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. The active substance cyflufenamide is included in Commission Directive 2009 /154/EC of 30 November 2009 and the active substance malathion is included in Commission Directive 2010 /17/EU of 9 March.

Moreover, by Commission Directive 2006 /6/EC of 17 January 2006, the active substance tolifluanide was included in that Annex I. Commission Decision 2007 /322/EC of 4 May 2007 established protective measures in relation to the use of plant protection products containing that active substance which could contaminate the drinking water, these measures have not demonstrated that they can ensure the protection of drinking water, therefore by Commission Directive 2010 /20/EU of 9 March, tolifluanide is withdrawn as an active substance and the withdrawal of the plant protection products containing it is available that substance.

The active substances clothianidin, thiamethoxam, fipronil and imidacloprid have been included in Annex I to Council Directive 91 /414/EEC of 15 July 1991, by Directives 2006 /41/EC, 2007 /6/EC, 2007 /52/EC and Commission Directive 2008 /116/EC, respectively, by Commission Directive 2010 /21/EU of 12 March amending the specific provisions of those active substances.

By Commission Directive 2009 /77/EC of 1 July the active substance penconazole has been included in Annex I to Council Directive 91 /414/EEC of 15 July 1991 and by Commission Directive 2010 /34/EU, On 31 May, the extension of the use of the active substance penconazole is available.

Commission Directives 2006 /41/EC of 7 July 2007 /6/EC of the Commission of 14 February 2007 /52/EC of the Commission of 16 August 2008 and 2008 /116/EC of 15 December 2008 have been transposed into national law. Order PRE/330 2/2006 of 27 October 2007, Order PRE/2171/2007 of 13 July 2007, Order PRE/696/2008 of 7 March 2009 and Order PRE/2671/2009 of 29 September 2009, which are included in Annex I to Royal Decree 2163/1994 of 4 March 2009 November, for which the Community harmonised system of authorisation to place on the market and use plant protection products.

This order incorporates into the internal legal order, Commission Directive 2009 /154/EC of 30 November 2009 on the inclusion of the active substance cyflufenamide, Commission Directive 2010 /17/EU of 9 December 2009. March, for the inclusion of the active substance malathion, Commission Directive 2010 /20/EU of 9 March on the suppression of tolifluanide as an active substance and the withdrawal of authorisations for plant protection products containing it that active substance, Commission Directive 2010 /21/EU of 12 March 2009, therefore, as regards the specific provisions concerning clothianidin, thiamethoxam, fipronil and imidacloprid and Commission Directive 2010 /34/EU of 31 May concerning the extension of the use of the active substance penconazole, all of which amending Annex I to Council Directive 91 /414/EEC of 15 July 1991 and being made in accordance with the final provision of Royal Decree No 2163/1994 of 4 November 1994, which entails the amendment of Annex I thereto, consequence of such incorporation.

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

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, according to 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 No 2163/1994 of 4 November 1994 imposing a harmonised Community system of authorisation to place plant protection products on the market and use of plant protection products is hereby amended as follows: specifies in the attachment of this order.

One. The active substances cyflufenamide and malathion are included.

Two. Tolifluanide is deleted as an active substance and authorisations for plant protection products containing that substance are withdrawn.

Three. The specific provisions for the inclusion of active substances clothianidin, thiamethoxam, fipronil and imidacloprid are amended.

Four. The use of the active substance penconazole is extended.

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, authorisations for plant protection products containing the active substances concerned, granted prior to the the start of their period of inclusion or renewal shall be reviewed by adopting and implementing 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.

By this Order, Commission Directive 2009 /154/EC of 30 November 2009 and Commission Directive 2010 /17/EU of 9 March 2010 amending the Directive are incorporated into Spanish law. Council Directive 91 /414/EEC to incorporate cyflufenamide and malathion as active substances, Commission Directive 2010 /20/EU of 9 March 2010 amending Annex I to Council Directive 91 /414/EEC as regards the introduction of cyflufenamide and malathion as active substances elimination of tolifluanide as an active substance and the withdrawal of authorisations for products plant protection products containing that substance, Commission Directive 2010 /21/EU of 12 March 2010 amending Council Directive 91 /414/EEC as regards the specific provisions relating to clothianidin, thiamethoxam, fipronil and imidacloprid, and Commission Directive 2010 /34/EU of 31 May 2010 amending Annex I to Council Directive 91 /414/EEC concerning the extension of the use of the active substance penconazole.

Final disposition second. Entry into force.

This provision shall enter into force on the day following that of its publication, without prejudice to the provisions of the single additional provision.

Madrid, 4 November 2010.-The Minister of the Presidency, José Ramón Jáuregui Atondo.

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 Ciflufenamide

Features:

Common name: Ciflufenamide.

CAS Number: 180409-60-3.

CIPAC Number: 759.

Chemical name (IUPAC):

(Z) -N-[α-(cycloprppilmethoxyimino) -2,3-difluoro-6-(trifluoromethyl) benzyl] -2-phenylacetamide

Minimum purity of the substance: ≥980 g/kg of technical product.

Conditions of inclusion:

Part A:

Uses: It can only be used as a fungicide.

Part B:

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 2 October 2009, should be addressed especially to:

The protection of groundwater when the active substance is applied in areas with vulnerable soil characteristics or sensitive climatic conditions, and include where appropriate, in the relevant authorisations, risk reduction measures.

Deadline for inclusion: From 1 April 2010 to 31 March 2020.

Deadlines for the implementation of the uniform principles: 30 September 2011 for formulations containing cyflufenamide as the only active substance or as one of several active substances included in their entirety Annex I to Royal Decree 2163/1994.

Data protection: For cyflufenamide 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 Malation

Features:

Common Name: Malation.

CAS Number: 121-75-5.

CIPAC Number: 12.

Chemical name (IUPAC): diethyl or S-1,2-bis (ethoxycarbonyl) ethyl or, or-dimethylphosphorodithioate racemate succinate.

Minimum purity of the substance: ≥950 g/kg of technical product. Impurities: Isomalation: 2 g/kg maximum.

Conditions of inclusion:

Part A:

Uses: It can only be used as an insecticide. Authorizations are limited to professional users.

Part B:

In the overall assessment, in accordance with the uniform principles, on the basis of the European Commission's assessment report, approved by the Standing Committee on the Food Chain and Animal Health at its meeting of 22 January 2010, Special attention must be given to:

The safety of operators and workers, and include in the conditions of use, the use of appropriate personal protective equipment.

The protection of aquatic organisms, and include in the authorisations of plant protection products, where appropriate, risk mitigation measures, as appropriate buffer zones.

The protection of insect birds and honey bees, and include in the authorisations of plant protection products, where appropriate, risk mitigation measures. In the case of bees, the label and instructions for use shall provide the necessary information to avoid exposure.

Malathion-based formulations must be accompanied by the necessary instructions to avoid any risk of isomalation formation in quantities greater than those permitted during storage and the transport.

Information should be submitted confirming the risk assessment for consumers and the assessment of the risk of short and prolonged exposure for insect birds and information on the different potency of malaoxon and malathion.

Deadline for inclusion: From 1 May 2010 to 30 April 2020.

Time limits for the implementation of the uniform principles: 30 September 2010 for formulations containing malathion as the only active substance or as one of several active substances included in the Annex I of Royal Decree 2163/1994.

Data Protection: For being malathion 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 Clotianidin

Conditions of inclusion:

Part A:

Uses: Can only be used as an insecticide.

As regards the protection of organisms not subject to treatment, in particular honey bees, when used for the treatment of seeds:

The application in the seeds will only be carried out in facilities for the professional treatment of seeds; these facilities will have to apply the best techniques available to ensure that the release of dust during the application in seeds, storage and transport can be reduced to the maximum.

Appropriate planters should be used to ensure a high level of incorporation to the soil, as well as a minimization of spills and dust emission.

On the labelling of the treated seeds, it shall be indicated that they have been treated with clothianidin and the risk mitigation measures set out in the authorisation shall be specified.

The conditions for authorisation, in particular in the case of applications in the form of an aerosol, shall include, where appropriate, risk mitigation measures to protect honey bees.

Monitoring programmes shall be implemented to verify the actual exposure of honey bees to clothianidin in areas commonly used by bees for libar or by beekeepers, where and as appropriate.

Conditions for the inclusion of the active substance Tiamethoxam

Conditions of inclusion:

Part A:

Uses: Can only be used as an insecticide.

As regards the protection of organisms not subject to treatment, in particular honey bees, when used for the treatment of seeds:

The application in the seeds will only be carried out in facilities for the professional treatment of seeds; these facilities will have to apply the best techniques available to ensure that the release of dust during the application in seeds, storage and transport can be reduced to the maximum.

Appropriate planters should be used to ensure a high level of incorporation to the soil, as well as a minimization of spills and dust emission.

The labelling of the treated seeds shall indicate that they have been treated with thiamethoxam and the risk mitigation measures set out in the authorisation shall be specified.

The conditions for authorisation, in particular in the case of applications in the form of an aerosol, shall include, where appropriate, risk mitigation measures to protect honey bees.

Monitoring programmes will be launched to verify the actual exposure of honey bees to thiamethoxam in areas commonly used by bees for libar or beekeepers, where and as appropriate.

Conditions for the inclusion of the active substance Fipronil

Conditions of inclusion:

Part A:

Uses: It can only be used as an insecticide for the treatment of seeds.

As regards the protection of organisms not subject to treatment, in particular honey bees:

The application in the seeds will only be carried out in facilities for the professional treatment of seeds; these facilities will have to apply the best techniques available to ensure that the release of dust during the application in seeds, storage and transport can be reduced to the maximum.

Appropriate planters should be used to ensure a high level of incorporation to the soil, as well as a minimization of spills and dust emission.

The labelling of the treated seeds shall indicate that they have been treated with fipronil and the risk mitigation measures set out in the authorisation shall be specified.

Monitoring programmes shall be implemented to verify the actual exposure of honey bees to fipronil in areas commonly used by bees for libar or beekeepers, where and as appropriate.

Part B:

The following sentence is deleted: "The use of appropriate equipment that ensures a high level of incorporation to the soil and the minimization of spills during the application".

Conditions for the inclusion of the active substance Imidacloprid

Conditions of inclusion:

Part A:

Uses: Can only be used as an insecticide.

As regards the protection of organisms not subject to treatment, in particular honey bees and birds, when used for the treatment of seeds:

The application in the seeds will only be carried out in facilities for the professional treatment of seeds; these facilities will have to apply the best techniques available to ensure that the release of dust during the application in seeds, storage and transport can be reduced to the maximum.

Appropriate planters should be used to ensure a high level of incorporation to the soil, as well as a minimization of spills and dust emission.

The labelling of the treated seeds shall indicate that they have been treated with imidacloprid and the risk mitigation measures set out in the authorisation shall be specified.

The conditions for authorisation, in particular in the case of applications in the form of an aerosol, shall include, where appropriate, risk mitigation measures to protect honey bees.

Monitoring programmes will be launched to verify the actual exposure of honey bees to imidacloprid in areas commonly used by bees for libar or beekeepers, where and as appropriate.

Part B:

The following sentence is deleted: "The protection of bees, in particular in the case of an application in the form of an aerosol, shall also include, where appropriate, risk mitigation measures."

Conditions for the inclusion of the active substance Penconazole

Conditions of inclusion:

Part A:

Uses: Can only be used as fungicide

Part B:

The following sentence is replaced: "Additional information on the fate and behaviour of the soil metabolite U1" shall be required to be submitted "for" Additional information on the destination and the destination shall be required. behaviour of the soil metabolite CGA179944 in acidic soils ".

Withdrawal of Tolifluanide as an active substance:

The active substance tolifluanide is deleted from Annex I to Directive 91 /414/EEC.

The authorisations of plant protection products containing the active substance tolifluanide shall be withdrawn by 30 November 2010 at the latest.

No authorisation of plant protection products containing tolifuanide shall be granted or renewed from 1 December 2010.

The extensions to be granted in accordance with Article 4 (6) of Directive 91 /414/EEC shall expire at the latest by 31 May 2011.