WRITTEN QUESTION E-1313/03 by Torben Lund (PSE) to the Commission. Polish special law on road-building, bypassing EIA requirements.
Date: 2003-04-07
Institutions: European Parliament, Provisional data
Subjects: EU law - national law, Poland, environmental impact, impact study, legal rule, national implementing measure, road building

15.1.2004

EN

Official Journal of the European Union

C 11 E/173

Class III devices can certainly not be approved under the procedure of Annex II solely on the basis of an
examination of the documentation of the quality system and the product’s design.

There are no indications that Annex II examination, as applicable to class III products, needs regulatory
change. However, as regards other classes of medical devices, for which in contrast to Class III devices a
specific design examination certificate is not necessary, the Commission intends to reinforce the provisions
of Annex II.

The aforementioned report clearly establishes that implementation of the Directive regarding conformity
assessment and market surveillance can and needs to be improved. Therefore, national authorities and the
Commission have already created special task forces such as the Notified Bodies Operations Group, the
Market Surveillance Operations Group, and the Clinical Evaluation Task Force,
the
necessary improvements by a number of measures.

to bring about

Measures like these are also important in the light of enlargement.
In this context, some candidate
countries are developing specific projects to improve networking with Member States. Furthermore,
bilateral programmes on training and advice exist between various Member States and candidate countries.
The Commission and national authorities are considering the organisation of
two workshops with
candidate countries on market surveillance and best practice in implementing the directives.

The Commission has no information that manufacturers outside the European Union choose systematically
to market their product first in Europe. These are commercial decisions. The medical devices sector is a
global market, where normally the same product finds access to different markets, even if different market
access procedures are applied. Depending on the products and the authorisation antecedents, market access
in the United States of America can be shorter or longer than in the Union. Discussions are in progress
between the United States of America, Canada, the European Union, Japan and Australia in the framework
of the Global Harmonisation Task Force (GHTF) concerning regulations and administrative convergence. In
the framework of GHTF also a global vigilance system is being set up.

The Commission will draw the attention of national authorities to the case reported in the question and
will ask to be informed of the results of their enquiries in view of assessing any possible relevant aspects
related to the functioning of the Directive.

(1) http://europa.eu.int/comm/enterprise/medical_devices/index.htm.

(2004/C 11 E/198)

WRITTEN QUESTION E-1313/03

by Torben Lund (PSE) to the Commission

(7 April 2003)

Subject: Polish special law on road-building, bypassing EIA requirements

I am aware that a special act will shortly be adopted in Poland on 2 April, to ‘simplify’ procedures for
planning and approval of major road schemes in Poland. This act proposes to apply such procedures until
the end of 2007.

Among the implications of ‘simplifying’ the procedures are reduced provisions for environmental impact
assessment and the repealing of several articles of the Polish law of environmental protection. This means,
for example, that the usual two-stage EIA reports are replaced with one single EIA report, and that several
key factors regarding examination of viable, environmentally-sustainable alternatives to the proposed
routes will be ignored. Further, the decision-making procedures under this new Act will significantly
reduce consultation of civil society and there is no duty to disclose the authors of the remaining EIA
report.

C 11 E/174

Official Journal of the European Union

EN

15.1.2004

These developments will no doubt concern the Commission, since Poland has already transposed EIA
legislation into national law, and it now appears it could backtrack on those legal provisions. Bearing in
mind that once a major road is built and has damaged or destroyed key environmental sites, this damage is
often irreversible, will the Commission please give its assessment of the situation, and can it then assure
Parliament that Poland will still apply the full EU environmental requirements to decisions on road-
building, both in the run-up to accession, and from the date of accession onwards?

Please note that it is necessary to act fast, since the vote will take place on 2 April in the Polish Senate!

Answer given by Mrs Wallström on behalf of the Commission

(16 May 2003)

On accession to the Union, Poland will be bound by Union law, including on environmental impact of
projects and in particular their impact on any natural site of special value. Moreover the Commission
encourages Acceding Countries to apply and implement the provisions of the environmental acquis already
during the pre-accession period,
in particular as regards all new investments such as motorways. The
relevant Directives are those on Habitats (92/43/EEC (1)), Birds (79/409/EEC (2)) and Environmental Impact
Assessment (EIA) (97/11/EC (3)) and the Directive on the Assessment of the Effects of Certain Plans and
Programmes on the Environment (2001/42/EC (4)), which has to be applied from July 2004. Community
funding for any such investment will only be made available if the requirements of Community legislation
on environment and interoperability are respected.

Regarding the ‘special act’ referred to, the Commission raised this matter at the Union-Poland Sub-
Committee No 6 on Transport, Environment, Energy and Trans-European Networks (TENs) held on
27 March 2003 in Warsaw. The Polish authorities assured the Commission that the concerns raised
regarding the ‘special act’ were not accurate. According to Poland, the only relevant legislation being
prepared is two regulations that will complete the transposition into Polish law of the EIA Directive. They
are a Regulation of the Minister of Agriculture on the requirements to be met by impact assessments
regarding the impact of motorways on farmland, and a Regulation of the Minister of Environment on
detailed requirements to be met regarding the impact of motorways on the environment and cultural
heritage.

(1) Council Directive 92/43/EEC of 21 May 1992 on the conservation of natural habitats and of wild fauna and flora,

OJ L 206, 22.7.1992.

(2) Council Directive 79/409/EEC of 2 April 1979 on the conservation of wild birds, OJ L 103, 25.4.1979.
(3) Council Directive 97/11/EC of 3 March 1997 amending Directive 85/337/EEC on the assessment of the effects of

certain public and private projects on the environment, OJ L 73, 14.3.1997.

(4) Directive 2001/42/EC of the Parliament and of the Council of 27 June 2001 on the assessment of the effects of

certain plans and programmes on the environment, OJ L 197, 21.7.2001.

(2004/C 11 E/199)

WRITTEN QUESTION E-1315/03

by Bernard Poignant (PSE) to the Commission

(7 April 2003)

Subject: French regions and variations in the rate of domestic duty on petroleum products

The French Republic is a unitary state. The President of the Republic and the Government, together with
Parliament when it comes to voting on legislation, exercised all state powers. Public legal bodies existing
within the French state (regions, departments, local authorities, public undertakings for intercommunal
cooperation, etc.) enjoy jurisdiction based on the ratione materiae, established by central government, laws
and regulations.