WRITTEN QUESTION E-2053/99 by Kyösti Virrankoski (ELDR) to the Commission. Plastics used in dentistry.
Date: 1999-11-03
Institutions: European Parliament, Provisional data
Subjects: European social policy, dental medicine, drug surveillance, market approval, medical device, plastics, toxic substance

C 203 E/124

Official Journal of the European Communities

EN

18.7.2000

(2000/C 203 E/158)

WRITTEN QUESTION E-2053/99

by Ky(cid:246)sti Virrankoski (ELDR) to the Commission

(3 November 1999)

Subject: Plastics used in dentistry

Is the Commission aware that the American-made PVC bite plane used in orthodontic treatment for
children and young people contains the compound DOP (di-octylphthalate) which is harmful to health?

The PVC product softened with DOP dissolves in the mouth, and in animal experiments it has been shown
to cause weight loss, enlargement of the liver and nervous and skeletal abnormalities. It has also been
shown to stunt growth.

The DOP compound contained in PVC has been identified beyond doubt in Finland in two expert analyses
at VTT (the State Technical Research Institute (cid:129) plastics laboratory) and TTK (Tampere Technical
University (cid:129) plastics technology).

In Finland the medical administration has banned the use of film wrappers containing softeners in the
packaging of fatty foodstuffs because of the solubility of the softener. The same compound hazardous to
health is also used in toys and childcare items for children under the age of 3. The Council of State in
Finland has also formally banned the use of phthalates (cid:129) suspected of being harmful (cid:129) as softeners in the
above-mentioned products with effect from the beginning of November.

In the USA, the risks of phthalate softeners have been made clear and the major toy manufacturers have
stopped using softeners in toys which may be placed in the mouth.

Bite planes are kept in the mouth for two or three years, for around 10 to 12 hours per day. In Finland it
is estimated that some 50 000 patients have these potentially dangerous bite planes in their mouths. On
this basis we may estimate that millions of people in the EU Member States are using this kind of
appliance.

Because this is an important matter for public health,
Commission proposes to take in this connection.

I should like to know what measures the

Even if the potentially dangerous raw material currently in use were to be prohibited in bite planes, no
treatment problems would arise, since a completely stable and harmless alternative has been discovered.

Answer given by Mr Byrne on behalf of the Commission

(16 December 1999)

Orthodontic devices are covered by Council Directive 93/42/EEC of 14 June 1993 concerning medical
devices (1). They are manufactured as custom made devices from intermediate products, such as plastics,
specifically intended by the manufacturer for this purpose. The intermediate products must meet the
provisions for medical devices as contained in the directive,
including the essential requirements. The
essential requirements detail the requirements which a medical device must meet, including a risk/ benefit
analysis and specific elements related to bio-compatibility and toxicity of the materials.

The Commission is aware that a variety of materials are used in orthodontic treatment including a number
of plastics. Typically, in orthodontic applications materials such as ethyl vinyl acetate (EVA) and poly-
methyl-methacrylate( PMMA) are used. Plastics containing phthalates may be used in dentistry for certain
applications such as checking the (cid:145)bite(cid:146) or for relining dentures but it is assumed that such (cid:146)soft(cid:146) materials
would have a limited utility for long term orthodontic work.

18.7.2000

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Official Journal of the European Communities

C 203 E/125

The Commission does not currently have specific information concerning the risk presented by di-octyl
phthalate (DOP) in orthodontic applications. Phthalates used as plasticizers in polyvinyl chloride (PVC) toys
and childcare articles are other than DOP. Nevertheless, the Commission has proposed, that all relevant
phthalates that could be used as plasticizers in PVC toys, of which di-octyl phthalate is one, should be
banned for use in toys intended to be put in the mouth by small children.

The Commission will seek further information, from amongst others the Finnish authorities, and ask the
scientific committee(cid:146)s advice if it appears necessary.

(1) OJ L 169, 12.7.1993.

(2000/C 203 E/159)

WRITTEN QUESTION P-2056/99

by Eryl McNally (PSE) to the Commission

(29 October 1999)

Subject: Local Exchange Trading Systems

What is the EC doing to promote the growth of LETS (Local Exchange Trading Systems) by including them
in Structural Fund possibilities and by disseminating good practice in Member States?

Answer given by Liikanen on behalf of the Commission

(11 November 1999)

As regards the dissemination of information about local exchange trading schemes (LETS), the Commission
would inform the Honourable Member that it is currently preparing a series of events in the Member
States to demonstrate (cid:145)best practices(cid:146) which have been tested in certain businesses and are considered likely
to be able to improve the competitiveness of other businesses. If the Honourable Member would kindly
send details of the LETS of which she has knowledge, and provided that these do not consist of barter and
can be demonstrated to have satisfied the requirements of the tax authorities, the Commission will
consider including them in the best practices to be exhibited as described above.

The Structural Fund problems attached to LETS may, subject to the reservations already mentioned, be
taken into account as part of the support for local development and employment activities, whether these
are a matter of new sources of jobs, or of new forms of business, craft industry or tourism.

(2000/C 203 E/160)

WRITTEN QUESTION P-2057/99

by Pat Gallagher (UEN) to the Commission

(5 November 1999)

Subject: Fifth framework programme (Energy)

Will the Commission state what steps are being taken to achieve the target set by the European Parliament
as regards renewable energy?

Answer given Mrs de Palacio on behalf of the Commission

(23 November 1999)

In its commentary on the 1999 budget for the Fifth research and technological development (RTD)
framework programme, the budgetary authority, at the initiative of the Parliament, requested that 60 % of