 DEAS 789: 2021 
ICS 77.100.40  
© EA C 2021                                                                                                                    Second  Edition 2021  
 
 DRAFT EAST AFRICAN STANDARD  
 Alcohol -based instant hand sanitizer – Specification  
EAST AFRICAN COMMUNITY  
 
 
 
 
 
 
 
 
   
  
 
 
 
 
 
 
 
 
 DEAS 789: 2021 
ii © EAC  2021 – All rights reserved 
 Copyright notice  
This EAC document is copyright -protected by EAC. While the reproduction of this d ocument by 
participants in th e EAC standards d evelopme nt process is per mitted 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 t o reprod uce 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  2021 — All rights reserved  
East Afric an Community   
P.O.Box 1096  
Arusha 
Tanzania  
Tel: 255 27  2504253/8  
Fax: 2 55 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  DEAS 789: 2021 
© EAC 2021 – All right s reserved  iii 
 Foreword  
Developm ent of the East A frican S tandards 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 barrie rs that are enco untered when good s and se rvices 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) and other deliverables. The Committee i s composed of rep resentat ives of 
the National Standards Bodies in Partner States, tog ether with the representatives from the public and private 
sector organizations in the community.  
East African Standards are developed throug h Technical Committees that a re 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 Bodi es in the 
Partner States. The  comments receive d are di scussed and incorporated before finalization of standards, i n 
accordance with the Principles and procedures for development of East African Standards.  
East African Standards and other deliverables are subject to review, to keep pa ce with technolog ical 
advances. Users of the East African Standards are therefore exp ected 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 074, Surface a ctive ag ents 
Attention is drawn to the possibility that 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 second  edition cancels and  replaces the first edition (EAS 789:2013), which has been technically revised.  DEAS 789: 2021 
iv © EAC  2021 – 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 o n the skin. The type of alcoho l used in most ha nd sanit izers is ethyl alcohol. Ethyl 
alcohol is the active ingredient in most hand sanitizers. A concentration of 6 0 % to 95  % alcohol in hand 
sanitizing product is recommended.  However, there are also non -alcohol based hand sanitizers wh ich can be 
effect ive in k illing germs. For instance, Benzalkonium Chloride ( BAC) has been proven effective in killing 99.9  
% of germs.  There are also several other non -active ingredients in hand sanitizer, the second most 
conc entrated ingredient is water. Most hand sanitiz ers also  have a form of moisturizer in their sanitizer such 
as Vitamin E or Aloe . This is to help leave the skin soft after appl ying. Fragrances and dyes are among some 
of the other inactive ingredients.  
  DRAFT EAST AFRICAN STANDARD  DEAS 789: 20 21 
 
© EAC 2021 – All rights reserved  1 
 Alcohol-based instant hand saniti zer — Specification  
1 Scope  
This Draft  East African standard specifies  the requirements , sampling  and test methods for alcohol based 
instant hand sanitizers. The standard  does not cover non -alcohol  base d hand sanitizers . 
2 Normative references  
The followin g referenced documents are indispensa ble for the application of this document. For dated 
references, only the edition cited applies. For undated references, the latest ed ition of the referenced 
document  (including any amendments) applies.  
EAS 104, Alcoholi c beverages – Method of sampling and test 
EAS 847 -17, Cosmetics – Analytical methods – Part 17: Determination of  pH 
EAS 377 -1, Cosmetics  and cosmetics products  — Part 1: List of substances prohibited in  cosmetic products  
EAS 377 -2, Cosmetics  and cosmetics product s — Part 2: List of substances which cosmetic products must 
not contain except subject to restrictions l aid down  
EAS 377 -3, Cosmetics  and cosmetics products  — Part 3: List of colourants allowed in cosmetic products  
EAS 377 -4, Cosmetics  and cosmetic s produ cts — Part 4: List of preservatives allowed in cosmetic products  
EAS 377 -5, Cosmetics  and cosmetics prod ucts — Part 5: Use of UV filters in cosmetic products  
ISO 862 , Surface active agents  — Voca bulary  
3 Terms and definitions  
For the purposes of thi s stand ard, terms and definitions given in ISO 862 and the following apply.  
ISO and IEC maintain terminolo gical databases for use in standardization at the following addresses:  
— ISO Online brows ing platform: available at http://www.iso.org/obp  
3.1 hand s anitizers  
antiseptic agents used to cleanse the hands when soap and water are unavailable. They are often use d to 
protect and prevent the passage of bac teria, virus and other pathogens that can c ause infect ions. 
3.2 alcohol  
organic compound that carries a t least one hydroxyl functional group bound to a saturated carbon atom  
 
  
2 © EAC  2021 – All rights reserved 
 3.3 alcohol -based  sanitizer  
preparation containing at least 60% ethyl  alcoh ol and/or isopropanol  or n-propanol  intended f or disinfecting 
hands  or surfaces  
 
3.4 disinfecting  efficacy  
efficiency of the product to kill or reduce microorganisms,  such as bacteria, fungi and viruses.  
4 Requirements   
4.1 General requirement s 
4.1.1 The alcohol -based instant hand sanitizer  shall be  a homogene ous mixture  in the form of liquid , foam 
orgel. 
4.1.2  The alcohol -based inst ant hand  sanitizer sh all contain ethanol , isopr opanol or the mixture  of the t wo 
4.1.3 The alcohol -based instant hand   sanitizer sh all not have objectionable odour. 
4.1.4 The substances used in the  alcohol -based instant ha nd sanitizer s shall conform to all the parts of EAS 
377.  
4.2 Specific requirements  
The alcohol -based instant hand sanitizer  shall comply wit h the specific requirements given in Table 1 when 
tested in  accordance with the correspondin g test method.  
Table 1 — Specific requirements for alcohol -based instant hand sanitizer   
Sl. No  Characteristic  Requirement  Test method  
i) Alcohol  content (ethanol and/or isopropanol, n -
propanol ), %, v/v, min . 60.0 
 EAS 104   
 
ii) pH  6.0 – 8.0 EAS 847 -17  
iii) Disinfecting  efficacy to pas s test Annex A  
 
 
5 Packag ing  
5.1 The alcohol -based instant hand sanitizer  shall be supplied in suitable well -closed container s/packages . 
5.2 The containers/packages (incl uding the closures) sh all not interact chemically with the san itizer and shall 
be s trong enough to p rotect the alcohol -based instant hand sanitizer  adequately during normal handling, 
transportation and storage . 
5.3 Only containers/packages of the same size and bearing the same batch identification shall be packed 
together in a bulk conta iner.  
© EAC 2021 – All right s reserved  3 
 6 Labelling 
The container/package shall be securely closed , legibly and indelibly labelled either in English, Kis wahili or 
French or combination or any other language as agreed bet ween the manufacturer and supplier with the 
following information : 
a) name of the  product as “ alcohol -based instant hand sanitizer ”  
b)  alcoh ol content  manufa cturer’s name and physical address  
c) batch or code number;  
d) net content in litres 
e) list of  ingredients used ; 
f) general instructions for use  
g) date of manufacture and expiry date; 
h) country of origin ;  
i) the following cautionary warni ngs: 
i) “Do not allow the sanitizer  to come int o contact with eyes ”; 
ii) “Keep Out Reach of Children ”; 
iii) “If swallowed contact a doctor ”; and  
iv) “Highly fla mmable, keep a way from fire or flame ”.   
NOTE  The name, physic al address of the distrib utor/supplier and trade m ark may be added as required  
7. Sampling  
Sampling shall be done in accordance with EAS 104  
 
  
4 © EAC  2021 – All rights reserved 
 Annex A 
(normat ive) 
 
Deter mination of disinfecting efficacy  
A.1 Outline of the method  
A.1.1   
The test consists o f challengin g the alcoho l-based inst ant h and sanitizer  with bacteri al inoculum, withdrawing 
a sam ple after a given time and culturi ng the sample in a suitable recovery medium.  After this sampling, the 
mixtur e is again challenged by a secon d inoculum and a fter a second inte rval, is agai n sampled for culturing.  
This proce ss is then repeated to provide  a third challenge.  
A.1.2 The samp le 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 7 °C ± 1 °C  
A.2.3 Stop clock , indicating in seconds  
A.2.4 Facility,  for refri geration at 4 °C ± 1 °C 
A.2.5 Unive rsal containers , made of glas s and having meta l tops with rubbe r liners . Plasti c containers or 
glass containers wit h plastic tops shall not be  used . 
A.2.6 Test tubes , 19 mm X 150 mm 
A.2.7 Filter paper , No. 4 Whatman (ster ile) or equivalent  
A.2.8 Facility , for autoclaving at 121  °C ± 1 °C 
A.2.9 Pipette , capable of disp ensing 0 .02 mL ± 0.005 mL  
A.2.10 pH meter  
A.2.11 Facility, to sterilize by filt ration  
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 organism s 
A.3.1.1  The g rowth  media for tes t organisms shall be Wright and Mundy Broth with Dex trose (WMBD) .  
© EAC 2021 – All right s reserved  5 
 A.3.1.2 Dispense 10 m L and 6 mL quantities of the Wright and Mundy Broth into universa l bott les, and 
autoclave at 121  °C ± 1 °C for 12 min . 
A.3.1.3 Add to t his medium, 10 % (m/V) dextrose so lution sterilize d by filtration, to give a final dex trose 
concentration of 0.1 % (m/v), ( that is, to 10 m L 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 nut rient broth pr epared as follow s: 
a) beef extract , 10 g; 
b) peptone , 10 g; 
c) sodium chloride , 5 g; and  
d) polyoxyethyle ne sorbitan  mono -oleate , 30 g 
A.3.2.2  Preparation  
Add the ingredi ents to 1  000 m L of water.  Mix wel l.  Dispense 10 m L quantities  into test tubes and  autoclave 
at 121 °C ± 1 °C for 15 min. 
A.3.3 Hard water   
Standard hard water with 342mg/L (ppm) hardn ess is prepared as follows: Dissolv e 0.301g of calcium chloride 
dihydrate and 0.336g o f magnesium sulfate heptahydrate in distilled water and make up the volume to one 
litre. Sterilize the st andard hard water by au toclaving at 121 ° C ± 1 °C for 15 min. All ow th is to reach room 
temperature b efore use.  
A.3.4 Yeast suspen sion 
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 heav y glas s rod for stirring.  Decan t the creamed po rtion into a flask, add 
more hard w ater to any lumpy residue rem aining and repeat the creaming and  decantation until no residue 
remains, and 500 m L of hard water has been use d. 
A.3.4.2  Shake the contents of the fla sk vigorously and strain -through a 150 μm sieve ( A.2.12) breaking 
down any remaining lumps.  
A.3.4.3  Add 500 m L sterile hard water, shake vigorously.  
A.3.4.4  Transfer 50 m L or 100 m L portions into screw -capped bottles , screw the caps tightly and 
autoclave a t 121 °C ± 1 °C for 15 min .  Allow the autoclave to cool w ithout 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 m L of sterilized 
yeast suspension an d dry to c onstant mass at 100  °C.  Calculate the average solids content of the 
suspension.  
A.3.4.6  Before use, pipette 25 m L of the sterilized yeast suspension into a beaker.  Determine the pH 
using a glass electrode, and dete rmine the volume of 40 g/ L sodium hydrox ide solution needed to adj ust the 
pH to  7.0 ± 0.1.   
6 © EAC  2021 – 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 t o 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 ca lcium chloride and 
0.20 g of s odium bica rbonate in water and dilut e to 1  000 m L. 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 st erilized 
by auto -claving at 12 1 °C ± 1 °C for 15 min . 
Other options  
Ringer’s solution or Buffered peptone buf fer, or Butterfields phosphate buffer . 
A.5 Preparation of inoculu m 
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 t he test, inocula te 10 m L 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 m L of the test organism culture ( A.5.1) and ( A.5.2) to 4 m L of the yeast suspension ( A.3.4) thus 
makin g 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/or ganism suspension for one minu te with a few sterile glass beads.  Immediately  
before the test, count the number of viable organisms in the inocu lum by decimal dilutions in 25 % Ringers 
solution (see A.3.5) and by the drop plate meth od.  The viable count sha ll be not less than 108 organi sms/ mL 
or more than 1010 organisms/m L or the test  results are considered invalid . 
A.7 Test procedure   
A.7.1 The test shal l be carried out at 27  °C ± 1 °C.  
A.7.2 Dispen se 3 mL of each dil ution of sanit izer ( A6) into separate universal bottles labelled A, B, and C, 
then allow to equilibrate to 27  °C ± 1°C.  
A.7.3 Add 1 m L of the i noculum to A, B and C at 0, 1 and 5 min  respec tively and  mix by swirling gently.   
A.7.4 Eight  minutes after the addition of th e inoculum, remove a sample of the inoculum/sanitizer mixture 
and put 0.02 m L into each of the first group of five tubes of recove ry broths. Retur n the remainder of the 
mixture  in the pi pette to the universal con tainer . 
A.7.5 Ten minutes afte r the first ad dition of the inoculum, add another 1 m L 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 m L into each of the  
second group of fi ve tubes of re covery broths.  
A.7.7 Twenty minutes after the first addition of the inoculum, add a f urther 1 mL of inoculum to each of the 
saniti zer dilutions and mix by swirling gently.  
A.7.8 After 8 min, remove a sample of th e mixture a s before and place 0.02 m L into e ach of the third group 
of five tubes of recovery broths.   
© EAC 2021 – All right s reserved  7 
 A.7.9 Swirl the rec overy 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 alcohol -based instant h and sanitizer  , shall be regarded as having passed the test at the 
recommended ‘use dilution’ if there is no growth in 40% (at least two of the five ) recovery broths for the first 
and second additions of the inoc ulum .A.8.2 To be acceptable, a n ins tant hand  sanitizer shal l pass the test 
on three separate occasions using freshly prepared sanitizer and freshly prepared inoculum on each 
occasion . 
 DEAS 789: 2021   
 
© EAC 2021 – All rights reserved  
  
  