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.

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 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, the Directive clearly states that active substances can only be accepted if it 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 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 for 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.