title: Commission Implementing Directive 2011/60/EU of 23 May 2011 amending Council Directive 91/414/EEC to include tebufenozide as active substance and amending Commission Decision 2008/934/EC  Text with EEA relevance

text:
               24.5.2011

               EN

               Official Journal of the European Union

               L 136/58

         COMMISSION IMPLEMENTING DIRECTIVE 2011/60/EU
   of 23 May 2011
   amending Council Directive 91/414/EEC to include tebufenozide 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 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 included tebufenozide.

               (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 2 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 tebufenozide.

               (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 Germany, 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)

               Germany 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 23 November 2009. 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 tebufenozide to the Commission on 19 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 tebufenozide.

               (6)

               It has appeared from the various examinations made that plant protection products containing tebufenozide 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 tebufenozide 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 confirmatory information as regards the relevance of metabolites RH-6595 (7), RH-2651 (8), M2 (9), the degradation of tebufenozide in soils of alkaline pH and the risk to Lepidoptera non-target insects.

               (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 6 months after inclusion to review existing authorisations of plant protection products containing tebufenozide 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 (10) 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 tebufenozide and the withdrawal of authorisations for plant protection products containing that substance by 31 December 2011. It is necessary to delete the line concerning tebufenozide 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 tebufenozide 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 tebufenozide 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 tebufenozide 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 tebufenozide 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 tebufenozide. 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 tebufenozide 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 tebufenozide 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, 23 May 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 tebufenozide. Summary: EFSA Journal 2010; 8(12): 1871. [120 pp.]. doi:10.2903/j.efsa.2010.1871. Available online: www.efsa.europa.eu

      (7)  N'-[(4-acetylphenyl)carbonyl]-N-tert-butyl-3,5-dimethylbenzohydrazide.

      (8)  4-({2-tert-butyl-2-[(3,5-dimethylphenyl)carbonyl]hydrazinyl}carbonyl)benzoic acid.

      (9)  Chemical name not yet identified.

      (10)  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

                     ‘355

                     Tebufenozide
                     CAS No: 112410-23-8
                     CIPAC No: 724

                     N-tert-butyl-N′-(4-ethylbenzoyl)-3,5-dimethylbenzohydrazide

                     ≥ 970 g/kg
                     Relevant impurity

                        t-butyl hydrazine < 0,001 g/kg

                     1 June 2011

                     31 May 2021

                     PART A
                     Only uses as insecticide may be authorised.
                     PART B
                     For the implementation of the uniform principles of Annex VI, the conclusions of the review report on tebufenozide, 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:

                                 (1)

                                 pay particular attention to the safety of operators and workers after re-entry and ensure that conditions of authorisation prescribe appropriate protective equipment;

                                 (2)

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

                                 (3)

                                 pay particular attention to the protection of aquatic organisms and ensure that conditions of use prescribe adequate mitigation measures;

                                 (4)

                                 pay particular attention to the risk to Lepidoptera non-target insects.

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

                                 (1)

                                 the relevance of metabolites RH-6595, RH-2651, M2;

                                 (2)

                                 the degradation of tebufenozide in anaerobic soils and soils of alkaline pH.

                           The Member States concerned shall ensure that the applicant submits to the Commission the information set out in points (1) and (2) by 31 May 2013.’

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


title: Commission Implementing Directive 2011/57/EU of 27 April 2011 amending Council Directive 91/414/EEC to include fluometuron 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 108/34

         COMMISSION IMPLEMENTING DIRECTIVE 2011/57/EU
   of 27 April 2011
   amending Council Directive 91/414/EEC to include fluometuron 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 fluometuron.

               (2)

               In accordance with Article 11e of Regulation (EC) No 1490/2002 the notifiers withdrew their 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 2008/934/EC of 5 December 2008 concerning the non-inclusion of certain active substances in Annex I to Directive 91/414/EEC and the withdrawal of authorisations for plant protection products containing these substances (4) was adopted on the non-inclusion of fluometuron.

               (3)

               Pursuant to Article 6(2) of Directive 91/414/EEC the original notifiers (hereinafter ‘the applicants’) 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 Greece, 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)

               Greece evaluated the additional data submitted by the applicants and prepared an additional report. It communicated that report to the European Food Safety Authority (hereinafter ‘the Authority’) and to the Commission on 27 January 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 fluometuron to the Commission on 14 December 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 fluometuron.

               (6)

               It has appeared from the various examinations made that plant protection products containing fluometuron 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 fluometuron 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 applicants submit further information confirming the toxicological properties of the plant metabolite trifluoroacetic acid and the analytical methods for the monitoring of fluometuron in air and the soil metabolite trifluoromethylaniline in soil and water. In case fluometuron is classified under Regulation (EC) No 1272/2008 of the European Parliament and of the Council (7) as ‘suspected of causing cancer’, the Member States concerned shall request the submission of further information confirming the relevance for groundwater of the soil metabolites desmethyl-fluometuron and trifluoromethylaniline.

               (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 6 months after inclusion to review existing authorisations of plant protection products containing fluometuron 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 (8) 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 fluometuron and the withdrawal of authorisations for plant protection products containing that substance by 31 December 2011. It is necessary to delete the line concerning fluometuron 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 fluometuron 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 fluometuron 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 fluometuron 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 fluometuron 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 fluometuron. 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 fluometuron 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 fluometuron 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 fluometuron. EFSA Journal 2011;9(1):1958. [54 pp.] doi:10.2903/j.efsa.2011.1958. Available online: www.efsa.europa.eu/efsajournal.htm

      (7)  OJ L 353, 31.12.2008, p. 1.

      (8)  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

                     ‘343

                     Fluometuron
                     CAS No: 2164-17-2
                     CIPAC No: 159

                        1,1-dimethyl-3-(α,α,α -trifluoro-m-tolyl)urea

                     ≥ 940 g/kg

                     1 June 2011

                     31 May 2021

                     PART A
                     Only uses as herbicide on cotton may be authorised.
                     PART B
                     For the implementation of the uniform principles of Annex VI, the conclusions of the review report on fluometuron, 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:

                                 (a)

                                 pay particular attention to the protection of the operators and workers and ensure that conditions of use include the application of adequate personal protective equipment;

                                 (b)

                                 pay particular attention to the protection of the groundwater where the active substance is applied in regions with vulnerable soil and/or climatic conditions; they shall ensure that conditions of authorisation include risk mitigation measures and the obligation to carry out monitoring programmes to verify potential leaching of fluometuron and soil metabolites desmethyl-fluometuron and trifluoromethylaniline in vulnerable areas, where appropriate;

                                 (c)

                                 pay particular attention to the risk to non-target soil macro-organisms others than earthworms and non-target plants, and ensure that conditions of authorisation include risk mitigation measures, where appropriate.

                           The Member States concerned shall ensure that the applicants submit to the Commission confirmatory information as regards:

                                 (a)

                                 the toxicological properties of the plant metabolite trifluoroacetic acid;

                                 (b)

                                 the analytical methods for the monitoring of fluometuron in air;

                                 (c)

                                 the analytical methods for the monitoring of the soil metabolite trifluoromethylaniline in soil and water;

                                 (d)

                                 the relevance for ground water of the soil metabolites desmethyl-fluometuron and trifluoromethylaniline, if fluometuron is classified under Regulation (EC) No 1272/2008 as “suspected of causing cancer”.

                           The Member States concerned shall ensure that the applicants submit to the Commission the information set out in points (a), (b) and (c) by 31 March 2013 and the information set out in point (d) within 6 months from the notification of the decision classifying fluometuron.’

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


title: Commission Implementing Directive 2014/96/EU of 15 October 2014 on the requirements for the labelling, sealing and packaging of fruit plant propagating material and fruit plants intended for fruit production, falling within the scope of Council Directive 2008/90/EC

text:
               16.10.2014

               EN

               Official Journal of the European Union

               L 298/12

         COMMISSION IMPLEMENTING DIRECTIVE 2014/96/EU
   of 15 October 2014
   on the requirements for the labelling, sealing and packaging of fruit plant propagating material and fruit plants intended for fruit production, falling within the scope of Council Directive 2008/90/EC
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Council Directive 2008/90/EC of 29 September 2008 on the marketing of fruit plant propagating material and fruit plants intended for fruit production (1), and in particular Article 9(1) thereof,
   Whereas:

               (1)

               It is appropriate to adopt requirements with regard to labelling, sealing and packaging of fruit plant propagating material and fruit plants intended for fruit production to ensure that marketing takes place in accordance with Directive 2008/90/EC.

               (2)

               As regards fruit plant propagating material officially certified as pre-basic, basic or certified material and fruit plants officially certified as certified material, it is necessary to provide for sealing and packaging requirements.

               (3)

               Pre-basic, basic or certified material should be marketed with a label satisfying certain requirements. That label should be prepared and affixed by the responsible official body. Member States should have the possibility to provide that the responsible official body may allow the supplier to prepare and affix the label under its supervision. The design of the label should in any case be established by the responsible official body, in accordance with the requirements set out in this Directive.

               (4)

               To allow lots of different varieties or types of pre-basic, basic or certified material to be marketed together, Member States should be permitted to provide for an accompanying document complementing the label in order to facilitate information of users and to improve traceability and controls of lots at all stages of marketing. This document should be prepared by the responsible official body, or by the supplier concerned under supervision of the responsible official body.

               (5)

               For marketing of CAC (Conformitas Agraria Communitatis) material a document prepared by the supplier should be required.

               (6)

               The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Propagating Material and Plants of Fruit Genera and Species,

         HAS ADOPTED THIS DIRECTIVE:
   Article 1
   Labelling, sealing and packaging requirements
   Member States shall ensure that fruit plant propagating material, hereinafter ‘propagating material’, officially certified as pre-basic material, basic material or certified material, and fruit plants intended for fruit production, hereinafter ‘fruit plants’, officially certified as certified material, are only marketed if they comply with the labelling, sealing and packaging requirements set out in Articles 2 and 4. Where appropriate, an accompanying document, as provided for in Article 3, may be used to complement the label.
   Member States shall ensure that propagating material and fruit plants which qualify as CAC (Conformitas Agraria Communitatis) material are only marketed if they comply with the requirements for the supplier's document set out in Article 5.
   Article 2
   Label for pre-basic, basic or certified material
   1.   Member States shall ensure that for pre-basic, basic or certified material a label complying with paragraphs 2 to 5 is prepared and affixed by the responsible official body to the plants or parts of plants to be marketed as propagating material or fruit plants. Member States may provide that the responsible official body may allow the supplier to prepare and affix the label under its supervision. The design of the label shall be established by the responsible official body, in accordance with paragraphs 2, 3 and 4.
   Propagating material or fruit plants forming part of the same lot may be marketed with a single label where such material or such plants are part of the same package, bundle or container, and that label is affixed in accordance with the second subparagraph of paragraph 5.
   Member States may provide that fruit plants, which are one or more years old, are to be labelled individually. In this case, labelling may be carried out in the field before or during uprooting or later. Where labelling is carried out later, plants of the same lot shall be uprooted together and be kept separate from other lots in labelled containers until those plants are labelled.
   2.   The label shall contain the following information:

               (a)

               the indication ‘EU rules and standards’;

               (b)

               Member State of labelling or the respective code;

               (c)

               responsible official body or the respective code;

               (d)

               name of supplier or its registration number/code issued by the responsible official body;

               (e)

               reference number of package or bundle, individual serial number, week number or batch number;

               (f)

               botanical name;

               (g)

               category, and for basic material also the generation number;

               (h)

               denomination of the variety and, where appropriate, the clone. In the case of rootstocks not belonging to a variety, the name of the species or the interspecific hybrid concerned. For grafted fruit plants such information shall be given for the rootstock and the top-graft. For varieties for which an application for official registration or for a plant variety right is pending, such information shall indicate: ‘proposed denomination’ and ‘application pending’;

               (i)

               the indication ‘variety with an officially recognised description’, where appropriate;

               (j)

               quantity;

               (k)

               country of production and the respective code, where different from the Member State of labelling;

               (l)

               year of issue;

               (m)

               in case the original label is replaced by another label: the year of issue of the original label.

         3.   The label shall be indelibly printed in one of the official languages of the Union, easily visible and legible.
   4.   If a coloured label is used in respect of any category of plants or parts of plants, the colour of the label shall be:

               (a)

               white with a diagonal violet stripe for pre-basic-material;

               (b)

               white for basic material;

               (c)

               blue for certified material.

         5.   The label shall be affixed to the plants or parts of plants to be marketed as propagating material or fruit plants. Where such plants or parts of plants are to be marketed in a package, bundle or container, the label shall be affixed to that package, bundle or container.
   Where, in accordance with the second subparagraph of paragraph 1, propagating material or fruit plants are marketed with a single label, that label shall be affixed to the package, bundle or container formed by that propagating material or those fruit plants.
   Article 3
   Accompanying document for pre-basic, basic or certified material
   1.   Member States may provide that an accompanying document maybe made by the responsible official body, or by the supplier concerned under the supervision of this body, for lots of different varieties or types of pre-basic, basic or certified material to be marketed together to complement the label referred to in Article 2.
   2.   The accompanying document shall fulfil the following requirements:

               (a)

               include the information set out in Article 2(2) and as indicated on the respective label;

               (b)

               be written in one of the official languages of the Union;

               (c)

               be delivered at least in duplicate (supplier and recipient);

               (d)

               accompany the material from the place of the supplier to the place of the recipient;

               (e)

               include the name and address of the recipient;

               (f)

               include the date of issue of the document;

               (g)

               include, where appropriate, additional information relevant to the lots concerned.

         3.   Where the information in the accompanying document contradicts the information on the label referred to in Article 2, the information on that label shall prevail.
   Article 4
   Sealing and packaging requirements for pre-basic, basic or certified material
   1.   Member States shall ensure that, where pre-basic, basic or certified material is marketed in lots of two or more plants or parts of plants, those lots are sufficiently homogeneous.
   Plants or parts of plants making up such lots shall fulfil the requirements of point (a) or point (b):

               (a)

               plants or parts of plants are in a package or container sealed as defined in paragraph 2; or

               (b)

               plants or parts of plants form part of a bundle sealed as defined in paragraph 2.

         2.   For the purposes of this Directive ‘sealing’ means: in the case of a package or container, closing in such a way that it cannot be opened without damaging the closure, in the case of a bundle, tying up in such a way that the plants or parts of plants forming part of the bundle cannot be separated without damaging the tie or ties. The package, the container or bundle shall be labelled in such a way that the removal of the label renders it invalid.
   Article 5
   Supplier's document for CAC material
   1.   Member States shall ensure that CAC material is marketed with a document prepared by the supplier and complying with paragraphs 2 and 3, hereinafter ‘the supplier's document’.
   Member States shall ensure that the supplier's document does not resemble a label referred to in Article 2 or an accompanying document referred to in Article 3, so as to avoid any possible confusion between the supplier's document and those two documents.
   2.   The supplier's document shall contain at least the following information:

               (a)

               the indication ‘EU rules and standards’;

               (b)

               Member State where the supplier's document has been prepared, or the respective code;

               (c)

               responsible official body or the respective code;

               (d)

               name of supplier or its registration number/code issued by the responsible official body;

               (e)

               individual serial number, week number or batch number;

               (f)

               botanical name;

               (g)

               CAC material;

               (h)

               denomination of the variety and, where appropriate, the clone. In the case of rootstocks not belonging to a variety, the name of the species or the interspecific hybrid concerned. For grafted fruit plants such information shall be given for the rootstock and the top-graft. For varieties for which an application for official registration or for a plant variety right is pending, such information shall indicate: ‘proposed denomination’ and ‘application pending’;

               (i)

               quantity;

               (j)

               country of production and the respective code, where different from the Member State where the supplier's document has been prepared;

               (k)

               date of issue of the document.

         3.   The supplier's document shall be indelibly printed in one of the official languages of the Union and easily visible and legible.
   Article 6
   Transposition
   1.   Member States shall adopt and publish, by 31 December 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 1 January 2017.
   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 7
   Review clause
   The Commission shall review Article 2(4) by1 January 2019.
   Article 8
   Entry into force
   This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
   Article 9
   Addressees
   This Directive is addressed to the Member States.

      Done at Brussels, 15 October 2014.

            For the Commission

            The President

         José Manuel BARROSO

      (1)  OJ L 267, 8.10.2008, p. 8.


title: Commission Delegated Directive 2014/10/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 alloys, as a superconductor or thermal conductor, used in cryo-cooler cold heads and/or in cryo-cooled cold probes and/or in cryo-cooled equipotential bonding systems, in medical devices (category 8) and/or in industrial monitoring and control instruments  Text with EEA relevance

text:
               9.1.2014

               EN

               Official Journal of the European Union

               L 4/63

         COMMISSION DELEGATED DIRECTIVE 2014/10/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 alloys, as a superconductor or thermal conductor, used in cryo-cooler cold heads and/or in cryo-cooled cold probes and/or in cryo-cooled equipotential bonding systems, in medical devices (category 8) and/or in industrial monitoring and control instruments
   (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 alloys as a superconductor or thermal conductor, used in cryo-cooler cold heads and/or in cryo-cooled cold probes and/or in cryo-cooled equipotential bonding systems, in medical devices (category 8) and/or in industrial monitoring and control instruments is currently not possible. Currently there are no viable lead-free devices available on the market for this application.

               (3)

               Time is required for reliability testing and product registration of alternative solutions.

               (4)

               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 29 is added:

                  ‘29.

                  Lead in alloys, as a superconductor or thermal conductor, used in cryo-cooler cold heads and/or in cryo-cooled cold probes and/or in cryo-cooled equipotential bonding systems, in medical devices (category 8) and/or in industrial monitoring and control instruments. Expires on 30 June 2021.’.


title: Commission Implementing Directive (EU) 2015/2392 of 17 December 2015 on Regulation (EU) No 596/2014 of the European Parliament and of the Council as regards reporting to competent authorities of actual or potential infringements of that Regulation

text:
               18.12.2015

               EN

               Official Journal of the European Union

               L 332/126

         COMMISSION IMPLEMENTING DIRECTIVE (EU) 2015/2392
   of 17 December 2015
   on Regulation (EU) No 596/2014 of the European Parliament and of the Council as regards reporting to competent authorities of actual or potential infringements of that Regulation
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Regulation (EU) No 596/2014 of the European Parliament and of the Council of 16 April 2014 on market abuse (market abuse regulation) and repealing Directive 2003/6/EC of the European Parliament and of the Council and Commission Directives 2003/124/EC, 2003/125/EC and 2004/72/EC (1), and in particular Article 32(5) thereof,
   Whereas:

               (1)

               Persons reporting actual or potential infringements of Regulation (EU) No 596/2014 (whistle-blowers) to competent authorities may bring new information to the attention of competent authorities and assist the latter in detecting and imposing sanctions for market abuse offences. However, whistleblowing of infringements may be deterred by fear of retaliation, discrimination or disclosure of personal data. Adequate arrangements regarding whistleblowing are hence necessary to ensure the overall protection and the respect of the fundamental rights of the whistle-blowers and the accused persons. Persons who knowingly report wrong or misleading information to competent authorities should not be considered as whistle-blowers and thus should not enjoy the protection mechanisms.

               (2)

               Anonymous reporting should be allowed by competent authorities and the protection mechanisms of this Directive should also apply where an anonymous whistle-blower decides to reveal its identity to the competent authority at a later stage. Whistle-blowers should be free to report either through internal procedures, where such procedures exist, or directly to the competent authority.

               (3)

               Dedicated staff members of the competent authorities, who are professionally trained, including on applicable data protection rules, would be necessary in order to handle reports of infringements of Regulation (EU) No 596/2014 and to ensure communication with the reporting person, as well as following up on the report in a suitable manner.

               (4)

               Persons intending to report actual or potential infringements of Regulation (EU) No 596/2014 should be able to make an informed decision on whether, how and when to report. Competent authorities should therefore publicly disclose and make easily accessible information about the available communication channels with competent authorities, about the applicable procedures and about the dedicated staff members within the authority dealing with reports of infringements. All information regarding reports of infringements should be transparent, easily understandable and reliable in order to promote and not deter reporting of infringements.

               (5)

               In order to allow for effective communication with its dedicated staff it is necessary that the competent authorities have in place and use different communication channels that should be user-friendly and allow for written and oral, as well as electronic and non-electronic communication.

               (6)

               It is important that the procedures for the protection of persons working under a contract of employment, irrespective of the nature of their working relationship and whether they are paid or not, who report infringements or are accused of infringements of Regulation (EU) No 596/2014 protect such persons against retaliation, discrimination or other types of direct or indirect unfair treatment. Unfair treatment can take very different forms depending on the circumstances. Thus individual cases need to be assessed through dispute resolution rules or judiciary procedures available under national law.

               (7)

               Member States should ensure that competent authorities have in place adequate protection procedures for the processing of reports of infringements and reported persons' personal data. Such procedures should ensure that the identity of every reporting and reported person is protected at all stages of the procedure. This obligation should be without prejudice to the necessity and proportionality of the obligation to disclose information when this is required by Union or national law and subject to appropriate safeguards under such laws, including in the context of investigations or judicial proceedings or to safeguard the freedoms of others, including the rights of defence of the reported person.

               (8)

               It is highly important and necessary that dedicated staff of the competent authority and staff members of the competent authority who receive access to the information provided by a reporting person to the competent authority comply with the duty of professional secrecy and the confidentiality when transmitting the data both inside and outside of the competent authority, including where a competent authority opens an investigation or an inquiry or subsequent enforcement activities in connection with the report of infringements.

               (9)

               Member States should ensure the adequate record-keeping of all reports of infringement and that every report is retrievable within the competent authority and that information received through reports could be used as evidence in enforcement actions where appropriate. Member States should ensure the compliance with Directive 95/46/EC of the European Parliament and of the Council (2) and national legislation transposing Directive 95/46/EC.

               (10)

               Protection of personal data of the reporting and reported person is crucial in order to avoid unfair treatment or reputational damages due to disclosure of personal data, in particular data revealing the identity of a person concerned. Hence, in addition to the national data protection legislation which transposes Directive 95/46/EC, competent authorities should establish adequate data protection procedures specifically geared to the protection of the reporting and reported person that should include a secure system within the competent authority with restricted access rights for authorised staff only.

               (11)

               Transmission of personal data connected to reports of infringements by the competent authority could be necessary to evaluate a report of infringements and to undertake the necessary investigation and enforcement actions. When transmitting data within the competent authority or to third parties, competent authorities should preserve the confidentiality to the maximum extent possible in accordance with national law.

               (12)

               The rights of the reported person accused of an infringement of Regulation (EU) No 596/2014 should be protected in order to avoid reputational damages or other negative consequences. Furthermore, the rights of defence and access to remedies of the reported person should be fully respected at every stage of the procedure following the report. Member States should ensure the right of defence of the reported person, including the right to access to the file, the right to be heard and the right to seek effective remedy against a decision concerning the reported person under the applicable procedures set out in national law in the context of investigations or subsequent judicial proceedings.

               (13)

               The regular and at least biannual (once every two years) review of the procedures of competent authorities should guarantee that these procedures are adequate and state of the art, and thus serving their purpose. For this purpose, it is important that competent authorities evaluate their own experiences and exchange experiences and good practices with other competent authorities.

               (14)

               Given that detailed rules on the protection of whistle-blowers would make it more difficult for Member States to ensure compatibility and operational fit with their national systems, including administrative, procedural and institutional aspects, some flexibility is needed for the implementing act. Such flexibility would best be achieved through a directive, rather than a regulation and hence a directive appears to be the most appropriate instrument in order to allow Member States to adapt the reporting of infringements regime efficiently into their national systems including the institutional framework.

               (15)

               Given the fact that Regulation (EU) No 596/2014 enters into application on 3 July 2016, it is appropriate that the Member States transpose and apply provisions pertaining to this Directive from 3 July 2016.

               (16)

               The measures provided for in this Directive are in accordance with the opinion of the European Securities Committee,

         HAS ADOPTED THIS DIRECTIVE:
   CHAPTER I

      SUBJECT MATTER AND DEFINITIONS

   Article 1
   Subject-matter
   This Directive lays down rules specifying the procedures set out in Article 32(1) of Regulation (EU) No 596/2014, including the arrangements for reporting and for following-up reports, and measures for the protection of persons working under a contract of employment and measures for the protection of personal data.
   Article 2
   Definitions
   For the purposes of this Directive, the following definitions shall apply:

               (1)

               ‘reporting person’ means a person reporting an actual or potential infringement of Regulation (EU) No 596/2014 to the competent authority;

               (2)

               ‘reported person’ means a person who is accused of having committed, or intending to commit, an infringement of Regulation (EU) No 596/2014 by the reporting person;

               (3)

               ‘report of infringement’ means a report submitted by the reporting person to the competent authority regarding an actual or potential infringement of Regulation (EU) No 596/2014.

         CHAPTER II

      PROCEDURES FOR THE RECEIPT OF REPORTS OF INFRINGEMENTS AND THEIR FOLLOW-UP

   Article 3
   Dedicated staff members
   1.   Member States shall ensure that competent authorities have staff members dedicated to handling reports of infringements (‘dedicated staff members’). Dedicated staff members shall be trained for the purposes of handling reports of infringements.
   2.   Dedicated staff members shall exercise the following functions:

               (a)

               providing any interested person with information on the procedures for reporting infringements;

               (b)

               receiving and following-up reports of infringements;

               (c)

               maintaining contact with the reporting person where the latter has identified itself.

         Article 4
   Information regarding the receipt of reports of infringements and their follow-up
   1.   Member States shall ensure that competent authorities publish on their websites in a separate, easily identifiable and accessible section the information regarding the receipt of reports of infringements set out in paragraph 2.
   2.   The information referred to in paragraph 1 shall include all of the following:

               (a)

               the communication channels for receiving and following-up the reporting of infringements and for contacting the dedicated staff members in accordance with Article 6(1), including:

                           (1)

                           the phone numbers, indicating whether conversations are recorded or unrecorded when using those phone lines;

                           (2)

                           dedicated electronic and postal addresses, which are secure and ensure confidentiality, to contact the dedicated staff members;

               (b)

               the procedures applicable to reports of infringements referred to in Article 5;

               (c)

               the confidentiality regime applicable to reports of infringements in accordance with the procedures applicable to reports of infringements referred to in Article 5;

               (d)

               the procedures for the protection of persons working under a contract of employment;

               (e)

               a statement clearly explaining that persons making information available to the competent authority in accordance with Regulation (EU) No 596/2014 are not considered to be infringing any restriction on disclosure of information imposed by contract or by any legislative, regulatory or administrative provision, and are not to be involved in liability of any kind related to such disclosure.

         3.   Competent authorities may publish on their websites more detailed information regarding the receipt and follow-up of infringements set out in paragraphs 2.
   Article 5
   Procedures applicable to reports of infringements
   1.   The procedures applicable to reports of infringements referred to in Article 4(2)(b) shall clearly indicate all of the following information:

               (a)

               that reports of infringements can also be submitted anonymously;

               (b)

               the manner in which the competent authority may require the reporting person to clarify the information reported or to provide additional information that is available to the reporting person;

               (c)

               the type, content and timeframe of the feed-back about the outcome of the report of infringement that the reporting person can expect after the reporting;

               (d)

               the confidentiality regime applicable to reports of infringements, including a detailed description of the circumstances under which the confidential data of a reporting person may be disclosed in accordance with Articles 27, 28 and 29 of Regulation (EU) No 596/2014.

         2.   The detailed description referred to in point (d) of paragraph 1 shall ensure awareness of the reporting person concerning the exceptional cases in which confidentiality of data may not be ensured, including where the disclosure of data is a necessary and proportionate obligation required under Union or national law in the context of investigations or subsequent judicial proceedings or to safeguard the freedoms of others including the right of defence of the reported person, and in each case subject to appropriate safeguards under such laws.
   Article 6
   Dedicated communication channels
   1.   Member States shall ensure that competent authorities establish independent and autonomous communication channels, which are both secure and ensure confidentiality, for receiving and following-up the reporting of infringements (‘dedicated communication channels’).
   2.   Dedicated communication channels shall be considered independent and autonomous, provided that they meet all of the following criteria:

               (a)

               they are separated from general communication channels of the competent authority, including those through which the competent authority communicates internally and with third parties in its ordinary course of business;

               (b)

               they are designed, set up and operated in a manner that ensures the completeness, integrity and confidentiality of the information and prevents access to non-authorised staff members of the competent authority;

               (c)

               they enable the storage of durable information in accordance with Article 7 to allow for further investigations.

         3.   The dedicated communication channels shall allow for reporting of actual or potential infringements in at least all of the following ways:

               (a)

               written report of infringements in electronic or paper format;

               (b)

               oral report of infringements through telephone lines, whether recorded or unrecorded;

               (c)

               physical meeting with dedicated staff members of the competent authority.

         4.   The competent authority shall provide the information referred to in paragraph 2 of Article 4 to the reporting person before receiving the report of infringement, or at the moment of receiving it at the latest.
   5.   Competent authorities shall ensure that a report of infringement received by means other than dedicated communication channels referred to in this Article is promptly forwarded without modification to the dedicated staff members of the competent authority by using dedicated communication channels.
   Article 7
   Record-keeping of reports received
   1.   Member States shall ensure that competent authorities keep records of every report of infringement received.
   2.   Competent authorities shall promptly acknowledge the receipt of written reports of infringements to the postal or electronic address indicated by the reporting person, unless the reporting person explicitly requested otherwise or the competent authority reasonably believes that acknowledging receipt of a written report would jeopardise the protection of the reporting person's identity.
   3.   Where a recorded telephone line is used for reporting of infringements, the competent authority shall have the right to document the oral reporting in the form of:

               (a)

               an audio recording of the conversation in a durable and retrievable form; or

               (b)

               a complete and accurate transcript of the conversation prepared by the dedicated staff members of the competent authority. In cases where the reporting person has disclosed its identity, the competent authority shall offer the possibility to the reporting person to check, rectify and agree with the transcript of the call by signing it.

         4.   Where an unrecorded telephone line is used for reporting of infringements, the competent authority shall have the right to document the oral reporting in the form of accurate minutes of the conversation prepared by the dedicated staff members of the competent authority. In cases where the reporting person has disclosed its identity, the competent authority shall offer the possibility to the reporting person to check, rectify and agree with the minutes of the call by signing them.
   5.   Where a person requests a physical meeting with the dedicated staff members of the competent authority for reporting an infringement according to Article 6(3)(c), competent authorities shall ensure that complete and accurate records of the meeting are kept in a durable and retrievable form. A competent authority shall have the right to document the records of the physical meeting in the form of:

               (a)

               an audio recording of the conversation in a durable and retrievable form; or

               (b)

               accurate minutes of the meeting prepared by the dedicated staff members of the competent authority. In cases where the reporting person has disclosed its identity, the competent authority shall offer the possibility to the reporting person to check, rectify and agree with the minutes of the meeting by signing them.

         Article 8
   Protection of persons working under a contract of employment
   1.   Member States shall put in place procedures ensuring effective exchange of information and cooperation between competent authorities and any other relevant authority involved in the protection of persons working under a contract of employment who report infringements of Regulation (EU) No 596/2014 to the competent authority or are accused of such infringements, against retaliation, discrimination or other types of unfair treatment, arising due to or in connection with reporting of infringements of Regulation (EU) No 596/2014.
   2.   The procedures set out in paragraph 1 shall ensure at least the following:

               (a)

               reporting persons have access to comprehensive information and advice on the remedies and procedures available under national law to protect them against unfair treatment, including on the procedures for claiming pecuniary compensation;

               (b)

               reporting persons have access to effective assistance from competent authorities before any relevant authority involved in their protection against unfair treatment, including by certifying the condition of whistle-blower of the reporting person in employment disputes.

         Article 9
   Protection procedures for personal data
   1.   Member States shall ensure that competent authorities store the records referred to in Article 7 in a confidential and secure system.
   2.   Access to the system referred to in paragraph 1 shall be subject to restrictions ensuring that the data stored therein is only available to staff members of the competent authority for whom access to that data is necessary to perform their professional duties.
   Article 10
   Transmission of data inside and outside of the competent authority
   1.   Member States shall ensure that competent authorities have in place adequate procedures for the transmission of personal data of the reporting person and reported person inside and outside of the competent authority.
   2.   Member States shall ensure that the transmission of data related to a report of infringement within or outside the competent authority does not reveal, directly or indirectly, the identity of the reporting person or reported person or any other references to circumstances that would allow the identity of the reporting person or reported person to be deduced, unless such transmission is in accordance with the confidentiality regime referred to in Article 5(1)(d).
   Article 11
   Procedures for the protection of the reported persons
   1.   Where the identity of reported persons is not known to the public, the Member State concerned shall ensure that their identity is protected at least in the same manner as for persons that are under investigation by the competent authority.
   2.   The procedures set out Article 9 shall also apply for the protection of the identity of the reported persons.
   Article 12
   Review of the procedures by competent authorities
   Member States shall ensure that their competent authorities review their procedures for receiving reports of infringements and their follow-up regularly, and at least once every two years. In reviewing such procedures competent authorities shall take account of their experience and that of other competent authorities and adapt their procedures accordingly and in line with market and technological developments.
   CHAPTER III

      FINAL PROVISIONS

   Article 13
   Transposition
   Member States shall adopt and publish, by 3 July 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 3 July 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.
   Article 14
   Entry into force
   This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
   Article 15
   Addressees
   This Directive is addressed to the Member States.

      Done at Brussels, 17 December 2015.

            For the Commission

            The President

         Jean-Claude JUNCKER

      (1)  OJ L 173, 12.6.2014, p. 1.

      (2)  OJ L 281, 23.11.1995, p. 31.


title: Commission Implementing Directive 2014/37/EU of 27 February 2014 amending Council Directive 91/671/EEC relating to the compulsory use of safety belts and child restraint systems in vehicles

text:
               28.2.2014

               EN

               Official Journal of the European Union

               L 59/32

      COMMISSION IMPLEMENTING DIRECTIVE 2014/37/EU
   of 27 February 2014
   amending Council Directive 91/671/EEC relating to the compulsory use of safety belts and child restraint systems in vehicles
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Council Directive 91/671/EEC relating to the compulsory use of safety belts and child restraint systems in vehicles (1), and in particular Article 7a thereof,
   Whereas:

               (1)

               On 24 March 1998, the European Community acceded to the Agreement of the United Nations Economic Commission for Europe (UNECE) concerning the adoption of uniform technical prescriptions for wheeled vehicles, equipment and parts which can be fitted to and/or be used on wheeled vehicles and the conditions for reciprocal recognition of approvals granted on the basis of these prescriptions (hereinafter referred to as the ‘Revised 1958 Agreement’), in accordance with Council Decision 97/836/EC (2).

               (2)

               In accordance with paragraph 1 of Annex II to Decision 97/836/EC, the technical requirements of UNECE Regulations under the Revised 1958 Agreement become alternatives to the technical annexes to the relevant separate Union Directives where the latter possess the same scope and where for the UNECE Regulations separate Union Directives exist. However, the additional provisions of Directives, such as those concerning fitting requirements or the approval procedure, remain in force.

               (3)

               A new UNECE Regulation on uniform provisions concerning the approval of Enhanced Child Restraint Systems used on board of motor vehicles (hereinafter referred to as ‘Regulation 129’) was established and adopted under the auspices of the UNECE.

               (4)

               Regulation 129 entered into force on 9 July 2013 as an annex to the Revised 1958 Agreement.

               (5)

               The standardised requirements of Regulation 129 constitute alternative enhanced requirements in relation to those established under Regulation 44 on uniform provisions concerning the approval of restraining devices for child occupants of power-driven vehicles (‘Child restraint systems’) (3) and reflect technical progress in several aspects of child restraint systems such as tests for side impacts, the rear facing position of children up to 15 months, compatibility with different vehicles, test dummies and test benches and adaptability to various child sizes;

               (6)

               As Directive 91/671/EEC lays down requirements for the approval and compulsory use of child restraint systems in motor vehicles within the Union, it should therefore be amended in order to include the use of child restraint systems approved according to the technical requirements of Regulation 129.

               (7)

               The measures provided for in this Directive are in accordance with the opinion of the Committee established in accordance with Article 7b of Directive 91/671/ECC,

         HAS ADOPTED THIS DIRECTIVE:
   Article 1
   Article 2 of Directive 91/671/EEC is amended as follows:

               (1)

               point 1(a)(i) shall be replaced by the following:

                           ‘(i)

                           for M1, N1, N2 and N3 vehicles, Member States shall require that all occupants of vehicles in use shall use the safety systems provided.
                           Children less than 150 cm in height occupying M1, N1, N2 and N3 vehicles fitted with safety systems shall be restrained by an integral or non-integral child-restraint system, within the meaning of Article 1(4)(a) and (b), which is suitable for the child's physical features in accordance with:

                                       —

                                       classification provided for in Article 1(3), for child restraint systems approved in accordance with point (c)(i) of this paragraph;

                                       —

                                       the size range and maximum occupant mass for which the child restraint system is intended, as indicated by the manufacturer, for child restraint systems approved in accordance with point (c)(ii) of this paragraph.

                                 In M1, N1, N2 and N3 vehicles that are not fitted with safety systems:

                                       —

                                       children under three years of age may not be transported,

                                       —

                                       without prejudice to point (ii), children aged three and over and less than 150 cm in height shall occupy a seat other than a front seat;’

               (2)

               point 1(c) shall be replaced by the following:

                           ‘(c)

                           where a child-restraint system is used, it shall be approved to the standards of:

                                       i)

                                       UNECE Regulation 44/03 or Directive 77/541/EEC or

                                       ii)

                                       UNECE Regulation 129;

                                 or any subsequent adaptation thereto.
                           The child restraint system shall be installed in accordance with fitting information (e.g. instruction manual, leaflet or electronic publication) provided by the manufacturer of the child restraint system declaring in what manner and in which vehicle types the system may be safely used.’

         Article 2
   1.   Member States shall adopt and publish the laws, regulations and administrative provisions necessary to comply with this Directive six months after its 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, 27 February 2014.

            For the Commission, On behalf of the President,
         Siim KALLAS

            Vice-President

      (1)  OJ L 373, 31.12.1991, p. 26.

      (2)  Council Decision 97/836/EC of 27 November 1997 with a view to accession by the European Community to the Agreement of the United Nations Economic Commission for Europe concerning the adoption of uniform technical prescriptions for wheeled vehicles, equipment and parts which can be fitted to and/or be used on wheeled vehicles and the conditions for reciprocal recognition of approvals granted on the basis of these prescriptions (OJ L 346, 17.12.1997, p. 78).

      (3)  OJ L 306, 23.11.2007, p. 1.