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. Directive 2007 /76/EC of the European Parliament and of the Council of 20 December 2007 on the active substances fludioxonil, clomazone and prosulfuron, by Directive 2008 /40/EC of 28 March 2008, includes the active substances amidosulfuron and nicosulfuron, Directive 2008 /41/EC of 31 March 2008 includes the active substance chloridazone, by Directive 2008 /44/EC of 4 April. The active substances bentiavalicarb, boscalid, carvone, fluoxastbin, Paecilomyces lilacinus and prothioconazole are included. Directive 2008 /45/EC of 4 April 2008 amending Council Directive 91 /414/EEC of 15 July 1991 on the extension of the use of the active substance metconazole. 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, of the Council of 15 July 1991 amending or withdrawing them in accordance with the established for the purpose in that Directive. This Order incorporates into national law the Commission Directives 2007 /76/EC of 20 December 2008 /40/EC of the Commission of 28 March 2008 /41/EC of 31 March 2008 /44/EC of the Commission of 4 April 2008 and of the Commission of the European Union 2008 /45/EC of the Commission of 4 April by the inclusion of the active substances fludioxonil, clomazone, prosulfocarb, amidosulfuron, nicosulfuron, chloridazone, bentiavalicarb, boscalid, carvone, fluoxastrobin, Paecilomyces lilacinus, prothioconazole and the extension of use of metconazole in Annex I to Royal Decree 2163/1994 of 4 November, and is issued in accordance with the final disposition of the same. 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 the Environment, and the Rural and Marine Environment and the Minister for Health and Consumer Affairs, 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.

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 following active substances are included:

"prosulfocarb, fludioxonil, clomazone, amidosulfuron, nicosulfuron, chloridazone, bentiavalicarb, boscalid, carvone, fluoxastrobin, Paecilomyces lilacinus, prothioconazole."

Two. The use of the active substance metconazole is extended.

Single additional disposition. Review of the authorisations.

1. In order to verify compliance with the conditions for inclusion and renewals set out in the Annex to this Order, the existing authorisations and provisional authorisations for plant protection products containing the active substances concerned, granted before the start of their period of inclusion or renewal, 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 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 contained in the Annex to the Order of 29 November 1995 laying down the uniform principles for the authorisation of plant protection products Assessment and authorisation of plant protection products shall be carried out by adopting and implementing 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 of 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, will be made available to interested parties in the review reports. European Commission, as referred to in the previous paragraph, and those of the Commission for the Evaluation of Plant Protection Products as 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 the Royal Decree.

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", without prejudice to the provisions of the single additional provision and the fulfilment of the deadlines for each active substance and for each stage are listed in the Annex.

Madrid, 10 October 2008. -First Vice-President of the Government and Minister of the Presidency, Maria Teresa Fernández de la Vega Sanz.

ANNEX Inclusion of the active substances in Annex I

Conditions for the inclusion of the active substance Prosulfocarb.

Features: Common Name: Prosulfocarb.

N ° CAS: 52888-80-9. CIPAC No 539. Chemical name (IUPAC): S-benzyl dipropylthiocarbamate. Minimum purity of the substance: 970 g/kg. Conditions of inclusion:

Uses: 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 at its meeting on 9 October 2007, must be addressed especially to:

The safety of the operators, and include as a condition in the corresponding authorisations, where appropriate the use of appropriate personal protective equipment.

The protection of aquatic organisms, and include as a condition in the relevant authorisations, where appropriate risk mitigation measures are appropriate. The protection of plants not subject to treatment, and include as a condition in the relevant authorisations, where appropriate, risk mitigation measures, e.g. buffer zones without spraying on parcels. Deadline for inclusion: 1 November 2008 to 31 October 2018. Deadline for the implementation of the conditions of inclusion: 31 October 2008. Time limit for the application of the requirements of an Annex II: 30 April 2009 for the holder of the authorisation to have or have access to a dossier satisfying the requirements of Annex II to Royal Decree 2163/1994. Deadline for the implementation of the uniform principles: 31 October 2012 for products containing prosulfocarb 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 prosulfocarb 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 Fludioxonil. Features:

Common Name: Fludioxonil.

CAS No 131341-86-1. CIPAC No 522. Chemical name (IUPAC): (4-(2,2-difluoro-1,3-benzodioxol-4-yl) -1H-pyrrole-3-carbonitrile. Minimum purity of the substance: 950 g/kg.

Conditions of inclusion:

Uses: can only be used as fungicide.

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 9 October 2007, must be addressed especially to:

The evaluation of plant protection products for other uses than for seed treatment.

Groundwater contamination in vulnerable areas in particular by the soil photolysis metabolites CGA 339833 and CGA 192155. The protection of aquatic fish and invertebrates, and shall include as a condition in the relevant authorisations, where appropriate, risk mitigation measures. Deadline for inclusion: 1 November 2008 to 31 October 2018. Deadline for the implementation of the conditions of inclusion: 31 October 2008. Time limit for the application of the requirements of an Annex II: 30 April 2009 for the holder of the authorisation to have or have access to a dossier satisfying the requirements of Annex II to Royal Decree 2163/1994. Deadline for the implementation of the uniform principles: 31 October 2012 for products containing fludioxonil 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 fludioxonil an active substance old, 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 Clomazone. Features:

Common Name: Clomazone.

CAS No: 81777-89-1. CIPAC No 509. Chemical name (IUPAC): 2-(2-chlorobenzyl) -4,4-dimethyl-1,2-oxazolidin-3-one. Minimum purity of the substance: 960 g/kg.

Conditions of inclusion:

Uses: can only be used as a herbicide.

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 9 October 2007, must be addressed especially to:

The safety of the operators, and include as a condition in the corresponding authorisations, where appropriate the use of appropriate personal protective equipment.

The protection of non-target plants, and include as a condition in the corresponding authorisations, where appropriate, risk mitigation measures, e.g. buffer zones. Deadline for inclusion: 1 November 2008 to 31 October 2018. Deadline for the implementation of the conditions of inclusion: 31 October 2008. Time limit for the application of the requirements of an Annex II: 30 April 2009 for the holder of the authorisation to have or have access to a dossier satisfying the requirements of Annex II to Royal Decree 2163/1994. Deadline for the implementation of the uniform principles: 31 October 2012 for products containing clomazone 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 clomazone 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 Amidosulfuron.

Features: Common name: Amidosulfuron.

CAS: 120923-37-7. CIPAC No 515. Chemical name (IUPAC): 3-(4,6-dimethoxypyrimidin-2-yl)-1-(N-methyl-N-methylsulfonyl-aminosulfonyl) urea.

or 1-(4,6-dimethoxypyrimidin-2-yl) -3-mesyl (methyl) sulfamo-ylurea.

Minimum purity of the substance: ≥ 970 g/kg.

Conditions of inclusion:

Uses: can only be used as a herbicide.

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 22 January 2008, Special attention must be given to:

The evaluation of uses not intended for grassland and grassland.

The protection of groundwater by the possibility of contamination of groundwater by some degradation products when applied in zones of vulnerable climatic or soil characteristics. The protection of aquatic plants, and include as a condition in the relevant authorisations, where appropriate, risk mitigation measures, for example buffer zones. Deadline for inclusion: 1 January 2009 to 31 December 2018. Deadline for the implementation of the conditions of inclusion: 31 December 2008. Time limit for the application of the requirements of an Annex II: 30 April 2009 for the holder of the authorisation to have or have access to a documentation meeting the requirements of Annex II to Royal Decree 2163/1994.

Deadline for implementation of the uniform principles: 31 October 2012 for products containing amidosulfuron as the only active substance, or as one of several active substances included in their entirety in the 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: as amidosulfuron 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 Nicosulfuron. Features:

Common name: Nicosulfuron.

N ° CAS: 111991-09-4. CIPAC No 709. Chemical name (IUPAC). 2-[(4,6-dimethoxypyrimidin-2-ylcarbamoyl) sulfamoyl] -N, N-dimethylnicotinamide

or 1-(4,6-dimethoxypyrimidin-2-yl) -3-(3 -dimethylcarbamoyl-2-pyridylsulfonyl) urea.

Minimum purity of the substance: ≥ 930 g/kg.

Conditions of inclusion:

Uses: can only be used as a herbicide.

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 22 January 2008, Special attention must be given to:

The exposure of the aquatic environment to the DUDN metabolite when nicosulfuron is applied in areas of vulnerable soil characteristics.

The protection of aquatic plants, and include as a condition in the relevant authorisations, where appropriate risk mitigation measures, for example buffer zones. The protection of plants not subject to treatment, and include as a condition in the relevant authorisations, where appropriate, risk mitigation measures, e.g. buffer zones without spraying on parcels. The protection of groundwater and surface water in vulnerable soil and climatic conditions. Deadline for inclusion: 1 January 2009 to 31 December 2018. Deadline for the implementation of the conditions of inclusion: 31 December 2008. Time limit for the application of the requirements of an Annex II: 30 April 2009 for the holder of the authorisation to have or have access to a documentation meeting the requirements of Annex II to Royal Decree 2163/1994. Deadline for the implementation of the uniform principles: 31 October 2012 for products containing nicosulfuron 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: as the nicosulfuron 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 Chloridazone. Features:

Common Name: Chloridazone.

CAS No: 1698-60-8. CIPAC No 111. Chemical name (IUPAC): 5-amino-4-chloro-2-phenylpyridazin-3 (2H)-one. Minimum purity of the substance: 920 g/kg.

Conditions of inclusion:

Uses: can only be used as a herbicide in applications of up to 2.6 kg/ha every three years in the same field.

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 4 December 2007, must be addressed especially to:

The safety of the operators, and include as a condition in the corresponding authorisations, where appropriate, the requirement of the use of appropriate personal protective equipment.

The protection of aquatic organisms. The protection of groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions, and to include as a condition in the relevant authorisations, where appropriate reduction measures Surveillance programmes should be initiated in vulnerable areas to monitor the potential for groundwater contamination by metabolites B and B1. Deadline for inclusion: 1 January 2009 to 31 December 2018. Deadline for the implementation of the conditions of inclusion: 31 December 2008. Time limit for the application of the requirements of an Annex II: 30 June 2009 for the holder of the authorisation to have or have access to a documentation meeting the requirements of Annex II to Royal Decree 2163/1994. Deadline for the implementation of the uniform principles: 31 December 2012 for products containing chloridazone 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 chloridazone 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 Bentiavalicarb. Features:

Common name: Bentiavalicarb.

CAS No 413615 -35-7. CIPAC No 744. Chemical name (IUPAC): [(S)-1-{[(R)-1-(6-fluoro-1,3 -benzothiazol-2-yl) ethyl] carbamoy1} -2 -methylpropy1] carbamicacid. Minimum purity of the substance: ≥ 910 g/kg.

The following manufacturing impurities involve toxicological risks, and the concentration of each of them in the technical product must not exceed:

6,6 '-difluoro-2,2'-dibenzothiazole: < 3,5 mg/kg.

bis (2-amino-5-fluorophe, nyl) disulfide: < 14 mg/kg.

Conditions of inclusion:

Uses: can only be used as fungicide.

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 22 January 2008, Special attention must be given to:

The safety of the operators.

The protection of arthropods not subject to treatment, and include as a condition in the relevant authorisations, where appropriate, risk mitigation measures.

In the assessment of applications for the authorisation of plant protection products containing bentiavalicarb for uses other than greenhouses, particular attention shall be paid to the criteria referred to above. in Article 15 of Royal Decree 2163/1994, all the necessary data and information must be provided before such authorisation is granted.

According to Article 30.3 of the aforementioned Royal Decree, the specifications of the commercially manufactured technical material will be reported.

Deadline for inclusion: 1 August 2008 to 31 July 2018.

Deadline for implementation of the conditions of inclusion: 31 July 2008. Time limit for the application of the requirements of an Annex II: 31 January 2009 for the holder of the authorisation to have or have access to a dossier satisfying the requirements of Annex II to Royal Decree No 2163/1994 Deadline for implementation of the uniform principles: 31 January 2010 for products containing benthiavalicarb as the only active substance, or as one of several active substances included in their entirety in Annex I to Royal Decree 2163/1994 for that date, or if it is later, on the deadline set by the Order for which the active substances are included in the a question in Annex I to that Royal Decree.

Data protection: as the bentiavalicarb is a new 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 Boscalid. Features:

Common Name: Bospwarm.

CAS No: 188425-85-6. CIPAC No 673. Chemical name (IUPAC): 2-chloro-N-(4 '-chlorobiphenyl-2-yl) nicotinamide. Minimum purity of the substance: ≥ 960 g/kg.

Conditions of inclusion:

Uses: can only be used as fungicide.

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 22 January 2008, Special attention must be given to:

The safety of the operators.

The long-term risk to birds and soil organisms. The risk of accumulation on the soil surface, if the substance is used in a perennial crop, or in subsequent crops in crop rotation systems, and include as a condition in the relevant authorisations, where appropriate, measures to reduce the risk. Term of inclusion: 1 August 2008 to 31 July 2018. Deadline for the implementation of the conditions of inclusion: 31 July 2008. Deadline for the application of the requirements of an Annex II: 31 January 2009 for the holder of the authorisation to have or have access to a documentation meeting the requirements of Annex II to Royal Decree 2163/1994. Deadline for the implementation of the uniform principles: 31 January 2010 for products containing boscalid 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: as a new active substance, the corresponding data protection regime provided for in Article 30 of Royal Decree No 2163/1994 shall apply. Conditions for the inclusion of the active substance Carvone. Features:

Common Name: Carvone.

CAS No: 99-49-0 (d/l mixture). CIPAC No 602. Chemical name (IUPAC): 5-isopropenyl-2-methylcyclohex-2-en-1-one Minimum purity of the substance: ≥ 930 g/kg with a d/l ratio of at least 100:1.

Conditions of inclusion:

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

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 22 January 2008, Special attention must be given to:

The safety of operators, and include as a condition in the corresponding authorisations, where appropriate, risk mitigation measures.

Deadline for inclusion: 1 August 2008 to 31 July 2018. Deadline for the implementation of the conditions of inclusion: 31 July 2008. Time limit for the application of the requirements of an Annex II: 31 January 2009 for the holder of the authorisation to have or have access to a dossier satisfying the requirements of Annex II to Royal Decree No 2163/1994 Deadline for implementation of the uniform principles: 31 January 2010 for products containing carvone as the only active substance, or as one of several active substances included in their entirety in Annex I to Royal Decree 2163/1994 for that date, or at the later date to be laid down by the Order for which the active substances are included in the a question in Annex I to that Royal Decree.

Data protection: as the carvone is a new 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 Fluoxastrobin. Features:

Common name: Fluoxastrobin.

CAS No: 361377-29-9. CIPAC No 746. Chemical name (IUPAC): (E)-{2-[6-(2-chlolrophenoxy) -5-fluoropyrimidin-4-yloxy] phenyl} (5,6-dihydro-1,4,2-dioxazin-3-yl) methanone O-methyloxime. Minimum purity of the substance: ≥ 940 g/kg.

Conditions of inclusion:

Uses: can only be used as fungicide.

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 22 January 2008, Special attention must be given to:

The safety of the operators, in particular when handling the undiluted concentrate. The conditions of use shall contain appropriate protective measures, such as wearing a facial screen.

The protection of aquatic organisms, and include as a condition in the corresponding authorisations, where appropriate, risk mitigation measures, for example buffer zones. The levels of residues of fluoxastrobin metabolites when used as feed the straw of treated areas. The conditions of use shall include restrictions as regards the feeding of animals. The risk of accumulation on the soil surface, if the substance is used in a perennial crop or in the following crops in crop rotation systems, and include as a condition in the relevant authorisations, where appropriate, measures to reduce the risk.

Within two years, from the date of inclusion of fluoxastrobin, the notifier of the active substance must present:

Data to allow for a broad determination of aquatic risk, taking into account erratic aerosols, runoff, drainage and the effectiveness of potential risk reduction measures.

Data on the toxicity of metabolites that do not come from rats, if used as feed the straw of treated areas. Term of inclusion: 1 August 2008 to 31 July 2018. Deadline for the implementation of the conditions of inclusion: 31 July 2008. Deadline for the application of the requirements of an Annex II: 31 January 2009 for the holder of the authorisation to have or have access to a documentation meeting the requirements of Annex II to Royal Decree 2163/1994. Deadline for the implementation of the uniform principles: 31 January 2010 for products containing fluoxastrobin 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 fluoxastrobin a new 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 Paecilomyces lilacinus Thom. Features:

Common name: Paecilomyces lilacinus Thom Samson 1974 strain 251 (AGAL: n ° 89/030550).

N ° CIPAC: 753. Chemical name (IUPAC): not applicable. Minimum purity of the substance:

Conditions of inclusion:

Uses: can only be used as 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 22 January 2008, it should be addressed In particular: the safety of operators (even if it is not necessary to establish an AOEL, it is generally considered that the micro-organisms are potential sensitisers).

The protection of arthropods not subject to the treatment of leaves, and include as a condition in the corresponding authorisations, where appropriate, risk mitigation measures. Term of inclusion: 1 August 2008 to 31 July 2018. Deadline for the implementation of the conditions of inclusion: 31 July 2008. Deadline for the application of the requirements of an Annex II: 31 January 2009 for the holder of the authorisation to have or have access to a documentation meeting the requirements of Annex II to Royal Decree 2163/1994. Deadline for the implementation of the uniform principles: 31 January 2010 for products containing Paecilomyces lilacinus 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 Paecilomyces lilacinus a new 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 Protioconazole. Features:

Common name: Protioconazole.

CAS No 178928-70-6. CIPAC No 745. Chemical name (IUPAC): (RS) -2-[2-(1-chlorocyclopropyl) -3-(2-chlorophenyl) -2-hydroxypropyl] -2,4-dihydro-1,2,4-triazole-3 -thione. Minimum purity of the substance: ≥ 970 g/kg.

The following manufacturing impurities involve toxicological risks, and the concentration of each of them in the technical product must not exceed:

Toluene: < 5 g/kg.

Protohiconazole-dethio (2-(1-chlorocyclopropyl) 1-(2-chlorophenyl) -3-(1,2,4-triazol-1-yl) propan-2-ol): < 0,5 g/kg (LOD).

Conditions of inclusion:

Uses: can only be used as fungicide.

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 22 January 2008, Special attention must be given to:

The safety of operators in applications in the form of an aerosol, and include as a condition in the corresponding authorisations, where appropriate, appropriate protective measures.

The protection of aquatic organisms, and include as a condition in the relevant authorisations, where appropriate risk mitigation measures, for example buffer zones. The protection of birds and small mammals, and include as a condition in the relevant authorisations, where appropriate, risk mitigation measures. Within two years of the date of the inclusion of prothioconazole, the notifier of the active substance shall submit: Information to enable the exposure of consumers to the derivatives of the metabolite triazole in crops primary, in rotation crops and in products of animal origin. The comparison of the mode of action of prothioconazole and of the triazole metabolite derivatives in order to assess the toxicity resulting from the combined exposure to those compounds. Information to continue to take into account the long-term risks that the use of prothioconazole for the treatment of seeds represents for granivorous birds and mammals. Term of inclusion: 1 August 2008 to 31 July 2018. Deadline for the implementation of the conditions of inclusion: 31 July 2008. Deadline for the application of the requirements of an Annex II: 31 January 2009 for the holder of the authorisation to have or have access to a documentation meeting the requirements of Annex II to Royal Decree 2163/1994. Deadline for the implementation of the uniform principles: 31 January 2010 for products containing prothioconazole 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: as prothioconazole is a new 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 Metconazole. Features:

Common name: Metconazole.

N ° CAS 125116-23-6 (unspecified stereochemistry). CIPAC No 706. Chemical name (IUPAC): (1RS. 5RS: 1RS, 5SR) -5-(4-chlorobenzyl) 2,2-dimethyl-1-(1 H-1,2,4-triazol-1-ylmethyl) cyclopentanol. Minimum purity of the substance: ≥ 940 g/kg (sum of cis and trans isomers).

Conditions of inclusion:

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

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 23 May 2006, Special attention must be given to:

The protection of aquatic organisms, birds and mammals, and include as a condition in the corresponding authorisations, where appropriate, risk mitigation measures.

The safety of the operators, and include as a condition in the corresponding authorizations, where appropriate, protective measures. Deadline for inclusion: 1 June 2007 to 31 May 2017. Deadline for the implementation of the uniform principles: 31 May 2011 for products containing metconazole 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: as metconazole an old active substance, the corresponding data protection regime provided for in Article 30 of Royal Decree 2163/1994 shall apply.