title: Commission Directive 2008/125/EC of 19 December 2008 amending Council Directive 91/414/EEC to include aluminium phosphide, calcium phosphide, magnesium phosphide, cymoxanil, dodemorph, 2,5-dichlorobenzoic acid methylester, metamitron, sulcotrione, tebuconazole and triadimenol as active substances (Text with EEA relevance)

text:
               20.12.2008

               EN

               Official Journal of the European Union

               L 344/78

      COMMISSION DIRECTIVE 2008/125/EC
   of 19 December 2008
   amending Council Directive 91/414/EEC to include aluminium phosphide, calcium phosphide, magnesium phosphide, cymoxanil, dodemorph, 2,5-dichlorobenzoic acid methylester, metamitron, sulcotrione, tebuconazole and triadimenol as active substances
   (Text with EEA relevance)
   THE COMMISSION OF THE EUROPEAN COMMUNITIES,
   Having regard to the Treaty establishing the European Community,
   Having regard to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (1), and in particular Article 6(1) thereof,
   Whereas:

               (1)

               Commission Regulations (EC) No 451/2000 (2) and (EC) No 1490/2002 (3) lay down the detailed rules for the implementation of the third stage of the programme of work referred to in Article 8(2) of Directive 91/414/EEC and establish a list of active substances to be assessed, with a view to their possible inclusion in Annex I to Directive 91/414/EEC. That list includes aluminium phosphide, calcium phosphide, magnesium phosphide, cymoxanil, dodemorph, 2,5-dichlorobenzoic acid methylester, metamitron, sulcotrione, tebuconazole and triadimenol.

               (2)

               For those active substances the effects on human health and the environment have been assessed in accordance with the provisions laid down in Regulations (EC) No 451/2000 and (EC) No 1490/2002 for a range of uses proposed by the notifiers. Moreover, those Regulations designate the rapporteur Member States which have to submit the relevant assessment reports and recommendations to the European Food Safety Authority (EFSA) in accordance with Article 10(1) of Regulation (EC) No 1490/2002. For aluminium phosphide, calcium phosphide, magnesium phosphide, 2,5-dichlorobenzoic acid methylester and sulcotrione the rapporteur Member State was Germany and all relevant information was submitted on 19 June 2007 for aluminium phosphide, calcium phosphide, magnesium phosphide and 2,5-dichlorobenzoic acid methylester and on 9 August 2006 for sulcotrione. For metamitron, and triadimenol the rapporteur Member State was the United Kingdom and all relevant information was submitted on 22 August 2007 and 29 May 2006 respectively. For cymoxanil, the rapporteur Member State was Austria and all relevant information was submitted on 15 June 2007. For dodemorph, the rapporteur Member State was the Netherlands and all relevant information was submitted on 9 February 2007. For tebuconazole the rapporteur Member State was Denmark and all relevant information was submitted on 5 March 2007.

               (3)

               The assessment reports have been peer reviewed by the Member States and the EFSA and presented to the Commission on 29 September 2008 for aluminium phosphide, calcium phosphide and metamitron, on 30 September 2008 for magnesium phosphide, on 17 September 2008 for cymoxanil and dodemorph, on 26 September 2008 for 2,5-dichlorobenzoic acid methylester, on 31 July 2008 for sulcotrione and on 25 September 2008 for tebuconazole and triadimenol in the format of the EFSA Scientific Reports (4). These reports have been reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health and finalised on 28 October 2008 in the format of the Commission review reports for aluminium phosphide, calcium phosphide, magnesium phosphide, cymoxanil, dodemorph, 2,5-dichlorobenzoic acid methylester, metamitron, sulcotrione, tebuconazole and triadimenol.

               (4)

               It has appeared from the various examinations made that plant protection products containing aluminium phosphide, calcium phosphide, magnesium phosphide, cymoxanil, dodemorph, 2,5-dichlorobenzoic acid methylester, metamitron, sulcotrione, tebuconazole or triadimenol may be expected to satisfy, in general, the requirements laid down in Article 5(1)(a) and (b) of Directive 91/414/EEC, in particular with regard to the uses which were examined and detailed in the Commission review reports. It is therefore appropriate to include these active substances in Annex I, in order to ensure that in all Member States the authorisations of plant protection products containing these active substances can be granted in accordance with the provisions of that Directive.

               (5)

               Without prejudice to that conclusion, it is appropriate to obtain further information on certain specific points. Article 6(1) of Directive 91/414/EEC provides that inclusion of a substance in Annex I may be subject to conditions. Therefore, it is appropriate for metamitron to require the notifier to submit further information as regards the impact of soil metabolite M3 on groundwater, on residues in rotational crops, on the long term risk to insectivorous birds and on the specific risk to birds and mammals that may be contaminated by the intake of water in field. Furthermore, for sulcotrione it is appropriate to require the notifier to submit further information as regards the degradation in soil and water of the cyclohexadione moiety and the long term risk to insectivorous birds. In addition, it is appropriate to require that tebuconazole should be subjected to further testing for the confirmation of the risk assessment for birds and mammals and such information should be presented by the notifier. Moreover, it is appropriate to require that tebuconazole and triadimenol be subjected to further testing of their potential endocrine disrupting properties, as soon as OECD test guidelines on endocrine disruption, or, alternatively, Community agreed test guidelines exist. Finally, it is appropriate to require that triadimenol should be subjected to further testing for confirmation of the chemical specification and the long risk to birds and mammals and that such information should be presented by the notifier.

               (6)

               A reasonable period should be allowed to elapse before an active substance is included in Annex I in order to permit Member States and the interested parties to prepare themselves to meet the new requirements which will result from the inclusion.

               (7)

               Without prejudice to the obligations defined by Directive 91/414/EEC as a consequence of including an active substance in Annex I, Member States should be allowed a period of six months after inclusion to review existing authorisations of plant protection products containing aluminium phosphide, calcium phosphide, magnesium phosphide, cymoxanil, dodemorph, 2,5-dichlorobenzoic acid methylester, metamitron, sulcotrione, tebuconazole and triadimenol to ensure that the requirements laid down by Directive 91/414/EEC, in particular in its Article 13 and the relevant conditions set out in Annex I, are satisfied. Member States should vary, replace or withdraw, as appropriate, existing authorisations, in accordance with the provisions of Directive 91/414/EEC. By way of derogation from the above deadline, a longer period should be provided for the submission and assessment of the complete Annex III dossier of each plant protection product for each intended use in accordance with the uniform principles laid down in Directive 91/414/EEC.

               (8)

               The experience gained from previous inclusions in Annex I to Directive 91/414/EEC of active substances assessed in the framework of Regulation (EEC) No 3600/92 has shown that difficulties can arise in interpreting the duties of holders of existing authorisations in relation to access to data. In order to avoid further difficulties it therefore appears necessary to clarify the duties of the Member States, especially the duty to verify that the holder of an authorisation demonstrates access to a dossier satisfying the requirements of Annex II to that Directive. However, this clarification does not impose any new obligations on Member States or holders of authorisations compared to the directives which have been adopted until now amending Annex I.

               (9)

               It is therefore appropriate to amend Directive 91/414/EEC accordingly.

               (10)

               The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,

         HAS ADOPTED THIS DIRECTIVE:
   Article 1
   Annex I to Directive 91/414/EEC is amended as set out in the Annex to this Directive.
   Article 2
   Member States shall adopt and publish by 28 February 2010 at the latest the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive.
   They shall apply those provisions from 1 March 2010.
   When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
   Article 3
   1.   Member States shall in accordance with Directive 91/414/EEC, where necessary, amend or withdraw existing authorisations for plant protection products containing aluminium phosphide, calcium phosphide, magnesium phosphide, cymoxanil, dodemorph, 2,5-dichlorobenzoic acid methylester, metamitron, sulcotrione, tebuconazole and triadimenol as active substances by 28 February 2010.
   By that date they shall in particular verify that the conditions in Annex I to that Directive relating to aluminium phosphide, calcium phosphide, magnesium phosphide, cymoxanil, dodemorph, 2,5-dichlorobenzoic acid methylester, metamitron, sulcotrione, tebuconazole and triadimenol are met, with the exception of those identified in part B of the entry concerning that active substance, and that the holder of the authorisation has, or has access to, a dossier satisfying the requirements of Annex II to that Directive in accordance with the conditions of Article 13 of that Directive.
   2.   By way of derogation from paragraph 1, for each authorised plant protection product containing aluminium phosphide, calcium phosphide, magnesium phosphide, cymoxanil, dodemorph, 2,5-dichlorobenzoic acid methylester, metamitron, sulcotrione, tebuconazole and triadimenol as either the only active substance or as one of several active substances all of which were listed in Annex I to Directive 91/414/EEC by 31 August 2009 at the latest, Member States shall re-evaluate the product in accordance with the uniform principles provided for in Annex VI to Directive 91/414/EEC, on the basis of a dossier satisfying the requirements of Annex III to that Directive and taking into account part B of the entry in Annex I to that Directive concerning aluminium phosphide, calcium phosphide, magnesium phosphide, cymoxanil, dodemorph, 2,5-dichlorobenzoic acid methylester, metamitron, sulcotrione, tebuconazole and triadimenol respectively. On the basis of that evaluation, they shall determine whether the product satisfies the conditions set out in Article 4(1)(b), (c), (d) and (e) of Directive 91/414/EEC.
   Following that determination Member States shall:

               (a)

               in the case of a product containing aluminium phosphide, calcium phosphide, magnesium phosphide, cymoxanil, dodemorph, 2,5-dichlorobenzoic acid methylester, metamitron, sulcotrione, tebuconazole or triadimenol as the only active substance, where necessary, amend or withdraw the authorisation by 28 February 2014 at the latest; or

               (b)

               in the case of a product containing aluminium phosphide, calcium phosphide, magnesium phosphide, cymoxanil, dodemorph, 2,5-dichlorobenzoic acid methylester, metamitron, sulcotrione, tebuconazole or triadimenol as one of several active substances, where necessary, amend or withdraw the authorisation by 28 February 2014 or by the date fixed for such an amendment or withdrawal in the respective Directive or Directives which added the relevant substance or substances to Annex I to Directive 91/414/EEC, whichever is the latest.

         Article 4
   This Directive shall enter into force on 1 September 2009.
   Article 5
   This Directive is addressed to the Member States.

      Done at Brussels, 19 December 2008.

            For the Commission

         Androulla VASSILIOU

            Member of the Commission

      (1)  OJ L 230, 19.8.1991, p. 1.

      (2)  OJ L 55, 29.2.2000, p. 25.

      (3)  OJ L 224, 21.8.2002, p. 23.

      (4)  EFSA Scientific Report (2008) 182, Conclusion regarding the peer review of the pesticide risk assessment of the active substance aluminium phosphide (finalised 29 September 2008).

      EFSA Scientific Report (2008) 183, Conclusion regarding the peer review of the pesticide risk assessment of the active substance calcium phosphide (finalised 29 September 2008).

      EFSA Scientific Report (2008) 190, Conclusion regarding the peer review of the pesticide risk assessment of the active substance magnesium phosphide (finalised 30 September 2008).

      EFSA Scientific Report (2008) 167, Conclusion regarding the peer review of the pesticide risk assessment of the active substance cymoxanil (finalised 17 September 2008).

      EFSA Scientific Report (2008) 170, Conclusion regarding the peer review of the pesticide risk assessment of the active substance dodemorph (finalised 17 September 2008).

      EFSA Scientific Report (2008) 180, Conclusion regarding the peer review of the pesticide risk assessment of the active substance 2,5-dichlorobenzoic acid methylester (finalised 26 September 2008).

      EFSA Scientific Report (2008) 185, Conclusion regarding the peer review of the pesticide risk assessment of the active substance metamitron (finalised 29 September 2008).

      EFSA Scientific Report (2008) 150, Conclusion regarding the peer review of the pesticide risk assessment of the active substance sulcotrione (finalised 31 July 2008).

      EFSA Scientific Report (2008) 176, Conclusion regarding the peer review of the pesticide risk assessment of the active substance tebuconazole (finalised 25 September 2008).

      EFSA Scientific Report (2008) 177, Conclusion regarding the peer review of the pesticide risk assessment of the active substance triadimenol (25 September 2008).

      ANNEX
      The following entry shall be added at the end of the table in Annex I to Directive 91/414/ECC:

                     No

                     Common Name, Identification Numbers

                     IUPAC Name

                     Purity (1)

                     Entry into force

                     Expiration of inclusion

                     Specific provisions

                     ‘266

                     Aluminium phosphide
                     CAS No 20859-73-8
                     CIPAC No 227

                        Aluminium phosphide

                     ≥ 830 g/kg

                     1 September 2009

                     31 August 2019

                     PART A
                     Only uses as insecticide and rodenticide in the form of ready-to-use aluminium phosphide containing products may be authorised.
                     As rodenticide only outdoor uses may be authorised.
                     Authorisations should be limited to professional users.
                     PART B
                     For the implementation of the uniform principles of Annex VI, the conclusions of the review report on aluminium phosphide, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 October 2008 shall be taken into account.
                     In this overall assessment Member States must pay particular attention to:

                                 —

                                 the protection of consumers and ensure that the spent ready-to-use aluminium phosphide containing products are removed from the food commodity in uses against storage pests and subsequently an adequate additional withholding period is applied;

                                 —

                                 the operator and worker safety and ensure that conditions of use prescribe the application of adequate personal and respiratory protective equipment;

                                 —

                                 the protection of operators and workers during fumigation for indoor uses;

                                 —

                                 the protection of workers at re-entry (after fumigation period) for indoor uses;

                                 —

                                 the protection of bystanders against leaking of gas for indoor uses;

                                 —

                                 the protection of birds and mammals. Conditions of authorisation should include risk mitigation measures, such as the closure of the burrows and the achievement of complete incorporation of granules in the soil, where appropriate;

                                 —

                                 the protection of aquatic organisms. Conditions of authorisation should include risk mitigation measures, such as buffer zones between treated areas and surface water bodies, where appropriate.

                     267

                     Calcium phosphide
                     CAS No 1305-99-3
                     CIPAC No 505

                        Calcium phosphide

                     ≥ 160 g/kg

                     1 September 2009

                     31 August 2019

                     PART A
                     Only outdoor uses as rodenticide in the form of ready-to-use calcium phosphide containing products may be authorised.
                     Authorisations should be limited to professional users.
                     PART B
                     For the implementation of the uniform principles of Annex VI, the conclusions of the review report on calcium phosphide, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 October 2008 shall be taken into account.
                     In this overall assessment Member States must pay particular attention to:

                                 —

                                 the operator and worker safety and ensure that conditions of use prescribe the application of adequate personal and respiratory protective equipment;

                                 —

                                 the protection of birds and mammals. Conditions of authorisation should include risk mitigation measures, such as the closure of the burrows and the achievement of complete incorporation of granules in the soil, where appropriate;

                                 —

                                 the protection of aquatic organisms. Conditions of authorisation should include risk mitigation measures, such as buffer zones between treated areas and surface water bodies, where appropriate.

                     268

                     Magnesium phosphide
                     CAS No 12057-74-8
                     CIPAC No 228

                        Magnesium phosphide

                     ≥ 880 g/kg

                     1 September 2009

                     31 August 2019

                     PART A
                     Only uses as insecticide and rodenticide in the form of ready-to-use magnesium phosphide containing products may be authorised.
                     As rodenticide only outdoor uses may be authorised.
                     Authorisations should be limited to professional users.
                     PART B
                     For the implementation of the uniform principles of Annex VI, the conclusions of the review report on magnesium phosphide, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 October 2008 shall be taken into account.
                     In this overall assessment Member States must pay particular attention to:

                                 —

                                 the protection of consumers and ensure that the spent ready-to-use magnesium phosphide containing products are removed from the food commodity in uses against storage pests and subsequently an adequate additional withholding period is applied;

                                 —

                                 the operator safety and ensure that conditions of use prescribe the application of adequate personal and respiratory protective equipment;

                                 —

                                 the protection of operators and workers during fumigation for indoor uses;

                                 —

                                 the protection of workers at re-entry (after fumigation period) for indoor uses;

                                 —

                                 the protection of bystanders against leaking of gas for indoor uses;

                                 —

                                 the protection of birds and mammals. Conditions of authorisation should include risk mitigation measures, such as the closure of the burrows and the achievement of complete incorporation of granules in the soil, where appropriate;

                                 —

                                 the protection of aquatic organisms. Conditions of authorisation should include risk mitigation measures, such as buffer zones between treated areas and surface water bodies, where appropriate.

                     269

                     Cymoxanil
                     CAS No 57966-95-7
                     CIPAC No 419

                        1-[(E/Z)-2-cyano-2-methoxyiminoacetyl]-3-ethylurea

                     ≥ 970 g/kg

                     1 September 2009

                     31 August 2019

                     PART A
                     Only uses as fungicide may be authorised.
                     PART B
                     For the implementation of the uniform principles of Annex VI, the conclusions of the review report on cymoxanil, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 October 2008 shall be taken into account.
                     In this overall assessment Member States must pay particular attention to:

                                 —

                                 the operator and worker safety and ensure that conditions of use prescribe the application of adequate personal protective equipment;

                                 —

                                 the protection of the groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions;

                                 —

                                 the protection of aquatic organisms and must ensure that the conditions of authorisation include risk mitigation measures such as buffer zones, where appropriate.

                     270

                     Dodemorph
                     CAS No 1593-77-7
                     CIPAC No 300

                        cis/trans-[4-cyclododecyl]-2,6-dimethylmorpholine

                     ≥ 950 g/kg

                     1 September 2009

                     31 August 2019

                     PART A
                     Only uses as fungicide on ornamentals in glasshouse may be authorised.
                     PART B
                     For the implementation of the uniform principles of Annex VI, the conclusions of the review report on dodemorph, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 October 2008 shall be taken into account.
                     In this overall assessment Member States must pay particular attention to:

                                 —

                                 the operator and worker safety and ensure that conditions of use prescribe the application of adequate personal protective equipment where appropriate;

                                 —

                                 the protection of the groundwater, when the active substance is applied in regions with vulnerable soil conditions;

                           Conditions of authorisation should include risk mitigation measures, where appropriate.

                     271

                     2,5-Dichlorobenzoic acid methylester
                     CAS No 2905-69-3
                     CIPAC No 686

                        methyl-2,5-dichlorobenzoate

                     ≥ 995 g/kg

                     1 September 2009

                     31 August 2019

                     PART A
                     Only indoor uses as plant growth regulator and fungicide for grafting of grapevines may be authorised.
                     PART B
                     For the implementation of the uniform principles of Annex VI, the conclusions of the review report on 2,5-Dichlorobenzoic acid methylester, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 October 2008 shall be taken into account.

                     272

                     Metamitron
                     CAS No 41394-05-2
                     CIPAC No 381

                        4-amino-4,5-dihydro-3-methyl-6-phenyl-1,2,4-triazin-5-one

                     ≥ 960 g/kg

                     1 September 2009

                     31 August 2019

                     PART A
                     Only uses as herbicide may be authorised.
                     PART B
                     In assessing applications to authorise plant protection products containing metamitron for uses other than on root crops, Member States shall pay particular attention to the criteria in Article 4(1) (b), and shall ensure that any necessary data and information is provided before such an authorisation is granted.
                     For the implementation of the uniform principles of Annex VI, the conclusions of the review report on metamitron, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 October 2008 shall be taken into account.
                     In this overall assessment Member States must pay particular attention to:

                                 —

                                 the operator safety and ensure that conditions of use prescribe the application of personal protective equipment where appropriate;

                                 —

                                 the protection of groundwater, when the active substance is applied in regions with vulnerable soil and/or climatic conditions;

                                 —

                                 the risk to birds and mammals, and non-target terrestrial plants.

                           Conditions of authorisation shall include risk mitigation measures, where appropriate.
                     The Member States concerned shall request the submission of further information on the impact of soil metabolite M3 on groundwater, on residues in rotational crops, on the long-term risk to insectivorous birds and the specific risk to birds and mammals that may be contaminated by the intake of water in field. They shall ensure that the notifiers at whose request metamitron has been included in this Annex provide such information to the Commission by 31 August 2011 at the latest.

                     273

                     Sulcotrione
                     CAS No 99105-77-8
                     CIPAC No 723

                        2-(2-chloro-4-mesylbenzoyl)cyclohexane-1,3-dione

                     ≥ 950 g/kg
                     Impurities:

                                 —

                                 hydrogen cyanide: not more than 80 mg/kg

                                 —

                                 toluene: not more than 4 g/kg

                     1 September 2009

                     31 August 2019

                     PART A
                     Only uses as herbicide may be authorised.
                     PART B
                     For the implementation of the uniform principles of Annex VI, the conclusions of the review report on sulcotrione, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 October 2008 shall be taken into account.
                     In this overall assessment Member States must pay particular attention to:

                                 —

                                 the operator safety and ensure that conditions of use prescribe the application of adequate personal protective equipment where appropriate;

                                 —

                                 the risk to insectivorous birds, aquatic and terrestrial non-target plants, and non-target arthropods.

                           Conditions of authorisation shall include risk mitigation measures, where appropriate.
                     The Member States concerned shall request the submission of further information on the degradation in soil and water of the cyclohexadione moiety and the long-term risk to insectivorous birds. They shall ensure that the notifier at whose request sulcotrione has been included in this Annex provide such information to the Commission by 31 August 2011 at the latest.

                     274

                     Tebuconazole
                     CAS No 107534-96-3
                     CIPAC No 494

                        (RS)-1-p-chlorophenyl-4,4-dimethyl-3-(1H-1,2,4-triazol-1-ylmethyl)-pentan-3-ol

                     ≥ 905 g/kg

                     1 September 2009

                     31 August 2019

                     PART A
                     Only uses as fungicide may be authorised.
                     PART B
                     For the implementation of the uniform principles of Annex VI, the conclusions of the review report on tebuconazole, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 October 2008 shall be taken into account.
                     In this overall assessment Member States must pay particular attention to:

                                 —

                                 the operator and worker safety and ensure that conditions of use prescribe the application of adequate personal protective equipment;

                                 —

                                 the dietary exposure of consumers to the tebuconazole (triazole) metabolites;

                                 —

                                 the protection of granivorous birds and mammals and herbivorous mammals and must ensure that the conditions of authorisation include, where appropriate, risk mitigation measures.

                                 —

                                 the protection of aquatic organisms and must ensure that conditions of authorisation include risk mitigation measures such as buffer zones, where appropriate.

                           The Member States concerned shall request the submission of further information to confirm the risk assessment for birds and mammals. They shall ensure that the notifier at whose request tebuconazole has been included in this Annex provide such information to the Commission by 31 August 2011 at the latest.
                     The Member States concerned shall ensure that the notifier submits to the Commission further information addressing the potential endocrine disrupting properties of tebuconazole within two years after the adoption of the OECD test guidelines on endocrine disruption or, alternatively, of Community agreed test guidelines.

                     275

                     Triadimenol
                     CAS No 55219-65-3
                     CIPAC No 398

                        (1RS,2RS;1RS,2SR)-1-(4-chlorophenoxy)-3,3-dimethyl-1-(1H-1,2,4-triazol-1-yl)butan-2-ol

                     ≥ 920 g/kg
                     isomer A (1RS,2SR), isomer B (1RS,2RS)
                     Diastereomer A, RS + SR, range: 70 to 85 %
                     Diastereomer B, RR + SS, range: 15 to 30 %

                     1 September 2009

                     31 August 2019

                     PART A
                     Only uses as fungicide may be authorised.
                     PART B
                     For the implementation of the uniform principles of Annex VI, the conclusions of the review report on triadimenol, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 28 October shall be taken into account.
                     In this overall assessment Member States must pay particular attention to:

                                 —

                                 the presence of N-methylpyrrolidone in formulated products as regards operator, worker and bystander exposure;

                                 —

                                 the protection of birds and mammals. In relation to these identified risks risk mitigation measures, such as buffer zones, should be applied where appropriate

                           The Member States concerned shall ensure that the notifier submits to the Commission

                                 —

                                 further information on the specification;

                                 —

                                 information to further address the risk assessment for birds and mammals.

                                 —

                                 information to further address the risk of endocrine disrupting effects on fish.

                           They shall ensure that the notifier at whose request triadimenol has been included in this Annex provide such information to the Commission by 31 August 2011 at the latest.
                     The Member States concerned shall ensure that the notifier submits to the Commission further information addressing the potential endocrine disrupting properties of triadimenol within two years after the adoption of the OECD test guidelines on endocrine disruption or, alternatively, of Community agreed test guidelines.’

         (1)  Further details on identity and specification of active substance are provided in the review report.


title: Commission Directive 2007/55/EC of 17 September 2007 amending certain Annexes to Council Directives 76/895/EEC, 86/362/EEC, 86/363/EEC and 90/642/EEC as regards maximum residue levels for azinphos-methyl (Text with EEA relevance )

text:
               18.9.2007

               EN

               Official Journal of the European Union

               L 243/41

      COMMISSION DIRECTIVE 2007/55/EC
   of 17 September 2007
   amending certain Annexes to Council Directives 76/895/EEC, 86/362/EEC, 86/363/EEC and 90/642/EEC as regards maximum residue levels for azinphos-methyl
   (Text with EEA relevance)
   THE COMMISSION OF THE EUROPEAN COMMUNITIES,
   Having regard to the Treaty establishing the European Community,
   Having regard to Council Directive 76/895/EEC of 23 November 1976 relating to the fixing of maximum levels for pesticide residues in and on fruit and vegetables (1), and in particular Article 5 thereof,
   Having regard to Council Directive 86/362/EEC of 24 July 1986 on the fixing of maximum levels for pesticide residues in and on cereals (2), and in particular Article 10 thereof,
   Having regard to Council Directive 86/363/EEC of 24 July 1986 on the fixing of maximum levels for pesticide residues in and on foodstuffs of animal origin (3), and in particular Article 10 thereof,
   Having regard to Council Directive 90/642/EEC of 27 November 1990 on the fixing of maximum levels for pesticide residues in and on certain products of plant origin, including fruit and vegetables (4), and in particular Article 7 thereof,
   Whereas:

               (1)

               The Commission was informed that for azinphos-methyl current MRLs may need to be revised in the light of the availability of new information on the toxicology and consumer intake. The Commission has asked the Member State which acted as rapporteur for azinphos-methyl under Council Directive 91/414/EEC (5), to make a proposal for the review of Community MRLs. Such a proposal was submitted to the Commission.

               (2)

               Community MRLs and the levels recommended by the Codex Alimentarius are fixed and evaluated following similar procedures. There are a number of Codex MRLs for azinphos-methyl. The Community MRLs based on Codex MRLs have also been evaluated by the Rapporteur Member State in the light of the new information on the risks for the consumers.

               (3)

               The lifetime and short-term exposure of consumers to the azinphos-methyl via food products has been reassessed and evaluated in accordance with Community procedures and practices, taking account of guidelines published by the World Health Organisation (6). On that basis, it is appropriate to fix new MRLs, which will ensure that there is no unacceptable consumer exposure.

               (4)

               In order to ensure that the consumer is adequately protected from exposure to residues resulting from unauthorised uses of plant protection products, MRLs should be set for the relevant product/pesticide combinations at the lower limit of analytical determination.

               (5)

               It is therefore necessary to modify the MRLs set out in the Annexes to Directives 76/895/EEC, 86/362/EEC, 86/363/EEC and 90/642/EEC to allow for proper surveillance and control of the prohibition of their uses and to protect the consumer.

               (6)

               Through the World Trade Organisation, the Community’s trading partners have been informed about the new MRLs and their comments on these levels will be taken into account.

               (7)

               Directives 76/895/EEC, 86/362/EEC, 86/363/EEC and 90/642/EEC should therefore be amended accordingly.

               (8)

               The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,

         HAS ADOPTED THIS DIRECTIVE:
   Article 1
   In Annex II to Directive 76/895/EEC the entry relating to azinphos-methyl is deleted.
   Article 2
   Directive 86/362/EEC is amended in accordance with Annex I to this Directive.
   Article 3
   Directive 86/363/EEC is amended in accordance with Annex II to this Directive.
   Article 4
   Directive 90/642/EEC is amended in accordance with Annex III to this Directive.
   Article 5
   Member States shall adopt and publish, by 18 March 2008 at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive.
   They shall apply those provisions from 19 March 2008.
   When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
   Article 6
   This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union.
   Article 7
   This Directive is addressed to the Member States.

      Done at Brussels, 17 September 2007.

            For the Commission

         Markos KYPRIANOU

            Member of the Commission

      (1)  OJ L 340, 9.12.1976, p. 26. Directive as last amended by Commission Directive 2007/8/EC (OJ L 63, 1.3.2007, p. 9).

      (2)  OJ L 221, 7.8.1986, p. 37. Directive as last amended by Commission Directive 2007/27/EC (OJ L 128, 16.5.2007, p. 31).

      (3)  OJ L 221, 7.8.1986, p. 43. Directive as last amended by Commission Directive 2007/28/EC (OJ L 135, 26.5.2007, p. 6).

      (4)  OJ L 350, 14.12.1990, p. 71. Directive as last amended by Commission Directive 2007/39/EC (OJ L 165, 27.6.2007, p. 25).

      (5)  OJ L 230, 19.8.1991, p. 1. Directive as last amended by Commission Directive 2007/52/EC (OJ L 214, 17.8.2007, p. 3).

      (6)  Guidelines for predicting dietary intake of pesticide residues (revised), prepared by the GEMS/Food Programme in collaboration with the Codex Committee on Pesticide Residues, published by the World Health Organisation 1997 (WHO/FSF/FOS/97.7).

      ANNEX I
      In Part A of Annex II to Directive 86/362/EEC, the following line is added:

                     Pesticide residues

                     Maximum levels in mg/kg

                     ‘Azinphos-methyl

                     0,05 (*)
                     CEREALS’

      ANNEX II
      In Part A of Annex II to Directive 86/363/EEC, the following line is added:

                     Maximum levels in mg/kg (ppm)

                     Pesticide residues

                     of fat contained in meat, preparations of meat, offal and animal fats listed in Annex I under headings Nos ex 0201, 0202, 0203, 0204, 0205 00 00, 0206, 0207, ex 0208, 0209 00, 0210, 1601 00 and 1602 (1) (4)

                     for cow’s milk and whole cream cow’s milk listed in Annex I under headings No 0401: for other foodstuffs in heading Nos 0401, 0402, 0405 00 and 0406 in accordance with (2) (4)

                     of shelled fresh eggs, for bird’s eggs and egg yolks listed in Annex I under headings Nos 0407 00 and 0408 (3) (4)

                     ‘Azinphos-methyl

                     0,01 (1)

                     0,01 (1)

                     0,01 (1)

         (1)  Indicates lower limit of analytical determination.’

      ANNEX III
      In Part A of Annex II to Directive 90/642/EEC, the following column is added:

                     ‘Groups and examples of individual products to which the MRLs apply

                     Azinphos-methyl

               1.   Fruit, fresh, dried or uncooked, preserved by freezing, not containing added sugar, nuts

                                 (i)

                                 CITRUS FRUIT

                     0,05 (1)

                     Grapefruit

                     Lemons

                     Limes

                     Mandarins (including clementines and other hybrids)

                     Oranges

                     Pomelos

                     Others

                                 (ii)

                                 TREE NUTS (shelled or unshelled)

                     0,5

                     Almonds

                     Brazil nuts

                     Cashew nuts

                     Chestnuts

                     Coconuts

                     Hazelnuts

                     Macadamia

                     Pecans

                     Pine nuts

                     Pistachios

                     Walnuts

                     Others

                                 (iii)

                                 POME FRUIT

                     0,5 (2)

                     Apples

                     Pears

                     Quinces

                     Others

                                 (iv)

                                 STONE FRUIT

                     0,5 (2)

                     Apricots

                     Cherries

                     Peaches (including nectarines and similar hybrids)

                     Plums

                     Others

                                 (v)

                                 BERRIES AND SMALL FRUIT

                                 (a)

                                 Table and wine grapes

                     0,05 (1)

                     Table grapes

                     Wine grapes

                                 (b)

                                 Strawberries (other than wild)

                     0,5 (2)

                                 (c)

                                 Cane fruit (other than wild)

                     0,5 (2)

                     Blackberries

                     Dewberries

                     Loganberries

                     Raspberries

                     Others

                                 (d)

                                 Other small fruit and berries (other than wild)

                     Bilberries

                     Cranberries

                     0,1

                     Currants (red, black and white)

                     0,5 (2)

                     Gooseberries

                     0,5 (2)

                     Others

                     0,05 (1)

                                 (e)

                                 Wild berries and wild fruit

                     0,05 (1)

                                 (vi)

                                 MISCELLANEOUS

                     0,05 (1)

                     Avocados

                     Bananas

                     Dates

                     Figs

                     Kiwi

                     Kumquats

                     Litchis

                     Mangoes

                     Olives (table consumption)

                     Olives (oil extraction)

                     Papaya

                     Passion fruit

                     Pineapples

                     Pomegranate

                     Others

               2.   Vegetables, fresh or uncooked, frozen or dry

                                 (i)

                                 ROOT AND TUBER VEGETABLES

                     0,05 (1)

                     Beetroot

                     Carrots

                     Cassava

                     Celeriac

                     Horseradish

                     Jerusalem artichokes

                     Parsnips

                     Parsley root

                     Radishes

                     Salsify

                     Sweet potatoes

                     Swedes

                     Turnips

                     Yam

                     Others

                                 (ii)

                                 BULB VEGETABLES

                     0,05 (1)

                     Garlic

                     Onions

                     Shallots

                     Spring onions

                     Others

                                 (iii)

                                 FRUITING VEGETABLES

                                 (a)

                                 Solanacea

                     0,05 (1)

                     Tomatoes

                     Peppers

                     Aubergines

                     Okra

                     Others

                                 (b)

                                 Cucurbits — edible peel

                     Cucumbers

                     0,2

                     Gherkins

                     Courgettes

                     Others

                     0,05 (1)

                                 (c)

                                 Cucurbits — inedible peel

                     0,05 (1)

                     Melons

                     Squashes

                     Watermelons

                     Others

                                 (d)

                                 Sweetcorn

                     0,05 (1)

                                 (iv)

                                 BRASSICA VEGETABLES

                     0,05 (1)

                                 (a)

                                 Flowering brassica

                     Broccoli (including Calabrese)

                     Cauliflower

                     Others

                                 (b)

                                 Head brassica

                     Brussels sprouts

                     Head cabbage

                     Others

                                 (c)

                                 Leafy brassica

                     Chinese cabbage

                     Kale

                     Others

                                 (d)

                                 Kohlrabi

                                 (v)

                                 LEAF VEGETABLES AND FRESH HERBS

                     0,05 (1)

                                 (a)

                                 Lettuce and similar

                     Cress

                     Lamb's lettuce

                     Lettuce

                     Scarole (broad-leaf endive)

                     Rocket

                     Leaves and stems of brassica, including turnip greens

                     Others

                                 (b)

                                 Spinach and similar

                     Spinach

                     Beet leaves (chard)

                     Others

                                 (c)

                                 Watercress

                                 (d)

                                 Witloof

                                 (e)

                                 Herbs

                     Chervil

                     Chives

                     Parsley

                     Celery leaves

                     Others

                                 (vi)

                                 LEGUME VEGETABLES (fresh)

                     0,05 (1)

                     Beans (with pods)

                     Beans (without pods)

                     Peas (with pods)

                     Peas (without pods)

                     Others

                                 (vii)

                                 STEM VEGETABLES (fresh)

                     0,05 (1)

                     Asparagus

                     Cardoons

                     Celery

                     Fennel

                     Globe artichokes

                     Leek

                     Rhubarb

                     Others

                                 (viii)

                                 FUNGI

                     0,05 (1)

                                 (a)

                                 Cultivated mushrooms

                                 (b)

                                 Wild mushrooms

                                 3.

                                 Pulses

                     0,05 (1)

                     Beans

                     Lentils

                     Peas

                     Lupines

                     Others

               4.   Oilseed

                     Linseed

                     Peanuts

                     Poppy seeds

                     Sesame seeds

                     Sunflower seed

                     Rapeseed

                     Soya bean

                     Mustard seed

                     Cotton seed

                     0,2

                     Hemp seed

                     Others

                     0,05 (1)

                                 5.

                                 Potatoes

                     0,05 (1)

                     Early potatoes

                     Ware potatoes

                                 6.

                                 Tea (dried leaves and stalks, fermented or otherwise, Camellia sinensis)

                     0,1 (1)

                                 7.

                                 Hops (dried), including hop pellets and unconcentrated powder

                     0,1 (1)

         (1)  Indicates lower limit of analytical determination.

         (2)  Temporary MRL until 18 September 2008. After this date the MRL will be 0,05 () mg/kg unless modified by a Directive or a Regulation.’


Important legal notice

|

32003L0079

Commission Directive 2003/79/EC of 13 August 2003 amending Council Directive 91/414/EEC to include Coniothyrium minitans as active substance (Text with EEA relevance)

Official Journal L 205 , 14/08/2003 P. 0016 - 0018

Commission Directive 2003/79/ECof 13 August 2003amending Council Directive 91/414/EEC to include Coniothyrium minitans as active substance(Text with EEA relevance)THE COMMISSION OF THE EUROPEAN COMMUNITIES,Having regard to the Treaty establishing the European Community,Having regard to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market(1), as last amended by Commission Directive 2003/70/EC(2), and in particular Article 6(1) thereof,Whereas:(1) In accordance with Article 6(2) of Directive 91/414/EEC the German authorities received on 10 September 1997 an application from Prophyta GmbH, hereafter referred to as the applicant, for the inclusion of the active substance Coniothyrium minitans in Annex I to the Directive. Commission Decision 98/676/EC(3) confirmed that the dossier was "complete" in the sense that it could be considered as satisfying, in principle, the data and information requirements of Annexes II and III to Directive 91/414/EEC.(2) For this active substance, the effects on human health and the environment have been assessed, in accordance with the provisions of Article 6(2) and (4) of Directive 91/414/EEC, for the uses proposed by the applicant. The nominated rapporteur Member State submitted a draft assessment report concerning the substance to the Commission on 13 March 2000.(3) The draft assessment report was reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health. The review was finalised on 4 July 2003 in the format of the Commission review report for Coniothyrium minitans.(4) The review did not reveal any open questions or concerns, which would have required a consultation of the European Food Safety Authority.(5) It has appeared from the various examinations made that plant protection products containing Coniothyrium minitans may be expected to satisfy, in general, the requirements laid down in Article 5(1)(a) and (b) of Directive 91/414/EEC in the light of Article 5(3) thereof, in particular with regard to the uses which were examined and detailed in the Commission review report. It is therefore appropriate to include this active substances in Annex I, in order to ensure that in all Member States the authorisations of plant protection products containing this active substance can be granted in accordance with the provisions of that Directive.(6) Although the Uniform Principles have still to be adopted for micro-organisms, it is appropriate that the Member States should apply the general provisions of Article 4 of the Directive when granting authorisations. It is appropriate to provide that the finalised review report, except for confidential information within the meaning of Article 14 of Directive 91/414/EEC, is kept available or made available by the Member States for consultation by any interested parties.(7) After inclusion, Member States should be allowed a reasonable period to implement the provisions of Directive 91/414/EEC as regards plant protection products containing Coniothyrium minitans and in particular to review existing provisional authorisations and, by the end of this period at the latest, to transform those authorisations into full authorisations, to amend them or to withdraw them in accordance with the provisions of Directive 91/414/EEC.(8) It is therefore appropriate to amend Directive 91/414/EEC accordingly.(9) The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,HAS ADOPTED THIS DIRECTIVE:Article 1Annex I to Directive 91/414/EEC is amended as set out in the Annex to this Directive.Article 2Member States shall adopt and publish by 30 June 2004 at the latest the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith inform the Commission thereof.They shall apply those provisions from 1 July 2004.When Member States adopt those provisions, they shall contain a reference to this Directive or shall be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.Article 31. Member States shall review the authorisation for each plant protection product containing Coniothyrium minitans to ensure that the conditions relating to this active substance set out in Annex I to Directive 91/414/EEC are complied with. Where necessary, they shall amend or withdraw authorisations in accordance with Directive 91/414/EEC by 30 June 2004 at the latest.2. For each authorised plant protection product containing Coniothyrium minitans as either the only active substance or as one of several active substances all of which were listed in Annex I to Directive 91/414/EEC by 31 December 2004 at the latest, Member States shall re-evaluate the product on the basis of a dossier satisfying the requirements of Annex III thereto. On the basis of that evaluation, they shall determine whether the product satisfies the conditions set out in Article 4(1)(b), (c), (d) and (e) of Directive 91/414/EEC. Where necessary and by 30 June 2005 at the latest, they shall amend or withdraw the authorisation for each such plant protection product.Article 4This Directive shall enter into force on 1 January 2004.Article 5This Directive is addressed to the Member States.Done at Brussels, 13 August 2003.For the CommissionDavid ByrneMember of the Commission(1) OJ L 230, 19.8.1991, p. 1.(2) OJ L 184, 23.7.2003, p. 9.(3) OJ L 317, 26.11.1998, p. 47.ANNEXIn Annex I the following row is added at the end of the table.">TABLE>"


Avis juridique important

|

31998L0047

Commission Directive 98/47/EC of 25 June 1998 including an active substance (azoxystrobin) in Annex I to Council Directive 91/414/EEC concerning the placing of plant protection products on the market (Text with EEA relevance)

Official Journal L 191 , 07/07/1998 P. 0050 - 0052

COMMISSION DIRECTIVE 98/47/EC of 25 June 1998 including an active substance (azoxystrobin) in Annex I to Council Directive 91/414/EEC concerning the placing of plant protection products on the market (Text with EEA relevance)THE COMMISSION OF THE EUROPEAN COMMUNITIES,Having regard to the Treaty establishing the European Community,Having regard to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (1), as last amended by Commission Directive 97/73/EC (2), hereafter referred to as 'the Directive`, and in particular Article 6(3) thereof,Whereas in accordance with Article 6(2) of Directive 91/414/EEC, Germany received on 15 September 1995 an application from Zeneca Agrochemicals, hereafter referred to as 'the applicant`, for the inclusion of the active substance azoxystrobin in Annex I to the Directive;Whereas in accordance with the provisions of Article 6(3) of the Directive the Commission confirmed in its Decision 96/523/EC (3) that the dossier submitted for azoxystrobin could be considered as satisfying, in principle, the data and information requirements of Annex II and for a plant protection product containing this active substance, of Annex III to the Directive;Whereas, in accordance with Article 5(1) of the Directive, an active substance should be included for a period not exceeding 10 years in Annex I when it may be expected that there will not be any harmful effects on human or animal health or on groundwater or any unacceptable influence on the environment;Whereas for azoxystrobin, the effects on human health and the environment have been assessed, in accordance with the provisions of Article 6(2) and (4) of the Directive, for the uses proposed by the applicant; whereas Germany acting as nominated rapporteur Member State, has submitted to the Commission on 5 February 1997 the assessment report concerned;Whereas the submitted report has been reviewed by the Member States and the Commission within the Standing Committee on Plant Health; whereas this review has been finalised on 22 April 1998 in the format of the Commission review report for azoxystrobin; whereas it may be necessary to update this report to take account of technical and scientific developments; whereas in such case the conditions for the inclusion of azoxystrobin in Annex I to Directive 91/414/EEC will also need to be amended pursuant to Article 6(1) of that Directive;Whereas the dossier and the information from the review have also been submitted to the Scientific Committee for Plants for consultation;Whereas it has appeared from the assessments made that plant protection products containing the active substance concerned may be expected to satisfy in general the requirements laid down in Article 5(1)(a), (b) and (3) of the Directive, in particular with regard to the uses which were examined; whereas therefore it is necessary to include the active substance concerned in Annex I, in order to ensure that in all Member States the authorisations of plant protection products containing the active substance concerned can be granted in accordance with the provisions of the Directive;Whereas after inclusion a reasonable period is necessary to permit Member States to implement the provisions of Directive 91/414/EEC on plant protection products containing azoxystrobin and in particular to review, within this period, existing provisional authorisations or to grant, by the end of this period at the latest, new authorisations in accordance with the provisions of the Directive; whereas a longer period may also be required for plant protection products containing azoxystrobin and other active substances included in Annex I;Whereas it is appropriate to provide that the finalised review report (except for confidential information in the meaning of Article 14 of the Directive) is kept available or made available by the Member States for consultation by any interested parties;Whereas the review report is required for the proper implementation by the Member States, of several sections of the uniform principles laid down in Annex VI to the Directive, where these principles refer to the evaluation of the Annex II data which were submitted for the purpose of the inclusion of the active substance in Annex I to the Directive;Whereas the measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Plant Health,HAS ADOPTED THIS DIRECTIVE:Article 1 Azoxystrobin is hereby designated as an active substance in Annex I to Directive 91/414/EEC, as set out in the Annex hereto.Article 2 1. Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive, at the latest by 1 January 1999.2. However for plant protection products containing azoxystrobin together with another active substance included in Annex I to Directive 91/414/EEC, the period referred to in paragraph 1 is extended to the extent that a longer implementation period is provided for by the provisions laid down in the Directive concerning the inclusion of this other active substance in Annex I to Directive 91/414/EEC.3. Member States shall keep available the review report (except for confidential information in the meaning of Article 14 of the Directive) for consultation by any interested parties or shall make it available to them on specific request.4. When Member States adopt the measures, these shall contain a reference to this Directive or shall be accompanied by such reference at the time of their official publication. The procedure for such reference shall be laid down by the Member States.Article 3 This Directive shall enter into force on 1 July 1998.Article 4 This Directive is addressed to the Member States.Done at Brussels, 25 June 1998.For the CommissionFranz FISCHLERMember of the Commission(1) OJ L 230, 19. 8. 1991, p. 1.(2) OJ L 353, 24. 12. 1997, p. 26.(3) OJ L 220, 30. 8. 1996, p. 25.ANNEX AZOXYSTROBIN 1. Identity(IUPAC) Methyl (E)-2-{2[6-(2-cyanophenoxy) pyrimidin-4-yloxy]phenyl}-3-methoxyacrylate2. Particular conditions to be fulfilled:2.1. The active substance shall have a minimum purity of 930 g/kg (Z isomer maximim 25 g/kg)2.2. Only uses as fungicide may be authorised.Particular attention should be given to the impact on aquatic organisms. Authorisation conditions should include appropriate risk mitigation measures.2.3. For the implementation of the uniform principles of Annex VI, the conclusions of the review report on azoxystrobin, and in particular Appendixes I and II thereof, as finalised in the Standing Committee on Plant Health on 22 April 1998 shall be taken into account.3. Expiry date of the inclusion: 1 July 2008.


title: Commission Directive 2009/4/EC of 23 January 2009 counter measures to prevent and detect manipulation of records of tachographs, amending Directive 2006/22/EC of the European Parliament and of the Council on minimum conditions for the implementation of Council Regulations (EEC) Nos 3820/85 and 3821/85 concerning social legislation relating to road transport activities and repealing Council Directive 88/599/EEC (Text with EEA relevance)

text:
               24.1.2009

               EN

               Official Journal of the European Union

               L 21/39

      COMMISSION DIRECTIVE 2009/4/EC
   of 23 January 2009
   counter measures to prevent and detect manipulation of records of tachographs, amending Directive 2006/22/EC of the European Parliament and of the Council on minimum conditions for the implementation of Council Regulations (EEC) Nos 3820/85 and 3821/85 concerning social legislation relating to road transport activities and repealing Council Directive 88/599/EEC
   (Text with EEA relevance)
   THE COMMISSION OF THE EUROPEAN COMMUNITIES,
   Having regard to the Treaty establishing the European Community,
   Having regard to Directive 2006/22/EC of the European Parliament and of the Council of 15 March 2006 on minimum conditions for the implementation of Council Regulations (EEC) Nos 3820/85 and 3821/85 concerning social legislation relating to road transport activities and repealing Council Directive 88/599/EEC (1), and in particular Article 15 thereof,
   Whereas:

               (1)

               In accordance with Article 15 of Directive 2006/22/EC, amendments to the Annexes to that Directive which are necessary to adapt them to developing best practice in the field of enforcement and checks of driving times and rest periods are to be adopted in accordance with the procedure set out in Article 12(2) thereof.

               (2)

               Following the introduction of the digital tachograph, the Commission has been made aware of a new threat posed by the installation of devices intended to defraud the system and thereby undermine the effectiveness of the implementation of the social legislation relating to road transport.

               (3)

               It is accordingly appropriate to ensure that Member States include dedicated checks of that equipment in roadside checks, and in checks at the undertaking.

               (4)

               In order to ensure the effectiveness of such checks, it is also necessary to further define the standard equipment to be made available to enforcement officers.

               (5)

               Annexes I and II of Directive 2006/22/EC should be adapted accordingly.

               (6)

               The measures provided for by this Directive are in accordance with the opinion of the Committee set up by Article 18(1) of Council Regulation (EEC) No 3821/85 (2),

         HAS ADOPTED THIS DIRECTIVE:
   Article 1
   Directive 2006/22/EC is amended as follows:

               1.

               In Part A of Annex I, the following point 5 is added:

                           ‘5.

                           Where appropriate, and with due regard to safety considerations, a verification of the recording equipment installed in vehicles in order to detect the installation and/or the use of any device, or devices, intended to destroy, suppress, manipulate or alter any data, or which is intended to interfere with any part of the electronic data exchange between the component parts of recording equipment, or which inhibits or alters the data in such ways prior to encryption.’

               2.

               In Annex II, the following point 3 is added:

                           ‘3.

                           Specific analysis equipment, with appropriate software, to verify and confirm the digital signature attached to data, as well as specific analysis software to provide a detailed speed profile of vehicles prior to the inspection of their recording equipment.’

         Article 2
   1.   The Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 31 December 2009 at the latest. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive.
   When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
   2.   Member States shall communicate to the Commission the texts of the provisions of national law which they adopt in the field governed by this Directive.
   Article 3
   This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union.
   Article 4
   This Directive is addressed to the Member States.

      Done at Brussels, 23 January 2009.

            For the Commission

         Antonio TAJANI

            Vice-President

      (1)  OJ L 102, 11.4.2006, p. 35.

      (2)  OJ L 370, 31.12.1985, p. 8.


title: Commission Directive 2010/34/EU of 31 May 2010 amending Annex I to Council Directive 91/414/EEC as regards an extension of the use of the active substance penconazole  (Text with EEA relevance)

text:
               1.6.2010

               EN

               Official Journal of the European Union

               L 134/73

         COMMISSION DIRECTIVE 2010/34/EU
   of 31 May 2010
   amending Annex I to Council Directive 91/414/EEC as regards an extension of the use of the active substance penconazole
   (Text with EEA relevance)
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (1), and in particular Article 6(1) thereof,
   Whereas:

               (1)

               By Commission Directive 2009/77/EC (2) penconazole was included as active substance in Annex I to Directive 91/414/EEC, with the specific provision that Member States may only authorise uses in greenhouses and that the notifier is to submit further information on the fate and behaviour of the soil metabolite U1 by 31 December 2011.

               (2)

               On 6 May 2009 the notifier submitted the required information to Germany, which had been designated rapporteur Member State by Commission Regulation (EC) No 451/2000 (3). Germany evaluated the additional information and submitted to the Commission on 6 November 2009 an addendum to the draft assessment report on penconazole, which was circulated for comments to the other Member States and to the European Food Safety Authority (EFSA). In the comments received no major concerns were raised and the other Member States and EFSA did not raise any point which would exclude the extension of the use. The draft assessment report together with that addendum was reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health and finalised on 11 May 2010 in the format of the Commission review report for penconazole.

               (3)

               The new information on the fate and behaviour of the metabolite U1 submitted by the notifier and the new assessment carried out by the rapporteur Member State indicate that plant protection products containing penconazole may be expected to satisfy, in general, the requirements laid down in Article 5(1)(a) and (b) of Directive 91/414/EEC, in particular with regard to the intended uses as set out in the original dossier which were examined and detailed in the Commission review report. Consequently, it is no longer necessary to restrict the use of penconazole to greenhouses, as laid down in Directive 91/414/EEC as amended by Directive 2009/77/EC.

               (4)

               Without prejudice to that conclusion, it is appropriate to obtain further information on certain specific points. Article 6(1) of Directive 91/414/EEC provides that inclusion of a substance in Annex I may be subject to conditions. Therefore, it is appropriate to require that the notifier submit further information on the fate and behaviour of the soil metabolite CGA179944 in acidic soils.

               (5)

               It is therefore appropriate to amend Directive 91/414/EEC accordingly.

               (6)

               The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,

         HAS ADOPTED THIS DIRECTIVE:
   Article 1
   Annex I to Directive 91/414/EEC is amended as set out in the Annex to this Directive.
   Article 2
   Member States shall adopt and publish by 30 June 2010 at the latest the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive.
   They shall apply those provisions from 1 July 2010.
   When Member States adopt those provisions, they shall contain a reference to this Directive or shall be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
   Article 3
   This Directive shall enter into force on the day following its publication in the Official Journal of the European Union.
   Article 4
   This Directive is addressed to the Member States.

      Done at Brussels, 31 May 2010.

            For the Commission

            The President

         José Manuel BARROSO

      (1)  OJ L 230, 19.8.1991, p. 1.

      (2)  OJ L 172, 2.7.2009, p. 23.

      (3)  OJ L 55, 29.2.2000, p. 25.

      ANNEX
      In Annex I to Directive 91/414/EEC, the column ‘Specific provisions’ of row 292 is amended as follows:

                  1.

                  Part A is replaced by the following:
                  ‘PART A
                  Only uses as fungicides may be authorised.’;

                  2.

                  in the fourth paragraph of Part B the first sentence:
                  ‘The Member States concerned shall request the submission of further information on the fate and behaviour of the soil metabolite U1.’,
                  is replaced by:
                  ‘The Member States concerned shall request the submission of further information on the fate and behaviour of the soil metabolite CGA179944 in acidic soils.’


title: Commission Directive 2010/15/EU of 8 March 2010 amending Council Directive 91/414/EEC to include fluopicolide as active substance (Text with EEA relevance)

text:
               9.3.2010

               EN

               Official Journal of the European Union

               L 58/5

         COMMISSION DIRECTIVE 2010/15/EU
   of 8 March 2010
   amending Council Directive 91/414/EEC to include fluopicolide as active substance
   (Text with EEA relevance)
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (1), and in particular Article 6(1) thereof,
   Whereas:

               (1)

               In accordance with Article 6(2) of Directive 91/414/EEC the United Kingdom received on 7 May 2004 an application from Bayer CropScience for the inclusion of the active substance fluopicolide in Annex I to Directive 91/414/EEC. Commission Decision 2005/778/EC (2) confirmed that the dossier was ‘complete’ in the sense that it could be considered as satisfying, in principle, the data and information requirements of Annexes II and III to Directive 91/414/EEC.

               (2)

               For that active substance, the effects on human health and the environment have been assessed, in accordance with the provisions of Article 6(2) and (4) of Directive 91/414/EEC, for the uses proposed by the applicant. The designated rapporteur Member State submitted a draft assessment report on 12 December 2005.

               (3)

               The assessment report was peer reviewed by the Member States and the EFSA and presented to the Commission in the format of the EFSA Scientific Report for fluopicolide on 4 June 2009 (3). This report was reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health and finalised on 27 November 2009 in the format of the Commission review report for fluopicolide.

               (4)

               It has appeared from the various examinations made that plant protection products containing fluopicolide may be expected to satisfy, in general, the requirements laid down in Article 5(1)(a) and (b) and Article 5(3) of Directive 91/414/EEC, in particular with regard to the uses which were examined and detailed in the Commission review report. It is therefore appropriate to include fluopicolide in Annex I to that Directive, in order to ensure that in all Member States the authorisations of plant protection products containing this active substance may be granted in accordance with the provisions of that Directive.

               (5)

               Without prejudice to that conclusion, it is appropriate to obtain further information on certain specific points. Article 6(1) of Directive 91/414/EEC provides that the inclusion of a substance in Annex I may be subject to conditions. It is appropriate, as regards fluopicolide, to require that the notifier submits further information on the relevance of the metabolite M15 for groundwater.

               (6)

               Without prejudice to the obligations defined by Directive 91/414/EEC as a consequence of including an active substance in Annex I, Member States should be allowed a period of six months after inclusion to review existing provisional authorisations of plant protection products containing fluopicolide to ensure that the requirements laid down by Directive 91/414/EEC, in particular in its Article 13 and the relevant conditions set out in Annex I, are satisfied. Member States should transform existing provisional authorisations into full authorisations, amend them or withdraw them in accordance with the provisions of Directive 91/414/EEC. By derogation from the above deadline, a longer period should be provided for the submission and assessment of the complete Annex III dossier of each plant protection product for each intended use in accordance with the uniform principles laid down in Directive 91/414/EEC.

               (7)

               It is therefore appropriate to amend Directive 91/414/EEC accordingly.

               (8)

               The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,

         HAS ADOPTED THIS DIRECTIVE:
   Article 1
   Annex I to Directive 91/414/EEC is amended as set out in the Annex to this Directive.
   Article 2
   Member States shall adopt and publish by 30 November 2010 at the latest the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive.
   They shall apply those provisions from 1 December 2010.
   When Member States adopt those provisions, they shall contain a reference to this Directive or shall be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
   Article 3
   1.   Member States shall in accordance with Directive 91/414/EEC, where necessary, amend or withdraw existing authorisations for plant protection products containing fluopicolide as active substance by 30 November 2010. By that date, they shall in particular verify that the conditions in Annex I to that Directive relating to fluopicolide are met, with the exception of those identified in part B of the entry concerning the active substance, and that the holder of the authorisation has, or has access to, a dossier satisfying the requirements of Annex II to that Directive in accordance with the conditions of Article 13(2) of that Directive.
   2.   By way of derogation from paragraph 1, for each authorised plant protection product containing fluopicolide as either the only active substance or as one of several active substances all of which were listed in Annex I to Directive 91/414/EEC by 31 May 2010 at the latest, Member States shall re-evaluate the product in accordance with the uniform principles provided for in Annex VI to Directive 91/414/EEC, on the basis of a dossier satisfying the requirements of Annex III to that Directive and taking into account part B of the entry in Annex I to that Directive concerning fluopicolide. On the basis of that evaluation, they shall determine whether the product satisfies the conditions set out in Article 4(1)(b), (c), (d) and (e) of Directive 91/414/EEC.
   Following that determination Member States shall:

               (a)

               in the case of a product containing fluopicolide as the only active substance, where necessary, amend or withdraw the authorisation by 30 November 2011 at the latest; or

               (b)

               in the case of a product containing fluopicolide as one of several active substances, where necessary, amend or withdraw the authorisation by 30 November 2011 or by the date fixed for such an amendment or withdrawal in the respective Directive or Directives which added the relevant substance or substances to Annex I to Directive 91/414/EEC, whichever is the latest.

         Article 4
   This Directive shall enter into force on 1 June 2010.
   Article 5
   This Directive is addressed to the Member States.

      Done at Brussels, 8 March 2010.

            For the Commission

            The President

         José Manuel BARROSO

      (1)  OJ L 230, 19.8.1991, p. 1.

      (2)  OJ L 293, 9.11.2005, p. 26.

      (3)  EFSA Scientific Report (2009) 299, 1-158, Conclusion regarding the peer review of the pesticide risk assessment of the active substance fluopicolide (finalised: 4 June 2009).

      ANNEX
      In Annex I to Directive 91/414/EEC, the following entry is added at the end of the table:

                     No

                     Common Name, Identification Numbers

                     IUPAC Name

                     Purity (1)

                     Entry into force

                     Expiration of inclusion

                     Specific provisions

                     ‘303

                     Fluopicolide
                     CAS No
                     239110-15-7
                     CIPAC No 787

                        2,6-dichloro-N-[3-chloro-5-(trifluoromethyl)-2-pyridylmethyl]benzamide

                     ≥ 970 g/kg
                     The impurity toluene must not exceed 3 g/kg in the technical material.

                     1 June 2010

                     31 May 2020

                     PART A
                     Only uses as fungicide may be authorised.
                     PART B
                     For the implementation of the uniform principles of Annex VI, the conclusions of the review report on fluopicolide, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 27 November 2009 shall be taken into account.
                     In this overall assessment, Member States must pay particular attention to:

                                 —

                                 the protection of aquatic organisms,

                                 —

                                 the protection of groundwater when the active substance is applied in regions with vulnerable soil and/or climatic conditions,

                                 —

                                 to the risk to operators during application,

                                 —

                                 the potential for long range transport via air.

                           Conditions of authorisation shall include risk mitigation measures and monitoring programmes shall be initiated to verify potential accumulation and exposure in vulnerable areas, where appropriate.
                     The Member States concerned shall ensure that the notifier submits to the Commission further information on the relevance of the metabolite M15 for groundwater by 30 April 2012 at the latest.’

         (1)  Further details on identity and specification of active substances are provided in the review report.