(1)

In accordance with Article 133a of Regulation (EC) No 73/2009 as inserted by Regulation (EU) No 671/2012 of the European Parliament and of the Council (2), certain new Member States may grant a transitional national aid in 2013 under the conditions applicable for the complementary national direct payments. For that reason, Chapter 2 of Title III of Commission Regulation (EC) No 1121/2009 of 29 October 2009 laying down detailed rules for the application of Council Regulation (EC) No 73/2009 as regards the support schemes for farmers provided for in Titles IV and V thereof (3) containing implementing rules for complementary national direct payments should be amended in order to take into account this transitional aid.

(2)

Article 10b of Regulation (EC) No 73/2009 as inserted by Regulation (EU) No 671/2012 provides for a voluntary adjustment mechanism of direct payments in respect of 2013. It is therefore appropriate to adapt Article 79(1) of Commission Regulation (EC) No 1122/2009 of 30 November 2009 laying down detailed rules for the implementation of Council Regulation (EC) No 73/2009 as regards cross-compliance, modulation and the integrated administration and control system, under the direct support schemes for farmers provided for that Regulation, as well as for the implementation of Council Regulation (EC) No 1234/2007 as regards cross-compliance under the support scheme provided for the wine sector (4) accordingly.

(3)

Regulations (EC) No 1121/2009 and (EC) No 1122/2009 should therefore be amended accordingly.

(4)

The measures provided for in this Regulation are in accordance with the opinion of the Management Committee for Direct Payments,

(1)

in Title III, the title of Chapter 2 is replaced by the following:

‘Complementary national direct payments and transitional national aid’;

(2)

Article 91 is replaced by the following:

(3)

Articles 93, 94 and 95 are replaced by the following:

(*1)   OJ L 83, 27.3.1999, p. 1.’."

(1)

Implementing Regulation (EU) No 543/2011 lays down, pursuant to the outcome of the Uruguay Round multilateral trade negotiations, the criteria whereby the Commission fixes the standard values for imports from third countries, in respect of the products and periods stipulated in Annex XVI, Part A thereto.

(2)

The standard import value is calculated each working day, in accordance with Article 136(1) of Implementing Regulation (EU) No 543/2011, taking into account variable daily data. Therefore this Regulation should enter into force on the day of its publication in the Official Journal of the European Union,

(1)

Commission Regulation (EC) No 1451/2007 of 4 December 2007 on the second phase of the 10-year work programme referred to in Article 16(2) of Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products on the market (2) establishes a list of active substances to be assessed, with a view to their possible inclusion in Annex I, IA or IB to Directive 98/8/EC. That list includes thiamethoxam.

(2)

Commission Directive 2008/77/EC of 25 July 2008 amending Directive 98/8/EC of the European Parliament and of the Council to include thiamethoxam as an active substance in Annex I thereto (3) included thiamethoxam as an active substance in Annex I to Directive 98/8/EC for use in product-type 8, wood preservatives, as defined in Annex V to Directive 98/8/EC.

(3)

Pursuant to Regulation (EC) No 1451/2007, thiamethoxam has now been evaluated in accordance with Article 11(2) of Directive 98/8/EC for use in product-type 18, insecticides, acaricides and products to control other arthropods, as defined in Annex V to that Directive.

(4)

Spain was designated as Rapporteur Member State and submitted the competent authority report, together with a recommendation, to the Commission on 2 March 2009 in accordance with Article 14(4) and (6) of Regulation (EC) No 1451/2007.

(5)

The competent authority report was reviewed by the Member States and the Commission. In accordance with Article 15(4) of Regulation (EC) No 1451/2007, the findings of the review were incorporated, within the Standing Committee on Biocidal Products on 21 September 2012, in an assessment report.

(6)

It appears from the evaluations that biocidal products used as insecticides, acaricides and products to control other arthropods and containing thiamethoxam may be expected to satisfy the requirements laid down in Article 5 of Directive 98/8/EC. It is therefore appropriate to extend the inclusion of thiamethoxam in Annex I to that Directive to product-type 18.

(7)

Not all potential uses have been evaluated at Union level. For example, neither outdoor use, nor use by non-professional users were assessed. It is therefore appropriate that Member States assess those uses or exposure scenarios and those risks to human populations and to environmental compartments that have not been representatively addressed in the Union level risk assessment and, when granting product authorisations, ensure that appropriate measures are taken or specific conditions imposed in order to reduce the identified risks to acceptable levels.

(8)

In the light of the unacceptable risks identified for professional users in the brushing application scenario, it is appropriate to require that products are not authorised for such uses, unless data are submitted demonstrating that the product will meet the requirements of both Article 5 of and Annex VI to Directive 98/8/EC, if necessary by the application of appropriate risk mitigation measures.

(9)

In the light of the risks identified for the aquatic and terrestrial ecosystems when products were emitted via a sewage treatment plant or directly to surface water, it is appropriate to require that products are not authorised for such uses, unless data are submitted demonstrating that the product will meet the requirements of both Article 5 of and Annex VI to Directive 98/8/EC, if necessary by the application of appropriate risk mitigation measures.

(10)

In the light of the risks identified in several scenarios of use without personal protective equipment, it is appropriate to require that products authorised for professional use be used with such equipment, unless it can be demonstrated in the application for product authorisation that risks to professional users can be reduced to an acceptable level by other means.

(11)

In the light of the possible indirect human exposure via consumption of food as a result of those uses presented in the assessment report, it is appropriate to require, where relevant, verification of the need to set new or to amend existing maximum residue levels in accordance with Regulation (EC) No 470/2009 of the European Parliament and of the Council of 6 May 2009 laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin, repealing Council Regulation (EEC) No 2377/90 and amending Directive 2001/82/EC of the European Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and of the Council (4) or with Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC (5). Measures should be adopted ensuring that the applicable maximum residue levels are not exceeded.

(12)

In view of the risks identified for the environment, it is appropriate to require that product authorisations are subject to appropriate risk mitigation measures for the protection of honey bees.

(13)

The provisions of this Directive should be applied simultaneously in all Member States in order to ensure equal treatment on the Union market of biocidal products containing the active substance thiamethoxam and also to facilitate the proper operation of the biocidal products market in general.

(14)

A reasonable period should be allowed to elapse before an active substance is included in Annex I to Directive 98/8/EC, in order to permit Member States and interested parties to prepare themselves to meet the new requirements entailed and to ensure that applicants who have prepared dossiers can benefit fully from the 10-year period of data protection, which, in accordance with Article 12(1)(c)(ii) of Directive 98/8/EC, starts from the date of inclusion.

(15)

After inclusion, Member States should be allowed a reasonable period to implement Article 16(3) of Directive 98/8/EC.

(16)

Directive 98/8/EC should therefore be amended accordingly.

(17)

In accordance with the Joint Political Declaration of 28 September 2011 of Member States and the Commission on explanatory documents (6), Member States have undertaken to accompany, in justified cases, the notification of their transposition measures with one or more documents explaining the relationship between the components of a directive and the corresponding parts of national transposition instruments.

(18)

The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Biocidal Products,

(1)

Commission Regulation (EC) No 1451/2007 of 4 December 2007 on the second phase of the 10-year work programme referred to in Article 16(2) of Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products on the market (2) establishes a list of active substances to be assessed, with a view to their possible inclusion in Annex I, IA or IB to Directive 98/8/EC. That list includes Didecyldimethylammonium Chloride.

(2)

Pursuant to Regulation (EC) No 1451/2007, Didecyldimethylammonium Chloride has been evaluated in accordance with Article 11(2) of Directive 98/8/EC for use in product type 8, wood preservatives, as defined in Annex V to that Directive.

(3)

Italy was designated as Rapporteur Member State and submitted the competent authority report, together with a recommendation, to the Commission on 14 August 2007 in accordance with Article 10(5) and (7) of Regulation (EC) No 1451/2007.

(4)

The competent authority report was reviewed by the Member States and the Commission. In accordance with Article 15(4) of Regulation (EC) No 1451/2007, the findings of the review were incorporated, within the Standing Committee on Biocidal Products on 21 September 2012, in an assessment report.

(5)

It appears from the evaluations that biocidal products used as wood preservatives and containing Didecyldimethylammonium Chloride may be expected to satisfy the requirements laid down in Article 5 of Directive 98/8/EC. It is therefore appropriate to include Didecyldimethylammonium Chloride for use in product type 8 in Annex I to that Directive.

(6)

Not all potential uses and exposure scenarios have been evaluated at Union level. For example, neither use by non-professionals, nor exposure of food or feeding stuff was assessed. It is therefore appropriate to require that Member States assess those uses or exposure scenarios and those risks to human populations and to environmental compartments that have not been representatively addressed in the Union level risk assessment and, when granting product authorisations, ensure that appropriate measures are taken or specific conditions imposed in order to reduce the identified risks to acceptable levels.

(7)

In view of the risks identified for human health, it is appropriate to require that safe operational procedures are established, that products are used with appropriate personal protective equipment, and that products are not applied on wood with which children may enter in direct contact, unless it can be demonstrated in the application for product authorisation that risks can be reduced to an acceptable level.

(8)

In view of the risks identified for the environment, it is appropriate to require that industrial or professional application is conducted within a contained area or on impermeable hard standing with bunding, that freshly treated timber is stored after treatment on impermeable hard standing to prevent direct losses to soil or water, and that any losses from the application of products used as wood preservatives and containing Didecyldimethylammonium Chloride are collected for reuse or disposal.

(9)

Unacceptable risks for the environment were identified for situations where wood treated with Didecyldimethylammonium Chloride was continually exposed to the weather or subject to frequent wetting (use class 3 as defined by OECD (3)), was used for outdoor constructions near or above water (the ‘bridge’ scenario in use class 3, as defined by OECD (4)) or was in contact with fresh water (use class 4b as defined by OECD (5)). It is therefore appropriate to require that products are not authorised for the treatment of wood intended for those uses, unless data is submitted demonstrating that the product will meet the requirements of both Article 5 of and Annex VI to Directive 98/8/EC, if necessary by the application of appropriate risk mitigation measures.

(10)

The provisions of this Directive should be applied simultaneously in all Member States in order to ensure equal treatment on the Union market of biocidal products of product type 8 containing the active substance Didecyldimethylammonium Chloride and also to facilitate the proper operation of the biocidal products market in general.

(11)

A reasonable period should be allowed to elapse before an active substance is included in Annex I to Directive 98/8/EC, in order to permit Member States and interested parties to prepare themselves to meet the new requirements entailed and to ensure that applicants who have prepared dossiers can benefit fully from the 10-year period of data protection, which, in accordance with Article 12(1)(c)(ii) of Directive 98/8/EC, starts from the date of inclusion.

(12)

After inclusion, Member States should be allowed a reasonable period to implement Article 16(3) of Directive 98/8/EC.

(13)

Directive 98/8/EC should therefore be amended accordingly.

(14)

In accordance with the Joint Political Declaration of 28 September 2011 of Member States and the Commission on explanatory documents (6), Member States have undertaken to accompany, in justified cases, the notification of their transposition measures with one or more documents explaining the relationship between the components of a directive and the corresponding parts of national transposition instruments.

(15)

The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Biocidal Products,

(1)

Commission Regulation (EC) No 1451/2007 of 4 December 2007 on the second phase of the 10-year work programme referred to in Article 16(2) of Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products on the market (2) establishes a list of active substances to be assessed, with a view to their possible inclusion in Annex I, IA or IB to Directive 98/8/EC. That list includes pyriproxyfen.

(2)

Pursuant to Regulation (EC) No 1451/2007, pyriproxyfen has been evaluated in accordance with Article 11(2) of Directive 98/8/EC for use in product-type 18, insecticides, acaricides and products to control other arthropods, as defined in Annex V to that Directive.

(3)

The Netherlands were designated as Rapporteur Member State and submitted the competent authority report, together with a recommendation, to the Commission on 2 October 2009 in accordance with Article 10(5) and (7) of Regulation (EC) No 1451/2007.

(4)

The competent authority report was reviewed by the Member States and the Commission. In accordance with Article 15(4) of Regulation (EC) No 1451/2007, the findings of the review were incorporated, within the Standing Committee on Biocidal Products on 21 September 2012, in an assessment report.

(5)

It appears from the evaluations that biocidal products used as insecticides, acaricides and products to control other arthropods and containing pyriproxyfen may be expected to satisfy the requirements laid down in Article 5 of Directive 98/8/EC. It is therefore appropriate to include pyriproxyfen for use in product type 18 in Annex I to that Directive.

(6)

Not all potential uses and exposure scenarios have been evaluated at Union level, which, in particular, included only professional use. It is therefore appropriate to require that Member States assess those uses or exposure scenarios and those risks to human populations and to environmental compartments that have not been representatively addressed in the Union level risk assessment and, when granting product authorisations, ensure that appropriate measures are taken or specific conditions imposed in order to reduce the identified risks to acceptable levels.

(7)

In the light of the findings in the assessment report that there is a possible indirect human exposure via consumption of food as a result of those uses represented in the assessment, it is appropriate to require, where relevant, verification of the need to set new or to amend existing maximum residue levels in accordance with Regulation (EC) No 470/2009 of the European Parliament and of the Council of 6 May 2009 laying down Community procedures for the establishment of residue limits of pharmacologically active substances in foodstuffs of animal origin, repealing Council Regulation (EEC) No 2377/90 and amending Directive 2001/82/EC of the European Parliament and of the Council and Regulation (EC) No 726/2004 of the European Parliament and of the Council (3) or with Regulation (EC) No 396/2005 of the European Parliament and of the Council of 23 February 2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC (4). Measures should be adopted ensuring that the applicable maximum residue levels are not exceeded.

(8)

In view of the assumptions made during the risk assessment, it is appropriate to require that products authorised for professionals are used with appropriate personal protective equipment, unless it can be demonstrated in the application for product authorisation that risks to workers and operators can be reduced to an acceptable level.

(9)

In view of the risks identified for the environment, it is appropriate to require that products are not authorised for direct use on surface water, unless it can be demonstrated in the application for product authorisation that risks to the aquatic and terrestrial ecosystems and groundwater can be reduced to an acceptable level, and that any authorisation of products intended to be used in waste treatment facilities is subject to appropriate risk mitigation measures to avoid contamination of the area outside the waste treatment site.

(10)

The provisions of this Directive should be applied simultaneously in all Member States in order to ensure equal treatment on the Union market of biocidal products of product-type 18 containing the active substance pyriproxyfen and also to facilitate the proper operation of the biocidal products market in general.

(11)

A reasonable period should be allowed to elapse before an active substance is included in Annex I to Directive 98/8/EC, in order to permit Member States and interested parties to prepare themselves to meet the new requirements entailed and to ensure that applicants who have prepared dossiers can benefit fully from the 10-year period of data protection, which, in accordance with Article 12(1)(c)(ii) of Directive 98/8/EC, starts from the date of inclusion.

(12)

After inclusion, Member States should be allowed a reasonable period to implement Article 16(3) of Directive 98/8/EC.

(13)

Directive 98/8/EC should therefore be amended accordingly.

(14)

In accordance with the Joint Political Declaration of 28 September 2011 of Member States and the Commission on explanatory documents (5), Member States have undertaken to accompany, in justified cases, the notification of their transposition measures with one or more documents explaining the relationship between the components of a directive and the corresponding parts of national transposition instruments.

(15)

The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Biocidal Products,

(1)

Pursuant to Article 109(8) of Regulation (EC) No 1224/2009 Member States shall establish a national plan for the implementation of the validation system, allowing Member States to make priorities for the validation and cross-checks and subsequent follow up on inconsistencies based on risk management.

(2)

National plans of the Kingdom of Belgium, the Republic of Bulgaria, the Kingdom of Denmark, the Federal Republic of Germany, the Republic of Estonia, Ireland, the Kingdom of Spain, the French Republic, the Italian Republic, the Republic of Cyprus, the Republic of Latvia, the Republic of Lithuania, the Republic of Malta, the Kingdom of the Netherlands, the Republic of Poland, the Portuguese Republic, the Republic of Slovenia, the Republic of Finland, the Kingdom of Sweden and the United Kingdom of Great Britain and Northern Ireland have been submitted to the Commission for approval. They are in line with Article 109 of Regulation (EC) No 1224/2009 and Articles 143 to 145 of Commission Implementing Regulation (EU) No 404/2011 of 8 April 2011 laying down detailed rules for the implementation of Council Regulation (EC) No 1224/2009 establishing a Community control system for ensuring compliance with the rules of the Common Fisheries Policy (2). They should therefore be approved.

(3)

This Decision constitutes the approval decision within the meaning of Article 109(8) of Regulation (EC) No 1224/2009.

(4)

The Commission will monitor the application of the national plans with respect to their effective operation. If, on the basis of the findings of the verifications, inspections and audits carried out by the Commission within the framework of Title X of Regulation (EC) No 1224/2009, amendments to the national validation plans will be deemed necessary, the Member States should amend the plan accordingly,