WRITTEN QUESTION E-3101/02 by Torben Lund (PSE) to the Commission. Hazardous PPD substances should be banned in cosmetics.
Date: 2002-10-29
Institutions: European Parliament, Provisional data
Subjects: access to information, allergy, consumer information, consumer protection, cosmetic product, product safety, scientific report, toxic substance, toxicology

C 110 E/164

Official Journal of the European Union

EN

8.5.2003

(2003/C 110 E/183)

WRITTEN QUESTION E-3101/02

by Torben Lund (PSE) to the Commission

(29 October 2002)

Subject: Hazardous PPD substances should be banned in cosmetics

Many cosmetic products contain chemicals which have not been adequately researched. Unfortunately
popular everyday items such as perfume, hair-spray, nail varnish and mascara seem in a number of cases
to provoke an allergic reaction in many users.

The field of cosmetics is constantly developing, and a wide range of analyses are constantly being carried
out. When a particular set of analyses shows that certain substances are harmful to health, they should be
banned as soon as possible: however, this is rarely done to a sufficient extent. The Danish Toxicology
Centre has tested 2-chloro-PPD, which is a permitted substance. The results show that 2-chloro-PPD is at
least as allergenic as PPD, which is banned. I would therefore ask the Commission to ensure that the
relevant scientific committee gives an opinion on these analyses and carries out evaluations, and that it
takes appropriate measures. Could the Commission please also inform me how many substances are
present in cosmetics which have not been investigated or evaluated. Finally, can the Commission state the
position of EU law vis-à-vis consumers and others who desire to inspect documents relating to a
producer’s analyses of the health and other risks posed by its products, and can it comment on what it
proposes to do to guarantee that consumers are provided with the best possible information?

Answer given by Mr Liikanen on behalf of the Commission

(12 December 2002)

Council Directive 76/768/EEC (1) aims at the safeguarding of public health by ensuring that only safe
cosmetic products are put on the market, while taking into account economic and technological
requirements. One of its main objectives is to protect public health, the Directive states as a general
principle that only cosmetic products that do not cause damage to human health can be put on the market
(Article 2 of the Directive). Therefore, cosmetic products can only contain safe ingredients. An ingredient,
which is not safe, should not be used.

To ensure this, measures have been taken, for example certain ingredients must not form part of a
cosmetic product (Annex II of the Directive) or certain substances shall only be used up to a maximum
concentration or under certain conditions of use (Annex III of the Directive). Furthermore, there is an
obligation for the manufacturer or his agent or the person to whose order a cosmetic product is
manufactured or the person responsible for placing an imported cosmetic product on the Community
market to keep information on their cosmetic products readily accessible for the control authorities of the
Member States (Article 7a of the Directive). This product safety file must contain the assessment of the
safety for human health of the finished product taking into consideration the general toxicological profile
of its ingredients.

At present, the Commission is considering all aspects of the use of hair dyes in cosmetic products and
their impact upon consumer health. Clearly, it is important that any actions taken are in the interests of
consumer information and the protection of public health.

To this end, the Scientific Committee on Cosmetic Products and Non-Food Products (SCCNFP) is mandated
to give opinion on consumer health and safety issues in the field of cosmetics, based on scientific data.
Once the SCCNFP finalises its opinions on each file submitted for risk evaluation the Commission takes
appropriate steps to adapt the Annexes to Directive 76/768/EEC. Currently, there are 17 hair-dyes (out of
which 12 are used in permanent hair-dye formulations) that have been banned and 60 hair-dyes (out of
which 47 are used in permanent formulations) that have been included in Annex III of the Directive.

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Official Journal of the European Union

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On the basis of an opinion from SCCNFP, a maximum concentration of 6 % in cosmetic products was
introduced for the specific hair dye para-phenylendiamin (PPD)
in the Directive (Annex III, No 8).
However, recently, PPD has been subject to a process of re-evaluation. The SCCNFP stated in its opinion
adopted on 27 February 2002 that the information submitted is insufficient to allow an adequate risk
assessment to be carried out and that additional data would be required before any further consideration.
Therefore, the Commission will require the industry to submit urgently the necessary data in order to
finalise the risk assessment. The Commission will consider the appropriate measures in relation to PPD.
The other hair dye mentioned, 2-Chloro-p-phenylenediamine had been evaluated and an opinion had been
adopted on 4 October 1991. Indeed it would be feasible to re-evaluate 2-Chloro-p-phenylenediamine on
the basis of new scientific data. Therefore, the Commission will ask for the data the Danish Toxicology
Centre had published to transmit them to the SCCNFP and ask for its expert view.

As cosmetic products even under normal conditions of use can produce undesirable effects,
the
manufacturer or the person responsible for placing cosmetic products on the market already collects data
on these effects within the product safety file. The way this information can be made accessible to the
public is being considered in the process of adopting the 7th Amendment to the Cosmetics Directive.

(1) 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.

(2003/C 110 E/184)

WRITTEN QUESTION E-3103/02

by Bart Staes (Verts/ALE) to the Commission

(29 October 2002)

Subject: Identification of football supporters at European matches

Football supporters in Belgium who want to attend a match in the stadium of a first division league club
are required by Belgian law to be in possession of a security pass, known as a ‘fan card’. This pass contains
the personal details of the holder and is for personal use only. If this system is correctly applied it means
that clubs know exactly who is in the stadium. This should prevent rowdy elements joining the army of
supporters. Violent supporters are denied access to the stadium.

In the case of matches between European teams this system does not operate. In other words, Belgian
football fans who obtain tickets for a Belgian club’s matches abroad are not expected to be able to prove
their identity. Anyone, including potential hooligans, is virtually free to obtain a ticket. In the country
where the match is taking place spotters from the visiting club are used. They travel with the visiting
supporters and can point out potential troublemakers to the law enforcement authorities on the spot.

Does the Belgian fan card system comply with Directive 95/46/EC (1) on the protection of individuals with
regard to the processing of personal data and on the free movement of such data?

Does the Commission share the view that for security reasons it is desirable that supporters attending
football matches outside their own Member State should have to be able to prove their identity? If so, what
steps will it take to introduce such a system? If not, why not?

(1) OJ L 281, 23.11.1995, p. 31.

Answer given by Mr Bolkestein on behalf of the Commission

(11 December 2002)

Directive 95/46/EC of the Parliament and of the Council of 24 October 1995 on the protection of
individuals with regard to the processing of personal data and on the free movement of such data, is a