FOR COMMENTS ONLY FINAL DRAFT UGANDA 
STANDARD  
  FDUS EAS 789 
First  Edition  
2013-mm-dd 
 
 Reference number  
FDUS EAS 789: 2013 
© UNBS 201 3 
  
Instant hand sanitizers — Specification  
 FOR COMMENTS ONLYFDUS EAS 789: 2013 
ii                © UNBS  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  
 FOR COMMENTS ONLYFDUS EAS 789: 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 789: 2013, Instant hand sanitizers  — Specification , is identical 
with and has been reproduced from an East Afr ican Standard, EAS 789: 2013 , Instant hand sanitizers  — 
Specification , and is being proposed for adoption as a Uganda Standard.  
This standard was developed by the Chemicals and environment Standards Technical Committee (UNBS/TC 
5). 
Wherever the words, “ East African Standard" appear, they should be replaced by "Uganda Standard." 
 FOR COMMENTS ONLY EAS 789: 2013 
ICS 77.100.40 
© EAC 2013                                                                                                                    First Edition 2013  
 
EAST AFRICAN STANDARD 
Instant hand sanitizers — Specification 
EAST AFRICAN COMMUNITY FOR COMMENTS ONLYFOR COMMENTS ONLYEAS 789: 2013 
ii © EAC  2013  – All rights reserved  
 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 FOR COMMENTS ONLYEAS 789: 2013 
© EAC 2013  – All rights reserved  iii 
 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 .  
EAS 789 was prepared by Technical Committee EAS/TC 074, Surface active agents . FOR COMMENTS ONLYEAS 789: 2013 
iv © EAC  2013  – All rights reserved  
 Introduction 
The alcohol contained within hand sanitizers, when rubbed on the surface of skin is effective in killing 99.9 % 
of dangerous germs on the skin. The type of alcohol used in most hand sanitizers is ethyl alcohol. Ethyl 
alcohol is the active ingredient in most hand sanitizers. A concentration of 60 % to 95 % alcohol in hand 
sanitizing product is recommended. However, there are also non-alcohol based hand sanitizers which can be 
effective in killing germs. For instance, Benzalkonium Chloride (BAC) has been proven effective in killing 99.9 
% of germ s. There are also several other non-active ingredients in hand sanitizer, the second most 
concentrated ingredient is water. Most hand sanitizers also have a form of moisturizer in their sanitizer such 
as Vitamin E or Aloe. This is to help leave the skin soft after applying. Fragrances and dyes are among some 
of the other inactive ingredients. 
 FOR COMMENTS ONLYEAST AFRICAN STANDARD  EAS 789: 2013  
 
© EAC 2013  – All rights reserved  1 
 Instant hand sanitizers — Specification 
1 Scope 
This East African standard specifies the requirements and methods of test for alcohol based instant hand 
sanitizers. The standard does not cover non-alcohol based hand sanitizers. 
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. 
EAS 104, Alcoholic beverages – Method of sampling and test  
EAS 377-1 , Cosmetics and cosmetics products — Part 1: List of substances prohibited in cosmetic produc ts 
EAS 377-2, Cosmetics and cosmetics products — Part 2: List of substances which cosmetic products must 
not contain except subject to restrictions laid down  
EAS 377-3 , Cosmetics and cosmetics products — Part 3: List of colourants allowed in cosmetic products 
EAS 377-4 , Cosmetics and cosmetics products — Part 4: List of preservatives allowed in cosmetic products 
EAS 377-5 , Cosmetics and cosmetics products — Part 5: Use of UV filters in cosmetic products  
3 Terms and definitions 
For the purposes of this standard terms and definitions given in ISO 862 and the following apply. 
hand sanitizers  
antiseptic agents used to cleanse the hands when soap and water are unavailable. They are often used to 
protect and prevent the passage of bacteria, virus and other pathogens that can cause infections. 
4 Requirements  
4.1 General requirements 
4.1.1  The sanitizer shall have an acceptable odour. 
4.1.2  The sanitizer shall be clear , colourless and in the form of liquid or gel. 
4.1.3  The sanitizer shall not have any disagreeable odour or smell. 
4.1.4  The substances used in the sanitizers shall conform to all the parts of EAS 377.  FOR COMMENTS ONLYEAS 789: 2013 
2 © EAC  2013  – All rights reserved  
 4.2 Specific quality requirements 
The hand sanitizer shall also comply with the specific quality requirements given in Table 1 when tested in 
accordance with the corresponding test method. 
Table 1 — Specific quality requirements for instant hand sanitizer  
Sl. No  Characteristic  Requirement  Test method  
i) Alcohol  content (ethanol and/or isopropanol, n -
propanol) , %,   v/v, min . 60.0 S 104  
ii) pH (neat) 6 - 8 — 
iii) Bactericidal efficacy  to pass test  Annex A  
 
5 Packaging and labelling  
5.1 Pack aging 
5.1.1  The sanitizer shall be supplied in suitable well-closed containers/packages. 
5.1.2  The containers/packages (including the closures) shall not interact chemically with the sanitizer and 
shall be strong enough to protect the sanitizer adequately during normal handling, transportation and storage. 
5.1.3 Only containers/packages of the same size and bearing the same batch identification shall be packed 
together in a bulk container. 
5.2 Marking 
The container/package shall be securely closed and marked legibly and indelibly with the following 
information: 
a) name of the product as ―hand sanitizer‖  
b) manufacturer‘s name and physical address  
 NOTE The name, physical address of the distributor/supplier and trade mark may be added as required 
c) batch or code number; 
d) net content; 
e) list of ingredients used; 
f) general instructions for use (be in either English, Kiswahili or French or in combination as agreed 
between the manufacturer and supplier); 
g) date of manufacture and expiry date; 
h) country of origin/manufacture;  
i) the following cautionary warnings: 
i) ―Do not allow the sanitizer to come into contact with eyes ‖; 
ii) ―Keep O ut Reach of Children ‖; FOR COMMENTS ONLYEAS 789: 2013 
© EAC 2013  – All rights reserved  3 
 iii) ―If swallowed contact a doctor ‖; and  
iv) ―Highly flammable, keep away from fire or flame ‖.   
 FOR COMMENTS ONLYEAS 789: 2013 
4 © EAC  2013  – All rights reserved  
 Annex A 
(normative) 
 
Determination of disinfecting efficacy 
A.1 Outline of the method 
A.1.1  The sanitizer is tested at the recommended ‗use‘ -dilution‘ and concurrently at 0.5 and 1.5 times tha t 
dilution. The test consists of challenging the diluted sanitizer with bacterial inoculum, withdrawing a sample 
after a given time and culturing the sample in a suitable recovery medium.  After this sampling, the mixture is 
again challenged by a second inoculum and after a second interval, is again sampled for culturing.  This 
process is then repeated to provide a third challenge. 
A.1.2  The sample is considered to have passed or failed the test according to the extent of growth shown in 
the first two cultured samples. 
A.2 Apparatus 
A.2.1 Facility, for incubation at 37 °C ± 1 °C 
A.2.2 Facility, for incubation at 2 °C ± 1 °C 
A.2.3 Stop clock, indicating in seconds 
A.2.4 Facility,  for refrigeration at 4 °C ± 1 °C 
A.2.5 Universal containers , made of glass and having metal tops with rubber liners. Plastic containers or 
glass containers with plastic tops shall not be used. 
A.2.6 Test tubes,  19 mm X 150 mm 
A.2.7 Filter paper, No. 4 Whatman (sterile) or equivalent 
A.2.8 Facility , for autoclaving at 121 °C ± 1 °C 
A.2.9 Pipette, capable of dispensing 0.02 mL ± 0.005 mL 
A.2.10 pH meter 
A.2.11 Facility , to sterilize by filtration 
A.2.12 150 μm test sieve  
A.2.13 Oven , capable of maintaining temperature at 100 °C ± 1 °C 
A.3 Media 
A.3.1 Growth media for test organisms 
A.3.1.1  The growth media for test organisms shall be Wright and Mundy Broth with Dextrose (WMBD). FOR COMMENTS ONLYEAS 789: 2013 
© EAC 2013  – All rights reserved  5 
 A.3.1.2  Dispense 10 mL and 6 mL quantities of the Wright and Mundy Broth into universal bottles, and 
autoclave at 121 °C ± 1 °C for 12 min. 
A.3.1.3  Add to this medium, 10 % (m/V) dextrose solution sterilized by filtration, to give a final dextrose 
concentration of 0.1 % (m/v), ( that is, to 10 mL broth add 0.1 mL dextrose solution and to 6.0 m L broth add 
0.06 m L dextrose solution). 
A.3.2 Recovery medium 
A.3.2.1 Composition  
A nutrient broth prepared as follows: 
a) beef extract, 10 g; 
b) peptone, 10 g; 
c) sodium chloride, 5 g; and 
d) polyoxyethylene sorbitan mono-oleate, 30 g 
A.3.2.2 Preparation 
Add the ingredients to 1 000 mL of water.  Mix well.  Dispense 10 mL quantities into test tubes and autoclave 
at 121 °C ± 1 °C for 15 min . 
A.3.3 Hard water  
Standard hard water with 342 mg/L (ppm) hardness prepared as follows: dissolve 0.304 g of anhydrous 
calcium chloride hexahydrate (MgCl 2.6H20) in distilled water and make up the volume to one litre.  Sterilize the 
standard hard water by autoclaving at 121 °C ± 1 °C for 15 min . Allow this to reach room temperature before 
use. 
A.3.4 Yeast suspension 
A.3.4.1  Weigh to the nearest gram about 65 g of active dry yeast.  Cream by the gradual addition of 
sterile hard water (A.3.3) using a heavy glass rod for stirring.  Decant the creamed portion into a flask, add 
more hard water to any lumpy residue remaining and repeat the creaming and decantation until no residue 
remains, and 500 mL of hard water has been used. 
A.3.4.2  Shake the contents of the flask vigorously and strain-through a 150 μm sieve ( A.2.12) breaking 
down any remaining lumps. 
A.3.4.3  Add 500 mL sterile hard water, shake vigorously. 
A.3.4.4  Transfer 50 mL or 100 m L portions into screw-capped bottles, screw the caps tightly and 
autoclave at 121 °C ± 1 °C for 15 min.  Allow the autoclave to cool without releasing the pressure. Store cold 
but not freezing. 
A.3.4.5  Dry two glass petri-dishes to constant mass.  Into each of these dishes, pipette 25 mL of sterilized 
yeast suspension and dry to constant mass at 100 °C.  Calculate the average solids content of the 
suspension. 
A.3.4.6  Before use, pipette 25 mL of the sterilized yeast suspension into a beaker.  Determine the pH 
using a glass electrode, and determine the volume of 40 g/L sodium hydroxide solution needed to adjust the 
pH to 7.0 ± 0.1. FOR COMMENTS ONLYEAS 789: 2013 
6 © EAC  2013  – All rights reserved  
 A.3.4.7  Immediately before use, add to each bottle of sterilized yeast suspension a volume of sterile hard 
water and a volume of 40 g/L sodium hydroxide calculated to adjust the concentration of dry yeast to 5 % 
(m/v) and the pH to 7.0 ± 0.1.  Discard prepared yeast, two weeks after preparation. 
A.3.5 Ringers solution, 25 % (v/v )  
Dissolve 9.00 g of sodium chloride, 0.42 g of potassium chloride, 0.24 g of anhydrous calcium chloride and 
0.20 g of sodium bicarbonate in water and dilute to 1 000 mL. Add one volume of this solution to three 
volumes of water to give a 25 % solution.  Dispense into test tubes fitted with suitable closures and sterilized 
by auto-claving at 121 °C ± 1 °C for 15 min. 
A.4 Selection of the most resistant organism by the minimum inhibitory 
concentration test  
A.4.1  The following organisms shall be used for the test: 
a) Pseudomonas aeruginosa (NCTC 6749 or equivalent);  
b) Proteus vulgaris  (NCTC 4635 or equivalent); and  
c) Staphyloccus aureus (NCTC 4163 or equivalent). 
These organisms may be obtained as freeze dried cultures. Once sub-cultured, the organisms shall be 
maintained on agar slopes of suitable nutrient medium at 4 °C ± 1 °C. 
A.4.2  Subculture each organism daily into a universal bottle containing 6 mL of growth medium (see A.3.1 ) 
and incubate for 24 h ± 2 h at 37 °C ± 1 ° C. 
A.4.3  Dilute one part of freshly grown sub-culture of each organism, which is at least a fifth sub-culture and 
not more than a fourteenth, with ten parts of the growth medium (see A. 3.1) before dilution, th e P. aeruginosa , 
culture shall be filtered using a Whatman No.4 filter paper. 
A.4.4  Prepared three sets of ten, doubling dilutions of the sanitizer in universal containers (A. 2.5).  For this 
purpose dilute the neat sanitizer in the growth medium (see A. 3.1) or the recovery medium (A. 3.2) to give a 
final volume of 5 mL of the diluted sanitizer for each dilution. 
A.4.5  Inoculate each dilution in one set with 0.02 mL of a diluted culture of one organism (see A. 4.3). 
A.4.6  Incubate all the three sets of inoculate dilutions at 37 °C ± 1 °C for 72 h, and examine to determine 
the organism most resistant to the sanitizer, that is the organism for which the minimum inhibitory 
concentration is highest. 
A.5 Preparation of inoculum 
A.5.1  Daily sub-cultures of the test organism selected as in A.4.6 shall be grown in 6 m L quantities of the 
growth medium (A. 3.1) and incubated at  37 °C ± 1 °C for 24 h ± 2 h. 
A.5.2  The day before the test, inoculate 10 mL of the growth medium (A. 3.1) with the test organism from a 
daily sub-culture and not more than a fourteenth.  Incubate the inoculated, broth at 37 °C ± 1 °C for 24 h ± 2 h. 
A.5.3  Add 6 mL of the test organism culture (A.5.1) and (A.5.2) to 4 mL of the yeast suspension (A. 3.4) thus 
making a final concentration of 2 % (m/v) of yeast in the yeast/organism suspension.  If a culture of P. 
aeruginosa  is used, it shall be filtered using a Whatman No.4 filter paper before addition. 
A.5.4  Shake the yeast/organism suspension for one minute with a few sterile glass beads. Immediately 
before the test, count the number of viable organisms in the inoculum by decimal dilutions in 25 % Ringers FOR COMMENTS ONLYEAS 789: 2013 
© EAC 2013  – All rights reserved  7 
 solution (see A. 3.5) and by the drop plate method.  The viable count shall be not less than 108 organisms/mL 
or more than 1010 organisms/mL or the test results are considered invalid. 
A.6 Preparation of the sanitizer dilutions  
Prepare three dilutions of the sanitizer in hard water (A.3.3) based on the recommended ‗use dilution‘ of the 
sanitizer, as follows :  
 A = 0.5 times the recommended ‗use -dilution‘ ; 
 B = 1.0 times the recommended  ‗use -dilution‘ ; and 
 C = 1.5 times the recommended  ‗use -dilution‘ . 
The sanitizer dilutions shall be prepared and tested on the same day.  
A.7 Test procedure  
A.7.1  The test shall be carried out at 27 °C ± 1 ° C.  
A.7.2  Dispense 3 mL of each dilution of sanitizer ( A6) into separate universal bottles labelled A, B, and C, 
then allow to equilibrate to 27 °C ± 1° C.  
A.7.3  Add 1 mL of the inoculum to A, B and C at 0, 1 and 5 min respectively and mix by swirling gently.  
A.7.4  Eight minutes after the addition of the inoculum, remove a sample of the inoculum/sanitizer mixture 
and put 0.02 mL into each of the first group of five tubes of recovery broths. Return the remainder of the 
mixture in the pipette to the universal container. 
A.7.5 Ten minutes after the first addition of the inoculum, add another 1 mL of the inoculum to each of the 
sanitizer dilutions and mix by swirling gently 
A.7.6  After 8 min, remove a sample of the mixture as put before (A.7.4) and put 0.02 mL into each of the 
second group of five tubes of recovery broths. 
A.7.7  Twenty minutes after the first addition of the inoculum, add a further 1 mL of inoculum to each of the 
sanitizer dilutions and mix by swirling gently. 
A.7.8  After 8 min, remove a sample of the mixture as before and place 0.02 mL into each of the third group 
of five tubes of recovery broths. 
A.7.9  Swirl the recovery broths and incubate at 37 °C ± 1 °C for 48 h ± 2 h.  Examine the growth and record 
the results. 
A.8 Interpretation of results 
A.8.1  The instant hand sanitizer, shall be regarded as having passed the test at the recommended ‗use 
dilution‘ if there is no growth in at least two of the five recovery broths for the first and second additions of the 
inoculum. 
A.8.2  To be acceptable, an instant hand sanitizer shall pass the test on three separate occasions using 
freshly prepared sanitizer and freshly prepared inoculum on each occasion. 
 FOR COMMENTS ONLYFOR COMMENTS ONLYEAS 789: 2013    
 
© EAC 2013 – All rights reserved