WRITTEN QUESTION E-0812/04 by María Sornosa Martínez (PSE) to the Commission. Infringement of European legislation on phytosanitary products in the Abac case (Valencia).
Date: 2004-03-15
Institutions: European Parliament, Provisional data
Subjects: Spain, application of EU law, consumer protection, environmental protection, insecticide, market approval, plant health legislation, product safety, toxic substance

C 84 E/676

Official Journal of the European Union

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3.4.2004

The Scientific Committee on Toxicology-Ecotoxicology and the Environment confirmed on 30 November
2001 that ‘the additional information which has become available on carcinogenic and other non-thermal
effects of radio frequency and microwave radiation frequencies in the last years does not justify a revision
of the exposure limits set by the Commission’. This view was generally supported in a conference on
mobile communication in January 2004 (1) and by a series of expert reports recently produced in some
Member States.

An implementation report on the Council Recommendation was published in March 2003 focusing on
measures taken in Member States. This report states in paragraph 8.3 that some recent findings in the
extremely low frequency area have to be further evaluated. This refers in particular to extreme low
frequency (ELF) magnetic fields at power frequencies (50/60 Hz) originating from power lines.

The World Health Organisation (WHO) is currently conducting a major assessment relating to EMF, both
in the low and radio frequency range. The Commission is following closely this project. It is to be expected
that the outcome of this work will provide key elements to determine eventual further steps.

Considerable research work has been and continues to be undertaken to investigate possible long term
effects on health of exposure to electromagnetic fields. The Commission is following closely any new
scientific results in the domain to react, if necessary, to any new scientific evidence not taken to date into
consideration. Once finalised (2004-2006),
the
5th Framework Programme for Research (FP5) should provide an important
to address the
knowledge gap and will also contribute to the related activities of the WHO.

the projects supported by the Community under

input

In addition, under the 6th Framework Programme, the new Coordination Action on EMF (EMF-NET) aimed
at improving the co-ordination of the results of the research activities related to the biological effects of
electromagnetic fields has just started (2004-2008). The consortium involves all the co-ordinators of the
EU (FP5) funded active projects, and of major research projects at national level (Germany, Greece, France,
Italy, Finland, United Kingdom, Hungary). In addition, it links to other international activities, such as
COST 281 Action, WHO EMF activities, associations of industries and manufacturers, regulatory bodies,
‘inter alia’, review European and
scientific associations, and trade union associations. This network will,
national EMF studies and support informed decision making for regulation and risk communication by
health and environmental authorities, consumer associations and individuals.

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

(2004/C 84 E/0763)

WRITTEN QUESTION E-0812/04

by María Sornosa Martínez (PSE) to the Commission

(15 March 2004)

Subject: Infringement of European legislation on phytosanitary products in the ‘Abac’ case (Valencia)

It was recently reported in Valencia that the Spanish Ministry of Agriculture was allegedly involved in the
‘Fabra’ case, in which the president of the Castellón regional government apparently asked the Ministry
that the insecticide ‘Abac’ (based on abamectin), marketed by the company Naranjax, be granted marketing
authorisation without having passed the relevant toxicity tests. It emerges that this phytosanitary product
had been refused authorisation three times before the intervention of the president of the regional
government. In actual fact other products with exactly the same composition manufactured under other
names have never obtained authorisation from the Ministry because they exceed the toxicity limits.
Furthermore, according to information revealed by the judicial process, it appears that ‘Abac’ began to be
sold before it had even received the disputed authorisation, which constitutes a twofold irregularity, since
the product was on sale for a certain period of time without a licence and without the relevant tests being
carried out.

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it may constitute a serious hazard for public health and the
If this really proves to be the case,
environment, an infringement of the principles of at least Directive 2002/79/EC (1)
(even the earlier
versions) amending the Annexes as regards the fixing of maximum levels for certain pesticide residues.
According to the Directive the maximum pesticide residue level for abamectin, the main ingredient of
‘Abac’, should be 0,01 mg/kg.

Quite apart from the legal proceedings and bearing in mind that the Ministry of Agriculture has not yet
publicly revealed either the actual composition of
the abamectin content or its reasons for
approving the conformity of the product, can the Commission say:

‘Abac’,

(cid:1) whether it does not consider that the Spanish Ministry of Agriculture, in view of its concealment of
information, may have committed a serious infringement of at least Community legislation on limit
values for phytosanitary products;

(cid:1) what steps it intends to take in response to this case?

(1) OJ L 291, 28.10.2002, p. 1.

Answer given by Mr Byrne on behalf of the Commission

(15 April 2004)

Council Directive 91/414/EEC of 15 July 1991 on the placing of plant protection products on the
market (1) provides that active substances may only be used in plant protection where it has been
demonstrated that the use has no unacceptable effects on human health or the environment. Pending
Community evaluations and Commission Decisions on individual substances that were already on the
market in July 1993, the Directive permitted national rules to stay in place on a temporary basis.
Abamectin is on the third priority list of substances established by the Commission under the Directive.
Under Commission Regulation (EC) No 451/2000 of 28 February 2000 laying down the detailed rules for
the implementation of the second and third stages of the work programme referred to in Article 8(2) of
Council Directive 91/414/EEC (2), industry indicated its interest in supporting the substance in the review
process. Dossiers had to be submitted to the rapporteur Member State, the Netherlands, by 25 November
2003. The rapporteur will examine the dossier and send its draft assessment report to the European Food
Safety Authority (EFSA). The Commission will decide on the acceptability of the use of abamectin in plant
protection on the basis of an evaluation of that report by the EFSA.

The Commission is aware that in Spain several plant protection products containing abamectin are
authorized. For all these products, including the product ‘Abac’, Spain can only grant authorizations if the
use of the product does not leave residues on the treated crops exceeding the maximum residue limit for
the crops involved. The maximum residue limits for abamectin are established in Commission Directive
2002/79/EC of 2 October 2002 amending the Annexes to Council Directives 76/895/EEC, 86/362/EEC,
86/363/EEC and 90/642/EEC as regards the fixing of maximum levels for certain pesticide residues in and
on cereals, foodstuffs of animal origin and certain products of plant origin, including fruit and vegetables,
and are varying between 0,1 and 0,005 milligrams per kilogram (mg/kg) depending on the crop or
foodstuff.

It cannot be excluded that certain plant protection products containing abamectine would not have been
authorized. In fact in such cases, insufficient information may have been provided to the authorities or the
information submitted may have shown that there are particular problems related to the specific product.

The Commission is not aware that there would be any particular safety problem with products containing
abamectin requiring immediate action before the review process in the framework of the Directive would
be finalised.

(1) OJ L 230, 19.8.1991.
(2) OJ L 55, 29.2.2000.