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 IV to Directive 2011/65/EU of the European Parliament and of the Council as regards an exemption for lead in platinized platinum electrodes used for certain conductivity measurements

EUROPEAN
                           COMMISSION
                                                     Brussels, 17.12.2019
                                                     C(2019) 9061 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 in platinized platinum electrodes used for certain conductivity
                                        measurements
                                  (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.
   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 current Annex IV exemption 37 permits the use of lead in platinized platinum electrodes
   used for conductivity measurements where certain conditions apply. The Commission
   received one application for renewal of this exemption in June 2017. While exemption 37 had
   31 December 2018 as expiration date for categories 8 and 9, in line with the requirements of
   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---    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. 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-containing platinized platinum electrodes are used in specialised instruments
              for measurements which require certain measurement qualities such as wide range,
              high accuracy, or high reliability for high concentration of acid and alkali. The
              electrodes are applied among others in electrical conductivity meters used for
              inspecting and testing of water (river waters, seawater, drinking water, industrial
              effluents etc.).
             Currently, a substitution or elimination of lead in the applications concerned is still
              scientifically and technically impracticable.
   The evaluation results for categories 8 and 9 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, a renewal of the exemption for the maximum period of seven years until 31
   December 2025 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.
   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 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.
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 in platinized platinum electrodes used for certain conductivity
                                                measurements
                                          (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 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 2014/73/EU2, the Commission granted an exemption for the
           use of lead in platinized platinum electrodes used for conductivity measurements
           where certain conditions apply (“the exemption”), by including the relevant
           applications 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 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.
   1
           OJ L 174, 1.7.2011, p. 88.
   2
           Commission Delegated Directive 2014/73/EU of 13 March 2014 amending, for the purposes of
           adapting to technical progress, Annex IV to Directive 2011/65/EU of the European Parliament and of
           the Council as regards an exemption for lead in platinized platinum electrodes used for conductivity
           measurements (OJ L 148, 20.5.2014, p. 80).
EN                                                      4                                                       EN
 ---pagebreak---    (7)     Lead-containing platinized platinum electrodes are used in specialised instruments for
           measurements which require certain measurement qualities such as wide range, high
           accuracy, or high reliability for high concentration of acid and alkali.
   (8)     Due to the lack of reliable alternatives, a substitution or elimination of lead in the
           applications concerned is currently scientifically and technically impracticable for
           certain measurement instruments. The renewal of the exemption is consistent with
           Regulation (EC) No 1907/2006 of the European Parliament and of the Council3 and
           thus does not weaken the environmental and health protection afforded by it.
   (9)     It is, therefore, appropriate to grant the renewal of the exemption.
   (10)    The exemption should be renewed for the maximum duration of 7 years until 31
           December 2025, in accordance with Article 4(3) and 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.
   (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 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].
             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.
   3
           Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006
           concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) and
           establishing a European Chemicals Agency (OJ L 396, 30.12.2006, p. 1).
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
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 ---documentbreak---                            EUROPEAN
                           COMMISSION
                                                     Brussels, 17.12.2019
                                                     C(2019) 9061 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 in platinized platinum electrodes used for certain conductivity
                                       measurements
EN                                                                                          EN
 ---pagebreak---                                                ANNEX
   In Annex IV to Directive 2011/65/EU, entry 37 is replaced by the following:
   "37.        Lead in platinized platinum electrodes used for conductivity measurements
               where at least one of the following conditions applies:
               (a) wide-range measurements with a conductivity range covering more than 1
                   order of magnitude (e.g. range between 0,1 mS/m and 5 mS/m) in laboratory
                   applications for unknown concentrations;
               (b) measurements of solutions where an accuracy of +/– 1 % of the sample range
                   and where high corrosion resistance of the electrode are required for any of
                   the following:
                   (i) solutions with an acidity < pH 1;
                   (ii) solutions with an alkalinity > pH 13;
                   (iii) corrosive solutions containing halogen gas;
               (c) measurements of conductivities above 100 mS/m that must be performed
                   with portable instruments.
               Expires on 31 December 2025."
EN                                                  1                                           EN