WRITTEN QUESTION E-0722/00 by Carles-Alfred Gasòliba i Böhm (ELDR) to the Commission. Community procedure for the recording and placing on the market of active substances and plant protection products.
Date: 2000-03-17
Institutions: European Parliament, Provisional data
Subjects: EC Directive, interpretation of the law, market approval, plant health product

C 53 E/20

Official Journal of the European Communities

EN

20.2.2001

OSPAR to take account of the outcome of a study by the nuclear energy agency of the Organisation for
economic cooperation and development (OECD) concerning a thorough review and assessment of the
reprocessing and non-reprocessing options for spent fuel management. The OECD has involved the
Commission in the preparation of this report for OSPAR. The Commission will continue to carry out a
programme of verifications in Member States under Article 35 Euratom Treaty. The Commission does not
have any plans to carry out inspections of reprocessing facilities in co-operation with the OSPAR
commission, since, while the Commission has a right of access under Article 35 of the Euratom Treaty,
this would be outside the OSPAR commission(cid:146)s mandate.

(2001/C 53 E/024)

WRITTEN QUESTION E-0722/00

by Carles-Alfred Gas(cid:242)liba i B(cid:246)hm (ELDR) to the Commission

(17 March 2000)

Subject: Community procedure for the recording and placing on the market of active substances and plant

protection products

Council Directive 91/414/EEC (1) of 15 July 1991 introduced a new system for the recording and placing
on the market of plant protection products, together with a non-standard procedure for the recording of
active substances and products containing those substances, which hitherto had been produced and
circulated freely. SMEs are now feeling the severe impact of this unusual state of affairs as the number of
substances added to Annex I of the Directive grows. In some instances, a party which gives notification of
an active substance included in Annex I interprets Article 13(3)(d) of the Directive for its own ends rather
than in keeping with Community principles and allows a third party to gain access to supplies of the
substance and to the protected data it has requested, but charges outrageous prices in the process and
attaches unreasonable conditions, given the market concerned. Those with exclusive rights take this course
of action to force small and medium-sized competitors which have been working with such substances
until their inclusion under Annex I of the Directive off the market.

Is the Commission aware of the threat which the aforementioned practice, based on a specific reading of
the Directive, poses to SMEs in the plant protection sector? Likewise, is it aware of the danger which might
emerge for traditional producers of active substances or manufacturers of plant protection products which
use certain active substances in their products?

Is it the Commission(cid:146)s intention to permit such a practice?

Does the Commission intend to ensure that third parties seeking access to protected data should pay fixed
amounts based exclusively on the cost of the file drawn up by the first notifying party, irrespective of the
intended use of the data, and on the nature of applicants(cid:146) products, their share of the market and their
capacity and potential in terms of distribution and marketing? What measures does it intend to adopt to
counteract the adverse effects of the Directive on SMEs in the sector?

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

Answer given by Mr Byrne on behalf of the Commission

(28 April 2000)

The use of plant protection products is regulated by Council Directive 91/414/EEC of 15 July 1991 (1)
concerning the placing of plant protection products on the market. The main objectives of this Directive
are to (a) ensure a high level of protection of human health, for the consumer and for the producers of
agricultural commodities, (b) ensure a high level of protection of the environment and resources and (c)
ensure free circulation of plant protection products and agricultural produce in the Community.

The Directive provides for a positive list of accepted active substances that are considered as safe for
human and animal health and the environment after a thorough evaluation. Member States can only
authorise a plant protection product if the active substances it contains are listed in the positive list and

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Official Journal of the European Communities

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provided certain criteria concerning efficacy and safety for humans and the environment are satisfied.
These criteria are harmonised (the so-called uniform principles). Also the Directive harmonises the data
industry has to submit when applying for an authorisation. The data required from industry in order to
demonstrate acceptable uses are much more demanding which implies that for products already on the
market before the implementation of the Directive sometimes an important number of additional studies
have to be provided.

The Directive contains provisions on data protection which have to be applied by Member States when
granting authorisations. These provisions constitute a balance between the interests of those companies
which are generating the necessary studies in order to demonstrate the acceptability of the use of a plant
protection product and the active substance it contains and the interest of free competition on the market.

The Directive does not provide for a general system whereby applicants are obliged to share data at a fixed
price with other interested applicants. On the contrary,
it provides that, after inclusion of an active
substance in the positive list, Member States may introduce national measures obliging applicants to share
the data involving testing on vertebrate animals with a view to avoiding duplicative testing on vertebrate
animals and determine the procedure for utilising information, and the reasonable balance of interests of
the parties concerned. The Commission is aware that only a very limited number of Member States have
made use of this possibility.

(1) OJ L 230, 19.8.1991.

(2001/C 53 E/025)

WRITTEN QUESTION E-0738/00

by Joan Colom i Naval (PSE) to the Commission

(17 March 2000)

Subject: Application of Directives 91/676/EEC and 96/61/EC in Catalonia

Competence in the areas of
the environment, agriculture and health has been transferred to the
Autonomous Community of Catalonia (Spain), which is thus responsible for implementing Directive 91/
676/EEC (1) concerning the protection of waters against pollution caused by nitrates from agricultural
sources and Directive 96/61/EC (2) concerning integrated pollution prevention and control.

In this context the Ter Protection Group (Torroella de Montgr(cid:237), Gerona) has detected an increase in
pollution levels in the Baix Ter aquifer at the lowest point of the river, shortly before it flows into the
Mediterranean. That pollution is caused by various substances, including a high concentration of nitrates.
The aquifer plays a vital role in supplying drinking water to the Baix Ter area, given that much of its flow
is diverted before it reaches the area in order to supply water to the city of Barcelona and for other
industrial uses, with the result that only a relatively small amount of water is left, particularly in summer,
in which all the pollution accumulated further upstream is concentrated.

Despite the Catalan administration(cid:146)s delay in designating vulnerable areas (decree 283/1998), much of the
Baix Ter area has been classed as vulnerable and is therefore covered by the code of good agricultural
practices (order of 22 October 1998). Nevertheless, no environmental policy has been put in place: the
impact on surface and ground water has been neither identified nor assessed, and the same applies to the
impact on the soil, flora and fauna, i.e. there is no action plan aimed at reducing pollution in the aquifer as
envisaged in Directive 91/676/EC. On the contrary, uncontrolled discharges of liquid manure continue.

Does the Commission have any record of significant pockets of pollution with a high concentration of
nitrates and other substances which are evidently having and will continue to have an adverse effect on
community life, public health and the environment around the Baix Ter aquifer?

Similar problems are to be found in other parts of Catalonia, notably the Osona district.

What measures will the Commission adopt to ensure that the above Directives are complied with in Spain,
and in Catalonia in particular?

(1) OJ L 375, 31.12.1991, p. 1.
(2) OJ L 257, 10.10.1996, p. 26.