COMMISSION DELEGATED DIRECTIVE (EU) .../… amending Annex II to Directive 2000/53/EC of the European Parliament and of the Council on end-of-life vehicles as regards the exemption for hexavalent chromium as anti-corrosion agent of the carbon steel cooling system in absorption refrigerators in motor caravans


title: COMMISSION DELEGATED DIRECTIVE (EU) .../… amending, for the purposes of adapting to scientific and technical progress, Annex IV to Directive 2011/65/EU of the European Parliament and of the Council as regards an exemption for lead as a thermal stabiliser in polyvinyl chloride used in certain in-vitro diagnostic medical devices for the analysis of blood and other body fluids and body gases

text:
                             EUROPEAN
                             COMMISSION
                                                      Brussels, 17.12.2019
                                                      C(2019) 9069 final
                   COMMISSION DELEGATED DIRECTIVE (EU) .../…
                                         of 17.12.2019
   amending, for the purposes of adapting to scientific and technical progress, Annex IV to
      Directive 2011/65/EU of the European Parliament and of the Council as regards an
    exemption for lead as a thermal stabiliser in polyvinyl chloride used in certain in-vitro
   diagnostic medical devices for the analysis of blood and other body fluids and body gases
                                   (Text with EEA relevance)
EN                                                                                EN
 ---pagebreak---                                      EXPLANATORY MEMORANDUM
   1.       CONTEXT OF THE DELEGATED ACT
   This Commission Delegated Directive amends, for the purpose of adapting to technical
   progress, Annex IV of Directive 2011/65/EU of the European Parliament and of the Council
   on the restriction of the use of certain hazardous substances in electrical and electronic
   equipment (recast)1 (RoHS 2) as regards an exemption for specific applications containing
   lead.
   RoHS 2 restricts the use of certain hazardous substances in electrical and electronic
   equipment, as provided for in its Article 4. It entered into force on 21 July 2011.
   The currently restricted substances as listed in Annex II to RoHS 2 are the following: lead,
   mercury, cadmium, hexavalent chromium, polybrominated biphenyls (PBB), polybrominated
   diphenyl ethers (PBDE), bis(2-ethylhexyl) phthalate (DEHP), butyl benzyl phthalate (BBP),
   dibutyl phthalate (DBP) and diisobutyl phthalate (DIBP). Annexes III and IV to RoHS 2 list
   the materials and components of electrical and electronic equipment (EEE) for specific
   applications exempted from the substance restriction of RoHS 2 Article 4(1).
   Article 5 makes provision for the adaptation to scientific and technical progress (inclusion,
   renewal, amendments and revoking of exemptions) of Annexes III and IV. Pursuant to
   Article 5(1)(a), exemptions are to be included in Annexes III and IV only if such inclusion
   does not weaken the environmental and health protection afforded by
   Regulation (EC) No 1907/20062 and where any of the following conditions is fulfilled: their
   elimination or substitution via design changes or materials and components which do not
   require any of the materials or substances listed in Annex II is scientifically or technically
   impracticable; the reliability of substitutes is not ensured; or the total negative environmental,
   health and consumer safety impacts caused by substitution are likely to outweigh the total
   environmental, health and consumer safety benefits thereof.
   Decisions on exemptions, and their duration, are furthermore to take into account the
   availability of substitutes and the socioeconomic impact of substitution; and decisions on the
   duration of exemptions shall take into account any potential impact on innovation. Life-cycle
   thinking on the overall impacts of the exemption shall apply, where relevant.
   Furthermore, Article 5(1) provides that the European Commission (the Commission) shall
   include materials and components of EEE for specific applications in the lists in Annexes III
   and IV by means of individual delegated acts in accordance with Article 20. Article 5(3) and
   Annex V establish the procedure for submitting applications for granting, renewing, or
   revoking an exemption.
   2.       CONSULTATIONS PRIOR TO THE ADOPTION OF THE ACT
   Since the publication of RoHS 2, the Commission has received numerous 3 requests from
   economic operators, according to the provisions in Article 5(3) and Annex V, for both
   granting new and renewing existing exemptions.
   The current Annex IV exemption 41 permits the use of 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
   1
           OJ L 174, 1.7.2011, p. 88.
   2
           OJ L 396, 30.12.2006, p. 1.
   3
           The list is given at: http://ec.europa.eu/environment/waste/rohs_eee/adaptation_en.htm
EN                                                          1                                         EN
 ---pagebreak---    for the analysis of blood and other body fluids and body gases. The Commission received one
   application for renewal of this exemption in June 2017. While exemption 41 had 31
   December 2018 as expiration date for category 8 in vitro diagnostic medical devices, in line
   with the requirements of the RoHS Directive (Article 5(5), second subparagraph), it continues
   to apply until a decision on the renewal application is taken by the Commission.4
   With a view to evaluating the request for exemption, the Commission launched a study to
   carry out the required technical and scientific assessment, including a six-week online
   open-ended stakeholder consultation5 on the application. One contribution was received
   during the stakeholder consultation.
   The final report containing the assessment of the application was published6; stakeholders
   were notified.
   Subsequently, the Commission consulted the Member States expert group for delegated acts
   under RoHS 2 during the expert meetings on 29 October 2018 and on 21 October 2019. At the
   meetings, a majority of the experts agreed with the proposal presented, with many members
   remaining silent. In the context of the meeting on 21 October 2019, one Member State
   submitted an additional written comment opposing the draft proposal, stating that the limit
   value for lead in PVC should be lowered to 0,01% weight by weight. In accordance with the
   Better Regulation Guidelines, the draft Delegated Directive was published on the Better
   Regulation Portal for a four-week public feedback period. No comments were received. All
   applicable steps relating to exemptions from the substance restriction pursuant to Articles 5(3)
   to 5(7) have been performed.7 The Council and the European Parliament were notified of all
   activities.
   The final report highlighted in particular the following technical information and assessment:
             Lead in the PVC sensor card of concerned in vitro medical devices (blood analysers)
              is enhancing sensor performance which is necessary for the optimum performance in
              terms of analytical reliability claimed in product publications and thus for fulfilment
              of requirements set by EU legislation on in vitro diagnostic medical devices.
             While lead-free technologies are available on the market for certain analysers of
              other manufacturers, the applicant requires additional time to test the reliability of
              substitutes and to achieve compliance. Should the lead-based applications be
              discontinued without providing additional time to the applicant, a premature
              generation of 112,000 kg of waste EEE can be expected. Furthermore, as the devices
              concerned cover 30 % of blood analysers market in the EU, significant costs for
              health providers are presumed.
             At least one of the relevant criteria specified in Article 5(1)(a) is met by the
              application subject to the exemption request: the total negative environmental, health
              and consumer safety impacts by substitution (i.e. premature generation of waste
   4
            The categories listed in Annex I of Directive 2011/65/EU are namely: 1. Large household appliances; 2.
            Small household appliances; 3. IT and telecommunications equipment; 4. Consumer equipment; 5.
            Lighting equipment; 6. Electrical and electronic tools; 7. Toys, leisure and sports equipment; 8. Medical
            devices; 9. Monitoring and control instruments including industrial monitoring and control instruments;
            10. Automatic dispensers; 11. Other EEE not covered by any of the categories above.
   5
            Consultation period: from 20.10.2017 to 01.12.2017.
   6
           https://publications.europa.eu/en/publication-detail/-/publication/33a336f0-e0ef-11e8-b690-
           01aa75ed71a1/language-en/format-PDF/source-85019010 .
   7
            A list of the required administrative steps is available on the Commission website. Current stage of the
            procedure can be viewed for each draft delegated act in the Interinstitutional Registry of Delegated Acts
            at https://webgate.ec.europa.eu/regdel/#/home.
EN                                                           2                                                        EN
 ---pagebreak---              EEE) are likely to outweigh the total environmental, health and consumer safety
             benefits thereof (avoidance of approx. 157 kg of lead to be placed on the market).
   The evaluation results for categories 8 in vitro medical devices show that the specific
   exemption would at this point not weaken the environmental and health protection afforded
   by Regulation (EC) No 1907/2006 (REACH), in accordance with Article 5 of Directive
   2011/65/EU. Under Regulation (EC) No 1907/2006 (REACH), there is a restriction process
   on lead in PVC ongoing since 2016. The recent publication of a draft restriction proposal
   under REACH8 provides sufficient indications with regard to lead in PVC in order to proceed
   with the decision under RoHS. In any case, in light of the ongoing REACH restriction
   process, the renewal of the exemption should be granted for a short validity period of 2 years
   starting from the date of the publication of the Delegated Directive in the Official Journal to
   ensure alignment with REACH once the restriction process is concluded. The validity period
   for the exemption being very short, it is also not expected to have adverse impacts on
   innovation. The exemption renewal granting additional time for achieving compliance will
   further avoid negative socioeconomic impacts of substitution for certain health providers that
   would otherwise arise. The granted validity period is also not expected to have adverse
   impacts on innovation.
   3.        LEGAL ELEMENTS OF THE DELEGATED ACT
   The Delegated Directive grants an exemption from the restrictions in Article 4(1), to be listed
   in Annex IV of Directive 2011/65/EU, for the use of lead in specific applications.
   The instrument is a Delegated Directive, as provided for by Directive 2011/65/EU, and in
   particular meeting the relevant requirements of Article 5(1)(a) thereof.
   The objective of the Delegated Directive is to contribute to the protection of human health and
   the environment and approximate the provisions for the functioning of the internal market in
   the field of electrical and electronic equipment, by allowing the use of otherwise banned
   substances for specific applications, in line with the provisions and under the conditions of
   RoHS 2 and the therein established procedure for the adaptation of the Annexes III and IV to
   scientific and technical progress.
   In accordance with the principle of proportionality, the measure does not go beyond what is
   necessary to achieve its objective.
   The proposal has no implications for the EU budget.
   8
           Draft Commission Regulation amending Annex XVII to Regulation (EC) No 1907/2006 of the
           European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction
           of Chemicals (REACH) as regards lead and its compounds is available here:
           http://ec.europa.eu/growth/tools-
           databases/tbt/en/search/?tbtaction=search.detail&Country_ID=EU&num=668&dspLang=en&basdatede
           b=10/07/2019&basdatefin=18/07/2019&baspays=&basnotifnum=&basnotifnum2=&bastypepays=ANY
           &baskeywords=.
EN                                                        3                                                      EN
 ---pagebreak---                        COMMISSION DELEGATED DIRECTIVE (EU) .../…
                                                 of 17.12.2019
    amending, for the purposes of adapting to scientific and technical progress, Annex IV to
       Directive 2011/65/EU of the European Parliament and of the Council as regards an
     exemption for lead as a thermal stabiliser in polyvinyl chloride used in certain in-vitro
   diagnostic medical devices for the analysis of blood and other body fluids and body gases
                                          (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 equipment1, and in particular Article 5(1)(a) thereof,
   Whereas:
   (1)     Article 4(1) of Directive 2011/65/EU requires Member States to ensure that electrical
           and electronic equipment placed on the market does not contain the hazardous
           substances listed in Annex II to that Directive. That restriction does not apply to
           certain exempted applications which are specific to medical devices and monitoring
           and control instruments and are listed in Annex IV to that Directive.
   (2)     The categories of electrical and electronic equipment to which Directive 2011/65/EU
           applies are listed in Annex I to that Directive.
   (3)     Lead is a restricted substance listed in Annex II to Directive 2011/65/EU.
   (4)     By Delegated Directive (EU) 2015/5732, the Commission granted an exemption for
           the use of 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 (“the exemption”), by including that application in
           Annex IV to Directive 2011/65/EU. The exemption was to expire on 31 December
           2018, in accordance with the third subparagraph of Article 5(2) of that Directive.
   (5)     The Commission received an application for renewal of the exemption (“the renewal
           request”) on 25 May 2017, that is within the time limit laid down in Article 5(5) of
           Directive 2011/65/EU. In accordance with that provision, the exemption remains valid
           until a decision on the renewal request has been adopted.
   (6)     The evaluation of the renewal request included stakeholder consultations in
           accordance with Article 5(7) of Directive 2011/65/EU.
   1
           OJ L 174, 1.7.2011, p. 88.
   2
           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 (OJ L 94, 10.4.2015, p. 4).
EN                                                      4                                                     EN
 ---pagebreak---    (7)   Lead in the PVC sensor card of concerned in vitro medical devices (blood analysers)
         enhances sensor performance which is necessary for the optimum performance of the
         device in terms of analytical reliability claimed in product publications and thus for
         fulfilment of requirements laid down in Directive 98/79/EC of the European
         Parliament and of the Council3.
   (8)   While lead-free technologies are available on the market for certain analysers of other
         manufacturers, reliability testing of substitutes for the specific application subject to
         the current renewal request requires additional time.
   (9)   Discontinuation of the exemption is expected to avoid a total of 157 kg of lead being
         placed on the Union market. At the same time, however, it will result in the need to
         replace the entire diagnostic device, and consequently, is expected to lead to
         a premature generation of 112 000 kg of waste electrical and electronic equipment.
         Furthermore, significant socioeconomic impacts on health providers using the devices
         concerned would be incurred.
   (10)  The exemption does not weaken the environmental and health protection afforded by
         Regulation (EC) No 1907/2006 of the European Parliament and of the Council.4 In
         light of the restriction process on lead in PVC provided for in Regulation (EC) No
         1907/2006, the exemption should be granted for a short validity period of 2 years to
         ensure full alignment with that Regulation once the relevant restriction process is
         concluded.
   (11)  It is, therefore, appropriate to grant the renewal of the exemption.
   (12)  The exemption concerns category 8 of electrical and electronic equipment to which
         Directive 2011/65/EU applies and it should be renewed for the duration of 2 years
         starting from [the date of the publication of the Delegated Directive in the Official
         Journal], in accordance with the third subparagraph of Article 5(2) of Directive
         2011/65/EU. In view of the results of the ongoing efforts to find a reliable substitution,
         the duration of the exemption is unlikely to have adverse impacts on innovation.
   (13)  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 adopt and publish, by [the last day of the 12th month after the
           date of entry into force of this Directive] 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 [the last day of the 12th month after the date
           of entry into force of this Directive + 1 day].
   3
         OJ L 331, 7.12.1998, p. 1–37.
   4
         Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006
         concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) and
         establishing a European Chemicals Agency (OJ L 396, 30.12.2006, p. 1).
EN                                                    5                                                  EN
 ---pagebreak---             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, 17.12.2019
                                                For the Commission
                                                The President
                                                Ursula VON DER LEYEN
EN                                                6                                                EN
 ---documentbreak---                              EUROPEAN
                             COMMISSION
                                                      Brussels, 17.12.2019
                                                      C(2019) 9069 final
                                                      ANNEX
                                            ANNEX
                                                to
                               Commission Delegated Directive
   amending, for the purposes of adapting to scientific and technical progress, Annex IV to
      Directive 2011/65/EU of the European Parliament and of the Council as regards an
    exemption for lead as a thermal stabiliser in polyvinyl chloride used in certain in-vitro
   diagnostic medical devices for the analysis of blood and other body fluids and body gases
EN                                                                                EN
 ---pagebreak---                                               ANNEX
   In Annex IV to Directive 2011/65/EU, entry 41 is replaced by the following:
   "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 [the last day of the 24th month after the publication of the Delegated
               Directive in the Official Journal]."
EN                                                1                                                EN


title: COMMISSION DELEGATED DIRECTIVE (EU) .../… amending, for the purposes of adapting to scientific and technical progress, Annex IV to Directive 2011/65/EU of the European Parliament and of the Council as regards an exemption for the use of cadmium in certain radiation tolerant video camera tubes

text:
                            EUROPEAN
                            COMMISSION
                                                     Brussels, 17.12.2019
                                                     C(2019) 9071 final
                  COMMISSION DELEGATED DIRECTIVE (EU) .../…
                                        of 17.12.2019
   amending, for the purposes of adapting to scientific and technical progress, Annex IV to
     Directive 2011/65/EU of the European Parliament and of the Council as regards an
     exemption for the use of cadmium in certain radiation tolerant video camera tubes
                                  (Text with EEA relevance)
EN                                                                                EN
 ---pagebreak---                                       EXPLANATORY MEMORANDUM
   1.        CONTEXT OF THE DELEGATED ACT
   This Commission Delegated Directive amends, for the purpose of adapting to technical
   progress, Annex IV of Directive 2011/65/EU of the European Parliament and of the Council
   on the restriction of the use of certain hazardous substances in electrical and electronic
   equipment (recast)1 (RoHS 2) as regards an exemption for specific applications containing
   cadmium.
   RoHS 2 restricts the use of certain hazardous substances in electrical and electronic
   equipment, as provided for in its Article 4. It entered into force on 21 July 2011.
   The currently restricted substances as listed in Annex II to RoHS 2 are the following: lead,
   mercury, cadmium, hexavalent chromium, polybrominated biphenyls (PBB), polybrominated
   diphenyl ethers (PBDE), bis(2-ethylhexyl) phthalate (DEHP), butyl benzyl phthalate (BBP),
   dibutyl phthalate (DBP) and diisobutyl phthalate (DIBP). Annexes III and IV to RoHS 2 list
   the materials and components of electrical and electronic equipment (EEE) for specific
   applications exempted from the substance restriction of RoHS 2 Article 4(1).
   Article 5 provides for the adaptation to scientific and technical progress (inclusion, renewal,
   amendments and revoking of exemptions) of Annexes III and IV. Pursuant to Article 5(1)(a),
   exemptions are to be included in Annexes III and IV only if such inclusion does not weaken
   the environmental and health protection afforded by Regulation (EC) No 1907/20062 and
   where any of the following conditions is fulfilled: their elimination or substitution via design
   changes or materials and components which do not require any of the materials or substances
   listed in Annex II is scientifically or technically impracticable; the reliability of substitutes is
   not ensured; or the total negative environmental, health and consumer safety impacts caused
   by substitution are likely to outweigh the total environmental, health and consumer safety
   benefits thereof.
   Furthermore, Article 5(1) provides that the European Commission (the Commission) shall
   include materials and components of EEE for specific applications in the lists in Annexes III
   and IV by means of individual delegated acts in accordance with Article 20. Article 5(3) and
   Annex V establish the procedure for submitting applications for granting, renewing, or
   revoking an exemption.
   2.        CONSULTATIONS PRIOR TO THE ADOPTION OF THE ACT
   Since the publication of RoHS 2, the Commission has received numerous3 requests from
   economic operators, according to the provisions in Article 5(3) and Annex V, for both
   granting new and renewing existing exemptions.
   The Commission received a request for a new exemption for use of cadmium in video
   cameras designed for use in environments exposed to ionising radiation with a dose rate in
   excess of 100 Gy/hour and a total dose in excess of 100 kGy with a centre resolution greater
   than 450 TV Lines in December 2015 (request no. A-2016).
   With a view to evaluating the application for exemption, the Commission launched a study to
   carry out the required technical and scientific assessment, including an eight-week online
   1
            OJ L 174, 1.7.2011, p. 88.
   2
            OJ L 396, 30.12.2006, p. 1.
   3
            The list is given at: http://ec.europa.eu/environment/waste/rohs_eee/adaptation_en.htm
EN                                                           1                                          EN
 ---pagebreak---    open-ended stakeholder consultation4 on the application. One contribution was made to the
   stakeholder consultation.
   The final report containing the assessment of the application was published5; stakeholders
   were notified.
   Subsequently, the Commission consulted the Member States expert group for delegated acts
   under RoHS 2 during an expert meeting on 22 September 2017. The experts agreed with the
   draft presented, with a large group of experts remaining silent. In accordance with the Better
   Regulation Guidelines, the draft Delegated Directive was published on the Better Regulation
   Portal for a four-week public feedback period. No comments were received. All necessary
   steps relating to exemptions from the substance restriction pursuant to Articles 5(3) to 5(7)
   have been performed.6 The Council and the European Parliament were notified of all
   activities.
   The final report highlighted in particular the following technical information and assessment:
             Radiation tolerant video cameras are used for inspection and general surveillance
              activities in nuclear power plants as well as in nuclear fuel waste processing plants.
              To withstand high radiation levels specific to these facilities while reaching a
              sufficient level of optical performance, specialised camera tubes with a layer containing
              58.7% of cadmium by weight are necessary.
             Currently, there are no cadmium-free alternatives available on the market which
              would provide the necessary combination of optical performance and sufficient radiation
              resistance.
   The applications concerned by the exemption request fall in category 97; the exemption
   request therefore relates to Annex IV of Directive 2011/65/EU. The evaluation results show
   the specific exemption would not weaken the environmental and health protection afforded by
   Regulation (EC) No 1907/2006 (REACH), in accordance with Article 5 of Directive
   2011/65/EU. Furthermore, at least one of the relevant criteria specified in Article 5(1)(a) is
   met by the exemption request: Since for the applications concerned, no reliable alternatives
   are available today or are likely to come on the market soon, granting the exemption with the
   maximum validity period of seven years is justified. As reliable substitutes are not yet
   available, no negative socioeconomic impacts of substitution are to be anticipated for this
   period. The granted validity period is also not expected to have adverse impacts on
   innovation.
   3.         LEGAL ELEMENTS OF THE DELEGATED ACT
   The Delegated Directive grants an exemption from the restrictions in Article 4(1), to be listed
   in Annex IV of Directive 2011/65/EU, for the use of cadmium in specific applications.
   4
            Consultation period: from 28 October until 22 December 2016.
   5
           https://publications.europa.eu/en/publication-detail/-/publication/e8c8a008-3e99-11e7-a08e-
           01aa75ed71a1
   6
            A list of the required administrative steps is available on the Commission website. Current stage of the
            procedure can be viewed for each draft delegated act in the Interinstitutional Registry of Delegated Acts
            at https://webgate.ec.europa.eu/regdel/#/home.
   7
            The categories listed in Annex I of Directive 2011/65/EU are namely: 1. Large household appliances; 2.
            Small household appliances; 3. IT and telecommunications equipment; 4. Consumer equipment; 5.
            Lighting equipment; 6. Electrical and electronic tools; 7. Toys, leisure and sports equipment; 8. Medical
            devices; 9. Monitoring and control instruments including industrial monitoring and control instruments;
            10. Automatic dispensers; 11. Other EEE not covered by any of the categories above.
EN                                                           2                                                        EN
 ---pagebreak---    The instrument is a Delegated Directive, as provided for by Directive 2011/65/EU, and in
   particular meeting the relevant requirements of Article 5(1)(a) thereof.
   The objective of the Delegated Directive is to contribute to the protection of human health and
   the environment and approximate the provisions for the functioning of the internal market in
   the field of electrical and electronic equipment, by allowing the use of otherwise banned
   substances for specific applications, in line with the provisions and under the conditions of
   RoHS 2 and the therein established procedure for the adaptation of the Annexes III and IV to
   scientific and technical progress.
   In accordance with the principle of proportionality, the measure does not go beyond what is
   necessary to achieve its objective.
   The proposal has no implications for the EU budget.
EN                                                3                                                EN
 ---pagebreak---                        COMMISSION DELEGATED DIRECTIVE (EU) .../…
                                              of 17.12.2019
    amending, for the purposes of adapting to scientific and technical progress, Annex IV to
       Directive 2011/65/EU of the European Parliament and of the Council as regards an
       exemption for the use of cadmium in certain radiation tolerant video camera tubes
                                      (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 equipment8, and in particular Article 5(1)(a) thereof,
   Whereas:
   (1)     Directive 2011/65/EU requires Member States to ensure that electrical and electronic
           equipment placed on the market does not contain the hazardous substances listed in
           Annex II to that Directive. That restriction does not apply to certain exempted
           applications which are specific to medical devices and monitoring and control
           instruments and are listed in Annex IV to that Directive.
   (2)     The categories of electrical and electronic equipment to which Directive 2011/65/EU
           applies are listed in Annex I to that Directive.
   (3)     Cadmium is a restricted substance listed in Annex II to Directive 2011/65/EU.
   (4)     On 3 December 2015, the Commission received an application made in accordance
           with Article 5(3) of Directive 2011/65/EU for an exemption to be listed in Annex IV
           to that Directive, for the use of cadmium in certain radiation tolerant video camera
           tubes ("the requested exemption").
   (5)     The evaluation of the request included stakeholder consultations in accordance with
           Article 5(7) of Directive 2011/65/EU.
   (6)     Cadmium in video camera tubes is necessary to achieve satisfactory radiation
           tolerance and optical performance of video cameras operating in environments with
           high radiation exposure, such as nuclear power plants and nuclear waste reprocessing
           facilities.
   (7)     Currently, there are no cadmium-free alternatives available on the market which would
           provide the necessary combination of optical performance and sufficient radiation
           resistance.
   (8)     Due to the lack of alternatives, a substitution or elimination of cadmium is
           scientifically and technically impracticable for certain video camera tubes. The
           exemption is consistent with Regulation (EC) No 1907/2006 of the European
   8
           OJ L 174, 1.7.2011, p. 88.
EN                                                  4                                            EN
 ---pagebreak---            Parliament and of the Council9 and thus does not weaken the environmental and health
           protection afforded by it.
   (9)     It is, therefore, appropriate to grant the requested exemption by including the
           applications covered by it in Annex IV to Directive 2011/65/EU with respect to
           electrical and electronic equipment of category 9.
   (10)    The requested exemption should be granted for a duration of 7 years starting from [the
           date of the publication of this Directive in the Official Journal], in accordance with the
           first subparagraph of Article 5(2) of Directive 2011/65/EU. In view of the results of
           the ongoing efforts to find a reliable substitution, the duration of the exemption is
           unlikely to have adverse impacts on innovation.
   (11)    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 adopt and publish, by [the last day of the 5th month after the
             date of entry into force of this Directive] 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 [the last day of the 5th month after the date of
             entry into force of this Directive + 1 day].
             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.
   9
           Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006
           concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) and
           establishing a European Chemicals Agency (OJ L 396, 30.12.2006, p. 1).
EN                                                      5                                                  EN
 ---pagebreak---                                              Article 4
   This Directive is addressed to the Member States.
   Done at Brussels, 17.12.2019
                                              For the Commission
                                              The President
                                              Ursula von der LEYEN
EN                                               6                 EN
 ---documentbreak---                             EUROPEAN
                            COMMISSION
                                                     Brussels, 17.12.2019
                                                     C(2019) 9071 final
                                                     ANNEX
                                          ANNEX
                                              to
                              Commission Delegated Directive
   amending, for the purposes of adapting to scientific and technical progress, Annex IV to
     Directive 2011/65/EU of the European Parliament and of the Council as regards an
     exemption for the use of cadmium in certain radiation tolerant video camera tubes
EN                                                                                EN
 ---pagebreak---                                               ANNEX
   In Annex IV to Directive 2011/65/EU, the following entry 44 is added:
   "44.        Cadmium in radiation tolerant video camera tubes designed for cameras with a
               centre resolution greater than 450 TV lines which are used in environments with
               ionising radiation exposure exceeding 100 Gy/hour and a total dose in excess of
               100kGy.
               Applies to category 9. Expires on [the last day of the 84th month after the
               publication of this Directive in the Official Journal]."
EN                                                1                                            EN


title: COMMISSION DELEGATED DIRECTIVE (EU) .../… amending Annex II to Directive 2000/53/EC of the European Parliament and of the Council on end-of-life vehicles as regards certain exemptions for lead and lead compounds in components

text:
                          EUROPEAN
                          COMMISSION
                                                   Brussels, 17.12.2019
                                                   C(2019) 9121 final
               COMMISSION DELEGATED DIRECTIVE (EU) .../…
                                       of 17.12.2019
   amending Annex II to Directive 2000/53/EC of the European Parliament and of the
     Council on end-of-life vehicles as regards certain exemptions for lead and lead
                               compounds in components
                                (Text with EEA relevance)
EN                                                                                EN
 ---pagebreak---                                     EXPLANATORY MEMORANDUM
   CONTEXT OF THE DELEGATED ACT
   This Commission Delegated Directive amends, for the purpose of adapting to technical and
   scientific progress, Annex II of Directive 2000/53/EC of the European Parliament and of the
   Council on the end-of-life vehicles1 (ELV) as regards four exemptions for specific
   applications containing lead. The draft delegated act is the result of the process under ELV
   Directive to amend Annex II according to technical and scientific progress, in accordance
   with the procedure established in the Article 4(2), point (b) of the ELV Directive and under
   Article 1(1) of Directive (EU) 2018/849 amending Directives 2000/53/EC on end-of-life
   vehicles, 2006/66/EC on batteries and accumulators and waste batteries and accumulators,
   and 2012/19/EU on electrical and electronic equipment2.
   The ELV Directive restricts the use of certain hazardous substances in materials and
   components of vehicles put on the market after 1 July 2003, as provided for in its Article
   4(2)(a). Currently, vehicles and parts for vehicles placed on the Union market shall not
   contain lead, mercury, cadmium and hexavalent chromium3.
   Annex II to the ELV Directive lists the materials and components of vehicles for specific
   applications that are exempted from the substance restriction of ELV Article 4(2).
   Article 4(2)(b) provides that Annex II shall be amended on a regular basis, according to
   technical and scientific progress. Furthermore, Article 1 of Directive (EU) 2018/849
   amending Article 4(2), point (b) of the ELV Directive provides that such amendment of
   Annex II shall be done by means of delegated acts.
   CONSULTATIONS PRIOR TO THE ADOPTION OF THE ACT
   The current exemptions 8(e), 8(f)(b), 8(g) and 8(j) in Annex II permit the use of lead in
   solders. Annex II to the ELV Directive4 provides that exemptions 8(e), 8(f)(b) and 8(g) shall
   be reviewed in 2019 and exemption 8(j) has been re-assessed in view of the latest information
   on technical difficulties in this area.
   With a view to evaluating these exemptions, the Commission launched a study to carry out
   the required technical and scientific assessment5, including an eight-week online open-ended
   stakeholder consultation.
   For exemption 8(e) it was assessed the progress achieved on component and material level
   since the last review in 2015/2016 (7th amendment of Annex II), in particular whether the
   substitution or elimination of lead is still technically and scientifically impracticable for attach
   of small dies. Furthermore, available lead-free solutions were investigated as to whether and
   how far they can be or are already qualified for use in automotive applications. The
   information available by the stakeholders suggests that the use of lead is still unavoidable. A
   review is proposed in 2024.
   For exemption 8(f)(b) the assessment showed that lead-free compliant pin connector systems
   (CoPICS) are increasingly available. However, as some additional time is needed to
   1
           OJ L 269, 21.10.2000, p.34.
   2
           OJ L 150, 14.6.2018, p. 93
   3
        See Article 4(2)(a) of the ELV Directive.
   4
           Commission Directive (EU) 2017/2096 amending Annex II to Directive 2000/53/EC of the European
           Parliament and the Council on end-of-life vehicles, OJ L 299, 16.11.2017, p. 24
   5
           http://ec.europa.eu/environment/waste/elv/events_en.htm.
EN                                                       1                                               EN
 ---pagebreak---    accommodate the automotive industry’s responsibility for the safety of their products, the
   exemption will be ended by 31 December 2023.
   Exemption 8(g) is relevant for all automotive models being designed, produced and currently
   on the market. Some examples of applications used in vehicles are electronic stability control
   system, advance emergency braking systems, distance control, lane departure warning system,
   frontal projection systems, pedestrian protection, hydrogen and hybrid cars, car radios, vision
   systems, navigation. The report also evaluated whether the new wording of exemption 15(a)
   of Annex III of Directive 2011/65/EU on the restriction of the use of certain hazardous
   substances in electrical and electronic equipment6 (RoHS Directive) can be adopted for
   exemption 8(g). However, a transition period is needed for the flip chip on lead frame (FCOL)
   to be adapted. Subsequently, the new wording granting an exemption with a more narrow
   scope, in alignment with the wording of exemption 15 of RoHS Annex III is introduced as
   from 1 October 2022. Until this time, the existing exemption remains valid. A review is
   proposed in 2024.
   For exemption 8(j) there are lead-free solutions. Although it cannot be excluded that lead
   could be replaced, there are still unsatisfactory testing results for some applications.
   Subsequently, in line with the EU policies and aquis, the existing exemption 8(j) expires by
   31 December 2019 and the new exemption 8(k) with a more narrow scope will be applicable
   until 31 December 2023.
   The final report containing the assessment of the exemptions was published.7
   The Commission consulted the Member States expert group for delegated acts under ELV
   during an expert meeting on 8 March 2019. The evaluation challenges, in particular for
   exemption 8(j) were discussed and the views of the Member States were collected. The
   Commission consulted the Member States expert group for delegated acts under ELV again
   on 3 September 2019 and their views were collected.
   The Council and the European Parliament were notified of the draft delegated act.
   LEGAL ELEMENTS OF THE DELEGATED ACT
   The Delegated Directive grants an exemption from the restrictions in Article 4(1), to be listed
   in Annex II of Directive 2000/53/EC, for the use of lead in specific applications.
   The instrument is a Delegated Directive, as provided for by Directive (EU) 2018/849, and in
   particular meeting the relevant requirements of Article 1(1)(b) thereof.
   On the basis of the information collected, the Commission proposes the following:
   for exemptions 8(e) the use of lead remains unavoidable, therefore, the use of lead will be
   prolonged and a review date in 2024 is proposed;
   for exemption 8(g) the use of lead remains unavoidable, therefore the use of lead will be
   prolonged. However, it is proposed to keep the current wording until 30 September 2022 to
   allow the automotive industry to transition to the scope changes and a new exemption with a
   more narrow scope is proposed as from 1 October 2022 with a review date in 2024;
   for exemption 8(f)(b) the use of lead can be avoided, therefore, it is proposed to end the
   exemption for the use of lead;
   6
           OJ L 174, 1.7.2011, p. 88
   7
           https://ec.europa.eu/environment/waste/elv/events_en.htm
EN                                                       2                                         EN
 ---pagebreak---    exemption 8(j) gives exemption for the use of lead in solders for soldering of laminated
   glazing for vehicles type approved before 1 January 2020 and spare parts for these vehicles.
   For exemption 8(j) the use of lead can be avoided. However, there is no certainty that suitable
   alternatives to the use of lead exist at this time for some applications. It is therefore
   appropriate to narrow the scope of the exemption, with a limited continuation, as follows:
   8(k). Soldering of heating applications with 0.5A or more of heat current per related solder
   joint to single panes of laminated glazings not exceeding wall thickness of 2.1 mm. This
   exemption does not cover soldering to contacts embedded in the intermediate polymer for
   vehicles type approved before 1 January 2024 and spare parts for these vehicles.
   In accordance with the principle of proportionality, the measure does not go beyond what is
   necessary to achieve its objective.
   The proposal has no implications for the EU budget.
EN                                                3                                                EN
 ---pagebreak---                       COMMISSION DELEGATED DIRECTIVE (EU) .../…
                                              of 17.12.2019
       amending Annex II to Directive 2000/53/EC of the European Parliament and of the
         Council on end-of-life vehicles as regards certain exemptions for lead and lead
                                      compounds in components
                                       (Text with EEA relevance)
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Directive 2000/53/EC of the European Parliament and of the Council of
   18 September 2000 on end-of-life vehicles8, and in particular Article 4(2)(b) thereof,
   Whereas:
   (1)    Pursuant to Article 4(2)(a) of Directive 2000/53/EC, Member States are to prohibit the
          use of lead, mercury, cadmium and hexavalent chromium in materials and components
          of vehicles put on the market after 1 July 2003.
   (2)    Annex II to Directive 2000/53/EC lists vehicle materials and components exempt from
          the prohibition pursuant to Article 4(2)(a) thereof. Pursuant to Annex II, exemptions
          8(e), 8(f)(b) and 8(g) are to be reviewed in 2019. Exemption 8(j) also needs to be re-
          assessed in view of the latest information on technical and scientific progress.
   (3)    An assessment of exemptions 8(e) and 8(g) in view of that information led to the
          conclusion that there are currently no suitable alternatives to the use of lead for the
          materials and components covered by those exemptions. A date for a new review of
          those exemptions should therefore be set. Exemption 8(g), however, should be further
          specified with a more narrow scope. In order to allow the automotive industry to
          adapt to those changes, the current scope of exemption 8(g) should be maintained for
          vehicles of a type approved before 1 October 2022, while the narrower scope of that
          exemption should apply for vehicles of a type approved from that date.
   (4)    The assessment of exemption 8(f)(b) leads to the conclusion that the use of lead in the
          applications covered by that exemption should not be prolonged because there are
          alternatives to the use of lead in those applications.
   (5)    The assessment of exemption 8(j) which gives an exemption to the use of lead in
          solders for soldering of laminated glazing led to the conclusion that, for some
          applications, there are alternatives to the use of lead in solders for soldering of
          laminated glazing. However, there are some glass panes and applications for which
          there is no certainty that suitable alternatives to the use of lead exist at this time. It is
          therefore appropriate to lay down a new, more limited, exemption 8(k) for those glass
          panes and applications.
   (6)    Exemption 8(j) applies only with respect to vehicles of a type approved before 1
          January 2020. In order to ensure that the use of lead continues to be exempted for
   8
         OJ L 269, 21.10.2000, p. 34.
EN                                                  4                                                   EN
 ---pagebreak---            those glass panes and applications for which there is no certainty that suitable
           alternatives to the use of lead exist at this time, it is necessary for the new exemption
           8(k) to apply as soon as possible. Therefore, this Directive should enter into force as a
           matter of urgency.
   (7)     Directive 2000/53/EC should therefore be amended accordingly.
   HAS ADOPTED THIS DIRECTIVE:
                                                Article 1
   Annex II to Directive 2000/53/EC is amended as set out in the Annex to this Directive.
                                                Article 2
   1.        Member States shall adopt and publish by (xxx one month after publication) 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.
   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, 17.12.2019
                                                  For the Commission
                                                  The President
                                                  Ursula VON DER LEYEN
EN                                                   5                                                EN
 ---documentbreak---                           EUROPEAN
                          COMMISSION
                                                   Brussels, 17.12.2019
                                                   C(2019) 9121 final
                                                   ANNEX
                                         ANNEX
                                            to
                            Commission Delegated Directive
   amending Annex II to Directive 2000/53/EC of the European Parliament and of the
     Council on end-of-life vehicles as regards certain exemptions for lead and lead
                               compounds in components
EN                                                                                EN
 ---pagebreak---                                                   ANNEX
   Annex II to Directive 2000/53/EC is amended as follows:
   (1)    entry 8(e) is replaced by the following:
   8(e). Lead in high melting temperature type                    (2)          X
   solders (i.e. lead-based alloys containing
   85 % by weight or more lead)
   (2)      entry 8(f)(b) is replaced by the following:
   8(f)(b). Lead in compliant pin connector             Vehicles type-         X
   systems other than the mating area of vehicle        approved before
   harness connectors                                   1 January 2024 and
                                                        spare parts for these
                                                        vehicles
   (3)      entry 8(g) is replaced by the following:
   8(g)(i). Lead in solders to complete a viable        Vehicles type          X
   electrical connection between semiconductor          approved before 1
   die and carrier within integrated circuit flip       October 2022 and
   chip packages                                        spare parts for these
                                                        vehicles
   8(g)(ii). Lead in solders to complete a viable                 (2)          X
   electrical      connection       between       the   Valid for vehicles
   semiconductor die and the carrier within             type-approved from
   integrated circuit flip chip packages where          1 October 2022 and
   that electrical connection consists of any of        spare parts for these
   the following:                                       vehicles
   (i)    a semiconductor technology node of 90
          nm or larger;
   (ii) a single die of 300 mm₂ or larger in
          any semiconductor technology node;
   (iii) stacked die packages with dies of
          300 mm₂ or larger, or silicon
          interposers of 300 mm₂ or larger.
   (4)      the following entry 8(k) is inserted:
   8(k). Soldering of heating applications with         Vehicles          type X(4)
   0,5A or more of heat current per related             approved        before
   solder joint to single panes of laminated            1 January 2024 and
   glazings not exceeding wall thickness of             spare parts for these
   2,1 mm. This exemption does not cover                vehicles
   soldering to contacts embedded in the
   intermediate polymer
EN                                                    1                             EN


title: COMMISSION DELEGATED DIRECTIVE (EU) .../… amending, for the purposes of adapting to scientific and technical progress, Annex III to Directive 2011/65/EU of the European Parliament and of the Council as regards an exemption for lead in solders and termination finishes used in certain hand-held combustion engines

text:
                            EUROPEAN
                            COMMISSION
                                                     Brussels, 17.12.2019
                                                     C(2019) 9066 final
                  COMMISSION DELEGATED DIRECTIVE (EU) .../…
                                        of 17.12.2019
   amending, for the purposes of adapting to scientific and technical progress, Annex III to
     Directive 2011/65/EU of the European Parliament and of the Council as regards an
      exemption for lead in solders and termination finishes used in certain hand-held
                                     combustion engines
                                  (Text with EEA relevance)
EN                                                                                EN
 ---pagebreak---                                      EXPLANATORY MEMORANDUM
   1.       CONTEXT OF THE DELEGATED ACT
   This Commission Delegated Directive amends, for the purpose of adapting to technical
   progress, Annex III of Directive 2011/65/EU of the European Parliament and of the Council
   on the restriction of the use of certain hazardous substances in electrical and electronic
   equipment (recast)1 (RoHS 2) as regards an exemption for specific applications containing
   lead.
   RoHS 2 restricts the use of certain hazardous substances in electrical and electronic
   equipment, as provided for in its Article 4. It entered into force on 21 July 2011.
   The restricted substances are listed in Annex II to RoHS 2. While the restrictions of lead,
   mercury, cadmium, hexavalent chromium, polybrominated biphenyls, and polybrominated
   diphenyl ethers are in force to date, the restrictions of bis(2-ethylhexyl) phthalate (DEHP),
   butyl benzyl phthalate (BBP), dibutyl phthalate (DBP), diisobutyl phthalate (DIBP) shall
   apply from 22 July 2019 or later. Annexes III and IV to RoHS 2 list the materials and
   components of electrical and electronic equipment (EEE) for specific applications exempted
   from the substance restriction of RoHS 2 Article 4(1).
   Article 5 makes provision for the adaptation to scientific and technical progress (inclusion,
   renewal, amendments and revoking of exemptions) of Annexes III and IV. Pursuant to
   Article 5(1)(a), exemptions are to be included in Annexes III and IV only if such inclusion
   does not weaken the environmental and health protection afforded by
   Regulation (EC) No 1907/20062 and where any of the following conditions is fulfilled: their
   elimination or substitution via design changes or materials and components which do not
   require any of the materials or substances listed in Annex II is scientifically or technically
   impracticable; the reliability of substitutes is not ensured; or the total negative environmental,
   health and consumer safety impacts caused by substitution are likely to outweigh the total
   environmental, health and consumer safety benefits thereof.
   Furthermore, Article 5(1) provides that the European Commission (the Commission) shall
   include materials and components of EEE for specific applications in the lists in Annexes III
   and IV by means of individual delegated acts in accordance with Article 20. Article 5(3) and
   Annex V establish the procedure for submitting applications for granting, renewing, or
   revoking an exemption.
   2.       CONSULTATIONS PRIOR TO THE ADOPTION OF THE ACT
   Since the publication of RoHS 2, the Commission has received numerous 3 requests from
   economic operators, according to the provisions in Article 5(3) and Annex V, for both
   granting new and renewing existing exemptions.
   The current Annex III exemption 41 permits the use of lead in solders and termination
   finishes of electrical and electronic components and finishes of printed circuit boards used in
   ignition modules and other electrical and electronic engine control systems, which for
   technical reasons must be mounted directly on or in the crankcase or cylinder of hand-held
   combustion engines (classes SH:1, SH:2, SH:3 of Directive 97/68/EC of the European
   Parliament and of the Council). The Commission received one application for renewal of this
   1
           OJ L 174, 1.7.2011, p. 88.
   2
           OJ L 396, 30.12.2006, p. 1.
   3
           The list is given at: http://ec.europa.eu/environment/waste/rohs_eee/adaptation_en.htm
EN                                                          1                                         EN
 ---pagebreak---    exemption in June 2017 for categories 6 and 11. While exemption 41 had 31 December 2018
   as expiration date for categories 1 to 7 and 10, in line with the requirements of the RoHS
   Directive (Article 5(5), second subparagraph), it continues to apply until a decision on the
   renewal application is taken by the Commission.4
   With a view to evaluating the request for exemption, the Commission launched a study to
   carry out the required technical and scientific assessment, including a six-week online
   open-ended stakeholder consultation5 on the application. No contributions were received
   during the stakeholder consultation.
   The final report containing the assessment of the application was published6; stakeholders
   were notified.
   Subsequently, the Commission consulted the Member States expert group for delegated acts
   under RoHS 2 during an expert meeting on 29 October 2018. The experts agreed with the
   proposal presented, with a majority of silent members. In accordance with the Better
   Regulation Guidelines, the draft Delegated Directive was published on the Better Regulation
   Portal for a four-week public feedback period. One comment supporting the draft proposal
   was received. All applicable steps relating to exemptions from the substance restriction
   pursuant to Articles 5(3) to 5(7) have been performed.7 The Council and the European
   Parliament were notified of all activities.
   The final report highlighted in particular the following technical information and assessment:
            Lead is a common alloying element in solder material to control the melting point.
             The applicant has successfully tested alternative materials to replace the restricted
             substance. However, additional time is needed to confirm the reliability of the lead-
             free products.
            Currently, the reliability of lead-free alternatives available on the market is still to be
             confirmed in further testing.
   The evaluation results for categories 1 to 7, 10 and 11 show that the specific exemption would
   not weaken the environmental and health protection afforded by Regulation (EC)
   No 1907/2006 (REACH), in accordance with Article 5 of Directive 2011/65/EU.
   Furthermore, at least one of the relevant criteria specified in Article 5(1)(a) is met by the
   exemption request: Since for the applications concerned, no reliable alternatives are available
   today, granting the exemption with a validity period of 24 months after the publication of the
   delegated directive in the Official Journal is justified. As reliable substitutes are not yet
   available, no negative socioeconomic impacts of substitution are to be anticipated for this
   period. The granted validity period is also not expected to have adverse impacts on
   innovation.
   For categories 8 and 9, the existing exemption remains as per the validity periods set out in
   Article 5(2).
   4
           The categories listed in Annex I of Directive 2011/65/EU are namely: 1. Large household appliances; 2.
           Small household appliances; 3. IT and telecommunications equipment; 4. Consumer equipment; 5.
           Lighting equipment; 6. Electrical and electronic tools; 7. Toys, leisure and sports equipment; 8. Medical
           devices; 9. Monitoring and control instruments including industrial monitoring and control instruments;
           10. Automatic dispensers; 11. Other EEE not covered by any of the categories above.
   5
           Consultation period: from 20.10.2017 to 01.12.2017.
   6
           https://publications.europa.eu/en/publication-detail/-/publication/33a336f0-e0ef-11e8-b690-
           01aa75ed71a1/language-en/format-PDF/source-85019010 .
   7
           A list of the required administrative steps is available on the Commission website. Current stage of the
           procedure can be viewed for each draft delegated act in the Interinstitutional Registry of Delegated Acts
           at https://webgate.ec.europa.eu/regdel/#/home.
EN                                                          2                                                        EN
 ---pagebreak---    3.        LEGAL ELEMENTS OF THE DELEGATED ACT
   The Delegated Directive grants an exemption from the restrictions in Article 4(1), to be listed
   in Annex III of Directive 2011/65/EU, for the use of lead in specific applications.
   The instrument is a Delegated Directive, as provided for by Directive 2011/65/EU, and in
   particular meeting the relevant requirements of Article 5(1)(a) thereof.
   The objective of the Delegated Directive is to contribute to the protection of human health and
   the environment and approximate the provisions for the functioning of the internal market in
   the field of electrical and electronic equipment, by allowing the use of otherwise banned
   substances for specific applications, in line with the provisions and under the conditions of
   RoHS 2 and the therein established procedure for the adaptation of the Annexes III and IV to
   scientific and technical progress.
   In accordance with the principle of proportionality, the measure does not go beyond what is
   necessary to achieve its objective.
   The proposal has no implications for the EU budget.
EN                                                3                                                EN
 ---pagebreak---                         COMMISSION DELEGATED DIRECTIVE (EU) .../…
                                                    of 17.12.2019
   amending, for the purposes of adapting to scientific and technical progress, Annex III to
       Directive 2011/65/EU of the European Parliament and of the Council as regards an
        exemption for lead in solders and termination finishes used in certain hand-held
                                               combustion engines
                                            (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 equipment1, and in particular Article 5(1)(a) thereof,
   Whereas:
   (1)     Directive 2011/65/EU requires Member States to ensure that electrical and electronic
           equipment placed on the market does not contain the hazardous substances listed in
           Annex II to that Directive. That restriction does not apply to the exempted applications
           listed in Annex III to Directive 2011/65/EU.
   (2)     The categories of electrical and electronic equipment to which Directive 2011/65/EU
           applies are listed in Annex I to that Directive.
   (3)     Lead is a restricted substance listed in Annex II to Directive 2011/65/EU.
   (4)     By Delegated Directive (EU) 2014/72/EU2, the Commission granted an exemption for
           the use of lead in solders and termination finishes of electrical and electronic
           components and finishes of printed circuit boards used in ignition modules and other
           electrical and electronic engine control systems, which for technical reasons must be
           mounted directly on or in the crankcase or cylinder of hand-held combustion engines
           (classes SH:1, SH:2, SH:3 of Directive 97/68/EC of the European Parliament and of
           the Council3) (“the exemption”) by including those applications in Annex III to
           Directive 2011/65/EU. The exemption was to expire for categories 1 to 7 and 10 on 31
   1
           OJ L 174, 1.7.2011, p. 88.
   2
           Commission Delegated Directive 2014/72/EU of 13 March 2014 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 solders and termination finishes of electrical and
           electronic components and finishes of printed circuit boards used in ignition modules and other
           electrical and electronic engine control systems (OJ L 148, 20.5.2014, p. 78).
   3
           Directive 97/68/EC of the European Parliament and of the Council of 16 December 1997 on the
           approximation of the laws of the Member States relating to measures against the emission of gaseous
           and particulate pollutants from internal combustion engines to be installed in non-road mobile
           machinery (OJ L 59, 27.2.1998, p.1). Directive 97/68/EC has been repealed by Regulation (EU)
           2016/1628 of the European Parliament and of the Council of 14 September 2016 on requirements
           relating to gaseous and particulate pollutant emission limits and type-approval for internal combustion
           engines for non-road mobile machinery, amending Regulations (EU) No 1024/2012 and (EU) No
           167/2013, and amending and repealing Directive 97/68/EC (OJ L 252, 16.9.2016, p. 53).
EN                                                         4                                                       EN
 ---pagebreak---          December 2018, in accordance with the second subparagraph of Article 5(2) of that
         Directive.
   (5)   The Commission received an application for renewal of the exemption for categories 6
         and 11 (“the renewal request”) on 30 June 2017, that is within the time limit laid down
         in Article 5(5) of Directive 2011/65/EU. In accordance with that provision, the
         exemption remains valid until a decision on the renewal request has been adopted.
   (6)   The evaluation of the renewal request included stakeholder consultations in
         accordance with Article 5(7) of Directive 2011/65/EU.
   (7)   Lead is a common alloying element in solder material to control the melting point.
         Alternative materials to replace the restricted substance have been successfully tested.
         However, additional time is needed to confirm the reliability of the lead-free products.
   (8)   Currently, there are no lead-free alternatives available on the market which would
         provide sufficient level of reliability for the applications covered by the exemption.
   (9)   Due to the lack of reliable alternatives, a substitution or elimination of lead is currently
         scientifically and technically impracticable for certain hand-held combustion engines.
         It is, therefore, appropriate, to renew the exemption. The renewal of the exemption is
         consistent with Regulation (EC) No 1907/2006 of the European Parliament and of the
         Council4 and thus does not weaken the environmental and health protection afforded
         by it.
   (10)  The exemption for categories 1 to 7, 10 and 11 should be renewed until [the last day of
         the 24th month after the publication of this Directive in the Official Journal], in
         accordance with Article 4(3) and the first subparagraph of Article 5(2) of Directive
         2011/65/EU. In view of the results of the ongoing efforts to find a reliable substitution,
         the duration of the exemption is unlikely to have adverse impacts on innovation.
   (11)  For categories 8 and 9, the existing exemption remains valid as per the validity periods
         set out in the second subparagraph of Article 5(2) of Directive 2011/65/EU. For
         reasons of legal clarity, the dates of expiry should be specified in Annex III to that
         Directive.
   (12)  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 [the last day of the 12th month after the
           date of entry into force of this Directive] 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.
   4
         Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006
         concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) and
         establishing a European Chemicals Agency (OJ L 396, 30.12.2006, p. 1).
EN                                                    5                                                  EN
 ---pagebreak---             They shall apply those provisions from [the last day of the 12th month after the date
            of entry into force of this Directive + 1 day].
            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, 17.12.2019
                                                  For the Commission
                                                  The President
                                                  Ursula von der Leyen
EN                                                  6                                              EN
 ---documentbreak---                             EUROPEAN
                            COMMISSION
                                                     Brussels, 17.12.2019
                                                     C(2019) 9066 final
                                                     ANNEX
                                          ANNEX
                                              to
                              Commission Delegated Directive
   amending, for the purposes of adapting to scientific and technical progress, Annex III to
     Directive 2011/65/EU of the European Parliament and of the Council as regards an
      exemption for lead in solders and termination finishes used in certain hand-held
                                     combustion engines
EN                                                                                EN
 ---pagebreak---                                                 ANNEX
   In Annex III to Directive 2011/65/EU, entry 41 is replaced by the following:
   "41          Lead in solders and termination      Applies to all categories and expires on:
                finishes of electrical and
                                                          [the last day of the 24th month after
                electronic components and
                                                            the publication of this Delegated
                finishes of printed circuit boards
                                                            Directive in the Official Journal] for
                used in ignition modules and other
                                                            categories 1 to 7, 10 and 11;
                electrical and electronic engine
                control systems, which for                21 July 2021 for categories 8 and 9
                technical reasons must be                   other than in vitro diagnostic
                mounted directly on or in the               medical devices and industrial
                crankcase or cylinder of hand-              monitoring and control instruments;
                held combustion engines (classes
                                                          21 July 2023 for category 8 in vitro
                SH:1, SH:2, SH:3 of Directive
                                                            diagnostic medical devices;
                97/68/EC of the European
                Parliament and of the Council *)          21 July 2024 for category 9
                                                            industrial monitoring and control
                                                            instruments."
   * Directive 97/68/EC of the European Parliament and of the Council of 16 December 1997 on
   the approximation of the laws of the Member States relating to measures against the emission
   of gaseous and particulate pollutants from internal combustion engines to be installed in non-
   road mobile machinery (OJ L 59, 27.2.1998, p. 1).
EN                                                 1                                               EN