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 mercury in fluorescent lamps for other general lighting and special purposes

text:
               EXPLANATORY MEMORANDUM

               1.CONTEXT OF THE DELEGATED ACT

               This Commission Delegated Directive amends, for the purpose of adapting to technical and scientific progress, Annex III to 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
                (the RoHS Directive). The amendment concerns an exemption for specified applications containing mercury in fluorescent lamps for other general lighting and special purposes.

               The RoHS Directive restricts the use of certain hazardous substances in electrical and electronic equipment (EEE), as specified in Article 4. Ten substances are currently restricted and listed in Annex II to the RoHS: 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 list EEE materials and components for specific applications that are exempt from the substance restrictions laid down in Article 4(1).

               Article 5 of the Directive provides for the adaptation of Annexes III and IV to scientific and technical progress, which can include granting, renewing and revoking  exemptions. Pursuant to Article 5(1)(a), exemptions are to be included in Annexes III and IV only if this does not weaken the environmental and health protection afforded by Regulation (EC) No 1907/2006 (REACH)
                  2
                and only if they meet any of the following conditions: (i) elimination or substituting the substance 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; (ii) the reliability of substitutes is not ensured; (iii) the total negative environmental, health and consumer safety impacts caused by substituting the substance are likely to outweigh the total environmental, health and consumer safety benefits thereof.

               Decisions on exemptions, and their duration, must also take into account the availability of substitutes and the socioeconomic impact of substitution. Decisions on the duration of exemptions must take into account any potential impact on innovation. Life-cycle thinking on the overall impacts of the exemption must be applied, where relevant.

               Article 5(1)(a) also specifies that, to include materials and components of EEE for specific applications listed in Annexes III and IV, the Commission must adopt  individual delegated acts. Article 5(3) and Annex V describe the procedure for submitting exemption-related applications.

               2.CONSULTATIONS PRIOR TO THE ADOPTION OF THE ACT

               The Commission received requests
                  3
                from economic operators to grant or renew exemptions under Article 5(3) and Annex V to the RoHS Directive.

               The current Annex III exemption 2(b)(4) permits the use of mercury in other fluorescent lamps for other general lighting and special purposes (e.g. induction lamps).

               The Commission received one application to renew this exemption on 15 January 2015. The applicant claimed that, due to a vast range of parameters relevant to lamps falling under exemption 2(b)(4), e.g. form, length or spectrum, these lamps cannot be easily replaced with light-emitting diodes (LED) alternatives.
                  4
                That application was renewed in January 2020, providing largely the same argumentation. In line with the requirements of the RoHS Directive (Article 5(5), second subparagraph), an exemption remains valid until the Commission takes a decision on the renewal application.

               To evaluate the applications to renew that exemption, the Commission launched a study in June 2015
                  5
               , concluded in 2016, to carry out the required technical and scientific assessment, including an eight-week online stakeholder consultation.
                  6
                Further to that study assessing the extensive technical and scientific data and contributions received, as documented in the study report, the Commission carried out two complementary studies/updates, including stakeholder involvement. The study published in 2019
                  7
                focused on the socioeconomic assessment and availability of substitutes, whilst an update based on recent figures and modelling was carried out in 2020
                  8
               . The final reports of the study and of the socioeconomic assessment update were published
                  9
               ; stakeholders were notified.

               The Commission consulted the Member State expert group for delegated acts under the RoHS Directive during the expert meetings of 1 September 2016, 29 October 2018 and 21 October 2019 to collect Member States’ views on an envisaged course of action in line with the conclusions of the evaluations. It carried out all the requisite procedural steps relating to exemptions from the substance restriction under Articles 5(3) to 5(7).
                  10
                The Council and the European Parliament were notified of all activities.

               The supporting study highlighted that:

               ·this exemption covers a wide range of lamps with different functions;

               ·data on the specific lamp types covered by this exemption is currently insufficient and information on the substitution of mercury in this broad range of applications is lacking. The current exemption should be extended for three years to allow industry to prepare more detailed information to justify the exemption for specific types of lamps that are understood to be covered by the term ‘other general lighting and special purposes’;

               ·there is sufficient information that substituting mercury in two specific applications covered by this exemption, namely (i) lamps emitting light in the non-visible spectrum and (ii) emergency lamps, is technically impracticable, hence the study recommended renewing the exemption for these applications for the maximum duration of five years.

               In conclusion, the scientific and technical assessments, including stakeholder consultations, detailed that the exemption criteria continue to be met with regard to exemption 2(b)(4) as reliable substitutes are not yet available. The evaluation results also showed that the exemption, as reviewed, would not weaken the environmental and health protection afforded by the REACH Regulation, in accordance with Article 5 of Directive 2011/65/EU.

               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. During the consultation on the draft act, three contributions were received. The points raised were considered and no amendment to the draft was deemed necessary.

               3.LEGAL ELEMENTS OF THE DELEGATED ACT

               The delegated directive renews exemption 2(b)(4) listed in Annex III to Directive 2011/65/EU for the use of mercury in fluorescent lamps for other general lighting and special purposes, by setting new validity periods, including for certain specified applications covered by that exemption.

               The Commission’s assessment, based on the supporting studies and consultations, concluded that the exemption request meets at least one of the relevant criteria laid down in Article 5(1)(a) of the RoHS Directive, that justifies extending the exemption: mercury cannot be reliably substituted in the lamp categories covered by this exemption.

               In summary, the conditions for the exemption are fulfilled, and the exemption under 2(b)(4) is to be renewed. The assessment also concluded that the scope of the exemption should be narrowed to further specified applications on one hand, and, on the other hand, to shorten the duration of the current broad exemption as follows: (I) to three years for other general lighting and special purposes lamps and to five years for (II) lamps emitting light in the non-visible spectrum and (III) emergency lamps.

               The expiry dates for this exemption are set in line with Article 5(2) (first subparagraph). The validity periods are not expected to have an adverse impact on innovation.

               The legal instrument is a delegated directive, which is in line with the enabling legal act, Directive 2011/65/EU, in particular with the delegation set out in Article 5(1) and 20 thereof.

               The objective of the delegated directive is to contribute to the protection of human health and the environment and to align 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, with the provisions and under the conditions of the RoHS and the procedure for adapting Annexes III and IV to scientific and technical progress.

               The delegated directive has no implications on the EU budget.

               COMMISSION DELEGATED DIRECTIVE (EU) .../…

               of 13.12.2021

               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 mercury in fluorescent lamps for other general lighting and special purposes

               (Text with EEA relevance)

               THE EUROPEAN COMMISSION,

               Having regard to the Treaty on the Functioning of the European Union,

               Having regard to Directive 2011/65/EU of the European Parliament and of the Council of 8 June 2011 on the restriction of the use of certain hazardous substances in electrical and electronic equipment
                  11
               , and in particular Article 5(1), point (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 listed in Annex III 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)Mercury is a restricted substance listed in Annex II to Directive 2011/65/EU.

               (4)By Decision 2010/571/EU
                  12
               , the Commission granted, among other things, an exemption for the use of mercury in other linear fluorescent lamps for other general lighting and special purposes (e.g. induction lamps)(‘the exemption’), which is now listed as exemption 2(b)(4) in Annex III to Directive 2011/65/EU .The exemption was to expire on 21 July 2016, in accordance with Article 5(2), second subparagraph, point (a), of that Directive.

               (5)The exemption covers an inhomogeneous group of lamps of different shapes, technologies, applications, and purposes. Mercury is used in the discharge tube, which is essential to convert electrical energy to light.

               (6)On 15 January 2015, the Commission received an application for renewal of the exemption (‘the renewal application’), that is within the time limit laid down in Article 5(5) of Directive 2011/65/EU, which was updated on 20 January 2020 by an additional renewal application. In accordance with Article 5(5) of that Directive, the exemption remains valid until a decision on the renewal application has been taken.

               (7)The evaluation of the renewal application, which took into account the availability of substitutes and the socioeconomic impact of substitution, concluded that the substitution or elimination of mercury in the applications concerned is currently technically impracticable. That evaluation included stakeholder consultations in accordance with Article 5(7) of Directive 2011/65/EU. The comments received during those consultations were made publicly available on a dedicated website.

               (8)The exemption is consistent with Regulation (EC) No 1907/2006 of the European Parliament and of the Council
                  13
                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 taking into account the general aim that exemptions from the restriction for certain specific materials or components should be limited in their scope and duration, in order to achieve a gradual phase-out of hazardous substances in EEE.

               (10)In order to allow for a timely reassessment of the availability of mercury-free replacement lamps for the wide variety of lamp types covered by this exemption, it is appropriate to grant the renewal of the exemption for a limited period of three years.  However, for specific lamp categories, namely lamps emitting light in the non-visible spectrum (new sub-entry 2(b)(4)-II of Annex III) and emergency lamps (new sub-entry 2(b)(4)-III of Annex III), there is sufficient information that substitution is technically impracticable in the next years and for those categories of lamps, a validity period of five years should be justified, in accordance with Article 5(2), first subparagraph, 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 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 sixth 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 sixth 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, 13.12.2021

                     For the Commission

                     The President
                     Ursula VON DER LEYEN

                     (1)

                        OJ L 174, 1.7.2011, p. 88.

                     (2)

                        OJ L 396, 30.12.2006, p. 1.

                     (3)

                        The list is available at:
                  https://ec.europa.eu/environment/waste/rohs_eee/adaptation_en.htm
                  .

                     (4)

                  https://rohs.exemptions.oeko.info/fileadmin/user_upload/RoHS_Pack_9/Exemption_2_b__34_/Lighting_Europe/2b4_LE_RoHS_Exemption__Req_Final.pdf
                   .

                     (5)

                        The final report of the study is available at
                  https://op.europa.eu/en/publication-detail/-/publication/a3fdcc8c-4273-11e6-af30-01aa75ed71a1
                  .

                     (6)

                        Consultation period: 21 August 2015 to 16 October 2015,
                  https://rohs.exemptions.oeko.info
                  .

                     (7)

                  https://rohs.exemptions.oeko.info/fileadmin/user_upload/reports/FWCW_RoHS_Lamps_SEA_20190729_Final.pdf

                     (8)

                     https://op.europa.eu/en/publication-detail/-/publication/f44f2383-dd0a-11ea-adf7-01aa75ed71a1/language-en/format-PDF/source-146144383

                  , starting on page 92.

                     (9)

                     https://ec.europa.eu/environment/waste/rohs_eee/studies_rohs1_en.htm
                     .

                     (10)

                        A list of the required administrative steps is available on the
                  Commission website
                  . The 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
                  .

                     (11)

                        OJ L 174, 1.7.2011, p. 88.

                     (12)

                        Commission Decision 2010/571/EU of 24 September 2010 amending, for the purposes of adapting to scientific and technical progress, the Annex to Directive 2002/95/EC of the European Parliament and of the Council as regards exemptions for applications containing lead, mercury, cadmium, hexavalent chromium, polybrominated biphenyls or polybrominated diphenyl ethers (OJ L 251, 25.9.2010, p. 28).

                     (13)

                        Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH),establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 396, 30.12.2006, p. 1).

    ---documentbreak---

               ANNEX

               In Annex III to Directive 2011/65/EU, entry 2(b)(4)  is replaced by the following:

                        Exemption

                        Scope and dates of applicability

                        ‘2(b)(4)- I

                        Lamps for other general lighting and special purposes (e.g. induction lamps): 15 mg

                        Expires on [PO: three years after the publication of the Delegated Directive in the Official Journal]

                        2(b)(4)- II

                        Lamps emitting mainly light in the ultraviolet spectrum: 15 mg

                        Expires on [PO: five years after the publication of the Delegated Directive in the Official Journal]

                        2(b)(4)- III

                        Emergency lamps: 15 mg

                        Expires on [five years after the publication of the Delegated Directive in the Official Journal]’


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 the use of mercury in double-capped linear fluorescent lamps for general lighting purposes

text:
               EXPLANATORY MEMORANDUM

               1.CONTEXT OF THE DELEGATED ACT

               This Commission Delegated Directive amends, for the purpose of adapting to technical and scientific progress, Annex III to 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
                (the RoHS Directive). The amendment concerns specified applications containing mercury in double-capped linear fluorescent lamps for general lighting purposes.

               The RoHS Directive restricts the use of certain hazardous substances in electrical and electronic equipment (EEE), as specified in Article 4. Ten substances are currently restricted and listed in Annex II to the Directive: 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 list EEE materials and components for specific applications that are exempt from the substance restrictions laid down in Article 4(1).

               Article 5 of the Directive provides for the adaptation of Annexes III and IV to scientific and technical progress, which can include granting, renewing or revoking exemptions. Pursuant to Article 5(1)(a), exemptions are to be included in Annexes III and IV only if this does not weaken the environmental and health protection afforded by Regulation (EC) No 1907/2006 (REACH)
                  2
                and only if they meet any of the following conditions: (i) elimination or substituting the substance 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; (ii) the reliability of substitutes is not ensured; (iii) the total negative environmental, health and consumer safety impacts caused by substituting the substance are likely to outweigh the total environmental, health and consumer safety benefits thereof.

               Decisions on exemptions, and their duration, must also take into account the availability of substitutes and the socioeconomic impact of substitution. Decisions on the duration of exemptions must take into account any potential impact on innovation. A life-cycle approach to assess the overall impacts of the exemption must be applied, where relevant.

               Article 5(1) also states that to include, or, where applicable, delete, materials and components of EEE for specific applications in the lists of Annexes III and IV, the Commission must adopt individual delegated acts. Article 5(3) and Annex V describe the procedure for submitting exemption-related applications.

               2.CONSULTATIONS PRIOR TO THE ADOPTION OF THE ACT

               The Commission received requests
                  3
                from economic operators to grant or renew exemptions under Article 5(3) and Annex V to the RoHS Directive.

               The current Annex III exemption 2(a) entries (1) to (5) permit the use of mercury in double-capped linear fluorescent lamps for general lighting purposes not exceeding the following values (per lamp):

               2(a) (1) Tri-band phosphor with normal lifetime and a tube diameter < 9 mm (e.g. T2): 4 mg;

               2(a) (2) Tri-band phosphor with normal lifetime and a tube diameter ≥ 9 mm and ≤ 17 mm (e.g. T5): 3 mg;

               2(a) (3) Tri-band phosphor with normal lifetime and a tube diameter > 17 mm and ≤ 28 mm (e.g. T8): 3,5 mg;

               2(a) (4) Tri-band phosphor with normal lifetime and a tube diameter > 28 mm (e.g. T12): 3,5 mg;

               2(a) (5) Tri-band phosphor with long lifetime (≥ 25 000 h): 5 mg.

               The Commission received two applications to renew this exemption in December 2014 and January 2015. One of the applications was renewed with additional information in January 2020. The applicants in essence claimed that substitutes for all the applications in question were not available. One applicant stated that, although mercury-free light-emitting diode (LED) alternatives were increasingly available on the EU market, they cannot always serve as a fully compatible replacement for the wide variety of LFL lamps for consumers and professional end users.
                  4
                The other applicant argued along the same lines.
                  5

               In line with the requirements of the RoHS Directive (Article 5(5), second subparagraph), an exemption remains valid until the Commission takes a decision on the renewal application.

               To evaluate the applications to renew that exemption, the Commission launched a study in June 2015
                  6
               , concluded in 2016, to carry out the required technical and scientific assessment, including an eight-week online stakeholder consultation.
                  7
                Further to that study assessing the extensive technical and scientific data and contributions received, as documented in the study report, the Commission carried out two complementary studies/updates, including stakeholder involvement. The study published in 2019
                  8
                focused on the socioeconomic assessment and on the availability of substitutes, whilst an update based on recent figures and modelling was carried out in 2020
                  9
               . The final reports of the study and of the socioeconomic assessment updates were published
                  10
               ; stakeholders were notified.

               The Commission consulted the Member State expert group for delegated acts under the RoHS Directive during the expert meetings of 1 September 2016, 29 October 2018 and 21 October 2019. In July 2020, the Commission also informed the Member State expert group via written consultation of the 2020 socioeconomic update and collected the Member States’ positions on a proposed course of action. It carried out all the requisite procedural steps relating to exemptions from the substances restriction under Article 5(3) to 5(7).
                  11
                The Council and the European Parliament were notified of all activities.

               The supporting study highlighted the following technical information and assessments:

               ·The 2015-2016 study concluded that reliable mercury-free substitutes are available on the European Union market. The study provided ample evidence that substituting mercury in the lamp categories covered by the exemption is scientifically and technically practicable.

               ·The 2019 and 2020 study updates focused on the availability of substitutes and the socioeconomic impact of substitution. The updates revealed that the total costs of substitution largely depend on the share of lamps available on the market as replacements and that the substitution costs would be relatively quickly offset by benefits generated by related energy savings. The 2020 socioeconomic assessment update showed that, overall, substituting mercury with LED alternatives in the lamp categories under assessment would avoid placing 2882 kg of mercury in lamps on the EU market.
                  12
                Overall, the premature generation of e-waste due to the need to rewire and replace lamps for certain lamp categories would be offset both by avoiding the use of mercury in the future and by generating substantial energy savings.
                  13
                In conclusion, the scientific and technical assessments, including stakeholder consultations, detailed that none of the exemption criteria are now met with regard to exemption 2(a)(1) to (5). The availability of substitutes has furthermore been documented and calculations based on the socioeconomic impact of substitution have shown to result in overall savings and in total environmental, health and consumer safety benefits.

               In conclusion, the scientific and technical assessments, including stakeholder consultations, detailed that none of the exemption criteria are now met with regard to exemption 2(a)(1) to (5). The availability of substitutes has been documented and calculations based on the socioeconomic impact of substitution have shown to result in overall savings and in environmental, health and consumer safety benefit.

               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. During the consultation on the draft act, 23 contributions were received. The points raised were considered and no amendment to the draft was deemed necessary.

               3.LEGAL ELEMENTS OF THE DELEGATED ACT

               On the basis of Article 5(1), the delegated directive revokes exemption 2(a) entries (1) to (5) listed in Annex III to Directive 2011/65/EU for the use of mercury in specified applications.

               The Commission’s assessment, based on the supporting studies and consultations, concluded that the exemption request does not meet any of the criteria laid down in Article 5(1)(a) of the RoHS Directive that justify extending the exemption: mercury can be substituted with reliable substitutes in the lamp categories covered by this exemption, this being scientifically and technically practicable, and evidence is provided that the total impact of substitution in environmental, health and consumer safety impacts largely outweigh any negative impacts. Substitution would not only avoid placing considerable quantities of mercury on the EU market, but would also generate energy savings and stimulate innovation
                  14
               . This assessment results from the most recent technical and scientific evidence and updated market information included in the above-mentioned supporting studies. In summary, the conditions for the exemption are no longer fulfilled, and entries 2(a)(1) to (5) are to be deleted, in accordance with Article 5 (1)(b).

               The expiry date for this exemption is set in line with Article 5(6) of the RoHS Directive which prescribes that, in the event an exemption is revoked, it shall expire at the earliest 12 months, and at the latest 18 months, after the date of that decision. For exemption 2(a) entries (1), (4) and (5), there are no particular elements that would justify setting a longer date than the earliest expiry date, 12 months after the date of the decision. For exemption entries 2(a) (2) (“T5 LFL lamps”) and (3) (“T8 LFL lamps”), however, a transition time of 18 months is proposed. This is the maximum possible transition period for a decision that revokes an exemption based on the assessment against the RoHS criteria and giving full consideration to the less advanced availability of substitutes and to the socioeconomic impact of substitution. Granting the maximum transition period possible also reflects the fact that this exemption applies to a high volume of lamps, and gives enough time to make the necessary arrangements for new mercury-containing lamps that may not be placed on the EU market after the expiry date.

               The legal instrument is a delegated directive, which is in line with the enabling legal act, Directive 2011/65/EU, in particular with the delegation set out in Articles 5(1) and 20 thereof. In line with common practice regarding delegated directives relating to RoHS exemptions, it sets a timeframe of six months after entry into force.

               The objective of the delegated directive is to contribute to the protection of human health and the environment and to align the provisions for the functioning of the internal market in the field of electrical and electronic equipment, by revoking an exemption for the use of otherwise banned substances for specific applications, with the provisions and under the conditions of the RoHS Directive and the procedure for adapting Annexes III and IV to scientific and technical progress.

               The delegated directive has no implications on the EU budget.

               COMMISSION DELEGATED DIRECTIVE (EU) .../…

               of 16.12.2021

               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 the use of mercury in double-capped linear fluorescent lamps for general lighting purposes

               (Text with EEA relevance)

               THE EUROPEAN COMMISSION,

               Having regard to the Treaty on the Functioning of the European Union,

               Having regard to Directive 2011/65/EU of the European Parliament and of the Council of 8 June 2011 on the restriction of the use of certain hazardous substances in electrical and electronic equipment
                  15
               , and in particular Article 5(1), point (b), 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 listed in Annex III to the 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)Mercury is a restricted substance listed in Annex II to Directive 2011/65/EU.

               (4)By Decision 2010/571/EU
                  16
               , the Commission granted, among other things, an exemption for the use of mercury in double-capped linear fluorescent lamps for general lighting purposes (‘the exemption’), which is now listed as exemption 2(a)(1), 2(a)(2), 2(a)(3), 2(a)(4) and 2(a)(5) in Annex III to Directive 2011/65/EU. The exemption was to expire on 21 July 2016, in accordance with Article 5(2), second subparagraph, point (a), of that Directive.

               (5)Mercury is used in double-capped linear fluorescent lamps for general lighting purposes to produce ultraviolet light, which is then converted into visible light by the fluorescent coating on the lamp.

               (6)On 19 December 2014 and 15 January 2015, the Commission received two applications for renewal of the exemption (‘the renewal applications’), that is within the time limit laid down in Article 5(5) of Directive 2011/65/EU, of which one was updated with a renewed application on 20 January 2020. In accordance with Article 5(5), second subparagraph, of Directive 2011/65/EU, the exemption remains valid until a decision on the renewal application has been taken.

               (7)The evaluation of the renewal applications, which took into account the availability of substitutes and the socioeconomic impact of substitution, concluded that sufficiently reliable mercury-free substitutes for the lamp types covered by the exemption have become available and that the substitution of mercury in these lamps is scientifically and technically practicable. Furthermore, that evaluation concluded that the benefits of substitution would clearly outweigh any negative impact.

               (8)The evaluation of the renewal applications included stakeholder consultations in accordance with Article 5(7) of Directive 2011/65/EU. The comments received during those consultations were made publicly available on a dedicated website.

               (9)As the conditions set out in Article 5(1), point (a), of Directive 2011/65/EU are no longer fulfilled, the renewal application should be rejected. Expiry dates for the exemption should be set in accordance with Article 5(6) of that Directive.

               (10)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 sixth 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 sixth 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, 16.12.2021

                     For the Commission

                     The President
                     Ursula VON DER LEYEN

                     (1)

                        OJ L 174, 1.7.2011, p. 88.

                     (2)

                        OJ L 396, 30.12.2006, p. 1.

                     (3)

                        The list is available at:
                  https://ec.europa.eu/environment/waste/rohs_eee/adaptation_en.htm
                  .

                     (4)

                        https://rohs.exemptions.oeko.info/fileadmin/user_upload/RoHS_Pack_9/Exemption_2_a__15_/
                  Lighting_Europe/2a1_LE_RoHS_Exemption__Req_Final.pdf

                     (5)

                        https://rohs.exemptions.oeko.info/fileadmin/user_upload/RoHS_Pack_9/Exemption_2_a__15_/
                  NARVA/01_02_a__2b3_4a.pdf

                     (6)

                        The final report of the study is available at
                  https://op.europa.eu/en/publication-detail/-/publication/a3fdcc8c-4273-11e6-af30-01aa75ed71a1
                  .

                     (7)

                        Consultation period: 21 August 2015 to 16 October 2015,
                  https://rohs.exemptions.oeko.info
                  .

                     (8)

                  https://rohs.exemptions.oeko.info/fileadmin/user_upload/reports/FWCW_RoHS_Lamps_SEA_20190729_Final.pdf

                     (9)

                     https://op.europa.eu/en/publication-detail/-/publication/f44f2383-dd0a-11ea-adf7-01aa75ed71a1/language-en/format-PDF/source-146144383

                  , starting on page 92.

                     (10)

                     https://ec.europa.eu/environment/waste/rohs_eee/studies_rohs1_en.htm
                     .

                     (11)

                        A list of the required administrative steps is available on the
                  Commission website
                  . The 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
                  .

                     (12)

                        The 2020 socioeconomic assessment update included compact fluorescent lamps non-integrated (CFLni), linear fluorescent lamps with a tube diameter 9-17 mm (e.g. T5) and 17-28 mm (e.g. T8).

                     (13)

                        Idem.

                     (14)

                        The products in scope are also regulated by Commission Regulation (EU) 2019/2020 of 1 October 2019 laying down ecodesign requirements for light sources and separate control gears that applies from 1 September 2021. Differently from Directive 2011/65/EU, the ecodesign legislation does not restrict substances in products but sets energy efficiency requirements to be respected in order for the products to be placed on the market. CFL with integrated control gear (CFLi) will not de facto be placed on the market from 1 September 2021 due to their non-compliance with these energy efficiency requirements. Commission Regulation (EU) 2019/2020 identifies mercury content as a significant environmental aspect in the lifecycle of a light source, but acknowledges that the use of hazardous substances, including mercury in light sources, is governed by Directive 2011/65/EU.

                     (15)

                        OJ L 174, 1.7.2011, p. 88.

                     (16)

                        Commission Decision 2010/571/EU of 24 September 2010 amending, for the purposes of adapting to scientific and technical progress, the Annex to Directive 2002/95/EC of the European Parliament and of the Council as regards exemptions for applications containing lead, mercury, cadmium, hexavalent chromium, polybrominated biphenyls or polybrominated diphenyl ethers (OJ L 251, 25.9.2010, p. 28).

    ---documentbreak---

               ANNEX

               In Annex III to Directive 2011/65/EU, entries 2(a), 2(a)(1), 2(a)(2), 2(a)(3), 2(a)(4) and 2(a)(5) are replaced by the following:

                        Exemption

                        Scope and dates of applicability

                        ‘2(a)

                        Mercury in double-capped linear fluorescent lamps for general lighting purposes not exceeding (per lamp):

                        2(a)(1)

                        Tri-band phosphor with normal lifetime and a tube diameter < 9 mm (e.g. T2): 4 mg

                        Expires on [PO: 12 months after the publication of the Delegated Directive in the Official Journal]

                        2(a)(2)

                        Tri-band phosphor with normal lifetime and a tube diameter ≥ 9 mm and ≤ 17 mm (e.g. T5): 3 mg

                        Expires on [PO: 18 months after the publication of the Delegated Directive in the Official Journal]

                        2(a)(3)

                        Tri-band phosphor with normal lifetime and a tube diameter > 17 mm and ≤ 28 mm (e.g. T8): 3,5  mg

                        Expires on [PO: 18 months after the adoption of the Delegated Directive ]

                        2(a)(4)

                        Tri-band phosphor with normal lifetime and a tube diameter > 28 mm (e.g. T12): 3,5 mg

                        Expires on [PO: 12 months after the publication of the Delegated Directive in the Official Journal]

                        2(a)(5)

                        Tri-band phosphor with long lifetime (≥ 25 000 h): 5 mg.

                        Expires on [PO: 12 months after the publication of the Delegated Directive in the Official Journal]’


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 lead in bismuth strontium calcium copper oxide superconductor cables and wires and lead in their electrical connections

text:
               EXPLANATORY MEMORANDUM

               1.CONTEXT OF THE DELEGATED ACT

               This Commission Delegated Directive amends, for the purpose of adapting to technical and scientific progress, Annex IV to 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 (‘the RoHS Directive’)
                  1
                as regards an exemption for specific applications containing lead.

               Article 4 of the RoHS Directive restricts the use of certain hazardous substances in electrical and electronic equipment (EEE). Currently, 10 substances are restricted and listed in Annex II to the Directive: 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 the RoHS Directive list the materials and components of EEE for specific applications exempted from the substance restrictions in Article 4(1) of the Directive. Article 5 provides for Annexes III and IV to be adapted to scientific and technical progress (on the granting, renewing and revoking of exemptions). Under Article 5(1)(a), exemptions are to be included in Annexes III and IV only if this does not weaken the environmental and health protection afforded by Regulation (EC) No 1907/2006 (REACH)
                  2
                and if any of the following conditions is fulfilled:

               –the elimination or substitution of the substance via design changes or materials and components that 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;

               –the total negative environmental, health and consumer safety impacts of substitution are likely to outweigh the total environmental, health and consumer safety benefits.

               Decisions on exemptions, and their duration, must take into account the availability of substitutes and the socio‑economic impact of substitution. Decisions on the duration of exemptions must take into account any potential impact on innovation. Life-cycle thinking on the overall impact of the exemption must apply, where relevant.

               Article 5(1) of the RoHS Directive provides for the Commission to include materials and components of EEE for specific applications in the lists in Annexes III and IV by means of individual delegated acts pursuant to Article 20. Article 5(3) and Annex V establish the procedure for submitting exemption applications.

               2.CONSULTATIONS PRIOR TO THE ADOPTION OF THE ACT

               The Commission receives numerous requests from economic operators to grant or renew exemptions according to Article 5(3) and Annex V to the RoHS Directive
                  3
               .

               On 25 March 2019, the Commission received one application for a new entry in Annex IV to the RoHS Directive. The requested exemption concerns the use of lead in superconducting material and the related electrical connections in specific devices.

               In August 2019, the Commission launched a study
                  4
                to evaluate how this new exemption was being applied and carry out the required technical and scientific assessment. The study, which included an eight-week public stakeholder consultation, finished in July 2020. Information about the consultation was provided on the project website
                  5
               , although no contributions were received in response to the consultation.

               The Commission consulted the Member State expert group for delegated acts under the RoHS Directive on 23 February 2021. Some experts agreed with the drafts that were presented, while many experts did not comment. The Commission carried out all the requisite procedural steps relating to exemptions from the restrictions on substances under Articles 5(3) to 5(7)
                  6
               , and the Council and the European Parliament were notified of all activities in this context.

               The technical and scientific assessment report highlighted that:

               ·Lead can be added to bismuth strontium calcium copper oxide material (lead-doped BSCCO). This material can be used in superconducting components like cables and wires which create an electromagnetic circuit for medical devices or (industrial) monitoring and control instruments (e.g. magnetic resonance imaging devices (MRI) or nuclear magnetic resonance (NMR) spectrometers). Tin-lead solder is used to connect these superconducting components.

               ·The addition of lead to BSCCO provides technical and functional advantages such as stronger magnetic fields and higher critical temperature, which cannot be achieved without the use of lead.

               ·For the connections, there is no other alternative material available for tin-lead solder with the same reliable properties (e.g. sufficient ductility and low electrical resistivity at low temperatures).

               ·The elimination or substitution of lead is scientifically and technically not practicable without loss of performance. Substituting or eliminating lead in the superconducting material and the related solders is not currently, or in the foreseeable future expected to be, scientifically or technically practicable.

               ·The technical and functional advantages can result in higher resolution images for medical diagnosis or for research and innovation, and they allow more stable operation of NMR or MRI. The total amount of lead placed on the market is expected to be around 15.5 kg per year.

               ·Lead-doped BSCCO will likely be used for stronger magnetic field strengths, whereas lead-free technology can be used to generate lower magnetic field strengths for less demanding conditions. Excluding lower field strengths from the scope of the exemption is not commensurate, as it would potentially limit innovation for lead-doped BSCCO (e.g. smaller devices) and the economically more favourable alternatives in the lower field strengths.

               3.LEGAL ELEMENTS OF THE DELEGATED ACT

               The evaluation results show that granting the exemption would not weaken the environmental and health protection afforded by the REACH Regulation, in accordance with Article 5 of Directive 2011/65/EU.

               One of the relevant criteria specified in Article 5(1)(a) is met, namely that the ‘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’.

               Therefore, the exemption is to be granted and an expiry date is to be set.

               The proposed act grants an exemption from the substance restrictions in Annex II to Directive 2011/65/EU, to be listed in Annex IV, for the use of lead in BSCCO superconductor cables and wires and in the related electrical connections.

               As no reliable substitutes are expected in the near future, it is appropriate to grant the exemption until 30 June 2027. The granted validity period is not expected to have adverse effects on innovation.

               The legal instrument is a delegated directive, as provided for in Directive 2011/65/EU and meeting the relevant requirements of Article 5(1)(a) of the Directive.

               The objective of the delegated directive is to help protect human health and the environment, and harmonise provisions for the functioning of the single market in the field of EEE, by allowing the use of otherwise banned substances for specific applications, in line with the RoHS Directive and the procedure established therein for adapting Annexes III and IV to the Directive to scientific and technical progress.

               The delegated directive has no implications for the EU budget.

               COMMISSION DELEGATED DIRECTIVE (EU) .../…

               of 12.5.2022

               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 lead in bismuth strontium calcium copper oxide superconductor cables and wires and lead in their electrical connections

               (Text with EEA relevance)

               THE EUROPEAN COMMISSION,

               Having regard to the Treaty on the Functioning of the European Union,

               Having regard to Directive 2011/65/EU of the European Parliament and of the Council of 8 June 2011 on the restriction of the use of certain hazardous substances in electrical and electronic equipment
                  7
               , and in particular Article 5(1), point (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 (EEE) 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)On 25 March 2019, 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 lead in bismuth strontium calcium copper oxide superconductor for use in cables and wires and lead in related electrical connections to other EEE components (‘the requested exemption’). Lead-doped BSCCO can be used to create superconducting magnetic circuits for medical devices and monitoring and control instruments.

               (5)The evaluation of the requested exemption included stakeholder consultations in accordance with Article 5(7) of Directive 2011/65/EU. The comments received during those consultations were made publicly available on a dedicated website.

               (6)Lead-containing solders are used to connect the superconducting wires and cables to other EEE components. There is currently no lead-free alternative available on the market that would provide a sufficient level of reliability for applications, where properties such as ductility and low electrical resistivity at low temperatures are required.

               (7)The evaluation of the requested exemption, which included a technical and scientific assessment study
                  8
               , concluded that the addition of lead to BSCCO provides technical and functional advantages that cannot be achieved without the use of lead. Those technical and functional advantages consist in higher resolution images for medical diagnosis or for research and innovation, and allow a more stable operation mode of the relevant applications.  The addition of lead to BSCCO makes it possible to produce more efficient and reliable equipment, which is beneficial for health care and innovation.

               (8) It is currently not possible to substitute or otherwise eliminate lead in the superconducting material and the related solders with the same technical performance, nor is it expected to be so in the foreseeable future. The requested exemption is consistent with Regulation (EC) No 1907/2006 of the European Parliament and of the Council
                  9
                and does not weaken the environmental and health protection afforded by it.

               (9)It is, therefore, appropriate to grant the requested exemption.

               (10)The technical advantages of the lead-doped BSCCO-material have the potential to promote improvements and innovation in medical diagnostics and in research. The duration of the exemption is unlikely to have adverse impacts on innovation. Therefore, it is appropriate to grant the exemption for an extensive validity period, in accordance with Article 5(2), first subparagraph, of Directive 2011/65/EU.

               (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 [OP please insert the date: 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 the text of those provisions to the Commission.

               They shall apply those provisions from [OP please insert the date: 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.

               Article 4

               This Directive is addressed to the Member States.

               Done at Brussels, 12.5.2022

                     For the Commission

                     The President
                     Ursula VON DER LEYEN

                     (1)

                        OJ L 174, 1.7.2011, p. 88.

                     (2)

                        Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) and establishing a European Chemicals Agency (OJ L 396, 30.12.2006, p. 1).

                     (3)

                        The list is available at
                  http://ec.europa.eu/environment/waste/rohs_eee/adaptation_en.htm
                  .

                     (4)

                        The final report from the study is available at
                  https://op.europa.eu/en/publication-detail/-/publication/f44f2383-dd0a-11ea-adf7-01aa75ed71a1/language-en/format-PDF/source-146144383
                  .

                     (5)

                        Consultation period: 3 December 2019 to 27 January 2020 (
                  https://rohs.exemptions.oeko.info/
                  ).

                     (6)

                        A list of the required administrative steps is available on the
                  Commission website
                  . The current stage of the procedure can be viewed for each draft delegated act in the Inter-institutional Registry of Delegated Acts at
                  https://webgate.ec.europa.eu/regdel/#/home
                  .

                     (7)

                        OJ L 174, 1.7.2011, p. 88.

                     (8)

                  Study to assess seven exemption requests relating to Annex III and IV to Directive 2011/65/EU
                  .

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

    ---documentbreak---

               ANNEX

               In Annex IV to Directive 2011/65/EU, the following entry is added:

                        ’48.

                        Lead in bismuth strontium calcium copper oxide (BSCCO) superconductor cables and wires and lead in electrical connections to these wires

                        Expires on 30 June 2027.’


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 lead in certain magnetic resonance imaging devices

text:
               EXPLANATORY MEMORANDUM

               1.CONTEXT OF THE DELEGATED ACT

               This Commission Delegated Directive amends, for the purpose of adapting to technical and scientific progress, Annex IV to 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 (‘the RoHS Directive’)
                  1
                as regards an exemption for specific applications containing lead.

               Article 4 of the RoHS Directive restricts the use of certain hazardous substances in electrical and electronic equipment (EEE). Currently, 10 substances are restricted and listed in Annex II to the Directive: 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 the RoHS Directive list the materials and components of EEE for specific applications exempted from the substance restrictions in Article 4(1) of the Directive. Article 5 provides for Annexes III and IV to be adapted to scientific and technical progress (on granting, renewing and revoking of exemptions). Under Article 5(1)(a), exemptions are to be included in Annexes III and IV only if this does not weaken the environmental and health protection afforded by Regulation (EC) No 1907/2006 (REACH)
                  2
                and if any of the following conditions is fulfilled:

               –the elimination or substitution of the substance via design changes or use of materials and components that 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;

               –the total negative environmental, health and consumer safety impacts of substitution are likely to outweigh the total environmental, health and consumer safety benefits.

               Decisions on exemptions, and their duration, must take into account the availability of substitutes and the socio‑economic impact of substitution. Decisions on the duration of exemptions must take into account any potential impact on innovation. Life-cycle thinking on the overall impacts of the exemption must apply, where relevant.

               Article 5(1) of the RoHS Directive provides for the Commission to include materials and components of EEE for specific applications in the lists in Annexes III and IV by means of individual delegated acts pursuant to Article 20. Article 5(3) and Annex V establish the procedure for submitting exemption applications.

               2.CONSULTATIONS PRIOR TO THE ADOPTION OF THE ACT

               The Commission receives numerous requests from economic operators to grant or renew exemptions under Article 5(3) and Annex V to the RoHS Directive
                  3
               .

               Exemption 27 was included in Annex IV to the RoHS Directive by Commission Delegated Directive 2014/7/EU
                  4
               . The expiry date set for this exemption was 30 June 2020. The exemption concerns the use of lead in specific components, which are used in magnetic fields produced by certain medical devices. On 12 December 2018, within the timeframe for renewal laid down in Article 5(5) of the RoHS Directive, the Commission received one application to renew the scope and duration of this exemption. The exemption consisted of two areas of application, (a) and (b). The applicant did not request the continuation of part (b) of Exemption 27 in Annex IV, which refers to specific magnets applied for particle therapy.

               In August 2019, the Commission launched a study
                  5
                to carry out the required technical and scientific assessment. The study, including an eight-week public consultation, finished in July 2020. Information about the consultation was provided on the project website
                  6
               , although no responses were received to the consultation.

               The Commission consulted the Member State expert group for delegated acts under the RoHS Directive on 23 February 2021. It carried out all the required procedural steps relating to exemptions from the restrictions on substances under Articles 5(3) to 5(7)
                  7
                and the Council and the European Parliament were notified of all activities in this context.

               The technical and scientific assessment report highlighted the following:

               ·Lead is used in solders, termination coatings, and connections of electrical wires, shields and enclosed connectors to provide non-magnetic components, which are necessary in magnetic resonance imaging (MRI) devices for diagnostic purposes.

               ·In newly designed MRI devices and components, the substitution and elimination of lead is scientifically and technically practicable.

               ·Old designed MRI devices are limited in their compatibility with new lead-free MRI components. In some MRI devices, the new design of lead-free components cannot be used. Other older MRI  devices will have to undergo an elaborate redesign process, which shifts manufacturers’ limited capacity from developing new lead-free medical devices with superior diagnostic capability to replacing lead in existing products.

               ·To address sufficiently the demand on MRI equipment for old designed MRI devices, which cannot be redesigned or replaced before the exemption period expires, the use of old MRI equipment containing lead is still necessary.

               ·The transition to lead-free MRI equipment has progressed at different speeds for MRI devices with integrated coils and those with non-integrated MRI coils.

               ·Newly designed lead-free non-integrated MRI coils are available in a sufficient variety for health facilities. Due to the complexity of MRI devices with integrated coils and the approval procedure required for these, the transition to non-lead MRI devices requires more time.

               ·Not granting the exemption may result into premature waste of MRI devices due to a lack of compatible components or redesign options. A supply gap in MRI equipment may also occur, which may result in poorer healthcare for patients.

               Newly designed MRI non-integrated coils do not need an exemption and MRI equipment including integrated coils will not need an exemption from 30 June 2024, thus these applications will be excluded in the new wording of the exemption. The distinction will be made by the Declaration of Conformity for this model, which is necessary for a product before being placed on the market in line with Article 7(c) and Article 13 of the RoHS Directive.

               3.LEGAL ELEMENTS OF THE DELEGATED ACT

               The evaluation results show that the exemption to be granted would not weaken the environmental and health protection afforded by the REACH Regulation, in accordance with Article 5 of Directive 2011/65/EU.

               The Commission’s assessment, based on the support study and consultations, concluded that the exemption application meets at least one of the criteria laid down in Article 5(1)(a), that justifies renewing the exemption: ‘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’.

               The delegated directive renews in part Exemption 27 listed in Annex IV to Directive 2011/65/EU for the use of lead in solders, termination coatings of electrical and electronic components and printed circuit boards, connections of electrical wires, shields and enclosed connectors for magnetic resonance imaging (MRI) devices. The old formulation in part (a) and (b) of the exemption 27 remains unchanged and remains listed for clarity for stakeholders. A new formulation is introduced in part (c) and (d) which is limited to the actual necessary applications.

               The date by which this exemption will expire is set in line with Article 5(2), first subparagraph. As concluded by the evaluation, the state of development of substitutes justifies renewing the exemption for non-integrated MRI coils and for MRI devices including integrated coils, whereby the latter can be substituted earlier. The validity period of the exemption is not expected to have adverse impacts on innovation.

               The legal instrument is a delegated directive, as provided for in the Directive 2011/65/EU and meeting the relevant requirements of its Article 5(1)(a).

               The objective of the delegated directive is to help protect human health and the environment, and harmonise provisions for the functioning of the single market in the field of EEE, by allowing the use of otherwise banned substances for specific applications, in line with the RoHS Directive and the procedure established therein for adapting Annexes III and IV to the Directive to scientific and technical progress.

               The delegated directive has no implications for the EU budget.

               COMMISSION DELEGATED DIRECTIVE (EU) .../…

               of 12.5.2022

               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 lead in certain magnetic resonance imaging devices

               (Text with EEA relevance)

               THE EUROPEAN COMMISSION,

               Having regard to the Treaty on the Functioning of the European Union,

               Having regard to Directive 2011/65/EU of the European Parliament and of the Council of 8 June 2011 on the restriction of the use of certain hazardous substances in electrical and electronic equipment
                  8
               , and in particular Article 5(1), point (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 2014/7/EU
                  9
               , the Commission granted an exemption for the use of lead in solders, termination coatings of electrical and electronic components and printed circuit boards, connections of electrical wires, shields and enclosed connectors that are used in certain medical magnetic resonance imaging (MRI) equipment (‘the exemption’), by including those applications in Annex IV to Directive 2011/65/EU. The exemption was to expire on 30 June 2020.

               (5)On 12 December 2018, the Commission received an application for renewal of the exemption (‘the renewal request’) 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. The comments received during those consultations were made publicly available on a dedicated website.

               (7)The evaluation of the renewal request, which included a technical and scientific assessment study
                  10
               , concluded that old design MRI devices depend on lead-containing MRI components and are highly limited in their compatibility with new lead-free MRI components. That evaluation further concluded that lead-free models of non-integrated MRI coils are already available. However, as concerns MRI devices with integrated coils, the technical development and the approval procedure to develop lead-free solutions require additional time.

               (8)The use of lead in newly designed non-integrated MRI coils and in upcoming lead-free MRI devices with integrated coils should be excluded from the exemption with specific dates.

               (9)Not granting the renewal request could result in premature wastage of MRI devices due to a lack of compatible components or redesigning options. This could result in a supply gap of MRI equipment, which could in turn adversely affect health care for patients.

               (10)The total negative environmental, health and consumer safety impacts of substitution are likely to outweigh the total environmental, health and consumer safety benefits thereof. The exemption is consistent with Regulation (EC) No 1907/2006 of the European Parliament and of the Council
                  11
                and thus does not weaken the environmental and health protection afforded by it.

               (11)It is, therefore, appropriate to grant the renewal of the exemption.

               (12)In order to provide compatible MRI equipment for health services and to allow time for the development of lead-free alternatives, it is appropriate to grant the renewal of the exemption, with a revised scope, for the maximum duration of 7 years until 30 June 2027, in accordance with Article 5(2), first subparagraph, 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 [OP please insert the date: 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 the text of those provisions to the Commission.

               They shall apply those provisions from [OP please insert the date: 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.

               Article 4

               This Directive is addressed to the Member States.

               Done at Brussels, 12.5.2022

                     For the Commission

                     The President
                     Ursula VON DER LEYEN

                     (1)

                        OJ L 174, 1.7.2011, p. 88.

                     (2)

                        Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) and establishing a European Chemicals Agency (OJ L 396, 30.12.2006, p. 1).

                     (3)

                        The list is available at:
                  http://ec.europa.eu/environment/waste/rohs_eee/adaptation_en.htm
                  .

                     (4)

                        OJ L 4, 9.1.2014, p. 57–58.

                     (5)

                        Final Report of the (Pack 18) study is available at
                  https://op.europa.eu/en/publication-detail/-/publication/f44f2383-dd0a-11ea-adf7-01aa75ed71a1/language-en/format-PDF/source-146144383

                     (6)

                        Consultation period: 3 December 2019 until 27 January 2020
                  https://rohs.exemptions.oeko.info/
                  .

                     (7)

                        A list of the required administrative steps is available on the
                  Commission website
                  . The current stage of the procedure can be viewed for each draft delegated act in the Inter-institutional Registry of Delegated Acts at
                  https://webgate.ec.europa.eu/regdel/#/home
                  .

                     (8)

                        OJ L 174, 1.7.2011, p. 88.

                     (9)

                        Commission Delegated Directive 2014/7/EU of 18 October 2013 amending, for the purposes of adapting to technical progress, Annex IV to Directive 2011/65/EU of the European Parliament and of the Council as regards an exemption for lead in solders, termination coatings of electrical and electronic components and printed circuit boards, connections of electrical wires, shields and enclosed connectors which are used (a) in magnetic fields within the sphere of 1 m radius around the isocentre of the magnet in medical magnetic resonance imaging equipment, including patient monitors designed to be used within this sphere, or (b) in magnetic fields within 1 m distance from the external surfaces of cyclotron magnets, magnets for beam transport and beam direction control applied for particle therapy (OJ L 4, 9.1.2014, p. 57).

                     (10)

                  Study to assess seven exemption requests relating to Annex III and IV to Directive 2011/65/EU
                   (Pack 18)
                  .

                     (11)

                        Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH),  establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 396, 30.12.2006, p. 1).

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               ANNEX

               In Annex IV to Directive 2011/65/EU, in entry 27, the following points (c) and (d) are added:

                         (c) MRI non-integrated coils, for which the Declaration of Conformity of this model is issued for the first time before [PO: the date of publication in the Official Journal of the Delegated Directive + 1 day], or

                        (d) MRI devices including integrated coils, which are used in magnetic fields within the sphere of 1 m radius around the isocentre of the magnet in medical magnetic resonance imaging equipment, for which the Declaration of Conformity is issued for the first time before 30 June 2024.

                        Expires on 30 June 2027.’