Order Pre / 2843/2009 Of 19 October, Amending Annex I Of Royal Decree 2163/1994, Of November 4, By The Community Harmonized Authorization System Is Implemented For Marketing And Use Of Plant Protection Products, R ...

Original Language Title: Orden PRE/2843/2009, de 19 de octubre, 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, r...

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Directive 91/414 / EEC of 15 July 1991 concerning the placing of plant protection products included in Annex I active substances that have been authorized for incorporation in plant protection products. The Directive is incorporated into Spanish law by Royal Decree 2163/1994, of November 4, by the Community harmonized authorization system is implemented for marketing and use of plant protection products. Moreover, in the Order of April 14, 1999, Annex I to that royal decree is established, under the name 'Community list of active substances', defined in Article 2.16 of this royal decree, as the list of the active substances of plant protection products accepted by the European Commission and the incorporation of which will be made public through national provisions issued under the relevant Community rules.

Directive 91/414 / EEC of 15 July 1991, has been modified by successive directives to include in its Annex I certain active substances. So by Directive 2004/30 / EC of 10 March, the active substance pyraclostrobin was included, with the specific provision that can only be authorized its use as a fungicide, transposed into national law by Order PRE / 3929 / 2004 of November 30. Subsequently, the main notifier of this substance applied for an amendment to those specific provisions to authorize the use of pyraclostrobin as plant growth regulator.

By Directive 2008/40 / EC of 28 March, the active substance nicosulfuron is included in Annex I to Directive 91/414 / EEC, setting a minimum level in terms of purity of the substance active, transposed into national law by Order PRE / 2957/2008 of 10 October. However, the usual practice is to base the level of minimum purity on specifications developed by the United Nations Organization for Food and Agriculture (FAO).

This Order incorporates into national law Directive 2009/25 / EC of 2 April 2009 amending Directive 91/414 / EEC is amended regarding the extension of use the active substance pyraclostrobin and Directive 2009/51 / EC of 25 May 2009 amending Directive 91/414 / EEC as regards the specification of the active substance nicosulfuron, and dictates according to the first final provision of Royal Decree 2163/1994, of November 4.

The Interministerial Commission for Food Regulation issued a mandatory report on this provision. Also, in processing they have been consulted the autonomous communities and the sectors concerned.

By virtue of a proposal from the Minister for Environment and Rural and Marine Affairs and the Minister of Health and Social Policy, I have:

Sole Article. Amendment of Annex I of Royal Decree 2163/1994, of November 4, by the Community harmonized authorization system is implemented for marketing and use of plant protection products.

Annex I of Royal Decree 2163/1994, of November 4, by the Community harmonized authorization system is implemented to market and use of plant protection products is amended as follows:

One. use as plant growth regulator of the active substance pyraclostrobin is extended, as set out in Part A of the Annex.

Two. the conditions for inclusion of the active substance nicosulfuron are modified, with respect to the minimum purity of the active substance as set out in Part B of the Annex.

Sole additional provision. Review of authorizations.

1. To verify that the conditions for inclusion and renewal set out in the Annex to this order are met, the provisional authorizations for plant protection products containing the active substance concerned, granted prior to the start of its term of inclusion or renewal, be revised by adopting and implementing the relevant resolutions before the expiry of the respective term.


2. The verification of compliance with documentation requirements specified in Article 29.1) of Royal Decree 2163/1994, of November 4, contained in Annex III of the Order of 4 August 1993, laying down the requirements for applications for authorization of plant protection products and evaluation according to the uniform principles contained in the annex to the Order of 29 November 1995 establishing uniform principles for evaluation and authorization of plant protection products should be made adopting and implementing the relevant resolutions before the expiry of the respective deadline for implementation of the uniform principles, taking into account the conditions of the final version of the relevant assessment report of the European Commission, approved by the Standing Committee on the Food Chain and Animal Health.

3. In the official register of products and plant material from the Directorate General of Agricultural and Livestock Resources, Ministry of Environment and Rural and Marine Affairs, will be available to interested parties the review report of the European Commission, referred the preceding paragraph, as well as of the evaluation Commission of Plant Protection Products set out in Article 3 of Royal Decree 2163/1994, of November 4. All with the exception of confidential information as defined in Article 32 of the Royal Decree.

First final provision. Incorporation of Community law.

By this order are incorporated into Spanish law Directive 2009/25 / EC of 2 April 2009 amending Directive 91/414 / EEC is amended regarding the extension of use of the active substance pyraclostrobin and Directive 2009/51 / EC of 25 May 2009 amending Directive 91/414 / EEC is amended as regards the specification of the active substance nicosulfuron.

Second final provision. Entry into force.

This provision shall enter into force on the day following its publication in the "Official Gazette", without prejudice to the only additional provision day.

Madrid, 19 October 2009.- The First Deputy Prime Minister and Minister of the Presidency, Maria Teresa Fernandez de la Vega Sanz.
ANNEX


Amendment of Annex I "Community list of active substances' Royal Decree 2163/1994, of November 4, by the Community harmonized authorization system is implemented for marketing and use of plant protection products

Part A. Conditions of the inclusion of the active substance pyraclostrobin.

Point "uses" paragraph "conditions of the inclusion of the active substance pyraclostrobin 'in Annex I of Royal Decree 2163/1994, of November 4, reads as follows:

"Uses: it can only be used as fungicide or plant growth regulator.

For the implementation of the uniform principles, based on the conclusions of the review report of the European Commission, approved by the Standing Committee on the Food Chain and Animal Health at its meeting of November 28, 2003, it should address especially:

- Protection of aquatic organisms, especially fish.

- Protection of terrestrial arthropods and earthworms, and include as a condition in the corresponding authorizations, where appropriate, risk mitigation measures.

Also should be informed about the specifications of the technical material commercially manufactured. "

Part B. Conditions of the inclusion of the active substance nicosulfuron.

At point "characteristics" paragraph "conditions of the inclusion of the active substance nicosulfuron 'in Annex I of Royal Decree 2163/1994, of November 4, the line concerning the minimum purity of the substance is read as follows:

"Minimum purity of the substance: 910 g / kg."

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