EN    EN EN 
EN    EN  EUROPEAN COMMISSION 
Brussels,  
xxx 
  
Draft 
COMMISSION DIRECTIVE ../…/EU 
of […] 
amending Council Directive 76/768/EEC, concern ing cosmetic products, for the purpose 
of adapting Annex III thereto to technical progress 
(Text with EEA relevance)  
EN 2   EN Draft 
COMMISSION DIRECTIVE ../…/EU 
of […] 
amending Council Directive 76/768/EEC, concern ing cosmetic products, for the purpose 
of adapting Annex III thereto to technical progress 
(Text with EEA relevance) 
THE EUROPEAN COMMISSION, 
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, 
After consulting the Scientific Committee on Consumer Safety, Whereas: (1) The use of hydrogen peroxide is already subj ect to restrictions and conditions laid 
down in Annex III, Part 1 to Directive 76/768/EEC.  
(2) The Scientific Committee on Consumer Pr oducts, which has been replaced by the 
Scientific Committee on Consumer Safe ty (hereinafter SCCS) pursuant to 
Commission Decision 2008/721/EC of 5 Augus t 2008 setting up an advisory structure 
of Scientific Committees and experts in the field of consumer safe ty, 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 conti nue to use hydrogen peroxide in that concentration in oral 
products, including tooth white ning or bleaching products. 
(3) The SCCS considers that the use of toot h whitening or bleaching products containing 
more than 0.1% and up to 6% of hydrogen pe roxide present or released from other 
compounds or mixtures in these products may be safe if the following conditions are satisfied. An appropriate clinical examinati on is necessary to ensure the absence of 
risk factors or other oral pathology of concern and th e exposure to these products 
should be limited in a manner that ensures th at 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. 
                                                
 
1 OJ L 262, 27.9.1976, p. 169.  
2 OJ L 241, 10.9.2008, p. 21.  
EN 3   EN (4) Therefore, those products should be regulated in such a way that ensures that they are 
not directly available to the consumer. For e ach cycle of use of t hose products, the first 
use should be limited to dental practitioners  as defined under Dir ective 2005/36/EC of 
the European Parliament and of the Counc il of 7 September 2005 on the recognition of 
professional qualifications3 or under their direct  supervision if an equivalent level of 
safety is ensured. Dental practitioners should then decide to use the product on 
consumers for the first time and should only provide access to those products for the rest of the cycle of use.  
(5) The SCCS considers that concentration leve ls above 6% of hydroge n peroxide present 
in tooth whitening or bleaching products  or released from other compounds or 
mixtures in these products are not safe in  products used by the consumer. Therefore 
these products should be regu lated in a way that ensures that they are not directly 
available to the consumer. In order to ensu re their safe use, these products should only 
be used by dental practitioners as defi ned under Directive 2005/36/EC or under their 
direct supervision if an equivalent  level of safety is ensured.  
(6) An appropriate labelling regarding the concen tration 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 a ppropriate use of these products. For this 
purpose, the exact concentra tion in percentage of hydr ogen peroxide present or 
released from other compounds and mixtures  in those products should be clearly 
indicated on the label.  
(7) Directive 76/768/EEC should therefore be amended accordingly. 
(8) In part 1 of Annex III, reference number 12 on the regulation of hydrogen peroxide 
present or released from other compounds or  mixtures in tooth whitening or bleaching 
products should be reconsidered in four years at the latest in the light of new scientific 
data available. 
(9) The measures provided for in this Directiv e are in accordance with the opinion of the 
Standing Committee on Cosmetic Products, 
HAS ADOPTED THIS DIRECTIVE: 
Article 1 
Annex III to Directive 76/768/EEC is amende d in accordance with the Annex to this 
Directive. 
Article 2 
 
1. Member States shall adopt and publish, by [Day, Month, Year = 12 months after the 
publication of the Directive4] at the latest, the laws, re gulations and administrative 
                                                 
3 OJ L 255, 30.9.2005, p.22. 
4 Date to be included.  
EN 4   EN provisions necessary to comply with this Directive. They shall forthwith 
communicate to the Commission the text of those provisions.  
They shall apply those provisions from [Day, Month, Year = 12 months after the 
publication of the Directive5]. 
When Member States adopt those provisions,  they shall contain a reference to this 
Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determin e how such reference is to be made. 
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 tw entieth day following that of its publication in 
the Official Journal of  the European Union . 
Article 4 
This Directive is addressed to the Member States. 
Done at Brussels, […] 
 For the Commission 
 […] 
 The President 
                                                
 
5 Date to be included.  
EN 5   EN ANNEX  
In Part 1 of Annex III to Directive 76/768/EEC , reference number 12 is replaced by the 
following: 
Restrictions Reference 
number Substance 
Field of 
application 
and/or use Maximum 
authorised 
concentration 
in the finished 
cosmetic 
product Other 
limitations 
and 
requirementsConditions of use 
and warnings which 
must be printed on 
the label 
"12 Hydrogen 
peroxide and other compounds or mixtures that release hydrogen peroxide, including carbamide peroxide and zinc peroxide (a) Hair care 
preparations 
     
b) Skin care 
preparations   (c) Nail hardening preparations   (d) Oral products, including mouth rinse, tooth paste and tooth whitening or bleaching products     (a) 12 % of 
H
2O2 (40 
volumes), present or released         (b) 4% of H
2O2, present 
or released  (c) 2% of H
2O2, present 
or released  (d) 0.1% of H
2O2,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.                        
                                                 
6 OJ L 255, 30.9.2005, p. 22.   
EN 6   EN (e) tooth 
whitening or bleaching products (e) 
1. >0.1% - ≤ 
6% of H
2O2,present 
or released             
 
          2. >6% of H
2O2,present 
or released (e) 
1. To be only sold to dental practitioners. For each cycle of use, 1
st use by 
dental practitioners as defined under Directive 2005/36/EC
6 
or under their direct supervision 
if an 
equivalent level of safety is ensured. Not to be used on a person under 18 years of age  2. To be only sold to dental practitioners. To be only used by dental practitioners as defined under Directive 2005/36/EC or under their direct supervision if an equivalent level of safety is ensured. 
Not to be 
used on a (e)  
1. Concentration of H
2O2 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.          2. Concentration of H
2O2 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. To be only used by dental practitioners or under their direct supervision if an equivalent level of safety is ensured.”  
EN 7   EN person under 
18 years of age