EN    EN EN  
EN 1   EN  EUROPEAN COMMISSION 
Brussels,  
COM 
  
Proposal for a 
COUNCIL DIRECTIVE 
amending Directive 76/768/EEC, concerning co smetic products, for the purpose of 
adapting Annex III theret o to technical progress 
(Text with EEA relevance)  
EN 2   EN EXPLANATORY MEMORANDUM  
The attached proposal for a Council Directive concerns the use of hydrogen peroxide and 
other compounds or mixtures that release hydr ogen peroxide, including carbamide peroxide 
and zinc peroxide, in tooth whitening or bleaching products, in the framework of the Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States 
relating to cosmetic products. It aims at implementing within Directive 76/768/EEC an 
opinion of the Scientific Committee on Consumer Safety of 2007. 
Indeed, in December 2007, the Scientific Committee on Consumer Products, which has been 
replaced by the Scientific Committee on Consum er Safety (hereinafter SCCS) pursuant to 
Commission Decision 2008/721/EC of 5 August 2008 setting up an advi sory structure of 
Scientific Committees and experts in the fiel d of consumer safety, public health and the 
environment and repealing Decision 2004/ 210/EC, delivered an opinion on hydrogen 
peroxide, in its free form or when release d, in oral hygiene produc ts and tooth whitening 
products. 
A draft Commission Directive aiming to implem ent within Directive 76/768/EEC the above-
mentioned scientific opinion was submitted to  the Standing Committee on Cosmetic Products 
on 6 May 2010 for vote by written procedure. Th e Committee did not deliver an opinion 
within the time-limit laid down by its Chairman : 16 Member States expressly voted in favour 
and 6 Member States were consid ered to have given tacitly their agreement, as they did not 
express opposition or intention to abstain within  the timeline set in th e written procedure (243 
votes in favour) and 5 Member States  voted against (102 votes against). 
Consequently, pursuant to Article 8(2) read in conjunction with Article 10 of Directive 
76/768/EEC and in accordance wi th Article 5 of Council Deci sion 1999/468/EC modified by 
Council Decision 2006/512/EC, the Commission is required to submit to the Council a 
proposal relating to the measures to be taken, the Council having three months in which to act 
by qualified majority, and to info rm the European Parliament.  
EN 3   EN Proposal for a 
COUNCIL DIRECTIVE 
amending Directive 76/768/EEC, concerning co smetic products, for the purpose of 
adapting Annex III theret o 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 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 4   EN (4) Therefore, those products should  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 shoul d then provide access to those products for 
the rest of the cycle of use. 
(5) 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. 
(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, 
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 
 
Transposition 
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 
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 + 1 day after 
the publication of the Directive
5]. 
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. 
                                                
 
3 OJ L 255, 30.9.2005, p.22. 
4 Date to be included. 
5 Date to be included.  
EN 5   EN 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 Council 
 The President  […]  
EN 6   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   (e) 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  
        (e) >0.1% ≤ 
6% of H
2O2, 
present or released  
                              (e) To be only sold to dental practitioners. For each cycle of use, (a) wear suitable 
gloves (a) (b) (c) (e) Contains hydrogen peroxide Avoid contact with eyes Rinse immediately if product comes into contact with them.                     (e) Concentration of H
2O2 present or 
released indicated in percentage.
 
 Not to be used on a  
EN 7   EN 1st 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 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 “