title: Commission Implementing Directive 2011/54/EU of 20 April 2011 amending Council Directive 91/414/EEC to include metaldehyde as active substance and amending Commission Decision 2008/934/EC  Text with EEA relevance

text:
               21.4.2011

               EN

               Official Journal of the European Union

               L 105/28

         COMMISSION IMPLEMENTING DIRECTIVE 2011/54/EU
   of 20 April 2011
   amending Council Directive 91/414/EEC to include metaldehyde 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 metaldehyde.

               (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 metaldehyde.

               (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 Austria, 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)

               Austria 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 5 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 metaldehyde to the Commission on 11 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 metaldehyde.

               (6)

               It has appeared from the various examinations made that plant protection products containing metaldehyde 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 metaldehyde 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 six months after inclusion to review existing authorisations of plant protection products containing metaldehyde 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 2008/934/EC provides for the non-inclusion of metaldehyde and the withdrawal of authorisations for plant protection products containing that substance by 31 December 2011. It is necessary to delete the line concerning metaldehyde in the Annex to that Decision.

               (12)

               It is therefore appropriate to amend Decision 2008/934/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 metaldehyde 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 metaldehyde 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 metaldehyde 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 metaldehyde 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 metaldehyde. 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 metaldehyde 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 metaldehyde 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, 20 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 metaldehyde. EFSA Journal 2010; 8(10):1856. [71 pp.]. doi:10.2903/j.efsa.2010.1856. 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

                     ‘360

                     Metaldehyde
                     CAS No:

                        108-62-3 (tetramer)

                        9002-91-9 (homopolymer)
                     CIPAC No: 62

                        r-2, c-4, c-6, c-8-tetramethyl-1,3,5,7- tetroxocane

                     ≥ 985 g/kg
                     acetaldehyde max. 1,5 g/kg

                     1 June 2011

                     31 May 2021

                     PART A
                     Only uses as molluscicide may be authorised.
                     PART B
                     For the implementation of the uniform principles of Annex VI, the conclusions of the review report on metaldehyde, 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 risk to operators and workers;

                                 (b)

                                 the dietary exposure situation of consumers in view of future revisions of maximum residue levels;

                                 (c)

                                 the acute risk and long-term risk to birds and mammals.

                           Member States shall ensure that authorisations shall contain an effective dog repellent agent.
                     Conditions of use shall include risk mitigation measures, where appropriate.’

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


title: Commission Implementing Directive 2012/1/EU of 6 January 2012 amending Annex I to Council Directive 66/402/EEC as regards the conditions to be satisfied by the crop Oryza sativa  Text with EEA relevance

text:
               7.1.2012

               EN

               Official Journal of the European Union

               L 4/8

         COMMISSION IMPLEMENTING DIRECTIVE 2012/1/EU
   of 6 January 2012
   amending Annex I to Council Directive 66/402/EEC as regards the conditions to be satisfied by the crop Oryza sativa
   (Text with EEA relevance)
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Council Directive 66/402/EEC of 14 June 1966 on the marketing of cereal seed (1), and in particular Article 21a thereof,
   Whereas:

               (1)

               Recent information and studies from Member States have shown the need to introduce a threshold for the presence of plants infected by Fusarium fujikuroi in fields where seed of Oryza sativa is produced, since Fusarium fujikuroi causes damage to rice and is not susceptible to efficient treatment with the available plant protection products. Those studies have also shown the need to reduce the presence of wild or red-grain plants in fields where seed of Oryza sativa is produced, since under the current threshold the yield and quality of rice seed are significantly decreased.

               (2)

               In view of that, a threshold for the presence of plants infected by Fusarium fujikuroi, in fields where seed of Oryza sativa is produced, should be introduced and the threshold for the presence of wild or red-grain plants, in fields where seed of Oryza sativa is produced, should be reduced for the production of the category of certified seed. Those thresholds should be set on the basis of the studies carried out by Members States.

               (3)

               Directive 66/402/EEC 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
   Amendments to Directive 66/402/EEC
   In Annex I to Directive 66/402/EEC, point 3.A. is replaced by the following:

               ‘A.

               Oryza sativa:
               The number of plants which are recognisable as obviously being infected by Fusarium fujikuroi shall not exceed:

                           —

                           2 per 200 m2 for the production of basic seed,

                           —

                           4 per 200 m2 for the production of certified seed, first generation,

                           —

                           8 per 200m2 for the production of certified seed, second generation.

                     The number of plants which are recognisable as obviously being wild or red-grain plants shall not exceed:

                           —

                           0 for the production of basic seed,

                           —

                           1 per 100 m2 for the production of certified seed, first and second generation,’

         Article 2
   Transposition
   1.   Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 31 May 2012 at the latest. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive.
   When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
   2.   Member States shall communicate to the Commission the texts of the main provisions of national law, which they adopt in the field covered by this Directive.
   Article 3
   Entry into force
   This Directive shall enter into force on the seventh day following its publication in the Official Journal of the European Union.
   Article 4
   Addressees
   This Directive is addressed to the Member States.

      Done at Brussels, 6 January 2012.

            For the Commission

            The President

         José Manuel BARROSO

      (1)  OJ 125, 11.7.1966, p. 2309/66.


title: Commission Delegated Directive 2014/3/EU of 18 October 2013 amending, for the purposes of adapting to technical progress, the Annex IV to Directive 2011/65/EU of the European Parliament and of the Council as regards an exemption for lead acetate marker for use in stereotactic head frames for use with CT (Computed Tomography) and MRI and in positioning systems for gamma beam and particle therapy equipment  Text with EEA relevance

text:
               9.1.2014

               EN

               Official Journal of the European Union

               L 4/49

         COMMISSION DELEGATED DIRECTIVE 2014/3/EU
   of 18 October 2013
   amending, for the purposes of adapting to technical progress, the Annex IV to Directive 2011/65/EU of the European Parliament and of the Council as regards an exemption for lead acetate marker for use in stereotactic head frames for use with CT (Computed Tomography) and MRI and in positioning systems for gamma beam and particle therapy equipment
   (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)

               Lead acetate is an ideal substance for use as marker within head-frames used for positioning for radiotherapy and gamma-ray tumour extractions procedures.

               (3)

               It is scientifically and technically impracticable to substitute or eliminate lead in the respective application and it appears that a practicable substitute will not become available in the near future.

               (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 22 is added:

                  ‘22.

                  Lead acetate marker for use in stereotactic head frames for use with CT and MRI and in positioning systems for gamma beam and particle therapy equipment. Expires on 30 June 2021.’


title: Commission Implementing Directive 2011/39/EU of 11 April 2011 amending Council Directive 91/414/EEC to include fenazaquin as active substance and amending Commission Decision 2008/934/EC  Text with EEA relevance

text:
               12.4.2011

               EN

               Official Journal of the European Union

               L 97/30

         COMMISSION IMPLEMENTING DIRECTIVE 2011/39/EU
   of 11 April 2011
   amending Council Directive 91/414/EEC to include fenazaquin 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 fenazaquin.

               (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 fenazaquin.

               (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 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 applicant and prepared an additional report. It communicated that report to the European Food Safety Authority (hereinafter ‘the Authority’) and to the Commission on 28 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 fenazaquin 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 fenazaquin.

               (6)

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

               (12)

               It is therefore appropriate to amend Decision 2008/934/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 fenazaquin 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 fenazaquin 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 fenazaquin 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 fenazaquin 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 fenazaquin. 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 fenazaquin 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 fenazaquin 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, 11 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 fenazaquin. EFSA Journal 2010; 8(11):1892. [74 pp.]. doi:10.2903/j.efsa.2010.1892. 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

                     ‘345

                     Fenazaquin
                     CAS No: 120928-09-8
                     CIPAC No: 693

                     4-tert-butylphenethyl quinazolin-4-yl ether

                     ≥ 975 g/kg

                     1 June 2011

                     31 May 2021

                     PART A
                     Only uses as acaricide on ornamentals in greenhouses may be authorised.
                     PART B
                     For the implementation of the uniform principles of Annex VI, the conclusions of the review report on fenazaquin, 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 protection of aquatic organisms;

                                 (2)

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

                                 (3)

                                 pay particular attention to the protection of bees and ensure that conditions of use include risk mitigation measures, where appropriate;

                                 (4)

                                 provide for conditions of use which ensure that there are no residues of fenazaquin in crops for human and animal consumption.’

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


title: Commission Implementing Directive (EU) 2015/1955 of 29 October 2015 amending Annexes I and II to Council Directive 66/402/EEC on the marketing of cereal seed (Text with EEA relevance)

text:
               30.10.2015

               EN

               Official Journal of the European Union

               L 284/142

         COMMISSION IMPLEMENTING DIRECTIVE (EU) 2015/1955
   of 29 October 2015
   amending Annexes I and II to Council Directive 66/402/EEC on the marketing of cereal seed
   (Text with EEA relevance)
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Council Directive 66/402/EEC of 14 June 1966 on the marketing of cereal seed (1), and in particular Article 21b thereof,
   Whereas:

               (1)

               The past years an increasing number of hybrid varieties of barley produced by the technique of cytoplasmic male sterility have been listed in the Common Catalogue of Varieties of Agricultural Plant Species pursuant to Article 17 of Directive 2002/53/EC (2).

               (2)

               Cytoplasmic male sterility (CMS) has been accepted worldwide as a breeding technique for the production of hybrid varieties of barley. It encompasses a genetic system which naturally occurs in the cytoplasm of plants. That genetic system can be introduced into plants by means of crossing. On the basis of that technique, the genetic diversity of two or more parent lines can be combined. Therefore the performance of those varieties, in areas such as disease resistance and yields, can be improved. In view of that technical development it is appropriate to establish specific conditions for hybrid varieties of barley.

               (3)

               Taking into account the technical similarities with the production of seeds of hybrids of rye and the needs of the users of the seed of hybrids of barley, it is appropriate to set out conditions for that seed similar to the conditions applying for the seeds of hybrids of rye.

               (4)

               Experience has shown that the specific blend production system applied in the field, in combination with the weather related risks during the flowering period, would require a reduction of the varietal purity standard to 85 %, in the case the CMS technique is applied, allowing stable seed production under less favourable weather conditions. Therefore it is appropriate to allow a lower level of varietal purity than required for other hybrids.

               (5)

               Annexes I and II to Directive 66/402/EEC should therefore be amended accordingly.

               (6)

               The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

         HAS ADOPTED THIS DIRECTIVE:
   Article 1
   Amendments to Directive 66/402/EEC
   Annexes I and II to Directive 66/402/EEC are amended in accordance with the Annex to this Directive.
   Article 2
   Transposition
   1.   Member States shall adopt and publish, by 30 June 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 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.
   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
   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 4
   Addressees
   This Directive is addressed to the Member States.

      Done at Brussels, 29 October 2015.

            For the Commission

            The President

         Jean-Claude JUNCKER

      (1)  OJ 125, 11.7.1966, p. 2309/66.

      (2)  Council Directive 2002/53/EC of 13 June 2002 on the common catalogue of varieties of agricultural plant species (OJ L 193, 20.7.2002, p. 1).

      ANNEX
      Annexes I and II to Directive 66/402/EEC are amended as follows:

                  (1)

                  Annex I is amended as follows:

                              (a)

                              The first sentence of point 5 is replaced by the following: ‘Crops to produce certified seed of hybrids of Avena nuda, Avena sativa, Avena strigosa, Oryza sativa, Triticum aestivum, Triticum durum, Triticum spelta and self-pollinating xTriticosecale and crops to produce certified seed of hybrids of Hordeum vulgare by means of a technique other than Cytoplasmic Male Sterility (CMS)’.

                              (b)

                              The following point is inserted after point 5:

                                          ‘5a.

                                          Crops to produce basic and certified seed of hybrids of Hordeum vulgare by means of the technique of CMS:

                                                      (a)

                                                      The crop shall conform to the following standards as regards distances from neighbouring sources of pollen which may result in undesirable foreign pollination:

                                                                  Crop

                                                                  Minimum distance

                                                                  For the production of basic seed

                                                                  100 m

                                                                  For the production of certified seed

                                                                  50 m

                                                      (b)

                                                      The crop shall have sufficient varietal identity and purity as regards the characteristics of the components.
                                                      In particular the crop shall conform to the following standards:

                                                                  (i)

                                                                  The percentage by number of plants which are obviously not being true to type shall not exceed:

                                                                              —

                                                                              for the crops used to produce basic seed, 0,1 % for the maintainer and the restorer line and 0,2 % for the CMS female component,

                                                                              —

                                                                              for the crops used to produce certified seed, 0,3 % for the restorer and the CMS female component and 0,5 % in case the CMS female component is a single hybrid.

                                                                  (ii)

                                                                  The level of male sterility of the female component shall be at least:

                                                                              —

                                                                              99,7 % for crops used to produce basic seed,

                                                                              —

                                                                              99,5 % for crops used to produce certified seed.

                                                                  (iii)

                                                                  The requirements of points (i) and (ii) shall be examined in official post-control test.

                                                      (c)

                                                      Certified seed may be produced in mixed cultivation of a female male-sterile component with a male component which restores fertility.’

                  (2)

                  Annex II is amended as follows:

                              (a)

                              Point 1.C is replaced by the following:
                              ‘C.   Hybrids of Avena nuda, Avena sativa, Avena strigosa, Hordeum vulgare, Oryza sativa, Triticum aestivum, Triticum durum, Triticum spelta, and self-pollinating xTriticosecale

                              The minimum varietal purity of the seed of the category certified seed shall be 90 %.
                              In case of Hordeum vulgare produced by means of CMS, it shall be 85 %. Impurities other than the restorer shall not exceed 2 %.
                              The minimum varietal purity shall be examined in official post-control test on an appropriate proportion of samples.’

                              (b)

                              The title of point 1.E of Annex II is replaced by the following:‘E.
                                 Hybrids of Secale cereale and CMS-hybrids of Hordeum vulgare
                                 ’.


title: Commission Delegated Directive (EU) 2016/1028 of 19 April 2016 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 of electrical connections to temperature measurement sensors in certain devices (Text with EEA relevance)

text:
               25.6.2016

               EN

               Official Journal of the European Union

               L 168/13

         COMMISSION DELEGATED DIRECTIVE (EU) 2016/1028
   of 19 April 2016
   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 of electrical connections to temperature measurement sensors in certain devices
   (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)

               Lead is used for electrical connections in cryogenic sensors for medical devices and monitoring and control instruments to prevent the formation of thick intermetallic phases, whiskers, and tin pest. Those sensors are used in some applications to measure very low temperatures for short periods.

               (3)

               Lead-free solders cannot be used in cryogenic applications, as they are prone to tin pest, which seriously affects the reliability of the appliances. It has been proven that, in typically operated cryogenic sensors, no alternative connection technologies other than soldering are both reliable and available.

               (4)

               Lead solders in the external contacts of temperature sensors that are used periodically at temperatures below – 150 °C should therefore be exempted until 30 June 2021, as the exemption in point 26 of Annex IV to Directive 2011/65/EU. In view of the innovation cycles for medical devices and monitoring and control instruments, duration of this exemption is unlikely to have adverse impacts on innovation.

               (5)

               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 30 April 2017 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, 19 April 2016.

            For the Commission

            The President

         Jean-Claude JUNCKER

      (1)  OJ L 174, 1.7.2011, p. 88.

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

                     ‘26.

                     Lead in the following applications that are used durably at a temperature below – 20 °C under normal operating and storage conditions:

                                 (a)

                                 solders on printed circuit boards;

                                 (b)

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

                                 (c)

                                 solders for connecting wires and cables;

                                 (d)

                                 solders connecting transducers and sensors.

                           Lead in solders of electrical connections to temperature measurement sensors in devices which are designed to be used periodically at temperatures below – 150 °C.
                     These exemptions expire on 30 June 2021.’


title: Commission Delegated Directive 2014/75/EU of 13 March 2014 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 mercury in cold cathode fluorescent lamps (CCFLs) for back-lighting liquid crystal displays, not exceeding 5 mg per lamp, used in industrial monitoring and control instruments placed on the market before 22 July 2017  Text with EEA relevance

text:
               20.5.2014

               EN

               Official Journal of the European Union

               L 148/84

         COMMISSION DELEGATED DIRECTIVE 2014/75/EU
   of 13 March 2014
   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 mercury in cold cathode fluorescent lamps (CCFLs) for back-lighting liquid crystal displays, not exceeding 5 mg per lamp, used in industrial monitoring and control instruments placed on the market before 22 July 2017
   (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 mercury in electrical and electronic equipment placed on the market.

               (2)

               Many industrial monitoring and control instruments (IMCIs) are equipped with back-lighting liquid crystal displays that require the use of cold cathode fluorescent lamps (CCFLs) with 5 mg mercury. The total negative environmental, health and consumer safety impacts caused by substitution of mercury containing CCFLs in industrial monitoring and control instruments are likely to outweigh the total environmental, health and consumer safety benefits thereof.

               (3)

               To enable the repair and prolong the service life of products, an exemption from the restriction of mercury in CCFLs for back-lighting liquid crystal displays in IMCIs should be granted. In accordance with the repair-as-produced principle, the exemption should apply to all products placed on the market before 22 July 2017, which is the compliance date for IMCIs, and the validity period of the exemption should be 7 years from that date. It is unlikely that the exemption will have adverse impacts on innovation.

               (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, 13 March 2014.

            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 35 is added:

                     ‘35.

                     Mercury in cold cathode fluorescent lamps for back-lighting liquid crystal displays, not exceeding 5 mg per lamp, used in industrial monitoring and control instruments placed on the market before 22 July 2017
                     Expires on 21 July 2024.’


title: Commission Implementing Directive 2011/38/EU of 11 April 2011 amending Annex V to Directive 2004/33/EC with regards to maximum pH values for platelets concentrates at the end of the shelf life  Text with EEA relevance

text:
               12.4.2011

               EN

               Official Journal of the European Union

               L 97/28

         COMMISSION IMPLEMENTING DIRECTIVE 2011/38/EU
   of 11 April 2011
   amending Annex V to Directive 2004/33/EC with regards to maximum pH values for platelets concentrates at the end of the shelf life
   (Text with EEA relevance)
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Directive 2002/98/EC of the European Parliament and the Council of 27 January 2003 setting standards of quality and safety for the collection, testing, processing, storage and distribution of human blood and blood components and amending Directive 2001/83/EC (1), and in particular point (f) of the second paragraph of Article 29 thereof,
   Whereas:

               (1)

               Point 2.4 of Annex V to Commission Directive 2004/33/EC of 22 March 2004 implementing Directive 2002/98/EC of the European Parliament and of the Council as regards certain technical requirements for blood and blood components (2) sets minimum (6,4) and maximum (7,4) pH levels for units of platelets at the end of the shelf life. Therefore, platelet units that do not meet these minimum or maximum values have to be discarded.

               (2)

               Recent scientific evidence and field practice experience has demonstrated that values higher than pH 7,4 do not affect the quality and safety of stored platelets, contrary to pH levels below 6,4 that systematically result in damaging the platelets, and that a maximum pH value for platelet concentrates is thus not necessary.

               (3)

               Discarding platelets that exceed the maximum pH value as set out in Annex V to Directive 2004/33/EC leads to considerable losses. These losses may increase in the future due to new collection methods and storage bags, which both generate higher pH values at the end of the shelf life.

               (4)

               Therefore the maximum (7,4) pH value for all platelet concentrates listed in Annex V to Directive 2004/33/EC should be removed.

               (5)

               The measures provided for in this Directive are in accordance with the opinion of the Committee set up by Article 28 of Directive 2002/98/EC,

         HAS ADOPTED THIS DIRECTIVE:
   Article 1
   Annex V to Directive 2004/33/EC is amended in accordance with 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 30 June 2011 at the latest. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive.
   When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
   2.   Member States shall communicate to the Commission the 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 day following its publication in the Official Journal of the European Union.

   Article 4
   This Directive is addressed to the Member States.

      Done at Brussels, 11 April 2011.

            For the Commission

            The President

         José Manuel BARROSO

      (1)  OJ L 33, 8.2.2003, p. 30.

      (2)  OJ L 91, 30.3.2004, p. 25.

      ANNEX
      In point 2.4 of Annex V to Directive 2004/33/EC, for the entries:

                  —

                  ‘Platelets, apheresis’,

                  —

                  ‘Platelets, aphaeresis, leucocyte-depleted’,

                  —

                  ‘Platelets, recovered, pooled’,

                  —

                  ‘Platelets, recovered, pooled, leucocyte-depleted’,

                  —

                  ‘Platelets, recovered, single unit’, and

                  —

                  ‘Platelets, recovered, single unit, leucocyte-depleted’,

            the acceptable results for quality measurements for pH are replaced by the following:
      ‘Minimum 6,4 corrected for 22 °C, at the end of the shelf life’.


title: Commission Implementing Directive 2011/42/EU of 11 April 2011 amending Council Directive 91/414/EEC to include flutriafol as active substance and amending Commission Decision 2008/934/EC  Text with EEA relevance

text:
               12.4.2011

               EN

               Official Journal of the European Union

               L 97/42

         COMMISSION IMPLEMENTING DIRECTIVE 2011/42/EU
   of 11 April 2011
   amending Council Directive 91/414/EEC to include flutriafol 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 flutriafol.

               (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 flutriafol.

               (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 the United Kingdom, 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)

               The United Kingdom 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 15 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 flutriafol to the Commission on 14 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 flutriafol.

               (6)

               It has appeared from the various examinations made that plant protection products containing flutriafol 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 flutriafol 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 information confirming the relevance of the impurities present in the technical specifications, the assessment as regards the residues of triazole derivative metabolites (TDMs) in primary crops, rotational crops and products of animal origin, and the long-term risk to insectivorous birds.

               (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 flutriafol 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 flutriafol and the withdrawal of authorisations for plant protection products containing that substance by 31 December 2011. It is necessary to delete the line concerning flutriafol 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 flutriafol 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 flutriafol 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 flutriafol 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 flutriafol 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 flutriafol. 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 flutriafol 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 flutriafol 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, 11 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 flutriafol. EFSA Journal 2010;8(10):1868. [50 pp.] doi:10.2903/j.efsa.2010.1868. Available online: www.efsa.europa.eu/efsajournal.htm

      (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

                     ‘346

                     Flutriafol
                     CAS No: 76674-21-0

                     CIPAC No: 436

                        (RS)-2,4′-difluoro-α-(1H-1,2,4-triazol-1-ylmethyl)benzhydryl alcohol

                     ≥ 920 g/kg
                     (racemate)
                     Relevant impurities: dimethyl sulphate: max content 0,1 g/kg
                     dimethylformamide: max content 1 g/kg
                     methanol: max content 1 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 flutriafol, 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 protection of the workers’ safety and ensure that conditions of use include the application of adequate personal protective equipment;

                                 (2)

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

                                 (3)

                                 pay particular attention to the long-term risk to insectivorous birds.

                           Conditions of authorisation shall include risk mitigation measures, where appropriate.
                     The Member States concerned shall ensure that the applicant submits to the Commission confirmatory information as regards:

                                 (a)

                                 the relevance of the impurities present in the technical specifications;

                                 (b)

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

                                 (c)

                                 the long-term risk to insectivorous birds.

                           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) and (c) by 31 May 2013.’

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


title: Commission Delegated Directive 2014/11/EU of 18 October 2013 amending, for the purposes of adapting to technical progress, the Annex IV to Directive 2011/65/EU of the European Parliament and of the Council as regards an exemption for hexavalent chromium in alkali dispensers used to create photocathodes in X-ray image intensifiers until 31 December 2019 and in spare parts for X-ray systems placed on the EU market before 1 January 2020  Text with EEA relevance

text:
               9.1.2014

               EN

               Official Journal of the European Union

               L 4/65

         COMMISSION DELEGATED DIRECTIVE 2014/11/EU
   of 18 October 2013
   amending, for the purposes of adapting to technical progress, the Annex IV to Directive 2011/65/EU of the European Parliament and of the Council as regards an exemption for hexavalent chromium in alkali dispensers used to create photocathodes in X-ray image intensifiers until 31 December 2019 and in spare parts for X-ray systems placed on the EU market before 1 January 2020
   (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 hexavalent chromium in electrical and electronic equipment placed on the market.

               (2)

               Hexavalent chromium is used in alkali dispensers that are used in order to create photocathodes in X-ray image intensifiers. Elimination or substitution of hexavalent chromium in the fabrication process of photocathodes is not possible as at present substitutes and alternative technologies are not sufficiently reliable or available to cover the full product demand range.

               (3)

               Some of the hexavalent chromium from the fabrication process of photocathodes inevitably remains inside the product that is placed on the market.

               (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 30 is added:

                  ‘30.

                  Hexavalent chromium in alkali dispensers used to create photocathodes in X-ray image intensifiers until 31 December 2019 and in spare parts for X-ray systems placed on the EU market before 1 January 2020.’


title: Commission Delegated Directive (EU) 2019/174 of 16 November 2018 amending, for the purposes of adapting to scientific and technical progress, Annex III to Directive 2011/65/EU of the European Parliament and of the Council as regards an exemption for lead bound in crystal glass as defined in Directive 69/493/EEC (Text with EEA relevance.)

text:
                  5.2.2019

                  EN

                  Official Journal of the European Union

                  L 33/20

         COMMISSION DELEGATED DIRECTIVE (EU) 2019/174
         of 16 November 2018
         amending, for the purposes of adapting to scientific and technical progress, Annex III to Directive 2011/65/EU of the European Parliament and of the Council as regards an exemption for lead bound in crystal glass as defined in Directive 69/493/EEC
         (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 requires Member States to ensure that electrical and electronic equipment placed on the market does not contain certain hazardous substances listed in Annex II to that Directive. That requirement does not apply to the applications listed in Annex III to Directive 2011/65/EU.

                     (2)

                     The different categories of electrical and electronic equipment for which Directive 2011/65/EU applies (categories 1 to 11) are listed in Annex I to that Directive.

                     (3)

                     Lead is a restricted substance listed in Annex II to Directive 2011/65/EU. The use of lead bound in crystal glass as defined in Annex I (Categories 1, 2, 3 and 4) to Council Directive 69/493/EEC (2) was, however, exempted from the restriction and is currently listed in entry 29 of Annex III to Directive 2011/65/EU. The expiry date of that exemption was, for categories 1 to 7 and 10, 21 July 2016.

                     (4)

                     The Commission received an application for renewal of that exemption before 21 January 2015, in accordance with Article 5(5) of Directive 2011/65/EU. The exemption remains valid until a decision on that application has been adopted.

                     (5)

                     Lead oxides (PbO or Pb3O4) are used as an intermediate for the chemical synthesis of lead crystal glass (LCG). LCG is used in electrical and electronic equipment because its unique combinations of processing (cooling time, working range), optical (refractive index, dispersion) and decorative (Vicker's hardness) properties allows the manufacturing of electrical and electronic articles which could not be produced otherwise, such as specific luminaires and chandeliers, electrified mirrors, clocks and watches, digital photo frames and building materials (illuminated blocks).

                     (6)

                     A substitution or elimination of lead in crystal glass is still scientifically and technically impracticable due to the lack of reliable substitutes. The exemption does not weaken the environmental and health protection afforded by Regulation (EC) No 1907/2006 of the European Parliament and of the Council (3). The exemption for the use of lead bound in crystal glass as defined in Annex I (Categories 1, 2, 3 and 4) to Directive 69/493/EEC should therefore be renewed for categories 1 to 7 and 10.

                     (7)

                     Since reliable alternatives for the applications concerned are not yet available on the market or are likely to be available on the market in the near future, the exemption for categories 1 to 7 and 10 should be renewed for the maximum duration of five years until 21 July 2021. In view of the results of the ongoing efforts to find a reliable substitution, the duration of the exemption is unlikely to have adverse impacts on innovation.

                     (8)

                     For categories other than 1 to 7 and 10, the existing exemption remains valid as per the validity periods set out in the second subparagraph of Article 5(2) of Directive 2011/65/EU. For reasons of clarity, the dates of expiry should be added in Annex III to that Directive.

                     (9)

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

               HAS ADOPTED THIS DIRECTIVE:

            Article 1
            Annex III to Directive 2011/65/EU is amended as set out in the Annex to this Directive.

            Article 2

               1.   Member States shall adopt and publish, by 29 February 2020 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 March 2020.
               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, 16 November 2018.

                  For the Commission

                  The President

               Jean-Claude JUNCKER

            (1)  OJ L 174, 1.7.2011, p. 88.

            (2)  Council Directive 69/493/EEC of 15 December 1969 on the approximation of the laws of the Member States relating to crystal glass (OJ L 326, 29.12.1969, p. 36).

            (3)  Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) and establishing a European Chemicals Agency (OJ L 396, 30.12.2006, p. 1).

            ANNEX
            In Annex III, entry 29 is replaced by the following:

                           ‘29

                           Lead bound in crystal glass as defined in Annex I (Categories 1, 2, 3 and 4) of Council Directive 69/493/EEC (*1)

                           Expires on:

                                       —

                                       21 July 2021 for categories 1-7 and 10;

                                       —

                                       21 July 2021 for categories 8 and 9 other than in vitro diagnostic medical devices and industrial monitoring and ontrol instruments;

                                       —

                                       21 July 2023 for category 8 in vitro diagnostic medical devices;

                                       —

                                       21 July 2024 for category 9 industrial monitoring and control instruments, and for category 11.

               (*1)  Council Directive 69/493/EEC of 15 December 1969 on the approximation of the laws of the Member States relating to crystal glass (OJ L 326, 29.12.1969, p. 36).’


title: Commission Implementing Directive (EU) 2018/1027 of 19 July 2018 amending Council Directive 66/402/EEC as regards isolation distances for Sorghum spp. (Text with EEA relevance.)

text:
                  20.7.2018

                  EN

                  Official Journal of the European Union

                  L 184/4

            COMMISSION IMPLEMENTING DIRECTIVE (EU) 2018/1027
      of 19 July 2018
      amending Council Directive 66/402/EEC as regards isolation distances for Sorghum spp.
      (Text with EEA relevance)
      THE EUROPEAN COMMISSION,
      Having regard to the Treaty on the Functioning of the European Union,
      Having regard to Council Directive 66/402/EEC of 14 June 1966 on the marketing of cereal seed (1), and in particular Article 21a thereof,
      Whereas:

                  (1)

                  The conditions for seed production provided for in Directive 66/402/EEC are based on the international standards established by the Seed Scheme of the Organisation for Economic Cooperation and Development (OECD).

                  (2)

                  At the 2017 Annual Meeting of the OECD on Seed Schemes, the standard for isolation distances for the cultivation of Sorghum spp. was amended especially to take into account areas where the presence of S. halepense or S. sudanense is a particular cross-pollination issue.

                  (3)

                  Directive 66/402/EEC should therefore be amended accordingly.

                  (4)

                  The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

            HAS ADOPTED THIS DIRECTIVE:
      Article 1
      Amendments to Directive 66/402/EEC
      Annex I to Directive 66/402/EEC is amended in accordance with the Annex to this Directive.
      Article 2
      Transposition
      1.   Member States shall adopt and publish, by 31 December 2018 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 2019.
      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 immediately 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
      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 4
      Addressees
      This Directive is addressed to the Member States.

         Done at Brussels, 19 July 2018.

               For the Commission

               The President

            Jean-Claude JUNCKER

         (1)  OJ 125, 11.7.1966, p. 2309/66.

         ANNEX
         Point 2 of Annex I to Directive 66/402/EEC is replaced by the following:

                        ‘2.

                        The crop shall conform to the following standards as regards distances from neighbouring sources of pollen which may result in undesirable foreign pollination:

                                    Crop

                                    Minimum distance

                                       Phalaris canariensis, Secale cereale other than hybrids:

                                                —

                                                for the production of basic seed

                                    300 m

                                                —

                                                for the production of certified seed

                                    250 m

                                       Sorghum spp.

                                                —

                                                for the production of basic seed (*1)

                                    400 m

                                                —

                                                for the production of certified seed (*1)

                                    200 m

                                       xTriticosecale, self-pollinating varieties

                                                —

                                                for the production of basic seed

                                    50 m

                                                —

                                                for the production of certified seed

                                    20 m

                                    Zea mays

                                    200 m

                              The minimum distances listed in the table above may be disregarded if there is sufficient protection from any undesirable foreign pollination.’

            (*1)  In the areas where the presence of S. halepense or S. sudanense is a particular cross-pollination issue, the following shall apply:

                     a)

                     crops to produce basic seed of Sorghum bicolor or its hybrids must be isolated not less than 800 m from any source of such contaminating pollen;

                     b)

                     crops to produce certified seed of Sorghum bicolor or its hybrids must be isolated not less than 400 m from any source of such contaminating pollen.


title: Commission Implementing Directive (EU) 2018/1028 of 19 July 2018 correcting Implementing Directive (EU) 2016/2109 amending Council Directive 66/401/EEC as regards the inclusion of new species and the botanical name of the species Lolium x boucheanum Kunth (Text with EEA relevance.)

text:
               20.7.2018

               EN

               Official Journal of the European Union

               L 184/7

         COMMISSION IMPLEMENTING DIRECTIVE (EU) 2018/1028
   of 19 July 2018
   correcting Implementing Directive (EU) 2016/2109 amending Council Directive 66/401/EEC as regards the inclusion of new species and the botanical name of the species Lolium x boucheanum Kunth
   (Text with EEA relevance)
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Council Directive 66/401/EEC of 14 June 1966 on the marketing of fodder plant seed (1), and in particular Article 21a thereof,
   Whereas:

               (1)

               Due to a clerical error in Commission Implementing Directive (EU) 2016/2109 (2) which amended Directive 66/401/EEC, the footnote reference ‘(1)’ in Annex III to Directive 66/401/EEC was erroneously deleted from the entry ‘Poaceae (Gramineae)’. As a result, it is no longer possible for Member States to authorise the maximum lot weight to be increased to 25 tonnes where the supplier has been authorised for this purpose by the competent authority.

               (2)

               The relevant Annex to Implementing Directive (EU) 2016/2109 should therefore be corrected accordingly.

               (3)

               The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,

         HAS ADOPTED THIS DIRECTIVE:
   Article 1
   Amendment to Implementing Directive (EU) 2016/2109
   The Annex to Implementing Directive (EU) 2016/2109 is amended in accordance with the Annex to this Directive.
   Article 2
   Transposition
   1.   Member States shall adopt and publish, by 31 December 2018 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 2019.
   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 immediately 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
   Entry into force
   This Directive shall enter into force on the day following that of its publication in the Official Journal of the European Union.
   Article 4
   Addressees
   This Directive is addressed to the Member States.

      Done at Brussels, 19 July 2018.

            For the Commission

            The President

         Jean-Claude JUNCKER

      (1)  OJ 125, 11.7.1966, p. 2298/66.

      (2)  Commission Implementing Directive (EU) 2016/2109 of 1 December 2016 amending Council Directive 66/401/EEC as regards the inclusion of new species and the botanical name of the species Lolium x boucheanum Kunth (OJ L 327, 2.12.2016, p. 59).

      ANNEX
      In point 2 of the Annex to Commission Implementing Directive (EU) 2016/2109, amending Annex III to Council Directive 66/401/EEC, in the first column of the table, the entry for ‘Poaceae (Gramineae)’ is replaced by the following entry with accompanying footnote:

         ‘Poaceae (Gramineae)
             (1)