Proposal for a COUNCIL DIRECTIVE amending Directive 76/768/EEC, concerning cosmetic products, for the purpose of adapting Annex III thereto to technical progress
Date: 2011-06-23
Institutions: European Commission
Subjects: cosmetic product, dental medicine, market approval, oxide, product safety

EUROPEAN COMMISSION 

Brussels, 23.6.2011 
COM(2011) 377 final 

2011/0164 (NLE) 

Proposal for a 

COUNCIL DIRECTIVE 

amending Directive 76/768/EEC, concerning cosmetic products, for the purpose of 
adapting Annex III thereto to technical progress 

(Text with EEA relevance) 

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EXPLANATORY MEMORANDUM 

The  attached  proposal  for  a  Council  Directive  concerns  the  use  of  hydrogen  peroxide  and 
other  compounds  or  mixtures  that  release  hydrogen  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Indeed, in December 2007, the Scientific Committee on Consumer Products, which has been 
replaced  by  the  Scientific  Committee  on  Consumer  Safety  (hereinafter  SCCS)  pursuant  to 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,  delivered  an  opinion  on  hydrogen 
peroxide,  in  its  free  form  or  when  released,  in  oral  hygiene  products  and  tooth  whitening 
products. 

A draft Commission Directive aiming to implement 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.  The  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 considered to have given tacitly their agreement, as they did not 
express opposition or intention to abstain within the timeline set in the 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 with Article 5 of Council Decision 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 inform the European Parliament. 

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2011/0164 (NLE) 

Proposal for a 

COUNCIL DIRECTIVE 

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  products1,  and  in  particular  Article  8(2) 
thereof, 

Having regard to the proposal from the European Commission, 

Whereas: 

(1) 

(2) 

(3) 

The  use  of  hydrogen  peroxide  is  already  subject  to  restrictions  and  conditions  laid 
down in Annex III, Part 1 to Directive 76/768/EEC. 

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/EC2,  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. 

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  appropriate  clinical  examination  is  necessary  to  ensure  the  absence  of 
risk  factors  or  other  oral  pathology  of  concern  and  the  exposure  to  these  products 
should be limited in a manner that ensures 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. 

1 
2 

OJ L 262, 27.9.1976, p. 169. 
OJ L 241, 10.9.2008, p. 21. 

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(4) 

(5) 

(6) 

(7) 

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 qualifications3 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. 

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  concentration  in  percentage  of  hydrogen  peroxide  present  or 
released  from  other  compounds  and  mixtures  in  those  products  should  be  clearly 
indicated on the label. 

Directive 76/768/EEC should therefore be amended accordingly. 

The  Standing  Committee  on  Cosmetic  Products  has  not  delivered  an  opinion  within 
the time-limit laid down by its Chairman, 

HAS ADOPTED THIS DIRECTIVE: 

Annex  III  to  Directive  76/768/EEC  is  amended  in  accordance  with  the  Annex  to  this 
Directive. 

Article 1 

Article 2 

Transposition 

Member States shall adopt and publish, by [Day, Month, Year = 12 months after the 
publication  of  the  Directive4]  at  the  latest,  the  laws,  regulations  and  administrative 
this  Directive.  They  shall  forthwith 
provisions  necessary 
communicate to the Commission the text of those provisions. 

to  comply  with 

They shall apply those provisions from [Day, Month, Year = 12 months + 1 day 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 determine how such reference is to be made. 

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. 

OJ L 255, 30.9.2005, p.22. 
Date to be included. 
Date to be included. 

1. 

2. 

3 
4 
5 

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This Directive shall enter into force on the twentieth day following that of its publication in 
the Official Journal of the European Union. 

Article 3 

Article 4 

This Directive is addressed to the Member States. 

Done at Brussels,  

For the Council 
The President 

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In  Part  1  of  Annex  III  to  Directive  76/768/EEC,  reference  number  12  is  replaced  by  the 
following: 

ANNEX  

Conditions of use 
and warnings which 
must be printed on 
the label 

Other 
limitations 
and 
requirements

suitable 

(a)  wear 
gloves 
(a) (b) (c) (e) 
Contains  hydrogen 
peroxide 
Avoid  contact  with 
eyes 
Rinse 
immediately 
if  product  comes 
into  contact  with 
them. 

Reference 
number 

Substance 

"12 

Hydrogen 
peroxide 
other 
and 
compounds 
or  mixtures 
that  release 
hydrogen 
peroxide, 
including 
carbamide 
peroxide 
and 
peroxide 

zinc 

Field of 
application 
and/or use 

(a)  Hair  care 
mixtures 

Restrictions 

Maximum 
authorised 
concentration 
in the finished 
cosmetic 
product 

(a)  12  %  of 
H2O2 
(40 
volumes), 
present 
released 

or 

b)  Skin  care 
mixtures 

(b)  4%  of 
H2O2,  present 
or released 

Nail 

(c) 
hardening 
mixtures 

of 
2% 
(c) 
H2O2,  present 
or released 

(d)  ≤  0.1%  of 
H2O2,  present 
or released 

Oral 

(d) 
products, 
including 
mouth  rinse, 
tooth  paste 
and 
tooth 
whitening  or 
bleaching 
products 

tooth 
(e) 
whitening  or 
bleaching 
products 

(e)  >0.1%  ≤ 
6%  of  H2O2, 
present 
or 
released 

(e)  To  be 
only  sold  to 
dental 
practitioners. 
each 
For 
cycle  of  use, 

(e) Concentration of 
H2O2  present  or 
released indicated in 
percentage. 

Not to be used  on a 

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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 
is  ensured. 
safety 
to  be 
Afterwards 
the 
provided 
consumer 
to 
complete  the  cycle 
of use. 

to 

an 

1st  use  by 
dental 
practitioners 
as 
defined 
under 
Directive 
2005/36/EC 
*  or  under 
their  direct 
supervision 
if 
equivalent 
level 
safety 
ensured. 
Afterwards 
to 
provided 
the 
consumer  to 
complete  the 
cycle of use. 
Not 
to  be 
used  on  a 
person under 
18  years  of 
age 

be 
to 

of 
is 

* OJ L 255, 30.9.2005, p. 22 “ 

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