Reference number  
DRS 392-1: 2018  
© RSB 2018  
 
 
 RWANDA 
STANDARD  DRS  
392-1 
 
First edition  
2018 -mm-dd 
 
Skin applied  mosquito repellents — 
Specification  — 
Part 1: 
Lotion s, cream s, gels and ointment s 
  DRS 392-1: 2018  
©RSB 2018 - All rights reserved                  ii 
 In order to match with technological development and to keep continuous progress in industries, 
standards are subject to periodic review. Users shall ascertain that they are in possession of the latest 
edition  
 
 
 
 
 
 
 
 
© RSB 2018  
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized 
in any form or by any means, electronic or mechanical, including photocopying and microfilm, without 
prior written permission from R SB. 
Requests for permission to reprodu ce this document should be addressed to : 
Rwanda Standards  Board  
P.O Box 7099 Kigali -Rwanda  
KK 15 Rd, 49  
Tel. +250 788303492  
Toll Free: 3250  
E-mail: info@rsb.gov.rw  
Website: www.rs b.gov.rw  
ePortal: www.portal.rsb.gov.rw  DRS 392-1: 2018  
iii                ©RSB 2018 - All rights reserved  
 Contents  Page 
Foreword  ................................ ................................ ................................ ................................ ...................  iv 
1 Scope  ................................ ................................ ................................ ................................ .............  1 
2 Normative references  ................................ ................................ ................................ ...................  1 
3 Terms and definitions  ................................ ................................ ................................ ..................  1 
4 Requirements  ................................ ................................ ................................ ................................  3 
4.1 General  ................................ ................................ ................................ ................................ ..........  3 
4.2 Active ingredients  ................................ ................................ ................................ ........................  3 
4.2.1  Natural repellents  ................................ ................................ ................................ .........................  3 
4.2.2  Synthetic repellents  ................................ ................................ ................................ .....................  4 
4.3 Specific requirements  ................................ ................................ ................................ ..................  4 
4.4 Biological efficacy  ................................ ................................ ................................ ......................  45 
5 Packaging and labelling ................................ ................................ ................................ ...............  5 
5.1 Packaging  ................................ ................................ ................................ ................................ ...... 5 
5.2 Labelling  ................................ ................................ ................................ ................................ ........  5 
6 Sampling  ................................ ................................ ................................ ................................ ....... 6 
Annex  A (normative)  Determination of DEET content  ................................ ................................ ..........  7 
A.1 General  ................................ ................................ ................................ ................................ ..........  7 
A.2 Apparatus  ................................ ................................ ................................ ................................ ...... 7 
A.3 Preparation of c alibration curve  ................................ ................................ ................................ . 7 
A.4 Procedure  ................................ ................................ ................................ ................................ ...... 7 
A.5 Calculation  ................................ ................................ ................................ ................................ .... 8 
Annex  B (Norma tive)  Determination of residue  ................................ ................................ ....................  9 
B.1 Procedure  ................................ ................................ ................................ ................................ ...... 9 
 DRS 392-1: 2018  
©RSB 2018 - All rights reserved                  iv 
 Foreword  
Rwanda Standard s are prepared  by Technical Committees and approved by R wanda Standards Board (RSB) 
Board  of Directors in  accordance with the procedures of RSB, in compliance with Annex 3 of the WTO/TBT 
agreement on the preparation, adoption and application of standards.  
The main task of technical committees is to prepare national standards.  Final Draft Rwanda S tandards adopted 
by Technical committ ees are ratifie d by me mbers of RSB Board of Director s for publication and gazettment as 
Rwanda Standards.  
DRS 392-1 was prepared by Technical Committee RSB/TC 015, Pharmaceutical Products . 
DRS 392 consists of the following parts, under the general title Skin appli ed mosquito repellents  — Specification : 
 Part 1: Lotion s, cream s, gels and ointment s 
 Part 2: Spray s and roll -ons 
Part 3: Wipes  
Part 4: Bathing s oaps  
Part 5: Bracelets , wristbands and patches  
Committee membership  
The following organizations were represented on the Technical Committee on Pharmaceutical Products 
(RSB/TC 015) in the preparation of this standard.  
National Industrial Research and Development Agency (NIRDA)  
National Pharmacy Council (NPC)  
University of R wanda/College of Sciences and Technology (UR/CST)  
Pharmacie NOVA  
Rwanda Development Board (RDB)  
AGROPY LTD  
IKIREZI NATURAL PRODUCTS  
HORIZON/SOPYRWA  DRS 392-1: 2018  
v                ©RSB 2018 - All rights reserved  
 Rwanda Social Security Board (RSSB)  
Pharmavie  
University of Rwanda/College of Medicine and Health Sciences ( UR/CMHS)  
Rwanda Biomedical Center/ Malaria and Other Parasitic Diseases Division  (RBC/MOPDD)  
Society for Family Health  (SFH) – Rwanda  
Rwanda Biomedical Center/Medical Procurement and Production Division (RBC/MPPD)  
INES - RUHENGERI  
Rwanda  Standards Board  (RSB) – Secretariat  DRS 392-1: 2018  
©RSB 2018 - All rights reserved                  vi 
 Introduction  
Mosquito repellents are an effective complement to bed nets in the prevention of mosquito borne diseases, 
especially malaria.   
 
Insecticides are used either for killing or controlling harmful insects. The insecticides which  are applied for 
repelling insects are termed as “Repellents". Mosquito is one of the most harmful insects for mankind. To 
destroy them, many preparations are available on the market in various recipes like pest killer spray, soap, oil, 
powder, repellent e tc. Out of these, mosquito repellent is the most popular as it has germicidal and 
disinfectant properties and is able to repel mosquitoes and is convenient to use.  
 
The mosquito repellent is used for warding off mosquitoes which are the most harmful insect s. Nowadays, 
mosquito repellents are used for controlling mosquito es and are complimenting  other  mosquito destroyers 
gradually. With the rise in the standard of living, increasing urbanization and population, the demand of 
mosquito repellent mat is constan tly increasing , particularly in tropical places. It is a convenient method for 
protection against mosquito, so it has a tremendous market potential. Thus , there is a very good scope for 
development of such units in the country . 
 
Skin applied mosquito repellents possess the potential to target residual transmission. Entomological evidence 
has shown that repellents provide personal protection against malaria.  Product examples that are c ommon ly 
used  include lotions, gels, creams, ointments among others . However , many more  types of skin applied 
repellent products are now developed  in various forms such as sprays and roll -ons, wipes, soaps and bracelets , 
wristbands and patches . 
 
 
 DRS 392-1: 2018  
1                ©RSB 2018 - All rights reserved  
 Skin applied  mosquito repellents  — Specification  — Part 1: Lotion s, 
cream s, gels and ointment s 
1 Scope  
This Draft Rwanda S tandard prescribes the requirements , sampling  and test methods for skin  applied  mosquito 
repellents formulated and prepared as lotion s, cream s, gels and ointment s and meant to be  applied directly to 
skin. 
2 Normative references  
The following documents are referred to in the text in such a way that some or all of  their content 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.  
RS EAS 846, Glossar y of terms relating to the cosmetic industry  
RS EAS 786, Skin care creams, lotions and gels — Specification  
RS EAS 377 (all parts), Cosmetics and cosmetic products  
RS ISO 24153 , Random sampling and randomization procedures  
RS 191, Refined pyrethrum concentrate ― Specification  
CIPAC 760, Determination of picaridin  
CIPAC 667, Determination of ethyl butylacetamidopropionate  
RS ISO 21149, Cosmetics ― Microbiology ― Enumeration and detection of aerobic mesophilic bacteria  
DRS 394-1, Mosquito repellents ― Performance Test Guidelines ― Part 1: Skin applied  repellents  
RS EAS 346, Label ling of cosmetic products — General requirements  
3 Terms and definitions  
For the purposes of this standard, the terms and definitions given in RS EAS 846 and  the follow ing apply.  
3.1 
mosquito   
©RSB 2018 - All rights reserved                  2 
 any of numerous arthropod animals of the class mosquito, having an adult stage characterized by three pairs 
of legs and a body segmented into head, thorax, and abdomen and usually having one or two pairs of wings. 
Mosquito include flies, crick ets, insects, beetles, butterflies, and bees  
3.2 
mosquito repellent  
substance applied to skin, clothing, or other surfaces which discourages mosquito  (and arthropods  in general) 
from landing or climbing on that surface  
3.3 
natural repellents /biopest icides  
repellents that contain natural, plant -based compounds  
3.4 
synthetic  repellents  
conventional repellents containing synth etic chemical compounds  
3.5 
DEET  
N,N-Diethyl -meta -toluamide  or diethyltoluamide  
3.6 
IR3535  
ethyl butylacetylaminopropionate  
3.7 
picaridin  
1-(1-methylpropoxycarbonyl) -2-(2-hydroxyethyl) piperidine or 2 -(2-hydroxyethyl) -1-piperidinecarboxylic acid 1-
methylpropyl ester  
 DRS 392-1: 2018  
3                ©RSB 2018 - All rights reserved  
 4 Requirements  
4.1 General  
4.1.1 The product shall constitute a mosquito repellent  that is formulated as lotion , cream , gel or ointment  
and shall be  essentially a product  which ha s active ingredient (s)  added t o a certain level.  
4.1.2 It shall be primarily composed of water, surfactants, fatty alcohol, fragrance , oil and other emollients. 
All ingredients shall meet the requirements of RS EAS 377.  
4.1.3 The products shall not cause any harmful effect to the skin when applied . 
4.1.4 When applied to the skin, the product  shall have the benefit of repelling mosquitoes . 
4.2 Active ingredients  
4.2.1  Natural repellents  
4.2.1.1  Active ingredients used in natural repellents shall be natural and plant based compounds such as 
essential oils or any other  plant extract  approved as mosquito repellents . 
4.2.1.3  The m anufacturer  shall provide adequate data on the repellence of such ingredients.  
4.2.1.4  The manufacturer  shall have adequate data justifying the proportion of ingredient(s) for which claims 
are made, used in the product.  
4.2.1.5  The essential oils used  and other plant extracts  in natural repellents shall be, but not limited  to:  
a) Cedarwood oil ; 
b) Tea tree oil ; 
c) Geranium oil ; 
d) Rosemary oil ; 
e) Lemongrass oil ; 
f) Citronella oil ; 
g) Eucalyptus oil ; 
h) Cinnamon oil ; and 
i) Neem oil   
©RSB 2018 - All rights reserved                  4 
 4.2.1.6 The proportion of single or blended active ingredient (s)  in natural repellent shall be set by the 
manufacturer in accordance with specific standard and records shall be availed.  
4.2.1.7 Pyrethrum extracts such as pyrethrin s shall be considered in natural repellents.  The limits of pyrethrin s 
in natural repellents shall not be less than 0.5% and the extract used shall meet the requirements of RS 191.  
4.2.2  Synthetic repellents  
4.2.2.1  Synthetic repellents shall contain synthetic ch emical compounds  which are able to discourage 
mosquitoes and send them flying or crawling away.  
4.2.2.2  If a synthetic active ingredient  is blended  with other active ingredient (s), either natural or synthetic, 
the proportion shall be set by the manufactur er based on scientific research and records shall be availed.  
4.2.2.3 Active ingredients and their content in synthetic repellents shall meet the requirements prescribed in 
table 1.  
Table 1 — Active ingredients content for synthetic repellents  
S/N Active ingredient s Limits  (%, w/w)  Identification 
method  
1 DEET  4 – 50  Annex A  
2 Picaridin  5 – 20 CIPAC 740  
3 IR3535  7.5 – 20 CIPAC 667  
 
4.2.2.4 Synthetic repellents and their active ingredients shall be approved and registered by competent 
authority  before being released to the market . 
4.3 Specific requirements  
The product shall comply with the specific requirement given in table 2 when tested in according to the methods 
described therein.  
Table 2— Specific requirements  
S/N Parameters  Requirements  Test methods  
i.  Thermal stability  To pass test  RS EAS 786  
ii.  pH range  3.5 – 8.5 
iii.  Total fatty substance content, % m/m, min  5 
iv.  Total viable count, cfu/g, max  100 in 0.1g  RS ISO 21149  
v.  Total residues, % m/m, max 40 Annex B 
vi.  Lead  (Pb), mg/kg, max  20 RS EAS 786  
vii.  Arsenic  (As), mg/kg, max  2 
viii.  Mercure  (Hg), mg/kg, max  2 
4.4 Biological efficacy  
When tested in accordance with DRS 394-1, the product shall repel 100 % of the mosquitoes from landing or 
climbing on that surface , within protection time indicated by the manufacturer.  DRS 392-1: 2018  
5                ©RSB 2018 - All rights reserved  
 5 Packaging and labelling  
5.1 Packaging  
The product shall be packaged in suitable well -sealed containers that shall protect the contents and shall not  
cause any contamination or react with the product.  
5.2 Labelling  
5.2.1 The labelling shall be in Engl ish, Kinyarwanda or French or in combination as agreed between the 
manufacturer and supplier.  
5.2.2 In addition to the labelling of RS EAS 346 , the following information shall be legibly and indelibly 
marked on the label:  
a) name of the product ; 
b) full address of the manufacture r; 
c) batch number ; 
d) manufacture and expiry dates ; 
e) net content ; 
f) active ingredient (s) content  
g) list of other Ingredients ; 
h) directions for use ; 
i) protection t ime. 
j) age group and/or health condition for which use is prohibited  
k) storage conditions  
5.2.3 The product shall also bear the following warning on the label:  
a) this product may cause irritation. If irritation persists discontinue use; and  
b) precaution /warning shall be ‘'do patch test before use’’.   
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 6 Sampling  
Random samples of the product shall  be drawn for test in accordance with RS ISO 24153 from the market, 
factory  or anywhere else . DRS 392-1: 2018  
7                ©RSB 2018 - All rights reserved  
 Annex  A 
(normative)  
 
Determination of DEET content  
A.1 General  
The sample is dissolved in carbon disulfide and the difference in absorbance at 14.18 µm and at 14.48 µm is 
determined. The quantity of meta -isomer is obtained from this value by means of a calibration curve prepared 
by the use of a reference standard.  
A.2 Apparatus  
A.2.1  Double -beam infrared spectrophotometer. Perkin -Elmer model 21 or equivalent.  
A.2.2  Two equivalent  infrared absorption cells, with sodium chloride windows and a path length of 
approximately 0.4  mm. 
A.3 Preparation of calibration curve  
A.3.1  Weigh (to the nearest 0.1 mg) into four volumetric flasks sufficient amounts of the reference DEET 
standard of known  purity to give concentrations of approximately 20, 40, 60 and 80 g/L when dissolved in carbon 
disulfide.  
A.3.2 Fill the reference cell with carbon disulfide and the sample cell with each of the standard solutions in 
turn, and record the spectra. The spect rum may be scanned rapidly, except for the region 12 – 15 µm, where a 
normal speed should be used. Carry out a blank measurement with carbon disulfide to correct for any inequality 
in the paired cells and to determine whether a cell correction is required.  
A.3.3 Measure the absorbance at 14.18 µm and at 14.48 µm and calculate the difference between these 
value s, ΔA, for each of the solutions. Plot the values of ΔA against the concentration (g/ L) of the meta -isomer.  
 
A.3.4  If a cell correction is required, the value of ΔA is determined from the formula:  
 
  ΔA = [A 14.18 – A14.48]ref. - [A14.48]blank 
 
  Where ref. = determination with reference standard  
    blank = determination on CS 2 blank  
 
A.4 Procedure  
Weigh (to the nearest 0.1  mg)about 0.5 g of the sample, transfer quantitatively to a 10 mL volumetric flask, 
and make up to the mark with carbon disulfide. Measure the infrared absorption at 14.18 μm and 14.48 μm 
using the same conditions as described in clause A.3. Determine the concentration of meta -isomer by 
comparing this value with the calibration curve. A standard sample should be run each day to check the 
calibration of the instrument.   
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 A.5 Calculation  
DEET content (g/kg) =𝐶1 𝑥 𝑃 
𝐶2 
where,  
 C1 = concentration (g/L) of standar d DEET found from calibration curve  
 C2 = concentration (g/L) of sample taken  
 P = purity (g/kg) of the reference standard  
 
  DRS 392-1: 2018  
9                ©RSB 2018 - All rights reserved  
 Annex  B 
(Normative)  
 
Determination of residue  
B.1 Procedure  
B.1.1  Weigh accurately about 5 g of the material in a weighed, clean and dry squat form weighing bottle and 
dry to constant mass at 105 ºC± 1ºC. Cool in desiccators and weigh.  
B.1.2  Calculation  
Residue percent by mass = 100  𝑀1
𝑀2 
where,  
 M1 = mass in g of the residue ; and 
 M2 = mass in g the material taken for test.   
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 Bibliography  
[1] USPC/USP Pharmacopeial Forum 2009 (Vol. 35 (3),  Topical and Transdermal Drug Products  
[2] IS 6608, Skin creams – Specification  
[3] Manual on development and use of FAO and WHO specifications for pesticides, November 2010, 2nd 
Edition.  
[4] Product Perfo rmance Test Guidelines. OPPTS 810.3700: Insect Repellents to be applied to human Skin  
 
 DRS 392-1: 2018  
ICS 65.100  
 
 
©RSB 2018 - All right s reserved