Council Directive 91 /414/EEC of 15 July concerning the placing of plant protection products on the market includes an Annex I, 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.

On the other hand, 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, laying down Annex I to that Royal Decree No 2163/1994, in accordance with Article 2 (16) of the same Royal Decree, which defines the Community list of active substances of plant protection products accepted by the European Commission and whose incorporation will be made public by national provisions.

A active substance (imazalil) is also included in Annex I to Directive 91 /414/EEC by Commission Directive 97 /73/EC of 15 December 2009.

This Order incorporates Directive 97 /73/EC and is issued in accordance with the provisions of 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 and of Health and Consumer, I have:

Single item.

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

2. The inclusion of imazalil, as referred to in paragraph 1, shall entail the revision of the authorisations granted in accordance with the national rules in force prior to the entry into force of Royal Decree 2163/1994, as a result of the the active substance at that time already placed on the market whose authorisations must be modified or withdrawn, where necessary, in order to apply the provisions of that Royal Decree to plant protection products containing this active substance.

3. This 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, taking into account the conclusions of the final version of the Review report on the imazalil of the European Commission, in particular Appendices I and II. However, compliance with the documentation requirements for the preparations and the decisions in accordance with the uniform principles for the assessment and authorisation of the preparations shall be required within the time limits specified in this Regulation. the Annex to this Order.

4. In the Official Register of Plant Protection Products of the Agriculture, Fisheries and Food Directorate-General of the Ministry of Agriculture, the European Commission's Assessment Report, referred to in the Article 3 of Royal Decree No 2163/1994, as well as that of the Evaluation Committee provided for in Article 3 of Royal Decree No 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 and for Health and Consumer Affairs.

ANNEX

Conditions for the inclusion of the active substance imazalil

Features: (View image page 9040) Common name: Imazalil.

Chemical name (IUPAC): (>) -1-(4-dichlorophenylethyl) imidazole.

Common chemical name: Ether (>)-allyl-1-(2, 4-dichlorophenyl) -2-imidazol-1-yl ethyl.

Minimum purity of the substance: 975 g/kg, determined by the most recent FAO specification prior to the date of inclusion, adopted in 1995.

Conditions of inclusion:

Uses: It can only be used as a fungicide. Uses in post-harvest (fruits, potatoes and vegetables) are conditioned to:

(a) that the user has an adequate system of decontamination of the treatment solution, unless it has been officially accepted in the assessment of a preparation that its evacuation does not involve risks to the environment; in particular for aquatic organisms.

b) That the disposal of land and other waste from the treatment of potatoes does not involve risks to aquatic organisms.

Until the assessment of the preparations of imazalil is produced, in accordance with the uniform principles established by the Order of 29 November 1995, all uses on outdoor crops are excluded.

Deadline for inclusion: From 1 January 1999 to 31 December 2008.

Deadlines for the implementation of the uniform principles:

The deadline set for the completion of the review of existing authorizations will end:

a) December 31, 2002 for simple formulations.

(b) In the case of mixtures with other active substances, not yet included in Annex I to Royal Decree 2163/1994, four years after the inclusion of the last of those substances in that Annex I.

Data Protection: For being the imazalil an existing active substance will apply the corresponding data protection regime provided for in Article 30 of Royal Decree 2163/1994.