DIRECTIVES  
COUNCIL DIRECTIVE 2011/84/EU  
of 20 September 2011  
amending Directive 76/768/EEC, concerning cosmetic products, for the purpose of adapting Annex 
III thereto to technical progress  
(Text with EEA relevance)  
THE COUNCIL OF THE EUROPEAN UNION,  
Having regard to the Treaty on the Functioning of the European 
Union,  
Having regard to Council Directive 76/768/EEC of 27 July 
1976 on the approximation of the laws of the Member States 
relating to cosmetic products (  1 ), and in particular Article 8(2) 
thereof,  
Having regard to the proposal from the European Commission,  
Whereas:  
(1) The use of hydrogen peroxide is already subject to 
restrictions and conditions laid down in Annex III, Part 
1 to Directive 76/768/EEC.  
(2) The Scientific Committee on Consumer Products, which 
has been replaced by the Scientific Committee on 
Consumer Safety (hereinafter SCCS) pursuant to 
Commission Decision 2008/721/EC of 5 August 2008 
setting up an advisory structure of Scientific Committees 
and experts in the field of consumer safety, public health 
and the environment and repealing Decision 
2004/210/EC (  2 ), has confirmed that a maximum 
concentration of 0,1 % of hydrogen peroxide present in 
oral products or released from other compounds or 
mixtures in those products is safe. It should therefore 
be possible to continue to use hydrogen peroxide in 
that concentration in oral products, including tooth 
whitening or bleaching products.  
(3) The SCCS considers that the use of tooth whitening or 
bleaching products containing more than 0,1 % and up to 6 % of hydrogen peroxide present or released from 
other compounds or mixtures in these products may be 
safe if the following conditions are satisfied: an appro ­
priate clinical examination is carried out in order to 
ensure there are no risk factors or any other oral 
pathology of concern and that exposure to these 
products is limited so as to ensure that the products 
are used only as intended in terms of frequency and 
duration of application. These conditions should be 
fulfilled in order to avoid reasonably foreseeable misuse.  
(4) Those products should therefore be regulated in a way 
that ensures that they are not directly available to the 
consumer. For each cycle of use of those products, the 
first use should be limited to dental practitioners, as 
defined under Directive 2005/36/EC of the European 
Parliament and of the Council of 7 September 2005 
on the recognition of professional qualifications (  3 ) or 
under their direct supervision if an equivalent level of 
safety is ensured. Dental practitioners should then 
provide access to those products for the rest of the 
cycle of use.  
(5) An appropriate labelling regarding the concentration in 
hydrogen peroxide of the tooth whitening or bleaching 
products containing more than 0,1 % of this substance 
should be provided for in order to ensure the appropriate 
use of these products. For this purpose, the exact concen ­
tration in percentage of hydrogen peroxide present or 
released from other compounds and mixtures in those 
products should be clearly indicated on the label.  
(6) Directive 76/768/EEC should therefore be amended 
accordingly.  
(7) The Standing Committee on Cosmetic Products has not 
delivered an opinion within the time limit laid down by 
its Chairman,EN L 283/36 Official Journal of the European Union 29.10.2011  
( 1 ) OJ L 262, 27.9.1976, p. 169.  
( 2 ) OJ L 241, 10.9.2008, p. 21.  (  3 ) OJ L 255, 30.9.2005, p. 22.HAS ADOPTED THIS DIRECTIVE:  
Article 1  
Annex III to Directive 76/768/EEC is amended in accordance 
with the Annex to this Directive.  
Article 2  
1. Before 30 October 2012 Member States shall adopt and 
publish the provisions necessary to comply with this Directive. 
They shall forthwith inform the Commission thereof.  
They shall apply these provisions from 31 October 2012.  
When Member States adopt these measures, they shall contain a 
reference to this Directive or shall be accompanied by such 
reference on the occasion of their official publication. The 
methods of making such reference shall be laid down by 
Member States.  2. Member States shall communicate to the Commission the 
text of the main provisions of national law which they adopt in 
the field covered by this Directive.  
Article 3  
This Directive shall enter into force on the 20th day following 
its publication in the  Official Journal of the European Union . 
Article 4  
This Directive is addressed to the Member States.  
Done at Brussels, 20 September 2011.  
For the Council  
The President  
M. SAWICKIEN 29.10.2011 Official Journal of the European Union L 283/37ANNEX  
In Part 1 of Annex III to Directive 76/768/EEC, reference number 12 is replaced by the following:  
Reference 
number  Substance  Restrictions  
Conditions of use and warnings which must be printed 
on the label  Field of application and/or use  Maximum authorised concentration 
in the finished cosmetic product  Other limitations and requirements  
‘12 Hydrogen peroxide and 
other compounds or 
mixtures that release 
hydrogen peroxide, 
including carbamide 
peroxide and zinc 
peroxide  (a) Hair care mixtures  (a) 12 % of H  2O 2 (40 volumes), 
present or released  (a) Wear suitable gloves 
(a) (b) (c) (e) 
Contains hydrogen peroxide 
Avoid contact with eyes 
Rinse immediately if product comes into contact 
with them.  (b) Skin care mixtures  (b) 4 % of H  2O 2, present or 
released  
(c) Nail hardening mixtures  (c) 2 % of H  2O 2, present or 
released  
(d) Oral products, including 
mouth rinse, tooth paste 
and tooth whitening or 
bleaching products  (d) ≤ 0,1 % of H  2O 2, present or 
released  
(e) Tooth whitening or 
bleaching products  (e) > 0,1 % ≤ 6 % of H  2O 2, 
present or released  (e) To be only sold to dental practitioners. 
For each cycle of use, first use by dental 
practitioners as defined under Directive 
2005/36/EC (*) or under their direct 
supervision if an equivalent level of 
safety is ensured. Afterwards to be 
provided to the consumer to complete 
the cycle of use. 
Not to be used on a person under 18 
years of age.  (e) Concentration of H  2O 2 present or released 
indicated in percentage. 
Not to be used on a person under 18 years of 
age. 
To be only sold to dental practitioners. For 
each cycle of use, the first use to be only 
done by dental practitioners or under their 
direct supervision if an equivalent level of 
safety is ensured. Afterwards to be provided 
to the consumer to complete the cycle of use.  
(*) OJ L 255, 30.9.2005, p. 22.’EN L 283/38 Official Journal of the European Union 29.10.2011