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 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 2000 /50/EC of 26 July an active substance (prohexadione calcium) is included in Annex I to Directive 91 /414/EEC, establishing the conditions for the placing on the market of products it does not have any 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 /50/EC into national law by the inclusion of the active substance prohexadione calcica in Annex I to Royal Decree 2163/1994.

This Order, which is issued in accordance with the final provision of Royal Decree 2163/1994, has been favourably informed by the Inter-Ministerial Commission for Food Management and has been consulted in its proceedings. the Autonomous Communities and the sectors concerned.

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

Single item.

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

2. The granting of 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, taking into account also the conclusions of the final version of the review report on the European Commission's calcium prohexadione, approved by the Standing Committee on Plant Health on 16 June 2000, in particular Appendices I and II thereof.

3. In the Official Register of Plant Protection Products of the Directorate-General for Agriculture of the Ministry of Agriculture, Fisheries and Food, the Review Report 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 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, 5 April 2001.

LUCAS GIMENEZ

Excms. Mr Messrs: Minister for Agriculture, Fisheries and Food, Minister for Health and Consumer Affairs and Minister for the Environment.

ANNEX

Conditions for the inclusion of the active substance prohexadione calcium

Features:

Common name: Prohexadione calcium.

Chemical name (IUPAC): (3, 5-dioxo-4-propionylcyclohexanecarboxylate calcium).

Minimum purity of the substance: 890 g/kg of technical product.

Conditions of inclusion:

Uses: You can only be used as a regulator.

Deadline for inclusion: From 1 October 2000 to 1 October 2010.

Deadlines for the implementation of the uniform principles:

As from 1 January 2001, any authorisation of plant protection products containing the composition of the substance calcium prohexadione 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 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 calcium prohexadione a new substance will apply the corresponding data protection regime provided for in Article 30 of Royal Decree 2163/1994.