WRITTEN QUESTION E-1320/03 by Richard Balfe (PPE-DE), John Bowis (PPE-DE),Charles Tannock (PPE-DE) and Theresa Villiers (PPE-DE) to the Commission. Clarification of the status of fenthion with regard to safety and Annex I to Council Directive 91/414/EEC.
Date: 2003-04-08
Institutions: European Parliament, Provisional data
Subjects: market approval, pesticide, plant health legislation, plant health treatment, precautionary principle, protection of animal life, toxic substance

7.11.2003

EN

Official Journal of the European Union

C 268 E/185

However, uses of tar acids as disinfectants in plant protection, with no direct application, were notifiable
under the fourth stage of the review programme established by Commission Regulation (EC) No 1112/
2002 (4). Armillatox is currently marketed for these same uses in Ireland and the United Kingdom but no
notification was received from Armillatox Ltd., the producer of Armillatox. Nevertheless, in October 2002
a notification under Regulation (EC) No 1112/2002 was received for high Boiling Tar Acids (cid:1) a complex
mixture of tar acids (HBTA) from another applicant located in the United Kingdom. Without prejudice to
the outcome of the further review process, the notification appears to be admissible and should this be the
case then HBTA can stay on the market pending its review under the Directive.

Given the limited market for these products in the Community, it is not unreasonable to suppose that
some potential notifiers for tar acids declined to notify primarily for economic reasons. Unfortunately, this
hinders companies from then forming task forces to share the costs of producing data packages supporting
the inclusion of their active substances in Annex I to Council Directive 91/414/EEC.

Thus, pending the Council Directive 91/414/EEC review, there is still a window of opportunity for
producers of HBTA used as disinfectants in plant protection to enter or stay on the market with their
product. However,
is
demonstrated that they can be used safely with respect to human or animal health or the protection of the
environment. In particular, it needs to be demonstrated that, as claimed in the question the product leaves
no residues that give reason for concern. Agronomic and other needs are secondary to this prime
consideration.

the Directive clearly states that active substances can only be accepted if

it

The Commission, given the above constraints, is currently discussing with Member States how procedures
and data requirements could be lightened for niche or low-risk substances. This could be the case where
producers could justify scientifically that certain data are unnecessary e.g. a consumer residue package is
not needed for a substance used exclusively on ornamental plants not used for human or animal
consumption. The Commission intends to find a suitable solution for the substances under review under
the fourth stage in order to combine the high level of consumer, animal and environmental protection
with a sensible and pragmatic approach in the review process.

(1) OJ L 230, 19.8.1991.
(2) 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, OJ L 055, 29.2.2000.

(3) Commission Regulation (EC) No 2076/2002 of 20 November 2002 extending the time period referred to in
Article 8(2) of Council Directive 91/414/EEC and concerning the non-inclusion of certain active substances in
Annex I to that Directive and the withdrawal of authorisations for plant protection products containing these
substances (Text with EEA relevance), OJ L 319, 23.11.2002.

(4) Commission Regulation (EC) No 1112/2002 of 20 June 2002 laying down the detailed rules

the
implementation of the fourth stage of the programme of work referred to in Article 8(2) of Council Directive 91/
414/EEC (Text with EEA relevance), OJ L 168, 27.6.2002.

for

(2003/C 268 E/209)

WRITTEN QUESTION E-1320/03

by Richard Balfe (PPE-DE), John Bowis (PPE-DE),
Charles Tannock (PPE-DE) and Theresa Villiers (PPE-DE) to the Commission

(8 April 2003)

Subject: Clarification of the status of fenthion with regard to safety and Annex I to Council Directive 91/

414/EEC

In answer to Written Question E-3811/02 (1), Commissioner Byrne on behalf of the Commission states that
the Scientific Committee on Plants determined in December 2002 that new toxicological information on
fenthion had not altered the Committee’s previous opinion regarding the mutagenic properties of fenthion,

C 268 E/186

Official Journal of the European Union

EN

7.11.2003

that the chemical is ‘unlikely to pose a risk of delayed neurotoxicity in humans’, but that ‘despite a change
of the application method and the provision of new studies, risks to birds from the proposed use of
fenthion are very uncertain and that therefore the concerns raised in the Committee’s previous opinion
remain unresolved’.

What change in the application method is the Commission referring to? Is the aerial spraying of fenthion
legal under Community law and what methods of application are consistent with the indications that
fenthion is unlikely to pose a risk of delayed neurotoxicity in humans?

Can the Commission confirm that as things stand fenthion has not been included on the Community’s list
of accepted active substances in Annex I to Council Directive 91/414/EEC (2) of 15 July 1991 and, if so,
does the Commission have discretion on whether to include it on the list so long as there are doubts about
the risks to birds or other forms of wildlife?

Regarding the precautionary principle, the Commission states that ‘a plant protection product can only be
authorised provided it is demonstrated, in the light of current scientific and technical knowledge, that its
residues and its use, consequent on application consistent with good plant protection practice, does not
have any harmful effects on human or animal health or any unacceptable influence on the environment.’

Given that, by the Commission’s own admission, the risks to birds from the proposed use of fenthion are
uncertain, why has the Commission not invoked the precautionary principle in this instance?

(1) OJ C 161 E, 10.7.2003, p. 148.
(2) OJ L 230, 19.8.1991, p. 1.

Answer given by Mr Byrne on behalf of the Commission

(27 May 2003)

In the Commission’s answer to Written Question E-3811/02 by Mr Tannock, it was concluded that the
Commission will follow the procedures established in Commission Regulation (EEC) No 3600/92 of
11 December 1992 laying down the detailed rules for the implementation of the first stage of the
programme of work referred to in Article 8(2) of Council Directive 91/414/EEC concerning the placing of
plant protection products on the market (1). It further indicated that after all consultations had been
finalised, the Commission would forward a proposal for a decision on fenthion to the Standing Committee
on the Food Chain and Animal Health as soon as possible and most likely at its meeting in April 2003.

The change in application method that the Commission mentioned in that earlier reply refers to use as a
spray bait application. Such an application method implies that only a part of about one third of the trees
are treated from the ground. With regard to delayed neurotoxicity (neuropathy) in humans, scientific
evidence did not confirm the former assumption that fenthion could give rise to this effect.

On 14 and 15 April 2003, the Commission discussed with the Member States a draft proposal for the
non-inclusion of fenthion in Annex I to Directive 91/414/EEC. A further discussion is planned in the
Committee at its next meeting in June 2003.

The Commission maintains the opinion that legislation on plant protection products takes into account the
precautionary principle as a product can only be authorized provided it is demonstrated, in the light of
current scientific and technical knowledge, that it does not have any harmful effects on human or animal
health or any unacceptable influence on the environment.

(1) OJ L 366, 15.12.1992.