title: COMMISSION DELEGATED DIRECTIVE (EU) .../… amending, for the purposes of adapting to scientific and technical progress, Annex III to Directive 2011/65/EU of the European Parliament and of the Council as regards an exemption for lead oxide in seal frit used for making window assemblies for certain laser tubes

text:
               EXPLANATORY MEMORANDUM

               1.CONTEXT OF THE DELEGATED ACT

               This Commission Delegated Directive amends, for the purpose of adapting to technical progress, Annex III of Directive 2011/65/EU of the European Parliament and of the Council on the restriction of the use of certain hazardous substances in electrical and electronic equipment (recast)
                  1
                (RoHS 2) as regards an exemption for specific applications containing lead.

               RoHS 2 restricts the use of certain hazardous substances in electrical and electronic equipment, as provided for in its Article 4. It entered into force on 21 July 2011.

               The restricted substances are listed in Annex II to RoHS 2. While the restrictions of lead, mercury, cadmium, hexavalent chromium, polybrominated biphenyls, and polybrominated diphenyl ethers are in force to date, the restrictions of bis(2ethylhexyl) phthalate (DEHP), butyl benzyl phthalate (BBP), dibutyl phthalate (DBP), diisobutyl phthalate (DIBP) shall apply from 22 July 2019 or later. Annexes III and IV to RoHS 2 list the materials and components of electrical and electronic equipment (EEE) for specific applications exempted from the substance restriction of RoHS 2 Article 4(1).

               Article 5 makes provision for the adaptation to scientific and technical progress (inclusion, renewal, amendments and revoking of exemptions) of Annexes III and IV. Pursuant to Article 5(1)(a), exemptions are to be included in Annexes III and IV only if such inclusion does not weaken the environmental and health protection afforded by Regulation (EC) No 1907/2006
                  2
                and where any of the following conditions is fulfilled: their elimination or substitution via design changes or materials and components which do not require any of the materials or substances listed in Annex II is scientifically or technically impracticable; the reliability of substitutes is not ensured; or the total negative environmental, health and consumer safety impacts caused by substitution are likely to outweigh the total environmental, health and consumer safety benefits thereof.

               Furthermore, Article 5(1) provides that the European Commission (the Commission) shall include materials and components of EEE for specific applications in the lists in Annexes III and IV by means of individual delegated acts in accordance with Article 20. Article 5(3) and Annex V establish the procedure for submitting applications for granting, renewing, or revoking an exemption.

               2.CONSULTATIONS PRIOR TO THE ADOPTION OF THE ACT

               Since the publication of RoHS 2, the Commission has received numerous
                  3
                requests from economic operators, according to the provisions in Article 5(3) and Annex V, for both granting new and renewing existing exemptions.

               The current Annex III exemption 32 permits the use of lead oxide in seal frit used for making window assemblies for Argon and Krypton laser tubes. The Commission received two applications for renewal of this exemption in January 2015. While exemption 32 had 21 July 2016 as expiration date for categories 1 to 7 and 10
                  4
               , in line with the requirements of the RoHS Directive (Article 5(5), second subparagraph), it continues to apply until a decision on the renewal application is taken by the Commission.

               With a view to evaluating the application for exemption, the Commission launched a study to carry out the required technical and scientific assessment, including an eightweek online openended stakeholder consultation
                  5
                on the application. Two contributions were made to the stakeholder consultation.

               The final report containing the assessment of the application was published
                  6
               ; stakeholders were notified.

               Subsequently, the Commission consulted the Member States expert group for delegated acts under RoHS 2 in written form as agreed during a previous meeting
                  7
               . The experts agreed with the draft presented by the Commission, with a large 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. Three comments were received, with two supporting the act and one proposing the instalment of an EU-wide auxiliary language. All necessary steps relating to exemptions from the substance restriction pursuant to Articles 5(3) to 5(7) have been performed
                  8
               . The Council and the European Parliament were notified of all activities.

               The final report highlighted in particular the following technical information and assessment:

               ·Lead oxide-based material in Argon and Krypton laser products provides a critical thermo-mechanically-stable and vacuum-tight seal between the optics and laser tube. Lead containing laser products are used as coherent light sources in a broad range of critical scientific and industrial applications, such as spectroscopy, microscopy and holography.

               ·Currently, a substitution or elimination of lead in the applications concerned is still scientifically and technically impracticable.

               The evaluation results for categories 1 to 7 and 10 show that at least one of the relevant criteria specified in Article 5(1)(a) is met by the exemption request relating to entry 32 in Annex III. 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 with a validity period until 21 July 2021 is justified; as reliable substitutes are not yet available, no negative socioeconomic impacts of substitution are to be anticipated for this period. The granted validity period is also not expected to have adverse impacts on innovation. For categories other than categories 1 to 7 and 10, the existing exemption remains as per the validity periods set out in Article 5(2). The specific exemption does 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.

               3.LEGAL ELEMENTS OF THE DELEGATED ACT

               The Delegated Directive grants an exemption from the restrictions in Article 4(1), to be listed in Annex III of Directive 2011/65/EU, for the use of lead in specific applications.

               The instrument is a Delegated Directive, as provided for by Directive 2011/65/EU, and in particular meeting the relevant requirements of Article 5(1)(a) thereof.

               The objective of the Delegated Directive is to contribute to the protection of human health and the environment and approximate the provisions for the functioning of the internal market in the field of electrical and electronic equipment, by allowing the use of otherwise banned substances for specific applications, in line with the provisions and under the conditions of RoHS 2 and the therein established procedure for the adaptation of the Annexes III and IV to scientific and technical progress.

               In accordance with the principle of proportionality, the measure does not go beyond what is necessary to achieve its objective.

               The proposal has no implications for the EU budget.

               COMMISSION DELEGATED DIRECTIVE (EU) .../…

               of 16.11.2018

               amending, for the purposes of adapting to scientific and technical progress, Annex III to Directive 2011/65/EU of the European Parliament and of the Council as regards an exemption for lead oxide in seal frit used for making window assemblies for certain laser tubes

               (Text with EEA relevance)

               THE EUROPEAN COMMISSION,

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

               Having regard to Directive 2011/65/EU of the European Parliament and of the Council of 8 June 2011 on the restriction of the use of certain hazardous substances in electrical and electronic equipment
                  9
                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 certain hazardous substances listed in Annex II to that Directive. That requirement does not apply to the applications listed in Annex III to Directive 2011/65/EU.

               (2)
                     The different categories of electrical and electronic equipment for which Directive 2011/65/EU applies (categories 1 to 11) are listed in Annex I to that Directive.

               (3)
                     Lead is a restricted substance listed in Annex II to Directive 2011/65/EU. The use of lead oxide in seal frit used for making window assemblies for Argon and Krypton laser tubes was, however, exempted from the restriction and is currently listed in entry 32 of Annex III to that Directive. The expiry date of that exemption was, for categories 1 to 7 and 10, 21 July 2016.

               (4)
                     The Commission received an application for renewal of that exemption before 21 January 2015, in accordance with Article 5(5) of Directive 2011/65/EU. The exemption remains valid until a decision on that application has been adopted.

               (5)
                     Lead containing laser products are used as coherent light sources in a broad range of critical scientific and industrial applications, such as spectroscopy, microscopy and holography. Lead oxide-based material in Argon and Krypton laser products provides a critical thermo-mechanically-stable and vacuum-tight seal between the optics and laser tube.

               (6)
                     A substitution or elimination of lead is still scientifically and technically impracticable for Argon and Krypton laser tubes due to the lack of reliable substitutes. The exemption does not weaken the environmental and health protection afforded by Regulation (EC) No 1907/2006 of the European Parliament and of the Council
                  10
               . The exemption for the use of lead oxide in seal frit used for making window assemblies for Argon and Krypton laser tubes should therefore be renewed for categories 1 to 7 and 10.

               (7)
                     Since, for the applications concerned, no reliable alternatives are available today or are likely to be available on the market in the near future, the exemption for categories 1 to 7 and 10 should be renewed for the maximum duration of five years until 21 July 2021. 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.

               (8)
                     For categories other than 1 to 7 and 10, the existing exemption remains valid as per the validity periods set out in the second subparagraph of Article 5(2) of Directive 2011/65/EU. For reasons of clarity, the dates of expiry should be added in Annex III to that Directive.

               (9)
                     Directive 2011/65/EU should therefore be amended accordingly,

               HAS ADOPTED THIS DIRECTIVE:

               Article 1

               Annex III to Directive 2011/65/EU is amended as set out in the Annex to this Directive.

               Article 2

               1.Member States shall adopt and publish, by [the last day of the 12th month after the date of entry into force of this Directive] at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions.

               They shall apply those provisions from [the last day of the 12th month after the date of entry into force of this Directive + 1 day].

               When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.

               2.Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.

               Article 3

               This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

               Article 4

               This Directive is addressed to the Member States.

               Done at Brussels, 16.11.2018

                     For the Commission

                     The President
                     Jean-Claude JUNCKER

                     (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

                     (4)

                        These categories 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; 10. Automatic dispensers. EEE categories are listed in Annex I to the RoHS Directive.

                     (5)

                  Consultation period
                  : from 21.08.2015 to 16.10.2015

                     (6)

                     https://bookshop.europa.eu/en/assistance-to-the-commission-on-technological-socio-economic-and-cost-benefit-assessment-related-to-exemptions-from-the-substance-restrictions-in-electrical-and-electronic-equipment-pbKH0416554/

                     (7)

                        The consultations were carried out in written form from 27 April until 18 May 2017.

                     (8)

                        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
                  .

                     (9)

                        OJ L 174, 1.7.2011, p. 88.

                     (10)

                        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).

    ---documentbreak---

               ANNEX

               In Annex III, entry 32 is replaced by the following:

                        "32

                        Lead oxide in seal frit used for making window assemblies for Argon and Krypton laser tubes

                        Expires on:

                        -21 July 2021 for categories 1-7 and 10;

                        -21 July 2021 for categories 8 and 9 other than in vitro diagnostic medical devices and industrial monitoring and control instruments;

                        -21 July 2023 for category 8 in vitro diagnostic medical devices;

                        -21 July 2024 for category 9 industrial monitoring and control instruments, and for category 11."


title: COMMISSION DELEGATED DIRECTIVE (EU) .../… amending, for the purposes of adapting to scientific and technical progress, Annex III to Directive 2011/65/EU of the European Parliament and of the Council as regards an exemption for lead and cadmium in printing inks for the application of enamels on glasses

text:
               EXPLANATORY MEMORANDUM

               1.CONTEXT OF THE DELEGATED ACT

               This Commission Delegated Directive amends, for the purpose of adapting to technical progress, Annex III of Directive 2011/65/EU of the European Parliament and of the Council on the restriction of the use of certain hazardous substances in electrical and electronic equipment (recast)
                  1
                (RoHS 2) as regards an exemption for specific applications containing lead and cadmium.

               RoHS 2 restricts the use of certain hazardous substances in electrical and electronic equipment, as provided for in its Article 4. It entered into force on 21 July 2011.

               The restricted substances are listed in Annex II to RoHS 2. While the restrictions of lead, mercury, cadmium, hexavalent chromium, polybrominated biphenyls, and polybrominated diphenyl ethers are in force to date, the restrictions of bis(2ethylhexyl) phthalate (DEHP), butyl benzyl phthalate (BBP), dibutyl phthalate (DBP), diisobutyl phthalate (DIBP) shall apply from 22 July 2019 or later. Annexes III and IV to RoHS 2 list the materials and components of electrical and electronic equipment (EEE) for specific applications exempted from the substance restriction of RoHS 2 Article 4(1).

               Article 5 makes provision for the adaptation to scientific and technical progress (inclusion, renewal, amendments and revoking of exemptions) of Annexes III and IV. Pursuant to Article 5(1)(a), exemptions are to be included in Annexes III and IV only if  such inclusion does not weaken the environmental and health protection afforded by Regulation (EC) No 1907/2006
                  2
                and where any of the following conditions is fulfilled: their elimination or substitution via design changes or materials and components which do not require any of the materials or substances listed in Annex II is scientifically or technically impracticable; the reliability of substitutes is not ensured; or the total negative environmental, health and consumer safety impacts caused by substitution are likely to outweigh the total environmental, health and consumer safety benefits thereof.

               Furthermore, Article 5(1) provides that the European Commission (the Commission) shall include materials and components of EEE for specific applications in the lists in Annexes III and IV by means of individual delegated acts in accordance with Article 20. Article 5(3) and Annex V establish the procedure for submitting applications for granting, renewing, or revoking an exemption.

               2.CONSULTATIONS PRIOR TO THE ADOPTION OF THE ACT

               Since the publication of RoHS 2, the Commission has received numerous
                  3
                requests from economic operators, according to the provisions in Article 5(3) and Annex V, for both granting new and renewing existing exemptions.

               The current Annex III exemption 21 permits the use of lead and cadmium in printing inks for the application of enamels on glasses, such as borosilicate and soda lime glasses. The Commission received one application for renewal of this exemption in January 2015. While exemption 21 had 21 July 2016 as expiration date for categories 1 to 7 and 10
                  4
               , in line with the requirements of the RoHS Directive (Article 5(5), second subparagraph), it continues to apply until a decision on the renewal application is taken by the Commission.

               With a view to evaluating the application for exemption, the Commission launched a study to carry out the required technical and scientific assessment, including an eightweek online openended stakeholder consultation
                  5
                on the application. Three contributions were made to the stakeholder consultation.

               The final report containing the assessment of the application was published
                  6
               ; stakeholders were notified.

               Subsequently, the Commission consulted the Member States expert group for delegated acts under RoHS 2 in written form as agreed during a previous meeting
                  7
               . The experts agreed with the draft presented by the Commission, with a large 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. Three comments were received, two supporting the act and one proposing to retain lead-related exemption for category 5. The comment was taken into account and the draft Delegated Directive correspondingly amended for reasons of legal clarity. All necessary steps relating to exemptions from the substance restriction pursuant to Articles 5(3) to 5(7) have been performed
                  8
               . The Council and the European Parliament were notified of all activities.

               The final report highlighted in particular the following technical information and assessment:

               ·Lead and cadmium in printing inks applied to glass provide a durable product marking, especially on the glass bulb of lamps. The marking serves several purposes such as CE and WEEE marking, identifying the producer and the lamp type and wattage, which is relevant for safety, correct lamp replacement and recycling. The durability of the marking is important to maintain the legibility of product markings throughout product-lifetime, as required by legislations and product safety standards.

               ·Lead provides essential properties such as good adhesion, lower enamelling temperatures, higher durability and opacity. Cadmium is used to achieve certain hues of the enamel in various application areas, including applications for safety and warning purposes where certain hues are considered to increase visibility. Cadmium also provides important filtering functions.

               ·Currently, a substitution or elimination of lead and cadmium is still scientifically and technically impracticable in certain applications.

               The evaluation results for categories 1 to 7 and 10 show that at least one of the relevant criteria specified in Article 5(1)(a) is met by the exemption request relating to entry 21 in Annex III. Since reliable alternatives are still not available for certain applications, the renewal of the exemption with amended wording creating separate subentries for respective substances (lead and cadmium) and reflecting the current status of alternative technologies is justified. The exemption renewals granted by the subentries shall be valid until 21 July 2021. The granted validity period is not expected to have adverse impacts on innovation. Where reliable substitution is available, limited socioeconomic impacts on certain manufacturers in form of necessary investment related to equipment adjustments are possible. For categories other than categories 1 to 7 and 10, the existing exemption remains as per the validity periods set out in Article 5(2). The specific exemption does 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.

               3.LEGAL ELEMENTS OF THE DELEGATED ACT

               The Delegated Directive grants an exemption from the restrictions in Article 4(1), to be listed in Annex III of Directive 2011/65/EU, for the use of lead and cadmium 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.

               COMMISSION DELEGATED DIRECTIVE (EU) .../…

               of 16.11.2018

               amending, for the purposes of adapting to scientific and technical progress, Annex III to Directive 2011/65/EU of the European Parliament and of the Council as regards an exemption for lead and cadmium in printing inks for the application of enamels on glasses

               (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
                  9
                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 certain hazardous substances listed in Annex II to that Directive. That requirement does not apply to the applications listed in Annex III to Directive 2011/65/EU.

               (2)
                     The different categories of electrical and electronic equipment for which Directive 2011/65/EU applies (categories 1 to 11) are listed in Annex I to that Directive.

               (3)
                     Lead and cadmium are restricted substances listed in Annex II to Directive 2011/65/EU. The use of lead and cadmium in certain printing applications for glasses was, however, exempted from the restriction and is currently listed in entry 21 of Annex III to that Directive. The expiry date of that exemption was, for categories 1 to 7 and 10, 21 July 2016.

               (4)
                     The Commission received an application for renewal of that exemption before 21 January 2015, in accordance with Article 5(5) of Directive 2011/65/EU. The exemption remains valid until a decision on that application has been adopted.

               (5)
                     Lead and cadmium in printing inks applied to glass provide a durable product marking, especially on the glass bulb of lamps. The marking serves several purposes such as European conformity (CE) and Waste Electrical and Electronic Equipment (WEEE) marking, identifying the producer and the lamp type and wattage, which is relevant for safety, correct lamp replacement and recycling. The durability of the marking is important to maintain the legibility of product markings throughout product-lifetime, as required by legislations and product safety standards.

               (6)
                     Lead provides essential properties such as good adhesion, lower enamelling temperatures, higher durability and opacity.

               (7)
                     Cadmium is used to achieve certain hues of the enamel in various application areas, including applications for safety and warning purposes where certain hues are considered to increase visibility. It also provides important filtering functions.

               (8)
                     A substitution or elimination of lead is still scientifically and technically impracticable for certain applications covered by the current exemption with regard to categories 1 to 7 and 10 due to the lack of reliable substitutes. The exemption does not weaken the environmental and health protection afforded by Regulation (EC) No 1907/2006 of the European Parliament and of the Council
                  10
               . The exemption should therefore be renewed for those particular applications and categories.

               (9)
                     A substitution or elimination of cadmium is still scientifically and technically impracticable for certain applications covered by the current exemption with regard to categories 1 to 7 and 10 due to the lack of reliable substitutes. The exemption does not weaken the environmental and health protection afforded by Regulation (EC) No 1907/2006. The exemption should therefore be renewed for those particular applications and categories.

               (10)
                     For all other applications currently covered by the exemption, the conditions for renewal are not fulfilled. The exemption for those applications should continue to apply for 12 months after the date of entry into force of this Delegated Directive in accordance with Article 5(6) of Directive 2011/65/EU.

               (11)
                     Since for the lead containing applications concerned by the renewal, no reliable alternatives are available on the market, the exemption for those applications should be renewed for categories 1 to 7 and 10 for the maximum duration of five years until 21 July 2021. 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.

               (12)
                     Since for the cadmium containing applications concerned by the renewal, no reliable alternatives are available on the market, the exemption for those applications should be renewed for categories 1 to 7 and 10 for the maximum duration of five years until 21 July 2021. 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)
                     For categories other than 1 to 7 and 10, the existing exemption remains valid as per the validity periods set out in the second subparagraph of Article 5(2) of Directive 2011/65/EU. For reasons of clarity, the dates of expiry should be added in Annex III to that Directive.

               (14)
                     Directive 2011/65/EU should therefore be amended accordingly,

               HAS ADOPTED THIS DIRECTIVE:

               Article 1

               Annex III to Directive 2011/65/EU is amended as set out in the Annex to this Directive.

               Article 2

               1.Member States shall adopt and publish, by [the last day of the 12th month after the date of entry into force of this Directive] at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions.

               They shall apply those provisions from [the last day of the 12th month after the date of entry into force of this Directive + 1 day].

               When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.

               2.Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.

               Article 3

               This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

               Article 4

               This Directive is addressed to the Member States.

               Done at Brussels, 16.11.2018

                     For the Commission

                     The President
                     Jean-Claude JUNCKER

                     (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

                     (4)

                        These categories 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; 10. Automatic dispensers. EEE categories are listed in Annex I to the RoHS Directive.

                     (5)

                  Consultation period
                  : from 21.08.2015 to 16.10.2015

                     (6)

                     https://bookshop.europa.eu/en/assistance-to-the-commission-on-technological-socio-economic-and-cost-benefit-assessment-related-to-exemptions-from-the-substance-restrictions-in-electrical-and-electronic-equipment-pbKH0416554/

                     (7)

                        The consultations were carried out in written form from 27 April until 18 May 2017.

                     (8)

                        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
                  .

                     (9)

                        OJ L 174, 1.7.2011, p. 88.

                     (10)

                        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).

    ---documentbreak---

               ANNEX

               In Annex III, entry 21 is replaced by the following:

                        "21

                        Lead and cadmium in printing inks for the application of enamels on glasses, such as borosilicate and soda lime glasses

                        Applies to categories 8, 9 and 11 and expires on:

                        -21 July 2021 for categories 8 and 9 other than in vitro diagnostic medical devices and industrial monitoring and control instruments;

                        -21 July 2023 for category 8 in vitro diagnostic medical devices;

                        -21 July 2024 for category 9 industrial monitoring and control instruments, and for category 11.

                        21(a)

                        Cadmium when used in colour printed glass to provide filtering functions, used as a component in lighting applications installed in displays and control panels of EEE

                        Applies to categories 1 to 7 and 10 except applications covered by entry 21(b) or entry 39 and expires on 21 July 2021.

                        21(b)

                        Cadmium in printing inks for the application of enamels on glasses, such as borosilicate and soda lime glasses

                        Applies to categories 1 to 7 and 10 except applications covered by entry 21(a) or 39 and expires on 21 July 2021.

                        21(c)

                        Lead in printing inks for the application of enamels on other than borosilicate glasses

                        Applies to categories 1 to 7 and 10 and expires on 21 July 2021."


title: COMMISSION DELEGATED DIRECTIVE (EU) .../… amending, for the purposes of adapting to scientific and technical progress, Annex III to Directive 2011/65/EU of the European Parliament and of the Council as regards an exemption for lead bound in crystal glass as defined in Directive 69/493/EEC

text:
               EXPLANATORY MEMORANDUM

               1.CONTEXT OF THE DELEGATED ACT

               This Commission Delegated Directive amends, for the purpose of adapting to technical progress, Annex III of Directive 2011/65/EU of the European Parliament and of the Council on the restriction of the use of certain hazardous substances in electrical and electronic equipment (recast)
                  1
                (RoHS 2) as regards an exemption for specific applications containing lead.

               RoHS 2 restricts the use of certain hazardous substances in electrical and electronic equipment, as provided for in its Article 4. It entered into force on 21 July 2011.

               The restricted substances are listed in Annex II to RoHS 2. While the restrictions of lead, mercury, cadmium, hexavalent chromium, polybrominated biphenyls, and polybrominated diphenyl ethers are in force to date, the restrictions of bis(2ethylhexyl) phthalate (DEHP), butyl benzyl phthalate (BBP), dibutyl phthalate (DBP), diisobutyl phthalate (DIBP) shall apply from 22 July 2019 or later. Annexes III and IV to RoHS 2 list the materials and components of electrical and electronic equipment (EEE) for specific applications exempted from the substance restriction of RoHS 2 Article 4(1).

               Article 5 makes provision for the adaptation to scientific and technical progress (inclusion, renewal, amendments and revoking of exemptions) of Annexes III and IV. Pursuant to Article 5(1)(a), exemptions are to be included in Annexes III and IV only if such inclusion does not weaken the environmental and health protection afforded by Regulation (EC) No 1907/2006
                  2
                and where any of the following conditions is fulfilled: their elimination or substitution via design changes or materials and components which do not require any of the materials or substances listed in Annex II is scientifically or technically impracticable; the reliability of substitutes is not ensured; or the total negative environmental, health and consumer safety impacts caused by substitution are likely to outweigh the total environmental, health and consumer safety benefits thereof.

               Furthermore, Article 5(1) provides that the European Commission (the Commission) shall include materials and components of EEE for specific applications in the lists in Annexes III and IV by means of individual delegated acts in accordance with Article 20. Article 5(3) and Annex V establish the procedure for submitting applications for granting, renewing, or revoking an exemption.

               2.CONSULTATIONS PRIOR TO THE ADOPTION OF THE ACT

               Since the publication of RoHS 2, the Commission has received numerous
                  3
                requests from economic operators, according to the provisions in Article 5(3) and Annex V, for both granting new and renewing existing exemptions.

               The current Annex III exemption 29 permits the use of lead bound in crystal glass as defined in Annex I (Categories 1, 2, 3 and 4) of Council Directive 69/493/EEC. The Commission received one application for renewal of this exemption in January 2015. While exemption 29 had 21 July 2016 as expiration date for categories 1 to 7 and 10
                  4
               , in line with the requirements of the RoHS Directive (Article 5(5), second subparagraph), it continues to apply until a decision on the renewal application is taken by the Commission.

               With a view to evaluating the application for exemption, the Commission launched a study to carry out the required technical and scientific assessment, including an eightweek online openended stakeholder consultation
                  5
                on the application. Twenty five contributions were made to the stakeholder consultation.

               The final report containing the assessment of the application was published
                  6
               ; stakeholders were notified.

               Subsequently, the Commission consulted the Member States expert group for delegated acts under RoHS 2 in written form as agreed during a previous meeting
                  7
               . The experts agreed with the draft presented by the Commission, with a large 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. Three comments were received, all supporting the act. All necessary steps relating to exemptions from the substance restriction pursuant to Articles 5(3) to 5(7) have been performed
                  8
               . The Council and the European Parliament were notified of all activities.

               The final report highlighted in particular the following technical information and assessment:

               ·Lead oxides (PbO or Pb3O4) are used as an intermediate for the chemical synthesis of lead crystal glass (LCG). LCG is used in EEE applications because its unique combinations of processing (cooling time, working range), optical (refractive index, dispersion) and decorative (Vicker's hardness) properties allow the manufacture of EEE articles which could not be produced otherwise, such as luminaires and chandeliers, electrified mirrors, clocks and watches, digital photo frames or building materials (illuminated blocks).

               ·Currently, a substitution or elimination of lead in the applications concerned is still scientifically and technically impracticable.

               The evaluation results for categories 1 to 7 and 10 show that at least one of the relevant criteria specified in Article 5(1)(a) is met by the exemption request relating to entry 29 in Annex III. 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 with a validity period until 21 July 2021 is justified; as reliable substitutes are not yet available, no negative socioeconomic impacts of substitution are to be anticipated for this period. The granted validity period is also not expected to have adverse impacts on innovation. For categories other than categories 1 to 7 and 10, the existing exemption remains as per the validity periods set out in Article 5(2). The specific exemption does 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.

               3.LEGAL ELEMENTS OF THE DELEGATED ACT

               The Delegated Directive grants an exemption from the restrictions in Article 4(1), to be listed in Annex III of Directive 2011/65/EU, for the use of lead in specific applications.

               The instrument is a Delegated Directive, as provided for by Directive 2011/65/EU, and in particular meeting the relevant requirements of Article 5(1)(a) thereof.

               The objective of the Delegated Directive is to contribute to the protection of human health and the environment and approximate the provisions for the functioning of the internal market in the field of electrical and electronic equipment, by allowing the use of otherwise banned substances for specific applications, in line with the provisions and under the conditions of RoHS 2 and the therein established procedure for the adaptation of the Annexes III and IV to scientific and technical progress.

               In accordance with the principle of proportionality, the measure does not go beyond what is necessary to achieve its objective.

               The proposal has no implications for the EU budget.

               COMMISSION DELEGATED DIRECTIVE (EU) .../…

               of 16.11.2018

               amending, for the purposes of adapting to scientific and technical progress, Annex III to Directive 2011/65/EU of the European Parliament and of the Council as regards an exemption for lead bound in crystal glass as defined in Directive 69/493/EEC

               (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
                  9
                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 certain hazardous substances listed in Annex II to that Directive. That requirement does not apply to the applications listed in Annex III to Directive 2011/65/EU.

               (2)
                     The different categories of electrical and electronic equipment for which Directive 2011/65/EU applies (categories 1 to 11) are listed in Annex I to that Directive.

               (3)
                     Lead is a restricted substance listed in Annex II to Directive 2011/65/EU. The use of lead bound in crystal glass as defined in Annex I (Categories 1, 2, 3 and 4) to Council Directive 69/493/EEC
                  10
                was, however, exempted from the restriction and is currently listed in entry 29 of Annex III to Directive 2011/65/EU. The expiry date of that exemption was, for categories 1 to 7 and 10, 21 July 2016.

               (4)
                     The Commission received an application for renewal of that exemption before 21 January 2015, in accordance with Article 5(5) of Directive 2011/65/EU. The exemption remains valid until a decision on that application has been adopted.

               (5)
                     Lead oxides (PbO or Pb3O4) are used as an intermediate for the chemical synthesis of lead crystal glass (LCG). LCG is used in electrical and electronic equipment because its unique combinations of processing (cooling time, working range), optical (refractive index, dispersion) and decorative (Vicker's hardness) properties allows the manufacturing of electrical and electronic articles which could not be produced otherwise, such as specific luminaires and chandeliers, electrified mirrors, clocks and watches, digital photo frames and building materials (illuminated blocks).

               (6)
                     A substitution or elimination of lead in crystal glass is still scientifically and technically impracticable due to the lack of reliable substitutes. The exemption does not weaken the environmental and health protection afforded by Regulation (EC) No 1907/2006 of the European Parliament and of the Council
                  11
               . The exemption for the use of lead bound in crystal glass as defined in Annex I (Categories 1, 2, 3 and 4) to Directive 69/493/EEC should therefore be renewed for categories 1 to 7 and 10.

               (7)
                     Since reliable alternatives for the applications concerned are not yet available on the market or are likely to be available on the market in the near future, the exemption for categories 1 to 7 and 10 should be renewed for the maximum duration of five years until 21 July 2021. 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.

               (8)
                     For categories other than 1 to 7 and 10, the existing exemption remains valid as per the validity periods set out in the second subparagraph of Article 5(2) of Directive 2011/65/EU. For reasons of clarity, the dates of expiry should be added in Annex III to that Directive.

               (9)
                     Directive 2011/65/EU should therefore be amended accordingly,

               HAS ADOPTED THIS DIRECTIVE:

               Article 1

               Annex III to Directive 2011/65/EU is amended as set out in the Annex to this Directive.

               Article 2

               1.Member States shall adopt and publish, by [the last day of the 12th month after the date of entry into force of this Directive] at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive. They shall forthwith communicate to the Commission the text of those provisions.

               They shall apply those provisions from [the last day of the 12th month after the date of entry into force of this Directive + 1 day].

               When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.

               2.Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.

               Article 3

               This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

               Article 4

               This Directive is addressed to the Member States.

               Done at Brussels, 16.11.2018

                     For the Commission

                     The President
                     Jean-Claude JUNCKER

                     (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

                     (4)

                        These categories 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; 10. Automatic dispensers. EEE categories are listed in Annex I to the RoHS Directive.

                     (5)

                  Consultation period
                  : from 21.08.2015 to 16.10.2015

                     (6)

                     https://bookshop.europa.eu/en/assistance-to-the-commission-on-technological-socio-economic-and-cost-benefit-assessment-related-to-exemptions-from-the-substance-restrictions-in-electrical-and-electronic-equipment-pbKH0416554/

                     (7)

                        The consultations were carried out in written form from 27 April until 18 May 2017.

                     (8)

                        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
                  .

                     (9)

                        OJ L 174, 1.7.2011, p. 88.

                     (10)

                        Council Directive 69/493/EEC of 15 December 1969 on the approximation of the laws of the Member States relating to crystal glass (OJ L 326, 29.12.1969, p. 36).

                     (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) and establishing a European Chemicals Agency (OJ L 396, 30.12.2006, p. 1).

    ---documentbreak---

               ANNEX

               In Annex III, entry 29 is replaced by the following:

                        "29

                        Lead bound in crystal glass as defined in Annex I (Categories 1, 2, 3 and 4) of Council Directive 69/493/EEC *

                        Expires on:

                        -21 July 2021 for categories 1-7 and 10;

                        -21 July 2021 for categories 8 and 9 other than in vitro diagnostic medical devices and industrial monitoring and control instruments;

                        -21 July 2023 for category 8 in vitro diagnostic medical devices;

                        -21 July 2024 for category 9 industrial monitoring and control instruments, and for category 11."

               * Council Directive 69/493/EEC of 15 December 1969 on the approximation of the laws of the Member States relating to crystal glass (OJ L 326, 29.12.1969, p. 36).


title: COMMISSION DELEGATED DIRECTIVE (EU) .../… amending, for the purposes of adapting to scientific and technical progress, Annex III to Directive 2011/65/EU of the European Parliament and of the Council as regards an exemption for lead in solders to complete a viable electrical connection between semiconductor die and carrier within integrated circuit flip chip packages

text:
               EXPLANATORY MEMORANDUM

               1.CONTEXT OF THE DELEGATED ACT

               This Commission Delegated Directive amends, for the purpose of adapting to technical progress, Annex III of Directive 2011/65/EU of the European Parliament and of the Council on the restriction of the use of certain hazardous substances in electrical and electronic equipment (recast)
                  1
                (RoHS 2) as regards an exemption for specific applications containing lead.

               RoHS 2 restricts the use of certain hazardous substances in electrical and electronic equipment, as provided for in its Article 4. It entered into force on 21 July 2011.

               The restricted substances are listed in Annex II to RoHS 2. While the restrictions of lead, mercury, cadmium, hexavalent chromium, polybrominated biphenyls, and polybrominated diphenyl ethers are in force to date, the restrictions of bis(2ethylhexyl) phthalate (DEHP), butyl benzyl phthalate (BBP), dibutyl phthalate (DBP), diisobutyl phthalate (DIBP) shall apply from 22 July 2019 or later. Annexes III and IV to RoHS 2 list the materials and components of electrical and electronic equipment (EEE) for specific applications exempted from the substance restriction of RoHS 2 Article 4(1).

               Article 5 makes provision for the adaptation to scientific and technical progress (inclusion, renewal, amendments and revoking of exemptions) of Annexes III and IV. Pursuant to Article 5(1)(a), exemptions are to be included in Annexes III and IV only if such inclusion does not weaken the environmental and health protection afforded by Regulation (EC) No 1907/2006
                  2
                and where any of the following conditions is fulfilled: their elimination or substitution via design changes or materials and components which do not require any of the materials or substances listed in Annex II is scientifically or technically impracticable; the reliability of substitutes is not ensured; or the total negative environmental, health and consumer safety impacts caused by substitution are likely to outweigh the total environmental, health and consumer safety benefits thereof.

               Furthermore, Article 5(1) provides that the European Commission (the Commission) shall include materials and components of EEE for specific applications in the lists in Annexes III and IV by means of individual delegated acts in accordance with Article 20. Article 5(3) and Annex V establish the procedure for submitting applications for granting, renewing, or revoking an exemption.

               2.CONSULTATIONS PRIOR TO THE ADOPTION OF THE ACT

               Since the publication of RoHS 2, the Commission has received numerous
                  3
                requests from economic operators, according to the provisions in Article 5(3) and Annex V, for both granting new and renewing existing exemptions.

               The current Annex III exemption 15 permits the use of lead in solders to complete a viable electrical connection between semiconductor die and carrier within integrated circuit flip chip packages. The Commission received one application for renewal of this exemption in January 2015. While exemption 15 had 21 July 2016 as expiration date for categories 1 to 7 and 10
                  4
               , in line with the requirements of the RoHS Directive (Article 5(5), second subparagraph), it continues to apply until a decision on the renewal application is taken by the Commission.

               With a view to evaluating the application for exemption, the Commission launched a study to carry out the required technical and scientific assessment, including an eightweek online openended stakeholder consultation
                  5
                on the application. Two contributions were made to the stakeholder consultation.

               The final report containing the assessment of the application was published
                  6
               ; stakeholders were notified.

               Subsequently, the Commission consulted the Member States expert group for delegated acts under RoHS 2 in written form as agreed during a previous meeting
                  7
               . The experts agreed with the draft presented by the Commission, with a large 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. Four comments were received, all supporting the act with one proposing an amended wording (which was assessed in the technical evaluation but rejected) and a prolongation of the transition period to 18 months. All necessary steps relating to exemptions from the substance restriction pursuant to Articles 5(3) to 5(7) have been performed.
                  8
                The Council and the European Parliament were notified of all activities.

               The final report highlighted in particular the following technical information and assessment:

               ·Leaded solders are used in flip chip connections as bumps and solders for attaching the die to the chip carrier. These solders must be resistant to electromigration failure at the extremely high current densities required; able to create a solder hierarchy that allows staged assembly and rework of components in the manufacture process; and have high ductility to reduce thermo-mechanical stress in under bump metallurgy structures, in particular in larger dies.

               ·Currently, substitution or elimination of lead is still scientifically and technically impracticable for certain flip chip packages.

               The evaluation results for categories 1 to 7 and 10 show that at least one of the relevant criteria specified in Article 5(1)(a) is met by the exemption request relating to entry 15 in Annex III. The existing wording of the exemption was amended to narrow down the scope of the exemption to applications for which reliable alternatives are still not available, adding subentry 15(a) to point 15. A validity period until 21 July 2021 was determined; this is not expected to have adverse impacts on innovation. Where reliable alternatives are already available, only negligible socioeconomic impacts of substitution are to be anticipated for this period as gradual substitution with lead free alternatives is already underway.

               For categories other than categories 1 to 7 and 10, the existing exemption remains as per the validity periods set out in Article 5(2). The specific exemption does 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.

               3.LEGAL ELEMENTS OF THE DELEGATED ACT

               The Delegated Directive grants an exemption from the restrictions in Article 4(1), to be listed in Annex III of Directive 2011/65/EU, for the use of lead in specific applications.

               The instrument is a Delegated Directive, as provided for by Directive 2011/65/EU, and in particular meeting the relevant requirements of Article 5(1)(a) thereof.

               The objective of the Delegated Directive is to contribute to the protection of human health and the environment and approximate the provisions for the functioning of the internal market in the field of electrical and electronic equipment, by allowing the use of otherwise banned substances for specific applications, in line with the provisions and under the conditions of RoHS 2 and the therein established procedure for the adaptation of the Annexes III and IV to scientific and technical progress.

               In accordance with the principle of proportionality, the measure does not go beyond what is necessary to achieve its objective.

               The proposal has no implications for the EU budget.

               COMMISSION DELEGATED DIRECTIVE (EU) .../…

               of 16.11.2018

               amending, for the purposes of adapting to scientific and technical progress, Annex III to Directive 2011/65/EU of the European Parliament and of the Council as regards an exemption for lead in solders to complete a viable electrical connection between semiconductor die and carrier within integrated circuit flip chip packages

               (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
                  9
                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 certain hazardous substances listed in Annex II to that Directive. That requirement does not apply to the applications listed in Annex III to Directive 2011/65/EU.

               (2)
                     The different categories of electrical and electronic equipment for which Directive 2011/65/EU applies (categories 1 to 11) are listed in Annex I to that Directive.

               (3)
                     Lead is a restricted substance listed in Annex II to Directive 2011/65/EU. The use of lead in solders to complete a viable electrical connection between semiconductor die and carrier within integrated circuit flip chip packages was, however, exempted from the restriction and is currently listed in entry 15 of Annex III to that Directive. The expiry date of that exemption was, for categories 1 to 7 and 10, 21 July 2016.

               (4)
                     The Commission received an application for renewal of that exemption before 21 January 2015, in accordance with Article 5(5) of Directive 2011/65/EU. The exemption remains valid until a decision on that application has been adopted.

               (5)
                     Leaded solders are used in flip chip connections as bumps and solders for attaching the die to the chip carrier. The solders must be resistant to electromigration failure at the extremely high current densities required and able to create a solder hierarchy that allows staged assembly and rework of components in the manufacturing process. They must also have high ductility to reduce thermo-mechanical stress in under bump metallurgy structures, in particular in larger dies.

               (6)
                     For certain applications covered by the current exemption, a substitution or elimination of lead is still scientifically and technically impracticable due to the lack of reliable substitutes. The exemption does not weaken the environmental and health protection afforded by Regulation (EC) No 1907/2006 of the European Parliament and of the Council
                  10
               . It should therefore be renewed for those particular applications.

               (7)
                     For all other applications currently covered by the exemption, the conditions for renewal are not fulfilled. The exemption for those applications should continue to apply for 12 months after the date of entry into force of this Delegated Directive in accordance with Article 5(6) of Directive 2011/65/EU.

               (8)
                     Since, for the applications concerned by that renewal, no reliable alternatives are available on the market, the exemption for those applications should be renewed for categories 1 to 7 and 10 for the maximum duration of five years until 21 July 2021. 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.

               (9)
                     For categories other than 1 to 7 and 10, the existing exemption remains valid as per the validity periods set out in the second subparagraph of Article 5(2) of Directive 2011/65/EU. For reasons of clarity, the dates of expiry should be added in Annex III to 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 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.

               Article 4

               This Directive is addressed to the Member States.

               Done at Brussels, 16.11.2018

                     For the Commission

                     The President
                     Jean-Claude JUNCKER

                     (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

                     (4)

                        These categories 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; 10. Automatic dispensers. EEE categories are listed in Annex I to the RoHS Directive.

                     (5)

                  Consultation period
                  : from 21.08.2015 to 16.10.2015

                     (6)

                     https://bookshop.europa.eu/en/assistance-to-the-commission-on-technological-socio-economic-and-cost-benefit-assessment-related-to-exemptions-from-the-substance-restrictions-in-electrical-and-electronic-equipment-pbKH0416554/

                     (7)

                        The consultations were carried out in written form from 27 April until 18 May 2017.

                     (8)

                        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
                  .

                     (9)

                        OJ L 174, 1.7.2011, p. 88.

                     (10)

                        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).

    ---documentbreak---

               ANNEX

               In Annex III, entry 15 is replaced by the following:

                        "15

                        Lead in solders to complete a viable electrical connection between semiconductor die and carrier within integrated circuit flip chip packages

                        Applies to categories 8, 9 and 11 and expires on:

                        -21 July 2021 for categories 8 and 9 other than in vitro diagnostic medical devices and industrial monitoring and control instruments;

                        -21 July 2023 for category 8 in vitro diagnostic medical devices;

                        -21 July 2024 for category 9 industrial monitoring and control instruments, and for category 11.

                        15(a)

                        Lead in solders to complete a viable electrical connection between the semiconductor die and carrier within integrated circuit flip chip packages where at least one of the following criteria applies:

                        -a semiconductor technology node of 90 nm or larger;

                        -a single die of 300 mm2 or larger in any semiconductor technology node;

                        -stacked die packages with die of 300 mm2 or larger, or silicon interposers of 300 mm2 or larger.

                        Applies to categories 1 to 7 and 10 and expires on 21 July 2021."


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

text:
                           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
EN                                               6                 EN
 ---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


title: COMMISSION IMPLEMENTING DIRECTIVE (EU) …/… establishing technical specifications for the marking of firearms and their essential components under Council Directive 91/477/EEC on control of the acquisition and possession of weapons

text:
               COMMISSION IMPLEMENTING DIRECTIVE (EU) …/…

               of 16.1.2019

               establishing technical specifications for the marking of firearms and their essential components under Council Directive 91/477/EEC on control of the acquisition and possession of weapons

               (Text with EEA relevance)

               THE EUROPEAN COMMISSION,

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

               Having regard to Council Directive 91/477/EEC of 18 June 1991 on control of the acquisition and possession of weapons
                  1
               , and in particular Article 4(2a) thereof,

               Whereas:

               (1)Article 4(1) of Directive 91/477/EEC obliges Member States to ensure that firearms and their essential components, whether part of a firearm or placed separately on the market, have a clear, permanent and unique marking applied to them. Article 4(2) of that Directive defines the information to be included in the marking in order to increase the traceability of firearms and their essential components and to facilitate their free movement. For very small essential components, the information that has to be included in the marking is confined to a serial number or alphanumeric or digital code. Article 4(4) of that Directive requires Member States to maintain a data-filing system and to record in it all information needed in order to trace and identify firearms, including information about the marking applied to a firearm and its essential components and information about any conversions or modifications to a firearm leading to a change in its category or sub-category, such as information about the entity that replaced or modified an essential component.

               (2)In the case of a transfer from government stocks to permanent civilian use, the identity of the transferring entity must also be included in the marking. Unless the identity is already present as part of an existing marking, it must be included when the transfer to civilian use occurs.

               (3)Directive 91/477/EEC further obliges Member States to ensure that each elementary package of complete ammunition is marked in such a way as to indicate the name of the manufacturer, the identification batch (lot) number, the calibre and the type of ammunition. Given current market practice for packaging ammunition and the current state of technology, it is not necessary at this stage to establish technical specifications for that marking. This Directive should therefore apply to the marking of firearms and their essential components only (including very small essential components).

               (4)Adequate font size of markings is critical to achieve the objective of increasing traceability of firearms and their essential components. The technical specifications should therefore lay down a minimum font size that Member States should be required to follow when setting the font size for those markings in their national law.

               (5)Having regard to the United Nations International Small Arms Control Standard (ISACS) on marking and recordkeeping, frames and receivers made from non-metallic materials of a kind that risks compromising the clarity and permanence of the marking (for example, frames or receivers made from certain categories of polymer) should be required to have their marking applied to a metal plate that is permanently embedded in the material of the frame or receiver. Member States should be free to allow the use of some other technique, such as deep cut laser engraving, that ensures an equivalent level of clarity and permanence for the marking of frames and receivers made of non-metallic materials.

               (6)To facilitate the traceability of firearms and their essential components in Member States' data-filing systems, Member States should be required to choose from amongst only Latin, Cyrillic or Greek when determining which alphabet or alphabets may be used to mark firearms and their essential components. Similarly, the numeral systems that may be used for the marking of firearms and their essential components should be restricted to Arabic or Roman, as determined by each Member State.

               (7)This Directive is without prejudice to Article 3 of Directive 91/477/EEC.

               (8)In accordance with the Joint Political Declaration of 28 September 2011 of Member States and the Commission on explanatory documents
                  2
               , Member States have undertaken to accompany, in justified cases, the notification of their transposition measures with one or more documents explaining the relationship between the components of a directive and the corresponding parts of national transposition instruments.

               (9)The measures provided for in this Directive are in accordance with the opinion of the Committee established by Article 13b(1) of Directive 91/477/EEC,

               HAS ADOPTED THIS DIRECTIVE:

               Article 1
               Scope

               This Directive applies to firearms and their essential components, but it does not apply to elementary packages of complete ammunition.

               Article 2
               Technical specifications for the marking of firearms and their essential components

               Member States shall ensure that the marking required by Article 4 of Directive 91/477/EEC meets the technical specifications set out in the Annex to this Directive.

               Article 3
               Transposition provisions

               1.Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by [OP: please insert the date that is 12 months after publication of this Directive in the Official Journal of the European Union] at the latest. They shall immediately inform the Commission thereof.

               When Member States adopt those measures, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. The methods of making such reference shall be laid down by Member States.

               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 4
               Entry into force

               This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

               Article 5
               Addressees

               This Directive is addressed to the Member States.

               Done at Brussels, 16.1.2019

                     For the Commission

                     The President
                     Jean-Claude JUNCKER

                     (1)

                        OJ L 256, 13.9.1991, p. 51

                     (2)

                        OJ C 369, 17.12.2011, p. 14.

    ---documentbreak---

               Annex

               Technical specifications for the marking of firearms and their essential components

               1.The font size used in the marking is as laid down by the Member State. The size or minimum size laid down by each Member State shall be at least 1.6 mm. Where required, a smaller font size may be used for the marking of essential components that are too small to be marked in compliance with Article 4 of Directive 91/477/ECC.

               2.For frames or receivers made from a non-metallic material of a kind specified by the Member State, the marking is applied to a metal plate that is permanently embedded in the material of the frame or receiver in such a way that:

               (a)the plate cannot be easily or readily removed, and

               (b)removing the plate would destroy a portion of the frame or receiver.

               Member States may also permit the use of other techniques for marking such frames or receivers, provided that those techniques ensure an equivalent level of clarity and permanence for the marking.

               In determining which non-metallic materials to specify for the purposes of this specification, Member States shall have regard to the extent to which the material may compromise the clarity and permanence of the marking.

               3.The alphabet used in the marking is as laid down by the Member State. The alphabet or alphabets laid down by each Member State shall be Latin, Cyrillic or Greek.

               4.The numeral system used in the marking shall be as laid down by the Member State. The numeral system or systems laid down by each Member State shall be Arabic or Roman.