Council Directive 91 /414/EEC of 15 July 1991 concerning the placing of plant protection products on the market includes in Annex I the active substances which have been authorised for incorporation in products plant protection. This Directive is incorporated into the Spanish legal order under Royal Decree No 2163/1994 of 4 November 1994 imposing a harmonised Community system of authorisation to market and use plant protection products. Furthermore, in the Order of 14 April 1999, Annex I to that royal decree is laid down, under the name 'Community list of active substances', as defined in Article 2.16 of that royal decree, as the list of substances active plant protection products accepted by the European Commission and whose incorporation will be made public by national provisions, issued under the relevant Community rules.

Council Directive 91 /414/EEC of 15 July 1991 has been amended by successive Directives in order to include certain active substances in Annex I thereto. Commission Directive 2009 /37/EC of 23 April 2009 includes the active substances chlormequat, compounds of copper, propakyzafop, chizalofop-P, teflubenzuron and zeta-cypermethrin, by Council Directive 2009 /82/EC, of 13 July 2009, the active substance tetraconazole is included, and the use of the active substance chlormequat is extended by Commission Directive 2010 /2/EU of 27 January 2010.

This order incorporates into national law the Commission Directive 2009 /37/EC of 23 April amending Council Directive 91 /414/EEC to include the active substances chlormequat, compounds for copper, propazafafop, quizalofop-P, teflubenzuron and zeta-cypermethrin, Council Directive 2009 /82/EC of 13 July 2009 to include the active substance tetraconazole, and Commission Directive 2010 /2/EU of 27 January 2010, for to extend the use of the active substance chlormequat, and is given in accordance with the provision Royal Decree No 2163/1994 of 4 November 1994, which entails the amendment of Annex I to that Royal Decree.

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

In its virtue, on the proposal of the Minister of the Environment, and the Rural and Marine Environment and the Minister of Health and Social Policy and in agreement with the State Council, 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 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 active substances chlormequat, copper compounds, propakyzafop, chizalofop-P, teflubenzuron, zeta-cypermethrin and tetraconazole are included as specified in the Annex to this Order.

Two. The use of the active substance chlormequat is extended, as specified in the Annex to this Order.

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, provisional authorisations for plant protection products containing the active substances concerned, granted with 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, shall be made available to interested parties in the review report. European Commission, as referred to in the previous paragraph, as well as that of the Commission for the Evaluation of Plant Protection Products provided for in Article 3 of Royal Decree No 2163/1994 of 4 November 1994. All this with the exception of confidential information as defined in Article 32 of that royal decree.

Final disposition first. Incorporation of Community law.

This Order incorporates into Spanish law the Commission Directive 2009 /37/EC of 23 April 2009, Council Directive 2009 /82/EC of 13 July 2009 and Commission Directive 2010 /2/EU of 27 June 2009 on the January 2010, amending Council Directive 91 /414/EEC with regard to the inclusion of chlormequat active substances, copper compounds, propazafopop, chizalofop-P, teflubenzuron, zeta-cypermethrin and tetraconazole and the use of the active substance chlormequat.

Final disposition second. 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.

Madrid, 13 September 2010. -First Vice-President of the Government and Minister of the Presidency, Maria Teresa Fernández de la Vega Sanz.

ANNEX

Amendment of Annex I "Community list of active substances" of Royal Decree 2163/1994 of 4 November 1994 imposing a harmonised Community system of authorisation to place on the market and use products Phytosanitary

Conditions for the inclusion of the active substance chlormequat

Features:

Common name: Chlormequat.

CAS: 7003-89-6 (chlormequat).

CAS: 999-81-5 (chlormequat chloride).

NO CIPAC: 143 (chlormequat).

NO CIPAC: 143.302 (chlormequat chloride).

Chemical name (IUPAC): 2-Chloroethyltrimethylammonium (chlormequat).

2-chloroethyltrimethylammonium Chloride (chlormequat chloride).

Minimum purity of the substance: ≥ 636 g/kg.

Impurities: 1,2-Dichloroethane: maximum 0,1 g/kg (in the dry content of chlormequat chloride); Chloroethylene (vinyl chloride): maximum 0,0005 g/kg (in the dry content of chlormequat chloride).

Conditions of inclusion:

PART A:

Uses: Can only be used as a plant growth regulator in cereals and non-edible crops.

PART B:

In the assessment of applications for authorisation of plant protection products containing chlormequat for other uses than those for rye and triticale plantings, in particular as regards the use of chlormequat consumer exposure, all necessary data and information must be provided before such authorisation is granted

For the implementation of 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 on 23 January In 2009, special attention should be given to:

The safety of operators, for which the use of appropriate personal protective equipment shall be required under the conditions of use of the product.

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

The notifier/s of the active substance shall submit by 30 November 2011 additional information on the destination and the behaviour (adsorption studies to be carried out at 20 ° C and new calculation). of the concentrations provided for in groundwater, surface water and sediment), monitoring methods for the determination of the substance in products of animal origin and in water and the risk to aquatic organisms, birds and mammals.

Deadline for inclusion: December 1, 2009 to November 30, 2019.

Deadline for implementation of the conditions of inclusion: 30 November 2009.

Deadline for implementation of the requirements of an Annex II: 31 May 2010 to provide that the holder of the authorisation has access to a documentation meeting the requirements of Annex II to Royal Decree 2163/1994, when its substance is of different origin from that of the main notifier.

Deadline for implementation of the uniform principles: 31 May 2014 for products containing chlormequat 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 chlormequat 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 copper compounds:

Features:

Common Name: Copper Compounds.

Copper hydroxide:

CAS: 20427-59-2.

NO CIPAC: 44.305.

Chemical Name (IUPAC): Copper Hydroxide (II).

Minimum purity of the substance: ≥ 573 g/kg.

Copper Oxchloride:

CAS: 1332-65-6 or 1332-40-47.

NO CIPAC: 44.602.

Chemical Name (IUPAC): Dicopper Trihydroxychloride.

Minimum purity of the substance: ≥ 550 g/kg.

Copper Oxide:

CAS: 1317-39-1.

NO CIPAC: 44,603.

Chemical Name (IUPAC): Copper Oxide.

Minimum purity of the substance: ≥ 820 g/kg.

Embroidery broth:

CAS: 8011-63-0.

NO CIPAC: 44,604.

Chemical name (IUPAC): Not assigned.

Minimum purity of the substance: ≥ 245 g/kg.

Copper tribasic sulfate:

CAS No. 12527-76-3.

NO CIPAC: 44,306.

Chemical name (IUPAC): Not assigned.

Minimum purity of the substance: ≥ 490 g/kg.

impurities: Lead: maximum 0,0005 g/kg of copper content; cadmium: maximum 0,0001 g/kg of copper content; arsenic: maximum 0,0001 g/kg of copper content.

Conditions of inclusion:

PART A:

Uses: They can only be used as bactericide and fungicide.

PART B:

In the assessment of applications for authorisation of plant protection products containing copper for uses not related to the cultivation of greenhouse tomatoes, all necessary data and information shall be provided to grant such authorization.

For the implementation of 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 on 23 January In 2009, special attention should be given to:

The specifications of the technical material, as commercially manufactured, shall be confirmed and substantiated by appropriate analytical data: the test material used in the toxicity dossiers shall be compare and verify in relation to these specifications of the technical material.

The safety of operators and other workers; the use of appropriate personal protective equipment shall be required under the authorised conditions of use.

The protection of the aquatic environment, and of the non-treatment organisms, and include as a condition in the relevant authorisations, where appropriate, risk mitigation measures as buffer zones.

The amount of active substance used, ensuring that the authorised quantities, in terms of dose and number of applications, are the minimum necessary to achieve the desired effect.

By 30 November 2011 at the latest, the notifier/res shall submit studies to better control:

The risk by inhalation.

Risk assessment for non-treatment organisms and for soil and water.

Surveillance programmes shall be launched in vulnerable areas where contamination by the presence of copper in the soil compartment presents toxicological risk, in order, where appropriate, to set limits such as maximum levels of application.

Deadline for inclusion: From 1 December 2009 to 30 November 2016.

Deadline for implementation of the conditions of inclusion: 30 November 2009.

Deadline for implementation of the requirements of an Annex II: 31 May 2010 to provide that the holder of the authorisation has access to a documentation meeting the requirements of Annex II to Royal Decree 2163/1994, when its substance is of different origin from that of the main notifier.

Deadline for implementation of the uniform principles: 31 May 2014 for products containing copper 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 coders 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 propaquizafop:

Features:

Common Name: Propaquizafop.

CAS No. 111479-05-1.

NO CIPAC: 173.

Chemical name (IUPAC): 2-Isopropylidenamino-oxyethyl (R)-2-[4-(6-chloro-quinoxin-2-yloxy) phenoxy] propionate.

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

Maximum toluene content: 5 g/kg.

Conditions of inclusion:

PART A:

Uses: Can only be used as a herbicide.

PART B:

For the implementation of 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 on 23 January In 2009, special attention should be given to:

The specification of the technical material, as commercially manufactured, must be confirmed and substantiated by appropriate analytical data; the test material used in the toxicity dossiers must be compared and verify in relation to these specifications of the technical material.

The safety of operators; the use of appropriate personal protective equipment shall be required under the authorised conditions of use.

The protection of aquatic organisms and plants not subject to treatment, and include as a condition in the relevant authorisations, where appropriate, risk mitigation measures as buffer zones.

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

By 30 November 2011 at the latest, the notifier shall submit:

Additional data on impurity Ro 41-5259.

Information to better control the risk to aquatic organisms and arthropods not subject to treatment.

Deadline for inclusion: From 1 December 2009 to 30 November 2019.

Deadline for implementation of the conditions of inclusion: 30 November 2009.

Deadline for implementation of the requirements of an Annex II: 31 May 2010 to provide that the holder of the authorisation has access to a documentation meeting the requirements of Annex II to Royal Decree 2163/1994, when its substance is of different origin from that of the main notifier.

Deadline for implementation of the uniform principles: 31 May 2014 for products containing propazafopop as the only active substance or as one of several active substances included in their entirety in Annex I of Royal Decree 2163/1994 for that date, or if it is later, on the deadline set by the Order for which the active substances concerned are included, in Annex I to that Royal Decree.

Data protection: for the purpose of propakizafop 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 quizalofop-P:

Features:

Common Name: Quizalofop-P.

Quizalofop-P-ethyl:

CAS No: 100646-51-3.

NO CIPAC: 641.202.

Chemical name (IUPAC): Etil (R) -2 [4-(6-chloroquinoxalin-2-yloxy) phenoxy] propionate.

Minimum purity of the substance: ≥ 950 g/kg.

Quizalofop-P-tefuril:

CAS No. 119738-06-6.

NO CIPAC: 641.226.

Chemical name (IUPAC): (RS) -Tetrahydro-furfuryl (R) -2-[4-(6-chloroquinoxalin-2-yloxy) phenoxy] propionate.

Minimum purity of the substance: ≥ 795 g/kg.

Conditions of inclusion:

PART A:

Uses: Can only be used as a herbicide.

PART B:

For the implementation of 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 on 23 January In 2009, special attention should be given to:

The specification of the technical material, as commercially manufactured, must be confirmed and substantiated by appropriate analytical data; the test material used in the toxicity dossiers must be compared and verify in relation to these specifications of the technical material.

The safety of operators and other workers; the use of appropriate personal protective equipment shall be required under the authorised conditions of use.

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

By 30 November 2011 at the latest, the notifier shall provide additional information regarding the risks to arthropods not subject to treatment.

Deadline for inclusion: From 1 December 2009 to 30 November 2019.

Deadline for implementation of the conditions of inclusion: 30 November 2009.

Deadline for implementation of the requirements of an Annex II: 31 May 2010 to provide that the holder of the authorisation has access to a documentation meeting the requirements of Annex II to Royal Decree 2163/1994, when its substance is of different origin from that of the main notifier.

Deadline for implementation of the uniform principles: 31 May 2014 for products containing chizalofop-P 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 quizalofop-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 teflubenzuron:

Features:

Common name: Teflubenzuron.

CAS: 83121-18-0.

NO CIPAC: 450.

Chemical name (IUPAC): 1-(3,5-Dichloro-2,4-difluorophenyl) -3-(2,6-difluorobenzoyl) urea.

Minimum purity of the substance: ≥ 970 g/kg

Conditions of inclusion:

PART A:

Uses: can only be used as insecticide for greenhouse crops (on artificial substrate or closed hydroponic systems)

PART B:

In the assessment of applications for authorisation of plant protection products containing teflubenzuron for uses not related to the cultivation of tomatoes in the greenhouse, attention shall be paid to the criteria of Article 15. of Royal Decree 2163/1994, requiring all data and information necessary for the granting of such authorisation.

For the implementation of 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 on 23 January In 2009, special attention should be given to:

The safety of operators and other workers; the use of appropriate personal protective equipment shall be required under the authorised conditions of use.

The protection of aquatic organisms; emissions from the use in greenhouses should be reduced as far as possible, and should not be allowed to reach the surrounding water bodies.

The protection of bees, whose entry into the greenhouses should be avoided.

The protection of pollinator colonies purposely placed in the greenhouse.

Safe disposal of condensation water, drainage water and substrate to prevent risk to organisms not subject to surface and groundwater treatment and contamination.

Deadline for inclusion: From 1 December 2009 to 30 November 2019.

Deadline for implementation of the conditions of inclusion: 30 November 2009.

Deadline for implementation of the requirements of an Annex II: 31 May 2010, to provide that the holder of the authorisation has access to a documentation meeting the requirements of Annex II to Royal Decree 2163/1994, when its substance is of different origin from that of the main notifier.

Deadline for implementation of the uniform principles: 31 May 2014 for products containing teflubenzuron as the only active substance or as one of several active substances included in their entirety in Annex I of Royal Decree 2163/1994 for that date, or if it is later, on the deadline set by the Order for which the active substances concerned are included, in Annex I to that Royal Decree.

Data protection: for being the teflubenzuron 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 zeta-cypermethrin.

Features:

Common name: Zeta-cipermethrin.

CAS No: 52315 -07-8.

NO CIPAC: 733.

Chemical name (IUPAC): Mixing of stereoisomers (S)-α-cyano-3-phenoxybenzyl (1RS, 3RS; 1RS, 3SR) -3-(2,2-dichlorovinyl) -2.2 dimethylcyclopropanecarboxylate, where the ratio of the pair of isomers (S): (1RS, 3RS) and the pair of isomers (S): (1RS, 3SR) is 45-55 to 55-45 respectively.

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

Impurities: Toluene: maximum 2 g/kg; Rents: maximum 12,5 g/kg.

Conditions of inclusion:

PART A:

Uses: Can only be used as an insecticide.

PART B:

In the assessment of applications for the authorisation of plant protection products containing zeta-cypermethrin for other uses than those for cereals, in particular as regards the exposure of consumers to mPBAldehido, a product of degradation that can be derived from the production, will pay attention to the criteria of article 15 of the Royal Decree 2163/1994, requiring all the data and the information necessary for the concession of such authorization.

For the implementation of 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 on 23 January In 2009, special attention should be given to:

The safety of operators; the use of appropriate personal protective equipment shall be required under the authorised conditions of use.

The protection of birds, aquatic organisms, bees, arthropods not subject to treatment and soil macroorganisms not subject to treatment, and include as a condition in the relevant authorisations, where appropriate, risk mitigation measures

By 30 November 2011 at the latest, the notifier of the active substance shall provide additional information on the destination and the behaviour (aerobic degradation in the soil) and the long-term risk to the birds, aquatic organisms and arthropods not subject to treatment.

Deadline for inclusion: From 1 December 2009 to 30 November 2019.

Deadline for implementation of the conditions of inclusion: 30 November 2009.

Deadline for implementation of the requirements of an Annex II: 31 May 2010 to provide that the holder of the authorisation has access to a documentation meeting the requirements of Annex II to Royal Decree 2163/1994, when its substance is of different origin from that of the main notifier.

Deadline for implementation of the uniform principles: 31 May 2014 for products containing zeta-cypermethrin 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 zeta-cipermethrin 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 tetraconazole:

Features:

Common name: Tetraconazole.

CAS number: 112281-77-3.

NO CIPAC: 726.

Chemical name (IUPAC): (RS) -2-(2,4-dichlorophenyl) -3-(1H-1,2,4-triazol-1-yl)-propyl-1,1,2,2-tetrafluoroethyl ether.

Minimum purity of the substance: ≥ 950 g/kg (racemic mixture).

Impurities: Toluene: maximum 13 g/kg.

Conditions of inclusion:

PART A:

Uses: It can only be used as fungicide in field crops in maximum applications of 0.100 kg/ha every three years in the same field. Uses in apples and grapes may not be authorised.

PART B:

For the implementation of 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 26 February 2009, should be addressed especially to:

The protection of aquatic organisms and plants not subject to treatment, and include as a condition in the relevant authorisations, where appropriate, risk mitigation measures as buffer zones.

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

By 31 December 2011 at the latest, the notifier of the active substance shall present:

Additional information on a more accurate risk assessment for consumers.

Additional information on the ecotoxicology specification.

Additional information on the fate and behavior of the possible metabolites in all relevant compartments.

A more accurate assessment of the risk posed by such metabolites for birds, mammals, aquatic organisms and arthropods not subject to treatment.

Additional information on possible endocrine disorders in birds, mammals, and fish.

Deadline for inclusion: From 1 January 2010 to 31 December 2019.

Deadline for implementation of the conditions of inclusion: 31 December 2009.

Deadline for implementation of the requirements of an Annex II: 30 June 2010 to provide 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: 30 June 2014 for products containing tetraconazole as the only active substance or as one of several active substances included in their entirety in Annex I of Royal Decree 2163/1994 for that date, or if it is later, on the deadline set by the Order for which the active substances concerned are included, in Annex I to that Royal Decree.

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