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 royal decree, as the list of substances, is hereby set out in the order of 14 April 1999. 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. Commission Directive 2006 /85/EC of 23 October 2006, including the active substances fenamiphos and ethephon, by Commission Directive 2007 /5/EC of 7 February 2007, includes active substances captan, folpet, formetanate and ethefon. Methiocarb and Commission Directive 2007 /6/EC of 14 February include the active substances metrafenone, Bacillus subtilis, spinosad and thiamethoxam. The above provisions lay down the conditions for the placing on the market of plant protection products containing those active substances which have no harmful effects on human health or animal health or on groundwater, they have no unacceptable impact on the environment, as well as for the review of existing authorisations for plant protection products containing one of the active substances listed in Annex I to Directive 91 /414/EEC Council of 15 July 1991 amending or withdrawing them in accordance with the (a) the effect on that directive. This order incorporates Commission Directives 2006 /85/EC of 23 October 2007 /5/EC of the Commission of 7 February 2007 /6/EC of 14 February 2007 on the inclusion of substances into the internal legal order fenamiphos, etefon, captan, folpet, formetanate, methiocarb, metrafenone, Bacillus subtilis, spinosad and thiamethoxam in Annex I to Royal Decree 2163/1994 of 4 November, and is given in accordance with the option provided for in the first provision 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 Ministries of Agriculture, Fisheries and Food, Health and Consumer Affairs and the Environment, I have:

Single item. Amendment to 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.

These are included in Annex I to Royal Decree 2163/1994 of 4 November, which implements the harmonised Community system of authorisation to place on the market and use plant protection products fenamipic active substances, etefon, captan, folpet, formetanate, methiocarb, metrafenone, Bacillus subtilis, spinosad and thiamethoxam, with the characteristics and conditions specified in the Annex to this order.

Single additional disposition. Review of the authorisations.

1. In order to verify compliance with the conditions of inclusion set out in the Annex to this order, existing authorisations for plant protection products containing the active substances concerned, granted prior to the the time limit for inclusion is to be reviewed, adopted and implemented by 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 period for the implementation of those uniform principles, which for each of the active substances is indicated in the Annex to this order, taking into account the conclusions of the report of the European Commission. 3. The official register of products and plant protection material of the Directorate-General for Agriculture of the Ministry of Agriculture, Fisheries and Food shall be made available to interested parties in the review reports of the European Commission. refers to the previous paragraph, as well as those 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 with the exception of confidential information as defined in Article 32 of that royal decree

Single end disposition. Entry into force.

This provision shall enter into force on the day following that of the publication of this order in the "Official Gazette of the State", without prejudice to the provisions of the single additional provision and compliance with the deadlines. for each active substance and for each stage listed in the Annex.

Madrid, 13 July 2007. -First Vice-President of the Government and Minister of the Presidency, Maria Teresa Fernández de la Vega Sanz.

ANNEX

Conditions for the inclusion of active substances fenamiphos, etefon, captan, folpet, formetanate, methiocarb, metrafenone, Bacillus subtilis, spinosad and thiamethoxam

Conditions for the inclusion of the active substance fenamiphos

Features:

Common name: Fenamiphos.

CAS: 22224-92-6. No. CIPAC: 692. Chemical name (IUPAC): (RS) Etil 4-(etilito)-m-tolyl isopropyl phosphoramidate. Minimum purity of the substance ≥ 940 g/kg.

Conditions of inclusion:

Uses: can only be used as a nematicide applied by drip irrigation in greenhouses with permanent structure.

In the overall assessment, in accordance with 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 14 July 2006, Special attention must be given to:

The protection of aquatic organisms, soil organisms other than the target of treatment and groundwater in vulnerable situations, and include as a condition in the relevant authorisations, when Risk mitigation measures are appropriate.

Monitoring programmes for vulnerable areas should be initiated to monitor the potential for groundwater contamination.

Deadline for inclusion: 1 August 2007 to 31 July 2017. Deadline for the implementation of the conditions of inclusion: 31 July 2007. Deadline for the application of the requirements of an Annex II: 31 January 2008. Deadline for the implementation of the uniform principles: 31 July 2011 for products containing fenamiphos 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 of 4 November 1994 for that date.

Data protection: for being the fenamiphos an old active substance, the corresponding data protection regime provided for in Article 30 of Royal Decree 2163/1994 of 4 November.

Conditions for the inclusion of the active substance ethephon

Features:

Common Name: Etefon.

CAS No. 16672-87-0. No. CIPAC: 373. Chemical name (IUPAC): 2-(chloroethyl) phosphonic acid. Minimum purity of the substance: ≥ 910 g/kg (technical material-TC). The manufacturing impurities MEPHA (mono ester 2-chloroethyl, 2-chloroethyl phosphonic acid) and 1,2-dichloroethane are considered to be of toxicological importance and should not exceed 20 g/kg and 0,5 g/kg respectively in the technical material.

Conditions of inclusion:

Uses: can only be used as a plant growth regulator.

In the overall assessment, according to the uniform principles, the evaluation report of the European Commission, approved by the Standing Committee on the Food Chain and Animal Health at its meeting of 14 July 2006, will be taken into account.

Deadline for inclusion: 1 August 2007 to 31 July 2017.

Deadline for implementation of the conditions of inclusion: 31 July 2007. Deadline for the application of the requirements of an Annex II: 31 January 2008. Deadline for the implementation of the uniform principles: 31 July 2011 for products containing ethefon 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 of 4 November 1994 for that date.

Data protection: for being the etefon an old active substance, the corresponding data protection regime provided for in Article 30 of Royal Decree 2163/1994 of 4 November.

Conditions for the inclusion of the active substance captan.

Features:

Common Name: Captan.

CAS No. 133-06-2. No. CIPAC: 40. Chemical name (IUPAC): N-(trichloromethylthio) cyclohex-4-ene-1,2-dicarboximide Minimum purity of the substance: ≥ 910 g/kg. Impurities: Perchloromethylmercaptan (R005406): max. 5 g/kg; Folpet: max. 10 g/kg; Carbon tetrachloride: max. 0,01 g/kg.

Conditions of inclusion:

Uses: It can only be used as a fungicide.

In the assessment of applications for authorisation of plant protection products containing captan for other uses than tomatoes, particular attention shall be paid to the criteria referred to in Article 15 (3) (b) of the Regulation. Royal Decree No 2163/1994 of 4 November 1994 and all necessary information and information must be provided before such authorisation is granted. In the overall assessment, in accordance with the uniform principles according to the evaluation report of the European Commission, approved by the Standing Committee on the Food Chain and Animal Health, and in particular Appendices I and II thereof, at its meeting of 29 September 2006, must be addressed in particular to:

The safety of operators and workers; the authorised conditions of use shall require the use of appropriate personal protective equipment and risk mitigation measures to reduce exposure.

The food exposure of consumers with a view to revising the maximum residue limits in the future. The protection of groundwater under vulnerable conditions; conditions of authorisation shall include, where appropriate, risk mitigation measures and the initiation of surveillance programmes in vulnerable areas. The protection of birds, mammals and aquatic organisms, and include in the relevant authorisations, measures for the protection of risks.

Further studies will be requested to confirm the long-term risk assessment for birds and mammals, as well as the toxicological assessment of metabolites potentially present in the waters. Underground in vulnerable conditions. The notifiers at the request of which the captan has been included in this Annex shall provide such studies within two years of the entry into force of this Order.

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

Deadline for implementation of the conditions of inclusion: 30 September 2007. Deadline for the application of the requirements of an Annex II: 31 March 2008. Deadline for the implementation of the uniform principles: 30 September 2011 for products containing captan 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 of 4 November 1994 for that date.

Data protection: for the capture of an old active substance, the corresponding data protection regime provided for in Article 30 of Royal Decree 2163/1994 of 4 November 1994 shall apply.

Conditions for the inclusion of the active substance folpet

Features:

Common Name: Folpet.

CAS No. 133-07-3. No. CIPAC: 75. Chemical name (IUPAC): N-(trichloromethylthio) phthalimide Minimum purity of the substance: ≥ 940 g/kg. Impurities: Perchloromethylmercaptan (R005406): max. 3,5 g/kg; Carbon tetrachloride: max. 4 g/kg.

Conditions of inclusion:

Uses: It can only be used as a fungicide.

In the assessment of applications for authorisation of plant protection products containing folpet for other uses than winter wheat, the criteria referred to in Article 15 (3) (b) of the Royal Regulation shall be met. Decree No 2163/1994 of 4 November 1994 providing all the necessary information and information before granting such authorisation. In the overall assessment, in accordance with the uniform principles according to the evaluation report of the European Commission, approved by the Standing Committee on the Food Chain and Animal Health, and in particular Appendices I and II thereof, at its meeting of 29 September 2006, must be addressed in particular to:

The safety of operators and workers; the conditions of use authorised shall require the use of appropriate personal protective equipment.

The food exposure of consumers with a view to revising the maximum residue limits in the future. The protection of birds, mammals and aquatic and soil organisms, the conditions of authorisation shall include risk mitigation measures.

Additional studies will be required to confirm the risk assessment for birds, mammals and earthworms. The notifier at the request of which the folpet has been included in this Annex shall provide such studies within two years of the entry into force of this Order.

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

Deadline for implementation of the conditions of inclusion: 30 September 2007. Deadline for the application of the requirements of an Annex II: 31 March 2008. Deadline for the implementation of the uniform principles: 30 September 2011 for products containing folpet 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 of 4 November 1994 for that date.

Data protection: for being the folpet an old active substance, the corresponding data protection regime provided for in Article 30 of Royal Decree 2163/1994 of 4 November.

Conditions for the inclusion of the active substance formetanate

Features:

Common Name: Formetanate.

CAS No. 23422-53-9. No. CIPAC: 697. Chemical name (IUPAC): 3-dimethylaminomethylene aminophenyl methylcarbamate. Purity of the active substance: ≥ 910 g/kg.

Conditions of inclusion:

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

In the assessment of applications for authorisation of plant protection products containing formetanate for other uses than those for field tomatoes and ornamental plants, the criteria shall be met. referred to in Article 15 (3) (b) of Royal Decree No 2163/1994 of 4 November 1994, making it possible to provide all the information and information necessary before granting such authorisation. In the overall assessment, in accordance with the uniform principles according to the evaluation report of the European Commission, approved by the Standing Committee on the Food Chain and Animal Health, and in particular Appendices I and II thereof, at its meeting of 29 September 2006, must be addressed in particular to:

The protection of birds, mammals, non-target arthropods and bees, and to include in relevant authorisations, where appropriate, risk mitigation measures.

The safety of operators and include in the conditions of use the use of appropriate personal protective equipment. The food exposure of consumers with a view to revising the maximum residue limits in the future.

Further studies will be required to confirm the risk assessment for birds, mammals and non-target arthropods. The notifier at the request of which the formetanate has been included in this Annex shall provide such studies within two years of the entry into force of this Order.

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

Deadline for implementation of the conditions of inclusion: 30 September 2007. Deadline for the application of the requirements of an Annex II: 31 March 2008. Deadline for the implementation of the uniform principles: 30 September 2011 for products containing formetanate 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 of 4 November 1994 for that date.

Data protection: for being the formetanate an old active substance, the corresponding data protection regime provided for in Article 30 of Royal Decree 2163/1994 of 4 November.

Conditions for the inclusion of the active substance methiocarb

Features:

Common Name: Metiocarb.

CAS No: 2032-65-7. No. CIPAC: 165. Chemical name (IUPAC): 4-methylthio-3,5-xylyl methylcarbamate. Purity of the active substance: ≥ 980 g/kg.

Conditions of inclusion:

Uses: It can only be used as a repellent in the treatment of seeds, such as insecticide and molluscicide.

In the assessment of applications for authorisation of plant protection products containing metiocarb for other uses than those for the treatment of maize seed, the criteria referred to in the Article shall be met. 15, paragraph 3, point (b) of Royal Decree No 2163/1994 of 4 November 1994, making it possible to provide all the necessary information and information before granting such authorisation. In the overall assessment, in accordance with the uniform principles according to the evaluation report of the European Commission, approved by the Standing Committee on the Food Chain and Animal Health, and in particular Appendices I and II thereof, at its meeting of 29 September 2006, must be addressed in particular to:

The protection of birds, mammals, non-target arthropods, and include in the corresponding authorisations, where appropriate, risk mitigation measures.

The safety of operators and persons outside the use of the products and to include in the conditions of use the use of appropriate personal protective equipment. The food exposure of consumers with a view to revising the maximum residue limits in the future.

Further studies will be requested to confirm the risk assessment for birds, mammals and arthropods other than the target of treatment, as well as to confirm the toxicological assessment. on metabolites potentially present in the crops. The notifier at the request of which methiocarb has been included in this Annex shall provide such studies within two years of the entry into force of this Order.

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

Deadline for implementation of the conditions of inclusion: 30 September 2007. Deadline for the application of the requirements of an Annex II: 31 March 2008. Deadline for the implementation of the uniform principles: 30 September 2011 for products containing methiocarb 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 of 4 November 1994 for that date.

Data protection: for being the methiocarb an old active substance, the corresponding data protection regime provided for in Article 30 of Royal Decree 2163/1994 of 4 November.

Conditions for the inclusion of the active substance metrafenone

Features:

Common Name: Metrafenone.

CAS: 220899-03-6. No. CIPAC: 752. Chemical name (IUPAC): 3 '-bromo-2,3,4,6'-tetramethoxy-2 ', 6-dimethylbenzophenone. Purity of the active substance: ≥ 940 g/kg.

Conditions of inclusion:

Uses: It can only be used as a fungicide.

In the overall assessment, the uniform principles shall be in accordance with the assessment report of the European Commission, approved by the Standing Committee on the Food Chain and Animal Health, and in particular Appendices I and II thereof, at its meeting of 14 July 2006. In accordance with Article 13 (5) of Directive 91 /414/EEC, the specifications of the commercially manufactured technical material shall be reported.

Deadline for inclusion: 1 February 2007 to 31 January 2017.

Deadline for implementation of the conditions of inclusion: 31 January 2007. Deadline for the application of the requirements of an Annex II: 31 July 2007. Deadline for the implementation of the uniform principles: 31 July 2008 for products containing metrafenone 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 of 4 November 1994 for that date.

Data protection: as metrafenone is a new active substance, the corresponding data protection regime provided for in Article 30 of Royal Decree 2163/1994 of 4 November.

Conditions for the inclusion of the active substance Bacillus subtilis

Features:

Common name: Bacillus subtilis (Cohn 1872).

QST Strain 713, identical to AQ strain 713. Crop collection No. NRRL B -21661. No. CIPAC: Unassigned. Chemical name (IUPAC): not applicable.

Conditions of inclusion:

Uses: It can only be used as a fungicide.

In the overall assessment, the uniform principles shall be in accordance with the assessment report of the European Commission, approved by the Standing Committee on the Food Chain and Animal Health, and in particular Appendices I and II thereof, at its meeting of 14 July 2006.

Deadline for inclusion: 1 February 2007 to 31 January 2017.

Deadline for implementation of the conditions of inclusion: 31 January 2007. Deadline for the application of the requirements of an Annex II: 31 July 2007. Deadline for the implementation of the uniform principles: 31 July 2008 for products containing Bacillus subtilis 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 of 4 November 1994 for that date.

Data protection: as the Bacillus subtilis a new active substance, the corresponding data protection regime provided for in Article 30 of Royal Decree 2163/1994 of 4 November 1994 shall apply.

Conditions for the inclusion of the active substance spinosad

Features:

Common Name: Spinosad.

CAS No. 131929-60-7 (Spinosyn A). 131929-63-0 (Spinosyn D). No. CIPAC: 636. Chemical name (IUPAC):

Spinosyn A: (2R, 3aS, 5aR, 5bS, 9S, 13S, 14R, 16aS, 16bR)-2-(6-deoxy-2,3,4-tri-O-methyl-α-L-manopyranosyloxy)-13-(4-dimethylamino-2,3,4,6-tetradeoxy--2,3,4,6-tetradylosyloxy)-9-ethyl-2,3,3. ª, 5b, 6,7,9,10,11,12,13,14,15,16. 16b-hexadecahydro-14-methyl-1H-8-oxacyclododeca [b] -indacene-7,15-dione.

Spinosyn D: (2S, 3aR, 5aS, 5bS, 9S, 13S, 14R, 16aS, 16bS)-2-(6-deoxy-2,3,4-tri-O-methyl-α-L-manopyranosyloxy)-13-(4-dimethylamino-2,3,4,6-tetradeoxy--2,3,4,6-tetradylosyloxy)-9-ethyl-2,3, 3a, 5a, 5b, 6,7,9,10,11,12,13,14,15,16a, 16b-hexadecahydro-4,14-dimethyl-1H-8-oxacyclododeca [b] -indacene-7,15-dione. The spinosad is a 50-95% mixture of spinosyn A and 5-50% of spinosyn D. Pureza of the active substance: ≥ 850 g/kg.

Conditions of inclusion:

Uses: It can only be used as an insecticide.

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, and in particular Appendices I and II thereof, At its meeting of 14 July 2006, it should be particularly addressed to:

The protection of aquatic organisms, and include in the corresponding authorisations, where appropriate, risk mitigation measures.

Earthworms, when the substance is used in greenhouses, and include in the authorizations, where appropriate risk mitigation measures.

Deadline for inclusion: 1 February 2007 to 31 January 2017.

Deadline for implementation of the conditions of inclusion: 31 January 2007. Deadline for the application of the requirements of an Annex II: 31 July 2007. Deadline for the implementation of the uniform principles: 31 July 2008 for products containing spinosad 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 of 4 November 1994 for that date.

Data protection: as the spinosad is a new active substance, the corresponding data protection regime provided for in Article 30 of Royal Decree 2163/1994 of 4 November 1994 shall apply.

Conditions for the inclusion of the active substance thiamethoxam

Features:

Common name: Tiamethoxam.

CAS No. 153719-23-4. No. CIPAC: 637. Chemical name (IUPAC): (E, Z)-3-(2-chloro-thiazole-5-ylmethyl)-5-methyl-[1,3, 5] oxadiazinan-4-ylidene-N-nitroamine. Purity of the active substance: ≥ 980 g/kg.

Conditions of inclusion:

Uses: It can only be used as an insecticide.

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, and in particular Appendices I and II thereof, at its meeting of 14 July 2006, it will be particularly attended to:

The risk of groundwater contamination, particularly of the active substance and its metabolites NOA 459602, SYN 501406 and CGA 322704, when the substance is applied in areas where soil or climatic conditions are delicate.

The protection of aquatic organisms, and include in appropriate authorisations where appropriate, risk mitigation measures. The long-term risk to small herbivores if the substance is used for the treatment of seeds, and include when appropriate risk mitigation measures.

Deadline for inclusion: 1 February 2007 to 31 January 2017.

Deadline for implementation of the conditions of inclusion: 31 January 2007. Deadline for the application of the requirements of an Annex II: 31 July 2007. Deadline for the implementation of the uniform principles: 31 July 2008 for products containing thiamethoxam 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 of 4 November 1994 for that date.

Data protection: for being the thiamethoxam a new active substance, the corresponding data protection regime provided for in Article 30 of Royal Decree 2163/1994 of 4 November.