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. The active substance fenbuconazole is included in Commission Directive 2010 /85/EU of 2 December 2010 on the active substance fenbuconazole, by Directive 2010 /87/EU of 3 December. The active substance fenbuconazole is included by Directive 2010 /85/EU. Commission Directive 2010 /89/EU of 6 December 2010 includes the active substance quinmerac, by Commission Directive 2010 /90/EU of 7 December 2009, including the active substance pyridaben, by Commission Directive 2010 /91/EU of 10 December 2010. includes the active substance metosulam, by Commission Directive 2011 /23/EU of 3 March 2011, it includes the active substance triflumuron and by Commission Directive 2011 /31/EU of 7 March it is amended with regard to the use of the active substance pyrimifos-methyl.

This order incorporates the internal legal order, Commission Directive 2010 /85/EU of 2 December of the inclusion of the active substance cinch phosphide, Commission Directive 2010 /87/EU of 3 December 2009, of the the inclusion of the active substance fenbuconazole, Commission Directive 2010 /89/EU of 6 December of 6 December inclusion of the active substance quinmerac, Commission Directive 2010 /90/EU of 7 December 2010 for the inclusion of the active substance Pyridaben, Commission Directive 2010 /91/EU of 10 December of the inclusion of the substance active metosulam, Commission Directive 2011 /23/EU of 3 March for the inclusion of the active substance triflumuron, and Commission Directive 2011 /31/EU of 7 March, as regards the restriction of the use of the active substance pyrimifos-methyl, all amendments to Annex I to Council Directive 91 /414/EEC of 15 July 1991 and is hereby given in accordance with the final provision of Royal Decree No 2163/1994 of 4 November 1994, which entails the amendment of Annex I to the itself, as a result of such incorporation.

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, Social Policy and Equality, and according to the State Council, I have:

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

Annex I to Royal Decree No 2163/1994 of 4 November 1994 imposing a harmonised Community system of authorisation to place plant protection products on the market and use of plant protection products is hereby amended as follows: specifies in the attachment of this order.

One. The active substances zinc phosphide, fenbuconazole, quinmerac, pyridaben, metosulam, triflumuron are included.

Two. Order PRE/696/2008/2010 of 7 March 2010 is amended as regards the restriction of the use laid down in Part A of the inclusion of the active substance pyrimifos-methyl in Annex I to Royal Decree 2163/1994 of 4 November 1994.

Single additional disposition. Revision of the authorizations.

1. In order to verify compliance with the conditions of inclusion set out in the Annex to this Order, existing or provisional authorisations for plant protection products containing the active substances concerned, granted with Prior to the commencement of their period of inclusion, they shall be reviewed by adopting and applying the relevant resolutions before the expiry of the respective time limit set out in that Annex.

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 period for the implementation of those uniform principles, which for each of the active substances are set out in the Annex to this Order, taking into account also the conditions the final version of the relevant evaluation report of the European Commission, approved by 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.

First Disposition first. Incorporation of community law.

This Order incorporates into Spanish law Commission Directive 2010 /85/EU of 2 December 2006 on the inclusion of the active substance cinch phosphide, Commission Directive 2010 /87/EU of 3 December 2009, of the the inclusion of the active substance fenbuconazole, Commission Directive 2010 /89/EU of 6 December of 6 December inclusion of the active substance quinmerac, Commission Directive 2010 /90/EU of 7 December 2010 for the inclusion of the active substance Pyridinen, Commission Directive 2010 /91/EU of 10 December 2006 on the inclusion of the active substance metosulam, Commission Directive 2011 /23/EU of 3 March, the inclusion of the active substance triflumuron, and Commission Directive 2011 /31/EU of 7 March, as regards the restriction of the use of the active substance pyrimifos-methyl.

Final Disposition second. Entry into effect.

This provision shall enter into force on the day following that of its publication in the Official Gazette of the State and shall apply from 1 November 2011 for the active substances zinc phosphide, fenbuconazole, quinmerac, pyridaben, metosulam, and pyrimifos-methyl, without prejudice to the provisions of the single additional provision.

Madrid, October 25, 2011. -Minister of the Presidency, Ramón Jáuregui Atondo.

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

Conditions of the active substance zinc Fosfuro:

Features:

-Common name: zinc phosphate.

-CAS NO: 1314-84-7.

-NO CIPAC: 69.

-Chemical name (IUPAC): Tricnc diphosphate.

-Minimum purity of the substance: ≥800 g/kg of technical product.

Conditions of inclusion:

Part A:

-Uses: It can only be used as a rodenticide in the form of ready-to-use baits placed in specific bait stations or places.

Part B:

In the overall assessment, in accordance with the uniform principles, on the basis of the European Commission's assessment report, approved by the Standing Committee on the Food Chain and Animal Health at its meeting on 28 October 2010, should be particularly addressed to:

-The protection of organisms not subject to treatment, and the application of risk mitigation measures in a proportionate manner, in particular to prevent the spread of baits whose content has been consumed only partially.

Deadline for inclusion: 1 May 2011 to 30 April 2021.

Deadline for implementation of the conditions of inclusion: 30 April 2011.

Deadline for the application of the equivalence requirements for the active substance and a complete Annex II: 1 November 2011, to provide for the authorisation holder to have access to a documentation meeting the requirements of this Directive. Requirements of Annexes I and II to Royal Decree 2163/1994, where the substance is of different origin than that of the main notifier.

Deadline for implementation of the uniform principles: 30 April 2015 for products containing zinc phosphide as the only active substance or as one of several active substances included in their entirety in Annex I of Royal Decree 2163/1994 for that date, or if it is later, on the deadline set by the Order for which the active substances concerned are included, in Annex I to that Royal Decree.

Data protection: for the zinc phosphide an old active substance, the corresponding data protection regime provided for in Article 30 of Royal Decree 2163/1994 shall apply.

Conditions for the inclusion of the active substance Fenbuconazole:

Features:

-Common name: Fenbuconazole.

-CAS No. 114369-43-6.

-NO CIPAC: 694.

-Chemical name (IUPAC): (R, S) 4-(4-chlorophenyl) -2-phenyl-2-(1H-1,2,4-triazol-1-ylmethyl) butyronitril.

-Minimum purity of the substance: ≥965 g/kg of technical product.

Conditions of inclusion:

Part A:

-Uses: It can only be used as a fungicide.

Part B:

In the overall assessment, in accordance with the uniform principles, on the basis of the European Commission's assessment report, approved by the Standing Committee on the Food Chain and Animal Health at its meeting on 28 October 2010, should be particularly addressed to:

-The safety of the operators and the guarantee that the use of appropriate personal protective equipment is prescribed in the conditions of use.

-Food exposure of consumers to residues of metabolites derived from triazole.

-The risk to aquatic organisms and mammals, and include in the authorisations of plant protection products, where appropriate, risk mitigation measures.

The notifier shall submit confirmation data on residues of triazole-derived metabolites in primary crops, rotating crops and products of animal origin, before 30 April 2013.

The notifier will present additional information on the potential endocrine disrupting properties of fenbuconazole within two years of the adoption of the OECD test guidelines on endocrine disruption, or either of the test guidelines agreed at Union level.

Deadline for inclusion: 1 May 2011 to 30 April 2021.

Deadline for implementation of the conditions of inclusion: 30 April 2011.

Deadline for the application of the equivalence requirements for the active substance and a complete Annex II: 1 November 2011, to provide for the authorisation holder to have access to a documentation meeting the requirements of this Directive. Requirements of Annexes I and II to Royal Decree 2163/1994, where the substance is of different origin than that of the main notifier.

Deadline for implementation of the uniform principles: 30 April 2015 for products containing fenbuconazole as the only active substance or as one of several active substances included in their entirety in Annex I of Royal Decree 2163/1994 for that date, or if it is later, on the deadline set by the Order for which the active substances concerned are included, in Annex I to that Royal Decree.

Data protection: for being fenbuconazole an old active substance, the corresponding data protection regime provided for in Article 30 of Royal Decree 2163/1994 shall apply.

Conditions for the inclusion of the active substance Quimmerac:

Features:

-Common name: Quendive.

-CAS No. 90717-03-6.

-NO CIPAC: 563.

-Chemical name (IUPAC): 7-chloro-3-methylquinoline-8-carboxylic acid.

-Minimum purity of the substance: ≥980 g/kg of technical product.

Conditions of inclusion:

Part A:

-Uses: It can only be used as a herbicide.

Part B:

In the overall assessment, in accordance with the uniform principles, on the basis of the European Commission's assessment report, approved by the Standing Committee on the Food Chain and Animal Health at its meeting on 28 October 2010, should be particularly addressed to:

-The protection of groundwater, when the active substance is applied in areas with vulnerable soil or unfavourable climatic conditions.

-Exposure to consumers through feeding to quinmerac residues (and their metabolites) in subsequent rotation crops.

-The risk to aquatic organisms and the long-term risk for earthworms, and include in the authorisations of plant protection products, where appropriate, risk mitigation measures.

The notifier will present information regarding the probability that the plant metabolism will result in the opening of the quinoline ring, and with respect to residues in rotation crops and long-term risk. for earthworms due to the metabolite BH 518-5, before 30 April 2013.

Deadline for inclusion: 1 May 2011 to 30 April 2021.

Deadline for implementation of the conditions of inclusion: 30 April 2011.

Deadline for the application of the equivalence requirements for the active substance and a complete Annex II: 1 November 2011, to provide for the authorisation holder to have access to a documentation meeting the requirements of this Directive. Requirements of Annexes I and II to Royal Decree 2163/1994, where the substance is of different origin than that of the main notifier.

Deadline for the implementation of the uniform principles: 30 April 2015 for products containing quinmerac 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, or if it is later, on the deadline set by the Order for which the active substances concerned are included, in Annex I to that Royal Decree.

Data protection: for being the quinmerac an old active substance, the corresponding data protection regime provided for in Article 30 of Royal Decree 2163/1994 shall apply.

Conditions for the inclusion of the active substance Piridaben:

Features:

-Common name: Piridaben.

-CAS No: 96489-71-3.

-NO CIPAC: 583.

-Chemical name (IUPAC): 2-tert-butyl-5-(4-tert-butyl-benzylthio)-4-chloropyrididazin-3 (2H)-one.

-Minimum purity of the substance: ≥980 g/kg of technical product.

Conditions of inclusion:

Part A:

-Uses: It can only be used as an insecticide and acaricide.

Part B:

In the overall assessment, in accordance with the uniform principles, on the basis of the European Commission's assessment report, approved by the Standing Committee on the Food Chain and Animal Health at its meeting on 28 October 2010, should be particularly addressed to:

-User security, to which the use of appropriate personal protective equipment should be stipulated in the conditions of use.

-The risk to aquatic organisms and mammals,

-The risk to arthropods, not subject to treatment, including bees,

To include in the authorisations of plant protection products, where appropriate, risk mitigation measures, and to start monitoring programmes to verify the actual exposure of bees to pyridiness in areas commonly used by bees for libar or beekeepers.

The notifier shall submit confirmatory information regarding the risks to the water compartment from exposure to the metabolites W-1 and B-3 from photolysis in aqueous medium, with respect to the potential risk in the long term for mammals and for the assessment of fat-soluble residues by 30 April 2013 at the latest.

Deadline for inclusion: 1 May 2011 to 30 April 2021.

Deadline for implementation of the conditions of inclusion: 30 April 2011.

Deadline for the application of the equivalence requirements for the active substance and a complete Annex II: 1 November 2011, to provide for the authorisation holder to have access to a documentation meeting the requirements of this Directive. Requirements of Annexes I and II to Royal Decree 2163/1994, where the substance is of different origin than that of the main notifier.

Deadline for implementation of the uniform principles: 30 April 2015 for products containing pyridaben 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, or if it is later, on the deadline set by the Order for which the active substances concerned are included, in Annex I to that Royal Decree.

Data protection: for being the pyridaben an old active substance, the corresponding data protection regime provided for in Article 30 of Royal Decree 2163/1994 shall apply.

Conditions for the inclusion of the active substance Metosulam:

Features:

-Common Name: Metosulam.

-CAS No. 139528-85-1.

-NO CIPAC: 707.

-Chemical name (IUPAC): 2 ', 6'-dichloro-5,7-dimethoxy-3 '-methyl [1,2, 4] triazolo

[1,5-α] pyrimidine-2-sulfonanilide.

-Minimum purity of the substance: ≥980 g/kg of technical product.

Conditions of inclusion:

Part A:

-Uses: It can only be used as a herbicide.

Part B:

In the overall assessment, in accordance with the uniform principles, on the basis of the European Commission's assessment report, approved by the Standing Committee on the Food Chain and Animal Health at its meeting on 28 October 2010, should be particularly addressed to:

-The protection of groundwater when the active substance is applied in areas with vulnerable soil or unfavourable climatic conditions.

-The risk to aquatic organisms.

-The risk to plants not subject to treatment, in the off-site area, and include in the authorisations of plant protection products, where appropriate, risk mitigation measures.

The notifier shall submit further information on the specification of the active substance as manufactured before 30 October 2011.

The notifier shall provide confirmatory information by 30 April 2013 at the latest on the possible pH dependence of soil adsorption, the leaching of groundwater and the exposure of water. surface in the case of metabolites M01 and M02, and confirmatory information on the possible genotoxicity of an impurity.

Deadline for inclusion: 1 May 2011 to 30 April 2021.

Deadline for implementation of the conditions of inclusion: 30 April 2011.

Deadline for the application of the equivalence requirements for the active substance and a complete Annex II: 1 November 2011, to provide for the authorisation holder to have access to a documentation meeting the requirements of this Directive. Requirements of Annexes I and II to Royal Decree 2163/1994, where the substance is of different origin than that of the main notifier.

Deadline for implementation of the uniform principles: 30 April 2015 for products containing metosulam 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, or if it is later, on the deadline set by the Order for which the active substances concerned are included, in Annex I to that Royal Decree.

Data protection: for being the metosulam an old active substance, the corresponding data protection regime provided for in Article 30 of Royal Decree 2163/1994 shall apply.

Conditions for the inclusion of the active substance Triflumuron:

Features:

-Common name: Triflumuron.

-CAS No. 64628-44-0.

-NO CIPAC: 548.

-Chemical name (IUPAC): 1-(2-chlorobenzoyl) -3-[4-trifluoromethoxyphenyl] urea.

-Minimum purity of the substance: ≥955 g/kg of technical product.

-impurities: N, N '-bis-[4-(trifluoromethoxy) phenyl] urea: not more than 1 g/kg.

4-trifluoro-methoxyaniline: not more than 5 g/kg.

Conditions of inclusion:

Part A:

-Uses: It can only be used as an insecticide.

Part B:

In the overall assessment, in accordance with the uniform principles, on the basis of the European Commission's assessment report, approved by the Standing Committee on the Food Chain and Animal Health at its meeting of 28 January 2011, Special attention must be given to:

-The protection of the aquatic environment.

-The protection of honey bees, and include in the authorisations of plant protection products, where appropriate, risk mitigation measures.

The notifier will present information confirming the conclusions regarding the long-term risk to birds, the risk to aquatic invertebrates and the risk to the development of bee colonies, before 31 December. March 2013.

Deadline for inclusion: 1 April 2011 to 31 March 2021.

Data protection: as a new active substance triflumuron, the corresponding data protection regime provided for in Article 30 of Royal Decree 2163/1994 shall apply.

Conditions of restriction of use of the active substance Pirimips-methyl:

Features:

-Common name: Pirimip-methyl.

-CAS No. 29232-93-7.

-NO CIPAC: 239.

-Chemical name (IUPAC): O-2-diethylamino-6-methylpyrimidin-4-yl

O, O-dimethylphosphorothioate.

-Minimum purity of the substance: ≥880 g/kg of technical product.

Conditions of inclusion.

Part A:

-Uses: It can only be used as insecticide for storage after harvest. Applications with portable equipment will not be authorized.

Part B:

In the overall assessment, in accordance with the uniform principles, of authorisation of plant protection products containing pyrimifos-methyl for uses other than applications with automated systems in empty cereal stores, provide all data and information necessary prior to the granting of the authorisation.

On the basis of the European Commission assessment report approved by the Standing Committee on the Food Chain and Animal Health at its meeting of 16 March 2007, it should be addressed in particular to:

-The safety of operators, authorised conditions of use shall require the use of appropriate personal protective equipment, including respiratory protective equipment, and risk mitigation measures for reduce exposure.

-The food exposure of consumers with a view to revising the maximum residue limits in the future.

Deadline for inclusion: 1 October 2007 to 30 September 2017.