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.
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 Commissionís report concerning ozone indicates that, in Greece, greater concentrations of ozone in terms of quantity and duration have been observed this year. The Commissionís 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 ádisproportionatelyí 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?