HTML PUBLIC "-//W3C//DTD HTML 4.01 Transitional//EN"L 139/8
EN
Official Journal of the European Union
25.5.2013
COMMISSION REGULATION (EU) No 483/2013
of 24 May 2013
amending Annex III to Regulation (EC) No 1223/2009 of the European Parliament and of the
Council on cosmetic products
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
products containing the substance. The opinion,
formulated by the Committee for Medicinal Products
for Human Use on 25 October 2011, concluded that
products containing polidocanol do not automatically
Having regard to the Treaty on the Functioning of the European
qualify as medicinal products falling under the definition
Union,
of medicinal product provided in Article 1(2) of Directive
2001/83/EC of the European Parliament and of the
Council of 6 November 2001 on the Community code
relating to medicinal products for human use ( 3 ). In
Having regard to Regulation (EC) No 1223/2009 of the
addition, polidocanol used in topical products at the
European Parliament and of the Council of 30 November
suggested concentrations and for the suggested topical
2009 on cosmetic products ( 1 ), and in particular Article 31(1)
use (3 % for leave-on products and 4 % for rinse-off
thereof,
products) acts as detergent or ionic surfactant and these
products do not present the characteristics of medicinal
products.
After consulting the Scientific Committee on Consumer Safety,
(4) Regulation
(EC)
No
1223/2009
should
therefore
be
Whereas:
amended accordingly.
(1) The
Scientific
Committee
on
Consumer
Products
(‘SCCP’), (5) The
application
of
the
abovementioned
restrictions
subsequently replaced by the Scientific Committee on
should be deferred by 12 months to allow the industry
Consumer Safety (‘SCCS’) pursuant to Commission
to make the necessary adjustments to product formu
Decision 2008/721/EC of 5 September 2008 setting up
lations.
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 ), concluded in its opinion of 2 October
(6) The
measures
provided
for
in
this
Regulation
are
in
2007 that the data included in the dossier demonstrate
accordance with the opinion of the Standing
that polidocanol is of low toxicity and does not pose a
Committee on Cosmetic Products,
risk to the health of the consumer when used up to 3 %
in leave-on and up to 4 % in rinse-off cosmetic products.
In addition, the SCCP maintained that recent scientific
evidence did not confirm the assumed local-anaesthetic
HAS ADOPTED THIS REGULATION:
effect of polidocanol. Thus, its presence in cosmetics and
skin care products will not affect cutaneous sensation. It
should therefore be included in Annex III to Regulation
(EC) No 1223/2009.
Article 1
Annex III to Regulation (EC) No 1223/2009 is amended in
accordance with the Annex to this Regulation.
(2)
The SCCS, in an Addendum of 13-14 December 2011 to
the SCCP opinion on polidocanol, confirmed the
conclusions of the SCCP.
Article 2
This Regulation shall enter into force on the twentieth day
(3) Given
that
polidocanol
was
found
in
both
injectable
and following that of its publication in the Official Journal of the
topical medicinal products at concentrations even lower
European Union.
than the ones considered safe by the SCCP, the
Commission requested the opinion of the European
Medicines Agency on the classification of topical
It shall apply from 1 April 2014.
( 1 ) OJ L 342, 22.12.2009, p. 59.
( 2 ) OJ L 241, 10.9.2008, p. 21.
( 3 ) OJ L 311, 28.11.2001, p. 67.

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EN
25.5.2013 Official
Journal
of
the
European
Union L
139/9
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 24 May 2013.
For the Commission
The President
José Manuel BARROSO

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L 139/10
ANNEX
The following entry shall be inserted in Annex III to Regulation (EC) No 1223/2009:
Substance identification Restrictions
Reference number
Wording of conditions of
use and warnings
Chemical name/INN
Name of Common
EN
Ingredients Glossary
CAS number EC
number Product
type,
body
parts
Maximum concentration in
ready for use preparation
Other

a
b
c
d
e
f
g
h
i
‘257 Polidocanol Laureth-9 3055-99-0 221-284-4 (a)
Leave-on
products (a)
3,0
%
(b) Rinse-off products (b)
4,0
%’
Off
icial
Jour
nal
of
the
European
Union
25.5.2013

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Document Outline

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