WRITTEN QUESTION P-0090/03 by Torben Lund (PSE) to the Commission. Hair dyes and cancer.
Date: 2003-01-20
Institutions: European Parliament, Provisional data
Subjects: carcinogenic substance, consumer information, consumer protection, cosmetic product, health risk, product safety, scientific report

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3.7.2003

The Commission organises regular meetings of the Committee of Senior Officials on Public Health
3.
and the Group of General System Co-ordinators for the purposes of the exchange of information and
discussion of
to free movement. The Commission does not dispose of any specific
information of the kind referred to.

issues relevant

4.
The Commission is generally aware of varying national practices. Registers or records of different
kinds tend to exist in all Member States. The way in which access of the public is allowed to all or part of
such registers or records is organised within the Member States in line with Community legislation on data
protection. The Commission is currently working on developing an informatic system to reinforce the
inter alia, the on-line exchange of the necessary
current network of national authorities to facilitate,
information. The recent proposal for a Directive on the recognition of professional qualifications (1) also
seeks to reinforce the role of national contact points.

The issue of disciplinary measures is covered by the proposal for a Directive on the recognition of
5.
professional qualifications. This proposal requires communication of information on such measures when
health professionals intend to establish themselves in another Member State. Annex VII of the proposed
Directive refers to the documents which may be required by the host Member State when deciding on the
recognition of the relevant professional qualifications.
In particular, evidence may be required to be
provided concerning the absence of serious professional misconduct or criminal offences which might
have led to suspension or prohibition of the pursuit of the relevant profession in the Member State of
origin. Article 46(2) reinforces the system for the cases in which there is more than one Member State of
origin. Any measure taken to ensure exchange of information on disciplinary has to respect the existing
Community principles on data protection.

(1) OJ C 181 E, 30.7.2002.

(2003/C 155 E/232)

WRITTEN QUESTION P-0090/03

by Torben Lund (PSE) to the Commission

(20 January 2003)

Subject: Hair dyes and cancer

It is not safe for European citizens to use hair dyes given that they contain harmful chemical substances.
Use of hair dyes is rising. Unfortunately, no-one knows the real extent of the damage as the adverse effects
of using the dyes are only apparent several years later when it is too late to intervene. The Commission
should therefore apply the cautionary principle and introduce further market regulation.

By far the most oxidative hair dyes contain paraphenylenediamine (PPD) or toluene-2.5-diamine. These
substances are very potent contact allergens and are allowed in hair dyes in concentrations which are
known to sensitize consumers and produce eczema reactions in people who are allergic to hair dye.

Since the EU’s scientific committee on cosmetics (SCCNFP) has linked oxidative hair dyes with the presence
of bladder cancer in women, will the Commission say whether it will ban PPD and related substances until
data is available to establish what concentrations of these substances do not cause any short-term or long-
term harm to human health (e.g. cancer and contact allergies)?

Answer given by Mr Liikanen on behalf of the Commission

(13 February 2003)

The Commission is aware of the concerns expressed in relation to the use of hair dyes. The Commission is
considering all aspects of the use of hair dyes in cosmetic products and their impact upon consumer
health. In particular, the Commission points out that in the specific area of oxidative hair dyes the majority

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of substances have already been banned or their use is subject to specific conditions. These decisions are
scientifically-based which means that
they are based on a risk assessment made by the Scientific
Committee on Cosmetic Products and Non-Food Products intended for Consumers (SCCNFP). The
Commission refers to its reply to the Honourable Member’s Written Question E-3101/02 (1) and wishes
further to highlight the following.

With regard to para-Phenylenediamine (PPD) and Toluene-2,5-diamine, the current legislation covers
labeling and fixes very strict maximum concentrations for the use of the two substances. The maximum
use concentration in hair dyes for PPD and Toluene-2,5-diamine is based on opinions of the SCCNFP and
the resulting entry in Annex III/1/8 and Annex III/1/9 of the Cosmetics Directive (2). The maximum
concentration is given as 6 % and 10 % respectively. Furthermore, the use of these substances is subject to
other conditions, as stated in Annex III. The following wording must be printed on the label: ‘Can cause
allergic reactions’, ‘Do not use to dye eyelashes or eyebrows’ and ‘Contains phenylenediamines’.

With regard to the general aspects of the risk assessment of hair dyes the SCCNFP on 27 February 2002
adopted a discussion paper that was placed on the web-site of the SCCNFP (3). Interested parties were
invited to comment. On 4 June 2002 it adopted ‘A strategy for testing hair-dye cosmetic ingredients for
their potential genotoxicity/mutagenicity.’ This was supplemented by a recent opinion of 17 December
2002 updating ‘Basic requirements for toxicological dossiers to be evaluated by the SCCNFP’.

Industry is required to submit files that must conform to the above-mentioned principles and the ‘Notes of
Guidance for testing of cosmetic ingredients for their safety evaluation’ which was adopted on 24 October
2000.

Finally, the Commission is discussing with Member States and representatives of both consumers and
industry the prioritisation of substances to be assessed or re-assessed. This includes setting up timetables
and actions to be put into force in relation to substances for which no appropriate file has been submitted
for risk assessment by the SCCNFP.

(1) OJ C 110 E, 8.5.2003, p. 164.
(2) Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to

cosmetic products (cid:1) OJ L 262, 27.9.1976.

(3) http://europa.eu.int/comm/food/fs/sc/sccp/index_en.html.

(2003/C 155 E/233)

WRITTEN QUESTION P-0123/03

by Bernd Lange (PSE) to the Commission

(21 January 2003)

Subject: Commission proposals still pending in connection with Directive 1999/96/EC

Directive 1999/96/EC (1) of the European Parliament and of the Council of 13 December 1999 on the
approximation of the laws of the Member States relating to measures to be taken against the emission of
gaseous and particulate pollutants from compression ignition engines for use in vehicles, and the emission
of gaseous pollutants from positive ignition engines fuelled with natural gas or liquefied petroleum gas for
use in vehicles and amending Council Directive 88/77/EEC (2) was published in the Official Journal on
16 February 2000.

Some of the details included in the Euro IV level, such as the introduction of on-board diagnostic systems
(OBDs), in-service monitoring and durability, were to be further specified by 31 December 2000. However,
the corresponding Commission proposals are still pending.

Given that the Euro IV level
extremely limited.

is to come into effect on 1 October 2005, the time remaining is now

Why has no corresponding Commission proposal been submitted?