title: Commission Implementing Directive 2014/111/EU of 17 December 2014 amending Directive 2009/15/EC with regard to the adoption by the International Maritime Organization (IMO) of certain Codes and related amendments to certain conventions and protocols  Text with EEA relevance

text:
               20.12.2014

               EN

               Official Journal of the European Union

               L 366/83

         COMMISSION IMPLEMENTING DIRECTIVE 2014/111/EU
   of 17 December 2014
   amending Directive 2009/15/EC with regard to the adoption by the International Maritime Organization (IMO) of certain Codes and related amendments to certain conventions and protocols
   (Text with EEA relevance)
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Directive 2009/15/EC of the European Parliament and of the Council of 23 April 2009 on common rules and standards for ship inspection and survey organisations and for the relevant activities of maritime administrations (1), and in particular the second sentence of Article 7(2) thereof,
   Acting in accordance with the conformity checking procedure set out in Article 5 of Regulation (EC) No 2099/2002 of the European Parliament and of the Council establishing a Committee on Safe Seas and the Prevention of Pollution from Ships (COSS) (2),
   Whereas:

               (1)

               Pursuant to Article 5(1) of Regulation (EC) No 2099/2002, Member States and the Commission shall cooperate in order to define, as appropriate, a common position or approach in the competent international fora with a view to reducing the risks of conflict between the maritime legislation of the Union and international instruments.

               (2)

               Directive 2009/15/EC forms together with Regulation (EC) No 391/2009 of the European Parliament and the Council (3) one coherent piece of legislation where the activities of recognised organisations are regulated in a consistent manner in accordance with the same principles and definitions. Pursuant to Article 3(2) of Directive 2009/15/EC, if a Member State decides, with respect to ships flying its flag, to authorise an organisation to carry out on its behalf the inspections and surveys related to statutory certificates, it shall entrust these duties only to a recognised organisation, which, pursuant to Article 2(g) of that Directive, means an organisation recognised in accordance with Regulation (EC) No 391/2009. Therefore, the set of rules on the basis of which the organisations concerned are recognised has an impact on both acts.

               (3)

               The term ‘international conventions’ as defined in Article 2(d) of Directive 2009/15/EC means the International Convention for the Safety of Life at Sea of 1 November 1974 (‘the SOLAS Convention’) with the exception of chapter XI-2 of the Annex thereto, the International Convention on Load Lines of 5 April 1966 (‘the Load Lines Convention’) and the International Convention for the Prevention of Pollution from Ships of 2 November 1973 (‘the MARPOL Convention’), together with the protocols and amendments thereto, and the related codes of mandatory status in all Member States, in their up-to-date version.

               (4)

               The IMO Assembly at its 28th session adopted an IMO Instruments Implementation Code (III Code), as set out in IMO resolution A.1070(28) of 4 December 2013, as well as amendments to the Load Lines Convention, with a view to rendering the III Code mandatory, together with an associated flag State audit scheme, as set out in IMO resolution A.1083(28) of 4 December 2013.

               (5)

               The IMO Marine Environment Protection Committee (MEPC) at its 66th session adopted amendments to the Protocol of 1978 relating to the MARPOL Convention, as set out in resolution MEPC.246(66) of 4 April 2014, and to the Protocol of 1997 relating to the MARPOL Convention, as modified by the Protocol of 1978 relating thereto, as set out in resolution MEPC.247(66) of 4 April 2014, with a view to rendering the III Code mandatory, together with an associated flag State audit scheme.

               (6)

               The IMO Maritime Safety Committee (MSC) at its 93rd session adopted amendments to the SOLAS Convention, as set out in resolution MSC.366(93) of 22 May 2014, and to the Protocol of 1988 relating to the Load Lines Convention, as set out in resolution MSC.375(93) of 22 May 2014, with a view to rendering the III Code mandatory, together with an associated flag State audit scheme.

               (7)

               The MEPC at its 65th session and the MSC at its 92nd session adopted an IMO Code for Recognized Organizations (RO Code), as set out in resolution MSC.349(92) of 21 June 2013.

               (8)

               The MEPC at its 65th session adopted amendments to the Protocol of 1978 relating to the MARPOL Convention with a view to rendering the RO Code mandatory, as set out in resolution MEPC.238(65) of 17 May 2013.

               (9)

               The MSC at its 92nd session adopted amendments to the SOLAS Convention and to the Protocol of 1988 relating to the Load Lines Convention with a view to rendering the RO Code mandatory, as set in resolutions MSC.350(92) and MSC.356(92) of 21 June 2013.

               (10)

               The III and RO Codes are therefore expected to enter into force during the period between 1 January 2015 until 1 January 2018 in accordance with the applicable rules for the adoption, ratification and entry into force of amendments under each of the IMO conventions concerned.

               (11)

               On 13 May 2013, the Council adopted Council Decision 2013/268/EU on the position to be taken on behalf of the European Union within the International Maritime Organization (IMO) with regard to the adoption of certain Codes and related amendments to certain conventions and protocols (4). Pursuant to Article 5 of that Decision, the Council authorised the Member States to give their consent to be bound, in the interest of the Union and subject to the declaration set in the Annex of that Decision, by the amendments referred to in recitals (4) to (9) of this Directive.

               (12)

               The declaration annexed to Council Decision 2013/268/EU states that Member States consider that the III Code and the RO Code contain a set of minimum requirements on which States can elaborate and improve as appropriate for the enhancement of maritime safety and the protection of the environment.

               (13)

               It also states that nothing in the III Code or RO Code shall be construed to restrict or limit in any way the fulfilment of Member States' obligations under the law of the Union in relation to the definition of ‘statutory certificates’ and ‘class certificates’, the scope of the obligations and criteria laid down for recognised organisations, and the duties of the European Commission as regards the recognition, assessment and, where appropriate, the imposition of corrective measures or sanctions on recognised organisations. The same declaration states that, in the case of an IMO audit, Member States will state that only compliance with those provisions of the relevant international conventions which Member States have accepted, including in the terms of this declaration, shall be verified.

               (14)

               In the legal order of the Union, the scope of Directive 2009/15/EC as well as that of Regulation (EC) No 391/2009 includes references to the ‘international conventions’ as described in recital (3). In this framework, amendments to IMO conventions are automatically brought into Union law at the same time when they enter into force at the international level, including the related codes of mandatory status such as the III and RO codes, which therefore form part of the IMO instruments relevant for the application of Directive 2009/15/EC.

               (15)

               Amendments to international conventions may however be excluded from the scope of Union maritime legislation in accordance with the conformity checking procedure if they meet at least one of the two criteria set out in Article 5(2) of Regulation (EC) No 2099/2002.

               (16)

               The Commission evaluated the amendments to the IMO conventions in accordance with Article 5 of Regulation (EC) No 2099/2002 and determined that a number of discrepancies exist between, on the one hand, the III Code and the RO Code, and, on the other hand, Directive 2009/15/EC and Regulation (EC) No 391/2009.

               (17)

               First, paragraph 16.1 of part 2 of the III Code provides for a minimum list of resources and processes which flag States have to establish, including the provision of administrative instructions pertaining inter alia to ship class certificates required by the flag State to demonstrate compliance with structural, mechanical, electrical, and/or other requirements of an international convention to which the flag State is a party or compliance with a requirement of the flag State's national regulation. As detailed in recital (21) below however, Union law draws a distinction between statutory certificates and class certificates. The latter are documents of a private nature and are neither acts of a flag State nor issued on any flag State's behalf. This provision of the III Code in fact refers to SOLAS Chapter II-1, Part A-1, Regulation 3-1, which provides that ships shall be designed, constructed and maintained in compliance with the structural, mechanical and electrical requirements of a classification society which is recognized by the Administration in accordance with the provisions of regulation XI-1/1. 1. The SOLAS convention clearly identifies the ship or its legal representation vis-à-vis the flag State as the object of this requirement. Furthermore, when acting in its capacity as class society, a recognised organisation issues ship class certificates in accordance with its own rules, procedures, conditions and private contractual arrangements, to which the flag State is not a party. Therefore, this provision of the III Code contradicts the delineation of class and statutory activities as set out in the existing EU legislation.

               (18)

               Second, paragraph 18.1 of part 2 of the III Code requires the flag State to determine, ”with regard only to ships entitled to fly its flag”, that a recognised organisation has adequate resources in terms of technical, managerial and research capabilities to accomplish the duties entrusted to it. In contrast, this aspect is addressed under Union law as a requirement for the purpose of the recognition as reflected in criterion A.3 in Annex I of Regulation (EC) No 391/2009, and with regard to the entire fleet in the class of the organisation concerned, without distinction based on flag. Should the above provision of the III Code be incorporated into Union law, it would restrict the application of criterion A.3 in Annex I of Regulation (EC) No 391/2009 to the recognised organisation's performance with regard only to ships flying the flag of Member States, in contradiction with the requirements currently in force.

               (19)

               Third, paragraph 19 of part 2 of the III Code introduces a prohibition for a flag State to mandate its recognised organisations to apply to ships, other than those entitled to fly its flag, any requirements pertaining to inter alia their classification rules, requirements or procedures. Pursuant to Directive 2009/15/EC, Member States can only authorise an organisation to act on their behalf for the statutory certification of their respective fleet if that organisation has been recognised and is being monitored for this purpose in accordance with Regulation (EC) No 391/2009. In this framework, the recognised organisations as such have to comply with certain requirements in their relevant activities across their classed fleet, irrespective of the flag. This relates to most of the criteria set out in Annex I of Regulation (EC) No 391/2009, as well as to other obligations, in particular Article 10(4) of that Regulation. Should the above provision of the III Code be incorporated into Union law, it would restrict the application of the existing recognition requirements in Regulation (EC) No 391/2009 inter alia if they qualify as rules, requirements and procedures to the recognised organisation's performance with regard only to ships flying the flag of Member States.

               (20)

               Fourth, section 1.1 of part 2 of the RO Code defines a ‘Recognized Organization’ as an organisation assessed by a flag State and found to comply with part 2 of the RO Code. In contrast, Article 2(g) of Directive 2009/15/EC provides that a recognised organisation is ‘an organisation recognised in accordance with Regulation (EC) No 391/2009’. Based on the Commission's evaluation set out in recitals (21) to (23), it appears that several provisions in part 2 of the RO Code are incompatible with Regulation (EC) No 391/2009. Consequently, a recognised organisation as defined in the RO Code would not fulfil all the requirements of Regulation (EC) No 391/2009 and could therefore not meet the definition of a recognised organisation as set out in Union law.

               (21)

               Fifth, section 1.3 of part 2 of the RO Code defines ‘statutory certification and services’ as a single category of activities that a recognised organisation is entitled to perform on behalf of the flag State, including the issuance of certificates pertaining to both statutory and class requirements. In contrast, the definitions set out in Article 2(i) and (k) of Directive 2009/15/EC draw a clear distinction between ‘statutory certificates’, which are those certificates issued by or on behalf of a flag State in accordance with the international conventions, and ‘class certificates’, which are those documents issued by a recognised organisation, in its capacity as class society, certifying the fitness of a ship for a particular use or service in accordance with the rules and procedures laid down and made public by that recognised organisation. It follows that, under Union law, statutory and class certificates are distinct and have different natures. Namely, statutory certificates have a public nature, while class certificates have a private nature, being issued by the class society in accordance with its own rules, procedures and conditions. It follows that classification certificates issued by a recognised organisation for a ship in order to attest compliance with classification rules and procedures, including when verified by a flag State as proof of compliance with SOLAS Chapter II-I, Part A-1, Regulation 3-1, are documents of a strictly private nature which are neither acts of a flag State nor carried out on any flag State's behalf. In the RO Code however, ‘statutory certification and services’ are systematically referred to as being performed by the RO ”on behalf of the flag State”, contradicting the legal distinction established in Union law. Notwithstanding this contradiction, this provision of the RO Code, if accepted as a norm in the Union legal order, entails a manifest risk that the recognition requirements contained in Regulation (EC) No 391/2009 which pertain to the entire activity of the organisation, irrespective of flag, could no longer be enforced within the EU. Due to the link between the two instruments as explained in recital (2), this risk is also relevant to Directive 2009/15/EC.

               (22)

               Sixth, section 3.9.3.1 of part 2 of the RO Code provides for a mechanism of co-operation between recognised organisations under the sole framework established by the flag State with the view to standardising processes concerning statutory certification and services for the flag State, as appropriate; whereas section 3.9.3.2 of part 2 of the same Code establishes a framework ”by a flag State or a group of flag States” to regulate co-operation among their recognised organisations on technical and safety-related aspects of ”statutory certification and services of ships […] on behalf of the said flag State(s)”. In contrast, co-operation between recognised organisations under Union law is governed by Article 10(1) of Regulation (EC) No 391/2009, which requires recognised organisations to consult with each other with a view to maintaining equivalence and aiming for harmonisation of their rules and procedures and the implementation thereof, and sets out a framework for the mutual recognition, in appropriate cases, of class certificates for materials, equipment and components. Those two co-operation processes under Article 10(1) pertain to the private activities of the recognised organisations, in their capacity as classification societies, and therefore apply without distinction based on flag. The co-operation mechanisms provided for in the RO Code, if incorporated into Union law, would therefore limit the scope of the co-operation framework established by Regulation (EC) No 391/2009 to the recognised organisations' activities with regard only to ships flying the flag of Member States, in contradiction with the requirements currently in force.

               (23)

               Seventh, section 3.9.3.3 of part 2 of the RO Code is identical to paragraph 19 of part 2 of the III Code; therefore the considerations made in recital (19) are equally relevant to this provision of the RO Code.

               (24)

               Nothing in either the III Code or the RO Code should place any restrictions on the Union's capacity to lay down, in accordance with the Treaties and international law, appropriate conditions for the granting of recognition to organisations wishing to be authorised by the Member States to carry out ship survey and certification activities on their behalf, with a view to achieving the Union's objectives and in particular to enhance maritime safety and the protection of the environment.

               (25)

               The scheme for the mutual recognition of class certificates for materials, equipment and components laid down by Article 10(1) of Regulation (EC) No 391/2009 is only enforceable within the Union in respect of ships flying the flag of a Member State. As far as foreign vessels are concerned, the acceptance of relevant certificates remains at the discretion of relevant non-EU flag States in the exercise of their exclusive jurisdiction, notably under the United Nations Convention on the Law of the Sea (UNCLOS).

               (26)

               Based on its evaluation, the Commission determined that the provisions of the III Code and of the RO Code referred to in the preceding recitals are incompatible with Directive 2009/15/EC, or with Regulation (EC) No 391/2009 and consequently with Directive 2009/15/EC due to the link between the two instruments as explained in recital (2), and should be excluded from the scope of that Directive. Therefore Article 2(d) of Directive 2009/15/EC should be amended accordingly.

               (27)

               As the RO Code enters into force on 1 January 2015, this Directive should enter into force as soon as possible after its date of publication.

               (28)

               The Committee on Safe Seas and the Prevention of Pollution from Ships (COSS) did not deliver an opinion on the measures provided for in this Directive. An implementing act was deemed to be necessary and the chair submitted the draft implementing act to the appeal committee for further deliberation. The measures provided for in this Directive are in accordance with the opinion of the appeal committee,

         HAS ADOPTED THIS DIRECTIVE:
   Article 1
   In Article 2 of Directive 2009/15/EC, point (d) is replaced by the following:

                  ‘(d)

                  “international conventions” means the International Convention for the Safety of Life at Sea of 1 November 1974 (SOLAS 74) with the exception of chapter XI-2 of the Annex thereto, the International Convention on Load Lines of 5 April 1966 and the International Convention for the Prevention of Pollution from Ships of 2 November 1973 (MARPOL), together with the protocols and amendments thereto, and the related codes of mandatory status in all Member States, with the exception of paragraphs 16.1, 18.1 and 19 of part 2 of the IMO Instruments Implementation Code, and of sections 1.1, 1.3, 3.9.3.1, 3.9.3.2 and 3.9.3.3 of part 2 of the IMO Code for Recognized Organizations, in their up-to-date version.’

   Article 2
   1.   Member States shall adopt and publish, by 31 December 2015 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 2016.
   When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
   2.   Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.
   Article 3
   This Directive shall enter into force on the 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, 17 December 2014.

            For the Commission

            The President

         Jean-Claude JUNCKER

      (1)  OJ L 131, 28.5.2009, p. 47.

      (2)  OJ L 324, 29.11.2002, p. 1.

      (3)  Regulation (EC) No 391/2009 of the European Parliament and of the Council of 23 April 2009 on common rules and standards for ship inspection and survey organisations (OJ L 131, 28.5.2009, p. 11).

      (4)  OJ L 155, 7.6.2013, p. 3.


title: Commission Implementing Directive 2011/45/EU of 13 April 2011 amending Council Directive 91/414/EEC to include diclofop as active substance and amending Commission Decision 2008/934/EC  Text with EEA relevance

text:
               14.4.2011

               EN

               Official Journal of the European Union

               L 100/47

         COMMISSION IMPLEMENTING DIRECTIVE 2011/45/EU
   of 13 April 2011
   amending Council Directive 91/414/EEC to include diclofop 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 diclofop.

               (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 diclofop.

               (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 11 August 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 diclofop (considered variant diclofop-methyl) to the Commission on 1 September 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 diclofop.

               (6)

               It has appeared from the various examinations made that plant protection products containing diclofop 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 diclofop 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 confirming the results of the risk assessment on the basis of most recent scientific knowledge as regards a metabolism study on cereals. Moreover, it is appropriate to require the submission of confirmatory information on the possible environmental impact of the preferential degradation/conversion of the isomers.

               (8)

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

               (9)

               Without prejudice to the obligations defined by Directive 91/414/EEC as a consequence of including an active substance in Annex I, Member States should be allowed a period of 6 months after inclusion to review existing authorisations of plant protection products containing diclofop 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 diclofop-methyl and the withdrawal of authorisations for plant protection products containing that substance by 31 December 2011. It is necessary to delete the line concerning diclofop-methyl 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 diclofop-methyl 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 diclofop 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 diclofop 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 diclofop 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 diclofop. 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 diclofop 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 diclofop 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 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 diclofop. EFSA Journal 2010; 8(10):1718. [74 pp.]. doi:10.2903/j.efsa.2010.1718 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

                     ‘348

                     Diclofop
                     CAS No 40843-25-2 (parent)
                     CAS No 257-141-8 (diclofop-methyl)
                     CIPAC No 358 (parent)
                     CIPAC No 358.201 (diclofop-methyl)

                                 Diclofop

                                    (RS)-2-[4-(2,4-dichlorophenoxy)phenoxy]propionic acid

                                 Diclofop-methyl
                                 methyl (RS)-2-[4-(2,4-dichlorophenoxy)phenoxy]propionate

                     ≥ 980 g/kg (expressed as diclofop-methyl)

                     1 June 2011

                     31 May 2021

                     PART A
                     Only uses as herbicide may be authorised.
                     PART B
                     For the implementation of the uniform principles of Annex VI, the conclusions of the review report on diclofop, 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 operators and workers safety and include as a condition for authorisation the application of adequate personal protective equipment,

                                 —

                                 pay particular attention to the risk to aquatic organisms and non-target plants and require risk mitigation measures to be applied.

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

                                 (a)

                                 a metabolism study on cereals;

                                 (b)

                                 an update of the risk assessment concerning the possible environmental impact of the preferential degradation/conversion of the isomers.

                           The Member States concerned shall ensure that the applicant submits to the Commission the information set out in point (a) by 31 May 2013 and the information set out in point (b) at latest 2 years after the adoption of a specific guidance document on evaluation of isomers mixtures.’

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


title: Commission Implementing Directive 2014/105/EU of 4 December 2014 amending Directives 2003/90/EC and 2003/91/EC setting out implementing measures for the purposes of Article 7 of Council Directive 2002/53/EC and Article 7 of Council Directive 2002/55/EC respectively, as regards the characteristics to be covered as a minimum by the examination and the minimum conditions for examining certain varieties of agricultural plant species and vegetable species  Text with EEA relevance

text:
               5.12.2014

               EN

               Official Journal of the European Union

               L 349/44

         COMMISSION IMPLEMENTING DIRECTIVE 2014/105/EU
   of 4 December 2014
   amending Directives 2003/90/EC and 2003/91/EC setting out implementing measures for the purposes of Article 7 of Council Directive 2002/53/EC and Article 7 of Council Directive 2002/55/EC respectively, as regards the characteristics to be covered as a minimum by the examination and the minimum conditions for examining certain varieties of agricultural plant species and vegetable species
   (Text with EEA relevance)
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Council Directive 2002/53/EC of 13 June 2002 on the common catalogue of varieties of agricultural plant species (1), and in particular Article 7(2)(a) and (b) thereof,
   Having regard to Council Directive 2002/55/EC of 13 June 2002 on the marketing of vegetable seed (2), and in particular Article 7(2)(a) and (b) thereof,
   Whereas:

               (1)

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

               (2)

               The CPVO and UPOV have since established further guidelines and have updated existing ones.

               (3)

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

               (4)

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

         HAS ADOPTED THIS DIRECTIVE:
   Article 1
   Annexes I and II to Directive 2003/90/EC are replaced by the text in part A of the Annex to this Directive.
   Article 2
   The Annexes to Directive 2003/91/EC are replaced by the text in part B of the Annex to this Directive.
   Article 3
   For examinations started before 1 January 2016 Member States may apply Directives 2003/90/EC and 2003/91/EC in the version applying before their amendment by this Directive.
   Article 4
   Member States shall adopt and publish, by 31 December 2015 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 2016.
   When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.
   Article 5
   This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
   Article 6
   This Directive is addressed to the Member States.

      Done at Brussels, 4 December 2014.

            For the Commission

            The President

         Jean-Claude JUNCKER

      (1)  OJ L 193, 20.7.2002, p. 1.

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

      (3)  Commission Directive 2003/90/EC of 6 October 2003 setting out implementing measures for the purposes of Article 7 of Council Directive 2002/53/EC as regards the characteristics to be covered as a minimum by the examination and the minimum conditions for examining certain varieties of agricultural plant species (OJ L 254, 8.10.2003, p. 7).

      (4)  Commission Directive 2003/91/EC of 6 October 2003 setting out implementing measures for the purposes of Article 7 of Council Directive 2002/55/EC as regards the characteristics to be covered as a minimum by the examination and the minimum conditions for examining certain varieties of vegetable species (OJ L 254, 8.10.2003, p. 11).

      ANNEX
      PART A
      ‘
            ANNEX I
            List of species referred to in Article 1(2)(a) which are to comply with CPVO test protocols

                        Scientific name

                        Common name

                        CPVO protocol

                           Festuca filiformis Pourr.

                        Fine-leaved sheep's fescue

                        TP 67/1 of 23.6.2011

                           Festuca ovina L.

                        Sheep's fescue

                        TP 67/1 of 23.6.2011

                           Festuca rubra L.

                        Red fescue

                        TP 67/1 of 23.6.2011

                           Festuca trachyphylla (Hack.) Krajina

                        Hard fescue

                        TP 67/1 of 23.6.2011

                           Lolium multiflorum Lam.

                        Italian ryegrass

                        TP 4/1 of 23.6.2011

                           Lolium perenne L.

                        Perennial ryegrass

                        TP 4/1 of 23.6.2011

                           Lolium × boucheanum Kunth

                        Hybrid ryegrass

                        TP 4/1 of 23.6.2011

                           Pisum sativum L.

                        Field pea

                        TP 7/2 of 11.3.2010

                           Brassica napus L.

                        Swede rape

                        TP 36/2 of 16.11.2011

                           Cannabis sativa L.

                        Hemp

                        TP 276/1 of 28.11.2012

                           Helianthus annuus L.

                        Sunflower

                        TP 81/1 of 31.10.2002

                           Linum usitatissimum L.

                        Flax/Linseed

                        TP 57/2 of 19.3.2014

                           Avena nuda L.

                        Small naked oat, Hulless oat

                        TP 20/1 of 6.11.2003

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

                        Oats and Red oat

                        TP 20/1 of 6.11.2003

                           Hordeum vulgare L.

                        Barley

                        TP 19/3 of 21.3.2012

                           Oryza sativa L.

                        Rice

                        TP 16/2 of 21.3.2012

                           Secale cereale L.

                        Rye

                        TP 58/1 of 31.10.2002

                           xTriticosecale Wittm. ex A. Camus

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

                        TP 121/2 rev. 1 of 16.2.2011

                           Triticum aestivum L.

                        Wheat

                        TP 3/4 rev. 2 of 16.2.2011

                           Triticum durum Desf.

                        Durum wheat

                        TP 120/3 of 19.3.2014

                           Zea mays L.

                        Maize

                        TP 2/3 of 11.3.2010

                           Solanum tuberosum L.

                        Potato

                        TP 23/2 of 1.12.2005

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

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

                        Scientific name

                        Common name

                        UPOV guideline

                           Beta vulgaris L.

                        Fodder beet

                        TG/150/3 of 4.11.1994

                           Agrostis canina L.

                        Velvet bent

                        TG/30/6 of 12.10.1990

                           Agrostis gigantea Roth.

                        Red top

                        TG/30/6 of 12.10.1990

                           Agrostis stolonifera L.

                        Creeping bent

                        TG/30/6 of 12.10.1990

                           Agrostis capillaris L.

                        Brown top

                        TG/30/6 of 12.10.1990

                           Bromus catharticus Vahl

                        Rescue grass

                        TG/180/3 of 4.4.2001

                           Bromus sitchensis Trin.

                        Alaska brome grass

                        TG/180/3 of 4.4.2001

                           Dactylis glomerata L.

                        Cocksfoot

                        TG/31/8 of 17.4.2002

                           Festuca arundinacea Schreb.

                        Tall fescue

                        TG/39/8 of 17.4.2002

                           Festuca pratensis Huds.

                        Meadow fescue

                        TG/39/8 of 17.4.2002

                           xFestulolium Asch. et Graebn.

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

                        TG/243/1 of 9.4.2008

                           Phleum nodosum L.

                        Small timothy

                        TG/34/6 of 7.11.1984

                           Phleum pratense L.

                        Timothy

                        TG/34/6 of 7.11.1984

                           Poa pratensis L.

                        Smooth-stalked meadow grass

                        TG/33/7 of 9.4.2014

                           Lotus corniculatus L.

                        Birdsfoot trefoil

                        TG 193/1 of 9.4.2008

                           Lupinus albus L.

                        White lupin

                        TG/66/4 of 31.3.2004

                           Lupinus angustifolius L.

                        Narrow-leaved lupin

                        TG/66/4 of 31.3.2004

                           Lupinus luteus L.

                        Yellow lupin

                        TG/66/4 of 31.3.2004

                           Medicago sativa L.

                        Lucerne

                        TG/6/5 of 6.4.2005

                           Medicago x varia T. Martyn

                        Sand lucerne

                        TG/6/5 of 6.4.2005

                           Trifolium pratense L.

                        Red clover

                        TG/5/7 of 4.4.2001

                           Trifolium repens L.

                        White clover

                        TG/38/7 of 9.4.2003

                           Vicia faba L.

                        Field bean

                        TG/8/6 of 17.4.2002

                           Vicia sativa L.

                        Common vetch

                        TG/32/7 of 20.3.2013

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

                        Swede

                        TG/89/6rev. of 4.4.2001 + 1.4.2009

                           Raphanus sativus L. var. oleiformis Pers.

                        Fodder radish

                        TG/178/3 of 4.4.2001

                           Arachis hypogaea L.

                        Groundnut/Peanut

                        TG/93/4 of 9.4.2014

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

                        Turnip rape

                        TG/185/3 of 17.4.2002

                           Carthamus tinctorius L.

                        Safflower

                        TG/134/3 of 12.10.1990

                           Gossypium spp.

                        Cotton

                        TG/88/6 of 4.4.2001

                           Papaver somniferum L.

                        Poppy

                        TG/166/4 of 9.4.2014

                           Sinapis alba L.

                        White mustard

                        TG/179/3 of 4.4.2001

                           Glycine max (L.) Merr.

                        Soya bean

                        TG/80/6 of 1.4.1998

                           Sorghum bicolor (L.) Moench

                        Sorghum

                        TG/122/3 of 6.10.1989

                  The text of these guidelines can be found on the UPOV website (www.upov.int).
         ’
      PART B
      ‘
            ANNEX I
            List of species referred to in Article 1(2)(a) which are to comply with CPVO test protocols

                        Scientific name

                        Common name

                        CPVO protocol

                           Allium cepa L. (Cepa group)

                        Onion and Echalion

                        TP 46/2 of 1.4.2009

                           Allium cepa L. (Aggregatum group)

                        Shallot

                        TP 46/2 of 1.4.2009

                           Allium fistulosum L.

                        Japanese bunching onion or Welsh onion

                        TP 161/1 of 11.3.2010

                           Allium porrum L.

                        Leek

                        TP 85/2 of 1.4.2009

                           Allium sativum L.

                        Garlic

                        TP 162/1 of 25.3.2004

                           Allium schoenoprasum L.

                        Chives

                        TP 198/1 of 1.4.2009

                           Apium graveolens L.

                        Celery

                        TP 82/1 of 13.3.2008

                           Apium graveolens L.

                        Celeriac

                        TP 74/1 of 13.3.2008

                           Asparagus officinalis L.

                        Asparagus

                        TP 130/2 of 16.2.2011

                           Beta vulgaris L.

                        Beetroot including Cheltenham beet

                        TP 60/1 of 1.4.2009

                           Brassica oleracea L.

                        Curly kale

                        TP 90/1 of 16.2.2011

                           Brassica oleracea L.

                        Cauliflower

                        TP 45/2 of 11.3.2010

                           Brassica oleracea L.

                        Sprouting broccoli or Calabrese

                        TP 151/2 of 21.3.2007

                           Brassica oleracea L.

                        Brussels sprouts

                        TP 54/2 of 1.12.2005

                           Brassica oleracea L.

                        Kohlrabi

                        TP 65/1 of 25.3.2004

                           Brassica oleracea L.

                        Savoy cabbage, White cabbage and Red cabbage

                        TP 48/3 of 16.2.2011

                           Brassica rapa L.

                        Chinese cabbage

                        TP 105/1 of 13.3.2008

                           Capsicum annuum L.

                        Chilli or Pepper

                        TP 76/2 of 21.3.2007

                           Cichorium endivia L.

                        Curled-leaved endive and Plain-leaved endive

                        TP 118/3 of 19.3.2014

                           Cichorium intybus L.

                        Industrial chicory

                        TP 172/2 of 1.12.2005

                           Cichorium intybus L.

                        Witloof chicory

                        TP 173/1 of 25.3.2004

                           Citrullus lanatus (Thunb.) Matsum. et Nakai

                        Watermelon

                        TP 142/2 of 19.3.2014

                           Cucumis melo L.

                        Melon

                        TP 104/2 of 21.3.2007

                           Cucumis sativus L.

                        Cucumber and Gherkin

                        TP 61/2 of 13.3.2008

                           Cucurbita pepo L.

                        Marrow or Courgette

                        TP 119/1rev. of 19.3.2014

                           Cynara cardunculus L.

                        Globe artichoke and Cardoon

                        TP 184/2 of 27.2.2013

                           Daucus carota L.

                        Carrot and Fodder carrot

                        TP 49/3 of 13.3.2008

                           Foeniculum vulgare Mill.

                        Fennel

                        TP 183/1 of 25.3.2004

                           Lactuca sativa L.

                        Lettuce

                        TP 13/5 of 16.2.2011

                           Solanum lycopersicum L.

                        Tomato

                        TP 44/4 rev. of 27.2.2013

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

                        Parsley

                        TP 136/1 of 21.3.2007

                           Phaseolus coccineus L.

                        Runner bean

                        TP 9/1 of 21.3.2007

                           Phaseolus vulgaris L.

                        Dwarf French bean and Climbing French bean

                        TP 12/4 of 27.2.2013

                           Pisum sativum L. (partim)

                        Wrinkled pea, Round pea and Sugar pea

                        TP 7/2 of 11.3.2010

                           Raphanus sativus L.

                        Radish, Black radish

                        TP 64/2 of 27.2.2013

                           Solanum melongena L.

                        Aubergine or Egg plant

                        TP 117/1 of 13.3.2008

                           Spinacia oleracea L.

                        Spinach

                        TP 55/5 of 27.2.2013

                           Valerianella locusta (L.) Laterr.

                        Corn salad or Lamb's lettuce

                        TP 75/2 of 21.3.2007

                           Vicia faba L. (partim)

                        Broad bean

                        TP Broadbean/1 of 25.3.2004

                           Zea mays L. (partim)

                        Sweet corn and Pop corn

                        TP 2/3 of 11.3.2010

                           Solanum lycopersicum L. × Solanum habrochaites S. Knapp & D.M. Spooner; Solanum lycopersicum L. × Solanum peruvianum (L.) Mill.; Solanum lycopersicum L. × Solanum cheesmaniae (L. Ridley) Fosberg

                        Tomato rootstocks

                        TP 294/1 of 19.3.2014

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

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

                        Scientific name

                        Common name

                        UPOV guideline

                           Beta vulgaris L.

                        Spinach beet or Chard

                        TG/106/4 of 31.3.2004

                           Brassica rapa L.

                        Turnip

                        TG/37/10 of 4.4.2001

                           Cichorium intybus L.

                        Large-leaved chicory or Italian chicory

                        TG/154/3 of 18.10.1996

                           Cucurbita maxima Duchesne

                        Gourd

                        TG/155/4rev. of 28.3.2007 + 1.4.2009

                           Rheum rhabarbarum L.

                        Rhubarb

                        TG/62/6 of 24.3.1999

                           Scorzonera hispanica L.

                        Scorzonera or Black salsify

                        TG/116/4 of 24.3.2010

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


title: Commission Delegated Directive 2014/71/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 lead in solder in one interface of large area stacked die elements  Text with EEA relevance

text:
               20.5.2014

               EN

               Official Journal of the European Union

               L 148/76

         COMMISSION DELEGATED DIRECTIVE 2014/71/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 lead in solder in one interface of large area stacked die elements
   (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)

               SDE (stacked die elements) detector technology is used in X-ray detectors of computed tomography (CT) and X-ray systems. It offers advantages for patients as it reduces the necessary X-ray dose exposure. Large area SDE detectors cannot yet be produced with lead-free solders. The substitution and the elimination of lead are therefore scientifically and technically impracticable for the above-mentioned applications.

               (3)

               The use of lead in large area stacked die elements with more than 500 interconnects per interface used in X-ray detectors of CT and X-ray systems should therefore be exempted from the prohibition until 31 December 2019. In view of the innovation cycles of the medical devices and monitoring and control instruments sectors this is a relatively short transition period which is unlikely to have adverse impacts on innovation.

               (4)

               In accordance with the repair-as-produced principle of Directive 2011/65/EU, which is meant to extend the lifetime of compliant products once placed on the market, spare parts shall benefit from this exemption past its end date without time limitations.

               (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, 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 38 is added:

                     ‘38.

                     Lead in solder in one interface of large area stacked die elements with more than 500 interconnects per interface which are used in X-ray detectors of computed tomography and X-ray systems.
                     Expires on 31 December 2019. May be used after that date in spare parts for CT and X-ray systems placed on the market before 1 January 2020.’


title: Commission Delegated Directive 2014/1/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 as an alloying element for bearings and wear surfaces in medical equipment exposed to ionising radiation  Text with EEA relevance

text:
               9.1.2014

               EN

               Official Journal of the European Union

               L 4/45

         COMMISSION DELEGATED DIRECTIVE 2014/1/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 as an alloying element for bearings and wear surfaces in medical equipment exposed to ionising radiation
   (Text with EEA relevance)
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Directive 2011/65/EU of the European Parliament and of the Council of 8 June 2011 on the restriction of the use of certain hazardous substances in electrical and electronic equipment (1), and in particular Article 5(1)(a) thereof,
   Whereas:

               (1)

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

               (2)

               The only reliable dry lubricant material with a long life that does not decompose when exposed to ionising radiation has been found to be alloys that contain particles of lead.

               (3)

               The current use of lead as an alloying element for bearings and wear surfaces in medical equipment exposed to ionising radiation cannot be eliminated, nor is a feasible substitute available.

               (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 23 is added:

                  ‘23.

                  Lead as an alloying element for bearings and wear surfaces in medical equipment exposed to ionising radiation. Expires on 30 June 2021.’


title: Commission Delegated Directive 2014/69/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 lead in dielectric ceramic in capacitors for a rated voltage of less than 125 V AC or 250 V DC for industrial monitoring and control instruments  Text with EEA relevance

text:
               20.5.2014

               EN

               Official Journal of the European Union

               L 148/72

         COMMISSION DELEGATED DIRECTIVE 2014/69/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 lead in dielectric ceramic in capacitors for a rated voltage of less than 125 V AC or 250 V DC for industrial monitoring and control instruments
   (Text with EEA relevance)
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Directive 2011/65/EU of the European Parliament and of the Council of 8 June 2011 on the restriction of the use of certain hazardous substances in electrical and electronic equipment (1), and in particular Article 5(1)(a) thereof,
   Whereas:

               (1)

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

               (2)

               Both the substitution of lead in dielectric ceramic in capacitors for a rated voltage of less than 125 V AC or 250 V DC used in industrial monitoring and control instruments (IMCIs) and the substitution of these components in IMCIs are still technically impracticable.

               (3)

               Although the substitution of lead in low voltage ceramic capacitors is possible for other applications, the use of these lead-free components in IMCIs requires manufacturers to redesign their IMCIs or parts thereof, and requalify the new designs, in order to make them technically practicable and to demonstrate reliability. The use of lead in low voltage ceramic capacitors for industrial monitoring and control instruments should therefore be exempted from the prohibition until 31 December 2020. In view of the innovation cycles for IMCIs this is a relatively short transition period which is unlikely to have adverse impacts on innovation.

               (4)

               In accordance with the repair-as-produced principle of Directive 2011/65/EU, which is meant to extend the lifetime of compliant products once placed on the market, spare parts shall benefit from this exemption past its end date without time limitations.

               (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, 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 40 is added:

                     ‘40.

                     Lead in dielectric ceramic in capacitors for a rated voltage of less than 125 V AC or 250 V DC for industrial monitoring and control instruments.
                     Expires on 31 December 2020. May be used after that date in spare parts for industrial monitoring and control instruments placed on the market before 1 January 2021.’


title: Commission Delegated Directive 2014/70/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 lead in micro-channel plates (MCPs)  Text with EEA relevance

text:
               20.5.2014

               EN

               Official Journal of the European Union

               L 148/74

         COMMISSION DELEGATED DIRECTIVE 2014/70/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 lead in micro-channel plates (MCPs)
   (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)

               Micro-channel plates (MCPs) are used for the detection and amplification of ions and electrons in medical devices and monitoring and control instruments. The substitution of lead in MCPs is scientifically and technically impracticable.

               (3)

               The substitution of MCPs as components with alternative detectors is not viable under conditions where extreme miniaturisation, very short response times or very high signal multiplication factors are required. The use of lead in those cases where the performance and specific features of MCPs exceed alternative detectors should therefore be exempted from the prohibition. As currently no lead-free alternatives are in sight, pursuant to Article 5(2) of Directive 2011/65/EU, the validity period of the exemption should be 7 years from the relevant compliance dates for medical devices, monitoring and control instruments, in vitro medical devices and industrial monitoring and control instruments, as laid down in Article 4(3) of Directive 2011/65/EU. In view of the innovation cycles for all medical devices and monitoring and control instruments 7 years is a relatively short transition period which is unlikely to 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 39 is added:

                     ‘39.

                     Lead in micro-channel plates (MCPs) used in equipment where at least one of the following properties is present:

                                 (a)

                                 a compact size of the detector for electrons or ions, where the space for the detector is limited to a maximum of 3 mm/MCP (detector thickness + space for installation of the MCP), a maximum of 6 mm in total, and an alternative design yielding more space for the detector is scientifically and technically impracticable;

                                 (b)

                                 a two-dimensional spatial resolution for detecting electrons or ions, where at least one of the following applies:

                                             (i)

                                             a response time shorter than 25 ns;

                                             (ii)

                                             a sample detection area larger than 149 mm2;

                                             (iii)

                                             a multiplication factor larger than 1,3 × 103.

                                 (c)

                                 a response time shorter than 5 ns for detecting electrons or ions;

                                 (d)

                                 a sample detection area larger than 314 mm2 for detecting electrons or ions;

                                 (e)

                                 a multiplication factor larger than 4,0 × 107.

                           The exemption expires on the following dates:

                                 (a)

                                 21 July 2021 for medical devices and monitoring and control instruments;

                                 (b)

                                 21 July 2023 for in-vitro diagnostic medical devices;

                                 (c)

                                 21 July 2024 for industrial monitoring and control instruments.’


title: Commission Delegated Directive 2014/109/EU of 10 October 2014 amending Annex II to Directive 2014/40/EU of the European Parliament and of the Council by establishing the library of picture warnings to be used on tobacco products  Text with EEA relevance

text:
               17.12.2014

               EN

               Official Journal of the European Union

               L 360/22

         COMMISSION DELEGATED DIRECTIVE 2014/109/EU
   of 10 October 2014
   amending Annex II to Directive 2014/40/EU of the European Parliament and of the Council by establishing the library of picture warnings to be used on tobacco products
   (Text with EEA relevance)
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Directive 2014/40/EU of the European Parliament and of the Council of 3 April 2014 on the approximation of the laws, regulations and administrative provisions of the Member States concerning the manufacture, presentation and sale of tobacco and related products and repealing Directive 2001/37/EC (1), and in particular Article 10(3)(b) thereof,
   Whereas:

               (1)

               Article 10 of Directive 2014/40/EU provides that each unit packet and any outside packaging of tobacco products for smoking is to carry combined health warnings unless exempted in accordance with Article 11. The combined health warnings are to contain, inter alia, one of the text warnings listed in Annex I and a corresponding colour photograph specified in the picture library in Annex II to that Directive.

               (2)

               Directive 2014/40/EU also empowers the Commission to adopt delegated acts to establish and adapt the picture library in Annex II taking into account scientific and market developments.

               (3)

               Therefore, Annex II to Directive 2014/40/EU should be amended accordingly,

         HAS ADOPTED THIS DIRECTIVE:
   Article 1
   Annex II to Directive 2014/40/EU is replaced 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 20 May 2016 at the latest. They shall forthwith communicate to the Commission the text of those provisions.
   They shall apply those provisions from 20 May 2016.
   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, 10 October 2014.

            For the Commission

            The President

         José Manuel BARROSO

      (1)  OJ L 127, 29.4.2014, p. 1.

      ANNEX

            ‘ANNEX II
            Picture Library (of combined health warnings)
            (referred to in Article 10(1))

               Set 1

               Set 2

               Set 3

                           ’


title: Commission Delegated Directive 2014/2/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 cadmium in phosphor coatings in image intensifiers for X-ray images 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 4/47

         COMMISSION DELEGATED DIRECTIVE 2014/2/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 cadmium in phosphor coatings in image intensifiers for X-ray images 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 cadmium in electrical and electronic equipment placed on the market.

               (2)

               The total negative environmental and health impacts of alternatives outweigh the benefits of substituting cadmium in phosphor coatings in image intensifiers for X-ray images and in spare parts for X-ray systems.

               (3)

               The use of cadmium in phosphor coatings in image intensifiers for X-ray images and in spare parts for X-ray systems should therefore be exempted from the prohibition.

               (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 21 is added:

                  ‘21.

                  Cadmium in phosphor coatings in image intensifiers for X-ray images until 31 December 2019 and in spare parts for X-ray systems placed on the EU market before 1 January 2020.’