title: Commission Implementing Directive 2011/43/EU of 13 April 2011 amending Council Directive 91/414/EEC to include lime sulphur as active substance and amending Commission Decision 2008/941/EC  Text with EEA relevance

text:
               14.4.2011

               EN

               Official Journal of the European Union

               L 100/39

         COMMISSION IMPLEMENTING DIRECTIVE 2011/43/EU
   of 13 April 2011
   amending Council Directive 91/414/EEC to include lime sulphur as active substance and amending Commission Decision 2008/941/EC
   (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)

               Commission Regulations (EC) No 1112/2002 (2) and (EC) No 2229/2004 (3) lay down the detailed rules for the implementation of the fourth 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 included lime sulphur.

               (2)

               In accordance with Article 24e of Regulation (EC) No 2229/2004 the applicant withdrew its support of the inclusion of that active substance in Annex I to Directive 91/414/EEC within 2 months from receipt of the draft assessment report. Consequently, Commission Decision 2008/941/EC of 8 December 2008 concerning the non-inclusion of certain active substances in Annex I to Council Directive 91/414/EEC and the withdrawal of authorisations for plant protection products containing these substances (4) was adopted on the non-inclusion of lime sulphur.

               (3)

               Pursuant to Article 6(2) of Directive 91/414/EEC the original notifier (hereinafter ‘the applicant’) submitted a new application requesting the application of the accelerated procedure provided for in Articles 14 to 19 of Commission Regulation (EC) No 33/2008 of 17 January 2008 laying down detailed rules for the application of Council Directive 91/414/EEC as regards a regular and an accelerated procedure for the assessment of active substances which were part of the programme of work referred to in Article 8(2) of that Directive but have not been included into its Annex I (5).

               (4)

               The application was submitted to Spain, which had been designated rapporteur Member State by Regulation (EC) No 2229/2004. The time period for the accelerated procedure was respected. The specification of the active substance and the supported uses are the same as were the subject of Decision 2008/941/EC. That application also complies with the remaining substantive and procedural requirements of Article 15 of Regulation (EC) No 33/2008.

               (5)

               Spain evaluated the additional data submitted by the applicant and prepared an additional report. It communicated that report to the European Food Safety Authority (hereinafter ‘the Authority’) and to the Commission on 14 February 2010. The Authority communicated the additional report to the other Member States and the applicant for comments and forwarded the comments it had received to the Commission. In accordance with Article 20(1) of Regulation (EC) No 33/2008 and at the request of the Commission, the Authority presented its conclusion on lime sulphur to the Commission on 28 October 2010 (6). The draft assessment report, the additional report and the conclusion of the Authority were reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health and finalised on 11 March 2011 in the format of the Commission review report for lime sulphur.

               (6)

               It has appeared from the various examinations made that plant protection products containing lime sulphur 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 have been examined and detailed in the Commission review report. It is therefore appropriate to include lime sulphur 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.

               (7)

               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.

               (8)

               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 6 months after inclusion to review existing authorisations of plant protection products containing lime sulphur 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 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.

               (9)

               The experience gained from previous inclusions in Annex I to Directive 91/414/EEC of active substances assessed in the framework of Commission Regulation (EEC) No 3600/92 of 11 December 1992 laying down the detailed rules for the implementation of the first stage of the programme of work referred to in Article 8(2) of Council Directive 91/414/EEC concerning the placing of plant protection products on the market (7) 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.

               (10)

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

               (11)

               Decision 2008/941/EC provides for the non-inclusion of lime sulphur and the withdrawal of authorisation of plant protection products containing that substance by 31 December 2011. It is necessary to delete the line concerning lime sulphur in the Annex to that Decision.

               (12)

               It is therefore appropriate to amend Decision 2008/941/EC accordingly.

               (13)

               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
   The line concerning lime sulphur in the Annex to Decision 2008/941/EC is deleted.
   Article 3
   Member States shall adopt and publish by 30 November 2011 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 2011.
   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 4
   1.   Member States shall in accordance with Directive 91/414/EEC, where necessary, amend or withdraw existing authorisations for plant protection products containing lime sulphur as an active substance by 30 November 2011.
   By that date they shall in particular verify that the conditions in Annex I to that Directive relating to lime sulphur 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 lime sulphur 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 30 April 2011 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 lime sulphur. 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 lime sulphur as the only active substance, where necessary, amend or withdraw the authorisation by 31 May 2015 at the latest; or

               (b)

               in the case of a product containing lime sulphur as one of several active substances, where necessary, amend or withdraw the authorisation by 31 May 2015 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 5
   This Directive shall enter into force on 1 June 2011.
   Article 6
   This Directive is addressed to the Member States.

      Done at Brussels, 13 April 2011.

            For the Commission

            The President

         José Manuel BARROSO

      (1)  OJ L 230, 19.8.1991, p. 1.

      (2)  OJ L 168, 27.6.2002, p. 14.

      (3)  OJ L 379, 24.12.2004, p. 13.

      (4)  OJ L 335, 13.12.2008, p. 91.

      (5)  OJ L 15, 18.1.2008, p. 5.

      (6)  European Food Safety Authority; Conclusion on the peer review of the pesticide risk assessment of the active substance lime sulphur. EFSA Journal 2010; 8(11):1890. [45pp].doi:10.2903/j.efsa.2010.1890. Available online: www.efsa.europa.eu

      (7)  OJ L 366, 15.12.1992, p. 10.

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

                     No

                     Common Name, Identification Numbers

                     IUPAC Name

                     Purity (1)

                     Entry into force

                     Expiration of inclusion

                     Specific provisions

                     ‘349

                     Lime sulphur
                     CAS No: 1344 – 81 – 6
                     CIPAC No: 17

                        Calcium polysulfide

                     ≥ 290 g/Kg.

                     1 June 2011

                     31 May 2021

                     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 lime sulphur, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 March 2011, shall be taken into account.
                     In this overall assessment Member States shall pay particular attention to:

                                 —

                                 operator safety and shall ensure that the conditions of authorisation include appropriate protective measures,

                                 —

                                 to the protection of aquatic organisms and non-target arthropods and shall ensure that the conditions of use include risk mitigation measures as appropriate.’

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


title: Commission Delegated Directive 2014/5/EU of 18 October 2013 amending, for the purposes of adapting to technical progress, Annex IV to Directive 2011/65/EU of the European Parliament and of the Council as regards an exemption for lead in solders on printed circuit boards, termination coatings of electrical and electronic components and coatings of printed circuit boards, solders for connecting wires and cables, solders connecting transducers and sensors that are used durably at a temperature below – 20 °C under normal operating and storage conditions  Text with EEA relevance

text:
               9.1.2014

               EN

               Official Journal of the European Union

               L 4/53

         COMMISSION DELEGATED DIRECTIVE 2014/5/EU
   of 18 October 2013
   amending, for the purposes of adapting to technical progress, Annex IV to Directive 2011/65/EU of the European Parliament and of the Council as regards an exemption for lead in solders on printed circuit boards, termination coatings of electrical and electronic components and coatings of printed circuit boards, solders for connecting wires and cables, solders connecting transducers and sensors that are used durably at a temperature below – 20 °C under normal operating and storage conditions
   (Text with EEA relevance)
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Directive 2011/65/EU of the European Parliament and of the Council of 8 June 2011 on the restriction of the use of certain hazardous substances in electrical and electronic equipment (1), and in particular Article 5(1)(a) thereof,
   Whereas:

               (1)

               Directive 2011/65/EU prohibits the use of lead in electrical and electronic equipment placed on the market.

               (2)

               The substitution or elimination of lead in solders on printed circuit boards, termination coatings of electrical and electronic components and coatings of printed circuit boards, solders for connecting wires and cables, solders connecting transducers and sensors that are used durably at a temperature below – 20 °C under normal operating and storage conditions is currently not possible.

               (3)

               Directive 2011/65/EU should therefore be amended accordingly,

         HAS ADOPTED THIS DIRECTIVE:
   Article 1
   Annex IV to Directive 2011/65/EU is amended as set out in the Annex to this Directive.
   Article 2
   1.   Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by the last day of the sixth month after entry into force at the latest. They shall forthwith communicate to the Commission the text of those provisions.
   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 text of the main provisions of national law which they adopt in the field covered by this Directive.
   Article 3
   This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
   Article 4
   This Directive is addressed to the Member States.

      Done at Brussels, 18 October 2013.

            For the Commission

            The President

         José Manuel BARROSO

      (1)  OJ L 174, 1.7.2011, p. 88.

      ANNEX
      In Annex IV to Directive 2011/65/EU the following point 26 is added:

                     ‘26.

                     Lead in

                                 —

                                 solders on printed circuit boards,

                                 —

                                 termination coatings of electrical and electronic components and coatings of printed circuit boards,

                                 —

                                 solders for connecting wires and cables,

                                 —

                                 solders connecting transducers and sensors,

                           that are used durably at a temperature below – 20 °C under normal operating and storage conditions.
                     Expires on 30 June 2021.’


title: Commission Implementing Directive 2011/56/EU of 27 April 2011 amending Council Directive 91/414/EEC to include cyproconazole as active substance and amending Commission Decision 2008/934/EC  Text with EEA relevance

text:
               28.4.2011

               EN

               Official Journal of the European Union

               L 108/30

         COMMISSION IMPLEMENTING DIRECTIVE 2011/56/EU
   of 27 April 2011
   amending Council Directive 91/414/EEC to include cyproconazole as active substance and amending Commission Decision 2008/934/EC
   (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)

               Commission Regulations (EC) No 451/2000 (2) and (EC) No 1490/2002 (3) lay down the detailed rules for the implementation of the second and third stages 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 included cyproconazole.

               (2)

               In accordance with Article 11e of Regulation (EC) No 1490/2002 the notifier withdrew its support of the inclusion of that active substance in Annex I to Directive 91/414/EEC within two months from receipt of the draft assessment report. Consequently, Commission Decision 2008/934/EC of 5 December 2008 concerning the non-inclusion of certain active substances in Annex I to Council Directive 91/414/EEC and the withdrawal of authorisations for plant protection products containing these substances (4) was adopted on the non-inclusion of cyproconazole.

               (3)

               Pursuant to Article 6(2) of Directive 91/414/EEC the original notifier (hereinafter ‘the applicant’) submitted a new application requesting the accelerated procedure to be applied, as provided for in Articles 14 to 19 of Commission Regulation (EC) No 33/2008 of 17 January 2008 laying down detailed rules for the application of Council Directive 91/414/EEC as regards a regular and an accelerated procedure for the assessment of active substances which were part of the programme of work referred to in Article 8(2) of that Directive but have not been included into its Annex I (5).

               (4)

               The application was submitted to Ireland, which had been designated rapporteur Member State by Regulation (EC) No 1490/2002. The time period for the accelerated procedure was respected. The specification of the active substance and the supported uses are the same as were the subject of Decision 2008/934/EC. That application also complies with the remaining substantive and procedural requirements of Article 15 of Regulation (EC) No 33/2008.

               (5)

               Ireland evaluated the additional data submitted by the applicant and prepared an additional report. It communicated that report to the European Food Safety Authority (hereinafter ‘the Authority’) and to the Commission on 12 February 2010. The Authority communicated the additional report to the other Member States and the applicant for comments and forwarded the comments it had received to the Commission. In accordance with Article 20(1) of Regulation (EC) No 33/2008 and at the request of the Commission, the Authority presented its conclusion on cyproconazole to the Commission on 8 November 2010 (6). The draft assessment report, the additional report and the conclusion of the Authority were reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health and finalised on 11 March 2011 in the format of the Commission review report for cyproconazole.

               (6)

               It has appeared from the various examinations made that plant protection products containing cyproconazole 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 have been examined and detailed in the Commission review report. It is therefore appropriate to include cyproconazole 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.

               (7)

               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 applicant submit further confirmatory information as regards the toxicological relevance of the impurities in the technical specification, analytical methods for the monitoring of cyproconazole in soil, body fluids and tissues, the residues of triazole derivative metabolites (TDMs) in primary crops, rotational crops and products of animal origin, the long-term risk to herbivorous mammals and the possible environmental impact of the preferential degradation and/or conversion of the mixture of isomers.

               (8)

               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.

               (9)

               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 cyproconazole 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 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.

               (10)

               The experience gained from previous inclusions in Annex I to Directive 91/414/EEC of active substances assessed in the framework of Commission Regulation (EEC) No 3600/92 of 11 December 1992 laying down the detailed rules for the implementation of the first stage of the programme of work referred to in Article 8(2) of Council Directive 91/414/EEC concerning the placing of plant protection products on the market (7) 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.

               (11)

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

               (12)

               Decision 2008/934/EC provides for the non-inclusion of cyproconazole and the withdrawal of authorisations for plant protection products containing that substance by 31 December 2011. It is necessary to delete the line concerning cyproconazole in the Annex to that Decision.

               (13)

               It is therefore appropriate to amend Decision 2008/934/EC accordingly.

               (14)

               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
   The line concerning cyproconazole in the Annex to Decision 2008/934/EC is deleted.
   Article 3
   Member States shall adopt and publish by 30 November 2011 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 2011.
   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 4
   1.   Member States shall in accordance with Directive 91/414/EEC, where necessary, amend or withdraw existing authorisations for plant protection products containing cyproconazole as an active substance by 30 November 2011.
   By that date they shall in particular verify that the conditions in Annex I to that Directive relating to cyproconazole 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 cyproconazole 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 2011 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 cyproconazole. 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 cyproconazole as the only active substance, where necessary, amend or withdraw the authorisation by 31 May 2015 at the latest; or

               (b)

               in the case of a product containing cyproconazole as one of several active substances, where necessary, amend or withdraw the authorisation by 31 May 2015 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 5
   This Directive shall enter into force on 1 June 2011.
   Article 6
   This Directive is addressed to the Member States.

      Done at Brussels, 27 April 2011.

            For the Commission

            The President

         José Manuel BARROSO

      (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)  OJ L 333, 11.12.2008, p. 11.

      (5)  OJ L 15, 18.1.2008, p. 5.

      (6)  European Food Safety Authority; Conclusion on the peer review of the pesticide risk assessment of the active substance cyproconazole. EFSA Journal 2010; 8(11):1897. [73 pp.]. doi:10.2903/j.efsa.2010.1897. Available online: www.efsa.europa.eu

      (7)  OJ L 366, 15.12.1992, p. 10.

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

                     No

                     Common name, identification numbers

                     IUPAC name

                     Purity (1)

                     Entry into force

                     Expiration of inclusion

                     Specific provisions

                     ‘358

                     Cyproconazole
                     CAS No: 94361-06-5

                     CIPAC No: 600

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

                     ≥ 940 g/kg

                     1 June 2011

                     31 May 2021

                     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 cyproconazole, and in particular Appendices I and II thereof, as finalised in the Standing Committee on the Food Chain and Animal Health on 11 March 2011 shall be taken into account.
                     In this overall assessment Member States shall pay particular attention to:

                                 (a)

                                 the dietary exposure of consumers to the residues of triazole derivative metabolites (TDMs);

                                 (b)

                                 the risk to aquatic organisms.

                           Conditions of use shall include risk mitigation measures, where appropriate.
                     The Member States concerned shall request the submission of confirmatory information as regards:

                                 (a)

                                 the toxicological relevance of the impurities in the technical specification;

                                 (b)

                                 analytical methods for the monitoring of cyproconazole in soil, body fluids and tissues;

                                 (c)

                                 residues of triazole derivative metabolites (TDMs) in primary crops, rotational crops and products of animal origin;

                                 (d)

                                 the long-term risk to herbivorous mammals;

                                 (e)

                                 the possible environmental impact of the preferential degradation and/or conversion of the mixture of isomers.

                           The Member States concerned shall ensure that the applicant submits to the Commission the information set out in point (a) by 1 December 2011, the information set out in points (b), (c) and (d) by 31 May 2013 and the information set out in point (e) within two years after the adoption of specific guidance.’

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


title: Commission Implementing Directive 2011/68/EU of 1 July 2011 amending Directives 2003/90/EC and 2003/91/EC setting out implementing measures for the purposes of Article 7 of Council Directives 2002/53/EC and 2002/55/EC respectively, as regards the characteristics to be covered as a minimum by the examination and the minimum conditions for examining certain varieties of agricultural plant species and vegetable species  Text with EEA relevance

text:
               2.7.2011

               EN

               Official Journal of the European Union

               L 175/17

         COMMISSION IMPLEMENTING DIRECTIVE 2011/68/EU
   of 1 July 2011
   amending Directives 2003/90/EC and 2003/91/EC setting out implementing measures for the purposes of Article 7 of Council Directives 2002/53/EC and 2002/55/EC respectively, as regards the characteristics to be covered as a minimum by the examination and the minimum conditions for examining certain varieties of agricultural plant species and vegetable species
   (Text with EEA relevance)
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Council Directive 2002/53/EC of 13 June 2002 on the common catalogue of varieties of agricultural plant species (1), and in particular Article 7(2)(a) and (b) thereof,
   Having regard to Council Directive 2002/55/EC of 13 June 2002 on the marketing of vegetable seed (2), and in particular Article 7(2)(a) and (b) thereof,
   Whereas:

               (1)

               Commission Directives 2003/90/EC (3) and 2003/91/EC (4) were adopted to ensure that the varieties the Member States include in their national catalogues comply with the guidelines established by the Community Plant Variety Office (CPVO) as regards the characteristics to be covered as a minimum by the examination of the various species and the minimum conditions for examining the varieties, as far as such guidelines had been established. For other varieties those Directives provide that guidelines of the International Union for Protection of new Varieties of Plants (UPOV) are to apply.

               (2)

               The CPVO has since established further guidelines for one other species, and has updated existing ones.

               (3)

               Directives 2003/90/EC and 2003/91/EC should therefore be amended accordingly.

               (4)

               The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Seeds and Propagating Material for Agriculture, Horticulture and Forestry,

         HAS ADOPTED THIS DIRECTIVE:
   Article 1
   Annexes I and II to Directive 2003/90/EC are replaced by the text in Part A of the Annex to this Directive.
   Article 2
   The Annexes to Directive 2003/91/EC are replaced by the text in Part B of the Annex to this Directive.
   Article 3
   For examinations started before 1 January 2012 Member States may apply Directives 2003/90/EC and 2003/91/EC in the version applying before their amendment by this Directive.
   Article 4
   Member States shall adopt and publish, by 31 December 2011 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 January 2012.
   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 5
   This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union.
   Article 6
   This Directive is addressed to the Member States.

      Done at Brussels, 1 July 2011.

            For the Commission

            The President

         José Manuel BARROSO

      (1)  OJ L 193, 20.7.2002, p. 1.

      (2)  OJ L 193, 20.7.2002, p. 33.

      (3)  OJ L 254, 8.10.2003, p. 7.

      (4)  OJ L 254, 8.10.2003, p. 11.

      ANNEX
      PART A
      ‘
            ANNEX I

               List of species referred to in Article 1(2)(a) which are to comply with CPVO test protocols

                        Scientific name

                        Common name

                        CPVO protocol

                           Pisum sativum L.

                        Field pea

                        TP 7/2 of 11.3.2010

                           Brassica napus L.

                        Swede rape

                        TP 36/1 of 25.3.2004

                           Helianthus annuus L.

                        Sunflower

                        TP 81/1 of 31.10.2002

                           Linum usitatissimum L.

                        Flax/Linseed

                        TP 57/1 of 21.3.2007

                           Avena nuda L.

                        Small naked oat, Hulless oat

                        TP 20/1 of 6.11.2003

                           Avena sativa L. (includes A. byzantina K. Koch)

                        Oats and Red oat

                        TP 20/1 of 6.11.2003

                           Hordeum vulgare L.

                        Barley

                        TP 19/2rev. of 11.3.2010

                           Oryza sativa L.

                        Rice

                        TP 16/1 of 18.11.2004

                           Secale cereale L.

                        Rye

                        TP 58/1 of 31.10.2002

                           xTriticosecale Wittm. ex A. Camus

                        Hybrids resulting from the crossing of a species of the genus Triticum and a species of the genus Secale

                        TP 121/2 rev. 1 of 16.2.2011

                           Triticum aestivum L.

                        Wheat

                        TP 3/4 rev. 2 of 16.2.2011

                           Triticum durum Desf.

                        Durum wheat

                        TP 120/2 of 6.11.2003

                           Zea mays L.

                        Maize

                        TP 2/3 of 11.3.2010

                           Solanum tuberosum L.

                        Potato

                        TP 23/2 of 1.12.2005

                  The text of these protocols can be found on the CPVO web site (www.cpvo.europa.eu).

            ANNEX II

               List of species referred to in Article 1(2)(b) which are to comply with UPOV test guidelines

                        Scientific name

                        Common name

                        UPOV guideline

                           Beta vulgaris L.

                        Fodder beet

                        TG/150/3 of 4.11.1994

                           Agrostis canina L.

                        Velvet bent

                        TG/30/6 of 12.10.1990

                           Agrostis gigantea Roth.

                        Red top

                        TG/30/6 of 12.10.1990

                           Agrostis stolonifera L.

                        Creeping bent

                        TG/30/6 of 12.10.1990

                           Agrostis capillaris L.

                        Brown top

                        TG/30/6 of 12.10.1990

                           Bromus catharticus Vahl

                        Rescue grass

                        TG/180/3 of 4.4.2001

                           Bromus sitchensis Trin.

                        Alaska brome grass

                        TG/180/3 of 4.4.2001

                           Dactylis glomerata L.

                        Cocksfoot

                        TG/31/8 of 17.4.2002

                           Festuca arundinacea Schreber

                        Tall fescue

                        TG/39/8 of 17.4.2002

                           Festuca filiformis Pourr.

                        Fine-leaved sheep’s fescue

                        TG/67/5 of 5.4.2006

                           Festuca ovina L.

                        Sheep’s fescue

                        TG/67/5 of 5.4.2006

                           Festuca pratensis Huds.

                        Meadow fescue

                        TG/39/8 of 17.4.2002

                           Festuca rubra L.

                        Red fescue

                        TG/67/5 of 5.4.2006

                           Festuca trachyphylla (Hack.) Krajina

                        Hard fescue

                        TG/67/5 of 5.4.2006

                           xFestulolium Asch. et Graebn.

                        Hybrids resulting from the crossing of a species of the genus Festuca with a species of the genus Lolium

                        TG/243/1 of 9.4.2008

                           Lolium multiflorum Lam.

                        Italian ryegrass

                        TG/4/8 of 5.4.2006

                           Lolium perenne L.

                        Perennial ryegrass

                        TG/4/8 of 5.4.2006

                           Lolium x boucheanum Kunth

                        Hybrid ryegrass

                        TG/4/8 of 5.4.2006

                           Phleum nodosum L.

                        Small timothy

                        TG/34/6 of 7.11.1984

                           Phleum pratense L.

                        Timothy

                        TG/34/6 of 7.11.1984

                           Poa pratensis L.

                        Smooth-stalked meadow grass

                        TG/33/6 of 12.10.1990

                           Lupinus albus L.

                        White lupin

                        TG/66/4 of 31.3.2004

                           Lupinus angustifolius L.

                        Narrow-leaved lupin

                        TG/66/4 of 31.3.2004

                           Lupinus luteus L.

                        Yellow lupin

                        TG/66/4 of 31.3.2004

                           Medicago sativa L.

                        Lucerne

                        TG/6/5 of 6.4.2005

                           Medicago x varia T. Martyn

                        Sand lucerne

                        TG/6/5 of 6.4.2005

                           Trifolium pratense L.

                        Red clover

                        TG/5/7 of 4.4.2001

                           Trifolium repens L.

                        White clover

                        TG/38/7 of 9.4.2003

                           Vicia faba L.

                        Field bean

                        TG/8/6 of 17.4.2002

                           Vicia sativa L.

                        Common vetch

                        TG/32/6 of 21.10.1988

                           Brassica napus L. var. napobrassica (L.) Rchb.

                        Swede

                        TG/89/6rev. of 4.4.2001 + 1.4.2009

                           Raphanus sativus L. var. oleiformis Pers.

                        Fodder radish

                        TG/178/3 of 4.4.2001

                           Arachis hypogea L.

                        Groundnut/Peanut

                        TG/93/3 of 13.11.1985

                           Brassica rapa L. var. silvestris (Lam.) Briggs

                        Turnip rape

                        TG/185/3 of 17.4.2002

                           Carthamus tinctorius L.

                        Safflower

                        TG/134/3 of 12.10.1990

                           Gossypium spp.

                        Cotton

                        TG/88/6 of 4.4.2001

                           Papaver somniferum L.

                        Poppy

                        TG/166/3 of 24.3.1999

                           Sinapis alba L.

                        White mustard

                        TG/179/3 of 4.4.2001

                           Glycine max (L.) Merrill

                        Soya bean

                        TG/80/6 of 1.4.1998

                           Sorghum bicolor (L.) Moench

                        Sorghum

                        TG/122/3 of 6.10.1989

                  The text of these guidelines can be found on the UPOV web site (www.upov.int).
         ’
      PART B
      ‘
            ANNEX I

               List of species referred to in Article 1(2)(a) which are to comply with CPVO test protocols

                        Scientific name

                        Common name

                        CPVO protocol

                           Allium cepa L. (Cepa group)

                        Onion and Echalion

                        TP 46/2 of 1.4.2009

                           Allium cepa L. (Aggregatum group)

                        Shallot

                        TP 46/2 of 1.4.2009

                           Allium fistulosum L.

                        Japanese bunching onion or Welsh onion

                        TP 161/1 of 11.3.2010

                           Allium porrum L.

                        Leek

                        TP 85/2 of 1.4.2009

                           Allium sativum L.

                        Garlic

                        TP 162/1 of 25.3.2004

                           Allium schoenoprasum L.

                        Chives

                        TP 198/1 of 1.4.2009

                           Apium graveolens L.

                        Celery

                        TP 82/1 of 13.3.2008

                           Apium graveolens L.

                        Celeriac

                        TP 74/1 of 13.3.2008

                           Asparagus officinalis L.

                        Asparagus

                        TP 130/2 of 16.2.2011

                           Beta vulgaris L.

                        Beetroot including Cheltenham beet

                        TP 60/1 of 1.4.2009

                           Brassica oleracea L.

                        Curly kale

                        TP 90/1 of 16.2.2011

                           Brassica oleracea L.

                        Cauliflower

                        TP 45/2 of 11.3.2010

                           Brassica oleracea L.

                        Sprouting broccoli or Calabrese

                        TP 151/2 of 21.3.2007

                           Brassica oleracea L.

                        Brussels sprouts

                        TP 54/2 of 1.12.2005

                           Brassica oleracea L.

                        Kohlrabi

                        TP 65/1 of 25.3.2004

                           Brassica oleracea L.

                        Savoy cabbage, White cabbage and Red cabbage

                        TP 48/3 of 16.2.2011

                           Brassica rapa L.

                        Chinese cabbage

                        TP 105/1 of 13.3.2008

                           Capsicum annuum L.

                        Chilli or Pepper

                        TP 76/2 of 21.3.2007

                           Cichorium endivia L.

                        Curled-leaved endive and Plain-leaved endive

                        TP 118/2 of 1.12.2005

                           Cichorium intybus L.

                        Industrial chicory

                        TP 172/2 of 1.12.2005

                           Cichorium intybus L.

                        Witloof chicory

                        TP 173/1 of 25.3.2004

                           Citrullus lanatus (Thumb.) Matsum. et Nakai

                        Watermelon

                        TP 142/1 of 21.3.2007

                           Cucumis melo L.

                        Melon

                        TP 104/2 of 21.3.2007

                           Cucumis sativus L.

                        Cucumber and Gherkin

                        TP 61/2 of 13.3.2008

                           Cucurbita pepo L.

                        Marrow or Courgette

                        TP 119/1 of 25.3.2004

                           Cynara cardunculus L.

                        Globe artichoke and Cardoon

                        TP 184/1 of 25.3.2004

                           Daucus carota L.

                        Carrot and Fodder carrot

                        TP 49/3 of 13.3.2008

                           Foeniculum vulgare Mill.

                        Fennel

                        TP 183/1 of 25.3.2004

                           Lactuca sativa L.

                        Lettuce

                        TP 13/5 of 16.2.2011

                           Lycopersicon esculentum Mill.

                        Tomato

                        TP 44/3 of 21.3.2007

                           Petroselinum crispum (Mill.) Nyman ex A. W. Hill

                        Parsley

                        TP 136/1 of 21.3.2007

                           Phaseolus coccineus L.

                        Runner bean

                        TP 9/1 of 21.3.2007

                           Phaseolus vulgaris L.

                        Dwarf French bean and Climbing French bean

                        TP 12/3 of 1.4.2009

                           Pisum sativum L. (partim)

                        Wrinkled pea, Round pea and Sugar pea

                        TP 7/2 of 11.3.2010

                           Raphanus sativus L.

                        Radish

                        TP 64/1 of 27.3.2002

                           Solanum melongena L.

                        Aubergine or Egg plant

                        TP 117/1 of 13.3.2008

                           Spinacia oleracea L.

                        Spinach

                        TP 55/3 of 11.3.2010

                           Valerianella locusta (L.) Laterr.

                        Corn salad or Lamb’s lettuce

                        TP 75/2 of 21.3.2007

                           Vicia faba L. (partim)

                        Broad bean

                        TP Broadbean/1 of 25.3.2004

                           Zea mays L. (partim)

                        Sweet corn and Pop corn

                        TP 2/3 of 11.3.2010

                  The text of these protocols can be found on the CPVO web site (www.cpvo.europa.eu).

            ANNEX II

               List of species referred to in Article 1(2)(b) which are to comply with UPOV test guidelines

                        Scientific name

                        Common name

                        UPOV guideline

                           Beta vulgaris L.

                        Spinach beet or Chard

                        TG/106/4 of 31.3.2004

                           Brassica rapa L.

                        Turnip

                        TG/37/10 of 4.4.2001

                           Cichorium intybus L.

                        Large-leaved chicory or Italian chicory

                        TG/154/3 of 18.10.1996

                           Cucurbita maxima Duchesne

                        Gourd

                        TG/155/4rev. of 28.3.2007 + 1.4.2009

                           Raphanus sativus L.

                        Black radish

                        TG/63/6 of 24.3.1999

                           Rheum rhabarbarum L.

                        Rhubarb

                        TG/62/6 of 24.3.1999

                           Scorzonera hispanica L.

                        Scorzonera or Black salsify

                        TG/116/4 of 24.3.2010

                  The text of these guidelines can be found on the UPOV web site (www.upov.int).
         ’


title: Commission Delegated Directive (EU) 2015/13 of 31 October 2014 amending Annex III to Directive 2014/32/EU of the European Parliament and of the Council, as regards the flowrate range of water meters  Text with EEA relevance

text:
               7.1.2015

               EN

               Official Journal of the European Union

               L 3/42

         COMMISSION DELEGATED DIRECTIVE (EU) 2015/13
   of 31 October 2014
   amending Annex III to Directive 2014/32/EU of the European Parliament and of the Council, as regards the flowrate range of water meters
   (Text with EEA relevance)
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Directive 2014/32/EU of the European Parliament and of the Council of 26 February 2014 on the harmonisation of the laws of the Member States relating to the making available on the market of measuring instruments (1), and in particular Article 47 (b) thereof,
   Whereas:

               (1)

               Directive 2014/32/EU sets out the requirements that certain measuring instruments have to satisfy with a view to their being placed on the market and/or put to use for specific measuring tasks prescribed by the Member States.

               (2)

               The first of the specific requirements for water meters (Requirement 1) included in Annex III to Directive 2014/32/EU refers to the rated operating condition for the flowrate range Q3/Q1 ≥ 10.

               (3)

               On 31 October 2011 an update of the standard EN 14154 which included the flowrate range Q3/Q1 ≥ 40 entered into force. The revised EN 14154 standard reflects the international standard. It is more exigent in relation to the flowrate range than the specific requirements set out in Annex III to Directive 2014/32/EU and results in more precise measurements.

               (4)

               Prior to the introduction of the flowrate range Q3/Q1 ≥ 10 by means of Directive 2004/22/EC of the European Parliament and of the Council (2) on measuring instruments, the international OIML standard which already contained a requirement for the flowrate range of Q3/Q1 ≥ 40 was applied in all Member States. As a result of the transitional provisions provided for in Article 50(2) of Directive 2014/32/EU, most of the water meters currently placed on the market are already in conformity with the requirement of Q3/Q1 ≥ 40.

               (5)

               Water meters with the flowrate range Q3/Q1 ≥ 10 may be significantly cheaper than those meeting the requirements of the standard EN 14154 (Q3/Q1 ≥ 40). Directive 2014/32/EU, in point 10 of Annex III thereto, gives discretion to the utility or the person legally designated for installing the water meter to determine, inter alia, what level of flowrate range is appropriate for the accurate measurement of consumption that is foreseen or foreseeable (3). Therefore, water meters not conforming to the standard EN 14154 for flowrate range but in line with the requirements set out in Annex III to Directive 2014/32/EU may be installed. This may, however, increase the possibility of customers having errors in bills resulting from the less precise measurement of the meter.

               (6)

               The flowrate range of Q3/Q1 ≥ 40 represents the state of the art embodied in the current international standard and manufacturing practice, as well as the minimum quality available at present on the Union market. It provides for more precise measurements thereby ensuring a higher level of protection of consumers. Given that the flowrate range of Q3/Q1 ≥ 40 has for many years been and still is the minimum being installed by the market, compliance does not involve additional costs for users.

               (7)

               Directive 2014/32/EU should be amended accordingly,

         HAS ADOPTED THIS DIRECTIVE:
   Article 1
   In Annex III to Directive 2014/32/EU, point 1 is replaced by the following:

                  ‘1.

                  The flowrate range of the water.
                  The values for the flowrate range shall fulfil the following conditions:

                              Q3/Q1 ≥ 40

                              Q2/Q1 = 1,6

                              Q4/Q3 = 1,25’

   Article 2
   1.   Member States shall adopt and publish, by 19 April 2016 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.
   They shall apply those provisions from 20 April 2016.
   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 text of the main provisions of national law which they adopt in the field covered by this Directive.
   Article 3
   This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
   Article 4
   This Directive is addressed to the Member States.

      Done at Brussels, 31 October 2014.

            For the Commission

            The President

         José Manuel BARROSO

      (1)  OJ L 96, 29.3.2014, p. 149.

      (2)  Directive 2004/22/EC of the European Parliament and of the Council of 31 March 2004 on measuring instruments (OJ L 135, 30.4.2004, p. 1).

      (3)  See point 10 of Annex III to Directive 2014/32/EU.