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, in the Order of 14 April 1999, Annex I to that Royal Decree No 2163/1994, under the name 'Community list of active substances', as defined in Article 2 (16) of that Regulation, is hereby established as the list of the active substances of plant protection products accepted by the European Commission and whose incorporation will be made public by national provisions, as a result of other Community provisions.

In Annex I to Directive 91 /414/EC, the active substance flumioxazine is included in Commission Directive 2002/81/EC of 10 October and, by Commission Directive 2003 /5/EC of 10 January, the active substance flumioxazine is included. active substance deltamethrin.

The above provisions lay down the conditions for the placing on the market of plant protection products containing those active substances which have no harmful effects on human health or animal health or on the groundwater, and have no unacceptable impact on the environment.

This Order incorporates Directives 2002/81/EC and 2003 /5/EC into national law by the inclusion of the active substances flumioxazine and deltamethrin in Annex I to Royal Decree 2163/1994, and is given by agreement with the faculty established in the final disposition of the Royal Decree.

The Inter-Ministerial Commission for Food Management has issued a mandatory report on this provision. In addition, the Autonomous Communities and the sectors concerned have been consulted.

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

Single item. Inclusion of active substances in Annex I to Royal Decree 2163/1994.

1. The active substances called flumioxazine and deltamethrin are 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 products plant protection, with the characteristics and conditions which are specified for each of them in the Annex to this Order.

2. In order to verify compliance with the conditions of inclusion set out in the Annex to this Order, provisional authorisations and authorisations for plant protection products containing the active substances concerned, granted with Before the start of their period of inclusion, they shall be reviewed, adopted and implemented by the relevant resolutions before the expiry of the respective time limit set out in that Annex.

3. The verification of compliance with the requirements of Annex III to Royal Decree 2163/1994 and the assessment in accordance with the uniform principles contained in Annex VI thereto shall be carried out, adopting and implementing the relevant resolutions before the time limit for the application of the said uniform principles expires, for each of the active substances referred to in the Annex to this Order, taking into account the conclusions of the final version of the corresponding review report of the European Commission, approved by the Standing Committee of the Food Chain and Animal Health.

4. The Official Journal of the Agriculture, Fisheries and Food Directorate-General of Agriculture of the Ministry of Agriculture, Fisheries and Food shall be made available to the interested parties for the review reports of the European Commission refers to the previous paragraph, as well as those of the Evaluation Committee provided for in Article 3 of Royal Decree 2163/1994.

All with the exception of confidential information as defined in Article 32 of that 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.

However, for the active substance deltamethrin, the entry into force will take place on 1 November 2003.

Madrid, 30 May 2003.

RAJOY BREY

Excmo. Mr Minister for Agriculture, Fisheries and Food and Excuse. Sras. Ministers for Health and Consumer Affairs and the Environment.

ANNEX (*)

39. Conditions for the inclusion of the active substance flumioxazine.

Features:

Common name: Flumioxazine.

CAS No. 103361-09-7.

NO CIPAC: 578.

Chemical name (IUPAC): N-(7-fluoro-3, 4-dihydro-3-oxo-4-prop-2-inyl-2H-1, 4-benzoxazin-6-yl) cyclohex-1-ene-1,2-dicarboximide.

Minimum purity of the substance: 960 g/kg of technical product.

Conditions of inclusion:

Uses: Can only be used as a herbicide.

In the overall assessment, according to the uniform principles, on the basis of the review report of the European Commission, approved by the Standing Committee on the Food Chain and Animal Health at its meeting of 28 June 2002, must pay particular attention to:

The risk to aquatic plants and algae and to include, as a condition in the corresponding authorisations, where appropriate, risk mitigation measures.

Deadline for inclusion: 1 January 2003 to 31 December 2012.

Deadline for implementation of the conditions of inclusion: 30 June 2003.

Deadlines for the implementation of the uniform principles:

On 30 June 2004, for formulations containing flumioxazine as the only active substance, or as one of several active substances included in their entirety in Annex I to Royal Decree 2163/1994 for 1 January 2004 2003.

Data protection: as flumioxazine is a new active substance, the corresponding data protection regime provided for in Article 30 of Royal Decree 2163/1994 shall apply.

40. Conditions for the inclusion of the active substance deltamethrin.

Features:

Common Name: Deltamethrin.

CAS No. 52918-63-5.

NO CIPAC: 333.

Chemical name (IUPAC): (1R, 3R) -3-(2, 2-dibrovinyl)-2,2-dimethylcyclopropane-carboxylate of (S)--cyano-3-phenoxybenzyl.

Minimum purity of the substance: 980 g/kg of technical product.

Conditions of inclusion:

Uses: It can only be used as an insecticide.

In the overall assessment, according to the uniform principles, on the basis of the Commission review report

(*) The numbering of the headings corresponds to the codification carried out by Directive 2000 /80/EC.

European, approved by the Standing Committee on the Food Chain and Animal Health at its meeting of 18 October 2002, will be particularly addressed to:

(a) The safety of operators, and include appropriate protective measures as a condition in the relevant authorisations.

b) The situation of the acute food exposure of consumers with a view to revising the maximum residue limits in the future.

c) The protection of beneficial aquatic organisms, bees and arthropods, and include as a condition in the relevant authorisations, where appropriate, risk mitigation measures.

Deadline for inclusion: 1 November 2003 to 31 October 2013.

Deadline for implementation of the conditions of inclusion: 30 April 2004.

Deadlines for the implementation of the uniform principles:

On 31 October 2007, for formulations containing deltamethrin as the only active substance, or as one of several active substances included in Annex I to Royal Decree 2163/1994 for 31 October 2003.

Data protection: For the deltamethrin an old active substance shall apply the corresponding data protection regime provided for in Article 30 of Royal Decree 2163/1994.