sistance derived from the above sources. 
 
 
  
DRAFT KENYA STANDARD       DKS 2765:2017  
 
© KEBS 2012 — All rights reserved                          1 Monitoring and sampling of fortified foods - guidelines  
1  Scope 
This Kenya Standard provides the minimum requirem ents for monitoring, sampling and documentation of 
nutrient premixes and fortified foods.  
2 Applications 
These guidelines are primarily applicable to premixes, fortif ied flours, edible salt, sugar, edible fats and oils. They 
may also be used for all other fortified food products. 
3 Normative references 
The following referenced documents are indispensable for the application of this document. For dated 
references, only the edition cited applies. For undated refe rences, the latest edition of the referenced document 
(including any amendments) applies. 
KS EAS 39 , Code of practice for hygiene in the food and drink manufacturing industry  
4 Definition 
For the purposes of this standard, t he following definitions shall apply: 
4.1  
internal quality control  
is quality control and assurance practices conducted by producers, importers or packers of fortified foods and 
premixes 
4.2  
external quality control 
is the inspection and auditing activities carried out at production centers (for factories and packers) and 
importation custom sites usually by regulatory bodies 
4.3  
establishment 
is a site where food fortif ication is taking place 
4.4  
control point 
stage in production process where it is important to  control the quality param eter of fortified foods 
4.5  
operational prerequisite program 
activity that is important to ensure proper fortification of product and which may not have a critical limit/measure.  DKS 2765:2017  
 
2          © KEBS 2017 — All rights reserved 4.5  
Food safety management system  
is an activity where an organization in food chain is supposed to demonstrate its ability to control food safety 
hazards in order to ensure food is safe at the time of consumption  
5 Requirements  
5.1  General requirements 
5.1.1   The production establishment shall comply with all legal requirements of the relevant Laws of Kenya. 
5.1.2   The establishments shall ensure and demonstrate good manufacturing practices (GMPs) are observed 
where specific requirements are not provided in this these guidelines. 
5.1.3   The establishments shall document all procedures an d maintain all records required by these guidelines. 
5.1.4   The establishment shall maintain documented info rmation required for control of documents including 
but not limited to approval, review & updating as well as retention of information generated for food fortification 
5.2  Internal quality control/assurance requirements 
5.2.1   Establishments shall develop, document and implem ent an internal quality system that will ensure the 
products will comply with the releva nt national standards and/or regulation 
5.2.2   The establishment shall ensure while handling the premix/fortificants that:  
a) All premix/fortificants received to  an establishment shall be accompanied by material safety data sheet 
and certificate of analysis including micronutrient profile  and the shelf life of the premix/fortificants. This 
record shall be maintained for at least to shelf life of the product or as may be defined in the 
establishments’  documented information. 
b) A proper schedule of movement of premix/fortificants to and from store is handled in a ‘First In First Out’ 
(in case of batches with same expiry date) and/or “f irst expiry first out” princi ple or any other principle 
that shall ensure the premix/fortificants do not keep long in the store. Records of these movements shall 
be maintained. 
c) A record of dispatches made to the production,  including at least but not limited to the type of 
fortificants/premix; date of production; shift (tim e); lot number where applicable and amount issued. A 
tabular module representation of this information is informatively annexed as Annex A. 
d) Any opened premix/fortificants container s shall be tightly closed to minimize exposure to air and light. 
e) The establishment shall ensure t hat expired premix/fortificant are not utilized and if any premix expires in 
the stores shall be disposed according to relevant regulations and records of its disposal shall be 
maintained for a period of not less than six (6) months after its disposal. 
5.2.3 The establishment shall ensure that in the production site:  
a) The hygiene condition is in compliance with   KS EAS 39 and all other relevant laws of Kenya; 
b) The calibration of the equipment used in food fort ification such as dosers, weighing scale is updated 
accordingly. Records of calibration shall be mainta ined. A schedule of inspection of the equipment at 
least on a weekly basis and record of finding shall be kept. A tabular module is attached as Annex B; 
c) Periodically in a shift, the dosage shall be inspected /verif ied to ensure that it is correct and records 
maintained; this shall apply in batch processing as well.  DKS 2765:2017  
 
© KEBS 2017 — All rights reserved                           3   d) A production log shall be kept indicating to the mi nimum time and date of production, amount of product 
produced, amount of premix used and product/premix ration and the name/officer responsible. A tabular 
module of this information is annexed as Annex C; and 
 e)  In the production of fortified foods, there shall be internal mechanism for demonstrating status of 
fortification in the product. Records shall be maintained.  
5.3  Planning and realization of safe products 
5.3.1  An establishment shall establish, document and im plement a food management system that shall ensure 
safe and quality production of fortifi ed foods such as HACCP, ISO 22000. 
5.3.2  As the minimum the documented procedure shall indicate 
a) Flow diagrams, process steps and control measures 
Flow diagrams shall be clear, accurate and sufficiently deta iled. Flow diagrams shall, as appropriate, include the 
following: 
i) the sequence and interaction of all steps in the operation; 
ii) any outsourced proces ses and subcontracted work; 
iii) where raw materials, ingredients a nd intermediate products enter the flow; 
iv) where reworking and recycling take place; and 
v) where end products, intermediate products, by-products and waste are released or removed. 
The production/quality control team s hall verify the accuracy of the fl ow diagrams by on-site checking. 
Verified flow diagrams shall be maintained as records. 
b)  Control points 
The documented system shall indicate the control points within the production point where control measures will 
be required to ensure consistency of the fortified products. 
c)  Monitoring of the control points 
The food management system shall identify and document c ontrol measures (either operational prerequisite 
program or a critical limit) for each control point that shall be capable of preventing,  eliminating or reducing 
fluctuation on the dosage levels to acceptable fa ctory range and be within the regulatory limits. 
d) Action to be taken when control limit is deviated  
Planned corrections and corrective actions to be taken when  control limits are deviated shall be specified in the 
food system plan under implementation. The actions shall en sure that the cause of non conformity is identified, 
that the parameter(s) controll ed at the control point is (are) brought bac k under control, and that recurrence is 
prevented.  
Documented procedures shall be established and maintained for the appropriate handling of non compliant 
products to ensure that they are not rele ased until corrective action is taken. 
e)  Verification of the food safety management system  
Verification planning shall define the purpose, method s, frequencies and responsibilities for the verification 
activities. The verification activities shall confirm that the control measures are working and new critical points (if  DKS 2765:2017  
 
4          © KEBS 2017 — All rights reserved any) are documented and appropriate control measures applied. 
6 External quality control 
6.1 General requirements 
6.1.1 Establishments producing fortified food  products shall be visited for inspection with intent to ensure 
compliance to regulatory limits as established. 
6.1.2  These visits shall be carried out at least twice in  a year and more frequent where the laboratory test 
result(s) consistently fails to co mply with the regulatory limits. 
6.1.3  These inspection visits may be pre-arranged or impromptu to an establishment. 
6.1.4  During the inspection the inspector shall be expected to the minimum confirm that the establishment is 
implementing the documented food system, confirm that all the records required by this standard are generated 
and documented according to the establishment’s policy. A detailed report of inspection shall be generated and 
documented in accordance with the institutions procedures. 
6.2 Sampling 
6.2.1  An inspector on each visit shall sample the fortifi ed food products for purposes on analysis in an external 
laboratory 
6.2.2  The samples shall be collected in amber glass bottles or similar appropriate containers drawn from the 
production line at intervals not less than 15 minutes from a particular point in the line 
6.2.3  The sample size shall be four (4) bottles of 200g each, drawn at intervals described in clause 6.2.2. The 
samples shall be delivered to the testing laboratory fo r compositing before analysis. The firm being inspected 
may draw parallel samples and composite for their own internal analysis. 
6.2.4  The inspector may draw more than four  samples if he/she deems it necessary. 
6.2.5  In the case of imported fortified foods and premixes , sampling shall be done in accordance to ISO 5555 
6.3 Analysis 
6.3.1  The samples submitted shall be composited and a repr esentative sample drawn from the composite in 
accordance to the methods of analysis being used. 
6.3.2  The sample shall be analyzed by a validated methods 
6.3.3  The results of analysis shall be communicated to the inspector  in accordance with the procedures of the 
testing laboratory. 
7 Documentation and records 
7.1 E stablishments shall document and im plement procedures related to various functions related to food 
fortification.  
7.2 All records that this standard requires shall be g enerated and stored in accordance to establishment 
procedures. 
7.3 All calibration evidence/records shall be kept. 
7.4 Records shall be maintained to demonstrate compliance with the requirements of this standard  DKS 2765:2017  
 
© KEBS 2017 — All rights reserved                           5    
Annex A 
 (informative ) 
Inventory 
 
Premix/fortificants inventory log 
 
ABC Co. Ltd 
Premix/fortificants bin card 
S.No. 0123456 
Location: Store 
Date (Time) Dispatched to the production site 
Quantity Lot number Expiry date Name/signature of 
issuing officer 
      
      
      
      
      
      
      
  DKS 2765:2017  
 
6          © KEBS 2017 — All rights reserved  
 
Annex B  
(informative ) 
(Weekly inspection) 
 
Weekly check up equipments 
 
ABC Co. Ltd 
Premix/fortificants bin card 
S.No. 0123456 Weekly inspection of equipments 
Location: QC/maintenance  
Name of inspector:  
 
 Signature:  
 
Date:   
  
Equipment Condition Observation/recommendations 
   
   
   
   
   
   
   
   
   
  DKS 2765:2017  
 
© KEBS 2017 — All rights reserved                           7    
Annex C  
(informative ) 
 
Production log 
 
Time 
and/or 
date Product 
produced Premix 
used 
(kg) Premix/fortificant to 
product ratio Name of 
supervisor Comments/observations
MT 
(A) Lot ID