WRITTEN QUESTION E-1456/02 by Chris Davies (ELDR) to the Commission. Scientific validity of animal toxicity tests.
Date: 2002-05-23
Institutions: European Parliament, Provisional data
Subjects: animal experimentation, animal welfare, protection of animals, research method

5.12.2002

EN

Official Journal of the European Communities

C 301 E/151

Is the Commission aware of this decline in the Eleonora’s Falcon population?

What measures has it taken or does it intend to take to prevent this species of falcons from becoming
extinct?

Certain nature protection organisations are calling for mammal repellents to be added to all pesticides
available on the market so as to prevent them being used illegally as poison to eliminate certain animals.

How does the Commission view this proposal? Will it consider implementing it in the context of pesticide
authorisation procedures?

(1) OJ L 103, 25.4.1979, p. 1.

Answer given by Mrs Wallström on behalf of the Commission

(8 July 2002)

the Commission services through a registered complaint

The Commission wishes to inform the Honourable Member that it is aware of the decline in the number of
Falco eleonorae (species included in Annex I of the Birds Directive (1)). The situation has been brought to
the attention of
launched against Greece.
Subsequently, a letter has been sent to the Greek authorities requesting information about the situation of
the population of Falco eleonorae in the island of Crete and of the measures that the Greek authorities
have taken as to alleviate the particular problem in the island. The reply to this letter is still pending. As
soon as the Greek authorities respond, the submitted information shall be analysed with a view to assess if
Greece has violated its obligations derived from Community environmental law in this case.

While the evaluation of Methomyl in the framework of Directive 91/414/EEC (2), is ongoing, the national
legislation of the Member States regarding placing on the market and use of plant protection products
applies. Use of the insecticide Methomyl is currently permitted in 10 Member States. The described use in
Crete is illegal and it remains the responsibility of the Greek authorities to take the necessary measures.

The proposal made by certain associations for nature conservation (Bird Life International and their Greek
associates, the Greek Ornithological Society) to add repulsive agents for the mammals to the preparations,
has already been applied by DuPont, one of the companies producing Methomyl. It seems however that
the repulsive effect on birds is not yet proven. However, there are indications that the application of
Methomyl according to label instructions poses a low risk to birds such as falcons. Recognising that the
decline of falcons can be attributed to the illegal use of Methomyl products, DuPont and the Greek
Ornithological Society, according to information provided to the Commission, are currently running a
joint project on the island of Crete. The project aims to raise public and farmers’ awareness about the
situation and to inform farmers about the effects on the falcon’s population by the misuse of the pesticide.

Further to the actions already taken regarding the case of Eleonora’s Falcons decline on the island of Crete,
the Commission is currently finalising a Communication to Parliament and to the Council entitled
‘Towards a Thematic Strategy on the Sustainable Use of Pesticides’. This Communication will launch a
broad consultation of all stakeholders to prepare the thematic strategy on the sustainable use of pesticides
requested in the 6th Environment Action Programme.

(1) Council Directive 79/409/EEC of 2 April 1979 on the conservation of wild birds.
(2) 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.

(2002/C 301 E/163)

WRITTEN QUESTION E-1456/02

by Chris Davies (ELDR) to the Commission

(23 May 2002)

Subject: Scientific validity of animal toxicity tests

Will
the Commission state whether any of the animal-based toxicity tests currently used to assess
chemicals have not been fully validated to modern standards such as those applied during the development
of new non-animal alternative tests?

C 301 E/152

Official Journal of the European Communities

EN

5.12.2002

Is it the case that for the purpose of regulatory toxicity testing, animal toxicity tests that have failed
retrospective validation are still in use and are currently included in Annex V of Directive 67/548/EEC (1)
(’the dangerous substances directive’)?

(1)

JO P 196 du 16.8.1967, p. 1.

Answer given by Mrs Wallström on behalf of the Commission

(9 July 2002)

Toxicity tests to assess the properties of chemicals which may be dangerous to human health and the
environment are included in Annex V of Council Directive 67/548/EEC (1), the ‘Dangerous Substances
Directive’. Most of the test methods set out in the Annex are based on those developed and recommended
by competent
the Organisation for Economic Cooperation and
Development (OECD). The quality of such methods is therefore recognised internationally. The test
methods should be performed in conformity with the principles of Good Laboratory Practice (GLP), in
order to ensure as wide as possible the mutual acceptance of data.

international bodies,

in particular

It is true that the current animal procedures have not been validated scientifically according to modern
standards. However, it could be considered fair and reasonable to evaluate them by a ‘weight-of-evidence’
approach. That is, since they have been in use for a long while, there is a great deal of experience on
which to base an evaluation of their relevance and reliability.

The 1998 OECD document on the ‘Validation of test methods considered for the adoption as OECD test
guidelines’ (ENV/MC/CHEM (98) 6) acknowledged that ‘… there seems to be a tendency towards being
stricter
so far
uncovered areas.’ The general problem that double standards may be operating has thus been recognised.

for’alternative‘or’replacement‘tests

than for’conventional‘animal

filling gaps of

tests,

The Commission is not aware of any formal retrospective validation of testing methods currently included
in Annex V of Council Directive 67/548/EEC. The European Centre for the Validation of Alternative
Methods (ECVAM) of the Joint Research Centre (JRC) has so far concentrated on prospective validation
studies.

The Commission considers that progress in the development and validation of alternative test methods is
necessary. ECVAM has recently compiled a report, provided for publication in August 2002, on the
current status and future prospects of alternative (non-animal) tests for chemicals testing for human health
effects. The report places the emphasis on methods that can replace existing animal tests, either entirely or
partially. It makes recommendations for the further development and validation of alternative tests and
strategies. According to the ECVAM report there is scope for reducing the numbers of animals required
through reconsideration of group sizes and of experimental design of existing methods.

(1) Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative

provisions relating to the classification, packaging and labelling of dangerous substances.

(2002/C 301 E/164)

WRITTEN QUESTION E-1469/02

by Michael Cashman (PSE) to the Commission

(27 May 2002)

Subject: Passenger protection plan

The 11th of September 2002 plunged the airline industry into an unprecedented crisis. The industry,
already weakened by the economic recession, saw the disappearance of a number of airlines, such as