WRITTEN QUESTION E-1307/03 by Bill Newton Dunn (ELDR) to the Commission. Armillatox.
Date: 2003-04-07
Institutions: European Parliament, Provisional data
Subjects: market approval, organic acid, plant health legislation, plant health product

C 268 E/184

Official Journal of the European Union

EN

7.11.2003

This practice creates two major problems:

(cid:1) the consumer is given misleading information in car registration ranking lists. Car manufacturers or
dealers can artificially inflate the registration figures so that their cars appear at the top of the lists.

(cid:1) statistics (on replacement or greening of the vehicle fleet) are systematically distorted.

In my view, this practice clearly goes beyond national interests and requires a European response.

Can the Commission therefore say:

(cid:1) whether it is aware of practices of this kind?

(cid:1) whether it intends to introduce measures to prevent or eliminate these practices?

Answer given by Mr Bolkestein on behalf of the Commission

(2 June 2003)

The Commission has no knowledge of the practices described by the Honourable Member.

It is not possible to conclude from the information provided by the Honourable Member that these
practices are contrary to the Community law currently in force. In specific cases, it is up to the national
authorities to initiate proceedings regarding the infringement of directive 84/450/EEC (1) if the consumer is
misled. In order to determine whether there is an infringement, the Court issued the necessary guidelines
in its judgment in Case C-373/90; Criminal proceedings against X (1992). At this stage, the Commission
does not intend to introduce measures to prevent or eliminate these practices.

The Commission will, nevertheless, carefully monitor developments in this field.

(1) Council Directive 84/450/EEC of 10 September 1984 relating to the approximation of the laws, regulations and

administrative provisions of the Member States concerning misleading advertising, OJ L 250, 19.9.1984.

(2003/C 268 E/208)

WRITTEN QUESTION E-1307/03

by Bill Newton Dunn (ELDR) to the Commission

(7 April 2003)

Subject: Armillatox

Armillatox, a widely used treatment of honey fungus, is under a threat to be banned under forthcoming
EU legislation. However Armillatox is produced by low-temperature distillation and is considered by some
to leave little if any toxic residue.

Can the Commission confirm whether Armillatox is to be banned, or whether an exemption is being
considered, or has already been made, for this treatment?

Answer given by Mr Byrne on behalf of the Commission

(16 May 2003)

Armillatox is a product containing a complex mixture of tar acids in castor oil. These tar acids are
considered as an active substance to be regulated under Council Directive 91/414/EEC of 15 July 1991
concerning the placing of plant protection products on the market (1). Their uses in plant protection were
notifiable under the procedure established in Commission Regulation (EC) No 451/2000 (2). Since they
were not notified and were not accepted as an essential use, according to Commission Regulation (EC) No
2076/2002 (3), Member States are obliged to withdraw authorisations of plant protection products
containing them by 25 July 2003 and to limit the duration of any possible sell-out period to a maximum
of six months thereafter. Other uses of tar acids are not affected by the above Regulations.

7.11.2003

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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,