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Order Pre/777/2009, Of 26 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, L...

Original Language Title: Orden PRE/777/2009, de 26 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, l...

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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. That Directive was incorporated into the Spanish legal order under Royal Decree No 2163/1994 of 4 November 1994 imposing a harmonised Community system of authorisation to place plant protection products on the market and use. Furthermore, the Order of 14 April 1999 sets out Annex I to that Royal Decree, under the heading 'Community list of active substances', as defined in Article 2 (16) of the royal decree itself, as the list of substances (a) which are accepted by the European Commission whose incorporation into plant protection products is authorised and which shall be made public by national provisions, as a result of other Community provisions.

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 2008 /66/EC of 30 June 2008 includes the active substances bifenox, diflufenican, fenoxaprop-P, fenpropidin and quinoclamine, by Directive 2008 /69/EC of 1 July 2008, including the active substances clofentecine, dicamba, difenoconazole, diflubenzuron, imazaquin, lenacil, oxadiazon, picloram and pyriproxyfen, by Directive 2008 /70/EC of 11 July, the active substance tritosulfuron is included, and Directive 2008 /91/EC of 29 September 2008 includes the active substance diuron.

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 the groundwater, and 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 this Regulation. Council Directive 91 /414/EEC of 15 July 1991 amending or removing them from compliance with the provisions set out in that Directive.

This order incorporates Commission Directives 2008 /66/EC of 30 June 2008 /69/EC of the Commission of 1 July 2008 /70/EC of 11 July 2008 and 2008 /91/EC of the Commission of the European Union into the internal legal order of 11 July 2008 By the inclusion of the active substances bifenox, diflufenican, phenoxaprop-P, fenpropidin, quinoclamine, clofentecine, dicamba, difenoconazole, diflubenzuron, imazaquin, lenacil, oxadiazon, picloram, pyriproxyfen, tritosulfuron and diuron, and is dictated according to the final disposition of the Royal Decree 2163/1994, dated 4 November.

The Inter-Ministerial Commission for Food Management has issued the mandatory report on this provision. In addition, the autonomous communities and the sectors concerned have been consulted.

Under the proposal of the Minister for the Environment, and the Rural and Marine Environment and the Minister for Health and Consumer Affairs, I have:

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

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

The following active substances are included: bifenox, diflufenican, phenoxaprop-P, fenpropidin, quinoclamine, clofenecin, dicamba, difenoconazole, diflubenzuron, imazaquin, lenacil, oxadiazon, picloram, pyriproxyfen, tritosulfuron and diuron.

Single additional disposition. Review of the authorizations.

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 prior to the commencement 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 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 that 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, March 26, 2009. -First Vice-President of the Government and Minister of the Presidency, Maria Teresa Fernandez de la Vega Sanz.

ANNEX

Inclusion of the active substances in Annex I

Conditions for the inclusion of the active substance Bifenox

Features:

Common name: Bifenox.

CAS No. 42576-02-3.

NO CIPAC: 413.

Chemical name (IUPAC): 5-(2,4-dichlorophenoxy) -2-methyl nitrobenzoate.

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

Max. 3 g/kg 2,4-dichlorophenol.

Max. 6 g/kg 2,4-dichloroanisole.

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 conclusions of the review report of the European Commission, approved by the Standing Committee on the Food Chain and Animal Health at its meeting of 14 March 2008, 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 exposure of consumers through feeding to bifenox residues in products of animal origin and in subsequent rotation crops.

Within two years from the date of inclusion of bifenox, the notifier/s of the active substance shall present:

Information on residues of bifenox and its metabolite hydroxy-bifenox in food of animal origin and on bifenox residues in crop rotation.

Information to control the long-term risk to herbivorous mammals derived from the use of bifenox.

Deadline for inclusion: From 1 January 2009 to 31 December 2018.

Deadline for implementation of the conditions of inclusion: 31 December 2008.

Deadline for implementation of the requirements of an Annex II: 30 June 2009, to provide that the holder of the authorisation has access to a documentation meeting the requirements of Annex II to Royal Decree 2163/1994 of 4 November, where the substance is of different origin than that of the main notifier.

Deadline for implementation of the uniform principles: 31 December 2012 for products containing bifenox 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, 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 bifenox 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 Diflufenican

Features:

Common name: Diflufenican.

CAS: 83164-33-4.

NO CIPAC: 462.

Chemical name (IUPAC): 2 ', 4'-difluoro-2-(,,-trifluoro-m-tolyloxy) nicotinanilide.

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 conclusions of the review report of the European Commission, approved by the Standing Committee on the Food Chain and Animal Health at its meeting of 14 March 2008, must be addressed especially to:

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

The protection of plants to which the product is not intended, and include when appropriate risk mitigation measures, for example buffer zones without spraying on plots

Deadline for inclusion: From 1 January 2009 to 31 December 2018.

Deadline for implementation of the conditions of inclusion: 31 December 2008.

Deadline for implementation of the requirements of an Annex II: 30 June 2009, to provide that the holder of the authorisation has access to a documentation meeting the requirements of Annex II to Royal Decree 2163/1994 of 4 November, where the substance is of different origin than that of the main notifier.

Deadline for implementation of the uniform principles: 31 December 2012 for products containing diflufenican 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 of 4 November 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 diflufenican an old active substance, the corresponding data protection regime provided for in Article 30 of Royal Decree 2163/1994 of 4 November will apply.

Conditions for the inclusion of the active substance Fenoxaprop-P

Features:

Common Name: Fenoxaprop-P.

CAS: 113158-40-0.

NO CIPAC: 484.

Chemical name (IUPAC): Acid (R) -2 [4-[(6-chloro-2-benzoxazolyl) oxy]-phenoxy]-propanoic.

Minimum purity of the substance: ≥ 920 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 conclusions of the review report of the European Commission, approved by the Standing Committee on the Food Chain and Animal Health at its meeting of 14 March 2008, must be addressed especially 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 plants that the product is not intended for.

The presence of the protective mefenpir-diethyl in formulated products, with respect to the exposure of workers, workers and others.

The persistence of the substance and some of its degradation products in areas and colder areas in which aerobic conditions may occur, and include, where appropriate, risk mitigation measures.

Deadline for inclusion: From 1 January 2009 to 31 December 2018.

Deadline for implementation of the conditions of inclusion: 31 December 2008.

Deadline for implementation of the requirements of an Annex II: 30 June 2009 to determine that the holder of the authorisation has access to a documentation meeting the requirements of Annex II to Royal Decree 2163/1994, 4 November, where the substance is of different origin than that of the main notifier.

Deadline for implementation of the uniform principles: 31 December 2012 for products containing fenoxaprop-P 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 of 4 November 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 phenoxaprop-P 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 Fenpropidin

Features:

Common name: Fenpropidine.

CAS: 67306-00-7.

No. CIPAC: 520.

Chemical name (IUPAC): (R, S)-1-[3-(4-tert-butylphenyl)-2-methylpropyl]-piperidine.

Minimum purity of the substance: ≥ 960 g/kg (racemate).

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 conclusions of the review report of the European Commission, approved by the Standing Committee on the Food Chain and Animal Health at its meeting of 14 March 2008, 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, for example buffer zones.

Within two years from the date of inclusion of fenpropidin, the notifier/s of the active substance shall present:

Information to control the long-term risk to herbivorous and insect birds derived from the use of fenpropidin.

Deadline for inclusion: From 1 January 2009 to 31 December 2018.

Deadline for implementation of the conditions of inclusion: 31 December 2008.

Deadline for implementation of the requirements of an Annex II: 30 June 2009 to determine that the holder of the authorisation has access to a documentation meeting the requirements of Annex II to Royal Decree 2163/1994 of 4 November, where the substance is of different origin than that of the main notifier.

Deadline for implementation of the uniform principles: 31 December 2012 for products containing fenpropidin 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 of 4 November 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 fenpropidin an old active substance, the corresponding data protection regime provided for in Article 30 of Royal Decree 2163/1994 of 4 November will apply.

Conditions for the inclusion of the active substance Quinoclamina

Features:

Common name: Quinoclamina.

CAS: 2797-51-5.

NO CIPAC: 648.

Chemical name (IUPAC): 2-amino-3-chloro-1,4-naphthoquinone.

Minimum purity of the substance: ≥ 965 g/kg impurities:

Max. 15 g/kg diclone (2,3-dichloro-1,4-naphthoquinone).

Conditions of inclusion:

Uses: Can only be used as a herbicide.

In the assessment of applications for authorisation of plant protection products containing quinoclamine for other uses than ornamental and nursery plants, they shall be assessed in accordance with the uniform principles, taking into account as set out in Article 15 of Royal Decree 2163/1994 of 4 November 1994.

In the overall assessment, in accordance with the uniform principles, on the basis of the conclusions of the review report of the European Commission, approved by the Standing Committee on the Food Chain and Animal Health at its meeting of 14 March 2008, must be addressed especially to:

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

The protection of aquatic organisms,

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

Deadline for inclusion: From 1 January 2009 to 31 December 2018

Deadline for implementation of the inclusion conditions: December 31, 2008

Deadline for implementation of the requirements of an Annex II: 30 June 2009 to determine that the holder of the authorisation has access to a documentation meeting the requirements of Annex II to Royal Decree 2163/1994 of 4 November, where the substance is of different origin than that of the main notifier.

Deadline for implementation of the uniform principles: 31 December 2012 for products containing quinoclamine 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 of 4 November 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 niclocamine 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 Clofentecine

Features:

Common Name: Cloffentecin.

CAS: 74115 -24-5.

NO CIPAC: 418.

Chemical name (IUPAC): 3,6-bis (2-chlorophenyl) -1,2,4,5-tetrazine.

Minimum purity of the substance: ≥ 980 g/kg (dry matter).

Conditions of inclusion:

Uses: Can only be used as acaricide.

In the overall assessment, according to the uniform principles, the conclusions of the review report of the European Commission, approved by the Standing Committee on the Food Chain and Animal Health at its meeting of March 14, 2008.

Deadline for inclusion: From 1 January 2009 to 31 December 2018

Deadline for implementation of the inclusion conditions: December 31, 2008

Deadline for implementation of the requirements of an Annex II: 30 June 2009 to determine that the holder of the authorisation has access to a documentation meeting the requirements of Annex II to Royal Decree 2163/1994 of 4 May 2009. November, where the substance is of different origin than the main notifier.

Deadline for implementation of the uniform principles: 31 December 2013 for products containing clofentecin as the only active substance or as one of several active substances included in the Annex to this Regulation I of Royal Decree 2163/1994 for that date, or if it is later, on the deadline set by the Order for which the active substances concerned are included in Annex I to that royal decree.

Data protection: For being the clofentecine 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 Dicamba

Features:

Common Name: Dicamba.

CAS: 1918-00-9.

NO CIPAC: 85.

Chemical name (IUPAC): 3,6-dichloro-2-methoxybenzoic acid.

Minimum purity of the substance: ≥ 850 g/kg.

Conditions of inclusion:

Uses: Dolo can be used as a herbicide.

In the overall assessment, according to the uniform principles, the conclusions of the review report of the European Commission, approved by the Standing Committee on the Food Chain and Animal Health at its meeting of March 14, 2008.

Deadline for inclusion: From 1 January 2009 to 31 December 2018

Deadline for implementation of the inclusion conditions: December 31, 2008

Deadline for implementation of the requirements of an Annex II: 30 June 2009 to determine that the holder of the authorisation has access to a documentation meeting the requirements of Annex II to Royal Decree 2163/1994 of 4 November, where the substance is of different origin than that of the main notifier.

Deadline for implementation of the uniform principles: 31 December 2013 for products containing dicamba 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, 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 use 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 Difenoconazole

Features:

Common name: Difenoconazole.

CAS: 119446-68-3.

NO CIPAC: 687.

Chemical name (IUPAC): 3-chloro-4-[(2RS, 4RS; 2RS, 4SR) -4-methyl-2-(1H-1,2,4-triazol-1-ylmethyl)] -1,3-dioxolan-2-ylphenyl 4-chlorophenyl ether.

Minimum purity of the substance: ≥ 940 g/kg.

Conditions of inclusion:

Uses: It can only be used as a fungicide.

In the overall assessment, in accordance with the uniform principles, on the basis of the conclusions of the review report of the European Commission, approved by the Standing Committee on the Food Chain and Animal Health at its meeting of 14 March 2008, must be addressed especially to:

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

Deadline for inclusion: From 1 January 2009 to 31 December 2018.

Deadline for implementation of the conditions of inclusion: 31 December 2008.

Deadline for implementation of the requirements of an Annex II: 30 June 2009 to determine that the holder of the authorisation has access to a documentation meeting the requirements of Annex II to Royal Decree 2163/1994 of 4 November, where the substance is of different origin than that of the main notifier.

Deadline for implementation of the uniform principles: 31 December 2013 for products containing difenoconazole 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 of 4 November 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 difenoconazole an old active substance, the corresponding data protection regime provided for in Article 30 of Royal Decree 2163/1994 of 4 November shall apply.

Conditions for the inclusion of the active substance Diflubenzuron

Features:

Common name: Diflubenzuron.

CAS: 35367-38-5.

NO CIPAC: 339.

Chemical name (IUPAC): 1-(4-chlorophenyl) -3-(2,6-difluorobenzoyl) urea.

Minimum purity of the substance: ≥ 950 g/kg, impurities: max. 0.03 g/kg 4-chloroaniline.

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 conclusions of the review report of the European Commission, approved by the Standing Committee on the Food Chain and Animal Health at its meeting of 14 March 2008, must be addressed especially to:

The protection of aquatic organisms.

The protection of terrestrial organisms.

The protection of arthropods not subject to treatment, including bees, and include in the respective authorisations, where appropriate, risk mitigation measures.

Deadline for inclusion: From 1 January 2009 to 31 December 2018.

Deadline for implementation of the conditions of inclusion: 31 December 2008.

Deadline for implementation of the requirements of an Annex II: 30 June 2009 to determine that the holder of the authorisation has access to a documentation meeting the requirements of Annex II to Royal Decree 2163/1994, where the substance is of different origin than that of the main notifier.

Deadline for implementation of the uniform principles: 31 December 2013 for products containing diflubenzuron 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 of 4 November 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 diflubenzuron an old active substance, the corresponding data protection regime provided for in Article 30 of Royal Decree 2163/1994 of 4 November shall apply.

Conditions for the inclusion of the active substance Imazaquin

Features:

Common Name: Imazaquin.

CAS number: 81335-37-7.

NO CIPAC: 699.

Chemical name (IUPAC): 2-[(RS) -4-isopropyl-4-methyl-5-oxo-2-imidazolin-2-yl] quinoline-3-carboxylic acid.

Minimum purity of the substance: ≥ 960 g/kg (racemic mixture).

Conditions of inclusion:

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

In the overall assessment, according to the uniform principles, the conclusions of the evaluation report of the European Commission, approved by the Standing Committee on the Food Chain and Animal Health at its meeting of March 14, 2008.

Deadline for inclusion: From 1 January 2009 to 31 December 2018

Deadline for implementation of the inclusion conditions: December 31, 2008

Deadline for implementation of the requirements of an Annex II: 30 June 2009 to determine that the holder of the authorisation has access to a documentation meeting the requirements of Annex II to Royal Decree 2163/1994 of 4 November, where the substance is of different origin than that of the main notifier.

Deadline for implementation of the uniform principles: 31 December 2013 for products containing imazaquin as the only active substance, or as one of several active substances included in their entirety in Annex I of Royal Decree No 2163/1994 of 4 November 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 imazaquin an old active substance, the corresponding data protection regime provided for in Article 30 of Royal Decree 2163/1994 of 4 November will apply.

Conditions for the inclusion of the active substance Lenacil

Features:

Common Name: Lenacil.

CAS: 2164-08-1.

NO CIPAC: 163.

Chemical name (IUPAC): 3-cyclohexyl-1,5,6,7-tetrahydrocyclopentapyrimidine-2,4 (3H)-dione.

Minimum purity of the substance: ≥ 975 g/kg.

Conditions of inclusion:

Uses: Can only be used as a herbicide.

In the overall assessment, according to the uniform principles, the conclusions of the review report of the European Commission, approved by the Standing Committee on the Food Chain and Animal Health at its meeting of March 14, 2008.

Deadline for inclusion: From 1 January 2009 to 31 December 2018.

Deadline for implementation of the conditions of inclusion: 31 December 2008.

Deadline for implementation of the requirements of an Annex II: 30 June 2009 to determine that the holder of the authorisation has access to a documentation meeting the requirements of Annex II to Royal Decree 2163/1994 of 4 November, where the substance is of different origin than that of the main notifier.

Deadline for implementation of the uniform principles: 31 December 2013 for products containing lenacil as the only active substance or as one of several active substances included in their entirety in Annex I of Royal Decree No 2163/1994 of 4 November 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 lenacil 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 Oxadiazon

Features:

Common name: Oxadiazon.

CAS No. 19666-30-9.

NO CIPAC: 213.

Chemical name (IUPAC): 5-tert-butyl-3-(2,4-dichloro-5-isopropoxyphenyl)-1,3,4-oxadiazole-2-(3H)-one.

Minimum purity of the substance: ≥ 940 g/kg.

Conditions of inclusion:

Uses: Can only be used as a herbicide.

In the overall assessment, according to the uniform principles, the conclusions of the review report of the European Commission, approved by the Standing Committee on the Food Chain and Animal Health at its meeting of March 14, 2008.

Deadline for inclusion: From 1 January 2009 to 31 December 2018.

Deadline for implementation of the conditions of inclusion: 31 December 2008.

Deadline for implementation of the requirements of an Annex II: 30 June 2009 to determine that the holder of the authorisation has access to a documentation meeting the requirements of Annex II to Royal Decree 2163/1994 of 4 November, where the substance is of different origin than that of the main notifier.

Deadline for implementation of the uniform principles: 31 December 2013 for products containing oxadiazon as the only active substance or as one of several active substances included in their entirety in Annex I of Royal Decree No 2163/1994 of 4 November 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 oxadiazon an old active substance, the corresponding data protection regime provided for in Article 30 of Royal Decree 2163/1994 of 4 November shall apply.

Conditions for the inclusion of the active substance Picloram

Features:

Common name: Picloram.

CAS No. 1918-02-1.

NO CIPAC: 174.

Chemical name (IUPAC): 4-amino-3,5,6-trichloropyridine-2-carboxylic acid.

Minimum purity of the substance: ≥ 920 g/kg.

Conditions of inclusion:

Uses: Can only be used as a herbicide.

In the overall assessment, according to the uniform principles, the conclusions of the review report of the European Commission, approved by the Standing Committee on the Food Chain and Animal Health at its meeting of March 14, 2008.

Deadline for inclusion: From 1 January 2009 to 31 December 2018.

Deadline for implementation of the conditions of inclusion: 31 December 2008.

Deadline for implementation of the requirements of an Annex II: 30 June 2009 to determine that the holder of the authorisation has access to a documentation meeting the requirements of Annex II to Royal Decree 2163/1994 of 4 November, where the substance is of different origin than that of the main notifier.

Deadline for implementation of the uniform principles: 31 December 2013 for products containing picloram as the only active substance or as one of several active substances included in their entirety in Annex I of Royal Decree No 2163/1994 of 4 November 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 picloram 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 Piriproxyfen

Features:

Common name: Piriproxyfen.

CAS: 95737-68-1.

NO CIPAC: 715.

Chemical name (IUPAC): 4-phenoxyphenyl (RS) -2-(2-pyridyloxy) propyl ether.

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

Conditions of inclusion:

Uses: Can only be used as an insecticide.

In the overall assessment, according to the uniform principles, the conclusions of the review report of the European Commission, approved by the Standing Committee on the Food Chain and Animal Health at its meeting of March 14, 2008, especially:

The protection of arthropods not subject to treatment, including bees, and include in relevant authorisations, where appropriate, risk mitigation measures.

Deadline for inclusion: From 1 January 2009 to 31 December 2018.

Deadline for implementation of the conditions of inclusion: 31 December 2008.

Deadline for implementation of the requirements of an Annex II: 30 June 2009 to determine that the holder of the authorisation has access to a documentation meeting the requirements of Annex II to Royal Decree 2163/1994 of 4 November, where the substance is of different origin than that of the main notifier.

Deadline for implementation of the uniform principles: 31 December 2013 for products containing pyriproxyfen 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 of 4 November 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 pyriproxyfen an old active substance, the corresponding data protection regime provided for in Article 30 of Royal Decree 2163/1994 of 4 November shall apply.

Conditions for the inclusion of the active substance Tritosulfuron

Features:

Common name: Tritosulfuron.

CAS No. 142469-14-5.

NO CIPAC: 735.

Chemical name (IUPAC): 1-(4-methoxy-6-trifluoromethyl-1,3,5-triazin-2-yl)-3-(2-trifluoromethyl-benzenesulfonyl) urea.

Minimum purity of the substance: ≥ 960 g/kg, the following manufacturing impurity is of toxicological concern and must not exceed a certain amount in the technical material: 2-amino-4-methoxy-6-(trifluoromethyl) -1,3,5-triazine: < 0,2 g/kg.

Conditions of inclusion:

Uses: Can only be used as a herbicide.

In the overall assessment, according to the uniform principles, the conclusions of the review report of the European Commission, approved by the Standing Committee on the Food Chain and Animal Health at its meeting of May 20, 2008, especially:

The possibility of groundwater contamination when the substance is applied in areas with vulnerable soil and/or climatic conditions.

The protection of aquatic organisms.

The protection of small mammals, and include in appropriate authorizations, where appropriate, risk mitigation measures.

Deadline for inclusion: From 1 December 2008 to 30 November 2018.

Deadline for implementation of the conditions of inclusion: 30 November 2008.

Deadline for implementation of the requirements of an Annex II: 31 May 2009 to determine that the holder of the authorisation has access to a documentation meeting the requirements of Annex II to Royal Decree 2163/1994 of 4 November, where the substance is of different origin than that of the main notifier.

Deadline for implementation of the uniform principles: 31 May 2010 for products containing tritosulfuron as the only active substance or as one of several active substances included in their entirety in Annex I of Royal Decree No 2163/1994 of 4 November 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 tritosulfuron 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 Diuron

Features:

Common Name: Diuron.

CAS: 330-54-1.

NO CIPAC: 100.

Chemical name (IUPAC): 3-(3,4-dichlorophenyl) -1,1-dimethylurea.

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

Conditions of inclusion:

Uses: Can only be used as a herbicide in quantities not exceeding 0.5 kg/ha (average per area).

In the overall assessment, according to the uniform principles, the conclusions of the review report of the European Commission, approved by the Standing Committee on the Food Chain and Animal Health at its meeting of July 11, 2008, especially:

The security of the operator when the conditions of use require, where appropriate, the use of personal protective equipment

The protection of aquatic organisms and non-target plants, and include in relevant authorisations, where appropriate, risk mitigation measures

Deadline for inclusion: From 1 October 2008 to 30 September 2018.

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