WRITTEN QUESTION P-1085/04 by Paul Lannoye (Verts/ALE) to the Commission. Evaluation of plant health products under Directive 91/414/EEC.
Date: 2004-04-01
Institutions: European Parliament, Provisional data
Subjects: market approval, plant health control, plant health legislation, plant health product, toxic substance

C 84 E/942

Official Journal of the European Union

EN

3.4.2004

GBP 16 400 to fly their aeroplanes to Dublin for maintenance instead, and given the apparent link to the
subsequent acquisition of FLS Aerospace by SR Technics of Switzerland, could the Commission also
investigate and comment on any possible breaches of European competition law?

(1) OJ L 254, 30.9.1994, p. 64.

Joint answer
to Written Questions P-1084/04 and P-1088/04
given by Mr Dimas on behalf of the Commission

(27 April 2004)

The Commission understands that there is an agreement between management and employee represen-
tatives in FLS Industries which the parties regard as being an agreement as envisaged in Article 13 of the
European Works Councils Directive (1). It is for the parties to the agreement themselves to assess whether
the announcement of the redundancies referred to by the Honourable Members are in breach of any
requirement
the agreement provides for a
mechanism to settle any disputes or controversies regarding its operation.

in that agreement. The Commission understands that

The Honourable Members will be aware that, regardless of the situation under the agreement referred to
above, the Directive on Collective Redundancies (2) provides that an employer contemplating collective
redundancies shall begin consultations with workers’ representatives in good time with a view to reaching
agreement. The consultations shall cover ways of avoiding the redundancies or reducing the numbers
affected and mitigating the consequences.

The transposition and application of the above-mentioned Directive are the responsibility of each Member
State. It is a matter for the competent national authorities, in the first place, to ensure correct application
of directives and to make provision in national legislation for administrative and judicial appeal. It is the
to use the means that it considers
task of the Commission,
appropriate, including those set out in Article 226 of the EC Treaty, to ensure, where necessary, that the
above-mentioned provisions are complied with. The Commission has no information to indicate that this
Directive has been infringed.

in its role as guardian of the Treaty,

(1) Council Directive 94/45/EC of 22 September 1994 on the establishment of a European Works Council or a
procedure in Community-scale undertakings and Community-scale groups of undertakings for the purposes of
informing and consulting employees, OJ L 254, 30.9.1994.

(2) Council Directive 98/59/ of 20 July 1998 on the approximation of the laws of the Member States relating to

collective redundancies, OJ L 225, 12.8.1998.

(2004/C 84 E/1041)

WRITTEN QUESTION P-1085/04

by Paul Lannoye (Verts/ALE) to the Commission

(1 April 2004)

Subject: Evaluation of plant health products under Directive 91/414/EEC

The evaluation of plant health products under Directive 91/414/EEC (1) is confined to that of the active
substances forming part of their composition.

Research carried out by a team headed by Gilles-Eric Séralini at the University of Caen has proved beyond
all doubt that the product Roundup® inhibits the action of aromatase, while for glyphosate, an active
substance forming part of the composition of that herbicide, the effect is visibly weaker, Research by the
same team on the viability of placenta cells has shown that Roundup® is toxic in small doses and that its
toxicity is approximately five times that of glyphosate.

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Research into sea-urchins by the cell cycle and development laboratory at the biological station in Roskoff
(France) has drawn attention to the action of Roundup® on a cell division regulator, whereas glyphosate,
used alone and without the additives of the commercial formula of Roundup®, does not have that effect.
It therefore appears clear that glyphosate, an active substance included in Annex I to Directive 91/414/
EEC, does not have the same properties as Roundup® and that the latter is considerably more dangerous
than its active substance.

Another example of pesticides being more toxic than the active substances forming part of
their
composition is the case of pyrethrinoids. Piperonyl butoxide is generally added to these as a synergist,
reinforcing the action of pyrethrinoids by inhibiting an enzyme capable of degrading those active
substances. These pesticides therefore visibly have toxicological properties that are different from those of
the active substances of which they are composed.

It is more than clear from these two examples that it is a serious methodological error to limit evaluation
to the active substances forming part of the composition of plant health products.

What measures does the Commission intend to introduce to put an end to this practice of incomplete
evaluation, which can occlude the existence of severe effects on health or ecosystems?

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

Answer given by Mr Byrne on behalf of the Commission

(23 April 2004)

While unable to comment on the validity of the studies the Honourable Member mentions, we consider
his question apposite, but wish to make some qualifications.

It is correct that only the active substance is included in Annex I to Directive 91/414/EEC (1). Inclusion
follows a safety evaluation in line with the requirements set out in Annex II.

However Annex III sets out specific requirements that have to be met for plant protection products, i.e. for
the actual product formulas. These have to be given a similar evaluation to that for active substances.

Detailed quantitative and qualitative information has to be provided on the product’s composition.
The additives, the amounts of these and their technical function must be correctly identified. Additives can
in specific cases be made subject to the same rules as those covering active substances.

It is accepted that the formulas authorised at national level can differ in order to take account of intended
use and of specific conditions, in particular climatic and geological. But this cannot be allowed to lead to
any decline in the high level of safety and protection required in the Union. Accordingly Annex VI to
Directive 91/414/EEC sets out the uniform principles that Member States must apply when evaluating
products and deciding whether they can be marketed.

We intend drawing up a proposal for amendment of Directive 91/414/EEC that will be submitted to
Parliament and the Council. In preparation for doing so we shall be reconsidering the legal position of the
various types of additive, in particular synergists, solvents and diluents, and if appropriate proposing that
in future they be subjected to specific requirements.

(1) Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market,

OJ L 230, 19.8.1991.