DRAFT UGANDA STANDARD FINAL DRAFT UGANDA 
STANDARD  
  FDUS EAS 4 
First  Edition  
2013-mm-dd 
 
 Reference number  
FDUS EAS 4: 2013 
© UNBS 201 3 
  
Infant formula — Specification  
 DRAFT UGANDA STANDARDFDUS EAS 4: 2013 
ii                © UN BS 2013 - All rights reserved 
 Compliance with this standard does not, of itself confer immunity from legal obligations  
A Uganda Standard does not purport to include all necessary provisions of a contract. Users are 
responsible for its correct application  
© UNBS 2013 
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilised in any 
form or by any means, electronic or mechanical, including photocopying and microfilm, without prior written 
permission from UNBS. 
Requests for permission to reproduce this document should be addressed to 
The Executive Director 
Uganda National Bureau of Standards 
P.O. Box 6329 
Kampala 
Uganda 
Tel: 256 41 505 995 
Fax: 256 41 286 123 
E-mail: unbs@infocom.co.ug  
Web: www.unbs.go.ug  
 DRAFT UGANDA STANDARDFDUS EAS 4: 2013 
© UNBS  2013 - All rights reserved                iii National foreword 
Uganda National Bureau of Standards (UNBS) is a parastatal under the Ministry of Tourism, Trade and 
Industry established under Cap 3 27, of the Laws of Uganda. UNBS is mandated to co-ordinate the elaboration 
of standards and is  
(a) a member of International Organisation for Standardisation (ISO) and  
(b) a contact point for the WHO/FAO Codex Alimentarius Commission on Food Standards, and  
(c) the National Enquiry Point on TBT/SPS Agreements of the World Trade Organisation (WTO). 
The work of preparing Uganda Standards is carried out through Technical Committees. A Technical 
Committee is established to deliberate on standards in a given field or area and consists of representatives of 
consumers, traders, academicians, manufacturers, government and other stakeholders. 
Draft Uganda Standards adopted by the Technical Committee are widely circulated to stakeholders and the 
general public for comments. The committee reviews the comments before recommending the draft standards 
for approval and declaration as Uganda Standards by the National Standards Council. 
This Final Draft Uganda Standard, FDUS EAS 4 : 2013 , Infant formula — Specification , is identical with  and 
has been reproduced from an East African  Standard , EAS 4: 2013 , Infant formula — Specification , and is 
being proposed for adoption as a Uganda Standard.  
Wherever the words, “ East African Standard" appear, they should be replaced by "Uganda Standard." 
 
  DRAFT UGANDA STANDARD FDEAS 4:2013 
ICS 67.230 
© EAC 2013                                                                                                                         Second Edition 2013  
 
FINAL DRAFT EAST AFRICAN STANDARD 
Infant formula — Specification 
EAST AFRICAN COMMUNITY DRAFT UGANDA STANDARDDRAFT UGANDA STANDARDFDEAS 4: 2013 
ii © EAC 2013  – All rights reser ved 
 Copyright notice 
This EAC document is copyright-protected by EAC. While the reproduction of this document by 
participants in the EAC standards 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 permission 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 2013  — All rights reserved 
East African Community  
P.O. Box 1096 
Arusha 
Tanzania 
Tel: 255 27 2504253/8 
Fax: 255 27 2504481/2504255 
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 persecuted DRAFT UGANDA STANDARDFDEAS 4:2013 
© EAC 2013  – All rights reserved  iii 
 Contents Page 
Foreword ............................................................................................................................................................  iv 
Introduction ......................................................................................................................................................... v  
1 Scope  ................................ ................................ ................................ ................................ ...................... 1 
2 Normative references  ................................ ................................ ............................................................  1 
3 Terms and definitions  ................................ ................................ ...........................................................  2 
4 Requirements  ................................................................ ................................ ................................ ......... 3 
4.1 General requirements  ................................ ................................ ...........................................................  3 
4.2 Essential compositional requirements  ................................ ...............................................................  3 
4.3 Optional ingredients  ................................ ................................ ..............................................................  6 
4.4 Specific prohibition  ................................ ................................ ...............................................................  6 
5 Food additives  ................................................................ ................................ ................................ ....... 6 
6 Contaminants  ................................................................ ................................ ................................ ......... 8 
6.1 Pesticide residues  ................................ ................................................................ ................................ . 8 
6.2 Other contaminants  ................................ ................................ ...............................................................  8 
7 Hygiene  ................................ ................................ ................................ ................................ ................... 8 
8 Packaging  ................................ ................................ ................................ ................................ ............... 8 
9 Fill of container  ................................ ................................................................ ................................ ...... 8 
10 Labelling  ................................ ................................ ................................ ................................ ................. 9 
10.1  General  ................................ ................................ ................................ ................................ ................... 9 
10.2  Name of the food  ................................ ................................................................ ................................ ... 9 
10.3  List of ingre dients  ................................ ................................................................ ................................ . 9 
10.4  Declaration of nutritive value  ................................ ................................ ................................ ............... 9 
10.5  Net contents  ................................................................ ................................ ................................ ........... 9 
10.6  Name and address  ................................ ................................................................ ...............................  10 
10.7  Country of origin  ................................ ................................................................ ................................ . 10 
10.8  Lot identification  ................................ ................................................................ ................................ .. 10 
10.9  Date marking and storage instructions  ................................ .............................................................  10 
10.10  Instructions for use  ................................ ................................ .............................................................  10 
10.11  Additional labelling requirements  ................................ ................................ ................................ ..... 10 
11 Sampling  ................................ ................................ ................................ ................................ .............. 11 
Annex A (normative)  Sampling of infant foods  ................................ ............................................................  12 
A.1 General requirements  ................................ ................................ .........................................................  12 
A.2 Scale of sampling  ................................ ................................................................ ................................  12 
A.3 Test samples and referee samples  ................................................................ ................................ .... 13 
A.4 Number of tests  ................................ ................................................................ ................................ ... 13 
A.5 Criteria for conformity ................................ ................................ .........................................................  14 
 DRAFT UGANDA STANDARDFDEAS 4: 2013 
iv © EAC 2013  – All rights reser ved 
 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 encountered when goods and services are exchanged 
within the Community will be removed.  
In order to achieve this objective, the Community established an East African Standards Committee mandated 
to develop and issue East African Standards.   
The Committee is composed of representatives of the National Standards Bodies in Partner States, together 
with the representatives from the private sectors and consumer organizations. Draft East African Standards 
are circulated to stakeholders through the National Standards Bodies in the Partner States. The comments 
received are discussed and incorporated before finalization of standards, in accordance with the procedures 
of the Community. 
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 .  
This Final Draft East African Standard, FDEAS 4:2013, was prepared by the Technical Committee 
EASC/TC 018, Nutrition and foods for special dietary uses. The Committee is composed of representatives 
from National Standards Bodies, regulators , academia, the private sector and consumer organizations in 
Partner States. 
This Final Draft East African Standard is based on CODEX STAN 72-1981, Standard for infant formula and 
formulas for special medical purposes intended for infants. 
This second edition FDEAS 4:2013 cancels and replaces the first edition, EAS 4:2000, which has been 
technically revised. 
 DRAFT UGANDA STANDARDFDEAS 4:2013 
© EAC 2013  – All rights reserved  v 
 Introduction 
This Final Draft East African Standard gives guidelines on the formulation of infant fo od manufactured to 
substitute human milk. This standard covers safety and quality requirements, methods of sampling and test. 
Due to time and career constraints, there is every possibility for mothers to resort to the use of infant food 
formula for the sake of convenience to substitute breast-feeding. It should be emphasized that breast-feeding 
is the best and safest mode of bringing up strong healthy babies. The first weeks of an infant‟s life are 
especially important i n that mother‟s milk containing colostrums is considered  necessary for proper 
development of the infant‟s defenc e mechanism. 
The use of infant food formula preparation should be understood in its proper perspective. The formula is a 
supplementary food for infants up to the age of 12 months. In unavoidable situations where mother‟s milk is 
not available, the formula can be used as the sole source of nourishment up to the age of six months. In order 
to get the best possible benefits from infant food formula, mothers should consult health professionals for 
advice and acquaint themselves fully with the manufacturer‟s  instructions in connection with proper feeding 
procedures, cleaning and sterilization procedures for feeding utensils and hygienic preparation of the formula. 
 DRAFT UGANDA STANDARDDRAFT UGANDA STANDARDFINAL DRAFT EAST AFRICAN STANDARD  FDEAS 4:2013  
 
© EAC 2013  – All rights reserved  1 
 Infant formula ― Specification 
1 Scope 
This Final Draft East African Standard specifies the requirements and methods of sampling and test for infant 
formula in liquid or powdered form intended for use, where necessary, as a substitute for human milk in 
meeting the normal nutritional requirements of infants. 
2 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. 
AOAC 936.14, Vitamin D in milk, vitamin preparations and feed concentrates ― Rat bioassay  
AOAC 952.20 , Cobalamin (Vitamin B 12 activity) in vitamin preparations ― Microbiological methods  
AOAC 970.65 , Riboflavin (Vitamin B 2) in foods and vitamin preparations ― Fluorometric method  
AOAC 974.29 , Vitamin A in mixed feeds, premixes, and human and pet foods ― Colorimetric method  
AOAC 984. 26, Vitamin C (Total) in food ― Semi-automated fluorometric method 
AOAC 984.27 , Calcium, Copper, Iron, Magnesium, Manganese, Phosphorus, Potassium, Sodium, and Zinc in 
Infant Formula ― Inductively Coupled Plasma Emission Spectroscopic method  
AOAC 985.35 , Minerals in Infant Formula, Enteral Products, and Pet Foods ― Atomic Absorption 
Spectrophotometric method  
AOAC 986.24 , Phosphorus in infant formula and enteral products ― Spectrophotometric method  
AOAC 986.26 , Chloride in milk based infant formula ― Potentiometric method  
AOAC 986.27 , Thiamine (Vitamin B 1) milk based infant formula ― Fluorometric method  
AOAC 992.03 , Vitamin E activity (All-rac- α-tocopherol) in milk based infant formula ― Liquid chromatographic 
method 
AOAC 992.04, Vitamin A (Retinol isomers) in milk and milk- based infant formula ― Liquid chromatographic 
method  
AOAC 992.05 , Total folate (pteroylglutamic acid) in infant formula ― Microbiological methods  
AOAC 992.07 , Pantothenic Acid in milk based infant formula ― Microbiological turbidimetric method  
AOAC 992.24 , Iodide in ready- to-feed milk-based infant formula ― Ion-selective electrode method  DRAFT UGANDA STANDARDFDEAS 4:2013 
2 © EAC 2013  – All rights reser ved 
 AOAC 992.26 , Vitamin D 3 (Cholecalciferol) in ready to feed milk based infant formula — Liquid 
chromatography method  
AOAC 999.11 , Lead, Cadmium, Copper, Iron, and Zinc in foods — Atomic absorption Spectrophotometry after 
dry ashing 
AOAC 999.14,  Isolated trans unsaturated fatty acid content in partially hydrogenated fats — Infrared 
spectrophotometric method  
AOAC 999.15 , Vitamin K in milk and infant formula — Liquid chromatography method  
AOAC 2004.07, Vitamin B 6 in reconstituted infant formula — Liquid chromatography method  
AOAC 2012.12 , Analysis of free and total myo-inositol in infant formula by HPAEC-PAD (High Performance 
Anion Exchange Chromatography With Pulsed Amperometric Detection)  
AOAC 2012.017, Free and total carnitine in infant formula and adult/paediatric nutritional formula by Liquid 
Chromatography/Tandem Mass Spectrometry  
CAC/GL 2-1985, Guidelines on nutrition labelling  
CAC/GL 10-1979, Advisory lists of nutrient compounds for use in foods for special dietary uses intended for 
infants and young children   
CAC/GL 21-1997, Principles for the establishment and application of microbiological criteria for foods  
CAC/RCP 66-2008, Code of hygienic practice for powdered formulae for infants and young children   
CODEX STAN 192-1995 , General standard for food additives 
EAS 38, General standard for the labelling of pre-packaged foods 
EAS 39, Hygiene in the food and drink manufacturing industry ― Code of practice 
ISO 8070 , Milk and milk products ― Determination of calcium, sodium, potassium and magnesium contents 
― Atomic Absorption Spectrometric Method   
3 Terms and definitions 
For the purposes of this standard, the following terms and definitions shall apply. 
3.1 
infant 
person not more than 12 months of age 
3.2 
infant formula 
breast-milk substitute specially manufactured to satisfy, by itself, the nutritional requirements of infants during 
the first six months of life up to the introduction of appropriate complementary feeding  
3.3 
calorie 
kilocalorie or „large calorie‟ (1 kilo joule is equivalent to  0.239 kilocalorie)  DRAFT UGANDA STANDARDFDEAS 4:2013 
© EAC 2013  – All rights reserved  3 
 3.4 
complementary foods 
food other than breast milk or infant formula whether manufactured or locally prepared and fed to infants and 
young children in addition to breast milk or to infant formula when either becomes insufficient to satisfy their 
nutritional requirements 
3.5 
young children 
person from the age of more than 12 months up to the age of three years (36 months) 
4 Requiremen ts 
4.1 General requirements 
4.1.1  The product shall be nutritionally adequate to promote normal growth and development when used in 
accordance with the directions for use on the label. Infant formula, when in liquid form, may be used either 
directly or diluted with water before feeding, as appropriate. In powdered form, it requires water for 
preparation. 
4.1.2  The product shall be processed by physical means only and packaged as to prevent spoilage and 
contamination under all normal conditions of handling, storage and distribution. 
4.1.3 When prepared according to the directions for use on the label, the product shall be free of lumps and 
of large coarse particles and suitable for adequate feeding of infants. 
4.1.4 The product shall have colour, flavour and odour suitable for infants.  
4.1.5 The nutritional safety and adequacy of infant formula shall be scientifically demonstrated to support 
growth and development of infants.  
4.2 Essential composition al requirements 
4.2.1  Ingredients 
4.2.1.1  Infant formula shall be based on milk from dairy animals and/or other edible constituents of 
animals including fish, or plant origin, which have been proven to be suitable for infant feeding. 
4.2.1.2  All ingredients shall have characteristic colour, flavour and odour and shall be clean, of good quality, 
safe and suitable for ingestion by infants  
4.2.1.3  All ingredients and food additives shall be gluten-free. 
4.2.2  Energy 
Infant formula prepared ready for consumption in accordance with the directions for use  on the label  shall 
contain per 100 m L not less than 60 kcal (250 kJ) and not more than 70 kcal (295  kJ) of energy.  
4.2.3  Proteins  
4.2.3 .1 The minimum value of protein for infant formula based on cows‟ milk shall be  1.8 g/100 kcal or 
0.45 g/100 kJ and the maximum value s hall be 3.0 g/100 kcal or 0.7 g/100 kJ . For infant formula based on 
non-cows‟ milk protein , other  minimum values may need to be applied. For infant formula based on soy 
protein isolate, a minimum value of  2.25 g/100 kcal (0.5 g/100 kJ) applies.   
NOTE The calculation of the protein content of the final product prepared ready for consumption is based on N x 
6.25. The conversion factor for protein content is 6.25 for formula based on cows‟ milk. The conversion factor for protein DRAFT UGANDA STANDARDFDEAS 4:2013 
4 © EAC 2013  – All rights reser ved 
 content is 6.38 for formula based on non-cows‟ milk. The conversion factor for protein content is 5.71 for formula based on 
soy products. Scientific justification may be provided for the use of a different conversion factor for a particular product. 
4.2.3 .2 For an equal energy value , the formula shall contain an available quantity of each essential and 
semi- essential  amino acid at least equal to that contained in the reference protein; nevertheless for calculation 
purposes, the concentrations of tyrosine and phenylalanine may be added to gether.  The concentrations of 
methionine and cysteine may be added together if the ratio is less than 2:1; in the case that  the ratio is 
between 2:1 and 3:1 , the suitability of the formula shall be demonstrated by clinical testing.  
4.2.3 .3 Isolated amino a cids may be added to infant formula only to improve its nutritional value for 
infants. Essential  and semi- essential amino acids may be added to improve protein quality, only in amounts 
necessary for that  purpose. Only L -forms of amino acids shall be used.  
4.2.3 .4 Infant formula based on non -hydrolysed milk protein co ntaining less than 2 g protein/ 100 kcal and 
infant  formula based on hydrolysed protein conta ining less than 2.25 g protein/ 100 kcal shall be clinically 
evaluated.  
4.2.4  Lipids  
4.2.4 .1 The minimu m value of lipids for  infant formula shall be 4.4 g/100 kcal or 1.05 g/100 kJ and the 
maximum value shall be 6.0 g/100 kcal or 1.4 g/100 kJ .  
4.2.4 .2 Lauric and myristic acids as constituents of fats,  in combination,  shall not exceed 20  % of total 
fatty ac ids.  
4.2.4 .3 The content of trans fatty acids shall not exceed 3 % of total fatty acids.  
NOTE Trans fatty acids are endogenous component s of milk fat. The acceptance of up to 3 % of trans fatty acids is 
intended to allow for the use of milk fat in infant formulae.  
4.2.4 .4 The erucic acid content shall not exceed 1  % of total fatty acids.  
4.2.4 .5 The total content of phospholipids shall not exceed 300 mg/100 kcal or 72 mg/100 kJ.  
4.2.4 .6 The total content of  Linoleic acid  shall be not less than 300  mg/100 kcal or 72 mg/100 kJ and not 
more than 1400 mg/100 kcal  or 330 mg/100 kJ.  
4.2.4.7 The total content of  α-Linolenic acid  shall be not less than 50  mg/100 kcal  or 12  mg/100 kJ. The 
maximum content for α-Linolenic acid  is not specified.  
4.2.4 .8 The ratio of Linoleic/ α-Linolenic acid shall be a minimum of 5:1 and a maximum of 15:1. 
4.2.5 Carbohydrates 
4.2.5 .1 The minimum value of total carbohydrates  for infant formula shall be 9.0 g/100 kcal or 2.2 g/100 
kJ and the maximum value shall be 14.0 g/100 kcal or 3.3 g/100 kJ .  
4.2.5 .2 Lactose and glucose polymers shall be used as the main source of carbohydrates for infant  
formula based on cows‟ milk protein  and hydrolyzed protein. Only pre -cooked and/or gelatinized starches 
gluten- free by nature may be added to infant formula up to 30  % of total carbohydrates and up to 2 g/100 m L. 
4.2.5 .3 Sucrose  shall not be used  in infant formula , unless  scientific justification is provided.  
4.2.5 .4 Fructose as an ingredient  shall not be used  in infant formula  because of potential life-threatening 
symptoms in young infants with unrecognized hereditary fructose intolerance.  DRAFT UGANDA STANDARDFDEAS 4:2013 
© EAC 2013  – All rights reserved  5 
 4.2.6 Vitamins  and minerals  
4.2.6.1  Vitamins, minerals and other nutrients added shall be selected from CAC/GL 10-1979. Infant 
formula shall contain, per 100 calo ries (and 100 kilojoules) of intake, not less than the  minimum and not more 
than the maximum levels of vitamins and  minerals as specified in Table 1 . 
Table 1 ― Limits of vitamins and minerals in infant formula 
Vitamin  Amounts per 100 calories  Amounts per 100 kilojoules  
Methods of test  
Minimum  Maximum  Minimum  Maximum  
Vitamin A  60 µg REa  180 µg RE 14 µg RE 43 µg RE AOAC 992.04   
Vitamin D3 (Cholec alciferol ) 1 µg b 2.5 µg 0.25 µg 0.6 µg AOAC 992.26   
Vitamin C (Ascorbic acid ) 10 mg NSc 2.5 mg NS c AOAC 984.26 
Vitamin .B1 (Thiamine ) 60 µg  NSc 14 µg  NS c AOAC 986.27  
Vitamin . B2 (Riboflavin ) 80 µg NSc 19 µg NS c AOAC 970.65  
Vitamin B6d 35 µg  NSc 8.5 µg NS c AOAC 2004.07  
Folic acid  10 µg NSc 2.5 µg NS c AOAC 992.05  
Pantothenic acid  400 µg  NSc 96 µg NS c AOAC 992.07  
Vitamin  B12 0.1 µg NSc 0.025 µg NS c AOAC 952.20  
Vitamin  K1 4 µg NSc 1.0 µg NS c AOAC 999.15  
Vitamin H (Biotin ) 1.5 µg  NSc 0.4 µ g NS c EN 1 5607  
Vitamin E (a -tocopherol 
compounds)  0.5 mg α-TEe  0.12 mg α-TE NS c AOAC 992.03  
a 1 µg RE = 3.33 IU (International Units) Vitamin A  
b 1 µg Chole calciferol  = 40 IU (International Units) Vitamin D 3 
c  NS = Not Specified.  
d Formula with a higher protein  content than 1.8 g protein/100 calories shall contain a minimum of 15 microgram Vitamin B 6 per gram 
of protein.  
e Or per gram polyunsaturated fatty acids, expressed as Linoleic acid. 
Minerals  Minimum  Maximum  Minimum  Maximum  Methods of test  
Sodium (mg)  20 60 5 14 AOAC 984.27  
Potassium (mg)  60 180 14 43 AOAC 984.27  
Chloride (mg)  50 160 12 38 AOAC 986.26  
Calcium a) (mg) 50 NS 12 NS ISO 8070  
Phosphorusa mg 25 NS 6 NS AOAC 986.24  
Magnesium (mg)  5 NS 1.2 NS ISO 8070  
Iron (mg)b 0.45 NS 0.1 NS AOAC 9 99.11  
Iodine (µg)  10 NS 2.5 NS AOAC 992.24  
Copper (µg)c 35 NS 8.5 NS AOAC 985.35  
Zinc (mg)c 0.5 NS 0.12 NS AOAC 985.35  
Manganese (µg)  1 NS 0.25 NS AOAC 985.35  
a Calcium: Phosphorus ratio shall be minimum 1:1 and maximum  2:21. 
b Products: containin g not less than 1 mg of iron/100 available calories shall be labelled “ Infant formula with iron”.  
c Zinc: copper ratio shall be not less than 1:15 . DRAFT UGANDA STANDARDFDEAS 4:2013 
6 © EAC 2013  – All rights reser ved 
 4.2.6.2  Infant f ormula may contain  other substances , per 100 calories (and 100 kilojoules) of intake, as 
specified in Table 2.  
Table 2 ―Limits of other substances in infant formula 
 
Substance  Amounts per 100 calories  Amounts per 100 kilojoules   Methods of test   
Minimum  Maximum  Minimum  Maximum  
Choline  7 mg NS 1.7 mg NS AOAC 999.14  
Myo-inositol  4 mg NS 1 mg NS AOAC 2012.12  
L-carnitine  1.2 mg NS 0.3 mg NS AOAC 2012.01 7 
 
4.3 Optional ingredients 
In addition to the compositional requirements in 4.2, other ingredients may be added in order to provide 
substances ordinarily found in human milk and to ensure that the formulation is suitable as the sole source of 
nutrition for the infant.  
The suitability and the safety of these substances for the particular nutritional uses of infants shall be 
scientifically demonstrated. The formula shall contain sufficient amounts of these substances to achieve the 
intended effect, taking into account levels in human milk. 
Taurine may be added in amounts not exceeding 12 mg/100 kcal (3 mg/100 kJ). 
Docosahexaenoic Acid (DHA) may be added in amounts not exceeding 0.5 % of fatty acids. 
If docosahexaenoic acid (22:6 n-3) is added to infant formula, arachidonic acid (20:4 n-6) contents shall reach 
at least the same concentration as DHA. The content of eicosapentaenoic acid (20:5 n-3), which can occur in 
sources of long chain polyunsaturated fatty acid (LC PUFA), shall not exceed the content of docosahexaenoic 
acid.  
Only L(+) Lactic acid producing cultures may be used. 
4.4 Specific prohibition 
The product and its components shall not have been treated by ionizing radiation. 
Fluoride shall not be added to infant formula. In any case, its level should not exceed 100 μg/100 kcal (24 
μg/100 kJ) in infant formula prepared ready for consumption as recommended by the manufacturer.  
Hydrogenated fat shall not be used in the manufacture of infant formula.  
Products derived from genetically modified organisms shall not be used as raw material for infant formula. 
5 Food additives 
5.1 The food additives listed in Table 3 may be used in the preparation of infant formu la. DRAFT UGANDA STANDARDFDEAS 4:2013 
© EAC 2013  – All rights reserved  7 
 Table 3 — List of food additives for use in infant formula 
Additive  Maximum level in 100 m L of the ready -to-drink product  
Thickening agents  
Guar gum  0.1 g in liquid formulas containing hydrolyzed  protein  
Locust bean gum  0.1 g in all types of infant f ormula  
Distarch Phosphate  
0.5 g singly or in combination with soya -based infant formula only  
Acetylated distarch prosphate  
Phosphated distarch phosphate  2.5 g singly or in combination in hydrolyzed protein  and/or amino acid 
based infant formula only  Hydroxypropyl starch  
Carrageen an 0.03 g in regular milk -and soy -based liquid infant formula only  
0.1 g in hydrolyzed  protein  and/or amino acid based liquid infant formula 
only 
Emulsifiers  
Lecithin  0.5 g in all types of infant formula  
Mono -and di -glyceride  0.4 g in all types of infant formula  
Acidity regulators  
Sodium hydroxide  0.2 g singly or in  combination and within the limits for sodium, potassium 
and calcium in Table 1 in all types of infant formula  
Sodium hydrogen carbonate  
0.2 g singly or in combination and within the limits for sodium, potassium 
and calcium in Table 1 in all types of infan t formula  Sodium carbonate  
Potassium hydrogen carbonate  
Potassium hydroxide  
Potassium carbonate  
Calcium hydroxide  
Sodium dihydrogen citrate  
Limited by GMP in all types of infant formula  
 Trisodium citrate  
Potassium citrate  
L (+) Lactic ac id 
Citric acid  
Antioxidants  
Mixed tocopherol concentrate  1 mg in all types of infant formula  singly or in combination  
L-Ascorbyl Palimitate  1 mg in all typ es of infant formula  singly or in combination  
Packaging gases  
Carbon dioxide  GMP  
Nitrogen  
 
5.2 The amount of the food additive in the raw materials or other ingredients (including food additives ) shall 
not exceed the maximum level specified. 
Any carry-over of food additives from the raw materials used shall be consistent with the provisions in the 
preamble of CODEX STAN 192-1995. DRAFT UGANDA STANDARDFDEAS 4:2013 
8 © EAC 2013  – All rights reser ved 
 6 Contaminants 
6.1 Pesticide residues 
The product shall be prepared with special care under good manufacturing practices, so that residues of those 
pesticides which may be required in the production, storage or processing of the raw materials or the finished 
food ingredient, do not remain or if technically unavoidable, are reduced to the maximum extent possible 
provided that the residual amounts do not impair the health of the infant. 
6.2 Other contaminants 
The product shall be free from residues of hormones and antibiotics, and practically free from other 
contaminants especially pharmacologically active substances. The product shall not contain contaminants or 
undesirable substances (for example, biologically active substances) in amounts which may represent a 
hazard to the health of the infant.  
The product shall comply with those maximum residue limits and maximum levels established by the Codex 
Alimentarius Commission. 
The maximum allowable limit in the ready to use product for lead shall be 0.02 mg/kg. 
The product shall not contain mycotoxins in amounts which may represent a hazard to the health of the infant.  
The maximum allowable limit in the ready to use product for melamine shall be 1.0 mg/kg for solid (powered) 
infant formula and 0.15 mg/kg for liquid infant formula. 
7 Hygiene 
Infant formula shall be prepared and packaged in the premises built and maintained under hygienic condition 
in accordance with EAS 39 and CAC/RCP 66-2008. 
Powdered infant formula shall conform to the microbiological limits specified in CAC/RCP 66-2008. 
8 Packaging 
8.1 The product shall be pack aged in containers, which will safeguard the hygienic and other qualities of 
the food. When in liquid form, the product shall be pack aged in hermetically sealed containers. Nitrogen and 
carbon dioxide may be used as packing media. 
8.2 The containers, including packaging materials, shall be made only of substances, which are safe and 
suitable for their intended uses. 
9 Fill of container 
In the case of products in ready- to-eat form, the fill of the container shall be: 
a) not less than 80 % v/v for products weighing less than 150 g; 
b) not less than 85 % v/v for products in the weight range 150 g to 250 g; and 
c) not less than 90 % v/v for products weighing more than 250 g of the water capacity of the container. 
The water capacity of the container is the volume of distilled water at 20 °C which the sealed 
container will hold when completely filled. DRAFT UGANDA STANDARDFDEAS 4:2013 
© EAC 2013  – All rights reserved  9 
 10 Labelling 
10.1 General 
In addition to the requirements of EAS 38, the specific requirements in 10.2 – 10.10 shall apply and shall be 
legibly and indelibly marked. 
10.2 Name of the food 
10.2.1 The name of the product shall be either “Infant formula ” or any appropriate designation indicating the 
true nature of the product. 
10.2.2 The sources of protein in the product shall be clearly shown on the label.  
10.2.3 The source and proportion of saturated and unsaturated fatty acids shall be indicated. 
10.2.4 If 90 % or more of the protein is derived from whole or skimmed milk, as such or with minor 
modification, the product may be labell ed “Infant formula based on m ilk”. 
10.2.5 A product which contains neither milk nor any milk derivatives may be labelled contains no milk or 
milk products or an equivalent phrase. 
10.2.6 A product intended for infants with special nutritional requirements shall be labelled to show clearly 
the special requirements for which the formula is to be used and the dietary properties on which this is based. 
10.2.7 Products containing not less than 1 mg iron (Fe) per 100 available calories shall be labelled “Infant 
Formula with Iron ”. 
10.3 List of ingredients 
10.3.1 A complete list of ingredients shall be declared on the label in descending order of proportion except 
that in the case of added vitamins and added minerals, these ingredients shall be arranged as separate 
groups for vitamins and minerals, respectively, and within these groups the vitamins and minerals need not be 
listed in descending order of proportion. 
10.3.2 The specific name shall be declared for ingredients of animal or plant origin and for food additives. In 
addition, appropriate class names for these ingredients and additives may be included on the label. 
10.4 Declaration of nutritive value 
The declaration of nutrition information shall contain the following information in the following order: 
a) the amount of energy, expressed in calories (kcal) and/or kilojoules (kJ) and the number of grams of 
protein, carbohydrate and fat per 100 grams of the foods as sold as well as per specified quantity of 
the food as suggested for consumption; and 
b) the total quantity of each vitamin, mineral, choline and any optional ingredient as listed in 4.2.6 and 
4.3 of  this standard per 100 g of the food as sold as well as per specified quantity of the food as 
suggested for consumption. In addition the declaration per 100 calories (or per 100 kilojoules) is 
permitted. 
10.5 Net contents 
The net content of infant formula shall be declared by volume if it is in liquid form or by weight if it is in 
powdered form. The declaration of weight or volume shall be in metric units. DRAFT UGANDA STANDARDFDEAS 4:2013 
10 © EAC 2013  – All rights reser ved 
 10.6 Name and address 
The name and address of the manufacturer packer, distributor, importer, exporter, or vendor of the food shall 
be declared. 
10.7 Country of origin 
10.7.1 The country of origin of the food shall be declared. 
10.7.2 When the food undergoes processing in a second country, which changes its nature, the latter country 
shall be considered the country of origin for the purpose of labelling. 
10.8 Lot identification 
Each container shall be embossed or otherwise permanently marked, in code or in clear, to identify the 
producing factory and the lot. 
10.9 Date marking and storage instructions 
10.9.1 The date of minimum durability (preceded by the words “best before” shall be declared by the day, 
month and year in uncoded numerical sequence except that for products with a shelf life of more than three 
months, the month of the year will suffice. 
In the case of products requiring a declaration of monthly and year only, and the shelf life of the product is 
valid to the end of a given year, the expression end (stated year) may be used. 
10.9.2 In addition to the date, any special conditions for the storage of the food shall be indicated if the 
validity of the date depends thereon. Where practicable, storage instructions shall be in close proximity to the 
date marking. 
10.10  Instructions for use 
10.10.1 Products in liquid form may be used either directly or in the case of concentrated liquid products, shall 
be prepared with water that is safe or has been rendered safe by previous boiling before feeding, according to 
directions for use. 
10.10.2 Products in powder form shall be reconstituted with water that is safe or has been rendered safe by 
previous boiling for preparation. 
10.10.3 Adequate directions for the appropriate preparation and use of the product, including its storage 
before use, after opening the container and after preparation shall be given. 
A statement that formula remaining after feeding should be discarded, shall appear on the label and in any 
accompanying leaflet. 
10.10.4 The label shall carry clear graphic instructions illustrating the method of preparation of the product. 
10.10.5 Adequate directions regarding the storage of the product after the container has been opened shall 
appear on the label and in any accompanying leaflet. 
10.11 Additional labelling requirements 
10.11.1 Labels shall not discourage breastfeeding or the use of human milk. The label shall not have any 
statement or information that implies that infant formula is superior to human milk or breastfeeding. 
10.11.2 The trade name or any other name or information on the label shall not be similar to names of other 
products of different nature not intended for infants. DRAFT UGANDA STANDARDFDEAS 4:2013 
© EAC 2013  – All rights reserved  11 
 10.11.3 Each container label shall have a clear, conspicuous and easily readable message which includes the 
words " Important notice" or their equivalent , followed by : 
i. a statement indicating  that infant formula is intended to r eplace or supplement breast -feeding, 
where breast feeding  or use of human milk  is not possible o r to supplement where breast milk is 
insufficient, may be given on the label ; 
ii. a statement "Breast milk is the best food for your baby" or a similar statement as to the 
superiority of breastfeeding or breast milk;  
iii. a statement that the product should only be used on advice of a independent health worker as to 
the need for its use and the proper method of use; and 
iv. a statement warning against the health hazards of inappropriate preparation, storage and use. 
10.11.4 The label shall have no pictures, photographs, drawings , or any other graphics which represent 
infants and /or women other than illustrating methods of preparation. The label shall not idealize the use of 
infant formula. 
10.11.3 The terms "humanized", "maternalized" or other similar terms shall not be used. 
10.11.4 Information shall appear on the label to the effect that infants should receive complementary foods in 
addition to the formula, from an age that is appropriate for their specific growth and development needs, as 
advised by an independent health worker, and in any case from the age over six months. 
10.11.5 The products shall be labelled in such a way as to avoid any risk of confusion between infant formula, 
follow-up formula, and formula for special medical purposes. 
11 Sampling 
Sampling of infant formula shall be done in accordance with Annex A. DRAFT UGANDA STANDARDFDEAS 4:2013 
12 © EAC 2013  – All rights reser ved 
 Annex A 
(normative) 
 
Sampling of infant foods  
A.1 General requirements 
A.1.1 In drawing, preparing, storing and handling samples, the precautions and directions in A. 1.2 – A.1.6 
shall be observed: 
A.1.2 Samples shall be taken in a protected place not exposed to damp air, dust or soot. 
A.1.3 The sampling instrument shall be clean and dry when used. When taking samples for bacteriological 
examination, it shall be sterile. 
A.1.4 Precautions shall be taken to protect the samples, the material being sampled, the sampling 
instrument and the containers for samples from adventitious contamination. The samples shall be placed in 
clean and dry glass containers. The sample containers shall be of such a size that they are almost completely 
filled by the sample. The sample containers shall in addition be sterile when they are used for samples for 
bacteriological examination. 
A.1.5 Each container shall be sealed airtight after filling and marked with full details of sampling, batch or 
code number, name of the manufacturer and other important particulars of the consignment. 
A.1.6 Samples shall be stored in a cool dark place and in such a manner that the temperature of the 
material does not vary unduly from the normal temperature. 
A.2 Scale of sampling 
All the containers in a single consignment of one type of material drawn from a single batch of manufacture 
shall constitute a lot. If the consignment is declared to consist of different batches of manufacture, the batches 
shall be marked separately and the group of containers in each batch shall constitute separate lots. 
Samples shall be tested from each lot for ascertaining its conformity to the requirements of the relevant East 
African Standard. 
The number of containers to be selected from the lot shall depend on the size of lot and shall be as given in 
Table 1. 
Table 1 — Number of containers to be selected for sampling) 
(1) (2) (3) 
Lot size  Number of samples (for tests other 
than microbiological)  Number of samples (for 
microbiological tests)  
2 to 25  2 2 
26 to 100  3 3 
101 to 300  5 5 
301 to 500  7 7 
501 and above  9 9 DRAFT UGANDA STANDARDFDEAS 4:2013 
© EAC 2013  – All rights reserved  13 
 The containers shall be chosen at random from the lot, and for this purpose a random number table as agreed 
to between the purchaser and the supplier shall be used. If such a table is not available, the following 
procedure shall be adopted. 
Starting from any container, in one order, count them as 1, 2, 3, etc., up to r and so on in a systematic manner 
and withdraw the rth container; r being the integral part of N/n where N is the total number of containers and n 
the number of containers to be selected according to column 2 or 3 of Table 1. 
A.3 Test samples and referee samples 
A.3.1 Microbiological examination samples 
Sampling for microbiological examination shall be carried out before sampling for chemical analysis. 
A.3.2 Preparation of individual sample 
Draw with a suitable sampling instrument approximately equal quantities of the material from different parts of 
the container till about 500 g of the material are obtained. From this, take about 150 g of the material and 
divide it into three equal parts. Each part so obtained shall constitute an individual sample representing the 
container and shall be transferred immediately to thoroughly clean and dry containers sealed air-tight with 
particulars given under A.1.5. The individual sample so obtained shall be divided into three sets in such a way 
that each set has a sample, representing each selected container. One of these shall be marked for the 
purchaser, another for the vendor and the third for the referee. 
A.3.3 Preparation of composite sample 
From the material from each selected container, remaining after the individual sample has been taken, 
approximately equal quantities of the material shall be taken and mixed together so as to form a composite 
sample weighing about 600 g. This composite sample shall be divided into three equal parts and transferred 
to clean and dry containers, sealed airtight and labelled with the particulars given in A.1.5. One of these 
composite samples shall be for the purchaser, another for the vendor and the third for the referee. Sufficient 
care shall be taken during the preparation of composite sample to avoid contamination. 
A.3.4 Preparation of samples for microbiological examination 
From the selected containers select a sub-sample according to column 3 of Table 1. Draw with a suitable 
sampling instrument, which is sterile, at least 100 g of the material and mix thoroughly under aseptic 
conditions to form a sample of container for microbiological examination. Divide the sample (taking care not to 
bring in microbiological contamination in the material) into three equal parts. Each part so obtained shall 
constitute a sample representing the container and shall be transferred to sterile glass containers, sealed air-
tight and labelled with particulars given in A.1.5. They shall be marked, in addition with the words, „For 
Microbiological Examination'. The samples so obtained shall be divided into three sets in such a way that 
each set has a sample representing each selected container. One of these sets shall be marked for the 
purchaser, another for the vendor and the third for the referee. 
A.3.5 Referee samples 
Referee samples shall consist of a set of individual samples (A.3.2), a composite sample (A.3.3) and a set of 
samples for microbiological examination (A.3.4) marked for this purpose and shall bear the seals of the 
purchaser and the vendor. These shall be kept at a place as agreed to between the two parties. 
A.4 Number of tests 
A.4.1 Test for the determination of moisture, flavour and fat shall be conducted on each of the samples 
constituting a set of individual samples. DRAFT UGANDA STANDARDFDEAS 4:2013 
14 © EAC 2013  – All rights reser ved 
 A.4.2 Tests for the determination of acid-insoluble ash, Vitamin A, added Vitamin D and iron total 
carbohydrate, and total milk protein shall be conducted on the composite sample. 
A.4.3 Test for bacterial count and coliform count shall be conducted on each of the samples constituting a 
set of test samples labelled with the words „For Microbiological Examination'.  
A.5 Criteria for conformity 
The lot shall be declared as conforming to all the requirements of this standard when the following are 
satisfied: 
a) the test results, on each of the individual samples for determination of moisture, total milk protein, total 
ash, fat and total carbohydrate shall satisfy the corresponding requirements; 
b) the test results on the composite sample for general characteristics flavour acid-insoluble ash, Vitamin 
A, added Vitamin D and iron shall satisfy the corresponding requirements; 
c) the test results shall also satisfy other requirements in the relevant East African Standard; and 
d) the test results for bacterial count and coliform count shall satisfy the corresponding  requirements.  
 
 DRAFT UGANDA STANDARDFDEAS 4:2013    
 
© EAC 2013 – All rights reserved