DEAS  377-2: 2021  
ICS 1.100.70  
 
© EAC 2021                                                                                                                              3rd Edition 2021   
 DRAFT EAST AFRICAN STANDARD  
Cosmetic and cosmetic products — Part 2: List of substances which 
cosmetic products must not contain except subject to the restrictions 
laid down  
EAST AFRICAN COMMUNITY  DEAS  377-2: 2021  
ii © EAC 2021  – All rights  reserved  
 Copyright notice  
This EAC document is copyri ght-protected by EAC. While the reproduction of this document by 
participants in the EAC standards development process is permitted without prior permission from EAC, 
neither this document nor any extract from it may be reproduced, stored or transmitted in  any form for 
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© East A frican Community  2021  — All rights reserved  
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Reproduction for sales purposes may be subject to royal ty payments or a licensing agreement.  
Violators may be prosecuted . 
 DEAS  377-2: 2021  
© EAC 2021  – All rights reserved  iii 
 Foreword  
Development of the East African Standards has been necessitated by the need for harmonizing requirements 
governing quality of products and services in the East African Community. It is envisaged that through 
harmonized standardization, trade barriers that are encountered when goods and services are exchanged 
within the Community will be removed.  
The Community has established an East African Standards Committee  (EASC)  mandated to d evelop and 
issue East African Standards  (EAS) . The Committee is composed of representatives of the National 
Standards Bodies in Partner States, together with the representatives from the public and private sector 
organizations  in the community .  
East Afric an Standards are developed through  Technical Committees that are representative of key 
stakeholders including government, academia, consumer groups, private sector and other interested parties. 
Draft East African Standards are circulated to stakeholders th rough the National Standards Bodies in the 
Partner States. The comments received are discussed and incorporated before finalization of standards, in 
accordance with the Principles and procedures for development of East African Standards. XXXXXX.  
East Afric an Standards are subject to review, to keep pace with technological advances. Users of the East 
African Standards are therefore expected to ensure that they always have the latest versions of the standards 
they are implementing .  
The committee responsible for this document is Technical Committee EASC/TC 071, Cosmetics and related 
products. . 
Attention is drawn to the possibility that some of the elements of this document may be subject of patent 
rights. EAC shall not be held responsible for identifying any o r all such patent rights.  
This third edition cancels and replaces the second edition ( EAS 377-1:2013 ), which has been technically 
revised.  
DEAS  377 consists of the following parts, under the general title, Cosmetics and cosmetic products  
Part 1: List of substances prohibited in cosmetic products  
Part 2: List of substances which cosmetic products must not contain except subject to the restrictions laid 
down  
Part 3: List of colorants , preservatives and UV filters  allowed in c osmetic products  DEAS  377-2: 2021  
iv © EAC 2021  – All rights  reserved  
 Introduction  
Cosmetic products should be safe under normal or reasonably foreseeable conditions of use. In particular, a 
risk-benefit reasoning should not justify a risk to human health. The safety of finished cosmetic products can 
already be ensured on the basis of knowledge of the safety of the ingredients that they contain. The European 
Regulation (EC) No 1223/2009 on cosmetics to which this East African Standard refers, aims at ensuring the 
safety of cosmetics.  
The general principle of the responsibility of the manufacturer or importer for the safety of the product should 
be supported by restrictions of some substances in Annex es II and III of the Regulation. Moreover, 
substances which are intended to be used as colorants, preservatives and UV -filters should be listed in the 
Annexes IV, V and VI respectively of the Regulation in order to be allowed for these uses.  
The Regulatio n relates only to cosmetic products and not to medicinal products, medical devices or biocidal 
products. The delimitation follows in particular from the detailed definition of cosmetic products, which refers 
both to their areas of application and to the pu rposes of their use.  
The information contained in the annexes II – VI of the Regulation has been developed through risk 
assessment of these substances by the Scientific Committee for Consumer Safety (SCCS) set up by 
Commission Decision 2008/721/EC of 5 September 2008 setting up an advisory structure of Scientific 
Committees and experts in the field of consumer safety, public health and the environment.  
Given the hazardous properties of substances classified as carcinogenic, mutagenic or toxic for r eproduction 
(CMR), category 1A, 1B and 2, their use in cosmetic products should be prohibited.  
The safety of cosmetic products and their ingredients may be ensured through the use of alternative methods 
which are not necessarily applicable to all uses of chemical ingredients. Therefore, the use of such methods 
by the whole cosmetic industry should be promoted and their adoption at Community level ensured, where 
such methods offer an equivalent level of protection to consumers.  
Therefore use of alternative s is encouraged where the substances are prohibited and , in the exceptional case 
that these substances comply with food safety requirements, inter alia as a result of their naturally occurring in 
food, and that no suitable alternative substances exist, ma y be used under prescribed conditions when found 
safe by SCCS in accordance to Annex III.  
To minimise the risk and assure the safety of cosmetic products in the region, EAS 377 -2 has been adapted 
from the EU Directive (EC) No 1223/2009 on Cosmetics from  Annex III taking into consideration the research  
done and the constant expert review . 
 DRAFT EAST AFRICAN STANDARD  DEAS  377-2:2021  
 
© EAC 2021  – All rights reserved  1 
 Cosmetic and cosmetic products — Part 2: List of substances which 
cosmetic products must not contain except subject to the restrictions 
laid down  
1 Scope   
This Draft African Standard prescribes the list of substances which cosmetic products must not contain except 
subject to the restrictions laid down.  
This Draft East African Standard applies only to cosmetic products and not to medicinal products, medical 
devices or biocidal products.   
2 Normative references   
There are no normative references in this document.  
3 Terms and definitions   
For the purposes of this document, the following terms and definitions 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  
3.1  
colorants  
substances which are exclusively or mainly intended to colour the cosmetic product, the body as a whole or 
certain parts thereof, by absorption or reflection of visible light; in addition, precursors of oxidative ha ir 
colorants shall be deemed colorants  
3.2  
cosmetic product  
substance or mixture intended to be placed in contact with the external parts of the human body (epidermis, 
hair system, nails, lips and external genital organs) or with the teeth and the mucous  membranes of the oral 
cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, 
protecting them, keeping them in good condition or correcting body odours  
3.3  
eye product  
cosmetic product which is intended to b e applied in the vicinity of the eyes  
3.4  
face product  
cosmetic product which is intended to be applied on the skin of the face  
3.5  
hair product  
cosmetic product which is intended to be applied on the hair of head or face, except eyelashes   
2 © EAC 2021  – All rights  reserved  
 3.6  
leave-on product  
cosmetic product which is intended to stay in prolonged contact with the skin, the hair or the mucous 
membranes  
3.7  
lip product  
cosmetic product which is intended to be applied on the lips  
3.8  
mixture  
preparation or solution composed of  two or more substances  
3.9  
nail product  
cosmetic product which is intended to be applied on nails  
3.10  
oral product  
cosmetic product which is intended to be applied on teeth or the mucous membranes of the oral cavity  
3.11  
preservatives  
substance s which are exclusively or mainly intended to inhibit the development of micro -organisms in the 
cosmetic product  
3.12 
product applied on mucous membranes  
cosmetic product which is intended to be applied on the mucous membranes of the oral cavity, on the  rim of 
the eyes, or of the external genital organs  
3.13 
professional use  
application and use of cosmetic products by persons in the exercise of their professional activity  
3.14 
rinse -off product  
cosmetic product which is intended to be removed after a pplication on the skin, the hair or the mucous 
membranes  
3.15 
serious undesirable effect  
undesirable effect which results in temporary or permanent functional incapacity, disability, hospitalisation, 
congenital anomalies or an immediate vital risk or dea th  
3.16 
skin product  
cosmetic product which is intended to be applied on the skin  
3.17 
substance  
chemical element and its compounds in the natural state or obtained by any manufacturing process, including 
any additive necessary to preserve its stabilit y and any impurity deriving from the process used but excluding 
any solvent which may be separated without affecting the stability of the substance or changing its 
composition   
© EAC 2021  – All rights reserved  3 
 3.18  
undesirable effect  
adverse reaction for human health attributable to the  normal or reasonably foreseeable use of a cosmetic 
product  
3.19  
UV-filters  
substances which are exclusively or mainly intended to protect the skin against certain UV radiation by 
absorbing, reflecting or scattering UV radiation  
4 Requirements  
Cosmetic products shall not contain any of the restricted substances which are not used in accordance with 
the restric tions laid down in Annex III of Regulation (EC) No. 1223/2009 on cosmetic products of the European 
Parliament and of the Council (as amended from time to time)  
   
4 © EAC 2021  – All rights  reserved  
 Bibliography  
Regulation (EC) No. 1223/2009 of the European Parliament and of the Council of 30 th November 2009 on 
cosmetic products  
 WEAS 377-1: 2021    
 
© EAC 2021  – All rights r eserved