title: Commission Implementing Directive 2011/40/EU of 11 April 2011 amending Council Directive 91/414/EEC to include sintofen 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 97/34

         COMMISSION IMPLEMENTING DIRECTIVE 2011/40/EU
   of 11 April 2011
   amending Council Directive 91/414/EEC to include sintofen 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 sintofen.

               (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 sintofen.

               (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 France, 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)

               France evaluated the additional data submitted by the applicant and prepared an additional report. It communicated that report to the European Food Safety Authority (hereinafter ‘the Authority’) and to the Commission on 14 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 sintofen to the Commission on 26 November 2010 (6). The draft assessment report, the additional report and the conclusion of the Authority were reviewed by the Member States and the Commission within the Standing Committee on the Food Chain and Animal Health and finalised on 11 March 2011 in the format of the Commission review report for sintofen.

               (6)

               It has appeared from the various examinations made that plant protection products containing sintofen 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 sintofen 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 specification of the technical material, the relevance of the impurities present in the technical specifications, the relevance of the test material used in the toxicity and ecotoxicity dossiers and the metabolic profile of sintofen in rotational crops.

               (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 sintofen 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 sintofen and the withdrawal of authorisations for plant protection products containing that substance by 31 December 2011. It is necessary to delete the line concerning sintofen 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 sintofen 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 sintofen 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 sintofen 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 sintofen 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 sintofen. 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 sintofen 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 sintofen 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 sintofen. EFSA Journal 2010;8(12): [49 pp.]. doi:10.2903/j.efsa.2010.1931. 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

                     ‘347

                     Sintofen
                     CAS No 130561-48-7
                     CIPAC No 717

                        1-(4-chlorophenyl)-1,4-dihydro-5-(2-methoxyethoxy)-4-oxocinnoline-3-carboxylic acid

                     ≥ 980 g/kg
                     Impurities:

                                 2-methoxyethanol, not more than 0,25 g/kg

                                 N,N-dimethylformamide, not more than 1,5 g/kg

                     1 June 2011

                     31 May 2021

                     PART A
                     Only uses as a plant growth regulator on wheat for hybrid seed production not intended for human consumption may be authorised.
                     PART B
                     For the implementation of the uniform principles of Annex VI, the conclusions of the review report on sintofen, and in particular Appendices I and II thereto, 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 the risk to operators and workers and shall ensure that conditions of use include the application of adequate risk mitigation measures. They shall ensure that wheat treated with sintofen does not enter the food and feed chain.
                     The Member States concerned shall request the submission of confirmatory information as regards:

                                 (1)

                                 the specification of the technical material, as commercially manufactured, supported by appropriate analytical data;

                                 (2)

                                 the relevance of the impurities present in the technical specifications, except of the impurities 2-methoxyethanol and N,N-dimethylformamide;

                                 (3)

                                 the relevance of the test material used in the toxicity and ecotoxicity dossiers in view of the specification of the technical material;

                                 (4)

                                 the metabolic profile of sintofen in rotational crops.

                           The Member States concerned shall ensure that the applicant submits to the Commission: the information set out in points (1) (2) and (3) by 1 December 2011 and the information set out in point (4) by 31 May 2013.’

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


title: Commission Delegated Directive 2014/7/EU of 18 October 2013 amending, for the purposes of adapting to technical progress, Annex IV to Directive 2011/65/EU of the European Parliament and of the Council as regards an exemption for lead in solders, termination coatings of electrical and electronic components and printed circuit boards, connections of electrical wires, shields and enclosed connectors which are used (a) in magnetic fields within the sphere of 1 m radius around the isocentre of the magnet in medical magnetic resonance imaging equipment, including patient monitors designed to be used within this sphere, or (b) in magnetic fields within 1 m distance from the external surfaces of cyclotron magnets, magnets for beam transport and beam direction control applied for particle therapy  Text with EEA relevance

text:
               9.1.2014

               EN

               Official Journal of the European Union

               L 4/57

         COMMISSION DELEGATED DIRECTIVE 2014/7/EU
   of 18 October 2013
   amending, for the purposes of adapting to technical progress, Annex IV to Directive 2011/65/EU of the European Parliament and of the Council as regards an exemption for lead in solders, termination coatings of electrical and electronic components and printed circuit boards, connections of electrical wires, shields and enclosed connectors which are used (a) in magnetic fields within the sphere of 1 m radius around the isocentre of the magnet in medical magnetic resonance imaging equipment, including patient monitors designed to be used within this sphere, or (b) in magnetic fields within 1 m distance from the external surfaces of cyclotron magnets, magnets for beam transport and beam direction control applied for particle therapy
   (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 currently used in solders, termination coatings of electrical and electronic components and printed circuit boards, connections of electrical wires, shields and enclosed connectors which are used on the one hand in magnetic fields within the sphere of 1 m radius around the isocentre of the magnet in medical magnetic resonance imaging equipment, including patient monitors designed to be used within this sphere; and on the other hand in magnetic fields within 1 m distance from the external surfaces of cyclotron magnets, magnets for beam transport and beam direction control applied for particle therapy.

               (3)

               There are currently no scientifically and technically practicable and sufficiently reliable substitutes available for the abovementioned applications of lead. Manufacturers need additional time to find reliable and safe lead-free solutions.

               (4)

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

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

      Done at Brussels, 18 October 2013.

            For the Commission

            The President

         José Manuel BARROSO

      (1)  OJ L 174, 1.7.2011, p. 88.

      ANNEX
      In Annex IV to Directive 2011/65/EU the following point 27 is added:

                  ‘27.

                  Lead in

                              —

                              solders,

                              —

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

                              —

                              connections of electrical wires, shields and enclosed connectors,

                        which are used in

                              (a)

                              magnetic fields within the sphere of 1 m radius around the isocentre of the magnet in medical magnetic resonance imaging equipment, including patient monitors designed to be used within this sphere, or

                              (b)

                              magnetic fields within 1 m distance from the external surfaces of cyclotron magnets, magnets for beam transport and beam direction control applied for particle therapy.

                        Expires on 30 June 2020.’


title: Commission Delegated Directive (EU) 2015/863 of 31 March 2015 amending Annex II to Directive 2011/65/EU of the European Parliament and of the Council as regards the list of restricted substances (Text with EEA relevance)

text:
               4.6.2015

               EN

               Official Journal of the European Union

               L 137/10

         COMMISSION DELEGATED DIRECTIVE (EU) 2015/863
   of 31 March 2015
   amending Annex II to Directive 2011/65/EU of the European Parliament and of the Council as regards the list of restricted substances
   (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 6(3) thereof,
   Whereas:

               (1)

               Directive 2011/65/EU lays down rules on the restriction of the use of hazardous substances in electrical and electronic equipment (EEE) with a view to contributing to the protection of human health and the environment, including the environmentally sound recovery and disposal of waste EEE.

               (2)

               Directive 2011/65/EU prohibits the use of lead, mercury, cadmium, hexavalent chromium, polybrominated biphenyls (PBB) and polybrominated diphenyl ethers (PBDE) in electrical and electronic equipment placed on the Union market. Annex II to that Directive lists those restricted substances.

               (3)

               The risks to human health and the environment arising from the use of Hexabromocyclododecane (HBCDD), Bis(2-ethylhexyl) phthalate (DEHP), Butyl benzyl phthalate (BBP) and Dibutyl phthalate (DBP) should be considered a priority in the periodic review of the list of restricted substances in Annex II. With a view to further restrictions, the substances that were subject to previous assessments should be re-investigated.

               (4)

               In accordance with Article 6(1) of Directive 2011/65/EU, interested parties, including economic operators, recyclers, treatment operators, environmental organisations and employee and consumer associations, have been consulted and a thorough assessment has been performed.

               (5)

               Bis(2-ethylhexyl) phthalate (DEHP), Butyl benzyl phthalate (BBP), Dibutyl phthalate (DBP) and Diisobutyl phthalate (DIBP) are substances of very high concern (SVHC). DIBP is a substance that can be used as a substitute for DBP and was subject to previous assessments performed by the Commission. The available evidence indicates that those four substances, when used in EEE, can have a negative impact on recycling and on human health and the environment during EEE waste management operations.

               (6)

               Substitutes that have less negative impacts are available for DEHP, BBP, DBP and DIBP in most EEE. The use of those substances in EEE should therefore be restricted. DEHP, BBP and DBP are already restricted through entry 51 of Annex XVII to Regulation (EC) No 1907/2006 of the European Parliament and of the Council, (2) so that toys containing DEHP, BBP or DBP in a concentration greater than 0,1 % by weight of the plasticised material, calculated for the three phthalates cumulatively, cannot be placed on the EU market. In order to avoid double regulation, the restriction through entry 51 of Annex XVII to that Regulation shall therefore continue to be the only restriction applicable to DEHP, BBP and DBP in toys.

               (7)

               In order to facilitate transition and to mitigate possible socioeconomic impacts, an appropriate transition period should be granted, which will allow economic operators to apply for exemptions from the substance restrictions in accordance with Article 5 of Directive 2011/65/EU. The longer innovation cycles for medical devices and monitoring and control instruments should be taken into account while determining the transitional period. The restriction of the use of DEHP, BBP, DBP and DIBP should therefore apply to medical devices, including in vitro medical devices, and monitoring and control instruments, including industrial monitoring and control instruments, from 22 July 2021.

               (8)

               Any adaptation of Annex III or IV to Directive 2011/65/EU to exempt applications in relation to DEHP or DBP should take place in a manner which, in order to avoid double regulation and unnecessary burden, ensures coherence with the administration of any authorisation granted under Regulation (EC) No 1907/2006 in relation to the incorporation of those substances in EEE. Operators considering whether to apply for exemptions under Directive 2011/65/EU should be aware that such exemptions may cover the entire life cycle of the EEE, including the manufacturing phase.

               (9)

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

         HAS ADOPTED THIS DIRECTIVE:
   Article 1
   Annex II to Directive 2011/65/EU is replaced by the text in the Annex to this Directive.
   Article 2
   1.   Member States shall adopt and publish, by 31 December 2016 at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions.
   They shall apply those provisions from 22 July 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 communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.
   Article 3
   This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
   Article 4
   This Directive is addressed to the Member States.

      Done at Brussels, 31 March 2015.

            For the Commission

            The President

         Jean-Claude JUNCKER

      (1)  OJ L 174, 1.7.2011, p. 88.

      (2)  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), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 396, 30.12.2006, p. 1).

      ANNEX

            ‘ANNEX II

               Restricted substances referred to in Article 4(1) and maximum concentration values tolerated by weight in homogeneous materials

                        Lead (0,1 %)

                        Mercury (0,1 %)

                        Cadmium (0,01 %)

                        Hexavalent chromium (0,1 %)

                        Polybrominated biphenyls (PBB) (0,1 %)

                        Polybrominated diphenyl ethers (PBDE) (0,1 %)

                        Bis(2-ethylhexyl) phthalate (DEHP) (0,1 %)

                        Butyl benzyl phthalate (BBP) (0,1 %)

                        Dibutyl phthalate (DBP) (0,1 %)

                        Diisobutyl phthalate (DIBP) (0,1 %)

                  The restriction of DEHP, BBP, DBP and DIBP shall apply to medical devices, including in vitro medical devices, and monitoring and control instruments, including industrial monitoring and control instruments, from 22 July 2021.
            The restriction of DEHP, BBP, DBP and DIBP shall not apply to cables or spare parts for the repair, the reuse, the updating of functionalities or upgrading of capacity of EEE placed on the market before 22 July 2019, and of medical devices, including in vitro medical devices, and monitoring and control instruments, including industrial monitoring and control instruments, placed on the market before 22 July 2021.
            The restriction of DEHP, BBP and DBP shall not apply to toys which are already subject to the restriction of DEHP, BBP and DBP through entry 51 of Annex XVII to Regulation (EC) No 1907/2006.’


title: Commission Delegated Directive 2014/9/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 and cadmium in metallic bonds creating superconducting magnetic circuits in MRI, SQUID, NMR (Nuclear Magnetic Resonance) or FTMS (Fourier Transform Mass Spectrometer) detectors  Text with EEA relevance

text:
               9.1.2014

               EN

               Official Journal of the European Union

               L 4/61

         COMMISSION DELEGATED DIRECTIVE 2014/9/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 and cadmium in metallic bonds creating superconducting magnetic circuits in MRI, SQUID, NMR (Nuclear Magnetic Resonance) or FTMS (Fourier Transform Mass Spectrometer) detectors
   (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 and of cadmium in electrical and electronic equipment placed on the market.

               (2)

               The existing exemption No 12 only covers MRI and SQUID detectors but an exemption is needed also for sub-category 9 industrial applications.

               (3)

               The substitution or elimination of lead and cadmium is currently not possible in MRI, SQUID, NMR and FTMS detectors.

               (4)

               Time is required for reliability testing and qualification of alternative solutions.

               (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 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 point 12 is replaced by the following:

                  ‘12.

                  Lead and cadmium in metallic bonds creating superconducting magnetic circuits in MRI, SQUID, NMR (Nuclear Magnetic Resonance) or FTMS (Fourier Transform Mass Spectrometer) detectors. Expires on 30 June 2021.’


title: Commission Implementing Directive (EU) 2017/1920 of 19 October 2017 amending Annex IV to Council Directive 2000/29/EC as regards the movement of seeds of Solanum tuberosum L. originating in the Union

text:
               20.10.2017

               EN

               Official Journal of the European Union

               L 271/34

         COMMISSION IMPLEMENTING DIRECTIVE (EU) 2017/1920
   of 19 October 2017
   amending Annex IV to Council Directive 2000/29/EC as regards the movement of seeds of Solanum tuberosum L. originating in the Union
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Council Directive 2000/29/EC of 8 May 2000 on protective measures against the introduction into the Community of organisms harmful to plants or plant products and against their spread within the Community (1), and in particular point (d) of the second paragraph of Article 14 thereof,
   Whereas:

               (1)

               Article 5(1) of Directive 2000/29/EC in conjunction with point 18.3 of Section II of Part A of Annex IV to that Directive, provides for special requirements concerning the movement of plants of stolon or tuber-forming species of Solanum L., or their hybrids, intended for planting, other than those tubers of Solanum tuberosum L. specified in points 18.1., 18.1.1. or 18.2. of Section II of Part A of Annex IV to that Directive, and other than culture maintenance material being stored in gene banks or genetic stock collections.

               (2)

               Certain Member States have requested for more specific requirements for the movement of seeds of Solanum tuberosum L., commonly also referred to as ‘true potato seeds’, originating in the Union (hereafter ‘the specified seeds’). Those requirements should ensure phytosanitary protection of the Union territory from harmful organisms potentially hosted by the specified seeds.

               (3)

               Seeds which are plants of stolon, or tuber-forming species of Solanum L., or their hybrids, intended for planting, being stored in gene banks or genetic stock collections, should not be considered as specified seeds, because they are intended for research and conservation purposes.

               (4)

               As Synchytrium endobioticum (Schilbersky) Percival, Clavibacter michiganensis ssp. sepedonicus (Spieckermann and Kotthoff) Davis et al., Ralstonia solanacearum (Smith) Yabuuchi et al. and Potato spindle tuber viroid present the major phytosanitary risk for the specified seeds, and taking into account the pest risk analysis of the Netherlands Food and Consumer Product Safety Authority of 2015 (2), it is appropriate to provide that either the specified seeds should originate in areas known to be free from those organisms, or the specified seeds and their production sites should be subject to specific requirements.

               (5)

               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
   Annex IV to Directive 2000/29/EC is amended in accordance with the Annex to this Directive.
   Article 2
   1.   Member States shall adopt and publish, by 31 March 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 April 2018.
   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 third 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 October 2017.

            For the Commission

            The President

         Jean-Claude JUNCKER

      (1)  OJ L 169, 10.7.2000, p. 1.

      (2)  PRA EU internal movement of True Potato Seeds of official varieties, NVWA, June 2015.

      ANNEX
      Section II of Part A of Annex IV to Directive 2000/29/EC is amended as follows:

                  (1)

                  Point 18.3 is replaced by the following:

                                          ‘18.3.

                                          Plants of stolon or tuber-forming species of Solanum L., or their hybrids, intended for planting, other than those tubers of Solanum tuberosum L. specified in points 18.1, 18.1.1 or 18.2, other than culture maintenance material being stored in gene banks or genetic stock collections, and other than seeds of Solanum tuberosum L. specified in point 18.3.1.

                                          (a)

                                          The plants shall have been held under quarantine conditions and shall have been found free of any harmful organisms in quarantine testing;

                                          (b)

                                          the quarantine testing referred to in (a) shall:

                                                      (aa)

                                                      be supervised by the official plant protection organisation of the Member State concerned and executed by scientifically trained staff of that organisation or of any officially approved body;

                                                      (bb)

                                                      be executed at a site provided with appropriate facilities sufficient to contain harmful organisms and maintain the material including indicator plants in such a way as to eliminate any risk of spreading harmful organisms;

                                                      (cc)

                                                      be executed on each unit of the material,

                                                                  —

                                                                  by visual examination at regular intervals during the full length of at least one vegetative cycle, having regard to the type of material and its stage of development during the testing programme, for symptoms caused by any harmful organisms,

                                                                  —

                                                                  by testing, in accordance with appropriate methods to be submitted to the Committee referred to in Article 18:

                                                                  —

                                                                  in the case of all potato material at least for

                                                                              —

                                                                              Andean potato latent virus,

                                                                              —

                                                                              Arracacha virus B. oca strain,

                                                                              —

                                                                              Potato black ringspot virus,

                                                                              —

                                                                              Potato spindle tuber viroid,

                                                                              —

                                                                              Potato virus T,

                                                                              —

                                                                              Andean potato mottle virus,

                                                                              —

                                                                              common potato viruses A, M, S, V, X and Y (including Yo, Yn und Yc) and Potato leaf roll virus,

                                                                              —

                                                                                Clavibacter michiganensis ssp. sepedonicus (Spieckermann and Kotthoff) Davis et al.,

                                                                              —

                                                                                Ralstonia solanacearum (Smith) Yabuuchi et al.;

                                                                  —

                                                                  in the case of seeds of Solanum tuberosum L., other than those specified in point 18.3.1, at least for the viruses and viroid listed above;

                                                      (dd)

                                                      by appropriate testing on any other symptom observed in the visual examination in order to identify the harmful organisms having caused such symptoms;

                                          (c)

                                          any material, which has not been found free, under the testing specified under (b) from harmful organisms as specified under (b) shall be immediately destroyed or subjected to procedures which eliminate the harmful organism(s);

                                          (d)

                                          each organisation or research body holding this material shall inform their official Member State plant protection service of the material held.’

                  (2)

                  The following point 18.3.1 is inserted after point 18.3:

                                          ‘18.3.1.

                                          Seeds of Solanum tuberosum L., other than those specified in point 18.4.

                              Official statement that:
                              The seeds derive from plants complying, as applicable, with the requirements set out in points 18.1., 18.1.1, 18.2 and 18.3;
                              and

                                          (a)

                                          the seeds originate in areas known to be free from Synchytrium endobioticum (Schilbersky) Percival, Clavibacter michiganensis ssp. sepedonicus (Spieckermann and Kotthoff) Davis et al., Ralstonia solanacearum (Smith) Yabuuchi et al. and Potato spindle tuber viroid;
                                          or

                                          (b)

                                          the seeds comply with all of the following requirements:

                                                      (i)

                                                      they have been produced in a site where, since the beginning of the last cycle of vegetation, no symptoms of disease caused by the harmful organisms referred to in point (a) have been observed;

                                                      (ii)

                                                      they have been produced at a site where all of the following actions have been taken:

                                                                  (1)

                                                                  separation of the site from other solanaceous plants and other host plants of Potato spindle tuber viroid;

                                                                  (2)

                                                                  prevention of contact with staff and items, such as tools, machinery, vehicles, vessels and packaging material, from other sites producing solanaceous plants and other host plants of Potato spindle tuber viroid, or appropriate hygiene measures concerning staff or items from other sites producing solanaceous plants and other host plants of Potato spindle tuber viroid to prevent infection;

                                                                  (3)

                                                                  only water free from all harmful organisms referred to in this point is used.’


title: Commission Delegated Directive (EU) 2015/573 of 30 January 2015 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 polyvinyl chloride sensors in in-vitro diagnostic medical devices  Text with EEA relevance

text:
               10.4.2015

               EN

               Official Journal of the European Union

               L 94/4

         COMMISSION DELEGATED DIRECTIVE (EU) 2015/573
   of 30 January 2015
   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 polyvinyl chloride sensors in in-vitro diagnostic medical 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)

               Blood, body fluid and body gas analysers serve as a critical analytical instrument in many diagnostic and therapeutic procedures. Lead is required as a stabiliser in the processing of the PVC for the sensor cards. Although research of substitutes is ongoing, a suitable alternative is not yet available. The performance of tested alternatives both to lead in PVC and to PVC itself does not meet the specific technical requirements.

               (3)

               Both the substitution of lead in PVC sensor cards for in-vitro diagnostic medical devices for blood, body fluid and body gas analysis and the elimination of lead via substitution of PVC in these applications are technically impracticable.

               (4)

               The use of lead in PVC sensors for blood, body fluid and body gas analysis used in in-vitro diagnostic medical devices should therefore be exempted until 31 December 2018. In view of the innovation cycles for medical devices this is a short transition period which 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 the last day of the ninth 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, 30 January 2015.

            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, the following point 41 is added:

                     ‘41.

                     Lead as a thermal stabiliser in polyvinyl chloride (PVC) used as base material in amperometric, potentiometric and conductometric electrochemical sensors which are used in in-vitro diagnostic medical devices for the analysis of blood and other body fluids and body gases.
                     Expires on 31 December 2018.’


title: Commission Delegated Directive (EU) 2016/1029 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 cadmium anodes in Hersch cells for certain oxygen sensors used in industrial monitoring and control instruments (Text with EEA relevance)

text:
               25.6.2016

               EN

               Official Journal of the European Union

               L 168/15

         COMMISSION DELEGATED DIRECTIVE (EU) 2016/1029
   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 cadmium anodes in Hersch cells for certain oxygen sensors used in industrial monitoring and control instruments
   (Text with EEA relevance)
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Directive 2011/65/EU of the European Parliament and of the Council of 8 June 2011 on the restriction of the use of certain hazardous substances in electrical and electronic equipment (1), and in particular Article 5(1)(a) thereof,
   Whereas:

               (1)

               Directive 2011/65/EU prohibits the use of cadmium in electrical and electronic equipment placed on the market. Cadmium is present in the anodes of Hersch Cells, which are used in specialised, high-sensitivity oxygen sensors. In comparison to the Hersch cell sensors, all available alternative technologies do not provide the same sensitivity, reliability and accuracy when measuring oxygen concentration at very low levels.

               (2)

               The reliability of alternatives to Hersch Cells using cadmium for oxygen sensors in industrial monitoring and control instruments is not ensured where sensitivity below 10 parts per million is required. The use of cadmium anodes in Hersch cells for oxygen sensors used in industrial monitoring and control instruments, where sensitivity below 10 parts per million is required, should therefore be exempted from the prohibition.

               (3)

               As currently no cadmium-free alternatives are sufficiently reliable for the specific use and considering that for monitoring and control instruments 7 years is a relatively short transition period which is unlikely to have adverse impacts on innovation, pursuant to Article 5(2) of Directive 2011/65/EU, a corresponding validity period of exemption should be granted.

               (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 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, the following point 43 is added:

                     ‘43.

                     Cadmium anodes in Hersch cells for oxygen sensors used in industrial monitoring and control instruments, where sensitivity below 10 ppm is required.
                     Expires on 15 July 2023.’


title: Commission Delegated Directive (EU) 2017/1011 of 15 March 2017 amending, for the purposes of adapting to technical progress, Annex III to Directive 2011/65/EU of the European Parliament and of the Council as regards an exemption for lead in white glasses used for optical applications (Text with EEA relevance. )

text:
               16.6.2017

               EN

               Official Journal of the European Union

               L 153/25

         COMMISSION DELEGATED DIRECTIVE (EU) 2017/1011
   of 15 March 2017
   amending, for the purposes of adapting to technical progress, Annex III to Directive 2011/65/EU of the European Parliament and of the Council as regards an exemption for lead in white glasses used for optical applications
   (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-based glasses are used because they have unique combinations of properties and characteristics, such as light transmission performance, optical dispersion, thermal conductivity, birefringence and others.

               (3)

               Lead-free optical glasses of alternative designs exist in the form of lead-free glass, plastic lenses and alternative equipment design. Nonetheless, those alternatives that cannot provide for several properties and their combinations comparable to lead-based glasses.

               (4)

               Where finding substitutes was relatively straightforward, this has already occurred and substitutes are being used. Alternatives for the remaining applications are still not available. Thus substitution for the full application range is not possible in general. Lead in white glasses used for optical applications should therefore be exempted until 21 July 2021 for categories 1 to 7 and 10. In view of the innovation cycles for this type of optical applications, the 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 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 6 July 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 6 July 2018.
   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, 15 March 2017.

            For the Commission

            The President

         Jean-Claude JUNCKER

      (1)  OJ L 174, 1.7.2011, p. 88.

      ANNEX
      In Annex III to Directive 2011/65/EU, point 13(a) is replaced by the following:

                     ‘13(a)

                     Lead in white glasses used for optical applications

                     Applies to all categories; expires on:

                                 —

                                 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;

                                 —

                                 21 July 2021 for all other categories and subcategories’


title: Commission Delegated Directive (EU) 2017/1009 of 13 March 2017 amending, for the purposes of adapting to technical progress, Annex III to Directive 2011/65/EU of the European Parliament and of the Council as regards an exemption for cadmium and lead in filter glasses and glasses used for reflectance standards (Text with EEA relevance. )

text:
               16.6.2017

               EN

               Official Journal of the European Union

               L 153/21

         COMMISSION DELEGATED DIRECTIVE (EU) 2017/1009
   of 13 March 2017
   amending, for the purposes of adapting to technical progress, Annex III to Directive 2011/65/EU of the European Parliament and of the Council as regards an exemption for cadmium and lead in filter glasses and glasses used for reflectance standards
   (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 and cadmium in electrical and electronic equipment placed on the market.

               (2)

               Optical filter glasses containing cadmium or lead are used in a wide variety of optical applications for many types of electrical and electronic equipment. Both cadmium and lead are used because of the unique optical properties that their use enables, such as ‘sharp cut-off’ in the visible spectrum that is unaffected by viewing angle.

               (3)

               Though various substitution routes exist, substitutes do not provide sufficient cut-off performance for all applications. In the few cases where alternatives are said to supply sufficient performance in this respect, the materials used are too sensitive to environmental conditions of operation and thus not sufficiently reliable.

               (4)

               In this sense, alternatives are still not suitable for many applications, for which finding alternatives is complicated and time-demanding, thus five years is a justified duration for the categories 1 to 7 and 10.

               (5)

               Certain optical filter glasses containing cadmium and/or lead should therefore be exempted until 21 July 2021 for categories 1 to 7 and 10. In view of the innovation cycles for the electrical and electronic equipment affected, the duration of this exemption is unlikely to have adverse impacts on innovation.

               (6)

               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 6 July 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 6 July 2018.
   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 2017.

            For the Commission

            The President

         Jean-Claude JUNCKER

      (1)  OJ L 174, 1.7.2011, p. 88.

      ANNEX
      In Annex III to Directive 2011/65/EU, point 13(b) is replaced by the following:

                     ‘13(b)

                     Cadmium and lead in filter glasses and glasses used for reflectance standards

                     Applies to categories 8, 9 and 11; expires on:

                                 —

                                 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;

                                 —

                                 21 July 2021 for other subcategories of categories 8 and 9

                     13(b)-(I)

                     Lead in ion coloured optical filter glass types

                     Applies to categories 1 to 7 and 10; expires on 21 July 2021 for categories 1 to 7 and 10’

                     13(b)-(II)

                     Cadmium in striking optical filter glass types; excluding applications falling under point 39 of this Annex

                     13(b)-(III)

                     Cadmium and lead in glazes used for reflectance standards


title: Commission Implementing Directive 2011/44/EU of 13 April 2011 amending Council Directive 91/414/EEC to include azadirachtin as active substance and amending Commission Decision 2008/941/EC  Text with EEA relevance

text:
               14.4.2011

               EN

               Official Journal of the European Union

               L 100/43

         COMMISSION IMPLEMENTING DIRECTIVE 2011/44/EU
   of 13 April 2011
   amending Council Directive 91/414/EEC to include azadirachtin as active substance and amending Commission Decision 2008/941/EC
   (Text with EEA relevance)
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (1), and in particular Article 6(1) thereof,
   Whereas:

               (1)

               Commission Regulations (EC) No 1112/2002 (2) and (EC) No 2229/2004 (3) lay down the detailed rules for the implementation of the fourth stage of the programme of work referred to in Article 8(2) of Directive 91/414/EEC and establish a list of active substances to be assessed, with a view to their possible inclusion in Annex I to Directive 91/414/EEC. That list included azadirachtin.

               (2)

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

               (3)

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

               (4)

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

               (5)

               Germany evaluated the additional data submitted by the applicant and prepared an additional report. It communicated that report to the European Food Safety Authority (hereinafter ‘the Authority’) and to the Commission on 10 December 2009. The Authority communicated the additional report to the other Member States and the applicant for comments and forwarded the comments it had received to the Commission. In accordance with Article 20(1) of Regulation (EC) No 33/2008 and at the request of the Commission, the Authority presented its conclusion on azadirachtin 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 azadirachtin.

               (6)

               It has appeared from the various examinations made that plant protection products containing azadirachtin 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 azadirachtin 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/EC 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 to confirm the relationship between azadirachtin A and the rest of the active components in the neem seeds extract with respect to amount, biological activity and persistence, in order to confirm the lead active compound approach with regard to azadirachtin A and to confirm specification of the technical material, residue definition and groundwater risk assessment.

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

               (13)

               It is therefore appropriate to amend Decision 2008/941/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 azadirachtin in the Annex to Decision 2008/941/EC is deleted.
   Article 3
   Member States shall adopt and publish by 30 November 2011 at the latest the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions and a correlation table between those provisions and this Directive.
   They shall apply those provisions from 1 December 2011.
   When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
   Article 4
   1.   Member States shall in accordance with Directive 91/414/EEC, where necessary, amend or withdraw existing authorisations for plant protection products containing azadirachtin 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 azadirachtin 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 azadirachtin as either the only active substance or as one of several active substances all of which were listed in Annex I to Directive 91/414/EEC by 30 April 2011 at the latest, Member States shall re-evaluate the product in accordance with the uniform principles provided for in Annex VI to Directive 91/414/EEC, on the basis of a dossier satisfying the requirements of Annex III to that Directive and taking into account Part B of the entry in Annex I to that Directive concerning azadirachtin. 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 azadirachtin 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 azadirachtin as one of several active substances, where necessary, amend or withdraw the authorisation by 31 May 2015 or by the date fixed for such an amendment or withdrawal in the respective Directive or Directives which added the relevant substance or substances to Annex I to Directive 91/414/EEC, whichever is the latest.

         Article 5
   This Directive shall enter into force on 1 June 2011.
   Article 6
   This Directive is addressed to the Member States.

      Done at Brussels, 13 April 2011.

            For the Commission

            The President

         José Manuel BARROSO

      (1)  OJ L 230, 19.8.1991, p. 1.

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

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

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

      (5)  OJ L 15, 18.1.2008, p. 5.

      (6)  European Food Safety Authority; Conclusion on the peer review of the pesticide risk assessment of the active substance azadirachtin. EFSA Journal 2011;9(3):2008[76pp.].doi:10.2903/j.efsa2011.2088. Available online: www.efsa.europa.eu

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

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

                     No

                     Common Name, Identification Numbers

                     IUPAC Name

                     Purity (1)

                     Entry into force

                     Expiration of inclusion

                     Specific provisions

                     ‘350

                     Azadirachtin
                     CAS No: 11141-17-6 as azadirachtin A
                     CIPAC No: 627 as azadirachtin A

                     Azadirachtin A:
                     dimethyl (2aR,3S,4S,4aR,5S,7aS,8S,10R,10aS,10bR)-10-acetoxy-3,5-dihydroxy-4-[(1aR,2S,3aS,6aS,7S,7aS)-6a-hydroxy-7a-methyl-3a,6a,7,7a-tetrahydro-2,7-methanofuro[2,3-b]oxireno[e]oxepin-1a(2H)-yl]-4-methyl-8-{[(2E)-2-methylbut-2-enoyl]oxy}octahydro-1H-naphtho[1,8a-c:4,5-b′c′]difuran-5,10a(8H)-dicarboxylate.

                     Expressed as azadirachtin A:
                     ≥ 111 g/kg
                     Sum of the aflatoxins B1, B2, G1 and G2 must not exceed 300 μg/kg of the azadirachtin A content.

                     1 June 2011

                     31 May 2021

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

                                 —

                                 the dietary exposure of consumers in view of future revisions of Maximum Residue Levels,

                                 —

                                 the protection of non-target arthropods and aquatic organisms. Risk mitigation measures shall be applied where appropriate.

                           The Member States concerned shall request the submission of confirmatory information as regards:

                                 —

                                 the relationship between azadirachtin A and the rest of the active components in the neem seeds extract with respect to amount, biological activity and persistence, in order to confirm the lead active compound approach with regard to azadirachtin A and to confirm specification of the technical material, residue definition and groundwater risk assessment.

                           The Member States concerned shall ensure that the applicant submits such information to the Commission by 31 December 2013.’

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


title: Commission Implementing Directive 2012/31/EU of 25 October 2012 amending Annex IV to Council Directive 2006/88/EC as regards the list of fish species susceptible to Viral haemorrhagic septicaemia and the deletion of the entry for Epizootic ulcerative syndrome  Text with EEA relevance

text:
               26.10.2012

               EN

               Official Journal of the European Union

               L 297/26

         COMMISSION IMPLEMENTING DIRECTIVE 2012/31/EU
   of 25 October 2012
   amending Annex IV to Council Directive 2006/88/EC as regards the list of fish species susceptible to Viral haemorrhagic septicaemia and the deletion of the entry for Epizootic ulcerative syndrome
   (Text with EEA relevance)
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Council Directive 2006/88/EC of 24 October 2006 on animal health requirements for aquaculture animals and products thereof, and on the prevention and control of certain diseases in aquatic animals (1), and in particular Article 61(2) thereof,
   Whereas:

               (1)

               Directive 2006/88/EC lays down, inter alia, certain animal health rules applicable to aquaculture animals and products thereof, including specific provisions concerning the exotic and non-exotic diseases and species susceptible thereto, listed in Part II of Annex IV to that Directive.

               (2)

               Epizootic ulcerative syndrome (EUS) is included in the list of exotic diseases set out in Part II of Annex IV to Directive 2006/88/EC.

               (3)

               Part I of Annex IV to Directive 2006/88/EC sets out the criteria for listing exotic and non-exotic diseases in Part II of that Annex. According to those criteria, exotic diseases are to have the potential for significant economic impact if introduced into the Union, either by production losses in Union aquaculture or by restricting the potential for trade in aquaculture animals and products thereof. Alternatively, they are to have potential for detrimental environmental impact if introduced into the Union, to wild aquatic animal populations of species, which are an asset worth protecting by Union law or international provisions.

               (4)

               On 15 September 2011, the European Food Safety Authority (EFSA) Panel on Animal Health and Welfare adopted a Scientific Opinion on Epizootic Ulcerative Syndrome (2) (the EFSA opinion). In that opinion, the EFSA concludes that the impact of EUS in Union aquaculture would range from no impact to low impact.

               (5)

               In addition, the EFSA opinion states that it is likely that EUS has repeatedly entered into the Union via ornamental fish import from third countries and that such fish may have released into Union waters. Under these circumstances, and considering the fact that no outbreaks of EUS have been reported in the Union, there is no evidence to suggest that EUS has the potential for detrimental environmental impact.

               (6)

               In view of the EFSA conclusions and of the available scientific evidence, EUS does no longer meet the criteria set out in Part I of Annex IV to Directive 2006/88/EC in order to be listed in Part II of that Annex.

               (7)

               It is therefore appropriate to delete the entry for Epizootic ulcerative syndrome from the list of exotic diseases set out in Part II of Annex IV to Directive 2006/88/EC.

               (8)

               In addition, Part II of Annex IV to Directive 2006/88/EC includes a list of species regarded as susceptible to Viral haemorrhagic septicaemia.

               (9)

               Olive flounder (Paralichthys olivaceus) is susceptible to the non-exotic fish disease Viral haemorrhagic septicaemia. Clinical outbreaks of that disease were confirmed in certain regions of Asia.

               (10)

               It is therefore appropriate to include Olive flounder (Paralichthys olivaceus) in the list of species susceptible to Viral haemorrhagic septicaemia set out in Part II of Annex IV to Directive 2006/88/EC.

               (11)

               Annex IV to Directive 2006/88/EC should therefore be amended accordingly.

               (12)

               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 IV to Directive 2006/88/EC is amended in accordance with the Annex to this Directive.
   Article 2
   1.   Member States shall adopt and publish, by 1 January 2013 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.
   2.   They shall apply those provisions from 1 January 2013.
   3.   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.
   4.   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, 25 October 2012.

            For the Commission

            The President

         José Manuel BARROSO

      (1)  OJ L 328, 24.11.2006, p. 14.

      (2)  EFSA Journal 2011; 9(10):2387.

      ANNEX
      Part II of Annex IV to Directive 2006/88/EC is replaced by the following:

         ‘PART II

            Listed diseases

                     Exotic diseases

                     Disease

                     Susceptible species

                     Fish

                     Epizootic haematopoietic necrosis

                     Rainbow trout (Oncorhynchus mykiss) and redfin perch (Perca fluviatilis)

                     Molluscs

                     Infection with Bonamia exitiosa

                     Australian mud oyster (Ostrea angasi) and Chilean flat oyster (O. chilensis)

                     Infection with Perkinsus marinus

                     Pacific oyster (Crassostrea gigas) and Eastern oyster (C. virginica)

                     Infection with Microcytos mackini

                     Pacific oyster (Crassostrea gigas), Eastern oyster (C. virginica), Olympia flat oyster (Ostrea conchaphila) and European flat oyster (O. edulis)

                     Crustaceans

                     Taura syndrome

                     Gulf white shrimp (Penaeus setiferus), Pacific blue shrimp (P. stylirostris), and Pacific white shrimp (P. vannamei)

                     Yellowhead disease

                     Gulf brown shrimp (Penaeus aztecus), Gulf pink shrimp (P. duorarum), Kuruma prawn (P. japonicus), black tiger shrimp (P. monodon), Gulf white shrimp (P. setiferus), Pacific blue shrimp (P. stylirostris), and Pacific white shrimp (P. vannamei)

                     Non-exotic diseases

                     Diseases

                     Susceptible species

                     Fish

                     Viral haemorrhagic septicaemia (VHS)

                     Herring (Clupea spp.), whitefish (Coregonus sp.), pike (Esox lucius), haddock (Gadus aeglefinus), Pacific cod (G. macrocephalus), Atlantic cod (G. morhua), Pacific salmon (Oncorhynchus spp.) rainbow trout (O. mykiss), rockling (Onos mustelus), brown trout (Salmo trutta), turbot (Scophthalmus maximus), sprat (Sprattus sprattus), grayling (Thymallus thymallus) and olive flounder (Paralichthys olivaceus),

                     Infectious haematopoietic necrosis (IHN)

                     Chum salmon (Oncorhynchus keta), coho salmon (O. kisutch), Masou salmon (O. masou), rainbow or steelhead trout (O. mykiss), sockeye salmon (O. nerka), pink salmon (O. rhodurus) chinook salmon (O. tshawytscha), and Atlantic salmon (Salmo salar)

                     Koi herpes virus (KHV) disease

                     Common carp and koi carp (Cyprinus carpio)

                     Infectious salmon anaemia (ISA)

                     Rainbow trout (Oncorhynchus mykiss), Atlantic salmon (Salmo salar), and brown and sea trout (S. trutta)

                     Molluscs

                     Infection with Marteilia refringens

                     Australian mud oyster (Ostrea angasi), Chilean flat oyster (O. chilensis), European flat oyster (O. edulis), Argentinian oyster (O. puelchana), blue mussel (Mytilus edulis) and Mediterranean mussel (M. galloprovincialis)

                     Infection with Bonamia ostreae

                     Australian mud oyster (Ostrea angasi), Chilean flat oyster (O. chilensis), Olympia flat oyster (O. conchaphila), Asiatic oyster (O. denselammellosa), European flat oyster (O. edulis), and Argentinian oyster (O. puelchana)

                     Crustaceans

                     White spot disease

                     All decapod crustaceans (order Decapoda)’