WRITTEN QUESTION E-0997/04 by Dominique Souchet (NI) to the Commission. Placing on the market of plant protection products.
Date: 2004-03-31
Institutions: European Parliament, Provisional data
Subjects: European Food Safety Authority, approval, evaluation method, marketing, plant health product, transparency in decision-making

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Can the Commission ascertain the causes of the unrest, which led to many deaths, and whether it is due to
the poor relations between the Syrian authorities and the Syrian Kurds?

Will the Commission raise this issue in the margins of the talks on the association agreement between
Syria and the EU?

Answer given by Mr Patten on behalf of the Commission

(30 April 2004)

The Commission through its Delegation in Damascus and together with Member States Embassies has
sought to obtain as clear and complete a picture as possible of the events in the week following 12 March
2004. The local EU Troika met with the Syrian Foreign Ministry on 18 March 2004 to seek information
and to express its concern about the situation and underline the importance of respect for human rights.
The Troika expressed the European Union’s continued interest in the matter and requested to be kept
informed about the evolution of the situation.

The Commission does not possess any information that allows it to ascertain the immediate causes that
triggered the widespread violence, apart from the fact that it started with riots related to a football game in
the town of Quamishli. This unrest quickly spread to other towns with a large Kurdish population, leading
to violent reactions and deaths.

As mentioned above, the Commission has raised this matter together with Member States in Damascus as
well as in the course of its contacts with Syrian authorities.

(2004/C 88 E/0568)

WRITTEN QUESTION E-0997/04

by Dominique Souchet (NI) to the Commission

Subject: Placing on the market of plant protection products

(31 March 2004)

introduced by Directive
The Community system for
91/414/EEC (1) is chiefly based on a system for evaluating the active substances, with a reporting Member
State being designated for each substance. This evaluation phase involves collecting studies carried out by
plant protection firms themselves and forwarding them to the European Food Safety Authority.

the approval of plant protection products

Does the Commission consider that this one-way evaluation procedure makes it possible to ensure that the
decision to approve a substance is taken in a sufficiently objective manner?

Furthermore, the protocols envisaged in the studies with a view to assessing the degree of toxicity of
substances have not been updated in line with the appearance of new molecules on the market.

Should their specifications not be adjusted to take account of the performance and modes of action of
these new substances, as otherwise it will not be possible to ascertain all the potential toxic effects of a
new molecule?

The process for evaluating active substances is based on a four-stage system corresponding to four lists of
substances.

Given that it is the undertakings concerned that choose which studies are to be carried out as a priority in
each of the stages, does the Commission believe that this is the best system for guaranteeing compliance
with health and environmental requirements?

(1) OJ L 230, 19.8.1991, p. 1.

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Answer given by Mr Byrne on behalf of the Commission

(30 April 2004)

Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the
market is based on the principle that the burden of proof of compliance with the Directive’s main
requirements rests with the applicant. Hence it is usual for the applicant to prepare, collate and submit the
requisite studies supporting the application. The rapporteur Member State is required to check whether the
file is complete, and only after that is the assessment proper started. The next stage comprises sending the
draft assessment report to the other Member States for peer review. The Commission takes the final
decision, in accordance with the procedures described in the Directive and its implementing rules. The
Commission is required to consult the Standing Committee on the Food Chain and Animal Health and
may also obtain scientific opinions from the European Food Safety Authority, which now carries out the
tasks assigned in the past to a number of scientific committees, including the Scientific Committee for
Pesticides and the Scientific Committee for Plants. Relevant comments from third parties may also be taken
into account. In addition to Member States, the applicant is requested to answer technical questions. The
discussions are clearly confined to scientific and technical matters relating directly to risk assessment.

In the light of the various aspects of the dossier (including, if necessary, the opinion of the European Food
Safety Authority), the Commission refers it to the Standing Committee on the Food Chain and Animal
Health, which gives its opinion on measures to be taken. Those measures may comprise inclusion of the
substance in Annex I to the Directive, accompanied by the requisite instructions to ensure correct use, or
non-inclusion. In both cases, a formal instrument is adopted.

The Commission therefore considers that the current procedure ensures a sufficient degree of transparency
and independence, while providing the requisite mechanisms for interested parties to express their views.

With regard to the second part of the question it is worth noting that, under Article 7 of Directive
91/414/EEC, the applicant must immediately notify the competent authority of all new information on a
potential
information immediately to the other
Member States and to the Commission, which is to refer it to the Committee.

risk. The competent authority is

to notify that

This case is different from the question relating to the speed of scientific and technological progress and
hence the obsolescence of studies supplied. The Commission is aware that, in the course of evaluation
procedures taking several years, studies supplied may be overtaken even before evaluation has been
completed. However, experience shows that these cases are exceptional. Although additional studies are
sometimes required during the procedure, it seems reasonable not to subject the applicant to constantly
renewed requirements and to confine retroactivity to cases where new facts have recently invalidated
existing data.

In general, decisions of this type can be taken only on a case-by-case basis, having regard to the high level
of protection which Community measures must reflect, the significance of the risk involved and the need
to provide legal certainty for the applicant.

The Commission nevertheless stresses that the cases referred to above may arise while substances are being
evaluated, but also after they have been authorised. That is why authorisations are valid for a limited
period and their renewal is subject to a fresh evaluation. In addition, Member States always have the
possibility of recourse to safeguard procedures for products which, for various reasons, do not or no
longer meet the required safety standard.

Lastly, Annexes II and III to the Directive (cid:1) which list the requirements for dossiers to be submitted (cid:1)
are currently being amended to reflect the latest scientific and technological developments.

With regard to the division of substance evaluation into four stages,
the
differentiation is based firstly on safety considerations (priority being given to substances which are widely
used and/or whose toxic and ecotoxic characteristics call
for particular care) and then on efficient
deployment of resources.

it should be noted that

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The Commission stresses that, at whichever stage a given substance is classified, the dossier will have to
contain the studies specified by Community legislation. Exemption from that rule, for example in cases
where the regulatory requirements are considered irrelevant,
is subject to express acceptance by the
Commission.

In addition, unsubstantiated absence or inadequacy of data constitutes grounds for the Commission to
decide automatically not to include the substances concerned.

The Commission therefore takes the view that the applicant’s margins of manœuvre are well-defined with
regard to the studies to be supplied.

(2004/C 88 E/0569)

WRITTEN QUESTION E-1003/04

by Daniel Hannan (PPE-DE) to the Commission

(31 March 2004)

Subject: Romanian motorway project

The EU has recently threatened to defer Romania’s accession if
it does not succeed in combating
corruption. One might hope that the Romanian Government had taken note, but there is evidence to
suggest that the problems continue and are worsening. One specific example is a planned Transylvanian
motorway that will destroy one of Europe’s last remaining medieval landscapes without offering benefits
except to those well-connected individuals who have acquired the land on which the motorway would be
constructed. Furthermore, an EU-backed plan already exists to build a motorway from the Hungarian
to the Black Sea.
border across Romania, through Brasov, Transylvania’s main city, and Bucharest,
Consequently, the new scheme for a second motorway heading north from Brasov and running parallel
with this road, a mere fifty miles away, then petering out meaninglessly just inside the Hungarian border,
is completely superfluous. This project was not put out to tender. No environmental assessment or
estimate of traffic volume was sought before it was approved, and the American company, Bechtel, was
awarded the contract under an emergency ‘ordinance’ (cid:1) a procedure specifically designed to bypass
parliamentary scrutiny. There is also evidence to suggest that the land needed for the motorway was
unfairly expropriated. A study by the Romanian Academic Society has argued that the EUR 3 billion
needed for the Bechtel motorway would be sufficient to fund the rehabilitation of the entire street structure
of Romania’s 3 000 municipalities or to complete modernisation work for more than 3 500 km of national
roads.

What is the Commission’s position on the Bechtel motorway project? Would the Commission agree that
the Romanian Government appears to have done very little to solve problems associated with corruption?
Would it also agree that it is no one’s interest to see this incomparable landscape and heritage destroyed
forever by inefficient, unnecessary and corrupt projects?

Answer given by Mr Verheugen on behalf of the Commission

(30 April 2004)

The decision to derogate from Romania’s public procurement rules, which are intended to implement the
EU public procurement directives, and to award a contract for the construction of the Brasov-Cluj-Bors
motorway without public tendering raises concerns about the Romanian government’s commitment to
competitive and transparent public procurement procedures. The Commission has asked Romania to
provide further information so that it might fully assess the implications of this decision. Since there was
no competitive and transparent tendering, the European Commission has already made it clear to the
Romanian side that it will not provide any financial support for this project and that it will not support
any International Financing Institution assistance for the construction of the motorway.