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 (fluroxypyr) is also included in Annex I to Directive 91 /414/EEC by Commission Directive 2000 /10/EC of 1 March 2000.

This provision is intended to ensure 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.

This Order incorporates Directive 2000 /10/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.

Under the proposal of the Minister for Health and Consumer Affairs and the Ministers for Agriculture, Fisheries and Food and the Environment, I have:

Single item.

1. The active substance known as fluroxypyr 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 fluroxypyr, as referred to in paragraph 1, shall entail the review of authorisations granted for plant protection products in accordance with the national rules in force prior to the entry into force of the Royal Decree. 2163/1994, as it is an active substance which has already been marketed, the authorisations of which must be amended or withdrawn, where necessary, in order to apply the provisions of that Royal Decree to plant protection products which contain this active substance.

3. This review and 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 Report on the evaluation of the European Commission's fluroxypyr approved by the Standing Committee on Plant Health on 30 November 1999, in particular Appendices I and II thereof. 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 Evaluation Report of the European Commission, referred to in Article 3, shall be made available to interested parties. 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, 19 December 2000.

RAJOY BREY

Excma. Ms Minister for Health and Consumer Affairs.

Messrs. Ministers for Agriculture, Fisheries and Food and the Environment.

ANNEX

Conditions for the inclusion of the active substance fluroxypyr

Features:

Common Name: Fluroxipir.

Chemical name (IUPAC): 4-amino-3, 5-dichloro-6-fluoro-2-pyridyloxyacetic acid.

Minimum Purity of the Technical Active Substance (as manufactured): 950 g/Kg.

Conditions of inclusion:

Uses: Can only be used as a herbicide. The overall assessment according to the uniform principles shall be:

(a) Take into account the additional information required in point 7 of the European Commission's assessment report.

b) Special attention to the protection of groundwater.

(c) Special attention to the impact on aquatic organisms and the determination of the measures to be established as conditions of the authorisation to mitigate the risks, where appropriate.

Deadline for inclusion: From 1 December 2000 to 30 November 2010.

Deadlines for the implementation of the uniform principles:

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

a) On November 30, 2004 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 fluroxypyr an existing active substance will apply the corresponding data protection regime provided for in Article 30 of Royal Decree 2163/1994.