HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"L 283/36
EN
Official Journal of the European Union
29.10.2011
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,
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
Having regard to the Treaty on the Functioning of the European
ensure there are no risk factors or any other oral
Union,
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
Having regard to Council Directive 76/768/EEC of 27 July
fulfilled in order to avoid reasonably foreseeable misuse.
1976 on the approximation of the laws of the Member States
relating to cosmetic products ( 1 ), and in particular Article 8(2)
thereof,
(4) Those
products
should
therefore
be
regulated
in
a
way
that ensures that they are not directly available to the
Having regard to the proposal from the European Commission,
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
Whereas:
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
(1) The
use
of
hydrogen
peroxide
is
already
subject
to
cycle of use.
restrictions and conditions laid down in Annex III, Part
1 to Directive 76/768/EEC.
(5) An
appropriate
labelling
regarding
the
concentration
in
(2) The
Scientific
Committee
on
Consumer
Products,
which
hydrogen peroxide of the tooth whitening or bleaching
has been replaced by the Scientific Committee on
products containing more than 0,1 % of this substance
Consumer Safety (hereinafter SCCS) pursuant to
should be provided for in order to ensure the appropriate
Commission Decision 2008/721/EC of 5 August 2008
use of these products. For this purpose, the exact concen
setting up an advisory structure of Scientific Committees
tration in percentage of hydrogen peroxide present or
and experts in the field of consumer safety, public health
released from other compounds and mixtures in those
and the environment and repealing Decision
products should be clearly indicated on the label.
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
(6) Directive
76/768/EEC
should
therefore
be
amended
that concentration in oral products, including tooth
accordingly.
whitening or bleaching products.
(3) The
SCCS
considers
that
the
use
of
tooth
whitening
or (7) The
Standing
Committee
on
Cosmetic
Products
has
not
bleaching products containing more than 0,1 % and up
delivered an opinion within the time limit laid down by
its Chairman,
( 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.

---

EN
29.10.2011 Official
Journal
of
the
European
Union L
283/37
HAS ADOPTED THIS DIRECTIVE:
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 1
Annex III to Directive 76/768/EEC is amended in accordance
with the Annex to 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 2
1. Before 30 October 2012 Member States shall adopt and
publish the provisions necessary to comply with this Directive.
Article 4
They shall forthwith inform the Commission thereof.
This Directive is addressed to the Member States.
They shall apply these provisions from 31 October 2012.
Done at Brussels, 20 September 2011.
When Member States adopt these measures, they shall contain a
reference to this Directive or shall be accompanied by such
For the Council
reference on the occasion of their official publication. The
methods of making such reference shall be laid down by
The President
Member States.
M. SAWICKI

---

L 283/38
ANNEX
In Part 1 of Annex III to Directive 76/768/EEC, reference number 12 is replaced by the following:
Restrictions
Reference
Conditions of use and warnings which must be printed
number
Substance
on the label
Field of application and/or use
Maximum authorised concentration
EN
in the finished cosmetic product
Other limitations and requirements

‘12 Hydrogen
peroxide
and
(a) Hair care mixtures (a)
12
%
of
H 2O 2 (40 volumes),
(a) Wear suitable gloves
other compounds or
present or released
mixtures that release
(a) (b) (c) (e)
hydrogen peroxide,
including carbamide
(b) Skin care mixtures (b)
4
%
of
H 2O 2, present or
Contains hydrogen peroxide
peroxide and zinc
released
Avoid contact with eyes
peroxide
(c) Nail hardening mixtures (c)
2
%
of
H 2O 2, present or
Rinse immediately if product comes into contact
released
with them.
Off
icial
(d) Oral products, including (d) ≤ 0,1 % of H 2O 2, present or
mouth rinse, tooth paste
released
Jour
and tooth whitening or
nal
bleaching products
of
the
(e) Tooth whitening or (e) > 0,1 % ≤ 6 % of H 2O 2, (e) To be only sold to dental practitioners. (e) Concentration of H 2O 2 present or released
bleaching products
present or released
For each cycle of use, first use by dental
indicated in percentage.
European
practitioners as defined under Directive
2005/36/EC (*) or under their direct
Not to be used on a person under 18 years of
supervision if an equivalent level of
age.
Union
safety is ensured. Afterwards to be
provided to the consumer to complete
To be only sold to dental practitioners. For
the cycle of use.
each cycle of use, the first use to be only
done by dental practitioners or under their
Not to be used on a person under 18
direct supervision if an equivalent level of
years of age.
safety is ensured. Afterwards to be provided
to the consumer to complete the cycle of use.
(*) OJ L 255, 30.9.2005, p. 22.’
29.10.2011

---