DEAS 1025 : 2019  
ICS 67.020  
 
© EAC 2019                                                                                                                               First Edition 2019   
 DRAFT EAST AFRICAN STANDARD  
Monitoring and sampling of premixes  and fortified  foods — Guidelines  
EAST AFRICAN COMMUNITY  DEAS 1025 : 2019  
ii © EAC  2019  – All rights reserved  
 Copyright notice  
This EAC document is copyright -protected by EAC. While the reproduction of this document by 
participants in the EAC st andards development process is permitted without prior permission from EAC, 
neither this document nor any extract from it may be reproduced, stored or transmitted in any form for 
any other purpose without prior written permission from EAC.  
Requests for per mission to reproduce this document for the purpose of selling it should be addressed 
as shown below or to EAC’s member body in the country of the requester:  
© East African Community  2019  — All rights reserved  
East African Community   
P.O. Box 1096 , 
Arusha  
Tanzania  
Tel: + 255 27 2 162100  
Fax: + 255 27 2162190  
E-mail: eac@eachq.org  
       Web: www.eac -quality.net  
Reproduction for sales purposes may be subject to royalty payments or a licensing agreement.  
Violators may be prosecuted . DEAS 1025 : 2019  
© EAC 2019  – All rights reserved  iii 
 Contents  Page 
Foreword  ................................ ................................ ................................ ................................ ............................  iv 
1 Scope  ................................ ................................ ................................ ................................ ......................  1 
2 Normative refere nces  ................................ ................................ ................................ ............................  1 
3 Terms and definitions  ................................ ................................ ................................ ...........................  1 
4.1 General requirements  ................................ ................................ ................................ ...........................  2 
4.2 Intern al quality control and assurance  ................................ ................................ ...............................  2 
4.3 Planning and realization of safe products  ................................ ................................ ..........................  3 
5 External quality control ................................ ................................ ................................ .........................  4 
5.1 General requirements  ................................ ................................ ................................ ...........................  4 
5.2 Sampling  ................................ ................................ ................................ ................................ ................  4 
5.3 Analysis  ................................ ................................ ................................ ................................ ..................  4 
6 Documentation and records  ................................ ................................ ................................ .................  4 
Annex  A (informative)  Workshop representation  ................................ ................................ ..........................  6 
Annex  B (informative)  W eekly inspection  ................................ ................................ ................................ ....... 7 
Annex  C (informative)  Weekly inspection  ................................ ................................ ................................ ....... 8 
Bibliography  ................................ ................................ ................................ ................................ ........................  9 
 DEAS 1025 : 2019  
iv © EAC  2019  – All rights reserved  
 Foreword  
Development of  the East African Standards has been necessitated by the need for harmonizing requirements 
governing quality of products and services in the East African Community. It is envisaged that through 
harmonized standardization, trade barriers that are encountere d when goods and services are exchanged 
within the Community will be removed.  
The Community has established an East African Standards Committee  (EASC)  mandated to develop and 
issue East African Standards  (EAS) . The Committee is composed of representatives  of the National 
Standards Bodies in Partner States, together with the representatives from the public and private sector 
organizations  in the community .  
East African Standards are developed through  Technical Committees that are representative of key 
stakeholders including government, academia, consumer groups, private sector and other interested parties. 
Draft East African Standards are circulated to stakeholders through the National Standards Bodies in the 
Partner States. The comments received are discus sed and incorporated before finalization of standards, in 
accordance with the Principles and procedures for development of East African Standards . 
East African Standards are subject to review, to keep pace with technological advances. Users of the East 
African Standards are therefore expected to ensure that they always have the latest versions of the standards 
they are implementing .  
The committee responsible  for this document is Technical Committee EASC /TC 018, Nutrition and foods for 
special dietary uses.  
Attention is drawn to the possibility that some of the elements of this document may be subject of patent 
rights. EAC should  not be held responsible for identifying any or all such patent rights.  
 DRAFT EAST AFRICAN STANDARD  DEAS 1025 : 2019  
 
© EAC 2019 – All rights reserved  1 
 Monitoring and sampling of premixes and fortified foods — Guidelines  
1 Scope   
This Draft East African Standard provides the guidelines  for monitoring, sampling and documentation of 
nutrient premixes and fortified foods.  
These guidelines are primarily applicable to premixes, fortified flours, edible salt, sugar, fat spreads , edible 
fats and oils. They may also be used for all other fortified food products.  
2 Normative references  
The following documents are referred to in the text in such a way that some or all of their content constitutes 
requirements of this docu ment.  For dated references, only the edition cited applies. For undated references, 
the latest edition of the referenced document (including any amendments) applies.  
EAS 39, Code of practice for hygiene in the food and drink manufacturing industry  
EAS 900,  Cereals and pulses — Sampling  
ISO 5555, Animal and vegetable fats and oils — Sampling  
3 Terms and definitions   
For the purposes of this document, the following terms and definitions apply.  
3.1  
internal quality control  
quality control and assurance pract ices conducted by producers, importers or packers of fortified foods and 
premixes  
3.2  
external quality control  
the inspection and auditing activities carried out at production centers (for factories and packers) and 
importation custom sit es and retail sit es usually by regulatory bodies  
3.3 
establishment  
site where food fortifi cation  takes place  
3.4 
control point  
stage in production process where it is important to control the quali ty parameter of fortified foods  
3.5 
operational prerequisite program me 
activity that is important to ensure proper fortification of product and which may not have a critical 
limit/measur e  
2 © EAC  2019  – All rights reserved  
 3.6 
monitoring  
process involving the auditing, quality control, quality assurance and inspection of manufacturing practices 
that ensure safe and  quality production of fortified foods. Monitoring includes internal quality assurance and 
control measures as well as ext ernal monitoring by reregulatory authorities.  
3.7 
quality assurance  
activities that facilitate the production of fortified foods with adequate micronutrient levels, of high quality, and 
are safe to consume  
3.8 
inspection  
examination, measurement, testing of products to verify confo rmance to specific requirements  
4 Requirements  
4.1 General requirements  
4.1.1 The production establishment should  comply with EAS 39 . 
4.1.2 The establishments should  document all procedures and maintain all records required by these 
guidelines.  
4.1.3 The establishment should maintain documented information required for control of documents 
including but not limi ted to approval, review and updating as well as retention of information generated for 
food fortification.  
4.2 Internal quality control  and assurance  
4.2.1 Establishments should  develop, document and implement an internal quality system that will ensure 
the products will comply with the relevant national standards and/or regulation  
4.2.2 The establishment should  ensure while handling the premix/fortificants that:  
a) All premix/fortificants received to an establishment should  be accompanied by material safe ty data sheet 
and certificate of analysis including micronutrient profile and the shelf life of the premix/fortificants. This 
record should  be maintained for at least to shelf life of the product or as may be defined in the 
establishments’ documented infor mation.  
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 
should  ensure the premix /fortificants do not keep long in the store. Records of these movements should  
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 num ber where applicable and amount issued. A 
tabular module representation of this information is informatively annexed as Annex A.  
d) Any opened premix/fortificants containers should  be tightly closed to minimize exposure to air and light.  
e) The establishme nt should  ensure that expired premix/fortificant are not utilized and if any premix expires 
in the stores should  be disposed according to relevant regulations and records of its disposal should  be 
maintained for a period of not less than six (6) months aft er its disposal.  
4.2.3 The establishment should  ensu re that in the production site:  
a) the hygiene condition is in compliance with  EAS 39.   
© EAC 2019  – All rights reserved  3 
 b) the calibration of the equipment used in food fortification such as dosers, weighing scale is updated 
accordingly . Records of calibration should  be maintained. A schedule of inspection of the equipment at 
least on a weekly basis and record of finding should  be kept. A tabular module is attached as Annex B;  
c) periodically in a shift, the dosage should  be inspected /v erified to ensure that it is correct and records 
maintained; this should  apply in batch processing as well;  and 
d) a production log should  be kept indicating to the minimum time and date of production, amount of product 
produced, amount of premix used and product/premix ration and the name/officer responsible. A tabu lar 
module of this information as per Annex C . 
4.3 Planning and realization of safe products  
4.3.1 An establishment should  establish, document and implement a food management system that should  
ensure safe and quality production of fortified foods such as HACCP, ISO 22000.  
4.3.2 As the minimum the documented procedure should  indicate the following:  
4.3.2.1  Flow diagrams, process steps and control measures  
4.3.2.1.1  Flow diagrams should  be clear, accurate and sufficiently detailed. Flow diagrams should , as 
appropriate, include the  following:  
a) the sequence and interaction of all steps in the operation;  
b) any outsourced processes and subcontracted work;  
c) where raw materials, ingredients and inte rmediate products enter the flow;  
d) where reworking and recycling take place; and  
e) where end products, intermediate products, by -products and waste are released or removed.  
4.3.2.1. 2 The production/quality control team should  verify the accuracy of the flow diagrams by on -site 
checking. Verified flow diagrams should  be maintained as records.  
4.3.2.2  Control points  
The documented system should  indicate the control points within the production point where control measures 
will be required to ensure consist ency of the fortified products.  
4.3.2.3  Monitoring of the control points  
The food management system should  identify and document control measures (either operational prerequisite 
program or a critical limit) for each control point that should  be capable of  preventing, eliminating or reducing 
fluctuation on the dosage levels to acceptable factory range and should  be within the regulatory limits.  
4.3.2.4  Action s to be taken when critical limits are not met  
4.3.2. 4.1 Planned corrections and corrective actions to be taken when critical limits are not met  should  be 
specified . The actions should  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 pre vented.  
4.3.2. 4.2 Documented procedures should  be established and maintained for the appropriate handling of 
non-compliant products to ensure that they are not released until corrective action is taken.   
4 © EAC  2019  – All rights reserved  
 4.3.2.5  Verification of the food safety management s ystem  
Verification planning should  define the purpose, methods, frequencies and responsibilities for the verification 
activities. The verification activities should  confirm that the control measures are working and new critical 
points (if any) are documen ted and appropriate control measures applied.  
5 External quality control  
5.1 General requirements  
5.1.1 Establishments producing fortified food products should  be visited for inspection with intent to ensure 
compliance to regulatory limits as established.  
5.1.2 These visits should  be carried out at least twice in a year and more frequent where the laboratory test 
result(s) consistently fails to comply with the regulatory limits.  
5.1.3 These inspection visits may be pre -arranged or impromptu to an establishm ent. 
5.1.4 During the inspection the inspector should  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 should  be 
generated and documented in accordance with the institutions procedures.  
5.2 Sampling   
5.2.1 An inspector on each visit should  sample the fortified food products for purposes on analysis in  an 
external laboratory.  
5.2.2 The samples should  be collected in amber glass bottles or similar appropriate containers drawn from 
the production line at intervals not less than 15 min from a particular point in the line.  
5.2.3 The sample size should  be fo ur (4) bottles of 200 g each, drawn at intervals described in 6.2.2. The 
samples should  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 . 
5.2.4 The inspector may draw more than four samples if he/she deems it necessary.  
5.2.5 In the case of points of entry and at market level, sampling of fortified fo ods and premixes, should be 
done in accordance  with either ISO 5555,  EAS 900  or CAC/GL 50.  
5.3 Analysis  
5.3.1 The samples submitted should  be composited and a representative sample drawn from the composite 
in accordance to the methods of analysis being used.  
5.3.2 The sample should  be analyzed by validated methods.  
5.3.3 The results of analysis  should  be communicated to the inspector in accordance with the procedures of 
the testing laboratory.  
6 Documentation and records  
6.1 Establishments should  document and implement procedures related to various functions  related to food 
fortification.   
© EAC 2019  – All rights reserved  5 
 6.2 All records that this standard requires should  be generated and stored in accordance to establishment 
procedures.  
6.3 All calibration evidence/records should  be kept.  
6.4 Records should  be maintained to demonstrate compliance with the requirements of this st andard.   
6 © EAC  2019  – All rights reserved  
 Annex  A 
(informative)  
 
Workshop representation  
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  
      
      
      
      
      
      
      
  
© EAC 2019  – All rights reserved  7 
 Annex  B 
(informative)  
 
Weekly inspection  
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 inspector:   
 
 
Signature:   
 
Date:   
  
Equipment  Condition  Observation/recommendations  
   
   
   
   
   
   
   
   
   
  
8 © EAC  2019  – All rights reserved  
 Annex  C 
(informative)  
 
Weekly inspection  
Production l og 
Time 
and/or 
date Product 
produced  Premix 
used 
(kg) Premix/fortific ant to 
product ratio  Name of 
supervisor  Comments/observations  
MT 
(A) Lot ID  
       
       
       
       
       
       
       
       
       
       
 
 
 
 
 
 
  
© EAC 2019  – All rights reserved  9 
 Bibliography  
[1] Guidelines on food fortification wit h micronutrients, 2006, WHO/FAO  
[2] CAC/GL 09 – 1987: General principles for the addition of essential nutrients to foods.  
[3] ECSA manuals for internal and external monitoring of fortified foods.  
[4] Vitamin and Mineral requirements in Human Nutrition, WHO/FAO, 2004, 2nd Edition.  
 DEAS 1025 : 2019    
 
© EAC 2019  – All rights reserved