WRITTEN QUESTION E-2881/01 by Torben Lund (PSE) to the Commission. Hair dyes with extremely damaging effects on health.
Date: 2001-10-22
Institutions: European Parliament, Provisional data
Subjects: chemical product, consumer protection, cosmetic product, dyestuff, labelling, public health, safety standard

16.5.2002

EN

Official Journal of the European Communities

C 115 E/185

States as a consequence of their membership of that company’s insurance market? Is the Commission
further aware of evidence that Lloyd’s syndicates had not properly reserved for that business as required by
Directive 73/239 (1)? Does the Commission propose to open infringement proceedings against the UK in
relation to this matter and will the Commission make available to Parliament any documentation and
correspondence which it possesses in relation to this matter?

(1) OJ L 228, 16.8.1973, p. 3.

Answer given by Mr Bolkestein on behalf of the Commission

(12 November 2001)

The Honourable Member has raised four issues.

The Member of the Commission responsible for the Internal Market has already responded to many of
these in the detailed briefing to the Petitions Committee on 18 June 2001:

5 First, the Commission is aware that a considerable number of Union citizens have suffered substantial
loss by being liable for a share of the losses that Lloyd’s of London has incurred in business written
the United States as a consequence of their membership of Lloyd’s.

5 Second, the Commission is aware that on an ex-post basis,

it became evident that many Lloyd’s
syndicates were under-reserved for their liabilities as a result of rising asbestosis claims in the United
States. However, as part of its enquiries into the respect of the requirements of the first Council
Directive 73/239/EEC of 24 July 1973 on the coordination of laws, regulations and administrative
provisions relating to the taking-up and pursuit of the business of direct insurance other than life
assurance, with regard to Lloyd’s, the Commission is examining whether sufficient reserves were
established on an ex-ante basis.

5 Third, the Commission is taking very seriously the many complaints it has received regarding alleged
infringements of the Community insurance directives with respect to Lloyd’s. In this regard The
General Directorate (DG) Internal Market has made official enquiries (what are termed pre-Article 226
(ex Article 169) of
to the British authorities. The situation is extremely
complicated and the Commission hopes to complete its preliminary analysis very shortly. The
Commission will then take a decision on whether to launch formal infringement proceedings under
Article 226 of the EC Treaty. The Parliament will be informed of the Commission’s decision.

the EC Treaty letters)

5 Fourth, the Commission has always sought to keep Parliament fully informed by submitting extensive
written comments and by oral explanation of Commission officials at Petitions Committee meetings.
In particular, the Honourable Member of the Commission responsible for the Internal Market made a
lengthy presentation to the Petitions Committee on 18 June 2001 and responded to detailed Members’
questions. The Commission has also sought to provide documents, unless bound by confidentiality
constraints, and the Commission provided a copy of questions it sent to the British authorities in
October 2000.

(2002/C 115 E/194)

WRITTEN QUESTION E-2881/01

by Torben Lund (PSE) to the Commission

(22 October 2001)

Subject: Hair dyes with extremely damaging effects on health

Many consumers who use hair dyes frequently or daily have, unfortunately, discovered that some dyes
have extremely damaging effects on health. The reactions vary from stinging, itching, sores, swelling of the
scalp, allergy and hair loss 5 in some cases even fainting. It is also well known that there is a potential risk
in using hair dyes of developing bladder cancer. Many of these effects are attributed to the chemical
colouring agent, para phenylenediamine (PPD), which is often used in such products.

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Official Journal of the European Communities

EN

16.5.2002

Will the Commission explain why PPD is allowed in quantities of up to 6 % in hair dyes when it is banned
in other products in quantities of more than 5 % (e.g. paint)?

Will the Commission also say why there is no positive list for hair dyes when there is a positive list of dyes
in all other cosmetic products?

Answer given by Mr Liikanen on behalf of the Commission

(17 January 2002)

The Commission is aware of the concerns expressed in relation to the use of hair dyes. Different meetings
have taken place with representatives of both consumers and industry and of the Member States.

Regarding the marketing and use of para-phenylenediamine (PPD)
there are no general
restrictions, although such paints must be classified and labelled with hazard warnings and safety advice
according to Directive 1999/45/EC of the Parliament and of the Council of 31 May 1999 concerning the
approximation of the laws, regulations and administrative provisions of the Member States relating to the
classification, packaging and labelling of dangerous preparations (1). This Directive requires paints to be
labelled as ‘toxic’ with a skull-and-crossbones symbol for paints containing over 25 % of PPD, as ‘irritant’
for concentrations above 20 %, as a skin sensitiser for concentrations above 1 % and as ‘dangerous for the
environment’ at concentrations above 0,25 %. The precise label would vary according to the concentration.

in paints,

However with regard to the use of PPD in hair dyes, the current legislation covers not only the labelling
but also fixes very strict maximum concentrations for the use of this substance. The maximum use
concentration in hair dyes for para-phenylenediamine (PPD) is based on the opinion of the Scientific
Committee on Cosmetic Products and Non-food Products intended for Consumers No 863/91 and the
resulting entry in Annex III/1/8 of the Cosmetics Directive, Council Directive 76/768/EEC of 27 July 1976
on the approximation of the laws of the Member States relating to cosmetic products (2). The maximum
concentration is given as 6 % but according to the same opinion ‘the compound is supplied as an oxidative
hair dye at concentrations up to 4 % and used at a concentration of 50 % of that supplied after dilution
with hydrogen peroxide’ (resulting in a use concentration of 2 %). Furthermore, the use of this substance is
subject to other conditions, as stated in Annex III. The following wording must be printed on the label:
‘Can cause allergic reactions’ and ‘Do not use to dye eyelashes or eyebrows’.

With regard to hair dyes in general, safety files for approximately 150 hair dyes have already been
submitted by the industry to the Scientific Committee on Cosmetic Products and Non-food Products
intended for Consumers for evaluation and opinions for about half of them have been issued. As an
immediate step, 60 hair dyes will be subject to strict regulation by the forthcoming 26th Adaptation to the
Cosmetics Directive. This is in addition to a number of hair dyes that are already regulated via Annex II or
Annex III of the Cosmetics Directive. In this context, discussions between Members States, the Commission
and representatives of the industry, are currently taking place on the issue of a positive list. According to
Article 2 of the Cosmetics Directive, it is the responsibility of the industry to market only products, which
do not cause damage to the human health when applied under reasonably foreseeable conditions of use.
Finally, according to Article 3 of this Directive, Member States shall take all necessary measures to ensure
that only cosmetic products, which conform to the provisions of this Directive, may be put on the market.

It is the intention of the Commission to pursue the current scientific evaluation being carried out by the
Scientific Committee on Cosmetic Products and Non-food Products intended for Consumers and to
continue the discussions with the Member States in order to prioritise the necessary actions.

(1) OJ L 200, 30.7.1999.
(2) OJ L 262, 27.9.1976.