ICS 71.100.71  
 
Reference number
DRS 333:2023
© RSB2023
  
 RWANDA 
STANDARD  DRS 
333 
 
Second edition  
2023-mm-dd  
 
Herbal cosmetic products— General 
requirements  
   
Formatted:  English (United States)DRS 333: 2023 
©RSB 2023- 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 
 
 
 
 
 
 
 
 
© RSB2023 
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 RSB. 
Requests for permission to reproduce 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.rsb.gov.rw  
ePortal: www.portal.rsb.gov.rw  Formatted:  French (France)
Field Code Changed
Formatted:  English (United Kingdom)
Formatted:  French (France)DRS 333: 2023 
iii                ©RSB2023- All rights reserved 
 Contents 
1 Scope ...................................................................................................................................................... 1  
2 Normative references ............................................................................................................................ 1  
3 Terms and definitions ........................................................................................................................... 1  
4 Requirements ......................................................................................................................................... 2  
4.1 Herb(s)/ Herbal preparation .................................................................................................................. 2  
4.2 Selection of herbs ............................................................................................................................... 32 
4.3 Herbal cosmetic benefits claims ........................................................................................................ 43 
4.4 Physical requirements .......................................................................................................................... 4  
4.5 Chemical requirements ....................................................................................................................... 54 
4.6 Contaminants of herbal ingredients .................................................................................................. 54 
4.7 Quality assurance ................................................................................................................................ 65 
4.8 Shelf-life data ....................................................................................................................................... 75 
4.9 Safety data ........................................................................................................................................... 76 
5 Packaging ............................................................................................................................................. 76 
6 Labelling ............................................................................................................................................... 76 
7 Storage ..................................................................................................... Error! Bookmark not defined. 7 
8 Sampling .............................................................................................................................................. 87 
 
 DRS 333: 2023 
©RSB 2023- All rights reserved                  iv 
 Foreword 
Rwanda Standardsarepreparedby Technical Committees and approved by Rwanda 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 Standards 
adopted by Technical committees are ratified by members of RSB Board of Directors for publication and 
gazettment as Rwanda Standards. 
DRS 333 was prepared by Technical Committee RSB/TC 011, Cosmetics and related products.  
The assistance derived from the above source is hereby acknowledged with thanks. 
This thirdedition cancels and replaces the first edition (RS 333:2018), of which has been technically revised. 
Committee membership  
The following organizations were represented on the Technical Committee on Cosmetics and related 
products .(RSB/TC 011) in the preparation of this standard. 
Paragraph of participants 
University of Rwanda/College of Science and Technology (UR-CST) 
Rwanda Food and Drugs Authority (Rwanda-FDA) 
Rwanda Inspectorate, Competition and Consumer protection Authority (RICA) 
Rwanda Forensic Laboratory (RFL) 
Kipharma 
SULFO Industries Rwanda 
ORIBUT Company Ltd 
Uburanga products 
Rwanda Medical Supply (RMS) 
 DRS 333: 2023 
v                ©RSB2023- All rights reserved 
 Rwanda Standards Board(RSB) – Secretariat 
 DRS 333: 2023 
1                ©RSB2023- All rights reserved 
 Herbal cosmetic products — General requirements 
1 Scope 
This Draft Rwanda Standard primarily provides general requirements for herbal cosmetic products aimed at 
ensuring the safety, efficacy and quality of these products for consumers. 
This document does not apply to cosmetic products intended to be used for medicinal purpose.  
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 editioncited applies. For undated references, 
the latest edition of the referenced document (including any amendments) applies. 
RS EAS 346, Labelling of cosmetics — General requirements 
 
RS EAS 377 (all parts) , Cosmetic and cosmetic products 
 
RS 278, Cosmetics — Methods of sampling  
3 Terms and definitions 
For the purposes of this standard, the following terms and definitions apply. 
3.1 
cosmetic 
any substance or preparationintended to beplaced in contact with the variousexternal parts of the human body 
(epidermis, hair system, nails, lips and externalgenitalorgans) or with the teeth and the mucous membranes of 
the oral cavitywith a viewexclusively or mainly to cleaningthem, perfumingthem, changingtheirappearance 
and/or correcting body odours and/or protectingthem or keepingthem in good condition. 
3.2 
herbs 
crude plant materialsuch as leaves, flowers, fruit, seeds, stems, wood, bark, roots, rhizomes or other plant 
parts, whichmaybeentire, fragmented or powdered 
3.3 
herbal material 
whole plants or parts of medicinal plants in the crude state. Theyincludeherbs, freshjuices, gums, fixedoils, 
essential oils, resins and dry powders of herbs. Formatted:  English (United States)
Formatted:  English (United States)
Formatted:  English (United States) 
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3.4 
herbal preparations 
preparationsobtained by subjectingherbal substances to treatmentssuch as extraction, distillation, expression, 
fractionation, purification, concentration, fermentation or otherphysical or biological process. 
Theseincludecommuted or powderedherbal substances, extracts, tinctures,essential oils, expressedjuices and 
processedexudates of herbalmaterials. Theyalsoincludepreparations made by steeping or 
heatingherbalmaterials in alcoholbeverages and/or honey, or in othermaterials 
3.5 
herbalcosmetics 
productsformulatedusingvarious permissible cosmeticingredients and to form the base in which one or more 
herbs/ herbalingredient are used to providedefinedcosmeticbenefits. 
4 Requirements 
4.1 Herb(s)/ Herbal preparation 
4.1.1 Theherb(s) herbal preparationused in the products shall include one or more of the following forms: 
a) fresh herbs; 
b) juices/pastes/oleoresins/gums made from whole or part(s) of plants; 
c) herbal extracts; 
d) dried powdered herbs; 
e) cold expressed and/or solvent extracted, fixed oils/fats from herbs, and 
f) distillates/essential oils of herbs. 
NOTE: Good Agricultural practices (GAP) are an integral part of quality control Formatted:  English (United States)
Formatted:  English (United States)DRS 333: 2023 
3                ©RSB2023- All rights reserved 
 4.1.2 The proportion of herbal preparations shall be not less than 15% in the product and records shall be 
kept, and availed when requested. 
4.1.3 All the ingredients used shall conform to the requirements in RS EAS 377 (all parts). 
4.2 Selection of herbs 
4.2.1 Selection of herbal ingredients 
4.2.1.1 Selection of herbal ingredients for the standardization of herbal cosmetics products involves several 
other steps like source and quality of raw materials, good agricultural practices and good manufacturing 
practices. These practices shall play a pivotal role in guaranteeing the quality and stability of herbal 
preparations. 
4.2.1.2 The quality of a plant product is determined by the prevailing growth conditions and accepted 
GoodAgricultural Practices (GAP) shall control this. These include: 
a) seed selection; 
b) growth conditions; 
c) fertilizers application; 
d) harvesting; 
e) drying; 
f) and storage. 
NOTE In fact, GAP procedures are an integral part of quality control. 
4.2.1.3 Using cultivated plants under controlled conditions instead of those collected from the wild could 
minimize most of these factors. Sometimes, the active principles are destroyed by enzymic processes that continue 
for long periods from collection to marketing, resulting in a variation of composition. Thus, proper standardization 
and quality control of both the raw material and the herbal preparations shall be conducted.  
4.2.1.4 Formulators shall also apply adequate care in selecting the forms in which the herbs shall be 
used as an ‘ingredient’ in the products. Formulators shall use new herbal ingredients provided, adequate datais 
available on such ingredients 
  
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 4.2.2 Quantity/proportions of herbs used 
4.2.2.1 Formulators shall have adequate data justifying the proportion of the herbs or the herbal 
ingredient(s) for which claims are made, used in the product . 
4.2.2.2 In the absence of scientific data, availability of the quantity of herb in a product to provide the 
intended cosmetic benefits, such data shall be scientifically generated using appropriate methods and/or based on 
the known knowledge, published literature, and reported knowledge.  
4.3 Herbal cosmetic benefits claims 
4.3 Herbal Cosmetic benefits claims 
 
4.3.1 The cosmetic benefit claims made for products shall be true, factual and based on the data as 
described in 4.2.2.  
4.3.2 Factors such as the use of fresh plants, age and part of plant collected, period, time and method of 
collection, temperature of processing, exposure to light, availability of water, nutrients, drying, packaging, 
transportation of raw material and storage can greatly affect the quality and hence, the benefit of herbal preparation. 
Apart from these criteria, factors such as the method of extraction, contamination with microorganisms, heavy 
metals, and pesticides which can alter the quality, safety, and efficacy of herbal preparations shall be controlled and 
records shall be kept.  
4.3.3 No formulators/marketers shall make any cosmetic benefit claims which are false, exaggerated or 
misleading. However, in cases where cosmetic benefit claims are linked specifically to herb/herbs ingredients, the 
formulator/marketer shall do so, based on adequate and appropriate data in their possession justifying that the 
particular benefit claim is actually provided by the herb/herbal ingredients.  
4.3.4 Formulators/marketers who are incorporating herbal ingredient(s) for variant purposes shall ensure any 
cosmetic benefit claim made shall be delivered by the product as a whole, even though such benefits are not 
attributable to any specific herbal ingredient, and such cosmetics shall be governed by the Rwandan regulations. 
However, no formulator/marketers shall make any cosmetic benefit claim, which is not delivered by the product. 
4.4 Physical requirements 
4.4.1 The herbal cosmetic product shall have: 
a)a characteristic colourof the plant material. 
b) an acceptable odour at room temperature when rubbed on the skin. 
4.4.2 Foreign organic matter 
It is not possible to collect herbal ingredients without small amounts of related parts of plant or other plants. 
Procedure shall be set in order to limit the percentage of such unwanted plant contaminants. 
 DRS 333: 2023 
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 4.5 Chemical requirements 
4.5.1 Herbal cosmetic formulator shall have chemical evaluation procedure which will cover screening, 
isolation, identification and purification of the chemical components.  
4.5.2 Chemical analysis of the herbal cosmetic shall be done to assess the potency of plant material in terms 
of its active principles . 
4.5.3 The chemical screening or tests shall include colour reaction test, which helps to determine the identity 
of the active substance and possible adulteration.  
4.5.4 Ash values : incineration of herbal ingredients produces ash which constitutes inorganic matter. 
Treatment of the ash with hydrochloric acid results in acid-insoluble ash which consists mainly of silica and should 
be used to act as a measure of soil present. Limits shall be set for ash and acid-insoluble ash of herbal ingredients.  
4.6 Contaminants of herbal ingredients 
Herbal ingredients of high quality shall be free from insects, animal matter and excreta. It is usually not possible to 
remove completely all contaminants; hence specifications shall be set in order to limit them: 
  
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 4.6.1 Microbial contamination  
Aerobic bacteria and fungi are normally present in plant material and may increase due to faulty growing, 
harvesting, storage or processing. Herbal ingredients, particularly those withhigh starch content, shall be prone to 
increase microbial growth. Pathogenic organisms includingEnterobacter, Enterococcus, Clostridium, Pseudomonas, 
Shigella and Streptococcus have been shown tocontaminate herbal ingredients. Limits shall therefore be set for 
microbial contamination.  
4.6.2 Pesticides  
Herbal ingredients, particularly those grown as cultivated crops, may be contaminated by DDT 
(dichlorodiphenyltrichloroethane) or other chlorinated hydrocarbons, organophosphates, carbamates 
orpolychlorinated biphenyls. Limit tests shall be necessary for acceptable levels of pesticide contamination ofherbal 
ingredients.  
4.6.3 Fumigants 
Ethylene oxide, methyl bromide, phosphine or others fumigants should be used to controlpests which 
contaminate herbal ingredients. Limit tests shall be necessary for acceptable levels of fumigantresidues 
contamination.  
4.6.4 Heavy metals 
Lead, cadmium, mercury, thallium and arsenic have been shown to be contaminants of some herbal 
ingredients. Limit tests for such toxic metals are essential for herbal ingredients.  
4.6.5 Radioactive contamination  
There are many sources of ionization radiation, including radionuclides,occurring in the environment. Hence, a 
certain degree of exposure is inevitable and limit tests shall benecessary for acceptable levels of radioactive 
contamination. 
4.6.6 Other contaminants 
As standards increase for the quality of herbal ingredients and tests to limit other contaminants such as 
endotoxins and mycotoxins shall be utilized to ensure high quality for herbalcosmetic purposes.  
4.7 Quality assurance 
4.7.1 It is recognized that testing of herbal ingredients in herbal cosmetics is not easy and practicable due 
the multi-component nature of herbal ingredients. Formulators using herb/herbal ingredients shall adopt necessary 
quality assurance techniques while deciding to use an herb/herbal ingredient. Adequate raw material quality control 
shall be adopted each time when an herb/herbal ingredient is used.  
4.7.2 Use of herb/herbal ingredients shall be done through ‘Certification by addition’ during manufacturing 
and such certification documentation shall be recorded and maintained in the relevant ‘Master product ‘specification’ 
duly authenticated by the production and quality personnel. Written procedures shall be available for it and records 
shall be maintained for having applied the procedures and their results of compliance  DRS 333: 2023 
7                ©RSB2023- All rights reserved 
 4.8 Shelf-life data 
4.8.1 Formulators may adopt suitable shelf-life study protocols which ensure product integrity throughout the 
intended shelf-life period through appropriate data. Visible signs of degradation such as fermentation, 
rancidity,change in colour and such other parameters as applicable to the product, shall be used to prove the 
stability of the product.  
4.8.2 Samples of the products exposed to pre-decided challenge conditions of storage shall also be 
testedfor confirming the claimed cosmetics benefits. Finger printing technique or any other suitable methods 
wouldbe acceptable while generating shelf-life data.  
4.8.3 Stability of herbal ingredient(s) proven in a cosmetics formulation base can be justified and extrapolated 
to cosmetics with similar base formulation with changes within normal ranges from provenproduct.  
4.9 Safety data 
4.9.1 Formulators shall ensure that the finished product is safe. Results of safety data or such studies shall 
be available with the formulators/marketers and shall be produced, whenever required.  
4.9.2 Formulators/marketers shall suitably inform the consumer if there are any precautions to be taken 
while using the products, which are known to show safety concerns in specific individual/population on the labels of 
such products.  
5 Packaging 
Herbal cosmetics shall be packaged in containers that shall protect the contents, effectively screen the 
content from UV light when stored and shall not cause any contamination or react with the product. 
6 Labelling 
The containers shall be securely closed and in addition to the labelling requirements of RS EAS 346, the 
following information shall be indelibly and legibly marked on the container: 
a) product name that is “Herbal cosmetic”; 
b) net contents; 
c) name and physical address of the manufacturer and trade mark if any; 
d) list of ingredients; 
e) batch number in code or otherwise; 
f) the date of manufacture in the form “mm/yyyy”; 
g) best before date in the form “mm/yyyy”;  
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 h) storage conditions; and 
i) country of origin. 
j) storage conditions 
7 Sampling 
The samplingof herbal cosmetic products shall be done in accordance with RS 278. 
  DRS 333: 2023 
9                ©RSB2023- All rights reserved 
 Bibliography 
[1] RS 333:2018, Herbal cosmetic products- drawings— General requirements  
 
 DRS 333:2023 
 
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