DRAFT KENYA STANDARDS        DKS 2765 :2017 
            ICS 67.020  
   
 
 
 
 
 
 
 
 
 
 
 
 
 
Monitoring and sampling of fortified foods - 
guidelines  
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
© KEBS 20 17          First Edition 20 17  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 represented on the Technical Committee:  
Egerton University – Department of Human Nutrition  
Jomo Kenyatta University of Science & Technology – Department of Food Science and Technology  
Ministry of Health – Nutrition and Dietetics Unit  
Ministry of Health – Food Safety Unit  
Government Chemist  
Kenya Medical Research I nstitute  
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, Kenya standards shall be regularly reviewed. Suggestion for 
improvements to published standards addressed to the Managing Director , Kenya Bureau 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, copyr ight subsists in 
all Kenya Standards and except as provided under Section 26 of this Act, no  Kenya Standard produced by Kenya Bureau 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.  
 DRAFT KENYA STANDARD         DKS 2765: 2017 
ICS 67.020  
© KEBS 2017 — All rights reserved                           v  
 
 
 
 
 
 
 
 
 
 
 
Monitoring and sampling of fortifie d foods - 
guidelines   
 
 
 
 
 
 
 
 
 
KENYA BUREAU OF STANDARDS (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 guidelines are expected to produce a homogeneous  sample for 
laboratory testing to reduce the varia tions  in results usually associated  with sampling. The guidelines will also 
assist the industries to establish and maintain a quality infrastructure for fortified food products. The y 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 additi on of essential nutrients to foods . 
ECSA manuals for internal and external 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 assistance derived from the above sources . 
 
 
  
DRAFT KENYA STANDARD       DKS 2765: 2017 
 
© KEB S 2012 — All rights reserved                           1 Monitoring and sampling of fortified foods - guidelines  
1  Scope  
This Kenya Standard  provides the minimum requirements for monitoring, sampling and documentation of 
nutrient premixes and fortified foods.  
2 Applications  
These guidelines are primarily applicable to  premixes,  fortified 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 references, the latest edition of the referenced document 
(including any amendments) applies.  
KS EAS 39 , Code of practice fo r hygiene in the food and drink manufacturing industry  
4 Definition  
For the purpose s of this standard , the following definition s 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 fortification is taking place  
4.4  
control point 
stage in production process  where  it is important to control the quality parameter of fortified foods  
4.5  
operational prerequisite program  
activity that is important to ensure proper fortificat ion 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 practic es (GMPs)  are observed 
where specific requirements are  not provided in this  these guidelines . 
5.1.3   The establishments shall document all procedures and maintain all records required by these guidelines . 
5.1.4  The establishment shall  maintain  documented information required for control of documents including 
but not limited to approval, review & updating  as well as retention of information  generated for food fort ification  
5.2  Internal quality control /assurance  requirements  
5.2.1   Establishments shall dev elop, document and implement an internal quality system that will ensure the 
products will comply with the relevant national standards and/or regulation  
5.2.2   The establishment shall ensure while handling the p remix/fortificants that:  
a) All premix/fortific ants 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 th e 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 ―first expiry first  out‖ principle 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 (time) ; lot number  where applicable and amount issued. A 
tabular module representation of this informati on is informatively annexed as A nnex A. 
d) Any opened premix/fortificants containers shall be tightly close d to minimize exposure to air and light.  
e) The establishment shall ensure that 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 
mainta ined 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 eq uipment  used in food fortification such as dosers, weighing scale  is updated 
accordingly. Records of calibration shall be maintained . A schedule of inspection of the equipment at 
least on  a weekly basis and record of finding shall be kept. A tabular m odule  is attached as A nnex  B; 
c) Periodically  in a shift, the dosage shall be inspected /verified to ensure that it is correct and record s 
maintained ; this shall apply in batch processing as well.   DKS 2765: 2017 
 
© KEBS 201 7 — All rights reserved                            3   d) A production log shall be kept indicating to the minimum time and d ate of production, amount of product 
produced, amount of premix used and product/premix ration and the name/office r 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 establish ment  shall establish, document and implement a food management system that shall ensure 
safe and quality production of fortified foods such as  HACCP, ISO 22000 . 
5.3.2  As the minimum the documented  procedure shall indicate  
a) Flow d iagrams , process steps and control measures  
Flow diagrams shall be clear, accurate and sufficiently detailed. Flow di agrams shall, as appropriate, include the  
following : 
i) the sequence and interaction of all steps in the operation;  
ii) any outsourced processes and subcontracted work;  
iii) where raw materials, ingredients and 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 shall verify the accuracy of the flow diagrams by on -site checking.  
Verified flow diagrams shall be mai ntained as records.  
b)  Control points  
The documented system shall  indicate the  control  points within the production point where control measure s will 
be required to ensure consistency of the fortified products . 
c)  Monitoring of the control points  
The foo d management system shall identify and document control 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 acceptabl e factory 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 implementati on. The actions shall ensure that the cause of nonconformity is identified, 
that the parameter(s) controlled at the control point is (are) brought back under control, and that recurrence is 
prevented .  
Documented procedures shall be established and maintai ned for the appropriate handling of non compliant 
products to ensure that they are not released until corrective action is taken.  
e)  Verification of the food  safety management  system  
Verification planning shall define the purpose, methods, frequencies an d responsibilities for the verification  
activities. The verification activities shall confirm that  the control measure s are working and new critical points (if  DKS 2765: 2017 
 
4          © KEBS 2017 — All rights reserved  any) are documented and appropriate control measure s 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 frequen t where the laboratory test 
result (s) consistently fails to comply with the regulatory limits . 
6.1.3 These inspection visit s may be  pre-arranged  or impromptu  to an establishment . 
6.1.4  During the inspection the inspector shall be  expected to the minimum co nfirm 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 fortified 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 for 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 necessar y. 
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 representative sample drawn from the composite  in 
accordance to the methods o f 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 Establishmen ts shall document  and implement procedures related to various functions related to food 
fortification .  
7.2 All record s that this standard requires shall be generated and stored in accordance to establishment 
procedures.  
7.3 All calibration evidence/record s shall be kept.  
7.4 Records shall be maintained to demonstrate compliance with the requirements of this standard   DKS 2765: 2017 
 
© KEBS 201 7 — 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 n umber  Expiry d ate Name/s ignature of 
issuing officer  
      
      
      
      
      
      
      
  DKS 2765: 2017 
 
6          © KEBS 2017 — All rights reserved   
 
Annex B  
(informative ) 
(Weekly i nspection ) 
 
Weekly check up e quipments  
 
ABC Co. Ltd  
Premix/fortificants bin card  
S.No. 0123456  
Weekly inspection of e quipments  
Location: QC/m aintenance   
Name of i nspector:   
 
 
Signature:   
 
Date:   
  
Equipment  Condition  Observation/recommendations  
   
   
   
   
   
   
   
   
   
  DKS 2765: 2017 
 
© KEBS 201 7 — All rights reserved                            7    
Annex C  
(informa tive) 
 
Production l og 
 
Time 
and/or 
date Product 
produced  Premix 
used 
(kg) Premix/fortificant to 
product ratio  Name of 
supervisor  Comments/observations  
MT 
(A) Lot ID