DRAFT AFRICAN 
STANDARD  DARS  
1470  
First Edition 2019  
 
 Reference No. ARS 1470: 2019 (E) 
ICS 71.100.40 
 
 
© ARSO 2019  
  
 
 
 
 
 
 
 
 
 
Hand sanitizers (alcohol based)  — Specification  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 DARS 1470: 2019  
ii © ARSO 2019 — All rights reserved   
Table of contents  
 
1 Scope  ................................ ................................ ................................ ................................ ....... 1 
2 Normative referen ces ................................ ................................ ................................ ................  1 
3 Definitions and abbreviations ................................ ................................ ................................ ..... 1 
4 Requirements ................................ ................................ ................................ ............................  1 
4.1 General r equirements  ................................ ................................ ................................ ....... 1 
4.2 Specific requirements ................................ ................................ ................................ ........  2 
5 Packaging and labelling ................................ ................................ ................................ .............  2 
5.1 Packaging  ................................ ................................ ................................ .........................  2 
5.2 Labelling  ................................ ................................ ................................ ...........................  2 
6 Sampling  ................................ ................................ ................................ ................................ ... 3 
6.1 General ................................ ................................ ................................ .............................  3 
6.2 Sample for inspection ................................ ................................ ................................ ........  3 
6.3 Sample for testing  ................................ ................................ ................................ .............  3 
Annex A (normative)  Determi nation of disinfecting efficacy  ................................ ...............................  4 
Annex B (normative)  Freedom from visible impurities  ................................ ................................ ........  8 
Annex C (normative)  Determination of derma l irritation  ................................ ................................ ..... 9 
Bibliography  ................................ ................................ ................................ ................................ .... 10 
 DARS 1470: 2019  
© ARSO 2019  — All rights reserved  iii  
Foreword  
 
The African Organization for Standardization (ARS O) is an African intergovernmental organization 
established by the Uni ted Nations Economic Commission for Africa (UNECA) and the Organization of 
African Unity (AU)  in 1977 . One of the fundamental mandates of ARSO is to develop and harmoniz e 
African Standards (ARS) for the purpose of enhancing Africa’s internal trading capaci ty, increase 
Africa’s product and service competitiveness globally and uplift the welfare of African communities.  
The work of preparing African  Standards is normally carried out through ARSO  technical committees. 
Each Member State  interested in a subject f or which a technical committee has been established has 
the right to be represented on that committee. International organizations, Regional Economic 
Communities (RECs), governmental and non -governmental  organizations , in liaison with ARSO , also 
take part in the work.  
 
ARSO  Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.  
 
The main task of technical committees is to prepare ARSO  Standards. Draft ARSO  Standards 
adopted by the technical committees are circulated to  the member bodies for voting. Publication as an 
ARSO  Standard requires approval by at least 75 % of the member bodies casting a vote.  
 
Attention is drawn to the possibility that some of the elements of this document may be the subject of 
patent rights. ARSO shall not be held responsible for identifying any or all such patent rights.  
 
This African Standard was prepared by the ARSO Technical Harmonization Committee Number 5 on 
Chemistry and Chemical Engineering  (ARSO/THC 05) . 
 
 
 
 
 
© African Organisation for Standardisation  2019 — All rights reserved* 
 
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* ©2019 ARSO — All rights of exploitation reserved worldwide for African Member States’ NSBs.  DARS 1470: 2019  
iv © ARSO 2019 — All rights reserved   
 
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© African Organisation for Standardisation 2019 — All rights reserved  
 
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International House 3rd Floor  
P.O. Box 57363 — 00200 City Square  
NAIROBI, KENYA  
 
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 DARS 1470: 2019  
© ARSO 2019  — All rights reserved  v  
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 germs. There are also several othe r 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.  
 
 DARS 1470: 2019  
© ARSO 2019 — All rights reserved  1  
Hand sanitizers (alcohol based)  — Specification  
 
 
1 Scope  
 
This African standard prescribes the requirements and methods of test for alcohol based instant hand 
sanitizers. The standard does no t 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.  
 
AOAC Official Method 942.06 Alcohol by Volume in Distilled Liquors Pycnometer Method  
 
Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 
on Cosmetic  Products  
 
ISO 862, Surface active agents — Vocabulary  
 
3 Definitions  and abbreviations  
 
For the purpose of this standard the terms and definitions in ISO 862 and the following definition s apply . 
 
3.1 
hygienic Hand Sanitizer  
postcontamination treatment pro cedure that involves rubbing hands without the addition of water, 
using a bactericidal preparation directed against transient microorganisms to prevent their 
transmission regardless of the resident skin flora  
 
3.2 
prevalue  
number of colony forming units (c fu) sampled from hands before treatment  
 
3.3 
postvalue  
number of colony forming units (cfu) sampled from hands after treatment  
 
3.4 
reduction factor (RF)  
ratio of prevalues and postvalues, generally expressed by decimal logarithms:  
 
log10 RF = log 10 preval ue – log10 postvalue  
 
4 Requirements  
 
4.1 General requirements  
 
4.1.1 The sanitizer shall be in the form of  a liquid or gel,  
 
4.1.2 The sanitizer should be clear  
 
4.1.3 When tested in accordance with Annex A , the mean reduction of the release of test 
organisms achieved by the hygienic Hand Sanitizer  product shall not be significantly smaller than that 
achieved by a reference Hand Sanitizer  (R) with propan -2-ol 60 % (V/V).  
 AFRICAN STANDARD  FDARS 1470: 2019  
2 © ARSO 2019 — All rights reserved  4.2 Specific requirements  
 
4.2.1 The hand sanitizer shall also comply with the requ irements given in Table 1 when tested in 
accordance with the corresponding test method.  
 
Table 1 — Specific requirements for instant hand sanitizer  
 
No Characteristic Requirement Test method 
i) Alcohol content (ethanol and/or isopropanol, 
n-propanol), %, v/v, min. 60.0 AOAC 942.06  
ii) pH, neat 6 - 8 ISO 10523  
iii) Bactericidal efficacy to pass test Annex A 
 
4.2.2 Freedom from visible impurities  
 
The sample shall  be free from physical impurities when tested according to Annex D . 
 
4.2.3 Dermal irritation  
 
Hand Sanitizer it shall not irritate or inflame the skin of any  member of the test panel  when the hand 
sanitizer is tested against the procedure in Annex C . 
 
5 Packaging and labelling  
 
5.1 Packaging  
 
5.1.1  The packaging shall ensure integrity of the produc t during handling, storage and 
transportation  
 
5.1.2  Bulk packaging: Only liquid detergents  of the same type and the same batch shall be packed 
together in one bulk package  
 
5.1.3 The closure shall not be made of cork or of any other material that contain s cork.  
 
5.2 Labelling  
 
The following  information shall appear in legible and indelible labelling  on each container or on a label 
securely  attached to each container:  
 
a) manufacturer’s name and physical address   
 
NOTE  The name, physical address of the dis tributor/supplier may be added as required.  
 
b) trade mark if applicable  
 
c) a statement that the product is a n alcohol -based hand  sanitizer ; 
 
d) the type and percentage of alcohol  used   
 
e) Net content  
 
f) the batch identification  
 
g) the expiry date or best before date  
 
h) general instructions for use;  
 
i) Storage instructions  
 DARS 1470: 2019  
© ARSO 2019 — All rights reserved  3 j) the following warnings:  
 
1) Avoid  contact with the eyes;  
 
2) Flammable material.  
 
6 Sampling  
 
6.1 General  
 
The following sampling procedure shall be applied in determining whe ther a lot submitted for  
inspection and testing complies with the relevant requirements of this standard. The sample so  drawn 
shall be deemed to represent the lot.  
 
6.2 Sample for inspection  
 
After inspecting the lot for compliance with  Clause 4,  take, at random, the number of containers, as  
relevant, shown in column 2 of Table 2, relative to the appropriate lot size shown in column 1.  
 
Table 2 — Samples for inspection and testing  
 
1 2 3 
Lot size 
number of containers Sample size for ph ysical 
examination 
number of containers Sample size for micro biological 
examin ation 
number of containers 
0 to 5 000  3 3 
5 001  to 12 5 00 6 3 
12 501 to 25 0 00 9 3 
25 001 to 50 0 00 16 3 
50 001 upwards 30 3 
 
6.3 Sample for testing  
 
After inspection of the containers taken in  accordance with 5.2, 
 
a) take, at random, half the number of containers and use them for the storage stability test; and  
 
b) thoroughly mix the contents of each of the remaining containers and, take from each 
container  the lesser of the total volume and 2 50 mL, and obtain a composite test sample by 
combining and  thoroughly mixing these quantities. Use these samples for testing for 
compliance with the  requirements of Clauses  4. 
 
 FDARS 1470: 2019  
4 © ARSO 2019 — All rights reserved   
Annex A  
(normative)  
 
Determination of disinfecting efficacy  
 
 
 
A.1 Outline o f the method  
 
A.1.1 The sanitizer is tested at the recommended ‘use’ -dilution’ and concurrently at 0.5 and 1.5 
times that 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 .  
 
A2 Apparatus  
 
A.2.1 Facility, for incubation at 37 ± 1 °C.  
 
A.2.2 Facility, for incubation at 27 ± 1 °C.  
 
A.2.3 Stop cl ock, indicating in seconds.  
 
A.2.4 Facility, for refrigeration at 4 ± 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 ± 1°C.  
 
A.2.9 Pipette, capable of dispensing 0.02 ± 1°C 0.005 ml.  
 
A.2.10 pH meter  
 
A.2.11 Facility, to sterilize by filtration.  
 
A2.12  150 μm test sieve.  
 
A.2.13 Oven, capable of maintaining temperature at 100 ± 1  °C.  
 
A3 Media  
 
A.3.1 Growth media for test organisms . Wright and Mundy Broth with Dextrose (WMBD) .  
 
A.3.1.1  Dispense 10 ml and 6 ml quantities of the Wright and Mundy Broth into universal bottles, and 
autoclave at 121 ± 1°C for 12 minutes.  
 
A.3.1.2  Add to this medium, 10 per cent (m/V) dextrose solution sterilized by filtration, to give a final 
dextrose concentration of 0.1 per cent (m/v), (i.e. to 10 mL broth add 0.1 dextrose solution and to 6.0 
mL broth add 0.06 mL dextrose solution).  
 
A.3.2 Recovery  medium ― A nutrient broth prepared as follows:  DARS 1470: 2019  
© ARSO 2019 — All rights reserved  5  
A.3.2.1  Composition  
 
 Beef extract 10 g  
 
 Peptone 10 g  
 
 Sodium chloride 5 g  
 
 Polyoxyethylene sorbitan mono -oleate 30 g  
 
A.3.2.2  Preparation ― Add the ingredients to 1000 mL of water. Mix well. Dispense 1 0 ml quantities 
into test tubes and autoclave at 121 ± 1°C for 15 minutes . 
 
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 (MgCl2 .6H2O) in distilled wate r and 
make up the volume to one litre. Sterilize the standard hard water by autoclaving at 121 ± 1° C for 15 
minutes. 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 yeas t. 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 remain s, 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 m 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 m l or 100 mL portions into screw -capped bottles, screw the caps tightly and 
autoclave at 121 ± 1°C for 15 minutes. 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. Deter mine 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.  
 
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 per cent (m/V) and the pH to 7.0 ± 0.1. Discard prepared yeast, two weeks after 
preparation.  
 
A.3.5 Ringers solution, 25 per cent (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 1000 ml. Add 1 volume of this 
solution to 3 volumes of water to give a 25 per cent solution. Dispense into test tubes fitt ed with 
suitable closures and sterilized by auto -claving at 121 ± 1°C for 15 minutes .  
 
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:  
 FDARS 1470: 2019  
6 © ARSO 2019 — All rights reserved   Pseudomonas aeru ginosa (NCTC 6749 or equivalent)  
 
 Proteus vulgaris (NCTC 4635 or equivalent)  
 
 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 ± 1°C.  
 
A.4.2 Subculture each organism daily into a universal bottle containing 6 ml of growth medium 
(A.3.1) and incubate for 24 ± 2 h at 37 ± 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 (A .3.1) before dilution, 
the P. aeruginosa , culture shall be filtered using a whatman No.4 filter paper.  
 
A.4.4 Prepared three sets of ten, doubling dilut ions of the sanitizer in universal containers (A .2.5). 
For this purpose dilute the neat sanitizer in the growth medium (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 ± 1°C for 72 hours, and examine to 
determine the organism most resistant to the sanitizer, that is the orga nism 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 ml quantities 
of the growth medium (A .3.1) and incubated at 37 ± 1°C for 24 ± 2 hours.  
 
A.5.2 The day before the test, inoculate 10 ml of the growth medium (A3.1) with the test organism 
from a daily sub -culture and not more than a fourteenth. Incubate the inoculated, broth at 37 ± 1°C for 
24 ± 2 hours.  
 
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 per cent (m/V) of yeast in the yeast/organism 
suspension. If a culture of P. aeruginosa is used, it shall be filtered using a whatman N o.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 per cent Ringers solut ion (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’  
 
C = 1.5 times the recommended ‘use -dilution’  
 
The sanitiz er dilutions shall be prepared and tested on the same day.  
 DARS 1470: 2019  
© ARSO 2019 — All rights reserved  7 A.7 Test procedure  
 
A.7.1 The test shall be carried out at 27 ± 1°C.  
 
A.7.2 Dispense 3 mL of each dilution of sanitizer (A .6) into separate universal bottles labelled A, B, 
and C, then allow to e quilibrate to 27 ± 1°C.  
 
A.7.3 Add 1 mL of the inoculum to A, B and C at 0, 1 and 5 minutes 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 m l 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 san itizer dilutions and mix by swirling gently  
 
A.7.6 Eight minutes later, 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 m L of inoculum to each 
of the sanitizer dilutions and mix by swirling gently.  
 
A.7.8 Eight minutes later, remove a sample of the mixture as before and place 0.02 ml into each of 
the third group of five tubes of recovery brot hs.  
 
A.7.9 Swirl the recovery broths and incubate at 37 ± 1°C for 48 ± 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 di lution’ 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 sanitiz er and freshly prepared inoculum on each occasion . 
 FDARS 1470: 2019  
8 © ARSO 2019 — All rights reserved  Annex B  
(normative)  
 
Freedom from visible impurities  
 
 
 
B.1 A sample of approximate ly 50 mL of each test sample is spread over the bottom of a 150 mm 
diameter Petri dish.   
 
B.2 When viewed at a range of approximately 600 mm , the number of visible specks of impurities 
shall not exceed five . 
 
 DARS 1470: 2019  
© ARSO 2019 — All rights reserved  9 Annex C  
(normative)  
 
Determination of dermal irritation  
 
 
 
C.1 Test panel  
 
A test panel that consists of three men and three women, none of whom is known to have an  
abnormally sensitive skin or has an injury or abrasion on the hands.  
 
C.2 Procedure  
 
Place approximately 5 mL of the test sample onto the cupped palm of one hand of each member of  
the panel, and get him or her to spread the Hand Sanitizer  over the back and  between the fingers of 
the other hand, and rub it thoroughly into the skin for 2 min. Repeat this procedure twice, with 30 min  
intervals between applications. Do not allow a treated hand to be washed until 2 h after the last  
application of the test sample . 
 
Immediately after the tests, and again 2 h, 24 h and 48 h later, examine the treated hand of each  
member of the panel for any signs of irritation or inflammation, using the untreated hand as a  control.  
 
 FDARS 1470: 2019  
10 © ARSO 2019 — All rights reserved   
Bibliography  
 
 
Working Group to identify and a cknowledge useful literature used in the preparation of this standard.  
 
SANS 490:2013, Disinfectant alcohol -based handrub  
 
KS EAS 789:2013, Kenya Standard — Instant Hand Sanitizer — Specification   
 
BS EN 1500:1997, Chemical d isinfectants and antiseptics — Hygienic handrub — Test method and 
requirements (phase 2/step 2)  
 FDARS 1470: 2019 
© ARSO 2019 — All rights reserved