Council Directive 91 /414/EEC of 15 July concerning the placing of plant protection products on the market includes an Annex entitled 'Active substances for which the incorporation into plant protection products is authorised'.

This Directive is incorporated into the Spanish legal order under Royal Decree No 2163/1994 of 4 November 1994 imposing a harmonised Community system of authorisation to market and use products plant protection. Furthermore, Commission Directive 98 /47/EC of 25 June, which includes an active substance (azoxystrobin) in Annex I to Directive 91 /414/EEC, is incorporated in our order by the Order of 14 April 1999, for which the Commission has been required to provide the Annex I to that Royal Decree No 2163/1994 is hereby established, in accordance with Article 2 (16) of that Royal Decree, which defines the Community list of active substances of plant protection products, accepted by the European Commission and whose incorporation shall be made public by national provisions.

The active substance (spiroxamine) in Annex I to Directive 91 /414/EEC is also provided by Commission Directive 1999 /73/EC of 19 July 1999.

With this provision, it is intended that the placing on the market of plant protection products does not have harmful effects on human health or animal health or on groundwater, nor does it have an unacceptable impact on the environment. environment.

This Order incorporates Directive 1999 /73/EC and is issued in accordance with the final provision of Royal Decree 2163/1994.

This Order has been favorably informed by the Inter-Ministerial Committee for Food and Food Management, and the sectors affected have been consulted.

In its virtue, on the proposal of the Ministers of Agriculture, Fisheries and Food, of Health and Consumer Affairs and Environment, I have:

Single item.

1. The active substance called spiroxamine is included in Annex I to Royal Decree 2163/1994 of 4 November 1994 imposing the Community harmonised system of authorisation to place plant protection products on the market and use with them. characteristics and conditions specified in the Annex to this Order.

2. The inclusion of spiroxamine, as referred to in paragraph 1, shall entail the revision of the provisional authorisations granted in accordance with Article 23 of Royal Decree No 2163/1994, in order to apply the provisions of the (a) to those plant protection products containing this substance.

3. That review, as well as the granting of new authorisations, shall be carried out in accordance with the uniform principles for the assessment and authorisation of plant protection products within the time limits specified in the Annex to this Order, in addition to the conclusions of the final version of the review report on spiroxamine of the European Commission, approved by the Standing Committee on Plant Health on 12 May 1999, in particular Appendices I and II thereof.

4. In the Official Register of Plant Protection Products of the Directorate-General for Agriculture of the Ministry of Agriculture, Fisheries and Food, the Evaluation Report and the Review Report of the Commission to which it is submitted will be made available to interested parties. refers to the previous paragraph, as well as that of the Evaluation Committee provided for in Article 3 of Royal Decree 2163/1994. All this with the exception of confidential information as defined in Article 32 of the Royal Decree.

Single end disposition. Entry into force.

This provision shall enter into force on the day following that of its publication in the Official Gazette of the State.

Madrid, 1 March 2000.

ALVEZ-HELMETS FERNANDEZ

Excms. Mr Ministers for Agriculture, Fisheries and Food, Health and Consumer Affairs and the Environment.

ANNEX

Conditions for the inclusion of the active substance spiroxamine

Features:

Common name: Espiroxamine.

Chemical name (IUPAC): (8-tert-butyl-1, 4-dioxaspiro [4, 5] decan-2-ylmethyl)-ethylpropyl-amine.

Minimum purity of the substance: 940 g/kg of technical product (sum of diastolic A and B).

Conditions of inclusion:

Uses: It can only be used as a fungicide. In any case, the uses shall be conditioned by the measures to be included in the authorisations in order to ensure the safety of the operator and to prevent its impact on aquatic organisms.

Deadline for inclusion: From 1 September 1999 to 1 September 2009.

Deadlines for the implementation of the uniform principles:

With effect from 1 January 2000, any authorisation of plant protection products containing only the substance spiroxamine shall be carried out in accordance with the uniform principles for the assessment and authorisation of products. plant protection. In the case of plant protection products containing spiroxamine together with another active substance, the time limit shall be that laid down in the conditions for the inclusion of this other substance, in case the latter is longer.

Data Protection: For being the spiroxamine a new substance will apply the corresponding data protection regime provided for in Article 30 of Royal Decree 2163/1994.