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Order Pre/696/2008, Of 7 March, Which Are Included In Annex I Of Royal Decree 2163 / 1994 Of 4 November, Whereby The Community Harmonised Authorisation System Is Implanted To Market And Use Of Plant Protection Products, The...

Original Language Title: ORDEN PRE/696/2008, de 7 de marzo, por la que se incluyen en 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, la...

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TEXT

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 2007 /25/EC of 23 April 2007 to include the active substances dimethoate, dimethomorf, glufosinate, metribuzin, fosmet and propamocarb, by Commission Directive 2007 /50/EC of 2 August 2005, includes the following: active substances beflubutamide and virus of the nuclear polyhedrosis of the Exigua Spodoptera, and by Commission Directive 2007 /52/EC of 16 August the active substances ethoprophos, methyl pyrimidos and fipronil are included. Commission Directive 2007 /21/EC of 10 April 2007 amending Council Directive 91 /414/EEC as regards the expiry of the time limit for the inclusion in Annex I of the active substances azoxystrobin, imazalil, creoxim methyl, expiroxamine, azimsulfuron, prohexadione calcium and to establish the necessary arrangements for the renewal of the inclusion of those active substances. 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 which are included and renew their inclusion in Annex I to the Council Directive 91 /414/EEC of 15 July 1991 amending or removing them from compliance with the provisions of that Directive. This Order incorporates into national law the Commission Directives 2007 /25/EC of 23 April 2007 /50/EC of the Commission of 2 August 2007 /52/EC of the Commission of 16 August 2007 /21/EC of the European Parliament and of the Council of 10 April 2007 by the inclusion of the active substances dimethoate, dimethomorf, glufosinate, methrizin, fosmet and propamocarb, beflubutamide and virus of the nuclear polyhedrosis of the Spodoptera exigua, ethoprophos, methyl pyrimidos and fipronil, and the renewal of the inclusion of the active substances azoxystrobin, imazalil, cresoxim methyl, spiroxamine, azimsulfuron, prohexadione calcica and fluroxypir in Annex I to Royal Decree 2163/1994 of 4 November, and is given in accordance with the first provision of that Annex. 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 Agriculture, Fisheries and Food of the Minister for Health and Consumer Affairs and the Minister for 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.

Annex I to Royal Decree 2163/1994 of 4 November 1994 laying down the harmonised Community system of authorisation for the marketing and use of plant protection products is hereby amended as follows: The following active substances are included:

"Dimetoate, dimethomorf, glufosinate, mettribuzin, fosmet, propamocarb, beflubutamide, nuclear polyhedrosis virus of the Spodoptera exigua, ethoprophos, methyl pyrimidos and fipronil."

Two. The inclusion of the following active substances is renewed:

"Azoxystrobin, imazalil, cresoxim methyl, spiroxamine, azimsulfuron, prohexadione calcium and fluroxypir."

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, 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 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 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. In the Official Register of products and plant protection material of the Directorate-General for Agriculture, the Ministry of Agriculture, Fisheries and Food, the European Commission's review reports shall be made available to interested parties. 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 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, 7 March 2008. -First Vice-President of the Government and Minister of the Presidency, Maria Teresa Fernández de la Vega Sanz.

Attachment

Inclusion of the active substances in Annex I

Conditions for the inclusion of the active substance Dimetoate. Features:

Common name: Dimetoate.

CAS: 60-51-5. No. CIPAC: 59. Chemical name: O, O-Dimethyl-S-(N-methyl-carbamoylmethyl) phosphoro-dithioat; 2-Dimethoxy-phosphinothioylthio-N-methylacetamide. Minimum purity of the substance: ≥ 950 g/kg. Impurities of the active substance: omethoate: max. 2 g/kg; isodimethoate: max. 3 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 24 November 2006, should be particularly addressed to:

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

the protection of birds, mammals, aquatic organisms and other non-target arthropods, and include as a condition in the relevant authorisations, where appropriate risk mitigation measures are appropriate. the food exposure of consumers.

Further studies will be presented to confirm the risk assessment for non-target birds, mammals and arthropods, as well as to confirm the toxicological assessment of potentially present metabolites. in the harvests. Such studies shall be provided to the Administration 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. Time limit 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 dimethoate 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 dimethoate 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 Dimetomorph.

Features:

Common Name: Dimetomorf.

CAS No: 110488-70-5. No. CIPAC: 483. Chemical name: (E, Z) 4-[3-(4-chlorophenyl) -3-(3,4-dimethoxyphenyl)-acrylyl] morpholine. Minimum purity of the substance: ≥ 965 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 24 November 2006, should be particularly addressed to:

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

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

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

Deadline for implementation of the conditions of inclusion: 30 September 2007. Time limit 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 dimethomorph 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 dimethomorf 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 Glufosinate.

Features:

Common Name: Glufosinate.

CAS: 77182-82-2. No. CIPAC: 437.007. Chemical name: ammonium (DL)-homoalanine-4-yl (methyl) phosphinate. Minimum purity of the substance: ≥ 950 g/kg.

Conditions of inclusion:

Uses: can only be used as a herbicide.

In the assessment of applications for authorisation of plant protection products containing glufosinate for uses other than those for apple plantations, particular attention shall be paid to the criteria In the case of operators and consumers, in particular as regards operators and consumers, all the necessary information and information must be provided before the granting of the aid is provided for in Article 15 (3) (b) of Royal Decree No 2163/1994 of 4 November 1994. authorisation. 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 24 November 2006, pay particular attention to:

the safety of operators, workers and bystanders, and include as a condition in the relevant authorisations, where appropriate protective measures are appropriate.

the potential for groundwater contamination, when the active substance is applied in areas with vulnerable soil and/or climatic conditions. the protection of mammals and arthropods and non-target plants, and include as a condition in the relevant authorisations, where appropriate risk mitigation measures are appropriate.

Further studies will be presented to confirm the risk assessment for mammals and non-target arthropods in apple plantations. Such studies shall be provided to the Administration 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. Time limit 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 glufosinate 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 glufosinate 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 Mettribuzin.

Features:

Common Name: Mettribuzin.

CAS No: 21087-64-9. No. CIPAC: 283. Chemical name: 4-amino-6-tert-butyl-3-methylthio-1,2,4-triazin-5 (4H)-one. Minimum purity of the substance: ≥ 910 g/kg.

Conditions of inclusion:

Uses: can only be used as a herbicide.

In the assessment of applications for authorisation of plant protection products containing metribuzin for other uses than those for selective post-emergency herbicide on potatoes, particular attention shall be paid to: the criteria laid down in Article 15 (3) (b) of Royal Decree No 2163/1994 of 4 November 1994, in particular as regards operators and consumers, in order to provide all the necessary information and information before granting the authorisation. 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 24 November 2006, pay particular attention to:

the protection of algae, aquatic plants and non-target plants outside the treated field, and include as a condition in the relevant authorisations, where appropriate risk mitigation measures are appropriate.

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

Further studies will be presented to confirm the risk assessment for groundwater. Such studies shall be provided to the Administration within two years of the entry into force of this Order.

Deadline for inclusion: 1 October 2007 to 30 September 2017. Deadline for the implementation of the conditions of inclusion: 30 September 2007. Time limit 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 metribuzin 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 mettribuzin 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 Fosmet.

Features:

Common Name: Fosmet.

CAS No: 732-11-6. No. CIPAC: 318. Chemical name: O, O-dimethyl S-phthalimido-methyl phosphorodithioate; N-(dimethoxyphosphinoyl-thiomethyl) fatalimide. Minimum purity of the substance: ≥ 950 g/kg. Impurities of the active substance: fosmet oxon: max. 0,8 g/kg; iso fosmet: max. 0,4 g/kg.

Conditions of inclusion:

Uses: can only be used as insecticide and acaricide.

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 24 November 2006, should be particularly addressed to:

the protection of birds, mammals, aquatic organisms, bees and other non-target arthropods, and include as a condition in the relevant authorisations, where appropriate risk mitigation measures, such as buffer zones and the reduction of the contribution of runoff and discharges to surface waters.

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

Further studies will be presented to confirm the risk assessment for birds (severe risk) and herbivorous mammals (long-term risk). Such studies shall be provided to the Administration 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 implementation of the uniform principles: 30 September 2011 for products containing fosmet as the only active substance, or as one of several active substances included in their entirety in Annex I to Royal Decree No 2163/1994 for that date, or if it is later, at the time limit set by the Order for which the active substances concerned are included in Annex I to the Royal Decree No 2163/1994 Decree.

Data protection: for being the phosmet 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 Propamocarb.

Features:

Common Name: Propamocarb.

CAS No. 24579-73-5. No. CIPAC: 399. Chemical name: Propyl 3-(dimethylamino)-propylcarbamate. Minimum purity of the substance: ≥ 920 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 24 November 2006, should be particularly addressed to:

the safety of operators and workers, and include as a condition in the relevant authorisations, where appropriate protective measures are appropriate.

the transfer of residues present in the soil in the following crop or crop crops. the protection of surface water or groundwater in vulnerable areas. the protection of birds, mammals and aquatic organisms, and shall include as a condition in the relevant authorisations, where appropriate risk mitigation measures are appropriate.

In the assessment of applications for authorisation of plant protection products containing propamocarb for different uses of foliar applications, particular attention shall be paid to the criteria Article 15 (3) (b) of Royal Decree No 2163/1994 as regards the exposure of workers, for which all the necessary information and information shall be provided before the authorisation is granted.

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

Deadline for implementation of the conditions of inclusion: 30 September 2007. Time limit 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 propamocarb 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 the purpose of propamocarb 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 Beflubutamide.

Features:

Common name: Beflubutamide.

CAS No: 113614-08-7. No. CIPAC: 662. Chemical name: (RS) -N-benzyl-2-(4-fluoro-3-trifluoromethylphenoxy) butanamide. 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 15 May 2007, must pay particular attention to:

the protection of aquatic organisms, and include as a condition in the relevant authorisations, where appropriate risk mitigation measures are appropriate.

Deadline for inclusion: 1 December 2007 to 30 November 2017.

Deadline for implementation of the conditions of inclusion: 30 November 2007. Time limit for the application of the requirements of an Annex II: 31 May 2008. Deadline for the implementation of the uniform principles: 31 May 2009 for products containing beflutamide 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 beflutamide 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 Virus from the Nuclear Poliedrosis of the Exigua Spodoptera.

Features:

Common Name: Nuclear Poliedrosis Virus of the Exigua Spodoptera.

N. CIPAC: Unassigned. Chemical name: not applicable.

Conditions of inclusion:

Uses: can only be used as an insecticide.

The assessment report of the European Commission, approved by the Standing Committee on the Food Chain and Animal Health at its meeting of 15 May 2007, will be taken into account in the overall assessment, according to the uniform principles. Deadline for inclusion: 1 December 2007 to 30 November 2017. Deadline for the implementation of the conditions of inclusion: 30 November 2007. Time limit for the application of the requirements of an Annex II: 31 May 2008. Deadline for the implementation of the uniform principles: 31 May 2009 for products containing VPNs, either 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 the said Royal Decree.

Data protection: for the VPNs to be 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 Etoprofos.

Features:

Common Name: Etoprofos.

CAS No. 13194-48-4. No. CIPAC: 218. Chemical name: O-ethyl dithiophosphate and S, S-dipropyl. Minimum purity of the substance: ≥ 940 g/kg.

Conditions of inclusion:

Uses: can only be used as nematicide and insecticide for application on soil, limited to professional users.

In the assessment of applications for the authorisation of plant protection products containing ethoprophos for other uses than potatoes not grown for human or animal consumption, particular attention shall be paid to the criteria Article 15 (3) (b) of Royal Decree No 2163/1994 provides that all the necessary information and information shall be provided before the authorisation is granted. 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 16 March 2007, it should be addressed especially to:

Waste and assess the food exposure of consumers with a view to revising the maximum residue limits in the future.

The safety of operators: the authorised conditions of use shall require the use of appropriate personal protective equipment and respiratory protection, and other risk mitigation measures, such as the use of a system Transfer closed for the distribution of the product. the protection of birds, mammals, aquatic organisms and surface waters and groundwater under vulnerable conditions, and include as a condition in the relevant authorisations, where appropriate risk mitigation measures are appropriate; as buffer zones, and the achievement of the total incorporation of the granules to the soil.

Further studies will be presented to confirm the short-and long-term risk assessment for birds and mammals that eat earthworms. Such studies shall be provided to the Administration 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 November 2007. Time limit 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 ethoprophos 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 ethoprophos 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 Metil-pyrimidos.

Features:

Common Name: Metil-pyrimidos.

CAS No. 29232-93-7. No. CIPAC: 239. Chemical name: O-(2-diethylamino-6-methylpyrimidin-4-yl) and O, O-dimethyl, thiophosphate. Minimum purity of the substance: ≥ 880 g/kg.

Conditions of inclusion:

Uses: can only be used as insecticide for post-harvest storage.

In the assessment of applications for authorisation of plant protection products containing methyl-pyrimyfos for other uses other than applications with automated systems in empty cereal stores, it shall be provided special attention to the criteria laid down in Article 15 (3) (b) of Royal Decree No 2163/1994, for which all the necessary information and information shall be provided before the authorisation is granted. 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 16 March 2007, it should be addressed especially to:

The safety of operators: the authorised conditions of use shall require the use of appropriate personal protective equipment and respiratory protection, and other risk mitigation measures to reduce the exposure.

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

Further studies will be presented in order to confirm the assessment of the operators ' exposure. Such studies shall be provided to the Administration 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 November 2007. Time limit 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 methyl-pyrimidos 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 the said Royal Decree.

Data protection: for being the methyl-pyrimidos 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 Fipronil.

Features:

Common Name: Fipronil.

CAS No. 120068-37-3. No. CIPAC: 581. Chemical name: (±)-5-amino-1-(2,6-dichloro-α, α, α-trylluoropara-tolyl)-4-trifluoromethylsulfinyl-pyrazole-3-carbonitrile. Minimum purity of the substance: ≥ 950 g/kg.

Conditions of inclusion:

Uses: can only be used as insecticide for the treatment of seeds. The application in the seed shall only be carried out in facilities for the professional treatment of seeds. Those facilities shall apply the best available techniques to ensure that dust clouds can be excluded during conservation, transport and application.

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 16 March 2007, Special attention must be given to:

Packaging of products marketed to avoid the generation of dangerous photodegradation products.

The possibility of groundwater contamination, especially by metabolites that are more persistent than the parent compound, when the active substance is applied in areas of climatic or soil characteristics. vulnerable. The protection of granivorous birds and mammals, aquatic organisms, non-target arthropods and melliferous bees, and include as a condition in the relevant authorisations, where appropriate risk mitigation measures are appropriate. The use of suitable equipment that ensures a high level of incorporation to the soil and the minimization of spills during the application.

Further studies will be presented in order to confirm the risk assessment for granivorous birds and mammals, as well as for melliera bees, especially bee breeding. Such studies shall be provided to the Administration within one year 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 November 2007. Time limit 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 finpronil 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 fipronil an old active substance, the corresponding data protection regime provided for in Article 30 of Royal Decree 2163/1994 shall apply.

Renewal of the inclusion of the active substances in Annex I Conditions for the renewal of the inclusion of the active substance Imazalil. Features:

Common Name: Imazalil.

CAS: 73790-28-0.35554-44-0. No. CIPAC: 335. Chemical name: (+) -1-(ß-allyloxy-2,4-dichlorophenylethyl) imidazole or (+)-allyl 1-(2,4-dichlorophenyl) -2-imidazol-1-ylethyl ether. Minimum purity of the substance: ≥ 975 g/kg.

Conditions of inclusion: Uses: It can only be used as a fungicide.

The uses listed below will be subject to the particular conditions indicated:

treatments after the collection of fruit, vegetables and potatoes may be authorised only if an adequate decontamination system is available or if, by means of a risk assessment, it has been demonstrated that the the treatment solution does not imply an unacceptable risk to the environment, and in particular to aquatic organisms.

treatments after the collection of potatoes may be authorised only if, by means of a risk assessment, it has been shown that the discharge of the treatment residues from the treated potatoes does not imply a unacceptable risk to aquatic organisms. Foliar outdoor uses may be authorised only if, by means of a risk assessment, it has been demonstrated that the use has no unacceptable effect on human or animal health or on the environment.

Deadline for renewal of inclusion: 1 January 1999 to 31 December 2011. Conditions for the renewal of the inclusion of the active substance Azoxystrobin.

Features:

Common name: Azoxistrobin.

CAS No. 131860-33-8. No. CIPAC: 571. Chemical name: (E) -2-2 [6-(2-cyanophenoxy) pyrimidin-4-yloxy] phenyl -3-methoxyacrylate methyl. Minimum purity of the substance: ≥ 930 g/kg (max. Z-isomer 25 g/kg).

Conditions of inclusion: Uses: It can only be used as a fungicide.

In decisions on the basis of uniform principles, the impact on aquatic organisms must be addressed in particular, and should include as a condition in the relevant authorisations, where appropriate risk reduction.

Deadline for renewal of inclusion: 1 July 1998 to 31 December 2011. Conditions for the renewal of the inclusion of the active substance Cresoxim-methyl.

Features:

Common Name: Cresoxim-methyl.

CAS No. 143390-89-0. No. CIPAC: 568. Chemical name: (E) -2-methoxyimino-2-[2-(o-tolyloxymethyl) phenyl] methyl acetate. Minimum purity of the substance: ≥ 910 g/kg.

Conditions of inclusion:

Uses: It can only be used as a fungicide.

In the decisions under the uniform principles, the protection of groundwater in vulnerable situations must be addressed in particular.

Deadline for renewal of inclusion: 1 February 1999 to 31 December 2011.

Conditions for the renewal of the inclusion of the active substance Expiroxamine.

Features:

Common name: Espiroxamine.

CAS: 1181134-30-8. No. CIPAC: 572. Chemical name: (8-tert-butyl-1,4-dioxaspiro [4.5] decan-2-ylmethyl)-ethylpropylamine. Minimum purity of the substance: ≥ 940 g/kg (diastereoisomers A and B combined).

Conditions of inclusion:

Uses: It can only be used as a fungicide.

In decisions in accordance with the uniform principles, special attention must be given to:

the safety of operators, and include as a condition in the relevant authorisations, where appropriate protective measures are appropriate.

the incidence on aquatic organisms, and include as a condition in the relevant authorisations, where appropriate risk mitigation measures are appropriate.

Deadline for renewal of the inclusion: from 1 September 1999 to 31 December 2011.

Conditions for the renewal of the inclusion of the active substance Azimsulfuron.

Features:

Common name: Azimsulfuron.

CAS No. 120162-55-2. No. CIPAC: 584. Chemical name: 1-(4,6-dimethoxypyrimidin-2-yl)-3-[1-methyl-4-(22-methyl-2H-tetrazole-5-yl)-pyrazole-5-yl-sulfonyl]-urea. Minimum purity of the substance: 980 g/kg.

Conditions of inclusion: Uses: It can only be used as a herbicide.

No air applications may be authorised. In decisions in accordance with the uniform principles, the impact on aquatic organisms and non-target terrestrial plants should be addressed in particular, and should include as a condition in the relevant authorisations, where appropriate risk mitigation measures (e.g. in paddy fields, minimum water retention periods prior to discharge).

Deadline for renewal of inclusion: 1 October 1999 to 31 December 2011. Conditions for the renewal of the inclusion of the active substance Fluroxipir.

Features:

Common Name: Fluroxipir.

CAS No. 69377-81-7. No. CIPAC: 431. Chemical name: 4-amino-3,5-dichloro-6-fluoro-2-pyridyloxyacetic acid. Minimum purity of the substance: 950 g/kg.

Conditions of inclusion: Uses: It can only be used as a herbicide.

In decisions in accordance with the uniform principles, special attention must be given to:

the additional information requested in point 7 of the review report of 30 November 1999.

the protection of groundwater. the impact on aquatic organisms, and include as a condition in the relevant authorisations, where appropriate risk mitigation measures are appropriate.

Deadline for renewal of inclusion: 1 December 2000 to 31 December 2011. Conditions for the renewal of the inclusion of the active substance Prohexadione calcium.

Features:

Common name: Prohexadione calcium.

CAS No. 127277-53-6. No. CIPAC: 567. Chemical name: 3,5-dioxo-4-propionyl cyclohexanecarboxylate calcium. Minimum purity of the substance: 890 g/kg.

Conditions of inclusion:

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

Deadline for renewal of inclusion: 1 October 2000 to 31 December 2011.