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.

By Commission Directive 2001 /87/EC of 12 October the active substances acibenzolar-S-methyl, cyclanilide, ferric phosphate, pymetrozine and pyraflufeno-ethyl, are included in Annex I to Directive 91 /414/EEC, laying 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 groundwater, or have an impact unacceptable for the environment.

This Order incorporates Directive 2001 /87/EC into national law by the inclusion of the active substances acibenzolar-S-methyl, cyclanilide, ferric phosphate, pymetrozine and pyraflufeno-ethyl, in Annex I of Royal Decree 2163/1994, and is dictated according to 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. The sectors concerned have also been consulted in their handling.

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

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

1. The active substances called acibenzolar-S-methyl, cyclanilide, ferric phosphate, pymetrozine and pyraflufeno-ethyl are included in Annex I to Royal Decree 2163/1994 of 4 November establishing the harmonised Community system of authorisation to place on the market and use plant protection products, with the characteristics and conditions which are specified for each of them in the Annex to this Order.

2. The inclusion of the active substances referred to in paragraph 1 shall entail the review of provisional authorisations for plant protection products containing them, granted in accordance with the provisions of Article 23 of the Royal Treaty. Decree 2163/1994, and, where appropriate, shall be replaced by full authorisations.

3. Those reviews, 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 European Commission review reports, approved in the Standing Committee on Plant Health on the dates which, for each of the active substances concerned, are set out in the Annex to this Order, 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. that Annex.

4. In the Official Register of Plant Protection Products of the Directorate-General for Agriculture of the Ministry of Agriculture, Fisheries and Food, the review reports of the European Commission referred to in this Article shall be made available to interested parties. Article 3 of Royal Decree No 2163/1994, as well as those 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, 5 June 2002

LUCAS GIMENEZ

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

ANNEX (*)

20. Conditions for the inclusion of the active substance acibenzolar-S-methyl:

Features:

Common Name: Acibenzolar-S-methyl.

CAS No. 135158-54-2.

NO CIPAC: 597.

Chemical name (IUPAC): Benzo (1,2,3 (thiadiazole-7-carbothioate of S-methyl.

Minimum purity of the substance: 970 g/kg of technical product.

Conditions of inclusion:

Uses: It can only be used as an activator of the vegetable resistance.

In the overall assessment, according to the uniform principles, the review report of the European Commission approved by the Standing Committee on Plant Health at its meeting of 29 June 2001 will be discussed.

Deadlines for inclusion: From 1 November 2001 to 31 October 2011.

Deadlines for the implementation of the uniform principles:

a) On March 31, 2003, for simple formulations.

(b) In the case of mixtures with other active substances, not yet included in Annex I to Royal Decree No 2163/1994, the period referred to in paragraph (a) shall be extended to the extent that a longer period of application is envisaged. the provisions laying down the conditions for the inclusion of these other active substances.

Data protection: For being the acibenzolar-S-methyl a new active substance shall apply the corresponding data protection regime provided for in Article 30 of Royal Decree 2163/1994.

21. Conditions for the inclusion of the active substance cyclanilide:

Features:

Common name: Cyclanilide.

CAS No: 113136-77-9.

NO CIPAC: 586.

Chemical name (IUPAC): Not available.

----------------------

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

Chemical name (C.A.): 1-[(2,4-dichlorophenyl) amino] [carbonyl] cyclopropanecarboxylic acid.

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

Conditions of inclusion:

Uses: It can only be used as a plant growth regulator.

In the overall assessment in accordance with the uniform principles, on the basis of the review report of the European Commission approved by the Standing Committee on Plant Health at its meeting of 29 June 2001, particular attention should be given to:

The maximum content of impurity 2, 4-diclo-roaniline (2,4-DCA) in the active substance as manufactured shall be 1 g/kg.

Deadlines for inclusion: From 1 November 2001 to 31 October 2011.

Deadlines for the implementation of the uniform principles:

a) On March 31, 2003, for simple formulations.

(b) In the case of mixtures with other active substances, not yet included in Annex I to Royal Decree No 2163/1994, the period referred to in paragraph (a) shall be extended to the extent that a longer period of application is envisaged. the provisions laying down the conditions for the inclusion of these other active substances.

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

22. Conditions for the inclusion of the active substance ferric phosphate.

Features:

Common Name: Ferric Phosphate.

CAS No. 10045-86-0.

NO CIPAC: 629.

Chemical Name (IUPAC): Ferric Phosphate.

Minimum purity of the substance: 990 g/kg of technical product.

Conditions of inclusion:

Uses: It can only be used as a molluscicide.

In the overall assessment, according to the uniform principles, the review report of the European Commission approved by the Standing Committee on Plant Health at its meeting of 29 June 2001 will be discussed.

Deadlines for inclusion: From 1 November 2001 to 31 October 2011.

Deadlines for the implementation of the uniform principles:

a) On March 31, 2003, for simple formulations.

(b) In the case of mixtures with other active substances, not yet included in Annex I to Royal Decree No 2163/1994, the period referred to in paragraph (a) shall be extended to the extent that a longer period of application is envisaged. the provisions laying down the conditions for the inclusion of these other active substances.

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

23. Conditions for the inclusion of the active substance pymetrozine.

Features:

Common name: Pimetrozina.

CAS No. 123312-89-0.

NO CIPAC: 593.

Chemical name (IUPAC):

(E) -6-methyl-4 [(pyridin-30yl-methylene) amino] -4,5-dihydro-2H [1,2, 4] triazin-3-one.

Minimum purity of the substance: 950 g/kg of technical product.

Conditions of inclusion:

Uses: It can only be used as an insecticide.

In the overall assessment in accordance with the uniform principles, on the basis of the review report of the European Commission approved by the Standing Committee on Plant Health at its meeting of 29 October 2001, particular attention should be given to:

The protection of aquatic organisms.

Deadlines for inclusion: From 1 November 2001 to 31 October 2011.

Deadlines for the implementation of the uniform principles:

a) On March 31, 2003, for simple formulations.

(b) In the case of mixtures with other active substances, not yet included in Annex I to Royal Decree No 2163/1994, the period referred to in paragraph (a) shall be extended to the extent that a longer period of application is envisaged. the provisions laying down the conditions for the inclusion of these other active substances.

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

24. Conditions for the inclusion of the active substance pyraflufene-ethyl.

Features:

Common Name: Piraflufeno-ethyl N. CAS: 129630-19-9 N. CIPAC: 605 Chemical name (IUPAC):

2-chloro-5 (4-chloro-5-difluoromethoxy-1 methylpyrazol-3-yl) -4-fluorophluoxyacetate ethyl.

Minimum purity of the substance: 956 g/kg of technical product.

Conditions of inclusion:

Uses: Can only be used as a herbicide.

In the overall assessment in accordance with the uniform principles, on the basis of the review report of the European Commission approved by the Standing Committee on Plant Health at its meeting of 29 October 2001, particular attention should be given to:

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

Deadlines for inclusion: From 1 November 2001 to 31 October 2011.

Deadlines for the implementation of the uniform principles:

a) On March 31, 2003, for simple formulations.

(b) In the case of mixtures with other active substances, not yet included in Annex I to Royal Decree No 2163/1994, the period referred to in paragraph (a) shall be extended to the extent that a longer period of application is envisaged. the provisions laying down the conditions for the inclusion of these other active substances.

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