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.
Date: 2000-02-28
Institutions: European Parliament, Provisional data
Subjects: China, EC conformity marking, competence of the Member States, medical device

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 Concepci(cid:243) 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 States(cid:146) 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 (cid:145)safeguard clause(cid:146)
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 Community(cid:146)s 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 Europe(cid:146)s 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