WRITTEN QUESTION E-0521/00 by Concepció Ferrer (PPE-DE) to the Commission. Rules on the manufacture of lint to be used for medicinal purposes.
C 26 E/56 Official Journal of the European Communities EN 26. 1. 2001 The Commission has written to the Spanish authorities requesting information on the specific situation at the Marjal de Almenara site described by the Honourable Member and asking for their comments, in particular as regards compliance with Community legislation in force. inter alia, It should be noted that the new rural development policy adopted in June 1999, to which the Honourable Member refers, has become the second cornerstone of the common agricultural policy. The support given to sustainable rural development by Council Regulation (EC) No 1257/1999 of 17 May 1999 on support for rural development from the European Agricultural Guidance and Guarantee Fund (EAGGF) and amending and repealing certain Regulations (2), relating to agricultural activities and their reconversion, the preservation and promotion of a high nature value and a sustainable may concern, agriculture respecting environmental requirements. Member States may include in their rural development programmes and Objective 1 operational programmes the establishment of the Natura 2000 network and the preservation of areas in the network. Compensatory payments can be made by the EAGGF for the maintenance of agricultural activity in these areas where farmers may lose income because of specific requirements deriving from the application of Community legislation, as would be the case in the area in question. Under the same Regulation investments with environmental protection objectives could also be cofinanced. (1) OJ L 206, 22. 7. 1992. (2) OJ L 160, 26. 6. 1999. (2001/C 26 E/070) WRITTEN QUESTION E-0521/00 by Concepció Ferrer (PPE-DE) to the Commission (28 February 2000) Subject: Rules on the manufacture of lint to be used for medicinal purposes Under Directive 93/42/EEC (1) on medical devices, all medical devices marketed within the EU must carry the CE mark, which guarantees that the device meets the requirements laid down in the directive. On account of those requirements, European companies have had to make substantial investment and they have to bear the additional cost of quality management. On the other hand, products made in China arrive at Community hospitals carrying the CE mark but they are not required to meet the standards demanded of Community companies. They do not therefore provide the medical guarantees offered by the CE mark and their manufacturers have not had to make the huge investment required of EU producers. Is the Commission aware of this state of affairs? If so, what action does it intend to take in response to it? (1) OJ L 169, 12. 7. 1993, p. 1. Answer given by Mr Liikanen on behalf of the Commission (12 April 2000) The Commission would like to stress that medical devices put on the market and into service in the Community and the European economic area (EEA), are submitted to the same rules and requirements regardless whether they are manufactured in the Community or EEA or imported from third countries. Therefore the manufacturer or authorised representative, whenever the manufacturer does not have a registered place of business in a Member State, has to fulfil the provisions as laid down in Directive 93/42/ EEC, and to ensure and declare their conformity. Then it can CE mark the devices. On the other hand, it is up to Member Statesí authorities to ensure that the manufacturer duly fulfils its obligations. 26. 1. 2001 EN Official Journal of the European Communities C 26 E/57 Member States take all necessary steps that devices may be placed on the market and put into service only if they do not compromise the safety and health of patients and users. They shall use the ásafeguard clauseí whenever the health or safety of patients and users are put at risk. Under this clause, measures can be taken to withdraw such devices from the market or prohibit or restrict their being placed on the market or put into service. Finally the Directive states that Member States shall not create any obstacle to the placing on the market or the putting into service within their territory of devices bearing the CE marking. (2001/C 26 E/071) WRITTEN QUESTION E-0524/00 by Giovanni Pittella (PSE), Joan Colom i Naval (PSE), Paulo Casaca (PSE), Vincenzo Lavarra (PSE) and Georges Garot (PSE) to the Commission Subject: Protecting European nut production (28 February 2000) The close of 1999 marked the end of the scheduled transitional period between the old rules governing nuts (Regulations (EEC) No 2159/89 (1) and (EEC) No 790/89 (2)) expiring and the entry into force of the general reform of the fruit and vegetables sector (Article 55 of Regulation (EC) No 2200/96 (3)), which involves the inclusion of nuts (i. e almonds, hazelnuts, sweet chestnuts and walnuts) in the new COM. So the new regulation puts an end to the special support measures which, however limited (with flat-rate aid provided for hazelnuts only), demonstrated the Communityís interest in a sector which is not only significant in terms of output, but also plays an irreplaceable role in terms of maintaining agricultural and environmental balance and conserving the landscape in many regions of the EU. Failure to take this factor into account in recent years has led to a number of natural disasters in Europe. Moreover, these measures were a useful means of offsetting the difficulties encountered by farms producing nuts, either as their principal crop or as a sideline, because of the marginal nature of the land. Finally, the sector is overlooked in the course of negotiations on free trade agreements with third countries. Consequently nut production is being gradually abandoned, even though demand remains stable, thus exacerbating Europeís balance of trade deficit in these products. What action does the Commission intend to take in connection with the new rules to ensure proper recognition of this sector, which mainly concerns regions whose development is lagging behind? Does the Commission agree that it is necessary to review the level of financial support and the nature of the aid provided to that sector, while coordinating the various organisational strategies of the new COM with the measures required to maintain precarious social and economic structures and preserve traditional agricultural and environmental features in fragile rural areas? Could the Commission consider the possibility of maintaining flat-rate aid for hazelnuts for a set period and introducing measures to provide support per hectare, with such aid being differentiated according to the main crops and conditional on the adoption of binding land use safeguards in the context of the new rules on rural development? (1) OJ L 207, 19. 7. 1989, p. 19. (2) OJ L 85, 30. 3. 1989, p. 6. (3) OJ L 297, 21. 11. 1996, p. 1. Answer given by Mr Fischler on behalf of the Commission (24 March 2000) The Commission is well aware of the difficulties that have, in the past, beset the nut sector, including the structural deficiencies leading to low productivity and high costs. It was in direct recognition of these difficulties that financial support was granted to the sector under the provisions of Title IIa of Regulation (EEC) No 1035/72 of the Council of 18 May 1972 on the common organisation of the market in fruit and