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 is laid down, under the name 'Community list of active substances', as defined in Article 2.16 of that royal decree, as the list of substances active plant protection products accepted by the European Commission and whose incorporation will be made public by national provisions, issued under the relevant Community rules.

Council Directive 91 /414/EEC of 15 July 1991 has been amended by successive Directives in order to include certain active substances in Annex I thereto. Thus, by Commission Directive 2004 /30/EC of 10 March, the active substance pyraclostrobin was included, with the specific provision that only its use as a fungicide, transposed into national law by Order, can be authorised. PRE/3929/2004 of 30 November. Subsequently, the main notifier of this substance requested a modification of this specific provision to authorize the use of piraclostrobin as a plant growth regulator.

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

This order incorporates into national law the Commission Directive 2009 /25/EC of 2 April 2009 amending Council Directive 91 /414/EEC as regards the extension of the use of the substance active piraclostrobin and Commission Directive 2009 /51/EC of 25 May 2009 amending Directive 91 /414/EEC as regards the specification of the active substance nicosulfuron, and is given in accordance with the final provision Royal Decree No 2163/1994 of 4 November 1994.

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 for the Environment, and the Rural and Marine Environment and the Minister of Health and Social Policy, I have:

Single item. Amendment of Annex I to Royal Decree 2163/1994 of 4 November imposing the harmonised Community system of authorisation to place plant protection products on the market and use.

Annex I to Royal Decree 2163/1994 of 4 November 1994 laying down the harmonised Community system of authorisation for the placing on the market and use of plant protection products is amended as follows:

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

Two. The conditions for the inclusion of the active substance nicosulfuron are amended as regards the minimum purity of the active substance as set out in Part B of the Annex.

Single additional disposition. Review of the authorizations.

1. In order to verify that the conditions for inclusion and renewals laid down in the Annex to this order are met, provisional authorisations for plant protection products containing the active substance concerned, granted with Prior to the start of their term of inclusion or renewal, they shall be reviewed by adopting and applying the relevant resolutions before the expiry of the respective period.

2. The verification of compliance with the documentation requirements specified in Article 29.1.a of Royal Decree No 2163/1994 of 4 November 1994 contained in Annex III to the Order of 4 August 1993 laying down the requirements for applications for authorisations for plant protection products, and the assessment in accordance with the uniform principles set out in the Annex to the Order of 29 November 1995 laying down the uniform principles for the assessment and authorisation of plant protection products shall be carried out by adopting and applying the corresponding resolutions before the expiry of the respective deadline for the implementation of these uniform principles, taking into account the conditions of the final version of the relevant European Commission assessment report, approved in the Standing Committee on the Food Chain and Animal Health.

3. The official register of products and plant protection material of the Directorate-General for Agricultural and Livestock Resources, the Ministry of the Environment, and the Rural and Marine Environment, shall be made available to interested parties in the review report. European Commission, as referred to in the previous paragraph, as well as that of the Commission for the Evaluation of Plant Protection Products provided for in Article 3 of Royal Decree No 2163/1994 of 4 November 1994. All this with the exception of confidential information as defined in Article 32 of that royal decree.

Final disposition first. Incorporation of Community law.

This order incorporates into Spanish law Commission Directive 2009 /25/EC of 2 April 2009 amending Council Directive 91 /414/EEC concerning the extension of the use of the substance of the substance active pyraclostrobin and Commission Directive 2009 /51/EC of 25 May 2009 amending Directive 91 /414/EEC as regards the specification of the active substance nicosulfuron.

Final disposition second. Entry into force.

This provision shall enter into force on the day following that of its publication in the "Official Gazette of the State", without prejudice to the provisions of the single additional provision.

Madrid, October 19, 2009. -First Vice-President of the Government and Minister of the Presidency, María Teresa Fernández de la Vega Sanz.

ANNEX

Amendment of Annex I "Community list of active substances" of Royal Decree 2163/1994 of 4 November 1994 imposing a harmonised Community system of authorisation to place on the market and use products Phytosanitary

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

The "uses" point of the "conditions for inclusion of the active substance pyraclostrobin" in Annex I to Royal Decree 2163/1994 of 4 November 1994 is read as follows:

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

For the implementation of the uniform principles, on the basis of 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 28 November 2003, shall be addressed in particular to:

-The protection of aquatic organisms, especially fish.

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

The specifications of the commercially manufactured technical material should also be reported. "

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

In the "characteristics" section of the "conditions for inclusion of the active substance nicosulfuron" in Annex I to Royal Decree 2163/1994 of 4 November 1994, the line concerning the minimum purity of the substance is Read as follows:

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