CELEX: 
Language: en
Date: 2019-12-17 00:00:00
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

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