WRITTEN QUESTION E-2269/99 by Alexandros Alavanos (GUE/NGL) to the Commission. Dangers arising from the use of medical equipment made from PVC with a large DEHP content.
Date: 1999-12-13
Institutions: European Parliament, Provisional data
Subjects: dangerous substance, health risk, medical device, plastics, product safety, testing

C 219 E/134

Official Journal of the European Communities

EN

1.8.2000

The International civil aviation organisation (ICAO) has developed Y2K assessment criteria covering air
traffic services, airports and aircraft operators, and invited its Member States to perform a critical Y2K
compliance assessment and provide appropriate information on the compliance status of their respective
services. This information is made available to authorised officials, and ICAO has presented a publicly
available global Y2K readiness status report.

Eurocontrol is focusing particularly on the development of contingency plans. In co-operation with ICAO,
Eurocontrol is setting up a European regional Y2K co-ordination unit for collection and dissemination of
information to the countries of the region, with a view to permitting corrective actions of operational
contingency measures to overcome potential disruptions of air traffic systems. This unit will be located in
the central flow management unit of Eurocontrol in Brussels, where it will operate on 31 December 1999
and 1 January 2000.

Complementing the ICAO initiative, the European civil aviation conference (ECAC) has examined the legal
aspects of eventual courses of action considered in connection with Y2K readiness, and regarding
limitations of operations in cases where there is no information on compliance status, or there is reason
to suspect non compliance. A common approach has been developed for addressing states where
information provided is considered inadequate, with a view to resolving outstanding issues. The situation
will be examined in the very near future and, if necessary, appropriate action will be considered.

The International air transport association (IATA), with which the Airports council international (ACI) has
focusing on raising
cooperated, has developed the Y2K industry project established in June 1998,
awareness, strengthening industry co-operation, collecting Y2K readiness information, and promoting
contingency planning. Through IATA the airlines have implemented a programme that includes air traffic
systems and airports, aircraft, engine and avionics manufacturers.

On the basis of the information and reports received, for example the reports from the representatives of
international governmental and industry organisations at a Workshop organised by the Commission on
29-30 September 1999, the Commission considers that the aviation industry is well advanced in its
preparations to combat potential problems in European countries, in accordance with plans aiming at
achieving compliance and providing for contingencies that may arise. Such plans cover immediate safety
concerns satisfactorily. However the possibility of capacity constraints in the days after the roll over cannot
be excluded.

More specifically as regards international airports in the Member States, the information available indicates
that thorough and comprehensive programmes to identify and remedy potential Y2K problems have been
implemented or are scheduled for completion in time for the rollover.

It may also be mentioned that, as requested by the European Council in Cologne, a high level working
party on the millennium date change has been established by the Commission in July 1999. It has been
holding monthly meetings and will continue during the remainder of this year to address various aspects
of the Y2K problem at Community level.

(2000/C 219 E/169)

WRITTEN QUESTION E-2269/99

by Alexandros Alavanos (GUE/NGL) to the Commission

(13 December 1999)

Subject: Dangers arising from the use of medical equipment made from PVC with a large DEHP content

Following the withdrawal of toys manufactured from PVC, Greenpeace has now drawn attention to the
very frequent use in hospitals of medical equipment such as flasks containing blood, serum or nutrients for
parenteral administration, made from the same substance with a DEHP content 800 times the admissible
limit.

1.8.2000

EN

Official Journal of the European Communities

C 219 E/135

It is thought that this toxic substance may be carcinogenic and could affect fertility and damage foetuses. It
causes irritation to the skin, eyes and respiratory system. Furthermore, on combustion in waste disposal
plants, it releases dioxins.

1. Will the Commission examine these fresh allegations by Greenpeace?

2. What measures will it take to limit the use of PVC as described above?

Answer given by Mr Byrne on behalf of the Commission

(20 January 2000)

Products such as bloodbags, perfusion sets and gastrointestinal tubing are manufactured using soft PVC,
i.e. PVC containing phthalates, and are covered by Council Directive 93/42/EEC of 14 June 1993
concerning safety requirements for medical devices (1). The manufacturer must ensure that the devices
meet all appropriate requirements and in particular perform a risk/ benefit analysis and evaluate the
biocompatibility and toxicity of the materials used. Furthermore, the products mentioned are subject to a
third party evaluation to verify their conformity with the directive. Indeed it should be stressed that the
situation for medical devices is not equivalent to that for other products such as toys.

The soft PVC used for medical devices is the subject of several standards and pharmocopia monographs
used by manufacturers when selecting and testing their materials.

The Commission has, within the framework of Council Regulation (EEC) No 793/93 of 23 March 1993,
launched several years ago a
on the evaluation and control of
comprehensive risk assessment of diethyl hexyl phthalate (DEHP). The risk assessment is expected to be
finalised in the first half of 2000, and will, among other aspects, cover the use of DEHP in medical
applications.

the risks of existing substances (2),

On the basis of the risk assessment, the Commission will, if appropriate, issue a recommendation for a risk
reduction strategy, which will form the basis for Community measures proposed in the framework of
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 (3) or in the framework of other relevant existing Community
legislative instruments.

(1) OJ L 125, 19.5.1999 (corrigendum).
(2) OJ L 224, 3.9.1993 (corrigendum).
(3) OJ L 262, 27.9.1976.

(2000/C 219 E/170)

WRITTEN QUESTION E-2270/99

by Alexandros Alavanos (GUE/NGL) to the Commission

(13 December 1999)

Subject: Increased ozone levels in Greece and other Mediterranean countries

The Commission(cid:146)s report concerning ozone indicates that, in Greece, greater concentrations of ozone in
terms of quantity and duration have been observed this year. The Commission(cid:146)s proposals seek to achieve
a 70 % reduction in ozone exposure compared with 1990. However, the southern Member States of the
EU argue that account has not been taken of special geographical and climatic factors (high temperatures,
sun, humidity) which aggravate the problem and maintain that any benefit is (cid:145)disproportionately(cid:146) out-
weighed by the cost.

Since it is imperative to take measures to reduce pollution levels, what does the Commission consider to
be likely areas in which funding could be earmarked for measures to overcome the problem?