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Order Pre/3338/2007, Of 15 November, Amending Annex I To Royal Decree 2163 / 1994 Of 4 November, Whereby The Community Harmonised Authorisation System Is Implanted To Market And Use Of Plant Protection Products...

Original Language Title: ORDEN PRE/3338/2007, de 15 de noviembre, por la que se modifica el anexo I del Real Decreto 2163/1994, de 4 de noviembre, por el que se implanta el sistema armonizado comunitario de autorización para comercializar y utilizar productos fitosanitarios ...

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TEXT

Council Directive 91 /414/EEC of 15 July 1991 concerning the placing of plant protection products on the market includes in Annex I the active substances which have been authorised for incorporation in products plant protection. 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 plant protection products. Furthermore, in the Order of 14 April 1999, Annex I to that Royal Decree, under the name 'Community list of active substances', as defined in Article 2.16 of that Regulation, is hereby established as the list of 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. Commission Directive 2007 /31/EC of 31 May 2007 amending Council Directive 91 /414/EEC as regards the extension of the use of the active substance fosthiazate as insecticide. This active substance has already been included in the Community List as a nematicide by Commission Directive 2003 /84/EC of 25 September, which is transposed into national law by Order PRE/1393/2004 of 20 May, for which it is include the active substances trifloxystrobin, carfentrazone-ethyl, mesotrione, fenamidone, isoxaflutol, mecoprop, mecoprop-p, propiconazole, coniothyrium minitans, molinate, thiram, ziram, flurtamone, flufenacet, iodosulfuron, dimethenamide-p, picoxystrobin, fosthiazate, silthiofan, paraquat, mesosulfuron, propoxycarbazone and zoxamide in Annex I to Royal Decree 2163/1994 of 4 November 1994 imposing a harmonised Community system of authorisation for the placing on the market and use of plant protection products. The above provisions lay down the conditions for the placing on the market as an insecticide of plant protection products containing the active substance concerned with no harmful effects on human health or animal health or on water underground, nor have any unacceptable effects on the environment with use as an insecticide. This order incorporates into national law the Commission Directive 2007/31 of 31 May 2007 by amending the inclusion of the active substance fostiazate in Annex I to Royal Decree No 2163/1994 and is hereby given as agreement with the faculty established in the final disposition of the aforementioned royal decree. The Inter-Ministerial Commission for Food Management has issued a mandatory report on this provision. The autonomous communities and the sectors concerned have also been consulted in their treatment. In its virtue, on a proposal from the Minister for Agriculture, Fisheries and Food, the Minister for Health and Consumer Affairs and the Minister for the Environment, I have:

Single item. Amendment of Royal Decree No 2163/1994 of 4 November 1994 imposing a harmonised Community system of authorisation for the placing on the market and use of plant protection products.

The paragraph concerning the technical specification of the active substance fosthiazate contained in Annex I to Royal Decree No 2163/1994 of 4 November laying down the harmonised Community system of authorisation for on the placing on the market and use of plant protection products, it is amended in the terms set out in the Annex to this order.

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, 15 November 2007. -First Vice-President of the Government and Minister of the Presidency, Maria Teresa Fernández de la Vega Sanz.

" ANNEX

Conditions for inclusion of the active substance fosthiazate

Features: Common name: Fostiazate. CAS No: 98886-44-3. No. CIPAC: 585. Chemical name (IUPAC): O-ethyl 2-oxo-1,3-thiazolidin-3-ylphosphonothioate of (RS)-S-sec-butyl. Minimum purity of the substance: 930 g/kg of technical product. Conditions of inclusion: Uses: It can only be used as an insecticide or nematicide. In the overall assessment, according to the uniform principles, on the basis of the evaluation report of the European Commission, approved by the Standing Committee on the Food Chain and Animal Health at its meeting of 4 July 2003, it should be addressed in particular to: The protection of groundwater in vulnerable situations, and to include as a condition in the relevant authorisations, the protection of birds and wild mammals, particularly if the active substance is applied during the period of reproduction, the protection of the soil organisms which are not the object of the treatment, and include, as a condition in the relevant authorisations, where appropriate, risk mitigation measures. Deadline for inclusion: From 1 January 2004 to 31 December 2013. Deadline for the application of the conditions of inclusion: 1 July 2004. Deadline for the implementation of the uniform principles: 30 June 2005 for products containing fosthiazate as the only active substance, or as one of several active substances included in their entirety in Annex I to the Royal Decree 2163/1994 for that date. Data protection: For the phosthiazate to be a new active substance, the corresponding data protection regime provided for in Article 30 of Royal Decree 2163/1994 shall apply. '