WRITTEN QUESTION P-0859/04 by Torben Lund (PSE) to the Commission. Hair dyes and serious damage to health.
Date: 2004-03-11
Institutions: European Parliament, Provisional data
Subjects: allergy, consumer protection, cosmetic product, health risk, product safety, toxicology

3.4.2004

EN

Official Journal of the European Union

C 84 E/687

According to Article 1(10) of Regulation (EC) No 316/2004 (2) amending Article 37(1)(e) of Regulation
(EC) No 753/2002, those conditions include the following:

(a)

(b)

(c)

the third countries must make a substantiated request to the Commission and forward the relevant
rules justifying recognition of the traditional indications;

the language of the traditional indication must be the official language of the third country which
makes the request, and the indication in that language must have been used for at least 10 years;

if the language of the traditional indication is not the official language, its use must be provided for by
the legislation of the third country in question; in that case, the traditional indication in that language
must have been used continuously for at least 25 years;

(d) other criteria stipulated by the same Regulation, such as the indication’s specific nature and distinctive

character and removing the possibility of deception, must likewise be met.

In the specific case of the Portuguese traditional
terms referred to in the written question to the
Commission, several conditions must therefore be met in order for them to be used in third countries. This
means that, in order for a traditional term such as ‘Ruby’, ‘Tawny’, ‘Vintage’, ‘Canteiro’ or ‘Frasqueira’ to be
used on a liqueur wine other than Port or Madeira, first of all either English or Portuguese must be the
official language of the third country and the traditional term must have been used for at least 10 years, or
English or Portuguese must be a second language recognised by the legislation of the third country in
question and in that case the term must have been used for at least 25 years. The term must also be
specific and distinctive, so as not to mislead the consumer if the wine is marketed in Europe. There must
likewise be some tradition behind the use of the term in the third country.

The conditions governing use of the traditional term ‘Reserva velha’ by third countries remain unchanged,
since that term was already listed in Annex III, Part A to Regulation (EC) No 753/2002.

(1) Commission Regulation (EC) No 753/2002 of 29 April 2002 laying down certain rules for applying Council
Regulation (EC) No 1493/1999 as regards the description, designation, presentation and protection of certain wine
sector products, OJ L 118, 4.5.2002.

(2) Commission Regulation (EC) No 316/2004 of 20 February 2004 amending Commission Regulation (EC) No 753/
2002 of 29 April 2002 laying down certain rules for applying Council Regulation (EC) No 1493/1999 as regards
the description, designation, presentation and protection of certain wine sector products, OJ L 55, 24.2.2004.

(2004/C 84 E/0773)

WRITTEN QUESTION P-0859/04

by Torben Lund (PSE) to the Commission

(11 March 2004)

Subject: Hair dyes and serious damage to health

On 4 March 2004, the Danish newspaper Jyllands Posten carried a report concerning several investigations
which indicate that a number of authorised hair dyes cause serious damage to consumers’ health. The
sector is regulated by the Cosmetics Directive.

In the light of the abovementioned investigations, does the Commission believe that a positive list should
be drawn up for hair dyes and that hair dyes should be tested for risk of cancer and allergy before they are
approved? The extent of the health hazards are not fully known as the industry will not allow access to its
records. Is this information known to the Commission and how many reports concerning allergies caused
by hair dyes does the Commission receive each year? Will the Commission also say whether a revision of
the Cosmetics Directive will compel the industry to allow public access to reports concerning health
problems caused by their products? Finally, will the Commission say when the eighth amendment of the
Cosmetics Directive (cid:1) or other relevant initiatives (cid:1) is expected to commence, what changes may be
proposed and whether the Commission will make the precautionary principle a key feature of the
forthcoming revision?

C 84 E/688

Official Journal of the European Union

EN

3.4.2004

Answer given by Mr Liikanen on behalf of the Commission

(15 April 2004)

In 2003 the Commission, together with Member States and representatives of both consumers and
industry, discussed a strategy for the systematic evaluation of hair dyes. The strategy was agreed on July
2003 and published on the web-site of the Commission, (Enterprise Directorate-General (DG)) (1). The main
element of the strategy is a tiered, modulated approach requiring industry to submit by certain deadlines
safety dossiers on hair dyes to be evaluated by the Scientific Committee on Cosmetic Products and Non-
Food Products intended for Consumers (SCCNFP). The overall objective of this strategy is to regulate the
use of substances as hair dye ingredients on the basis of the most recent scientific evaluation of safety
dossiers.

These dossiers must conform to the ‘Notes of Guidance for testing of cosmetic ingredients for their safety
evaluation’. The 5th revision of these notes was adopted on 20 October 2003 and was published on the
web-site of the Commission, (Health and Consumer Safety DG) (2). The basic toxicological requirements
include data requirement on skin sensitization and on genotoxicity/mutagenicity.
In its ‘Assessment
Strategies for Hair Dyes’ the SCCNFP recommended that ‘in particular, for the risk assessment of hair dyes,
the following must be submitted: … data on genotoxicity (cid:1) the studies must be consistent with
internationally accepted guidelines (Organization for Economic Cooperation and Development (OECD),
EU) and/or with modern testing strategies …’

This strategy received a wide consensus between Member States, consumers and industry represented in
the Cosmetics Working Party and should eventually lead to the setting up of a positive list for hair-dyes.

In relation to concrete measures already being taken, the Commission refers as well to the reply given
recently in relation to the Written Question E-0391/04 by Mr De Roo (3).

Article 7a of the Cosmetics Directive 76/768/EEC (4) stipulates that the manufacturer or importer of a
cosmetic product should keep information on their cosmetic products readily accessible for the competent
control authorities of the Member States. This information includes the assessment of the safety for human
health of the finished product as well as existing data on undesirable effects on human health resulting
from use of the cosmetic products. Allergies are included in this category. Further to the adoption of the
to the Cosmetics Directive 2003/15/EC (5)
7th amendment
this information should be made ‘easily
accessible to the public by any appropriate means, including electronic means’.

In view of strengthening the competitiveness of the cosmetic sector and improving consumer safety, the
Commission will carry out an analysis of the current situation of the sector and the application of the
legislation.

(1) http://pharmacos.eudra.org/F3/cosmetic/doc/HairDyeStrategyInternet.pdf
(2) http://europa.eu.int/comm/health/ph_risk/committees/sccp/documents/out242_en.pdf
(3) See page 386.
(4) Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to

cosmetic products, OJ L 262, 27.9.1976.

(5) Directive 2003/15/EC of the Parliament and of the Council of 27 February 2003 amending Council Directive 76/

768/EEC, OJ L 66, 11.3.2003.

(2004/C 84 E/0774)

WRITTEN QUESTION P-0860/04

by Eluned Morgan (PSE) to the Commission

(15 March 2004)

Subject: The Constitution and funding

In your answer to my Written Question P-0524/04 (1), you detail the constitutional position of a region of
the current EU, if it were to become a fully independent state. Could you clarify the position of such a
state, in relation to EU funding?