WRITTEN QUESTION E-2392/02 by Kathleen Van Brempt (PSE) to the Commission. Phthalates in cosmetics.
Date: 2002-08-02
Institutions: European Parliament, Provisional data
Subjects: carcinogenic substance, consumer protection, cosmetic product, cosmetics industry, health risk, product safety, toxicology

C 52 E/158

Official Journal of the European Union

EN

6.3.2003

headquarters of the Swiss air-traffic control authorities as well as an unauthorised absence of one of the
duty controllers at the time of the crash. In addition, there are reports that the radar used by the Swiss
authorities did not meet standards laid-down by Eurocontrol.

Without prejudice to the findings of the accident investigators, what lessons does the Commission believe
the European Union can learn from the disaster, and what impact does the Commission believe the Single
Sky proposals would have, with particular reference to the quality of ground radar and onboard collision
warning systems?

Answer given by Ms de Palacio on behalf of the Commission

(15 October 2002)

According to the information available at present, the accident occurred in a sector of airspace above
German territory but managed by Swiss air traffic control, as provided for in an agreement between the
two countries, at a moment when there was not much air traffic in that area and shortly after the aircraft
had crossed the boundary separating the German sector and the sector controlled by Switzerland, i.e. the
transfer of the Russian aircraft from one centre to another. The Commission proposals on the Single
European Sky (1) package include measures to harmonise the definition of upper airspace and establish
functional airspace blocks, which should in the long run reduce the number of times aircraft have to be
transferred from one control centre to another and optimise the transfer procedure. Transfer represents a
break in continuity, and, as such, a risk factor.

The Commission proposal on the interoperability of the European air traffic control network (part of the
(radar). The
Single European Sky package) will also have a positive impact on ground equipment
development of interoperable equipment and procedures will benefit the aviation industry throughout
Europe. Switzerland is involved in the Single European Sky initiative, and under the Community/
Switzerland agreement it will adopt part of the Community acquis in the field of air transport.

Within the framework of its research policy, the Commission has for several years been supporting work
on tools which will give pilots a much clearer picture of the flight environment and improve the standard
and relevance of the information supplied to pilots and air traffic controllers. The introduction of these
new instruments and procedures should improve safety and at the same time free up spare capacity.

(1) COM(2001) 123 final and COM(2001) 564 final.

(2003/C 52 E/176)

WRITTEN QUESTION E-2392/02

by Kathleen Van Brempt (PSE) to the Commission

(2 August 2002)

Subject: Phthalates in cosmetics

The American Food and Drug Administration has recently announced that it intends to carry out detailed
investigations on the use of phthalates in cosmetics. Phthalates are carcinogenic substances which cause
damage to kidneys, liver and lungs and affect fertility. Three American environmental groups carried out
independent studies on phthalates in a number of gels, perfumes and creams. The studies looked at
72 samples of which 52 proved to contain phthalates. These included several well-known brands which
are also marketed in Europe, such as Poison by Christian Dior, Nivea Crème, deodorants and hair gels by
Revlon, Calvin Klein and Procter & Gamble.

Is the Commission aware of this study?

Does the Commission know of any European studies on the use of phthalates in cosmetics?

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Does the Commission agree with the view that phthalates are not really essential for the quality of a
cosmetic product?

Is there not a need for stricter legislation on phthalates?

Should there not be a ban on phthalates in cosmetics until more is known about them and their effects?

Answer given by Mr Liikanen on behalf of the Commission

(20 September 2002)

The Commission is aware of the study ‘Not too pretty (cid:1) Phthalates, Beauty Products & the Food and
Health Administration (FDA)’ published 8 July 2002 by three American environmental groups.

Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States
relating to cosmetic products (1) is laying down the principles which regulate the composition, labelling
and packaging of cosmetic products and the procedures to adapt this Directive to technical progress.
According to this Directive a cosmetic product put on the market must not cause damage to human health
when applied under normal or reasonably foreseeable conditions of use. Further to this general obligation
the Directive provides for measures either to prohibit the use of ingredients (Annex II of the Directive) or
to allow their use under certain conditions (Annex III), after having consulted the Scientific Committee on
Cosmetic Products and Non-Food Products intended for Consumers (SCCNFP).

In the above-mentioned study five phthalates have been found in cosmetic products: dibutyl phthalate
(DBP), diethyl phthalate (DEP), diethylhexyl phthalate (DEHP), butylbenzyl phthalate (BBzP) and dimethyl-
phthalate (DMP). Although all these substances are phthalates, their toxicological profile is different and
has to be evaluated case by case.

DBP and DEHP have been classified ‘toxic to reproduction (category 2)’
in the Dangerous Substances
Directive (2) and will be included in the Restrictions on Marketing and Use Directive (3). The Commission is
just preparing a ‘28th Directive adapting to technical progress Annex II to Council Directive 76/768/EEC
on the approximation of the laws of the Member States relating to cosmetic products’. This draft amends
Annex II to include all carcinogenic, mutagenic or substances toxic to reproduction, which were classified
category 1 and 2 and restricted according to Directive 76/769/EEC, via a cross-reference to that Directive.
Annex II is the list of substances, which must not form part of the composition of cosmetic products.
Therefore, those substances will be automatically banned from use in the cosmetic products unless a
specific safety assessment allows for their safe use in cosmetics. Concerning DBP, the Commission has
asked the SCCNFP for its safety assessment.

The SCCNFP has recently evaluated DEP (Opinion of The Scientific Committee on Cosmetic Products and
Non-Food Products intended for Consumers concerning Diethyl Phthalate adopted by the SCCNFP during
the 20th Plenary meeting of 4 June 2002 http://europa.eu.int/comm/food/fs/sc/sccp/out168_en.pdf). In its
opinion the SCCNFP stated that ‘the safety profile of diethyl phthalate supports its use in cosmetic
products at current
the SCCNFP does not recommend any specific warnings or
levels. At present
restrictions under the currently proposed conditions of use.’

The Commission will take the necessary steps to complete the safety assessment of the other phthalates
(BBzP and DMP) in cosmetic products including the appropriate consultation of the Scientific Committee,
and will act accordingly.

(1) OJ L 262, 27.9.1976.
(2) Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative
provisions relating to the classification, packaging and labelling of dangerous substances, OJ P 196, 16.8.1967.
(3) Council Directive 76/769/EEC of 27 July 1976 on the approximation of the laws, regulations and administrative
provisions of the Member States relating to restrictions on the marketing and use of certain dangerous substances
and preparations, OJ L 262, 27.9.1976.