CDC 3(910) DTZS  
 
  ICS 71.100. 70 
 
 
 
 
  
 
 
 
 
DRAFT TA NZANIA STANDARD 
 
 
 
 
 
 
 
 
 
 
 
Herbal cosmetics — General guidelines  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
TANZANIA BUREAU  OF STANDARDS 
 
 
 
 
 
 
 
 
 
 
 
 
  
 
1st Edition 
© TBS 2022 
 
 
  
 
 Foreword  
This Draft Tanzania Standard is being prepared by Cosmetics and creameries  Technical Committee under the 
supervision of Chemicals Divisional Standards Committee and it is in accordance with the procedures of the 
Bureau.  
During pr eparation of this Draft Standard, reference was made from the Indian Standard, IS 15735:200 6 Herbal 
Cosmetics — General Guidelines , published by Bureau of Indian Standards  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 CDC 3( 910) DTZS  
© TBS – All rights reserved   
 Introduction  
The awareness and need for cosmetics with herbs are on the rise, primarily because consumer believes that 
these products are safe and free from side  effects. There is a need to provide assurance to the consumers that 
such products generally  claimed and/or labelled to as “Herbal Cosmetics ” are actually delivering the benefit 
claims, safe and are of standard quality. There is a need for manufacturers of herbal cosmetics to adopt general  
guidelines by the formulators and marketers of such cosmetics.  
Cosmetics claimed and labelled as ‘Herbal’ could be those products which are formulated using cosmetic base 
into which herbs are added for providing the claimed product benefits. These guidel ines address identified 
areas, which manufacturers  of herbal cosmetics need to comply. Manufacturers  who claim their cosmetic 
product (s) as herbal cosmetic by labeling  them with such words on the pack age need to comply with the general 
guidelines for herba l cosmetics.  
This guideline does not stipulate  the composition of the herbal cosmetics. However, it is necessary that the raw 
materials used in formulation of herbal cosmetics  are in concentrations which would  be present in the finished 
cosmetics, after i nteraction with the other raw materials used in the formulation  and are free from  any harmful  
effects.  
It is a responsibility of the manufacturers of finished cosmetic, to satisfy  that their cosmetic products are  
dermatological ly safe. 
© TBS  – All rights reserved  1 
 DRAFT TANZANIA STANDARD                              CDC 3(910) DTZS  
 
 
Herbal Cosmetics — General guidelines  
 
1. Scope  
This Draft Tanzania Standard provide general guidelines for herbal cosmetics.   
This guideline does not cover herbal products which therapeutical claims are made.  
2. Normative references  
The following referenced doc uments 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.  
TZS 638 (1 -5)/EAS 377 (1 -5), Cosmetics and cosmetic products  
TZS 314, Cosmetics and toilet products – Methods of sampling  
TZS 774/EAS 346, Labeling of cosmetic products – General requirements  
ISO 24153, Random sampling and randomization procedures  
ISO 22716,  Cosmetics — Good Manufactu ring Practices (GMP) — Guidelines on good 
manufacturing practices  
ISO 17516 , Cosmetics — Microbiology — Microbiological limits  
3. Terms and definitions  
For the purposes of this document, the terms and definitions given in EAS 846 and the following 
apply.  
 
ISO and IEC maintain terminological databases for use in standardization at the following 
addresses: — ISO Online browsing platform: available at http://www.iso.org/obp  
 
herbal cosmetics  
cosmetic products formulated using various permissible cosmetic ingredients to form the base in 
which one or more herb(s)/herbal ingredient are used to provide defined cosmetic bene fits with a 
label declaration as ‘ herbal cosmetic’.  
 
4. Herb(s)/Herbal Ingredient(s)  
The herb(s)/herbal ingredient(s) for use in products covered under these guidelines, shall mean 
to include one or more of the following:  
(a) Fresh herbs/juices/pastes/oleoresins made from whole or part(s) of plants,  
(b) Dried powdered herbs,  
(c) Herbal extracts,   
© TBS  – All rights reserved  2 
 (d) Cold pressed and/or solvent extracted, fixed oils/ fats from herbs, and  
(e) Distillates/Essential oils of herbs  
 
5. Selections of herb  
5.1 Manufacturers of herbal cosmetics should carefully select herbs/herbal ingredients based on 
their known and reported properties (in literature), properties known in cultural heritage or/and  
traditional use .  
5.2 Manufacturers of herbal cosmetics shall apply adequate care in selecting the f orms in which 
the herbs would be used as an ingredient in  the products. They may use an herbal ingredient for 
new uses  than known earlier provided; adequate data should be available on that ingredient and 
its new use s. 
 
6. Quantity/proportions of herbs used  
Manufacturers of herbal cosmetics should have adequate data on the proportion of the herbs or 
the herbal ingredient(s) for which claims are made, used in the product. In the absence of scientific 
data, on availability o f the quantity of herb in a product to provide the intended cosmetic benefits, 
such data may be based on the known knowledge, published literature, and reported knowledge 
in traditional books and/ or scientifically generated data using appropriate in -vitro and/or in -vivo 
(clinical) methods.  
7. Herbal cosmetic benefits claims  
The cosmetic benefit claims made for products sh ould be true, factual and based on the data in 
possession with the formulators/ marketers.  Manufacturers should not make  any cosmetic 
claim/claims, which are false, exaggerated or misleading. However, in cases where cosmetic 
benefit claims are linked  specifical ly to herbs/herbal  ingredients, manufacturer  shall do so, based 
on adequate and appropriate data in their possession justi fying that the particular benefit claim is 
actually provided by the herb/herbal  ingredients.  
8. Quality assurance  
Testing of herbal ingredients in herbal cosmetics is not easy and practicable due the 
multicomponent nature of herbal ingredients, manufacturers 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 a herb/herbal ingredient 
is used. The u se of herb/herbal ingredients shall be recorded and maintained in the relevant 
‘Master product specification’ or ‘Bill of materials’ or ‘Weighment sheet’ duly authenticated by the 
production and quality personnel. Written procedures should  be available for  it and records shall 
be maintained for having applied the procedures and their results of compliance.  
9. Shelf-life data  
Manufacturers may adopt suitable shelf -life study protocols which ensure product integrity 
throughout the intended shelf -life period through appropriate data. Viable  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. Samples of the products exposed to  
pre-decided challenge conditions of storage shall also be tested for confirming the claimed  
© TBS  – All rights reserved  3 
 cosmetics benefits. Finger printing technique or any other suitable methods would be acceptable 
while generating shelf -life data.  
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 
proven product.  
10. Data of s afety of the product   
Manufacturers  should  ensure that the finished product is safe. Results of safety data/such studies 
should be available with the manufacturer  and shall be produced  whenever required . 
Manufacturer  should suitably inform the consumer on the labels of such products if there are a ny 
precautions to be taken while using the products which are known to show safety concerns in 
specific individual /population.  
For microbiological evaluation/examination, reference may be made to ISO 17516,  For the 
purpose of hygienic manufacture of cosmetics, reference may be made to  ISO 22716  and for 
sampling details, reference may  be made to  TZS 314 . 
11 Packaging and labelling  
 
11.1 Packaging  
Herbal cosmetics should be packaged in suitable well -sealed containers that protect the contents 
and not cause any contamination or react with the product.  
11.2 Labelling  
In addition to the labelling requirements given in TZS 774/EAS 346 , each package of herbal 
cosmetics should  be legibly and indelibly marked with following information:  
a) Name of product   
b) Herbal ingredient contained