DJS 351: 202(X)  
i 
 ICS 71.100.40  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Draft Jamaican Standard  
Specification  
 
for 
 
Instant hand sanitizers  
 
 
 
         
 
   BUREAU OF STANDARDS JAMAICA  
 
DJS 351: 202(X)  
ii 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
IMPORTANT NOTICE  
 
Jamaican standards are subjected to periodic review. The next amendment will be sent without charge if you cut along the 
dotted line and return the self -addressed label. If we do not receive this label we have no record that you wish to be kept up -to-
date. Our address:  
 
Bureau of Standards Jamaica  
6 Winchester Road  
P.O. Box 113  
Kingston 10  
Jamaica W.I.  
 
------------------------------------------------------- (
cut along the line) ------------------------------------------------------------- -------  
        
         DJS 351: 202X  
 
NAME OR 
DESIGNATION…………………………………………………….…………………………… ………  
 
ADDRESS……………………………………………………………………….………….…… ………  
 
……………………………………….…………………………………………………………… ………  
 
…………………………………………………………………………………………………… ………  DJS 351: 202(X)  
iii 
  
 
 
 
 
 
JBS CERTIFICATION MARK PROGRAMME  
 
The general policies of the JBS Certification Mark Programme are as follows:  
 
- The JBS provides certification services for manufacturers participating in the programme and 
licensed to use the gazetted JBS Certification Marks to indicate conformity with Jamaican 
Standards.  
- Where feasible, programmes will be developed to meet special requirements of the submittor.  
- JBS certification is provided in the interest of maintaining agreed -upon standard requirements.  
Where applicable, certification  may form the basis for acceptance by inspection authorities 
responsible for enforcement of regulations.  
- In performing its functions in accordance with its policies, JBS does not assume or undertake to 
discharge any responsibility of the manufacturer or an y other party.  
Participants in the programme should note that in the event of failure to resolve an issue arising from 
interpretation of requirements, there is a formal appeal procedure.  
Further information concerning the details of JBS Certification Mark Programme may be obtained from 
the Jamaica Bureau of Standards, 6 Winchester Road, Kingston 10.  
 
 
 
 
CERTIFICATION 
MARKS 
 
 
 
 
 
 
Product Certification Marks Plant Certification Mark 
 
 
 
 
 
 
Certification of Agricultural Produce Jamaica-Made Mark 
(CAP) Mark 
 
 
 
 
 
 
 
 
DJS 351: 202(X)  
iv 
  
 
 
 
 
 
 
 
 
 
 
 
Draft Jamaican Standard Specification  
 
 
for  
 
Instant hand sanitizers  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Bureau of Standards Jamaica  
6 Winchester Road  
P.O. Box 113  
Kingston 10  
JAMAICA, W. I.  
Tel: (876) 926 -3140 -5/ 618 – 1534 / 632- 4275  
Fax: (876) 929 -4736  
Website: www.bsj.org.jm   
E-mail: info@bsj.org.jm   
 
Month 201  DJS 351: 202(X)  
v 
  
 
© 20 XX Bureau of Standards   
All rights reserved. Unless otherwise specified, no part of a Bureau of Standards publication may be reproduced 
or utilized in any form or by any means, electronic or mechanical, including, photocopying microfilm or scanning, 
without permission in writing.  
 
ISBN XXX XXX XXX XXX X  
Declared by the Bureau of Standards to be a standard specification pursuant to section 7 of the Standards Act 
1968.  
 
First published Month 201 X 
 
This standard was circulated in the draft form for comment under the reference DJS 351: 20XX 
Jamaican Standards establish requirements in  relation to commodities, processes and practices, but do not 
purport to include all the necessary provisions of a contract.  
 
The attention of those using this standard specification is called to the necessity of complying with any relevant 
legislation.  
Amendments  
 
No.  
Date of Issue   
Remarks   
Entered by and date  
 
 
 
 
 
 
 
 
 
 
 
 
 
    
 
 
  DJS 351: 202(X)  
vi 
 Contents  
 
Foreword  ................................ ................................ ................................ ..........................  viii 
1 Scope  ................................ ................................ ................................ .......................  3 
2 Definitions  ................................ ................................ ................................ ................  3 
3 Requirements -product composition  ................................ ................................ ...... 3 
4 Requirements - Esta blishment…………………………………………………………    4      
     5  Packaging & Labeling………………………………………………………………….. .   6  
  
  DJS 351: 202(X)  
vii 
  
Foreword  
 
The use of alcohol -based hand sanitizer products is widespread. It is therefore important to ensure that 
these products are safe and suitable for the intended use.  
 
The safety and efficacy of the product is dependent on its composition and the manufacturing process  
therefore  its physical, chemical and microbiological properties  must be specified and controlled.  All 
manufacturers, importers, distributors and other entities engaged in the production a nd/or trade of 
alcohol -based hand sanitizers shall comply with the requirements  of this standard.  
 
This Standard is intended to be compulsory.  
 
 
Related Documents  
 
This Standard makes reference to the following:  
 
a) World Health Organization (WHO) 2009 Recommended hand rub formulation  
b) JS 170 Jamaican standard sp ecification for Cosmetics Part 1: General requirements  
c)  JS 170 Jamaican standard specification for Cosmetics Part 2: Water used in the preparation 
of cosmetics  
d) CRS 55 -1: 2016  Labelling of goods — Part 1: General requirements  
e)  CRS 55 -1: 2016 Labelling of goods — Part 2 : Specific requirements for prepackaged goods  
 
 
 
 
 
 
 DJS 351: 202(X)  
3 
 Instant Hand Sanitizer  - Specification  
  
1. Scope  
 
This Jamaican standard prescribes the requirements for alcohol -based instant hand sanitizers. 
The standard does not include requirements for non-alcohol -based hand sanitizers . 
 
2. Definition  
              
For the purpose of this standard the following definition applies : 
 
2.1. hand  sanitizer . An alcohol -containing preparation (liquid, gel or foam) designed for 
application to the hands to inactivate microorganisms and/or temporarily suppress their 
growth.  
 
NOTE  Such preparations may contain one or more types of alcohol, other active ingredients 
with excipients, and humectants . 
 
3. General Requirements    
 
3.1 Product Description  
 
3.1.1  The hand sanitizer shall be in the form of  liquid , foam  or gel.  
 
3.1.2   The hand sanitizer shall also comply with the requirements  outlined  in Table 1 when 
tested with the appropriate methods . 
 
                  Table 1 — Requirements for Instant Hand Sanitizer  
The table shows a minimum and maximum range for alcohol content and pH. All other values  within 
the table  are maximum allowable limits.  
Characteristics  
 Requirement   
Alcohol content  (ethanol and /or isopropanol) v/v  
 60-80%  
 
Turbidity  
 10 (NTU ) 
 
Ph 
 6-8 
 
Total hardness (CaCO 3) 
 5 mg/L  
 
Total solids  
 10 mg/L  
 
Chloride  
 0.5 mg/L  
 
Sulphate  
 1 mg/L  
Calcium  
 5 mg/L  
 DJS 351: 202(X)  
4 
 Characteristics  
 Requirement   
Heavy metals  
 Cadmium  
 Copper  
 Manganese  
 Mercury  
 Lead  
  
0.003  mg/L  
2.0 mg/L  
0.5 mg/L  
0.001 mg/L  
0.01 mg/L  
 
Iron 
 1 mg/L  
 
Non-volatile residue  5 mg/L  
 
Specific  conductance  
 10 µmho/cm  
 
Bactericidal efficacy  to pass test  
 
4. Requirements for  establishments  producing  hand sanitizer  
 
4.1 Buildings and   facilities  
 
4.1.1  Building s used in the manufacture or storage of hand sanitizers shall be of suitable 
size, design and construction to pe rmit unobstructed placement of equipment, orderly 
storage  of materials  and products, sanitary operation and adequate cleaning and  
maintenance.  
 
4.1.2  Floors, walls and ceilings shall be constructed of smooth easily cleanable surfaces 
and shall be kept clean and in good  repair.  
 
4.1.3  Fixtures,  ducts  and  pipes  shall  be installed  in such  a manner  that  drip  or 
condensate  does not contaminate  cosmetic  materials,  utensils,  cosmetic  contact  
surfaces  of equipment  or finished products in  bulk.  
 
4.1.4  Lighting and ventilation shall be sufficient for the intended operation and comfort 
of personnel.  
 
4.1.5  Water supply, washing and bathroom facilities, floor drainage and sewage system 
shall be adequate for sanitary operation and cleaning of facilities, equipment and utensils, 
as well as to satisfy employee needs and facilitate personal  cleanliness.  
4.2 Equipment  
 
4.2.1  Equipment and utensils used in processing,  handling,  holding, transferring and 
filling shall be of appropriate design, material and workmanship to prevent corrosion, 
build -up of material, or adul teration with lubricants, dirt or sanitizing  agent s. 
 
4.2.2  Utensils, transfer piping and  contact  surfaces o f equipment shall be well 
main tained and cleaned and shall be sanitized at appropriate  intervals.  
 
 4.2.3   Cleaned and sanitized po rtable equipment, utensils and contact surfaces shall 
either be covered and protected, or stored and located in a  manner  that  protects  them  
from d ust, harmful micro -organisms or other  contamination.  DJS 351: 202(X)  
5 
 4.3 Personnel  
 
4.3.1  The personnel supervising or performing the manufacture or control of the hand 
sanitizer shall  have the education, training and/or experience to perform the assigned  
functions.  
 
4.3.2  Persons c oming into direct contact with materials  used to make the hand 
sanitizer , finished products in bulk or contact surfac es, shall wear appropriate outer 
garments, glo ves, hair restraints  and other protective garments as necessary a nd shall 
maintain  adequate personal cleanliness, to prevent adulteration of the hand sanitizer .  
 
4.4 Raw  materials  
4.4.1  Raw materials and primary packaging materials shall be stored and handled in 
a manner which prevents their mixing, contamination with micro -organism s or other 
chemicals, or decom position from exposure to excessive heat, cold, sunlight or  
moisture.  
4.4.2  Containers of  raw materials shall be closed and bagged or boxed. Raw m aterials 
shall be  stored off the  floor  and away from walls . 
 
4.4.3  Containers of raw materials shall be labelled and colour coded with respect 
to identity. They shall also be labelled with respect to lot identification and control  
status.  
 
4.4.4  Raw m aterials shall be sampled and tested or examined in accordance with 
documented procedures assuring the absence of contamination with filth, micro -
organisms or other extraneous substances to the extent necessary to prevent 
adulteration of finished products.   
 
4.4.5  Materials not meeting acceptance specifications shall be pr operly identified and 
controlled  to prevent their use in  the manufacture of the hand sanitizers.  
4.5 Production  control  
 
4.5.1  Manufacturing  and  control  procedures  shall  be established  and  written  
instructions,  that  is, formulations, processing, transfer and filling instructions, in -
process control methods among  others     shall be  maintained.  · 
4.5.2  The equipment  used  for processing, transfer and filling, and the utensils and the 
containers for hold ing raw and bulk materials, shall be clean, in good repair and in 
sanitary  condition.  
4.5.3  Samples shall be taken, as appropriate, during and/or after processing, transfer 
or filling, for testing for adequacy of mixing or other forms of processing, absence of 
hazardous micro­organisms or chemical contaminants and compliance with any other 
acceptance  specification s. 
 
4.5.4  Major equipment, transfer lines, containers and tanks used for processing, filling 
or holding the hand sanitizer  shall be identified to indicate co ntents, batch designatio n, 
control status and other per tinent  information.   
 
4.5.5  The  equipment  for processing,  holding,  transferring  and  filling  of each  batch  
shall  be labelled regarding identity, batch identification and control  status.  
 DJS 351: 202(X)  
6 
 4.6 Laboratory  control  
 
4.6.1  Raw materials, in -process samples and finished products shall be tested or 
examined to verify their identity and determine their compliance with specifications 
for physical and chemical properties and microbial contamination, as well as for 
hazardous or ot her unwanted chemical contaminants normally associated with the 
raw  material.  
 
4.6.2  Reference samples of approved lots or batches of raw materials and finished 
products shall be retained for a specified time period , shall be stored under conditions 
that protect  them against contamination or deterioration, and shall be retested for 
continued compliance with established acceptance  specifications.  
 
4.6.3  The water supply, particularly the water used as a hand sanitizer  ingredient, 
shall be tested regularly for its confor mity with chemical, analytical and microbiological  
specifications.  
 
4.7 Records  
 
4.7.1  Control records shall be maintained for raw materials, primary packaging 
materials, batch manufacturing and distribution purposes.  
 
4.7.2  Documentation of the handling, storage, laboratory control and us e of raw 
materials and primary packaging materials , as well as disposal of rejected material 
shall be  maintained.  
4.7.3  During  the manufacture  of batches,  the following  shall  be documented:  
(a) names , lot numbers  and quantities of raw materials used;  
(b) names of personnel performing different duties  
(c) processing, handling, transferring, holding and  filling;  
(c) sampling, controlling, adjusting and  reworking;  and  
(d) code marks of batches and finished  products.  
4.7.4  Details of sampling, individual laboratory controls test results and control 
status of the finished products shall be  recorded.  
 
4.7.5  For distribution  and traceability purposes,  records  of initial  shipment,  code  
marks  and  consignees  shall  be kept.  
 
5. Packaging and  Labelling  
 
5.1 Pack aging 
 
5.1.1  The sanitizer shall be supplied in suitable sealed  containers/packages . 
 
5.1.2  The containers/packages (including the closures) shall not interact chemically 
or physically with the sanitizer and shall be strong enough to protect the sanitizer 
adequately during normal handling, transportation and  storage.  
 DJS 351: 202(X)  
7 
 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 Labeling  
 
     5.2.1  General Requirements  
5.2.1.1   A label affixed to, or marked on any product , or its external p acking or  
referring to any product , shall conform to the following requirements:  
a) It shall provide  the common name of the product ‘hand sanitizer’,  a description of 
the product  and adequate i nformation to a potential purchaser to enable  the 
purchaser  or consumer to select the product  best suited to their needs. This 
information shall include the weight, net weight, volume, net volume, measurement, 
specification, or size as applicable and shall  give an accurate descri ption of 
components of the product  as is necessary.  
 
b) The name and st rength of the active ingredient (s).  
 
c) It shall provide a purchaser  or consumer with appropriate safety instructions, and 
precautions  for use where:  
 
1) There is a risk to the health and safety of a consumer;  
 
EXAMPLE   The inclusion of Health warnings or allergy risks  
 
2) A ny significant deterioration of the quality, performance or life durabili ty which may 
result if the product is not properly stored ; 
 
d) The name and identifiable address, the principal place of business or registered office of 
the manufacturer, agent, distributor, seller, re -filler, packer, importer or organization 
responsible for the product and the name of the country of origin.  It  shall  be  preceded  by  
the  words  “manufactured by  ....”,  “packed  by......”, “distributed by....”, “imported by.....”, as 
applicable, and the following words as a ppropriate:  
1) “made in (name of territory)”;  
2) “product of (name of territory)”;  
3) “packaged in (name of territory)”;  
4) “manufactured in (name of territory);  
5) “assembled in (name of territory).  
 
e) It shall be legible and durable up to the point -of-sale  to the ultimate consumer . For 
legibility, the information appearing on a label shall be in a minimum ty pe size in 
accordance Table 2 below . 
f) The minimum type size shall be the smallest type size that is permitted based on space 
available for labelling. The height of the type shall be determined by measuring the height 
of the lower case ‘o’ or its equivalent when mixed upper and lower case lette rs are used, or 
the height of the upper case letters when only upper case letters are used. Minimum type 
sizes shall be as outlined in Table 2 below:  
 
Table 2  — Minimum type size  
 DJS 351: 202(X)  
8 
  
 
 
g) The label shall not be false , misleading or  deceptive.  
 
h) The label shall provide information regarding any specific dangers which might b e 
related to the use of the product  and shall provide first aid instructions where  necessary.  
 
i) The label shall not contain any information by words, pictorial or other devices which 
refer to, or are suggestive,  either  directly  or indirectly,  of another  product  with  which  
such  a product  might  be confused, or in such a manner as to lead the purchaser, or 
consumer to assume that the product  is connected with such other  products.  
 
 
5.2.2  Prevention of  deception  
 
A label  on the package  of the product  may  contain  other  information,  designs,  symbols  or 
pictorial matter, provided that no words, illustration, symbols, or other matter are used  to: 
a) give an erroneous impression of the net contents of the  package;  
 
b) give an erroneous impression of any ingredient or component of the product  or that the 
product  contain s an ingredient or component that is does not contain;  
 
c) refer to the nature, origin, type, quality, performance, function, or method of 
manufacture or production  of the product  that  is likely  to give  an erroneous  impression  
of the matter  described  or depicted;  
 
d) give an erroneous impression of the country of origin of the  product ; and 
 
e) give an erroneous impression of the price or unit price of the  product . 
 
 
5.2.3  Language to be used on labels of pre -packaged  goods  
 
5.2.3.1  All statements required shall be in the official language or languages of the country 
in which the product is being  sold.  
 
5.2.4   Presentation of  Information  
 
5.2.4.1  All labelling information required by this standard shall b e clearly presented and 
readily discernible under normal conditions of  sale.  
 
5.2.4.2  Where the statements of common name, manufacturer’s name, manufacturer’s 
address or country of origin consist of more than one word , the statements 
required by (6.2.1.1 d)  shall be in letters of identical size and style of  print.  
 Minimum type size  Area of principal display panel  
1.6 mm (1/16 in)  32 cm2 (5 in2) or less  
3.2 mm (1/8 in)  more than 32 cm2 (5 in2) DJS 351: 202(X)  
9 
 5.2.5  Date markings and expiry  dates  
 
5.2.5.1  Where the product is likely  to deteriorate after the date of manufacture or 
packaging so that the quality, safety, hygiene or other desirable characteristics are 
not likely to be maintained, the expected shelf life shall be indicated with a date of 
minimum durability and it shall be  placed on the product , label or  package.  Such  a 
date  mark  shall  not be defaced  or removed  from  the product  or from  the label  on the 
packag e before possession of the product  by the  purchaser.  
 
5.2.5.2  The format for the date markings shall be as  follows:  
a) the day, month and the year for hand sanitizer  produced for consumption within a 
period of not more than three months;  and 
 
b) the month and the year for hand sanitizer  produced for consumption within a period 
longer than three months.  
 
5.2.5 .3 The month shall be declared using the first three letters, first four letters, full word or 
numerical  format.  
 
5.2.5.4  The year shall be declared as  follows:  
 
a) a two digit  numerical  representation  is adequate  when  accompanied  by the first  three  
letters  of the month;  or 
 
EXAMPLE  JAN 08  
 
b) a four digit numerical representation, such as 2008, when the two digit numerical 
representation of the month is  used.  
EXAMPLE  01 2008  
 
5.2.5.5  The date of minimum durability shall be declared by the words “best before” or 
words expressing similar intent including “expiry” or “use by”, “BB” or “EXP”. The words 
used to express date of minimum durability shall be accompanied  by: 
 
a) either the date itself; or  
b) a reference to where the date is  given.  
5.2.5.6  In addition to the date of minimum durability if  there are any special 
conditions for storage of the good, it shall be declared on the label if the validity of the 
date depends on  it. 
 
 
 
 
 
 
 
 
 
 
Standards Council  
 
The Standards Council is the controlling body of the Bureau of Standards  Jamaica and is responsible for the policy and general 
administration of the Bureau.  DJS 351: 202(X)  
10 
  
The Council is appointed by the Minister in the manner provided for in the Standards Act, 196 9.  Using its powers in the 
Standards Act, the Council appoints committees fo r specified purposes.  
 
The Standards Act, 196 9 sets out the duties of the Council and the steps to be followed for the formulation of a standard.  
 
Preparation of standards documents  
 
The following is an outline of the procedure which must be followed in th e preparation of documents:  
 
1. The preparation of standards documents is undertaken upon the Standard Council’s authorisation.  This may arise 
out of representation from national organisations or existing Bureau of Standards ’ Committees of Bureau staff.  If the 
project is approved it is referred to the appropriate sectional committee or if none exists a new committee is formed, 
or the project is allotted to the Bureau’s staff.  
 
2. If necessary, when the final draft of a standard is ready, the Council authorises an approach to the Minister in order to 
obtain the formal concurrence of any other Minister who may be responsible for any area which the standard may 
affect.  
 
3. The draft document is made available to the general public for comments. All inter ested parties, by means of a notice 
in the Press, are invited to comment. In addition, copies are forwarded to those known, interested in the subject.  
 
4. The Committee considers all the comments received and recommends a final document to the Standards Co uncil 
 
5. The Standards Council recommends the document to the Minister for publication.  
 
6. The Minister approves the recommendation of the Standards Council.  
 
7. The declaration of the standard is gazetted and copies placed on sale.  
 
8. On the recommenda tion of the Standards Council the Minister may declare a standard compulsory.  
 
9. Amendments to and revisions of standards normally require the same procedure as is applied to the preparation of 
the original standard.  
 
 
 
Overseas standards documents  
 
The B ureau of Standards  Jamaica  maintains a reference library which includes the standards of  many overseas standards 
organis ations.  These standards can be  inspected upon request.  
 
The Bureau can supply on demand copies of standards produced by some national s tandards bodies and is the agency for the 
sale of standards produced by the International Organization for Standardization (ISO) members.  
 
Application to use the reference library and to purchase Jamaican and other standar ds documents should be addressed  to: 
 
Bureau of Standards Jamaica  
6 Winchester Road  
P.O. Box 113,  
Kingston 10  
JAMAICA, W. I.  
 
 
 
 