DRAFT UGANDA 
STANDARD  
  DUS DEAS 4 
 
Third  Edition  
2019-mm-dd 
 
 Reference number  
DUS DEAS 4: 2019  
 
© UNBS 2019 
   
Infant formula — Specification  
 
 DUS DEAS 4: 2019  
ii                © UNBS  2019 - 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 applica tion 
© UNBS 2019  
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 U NBS.  
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 7 333 2 50/1/2 
Fax: +256 41 286 123  
E-mail: info@unbs.go.ug  
Web: www.unbs.go.ug  
 DUS DEAS 4: 2019  
© UNBS  2019 - All rights reserved                 iii National foreword  
Uganda National Bureau of Standards (UNBS) is a parastatal under the Ministry of Trade, Industry and 
Cooperatives established under Cap 327, of the Laws of Uganda, as amended.  UNBS is mandated to  co-
ordinate the elaboration of standards and is  
(a) a member of International Organisatio n for Standardisation (ISO),  
(b) a contact point for the WHO/FAO Codex Alimentarius Commission on Food Standards, and  
(c) the National Enquiry Point on TBT Agreement of the Wor ld 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 Uganda Standard, US EAS 4: 2019 , Infant formula — Specification , is identical with and has been 
reproduced from an East African  Standard, EAS 4: 2019 , Infant formula — Specification , and adopted  as a 
Uganda Standard.  
The committee responsible for this document is Technical Committee UNBS/TC 2 , Food and agriculture , 
Subcommittee SC 5 , Nutrition and special dietary f oods . 
This third edition cancels and re places the first edition ( US EAS 4:2013), which has been technically revised.  
Wherever the words, “ East African  Standard " appear, they should be replaced by "Uganda Standard."   DEAS 4 : 2019  
ICS 67.230  
 
© EA C 2019                                                                                                                              Third Edition  2019   
 DRAFT EAST AFRICAN STANDARD  
Infant formula  — Specification  
EAST AFRICAN COMMUNITY  DEAS 4 : 2019  
ii © EAC 2019 – All rights rese rved 
 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 permitt ed 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  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 4 : 2019  
© EAC 2019 – All rights reserved  iii 
 Contents  Page 
Foreword  ................................ ................................ ................................ ................................ ............................  iv 
1 Scope  ................................ ................................ ................................ ................................ ......................  1 
2 Normative references  ................................ ................................ ................................ ............................  1 
3 Terms and definitions  ................................ ................................ ................................ ...........................  2 
4 Requirements  ................................ ................................ ................................ ................................ .........  3 
4.1 General requirements  ................................ ................................ ................................ ...........................  3 
4.2 Specific requirements  ................................ ................................ ................................ ...........................  3 
4.2.1  Ingredients  ................................ ................................ ................................ ................................ .............  3 
4.2.2  Energy  ................................ ................................ ................................ ................................ ....................  3 
4.2.3  Proteins  ................................ ................................ ................................ ................................ ..................  3 
4.2.4  Lipids  ................................ ................................ ................................ ................................ ......................  4 
4.2.5  Carbohydrates  ................................ ................................ ................................ ................................ ....... 4 
4.2.6  Vitamins and minerals  ................................ ................................ ................................ ..........................  4 
4.3 Optional ingredients  ................................ ................................ ................................ ..............................  6 
4.4 Specific prohibition  ................................ ................................ ................................ ...............................  6 
5 Food additives  ................................ ................................ ................................ ................................ ....... 6 
6 Contaminants  ................................ ................................ ................................ ................................ .........  7 
6.1 Residues of pesticides, hormones and antibiotics  ................................ ................................ ...........  7 
6.2 Other contaminants  ................................ ................................ ................................ ...............................  7 
7 Hygiene  ................................ ................................ ................................ ................................ ...................  8 
8 Packaging  ................................ ................................ ................................ ................................ ...............  8 
9 Fill of container  ................................ ................................ ................................ ................................ ...... 8 
10 Labelling  ................................ ................................ ................................ ................................ .................  8 
10.1  General  ................................ ................................ ................................ ................................ ...................  8 
10.2  The name of the food  ................................ ................................ ................................ ............................  8 
10.3  List of ingredients  ................................ ................................ ................................ ................................ . 9 
10.4  Declaration of nutritive value  ................................ ................................ ................................ ...............  9 
10.5  Net contents  ................................ ................................ ................................ ................................ ...........  9 
10.6  Name and address  ................................ ................................ ................................ ................................ . 9 
10.7  Country of origin  ................................ ................................ ................................ ................................ ... 9 
10.8  Lot identification  ................................ ................................ ................................ ................................ .... 9 
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 (norma tive)  Sampling of infant formula  ................................ ................................ ........................  12 
A.1 General requirements  ................................ ................................ ................................ .........................  12 
A.2 Scale of sampling  ................................ ................................ ................................ ................................  12 
A.3 Test samples and referee samples  ................................ ................................ ................................ .... 13 
A.3.1  Microbiological examination samples ................................ ................................ ...............................  13 
A.3.2  Preparation of indivi dual sample  ................................ ................................ ................................ ....... 13 
A.3.3  Preparation of composite sample  ................................ ................................ ................................ ...... 13 
A.3.4  Preparation of samples for microbiological examination  ................................ ...............................  13 
A.3.5  Referee samples  ................................ ................................ ................................ ................................ .. 13 
A.4 Number of tests  ................................ ................................ ................................ ................................ ... 14 
 DEAS 4 : 2019  
iv © EAC 2019 – All rights rese rved 
 Foreword  
Development of the East African Standards has been nece ssitated 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.  
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 Part ner 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 discussed 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 t hat some of the elements of this document may be subject of patent 
rights. EAC shall not be held responsible for identifying any or all such patent rights.  
This third edition cancels and  replaces the  first edition ( EAS 4: 2013 ), which has been  technically revised.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 DEAS 4 : 2019  
© EAC 2019 – All rights reserved  v 
 Introduction  
This Draft East African Standard gives guidelines on the formulation of infant food 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 stro ng healthy babies. The first weeks of an infant’s life are 
especially important in that mother’s milk containing colostrums is considered necessary for proper 
development of the infant’s defence 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, cleanin g and sterilization procedures for feeding utensils and hygienic preparation of the formula.  
 DEAS 4 : 2019    
 
© EAC 2019 – All rights reserved  
  
 Infant formula  — Specification  
 
1 Scope  
This Draft East African Standard specifies the requirements sampling and test methods for infant formula in 
liquid or pow dered form intended for use, where necessary, as a substitute for breast  milk in meeting the 
normal nutritional requirements of infants.  
2 Normative references  
The following documents are referred to in the text in such a way that some or all of their cont ent constitutes 
requirements of this document. For dated references, only the edition cited applies. For undated references, 
the latest edition of the referenced document (including any amendments) applies.  
AOAC 952.20, Cobalamin (Vitamin B12 Activity) in vitamin preparations ― Microbiological methods  
AOAC 970.65, Riboflavin (Vitamin B2) in foods and vitamin preparations ― Fluorometric method  
AOAC 984.26, Vitamin C (Total) in food ― Semi -automated fluorometric method  
AOAC 984.27, Calcium, Copper, Iron, Magn esium, 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 ― Protentiometric method  
AOAC 986.27, Thiamine (Vitamin B1) milk based infant formula ― Flurometric 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  
AOAC 992.26, Vitamin D3 (Cholecalciferol) in ready to feed milk based infant formula – Liquid 
chromatography method   
2 © EAC 2019 – All rights rese rved 
 AOAC 9 99.11 , 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 B6 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)  
CAC/RCP 66 , Code of hygienic practice for powdered formulae for infants and young children   
CODEX STAN 192 , 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  
ISO 20649, Infant formula and adult nut ritionals — Determination of chromium, selenium and molybdenum — 
Inductively coupled plasma mass spectrometry (ICP -MS) 
3 Terms and definitions   
For the purposes of this document, the following terms and definitions apply.  
3.1  
infant  
person not more than 1 2 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)  
3.4 
complementary foods  
food other than breast milk or infant formula whether manufactured or locally prepared and fed to older infants 
and young children in addition to breast mi lk 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)   
© EAC 2019 – All rights reserved  3 
 4 Requirements  
4.1 General requirements  
4.1.1  The prod uct 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 appropr iate. 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 prepa red 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.  
NOTE  The nutritional safety and adequacy of infant formula should  be scientifically demonst rated to support growth 
and development of infants.  
4.2 Specific  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 pr oven to be suitable for infant feeding.  
4.2.1.2  All ingredients shall l be clean, of good quality, safe and suitable for ingestion by infants  and shall 
conform with their normal quality requirementss such as colour, flavour and odour.  
4.2.1.3  All ingredien ts 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 mL not less than 60 kcal (250 kJ) and not more than 70 kcal (295 kJ) of ener gy. 
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 shall 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) appli es. 
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  
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 p roducts. 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 l east equal to that contained in the reference protein; nevertheless for calculation 
purposes, the concentrations of tyrosine and phenylalanine may be added together. The concentrations of 
methionine and cysteine may be added together if the ratio is less t han 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 acids may be added to infant formula only to improve its nutritional value for 
infants. Essential a nd 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 © EAC 2019 – All rights rese rved 
 4.2.3.4  Infant formula based on non -hydrolysed milk protein containing less than 2 g protein/100 k cal and 
infant formula based on hydrolysed protein containing less than 2.25 g protein/100 kcal shall be clinically 
evaluated.  
4.2.4  Lipids  
4.2.4.1  The minimum value of lipids for infant formula shall be 4.4 g/100 kcal or 1.05 g/100 kJ and the 
maximum valu e 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 acids.  
4.2.4.3  The content of trans fatty acids shall not exceed 3 % of total fatty acids.  
NOTE  Trans fatty acids are endogenous components 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 conte nt 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 mL.  
4.2.5.3  Sucrose shall not be us ed 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.  
4.2.6 Vitamins and minerals  
4.2.6.1  Vitamins, minerals and other nutrients added shall be selected from CAC/GL 10. Infant formula 
shall contain, per 100 calories (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  
Test m ethod  
Minimum  Maximum  Minimum  Maximum  
Vitamin A  60 µg REa  180 µg RE 14 µg RE 43 µg RE AOAC 992.04  
Vitamin D3 (Cholecalciferol)  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 98 4.26  
© EAC 2019 – All rights reserved  5 
 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 B 6d 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 µg  NS c EN 15607  
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 Cholecalciferol = 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  Test m ethod  
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 999.11  
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  
Selenium ( µg) 1 NS 0.24 NS ISO 20649  
a Calcium: Phosphorus ratio shall be minimum 1:1 and maximum  2:21. 
b Products: containing 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 . 
NS Not Specified  
 
4.2.6.2 Infant formula 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   Test methods  
Minimum  Maximum  Minimum  Maximum  
Choline  7 mg  NS 1.7 mg  NS AOAC 999.14   
6 © EAC 2019 – All rights rese rved 
 Myo-inositol  4 mg  NS 1 mg  NS AOAC 2012.12  
L-carnitine  1.2 mg  NS 0.3 mg  NS AOAC SMPR 2012.010  
4.3 Optional ingredients  
4.3.1  In addition to the compositional requirements in 4.2, oth er 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.  
4.3.2  The suitability and the safety of these substances for the partic ular 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.  
4.3.3  Taurine may be added in amounts not exce eding 12 mg/100 kcal (3 mg/100 kJ).  
4.3.4  Docosahexaenoic Acid (DHA) may be added in amounts not exceeding 0.5 % of fatty acids.  
4.3.5  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.  
4.4 Specific prohibition  
4.4.1 The product  and its components shall not have been treated by ionizing radiation.  
4.4.2 Fluoride shall not be added to infant formula. In any case, its level should not exceed 10 0 μg/100 kcal 
(24 μg/100 kJ) in infant formula prepared ready for consumption as recommended by the manufacturer.  
4.4.3 Commercially hydrogenated oils and fats shall not be used in infant formulas.  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 formula.  
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 formula  
Distarch Phosphate  
0.5 g singly or in combination with soya -based infant formula only  
Acetyla ted 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  
Carrageenan  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   
© EAC 2019 – All rights reserved  7 
 Mono -and di -glyceride  0.4 g in all types of infant formula  
Acidity regulators  
Sodium hydroxide  0.2 g singly or in co mbination 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 infant f ormula  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 acid  
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.  
5.3 Any carry -over of food additives from the raw materials used shall be consistent with the provisions in 
the preamble of CODEX STAN 192 . 
6 Contaminants   
6.1 Residues  of pesticides, hormones and antibiotics  
6.1.1  Infant formula shall comply with the maximum pesticide residue limits established by Codex 
Alimentarius Commission for this commodity . 
6.1.2  The prod uct shall be free from residues of hormones and antibiotics, and practically free from other 
contaminants especially pharmacologically active substances . 
6.2 Other contaminants  
Infant formula shall comply with the maximum limits for contaminants specified in table 2, when tested in 
accoradance with test methods therein.  
Table  2 — Maximum limits for contaminants in infant formula  
S/N Contaminant  Maximum Limit  Test method   
8 © EAC 2019 – All rights rese rved 
 1.  Lead , mg/kg  0.02  ISO 6633  
2.  Aflatoxin M1, µg/kg  0.5  ISO 14501.  
3.  Melamine , mg/kg  Solid 
(pow dered) 
infant 
formula  1.0  AOAC 2016.015  
Liquid infant 
formula  0.15  
7 Hygiene  
7.1 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 . 
7.2 Powdere d infant formula shall conform to the microbiological limits specified in CAC/RCP 66 . 
8 Packaging  
8.1 The product shall be packaged in containers, which will safeguard the hygienic and other qualities of 
the food. When in liquid form, the product shall be packaged 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 contai ner 
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.  
10 Labelling  
10.1 General  
In addition t o the requirements of EAS 38, the specific requirements in 10.2 – 10.10 shall apply and shall be 
legibly and indelibly marked.  
10.2 The name of the food  
10.2.1  The name of the product shall be either “Infant formula” or any appropriate designation indicati ng the 
true nature of the product.  
10.2.2  The sources of protein in the product shall be clearly shown on the label.   
© EAC 2019 – All rights reserved  9 
 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 deri ved from whole or skimmed milk, as such or with minor 
modification, the product may be labelled “Infant formula based on milk”.  
10.2.5  A product which contains neither milk nor any milk derivatives may be labelled contains no milk or 
milk products or an eq uivalent 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 c ontaining 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 t he 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 spe cified 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 weigh t if it is in 
powdered form. The declaration of weight or volume shall be in metric units.  
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 orig in 
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 iden tification  
Each container shall be embossed or otherwise permanently marked, in code or in clear, to identify the 
producing factory and the lot.   
10 © EAC 2019 – All rights rese rved 
 10.9 Date marking and storage instructions  
10.9.1  The date of minimum durability (preceded by the words “best b efore” 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 dep ends 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 preparat ion. 
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 discarde d, 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 contain er 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 imp lies 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.  
10.11.3  Each container l abel shall have a clear, conspicuous and easily readable message which includes the 
words "Important notice" or their equivalent, followed by:  
a) a statement indicating that infant formula is intended to replace or supplement breast -feeding, where 
breast feed ing or use of human milk is not possible or to supplement where breast milk is insufficient, 
may be given on the label;  
b) a statement "Breast milk is the best food for your baby" or a similar statement as to the superiority of 
breastfeeding or breast milk;  
c) 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  
d) a statement warning against the health hazards of inappropriate preparation, storage and use.   
© EAC 2019 – All rights reserved  11 
 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. 4 The terms "humanized", "materna lized" or other similar terms shall not be used.  
10.11.5  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 developme nt needs, as 
advised by an independent health worker, and in any case from the age over six months.  
10.11. 6 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 me dical purposes.  
11 Sampling  
Sampling of infant formula shall be done in accordance with Annex A.   
12 © EAC 2019 – All rights rese rved 
 Annex  A 
(normative)  
 
Sampling of infant formula  
A.1 General  requirements  
A.1.1  In drawing, preparing, storing and handling samples, the precautions and direct ions 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 samp le 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 aft er 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 
mate rial does not vary unduly from the normal temperature.  
A.2 Scale of sampling  
A.2.1 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.  
A.2.2 Samples shall be tested from each lot for ascertaining its conformity to the requirements of the 
relevant East African Standard.  
A.2.3 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  
© EAC 2019 – All rights reserved  13 
 501 and above  9 9 
A.2.4 The containers shall be chosen at random from the lot, and for this purpose a random n umber 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.  
A.2.5 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 mate rial 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 
contain er 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 ea ch 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 bee n 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, seal ed 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 avoi d 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 
constit ute 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  
Refer ee 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 a t a place as agreed to between the two parties.   
14 © EAC 2019 – All rights rese rved 
 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.  
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'.   
© EAC 2019 – All rights reserved  15 
 SECTION B: FORMULA FOR SPECIAL MEDICAL PURPOSES INTENDED FOR INFANTS  
1. SCOPE   
1.1 This section of the Standard applies to Formula for Special Medical Purposes Intended for Infants in 
liquid  or powdered form intended for use, where necessary, as a substitute for breast milk or infant 
formula in meeting the special nutritional requirements arising from the disorder, disease or medical 
condition for whose dietary management the product has been  formulated.  
1.2 This section of the Standard contains compositional, quality, labelling and safety requirements for 
Formula for Special Medical Purposes Intended for Infants.  
1.3 Only products that comply with the criteria laid down in the provisions of t his section of this standard 
would be accepted for marketing as formula for special medical purposes intended for infants.  
1.4 The application of this section of the Standard should take into account, as appropriate for the products to 
which the section ap plies and the special needs of the infants for whom they are intended, the 
recommendations made in the International Code of Marketing of Breast -milk Substitutes (1981), the Global 
Strategy for Infant and Young Child Feeding and World Health Assembly resol ution WHA54.2 (2001).  
2. DESCRIPTION   
2.1 Product definition  
2.1.1 Formula for Special Medical Purposes Intended for Infants means a substitute for breast milk or infant  formula 
that complies with description of foods for special medical purposes and is speci ally manufactured to satisfy, 
by itself,  the special nutritional requirements of infants with specific disorders, diseases or medical conditions 
during the first months of life up to the introduction of appropriate complementary feeding.  
2.1.2 Foods for sp ecial medical purposes are a category of foods for special dietary uses which are specially 
processed or formulated and presented for the dietary management of patients and may be used only 
under medical supervision. They are intended for the exclusive or partial feeding of patients with limited 
or impaired capacity to take, digest, absorb or metabolize ordinary foodstuffs or certain nutrients 
contained therein, or who have other special medically -determined nutrient requirements, whose dietary 
management c annot be achieved only by modification of the normal diet, by other foods for special 
dietary uses, or by a combination of the two.  
2.1.3 The product is so processed by physical means only and so packaged as to prevent spoilage and 
contamination under all normal conditions of handling, storage and distribution in the country where the 
product is sold.  
2.1.4 The term infant means a person not more than 12 months of age.  
3 ESSENTIAL COMPOSITION AND QUALITY FACTORS  
3.1 Essential Composition  
3.1.1 Formula for Special Medical Purposes intended for Infants is a product based on ingredients based of  
animal, plant and/or synthetic origin suitable for human consumption. All ingredients and food additives 
shall be gluten -free. 
3.1.2 The composition of Formula for Spe cial Medical Purposes Intended for Infants shall be based on sound  
medical and nutritional principles. The nutritional safety and adequacy of the formula shall be 
scientifically demonstrated to support growth and development in the infants for whom it is i ntended, as 
appropriate for the specific products and indications. Their use shall be demonstrated by scientific 
evidence to be beneficial in the dietary management of the infants for whom it is intended.   
16 © EAC 2019 – All rights rese rved 
 3.1.3 The energy content and nutrient composition o f Formula for Special Medical Purposes intended for 
infants  shall be based on the requirements for infant formula as given in sections A 3.1.2 and A 3.1.3, 
except for the compositional provisions which must be modified to meet the special nutritional 
requi rements arising from the disease(s), disorder(s) or medical condition(s) for whose dietary 
management the product is specifically formulated, labelled and presented.  
3.1.4 In addition to the requirements in 3.1.3 the following requirements shall also be ta ken into account, 
where  appropriate:  
Chromium  
Unit Minimum  Maximum  GUL 
g/100 kcal  1.5 - 10 
g/100 kJ  0.4 - 2.4 
Molybdenum  
Unit Minimum  Maximum  GUL 
g/100 kcal  1.5 - 10 
g/100 Kj 0.4 - 2.4 
3.2 Optional ingredients  
3.2.1 In addition to the compositional requirements listed under 3.1.3, other ingredients may be added in o rder 
to provide substances ordinarily found in human milk or required to ensure that the formulation is 
suitable as the sole source of nutrition for the infant and for the dietary management of his/her disease, 
disorder or medical condition.  
3.2.2 The suit ability for the intended special medical purpose, the suitability for the particular nutritional use of  
infants and the safety of these substances shall be scientifically demonstrated. The formula shall 
contain sufficient amounts of these substances to ach ieve the intended effect.  
3.2.3 Only L(+)lactic acid producing cultures may be used in Formulas for Special Medical Purposes for 
infants  if shown to be safe and appropriate for use in these vulnerable populations.  
3.3 Vitamin Compounds and Mineral Salts  
Vitamins and minerals added in accordance be selected from the Advisory Lists of Mineral Salts and 
Vitamin Compounds  for Use in Foods for Infants and Children  (CAC/GL 10 -1979).  
3.4 Consistency and Particle Size  
When prepared according to the label directions for use, the product shall be free of lumps and of large 
coarse particles and  suitable for adequate feeding of young infants.  
3.5 Purity Requirements  
All ingredients shall be clean, of good quality, safe and suitable for ingestion by infants. They shall conform 
with their normal quality requirements, such as colour, flavour and odo ur. 
3.6 Specific Prohibitions  
3.6.1  The product and its components shall not have been treated by ionizing radiation.   
© EAC 2019 – All rights reserved  17 
 3.6.2  Fluoride shall not be adde d 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.  
3.6.3  Commercially hydrogenated oils and fats shall not be used in infant formulas.  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 formula for special medical 
purposes.  
Table 3 — List of food additives for use in infant formula for special medical purposes  
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 ty pes of infant formula  
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  
Carrageenan  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 infant 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 acid  
Citric acid  
Antioxidants  
Mixed tocopherol concentrate  1 mg in all types of infant formula  singly or in combination  
L-Ascorbyl Palimit ate 1 mg in all typ es of infant formula  singly or in combination   
18 © EAC 2019 – All rights rese rved 
 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 s pecified.  
Any carry -over of food additives from the raw materials used shall be consistent with the provisions in the 
preamble of CODEX STAN 192.  
6 Contaminants   
6.1 Residues of pesticides, hormones and antibiotics  
6.1.1 Infant formula shall comply with th e maximum pesticide residue limits established by Codex Alimentarius 
Commission for this commodity . 
6.1.2 The product shall be free from residues of hormones and antibiotics, and practically free from other 
contaminants especially pharmacologically active substances  
6.2 Other contaminants  
infant formula for special medical purposes shall comply with the maximum limits for contaminants specified in 
table 2, when tested in accoradance with test methods therein.  
 
Table 2 - Maximum limits for contaminants in infant formula for special medical purposes  
S/N Contaminant  Maximum Limit  Test method  
i.  Lead , mg/kg  0.02  ISO 6633  
ii.  Aflatoxin M1, µg/kg  0.5  ISO 14501  
iii.  Melamine , mg/kg  Solid 
(powdered) 
infant 
formula  1.0  ISO/TS  15495  
Liquid 
infant 
formula  0.15  
7 Hygi ene 
Infant formula for special medical purposes shall be prepared and packaged in the premises built and 
maintained under hygienic condition in accordance with EAS 39 and CAC/RCP 66 . 
Powdered infant formula for special medical purposes shall conform to the  microbiological limits specified in 
CAC/RCP 66 .  
© EAC 2019 – All rights reserved  19 
 8 Packaging  
8.1 The product shall be packaged in containers, which will safeguard the hygienic and other qualities of 
the food. When in liquid form, the product shall be packaged in hermetically sealed conta iners. 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.  
10 Labelling   
10.1 General  
In addition to the requirements of EAS 38, the speci fic requirements in 10.2 – 10.10 shall apply and shall be 
legibly and indelibly marked.  
10.1  The Name of the Food  
10.1.1 The text of the label and all other information accompanying the product shall be written in the  
appropriate language(s).  
10.1.2 The na me of the product shall be "Formula for Special Medical Purposes Intended for Infants" or any  
appropriate designation indicating the true nature of the product, in accordance with national usage.  
10.1.3 If cows’ milk is the only source of protein, the prod uct may be labelled "Formula for Special 
Medical  Purposes Intended for Infants Based on Cows’ Milk".  
10.2  List of Ingredients  
10.2.1 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.  
10.2.2 The specific n ame 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.  
10.3  Declaration of Nutritive Value  
Formula for Special Medical P urposes Intended for Infants shall be labelled with complete nutrition labelling 
according to Section 4.2 of Standard for the Labelling of and Claims for Foods for Special Medical  Purposes 
(CODEX STAN 180 -1991).  
10.4  Date Marking and Storage Instructions   
20 © EAC 2019 – All rights rese rved 
 10.4.1 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.  
10.4.2 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 i nstructions shall be in close proximity to the 
date marking.  
10.5 Information  for Use  
10.5.1 Products in liquid form may be used either directly or in the case of concentrated liquid products, must  
be prepared with water that is safe or has been rendered s afe by previous boiling before feeding, 
according to directions for use. Products in powder form should be reconstituted with water that is safe 
or has been rendered safe by previous boiling for preparation. Adequate directions for the appropriate 
preparat ion and handling should be in accordance with Good Hygienic Practice.  
10.5.2 Adequate directions for the appropriate preparations and use of the product, including its storage and  
disposal after preparation, i.e. that formula remaining after feeding should  be discarded, shall appear 
on the label and in any accompanying leaflet.  
10.5.3  The label shall carry clear graphic instructions illustrating the method of preparation of the product.  
10.5.4 The directions should be accompanied by a warning about the hea lth hazards of inappropriate  
preparation, storage and use.  
10.5.5 Adequate directions regarding the storage of the product after the container has been opened, shall  
appear on the label and in any accompanying leaflet.  
10.6  Additional Labelling Requirement s 
10.6.1 Formula for Special Medical Purposes Intended for Infants shall be labelled with the additional 
information  as specified in Sections 4.4.1, 4.4.3, 4.4.4, 4.5.1 and 4.5.5 of Standard for Labelling of and 
Claims for  Foods for Special Medical Purposes (CODEX STAN 180 -1991).  
10.6.2 A prominent statement indicating that the product is intended as the sole sour ce of nutrition shall 
appear  on the label.  
10.6.3 In addition, the information specified in Sections 4.5.2, 4.5.3 and 4.5.6 of  Standard for Labelling of and  
Claims for Foods for Special Medical Purposes (CODEX STAN 180 -1991)  shall be included on the label  
or be provided separately from the package.  
10.6.4 Labels and information provided separately from the package  should not discourage breastfeeding, 
unless  breastfeeding is contraindicated on medical grounds for the disease(s), disorder(s) or medical 
condition(s) for which the product is intended.  
10.6.5 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.