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 dielectric ceramic in certain capacitors

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 7(c)-II permits the use of lead in dielectric ceramic in capacitors for a rated voltage of 125 V AC or 250 V DC or higher. The Commission received two applications for renewal of this exemption in January 2015. While exemption 7(c)-II 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. One contribution was 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 draft 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:

               ·Discrete ceramic capacitors for a rated voltage of 125 V AC or 250 V DC or higher bear the capability of storing and releasing electric charges (electrostatic capacitance) and are incorporated into high voltage circuits in a wide variety of electrical and electronic equipment. They are used in all types of markets and applications, for example public infrastructure systems, industry automation, oil and mineral exploration, power conversion, high power supplies, telecommunication, and medical devices.

               ·The function of lead in the dielectric ceramic is to obtain high dielectric constant at high operating voltage; high energy storage capability (also at high temperatures); low leakage at high voltage and high temperatures; and low loss at high current, frequency, and temperatures. Currently, substitution or elimination of lead is still scientifically and technically impracticable for some applications. It appears that alternatives can be applied only in some cases.

               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 7(c)-II in Annex III. Since for certain 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. In order to avoid overlapping scopes of exemptions within Annex III, the proposed wording clarifies that applications covered by exemption 7(c)-I and 7(c)-IV are excluded from the exemption 7(c)II.

               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 dielectric ceramic in certain capacitors

               (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 dielectric ceramic in capacitors for a rated voltage of 125 V AC or 250 V DC or higher was, however, exempted from the restriction and is currently listed in entry 7(c)II 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)
                     Discrete ceramic capacitors for a rated voltage of 125 V AC or 250 V DC or higher bear the capability of storing and releasing electric charges (electrostatic capacitance) and are incorporated into high voltage circuits in a wide variety of electrical and electronic equipment. They are used in all types of markets and applications, for example social infrastructure systems, industry automation, oil and mineral exploration, power conversion, high power supplies, telecommunication, and medical devices.

               (6)
                     The function of lead in the dielectric ceramic is to obtain high dielectric constant at high operating voltage, high energy storage capability (also at high temperatures), low leakage at high voltage and high temperatures, and low loss at high current, frequency, and temperatures.

               (7)
                     A substitution or elimination of lead is still scientifically and technically impracticable for certain ceramic capacitors 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 in dielectric ceramic in capacitors for a rated voltage of 125 V AC or 250 V DC or higher should therefore be renewed. For reasons of clarity, it should be added in Annex III to Directive 2011/65/EU that applications covered by entries 7(c)-I and 7(c)-IV are excluded from entry 7(c)-II.

               (8)
                     Since, for the applications concerned, no reliable alternatives are yet available on the market, 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.

               (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 7(c)-II is replaced by the following:

                        "7(c)-II

                        Lead in dielectric ceramic in capacitors for a rated voltage of 125 V AC or 250 V DC or higher

                        Does not apply to applications covered by point 7(c)-I and 7(c)-IV of this Annex.

                        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 in bearings and bushes applied in certain non-road professional use equipment

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 Commission received a request for a new exemption to Annex III for use of lead in bearings and bushes of diesel or gaseous fuel powered internal combustion engines applied in non-road professional use equipment in July 2015 (request no. 2016-1). The exemption was requested for category 11
                  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 an eightweek online openended stakeholder consultation
                  5
                on the application. No contributions were received during 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 during an expert meeting on 22 September 2017. The experts agreed with the proposal 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. 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 bearings and bushes are necessary to achieve satisfactory reliability in large size engines and those operating in harsh or demanding environments to be used in professional use non-road equipment. Such bearings and bushes are used for example in mobile air compressors, mobile welding equipment or cranes.

               ·Currently, there are no lead-free alternatives available on the market which would provide sufficient level of reliability in terms of seizure resistance, conformability, embedability and debris resistance for application areas of professional use non-road equipment engines. Therefore, substitution or elimination of lead is still scientifically and technically impracticable for applications concerned.

               The evaluation results for category 11 show the specific exemption would not weaken the environmental and health protection afforded by Regulation (EC) No 1907/2006 (REACH), in accordance with Article 5 of Directive 2011/65/EU. Furthermore, at least one of the relevant criteria specified in Article 5(1)(a) is met by the exemption request: Since for the applications concerned, no reliable alternatives are available today or are likely to come on the market soon, granting the exemption with the maximum validity period of five years, starting from 22 July 2019
                  8
               , 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. In order to avoid overlapping scopes of exemptions within Annex III, the proposed wording clarifies that applications covered by exemption 6(c) are excluded from the newly granted exemption.

               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 bearings and bushes applied in certain non-road professional use equipment

               (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 are listed in Annex I to that Directive.

               (3)
                     Lead is a restricted substance listed in Annex II to Directive 2011/65/EU. The Commission received, in accordance with Article 5(3) of Directive 2011/65/EU, in July 2015 an application for granting an exemption for category 11, to be listed in Annex III, for use of lead in bearings and bushes of diesel or gaseous fuel powered internal combustion engines applied in non-road professional use equipment.

               (4)
                     Lead containing bearings and bushes are necessary to achieve satisfactory reliability in terms of seizure resistance, conformability, embedability and debris resistance in large size engines and those operating in harsh or demanding environments to be used in professional use non-road equipment, such as mobile air compressors, mobile welding equipment and mobile cranes.

               (5)
                     Currently, there are no lead-free alternatives available on the market which would provide sufficient level of reliability for application areas of professional use non-road equipment engines.

               (6)
                     Due to the lack of reliable substitutes, a substitution or elimination of lead is scientifically and technically impracticable for certain professional use non-road equipment engines. The exemption is consistent with Regulation (EC) No 1907/2006 of the European Parliament and of the Council
                  10
                and thus does not weaken the environmental and health protection afforded by it. The exemption for the use of lead in bearings and bushes of certain diesel or gaseous fuel powered internal combustion engines applied in non-road professional use equipment should therefore be granted, adding a new entry 42 to Annex III to Directive 2011/65/EU. To avoid overlapping scopes of exemptions within Annex III and to ensure legal clarity, it should be added that applications covered by entry 6(c) of Annex III are excluded from the new entry 42 to Annex III to Directive 2011/65/EU.

               (7)
                     Since, for the applications concerned, no reliable alternatives are yet available on the market or are likely to be available on the market in the near future, the exemption for category 11 of Annex I to Directive 2011/65/EU should be granted for the maximum validity period of five years starting from 22 July 2019, which is the date that category 11 enters into the scope of Article 4(1) 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.

               (8)
                     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 21 July 2019 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 22 July 2019.

               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)

                        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 14.03.2015 to 09.05.2016.

                     (6)

                        https://publications.europa.eu/en/publication-detail/-/publication/44a95380-f4e3-11e6-8a35-01aa75ed71a1

                     .

                     (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
                  .

                     (8)

                        Category 11 enters in scope of Directive 2011/65/EU on 22 July 2019. The validity period for category 11 is specified in Article 1 (4) (a) of
                  Directive (EU) 2017/2102 of the European Parliament and of the Council of 15 November 2017
                   amending RoHS 2.

                     (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 42 is added:

                        "42

                        Lead in bearings and bushes of diesel or gaseous fuel powered internal combustion engines applied in non-road professional use equipment:

                        -with engine total displacement ≥ 15 litres;
                           or

                        -with engine total displacement < 15 litres and the engine is designed to operate in applications where the time between signal to start and full load is required to be less than 10 seconds; or regular maintenance is typically performed in a harsh and dirty outdoor environment, such as mining, construction, and agriculture applications.

                        Applies to category 11, excluding applications covered by entry 6(c) of this Annex.

                        Expires on 21 July 2024."


title: COMMISSION DELEGATED DIRECTIVE (EU) .../… amending Annexes II, III and V to Directive (EU) 2016/1629 of the European Parliament and of the Council laying down technical requirements for inland waterway vessels

text:
               EXPLANATORY MEMORANDUM

               1.CONTEXT OF THE DELEGATED ACT

               1.1 European Committee for drawing up Standards in Inland Navigation (CESNI)

               The Central Commission for Navigation on the Rhine (CCNR) is an international organisation with regulatory competences for inland navigation transport matters in the Rhine. Four Member States (Belgium, France, Germany and the Netherlands) and Switzerland are parties to the CCNR.

               In 2015, the CCNR approved the creation and functioning of the European Committee for drawing up Standards in Inland Navigation (CESNI). Its mission includes the adoption of technical standards in inland navigation in various fields, in particular as regards vessels, information technology and crew, the uniform interpretation of these standards and of the corresponding procedures as well as deliberations on safety of navigation, protection of environment or other areas of navigation.

               CESNI is composed of experts representing Member States of the CCNR and of the EU which have voting rights on the basis of one vote per State.

               The EU is not a party to the CCNR or to CESNI. However, it may participate in the work of CESNI, along with international organisations whose mission covers the areas concerned by CESNI, without voting rights.

               CESNI adopts standards by unanimity of the CCNR and EU Member States present. In the absence of a consensus regarding the decision to put the adoption of standards on the agenda, CESNI decides by two-thirds majority of the votes of those Members present at the meeting. In a second step, the CESNI adopts standards by unanimity of the votes of the CCNR and EU Member States present. Once decided, standards are given a unique reference number and are published.

               The CCNR has built up significant experience in establishing technical requirements for inland waterway vessels. Established in the framework of the CCNR and with the participation of all EU Member States, CESNI therefore possesses the necessary expertise and geographical representativeness to draw up standards common to the entire network of inland waterways in the European Union.

               1.2 The European standard laying down technical requirements for inland navigation vessels (ES-TRIN)

               One of the standards established by CESNI is the European standard laying down technical requirements for inland navigation vessels (the ES-TRIN standard). This standard lays down the uniform technical requirements necessary to ensure the safety of inland waterway vessels. It includes provisions regarding shipbuilding, fitting out and equipment for inland waterway vessels, special provisions regarding specific categories of vessels such as passenger vessels, pushed convoys and container vessels, provisions regarding vessel identification, model of certificates and register, transitional provisions as well as instructions for the application of the technical standard.

               The first version of the ES-TRIN standard (ES-TRIN 2015) was adopted at the CESNI meeting on 26 November 2015.

               The ES-TRIN standard is regularly updated taking account of the work of the CESNI working groups.

               Regular up-date of the ES-TRIN standard is necessary to:

               maintain the high level of safety in inland navigation

               follow the technical evolution (ex. wheelhouse, navigation equipment)

               ensure compatibility with EU legal framework (ex. Non-Road Mobile Machinery regulation)

               CESNI adopted the updated version of the ES-TRIN standard (ES-TRIN 2017/1) at the meeting on 6 July 2017. This edition incorporates various amendments in particular concerning the following areas:

               elevating wheelhouse

               updating of the reference to various international standards

               emission of gaseous and particulate pollutants from engines

               requirements for traditional craft

               electrical equipment and installations

               fire – fighting systems

               manufacturer’s plate for cranes

               updating of the provisions on navigation and information equipment

               corrections of the transitional provisions on type approved equipment

               1.3 Consistency of the legal regimes for technical requirements

               Directive (EU) 2016/1629 of the European Parliament and of the Council of 14 September 2016 laying down technical requirements for inland waterway vessels, amending Directive 2009/100/EC and repealing Directive 2006/87/EC, includes a direct reference to the ES-TRIN standard.

               In order to ensure consistency of two existing legal regimes for technical requirements for inland navigation vessels (Rhine and UE) it is necessary to provide the same standards. Both EU law and CCNR Regulations will be referring to standards delivered by CESNI – to the ES-TRIN standard 2017/01 from 7 October 2018 (deadline of transposition of Directive (EU) 2016/1629 and date of applicability of ES-TRIN 2017/01).

               EU law and the regulatory regime of the CCNR for inland waterway vessels will be fully aligned as of 7 October 2018.

               In addition to the amendment of Annex II (reference to the ES-TRIN standard 2017/1), the amendments of Annex III and V are necessary to keep consistency between Directive 2016/1629 and ES-TRIN 2017/01.

               2.CONSULTATIONS PRIOR TO THE ADOPTION OF THE ACT

               In accordance with Article 32 of Directive (EU) 2016/1629 before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with principles laid down in the Interinstitutional Agreement of 13 April 2016 on Better Law-Making. It is foreseen to present the draft of the delegated act at the meeting of the Commission expert group on technical requirements for inland waterway vessels. The meeting was organized on 13 of October 2017.

               Moreover, in order to inform widely experts and to ensure consistency between CESNI activities and the EU legal framework, the European Commission gave a presentation of the draft delegated act at the meeting of working group CESNI/PT scheduled on 27 and 28 September 2017.

               3.LEGAL ELEMENTS OF THE DELEGATED ACT

               3.1 Update the reference to ES-TRIN

               Annex II to Directive (EU) 2016/1629 directly refers to the ES-TRIN standard 2015/1 for technical requirements applicable for craft. In accordance with Article 31 (1) of this Directive, the Commission is empowered to update that reference to the most recent version of the ES-TRIN standard and to set the date of its application. Considering the publication of the ES-TRIN standard 2017/1, as most recent version of the ES-TRIN, the draft delegated act ensures the relevant updates. The date of application is 7 October 2018.

               3.2 Procedural provisions for traditional craft

               The ES-TRIN standard 2017/1 includes special provisions for the traditional craft. To keep the consistency between requirements of Directive (EU) 2016/1629 and the ES-TRIN standard, as well as to streamline the procedural provisions, it is necessary to amend Annex V to the Directive regarding detailed procedural provisions. Article 2.01 (2) of Annex V regulates composition of the inspection body. In accordance with ES-TRIN 2017/1 in case of obtaining the certificate for traditional craft, it is necessary to carry out an inspection by an expert who has a special knowledge related requirements for traditional vessels. The traditional craft expert is defined by the ES-TRIN standard 2017/1 as follows: “A person appointed by the competent authority or by an authorised institution of a Member State, who possesses special knowledge in the field of traditional craft due to his or her training and experience in the subject, and who is familiar with the relevant technical requirements and rules, also from the time period of the traditional craft.”. This expert has to be a part of the inspection body.

               In accordance with Article 31 (4) of Directive the Commission is empowered to adopt delegated acts concerning the adaptation of Annex V to update and streamline administrative provisions. The draft delegated act ensures the adaptation of Article 2.01 (2) of Annex V to Directive (EU) 2016/1629 to meet ES-TRIN 2017/1 provisions

               3.3 Clarification of the list of possible additional technical requirements applicable to craft on inland waterways of Zones 1, 2 and non-linked 3

               Annex III to Directive (EU) 2016/1629 provides a limitative list of subjects for the national requirements to be adopted by a Member State under Article 23(1) and (2) of this Directive.

               In accordance with Article 31 (3) of Directive (EU) 2016/1629 the Commission is empowered to adopt delegated acts concerning the adaptation of Annex III to scientific and technical progress.

               Paragraph 2 of Annex III to Directive (EU) 2016/1629 should be updated in order to improve consistency with the provisions of the ES-TRIN standard. This paragraph 2 covers the provisions on “Strength” as well as “Stability”, by analogy with Article 3.02 of ES-TRIN. The current title of paragraph 2 is not exactly corresponding to the content of the indents. The draft delegated act ensures the relevant adaptations.

               In July 2017, the Group of recognised inland navigation classification societies (GERC) has pointed out the opportunity to improve the list of Annex III to Directive (EU) 2016/1629.

               Annex III listed subjects for possible additional technical requirements applicable to craft on inland navigation waterways of zones 1,2 and non-linked 3.

               This list is restrictive and does not include subjects for machinery installations.

               For navigation in zones 1 and 2, it seems evident to request the reinforcement of the hull structure in order to resist to a certain wave height (paragraph 2 of Annex III of Directive (EU) 2016/1629). There are not foreseen corresponding subjects for possible technical requirements applicable to machinery installations for operation in such navigation zones, especially in order to assure reliable propulsion for the craft.

               Article 8.01(1) of the ES-TRIN standard does not provide specified requirements for machinery installation and requires only that engines and their ancillaries shall be designed, built and installed in accordance with best practice.

               Adding paragraph “8. Machinery” in Annex III to Directive (EU) 2016/1629 will allow complementary national provisions to be adopted by a Member State for safety purpose.

               The delegated act ensures the relevant adaptations.

               The impacts of the suggested changes of Annex III to Directive (EU) 2016/1629 are very limited because these changes will not require any modifications of the existing national regulations but at the contrary they will improve the legal certainty and the possibilities to ensure safety in zones 1 and 2.

               COMMISSION DELEGATED DIRECTIVE (EU) .../…

               of 18.4.2018

               amending Annexes II, III and V to Directive (EU) 2016/1629 of the European Parliament and of the Council laying down technical requirements for inland waterway vessels

               THE EUROPEAN COMMISSION,

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

               Having regard to Directive (EU) 2016/1629 of the European Parliament and of the Council of 14 September 2016 laying down technical requirements for inland waterway vessels, amending Directive 2009/100/EC and repealing Directive 2006/87/EC
                  1
               , and in particular Article 31(1), (3) and (4) thereof,

               Whereas:

               (1)Directive 2006/87/EC of the European Parliament and of the Council
                  2
                is repealed with effect from 7 October 2018 by Directive (EU) 2016/1629. Annex II to Directive (EU) 2016/1629 lays down that the technical requirements applicable to crafts are those set out in ES-TRIN standard 2015/1.

               (2)Union action in the sector of inland navigation should aim to ensure uniformity in the development of technical requirements for inland waterway vessels to be applied in the Union.

               (3)The European Committee for drawing up standards in the field of inland navigation ('CESNI') has been created on 3 June 2015 in the framework of the Central Commission for the Navigation on the Rhine ('CCNR') in order to develop technical standards for inland waterways in various fields, in particular as regards vessels, information technology and crew.

               (4)CESNI has adopted new European Standard laying down Technical Requirements for Inland Navigations vessels, the ES-TRIN standard 2017/1 at its meeting on 6 July 2017
                  3
               .

               (5)ES-TRIN standard lays down the uniform technical requirements necessary to ensure the safety of inland navigation vessels. It includes provisions regarding shipbuilding, fitting out and equipment for inland navigation vessels, special provisions regarding specific categories of vessels such as passenger vessels, pushed convoys and container vessels, provisions regarding the automatic identification system equipment, provisions regarding vessels identification, a model of certificates and register, transitional provisions as well as instructions for the application of the technical standard.

               (6)The CCNR will amend its legislative framework, the Rhine Vessel Inspection Regulations, to refer to the new standard and make that new standard mandatory in the framework of the application of the Revised Convention for Rhine navigation.

               (7)Directive (EU) 2016/1629 of the European Parliament and of the Council should therefore be amended accordingly.

               (8)In the interest of coherence, the amended provisions should be transposed and apply from the same date, as initially provided for the transposition and the application of Directive (EU) 2016/1629.

               HAS ADOPTED THIS DIRECTIVE:

               Article 1

               Directive (EU) 2016/1629 is amended as follows:

               (1)Annex II is replaced by the text in Annex I to this Directive;

               (2)Annex III is amended in accordance with Annex II to this Directive;

               (3)Annex V is amended in accordance with Annex III to this Directive.

               Article 2

               1.Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive at the latest by 7 October 2018 and which shall apply from this date. They shall forthwith communicate to the Commission the text of those provisions.

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

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

               Article 3

               This Directive shall enter into force on the 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, 18.4.2018

                     For the Commission

                     The President
                     Jean-Claude JUNCKER

                     (1)

                        OJ L 252, 16.9.2016, p. 118.

                     (2)

                        Directive 2006/87/EC of the European Parliament and of the Council of 12 December 2006 laying down technical requirements for inland waterway vessels and repealing Council Directive 82/714/EEC (OJ L 389, 30.12.2006, p. 1).

                     (3)

                        Resolution CESNI 2017-II-1

    ---documentbreak---

               ANNEX I

               "ANNEX II

               MINIMUM TECHNICAL REQUIREMENTS APPLICABLE TO CRAFT ON INLAND WATERWAYS OF ZONES 1, 2, 3 AND 4

               The technical requirements applicable to craft are those set out in ES-TRIN standard 2017/1.".

               ANNEX II

               Annex III to Directive (EU) 2016/1629 is amended as follows:

               (1) point 2 is replaced by the following:

               "2. Strength and stability

               — Structure reinforcement and stability

               — Certificate/attestation by a recognised classification society";

               (2) the following point 8 is added:

               "8. Machinery

               –Steering systems

               –Propeller shafts and accessories

               –Propulsion engines, coupling and accessories

               –Presence of a bow-thruster

               –Bilge systems and firefighting installations

               –Emergency power sources and electrical installations

               –Certificate/attestation by a recognised classification society".

               ANNEX III

               In Annex V to Directive (EU) 2016/1629, in Article 2.01, paragraph 2 is amended as follows:

               (1) point (c) is replaced by the following:

               "(c) a nautical expert in possession of an inland waterways boatmaster's licence which authorises the holder to sail the vessel to be inspected;";

               (2) the following point (d) is added:

               "(d) a traditional craft expert for the inspection of  traditional craft.".


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 as activator in the fluorescent powder of discharge lamps containing phosphors

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 18(b) permits the use of lead as activator in the fluorescent powder (1% lead by weight or less) of discharge lamps when used as sun tanning lamps containing phosphors such as BSP (BaSi2O5:Pb). The Commission received two applications for renewal of this exemption in December 2014 and January 2015. While exemption 18(b) 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. Moreover, the Commission received in January 2015 a request no. 2015-3 for a new exemption to be added to Annex IV for discharge lamps when used as phototherapy lamps containing phosphors. As the assessment showed that it is mechanically possible that a lamp intended for medical use can fit in tanning equipment and vice versa, it was decided to merge these exemption requests under the assessment of exemption 18(b).

               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. One contribution was 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 during an expert meeting on 15 December 2016, which also involved presentations from the applicants and stakeholders most concerned. The experts agreed with the draft presented by the Commission, with a large majority of absent or 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. Two comments were received, both addressing the issue of categories applicable to the wording of the draft Delegated Directive. The comments were taken into account and the draft Delegated Directive was correspondingly amended. During the second four-week public feedback period following this amendment, four comments were received, all of them supporting the draft Delegated Directive, with one requesting an immediate applicability and longer validity period. All necessary 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 activator in the fluorescent powder is required to allow the barium silicate phosphor to fluoresce. It transforms the 254 nm radiation to the designed UV (290nm-400nm) radiation and it is used in over 95% of the indoor low pressure mercury vapour fluorescent lamps in tanning and certain medical applications. It provides UV intensity at the wavelength of 350 nm that is crucial in order to initiate skin pigmentation (tanning result).

               ·Tanning equipment is strictly regulated in the EU and any possible alternative to lead would have to fulfil criteria on reliability, safety and health risk concerns. Currently, there are no such alternatives available and the substitution of lead hence is scientifically and technically impracticable.

               The evaluation results for category 1 to 7 and 10 show the specific exemption is consistent with Regulation (EC) No 1907/2006 (REACH) and thus does not weaken the environmental and health protection afforded by it, 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 relating to entry 18(b) in Annex III. Since for the applications concerned, no sufficiently reliable alternatives are available today or are likely to come on the market soon, 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. Furthermore, in view of request no. 2015-3 and the fact that it is mechanically possible that a lamp intended for medical or tanning use can fit in the same luminaire or equipment, a new sub-entry to the exemption 18(b) specific to medical applications (except those covered under point 34 of Annex IV) shall be added.

               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).

               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 as activator in the fluorescent powder of discharge lamps containing phosphors

               (Text with EEA relevance)

               THE EUROPEAN COMMISSION,

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

               Having regard to Directive 2011/65/EU of the European Parliament and of the Council of 8 June 2011 on the restriction of the use of certain hazardous substances in electrical and electronic equipment
                  8
                and in particular Article 5(1)(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 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 as activator in the fluorescent powder (1% lead by weight or less) of discharge lamps when used as sun tanning lamps containing phosphors such as BSP (BaSi2O5:Pb) was, however, exempted from the restriction and is as such currently listed in entry 18(b) of Annex III to that Directive. The original expiry date of that exemption was, for categories 1 to 7 and 10, 21 July 2016, in accordance with the second subparagraph of Article 5(2) of that Directive.

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

               (5)
                     Moreover, the Commission received in January 2015 a request no. 2015-3 for a new exemption to be added to Annex IV for discharge lamps when used as phototherapy lamps (medical equipment) containing phosphors. As the assessment showed that it is mechanically possible that a lamp intended for medical use can fit in tanning equipment and vice versa, it was decided to merge these exemption requests under the assessment of exemption under entry 18(b) in Annex III.

               (6)
                     Lead activator in the fluorescent powder is required to allow the barium silicate phosphor to fluoresce. It transforms the 254 nm radiation to the designed UV (290nm-400nm) radiation and it is used in over 95% of the indoor low pressure mercury vapour fluorescent lamps in tanning and certain medical applications. It provides UV intensity at the wavelength of 350 nm that is crucial in order to initiate skin pigmentation.

               (7)
                     Tanning equipment is strictly regulated in the Union and any possible alternative to lead would have to fulfil criteria on reliability, safety and health risk concerns. Currently, there are no such alternatives available.

               (8)
                     Due to the lack of reliable substitutes, a substitution or elimination of lead is still scientifically and technically impracticable for certain discharge lamps containing phosphors. The exemption is consistent with Regulation (EC) No 1907/2006 of the European Parliament and of the Council
                  9
                and thus does not weaken the environmental and health protection afforded by it. The exemption for the use of lead as activator in the fluorescent powder (1% lead by weight or less) of discharge lamps when used as sun tanning lamps containing phosphors should therefore be renewed.

               (9)
                     Since, for the applications concerned, no reliable alternatives are yet available on the market, the exemption for categories 1 to 7 and 10 of Annex I to Directive 2011/65/EU should be renewed for the maximum validity period 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.

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

               (11)
                     In view of request no. 2015-3 and the fact that it is mechanically possible for a lamp intended for medical use to fit in tanning equipment and vice versa, a new sub-entry 18(b)-I should be added in Annex III to Directive 2011/65/EU specific to medical applications with the exception of those covered by entry 34 of Annex IV to Directive 2011/65/EU. This sub-entry should apply to categories 5 and 8 and be valid until 21 July 2021.

               (12)
                     Directive 2011/65/EU should therefore be amended accordingly,

               HAS ADOPTED THIS DIRECTIVE:

               Article 1

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

               Article 2

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

               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)

                        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
                  .

                     (8)

                        OJ L 174, 1.7.2011, p. 88.

                     (9)

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

    ---documentbreak---

               ANNEX

               In Annex III, entry 18(b) is replaced by the following:

                        "18(b)

                        Lead as activator in the fluorescent powder (1% lead by weight or less) of discharge lamps when used as sun tanning lamps containing phosphors such as BSP (BaSi2O5:Pb)

                        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.

                        18(b)-I

                        Lead as activator in the fluorescent powder (1 % lead by weight or less) of discharge lamps containing phosphors such as BSP (BaSi2O5:Pb) when used in medical phototherapy equipment

                        Applies to categories 5 and 8, excluding applications covered by entry 34 of Annex IV, and expires on 21 July 2021."


title: COMMISSION IMPLEMENTING DIRECTIVE (EU) …/… amending the list of genera and species in Article 2(1)(b) of Council Directive 2002/55/EC, in Annex II to Council Directive 2008/72/EC and in the Annex to Commission Directive 93/61/EEC

text:
               COMMISSION IMPLEMENTING DIRECTIVE (EU) …/…

               of 17.6.2019

               amending the list of genera and species in Article 2(1)(b) of Council Directive 2002/55/EC, in Annex II to Council Directive 2008/72/EC and in the Annex to Commission Directive 93/61/EEC

               (Text with EEA relevance)

               THE EUROPEAN COMMISSION,

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

               Having regard to Council Directive 2002/55/EC of 13 June 2002 on the marketing of vegetable seed
                  1
               , and in particular Article 2(2) thereof,

               Having regard to Council Directive 2008/72/EC of 15 July 2008 on the marketing of vegetable propagating and planting material other than seed
                  2
               , and in particular Articles 1(3) and 22 thereof,

               Having regard to Commission Directive 93/61/EEC of 2 July 1993 setting out the schedules indicating the conditions to be met by vegetable propagating and planting material, other than seed pursuant to Council Directive 92/33/EEC
                  3
               , and in particular Article 1 thereof,

               Whereas:

               (1)Council Directives 2002/55/EC and 2008/72/EC provide for the species they cover by way of a two-column table, one column listing the scientific name of the species and the other one listing one or several common names for each species.

               (2)Certain varieties of vegetable species belong to species listed under their scientific names, but not to the types of varieties described by the common names. Therefore, it should be specified whether a variety is covered by the scope of Directives 2002/55/EC and 2008/72/EC.

               (3)This specification should take into account the fact that, while some varieties of certain diverse vegetable species are marketed widely in the Union, others have nationally or regionally limited markets. It would thus not be appropriate to cover all varieties of those vegetable species. It should therefore be specified that for certain species all varieties are to be covered, while for certain other species only certain varieties should be covered.

               (4)The International Code of Nomenclature for Cultivated Plants (ICNCP) introduced the formal category of 'Group' to classify varieties of cultivated species. The category of 'Group' is a suitable instrument to define the varieties belonging to a certain species, which fall within the scope of Directives 2002/55/EC and 2008/72/EC.

               (5)For the purpose of specifying whether all varieties of a vegetable species or only certain Groups are covered, the tables of species provided for in Directives 2002/55/EC and 2008/72/EC should be amended. The respective botanical names of vegetable species and the Group names belonging to them should be presented in a hierarchical order as to eliminate any possible ambiguity with respect to the scope of the varieties of the species concerned.

               (6)The use of interspecific hybridisation and of intra-specific hybridisation of varieties can result in varieties of vegetable species that are not included into any established species or Group. In order to include such types of varieties in the scope of Directive 2002/55/EC, the list of species should include hybrids between species and Groups indicated in the list in point (b) of Article 2.1 of that Directive.

               (7)The Groups indicated in the list in point (b) of Article 2.1 of Directive 2002/55/EC should also be reflected, where appropriate, in the lists in Annex II, point 3(a), and Annex III, point 2 of that Directive.

               (8)Directives 2002/55/EC, 2008/72/EC and 93/61/EEC should therefore be amended accordingly.

               (9)Moreover, Commission Directive 93/61/EEC implements Article 4 of Council Directive 92/33/EC, which has been repealed and replaced by Article 4 of Council Directive 2008/72/EC. The Annex to Directive 93/61/EEC establishes a schedule indicating the conditions to be met by vegetable propagating material listing those species and the harmful organisms liable to affect their quality.

               (10)The botanical names of certain species in Directive 93/61/EEC should be updated in accordance with the development of scientific knowledge, as part of updating the respective schedule.

               (11)The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed.

               HAS ADOPTED THIS DIRECTIVE:

               Article 1
               Amendments to Directive 2002/55/EC

               Directive 2002/55/EC is amended in accordance with part A of the Annex to this Directive.

               Article 2
               Amendments to Directive 2008/72/EC

               Annex II to Directive 2008/72/EC is replaced by the text set out in part B of the Annex to this Directive.

               Article 3
               Amendments to Directive 93/61/EEC

               The Annex of Directive 93/61/EEC is amended in accordance with part C of the Annex to this Directive.

               Article 4
               Transposition

               Member States shall adopt and publish, by 30 June 2020, the laws, regulations and administrative provisions necessary to comply with this Directive. They shall immediately inform the Commission thereof.

               They shall apply those provisions from 1 July 2020.

               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.

               Article 5
               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 6
               Addressees

               This Directive is addressed to the Member States.

               Done at Brussels, 17.6.2019

                     For the Commission

                     The President

                     Jean-Claude JUNCKER

                     (1)

                        OJ L 193, 20.7.2002, p. 33.

                     (2)

                        OJ L 205, 1.8.2008, p. 28.

                     (3)

                        Commission Directive 93/61/EEC of 2 July 1993 setting out the schedules indicating the conditions to be met by vegetable propagating and planting material, other than seed pursuant to Council Directive 92/33/EEC (OJ L 250, 7.10.1993, p. 19).

    ---documentbreak---

               EN

               ANNEX

               Part A

               Directive 2002/55/EC is amended as follows:

               (1) point (b) of Article 2(1) is replaced by the following:

               "Allium cepa L.

               — Cepa Group (Onion, Echalion)

               — Aggregatum Group (Shallot)

               Allium fistulosum L. (Japanese bunching onion or Welsh onion)

               — all varieties

               Allium porrum L. (Leek)

               — all varieties

               Allium sativum L. (Garlic)

               — all varieties

               Allium schoenoprasum L. (Chives)

               — all varieties

               Anthriscus cerefolium (L.) Hoffm. (Chervil)

               — all varieties

               Apium graveolens L.

               — Celery Group

               — Celeriac Group

               Asparagus officinalis L. (Asparagus)

               — all varieties

               Beta vulgaris L.

               — Garden Beet Group (Beetroot including Cheltenham beet)

               — Leaf Beet Group (Spinach beet or Chard)

               Brassica oleracea L.

               — Kale Group

               — Cauliflower Group

               — Capitata Group (Red cabbage and White cabbage)

               — Brussel Sprouts Group

               — Kohlrabi Group

               — Savoy Cabbage Group

               — Broccoli Group (calabrese type and sprouting type)

               — Palm Kale Group

               — Tronchuda Group (Portuguese cabbage)

               Brassica rapa L.

               — Chinese Cabbage Group

               — Vegetable Turnip Group

               Capsicum annuum L. (Chili or Pepper)

               — all varieties

               Cichorium endivia L. (Endive)

               — all varieties

               Cichorium intybus L.

               — Witloof Chicory Group

               — Leaf Chicory Group (Large-leaved chicory or Italian chicory)

               — Industrial (Root) Chicory Group

               Citrullus lanatus (Thunb.) Matsum. et Nakai (Watermelon)

               — all varieties

               Cucumis melo L. (Melon)

               — all varieties

               Cucumis sativus L.

               — Cucumber Group

               — Gherkin Group

               Cucurbita maxima Duchesne (Gourd)

               — all varieties

               Cucurbita pepo L. (Marrow, including mature pumpkin and scallop squash, or Courgette, including immature scallop squash)

               — all varieties

               Cynara cardunculus L.

               — Globe Artichoke Group

               — Cardoon Group

               Daucus carota L. (Carrot and Fodder Carrot)

               — all varieties

               Foeniculum vulgare Mill. (Fennel)

               — Azoricum Group

               Lactuca sativa L. (Lettuce)

               — all varieties

               Solanum lycopersicum L. (Tomato)

               — all varieties

               Petroselinum crispum (Mill.) Nyman ex A. W. Hill

               — Leaf Parsley Group

               — Root Parsley Group

               Phaseolus coccineus L. (Runner bean)

               — all varieties

               Phaseolus vulgaris L.

               — Dwarf French Bean Group

               — Climbing French Bean Group

               Pisum sativum L.

               — Round Pea Group

               — Wrinkled Pea Group

               — Sugar Pea Group

               Raphanus sativus L.

               — Radish Group

               — Black Radish Group

               Rheum rhabarbarum L. (Rhubarb)

               — all varieties

               Scorzonera hispanica L. (Scorzonera or Black salsify)

               — all varieties

               Solanum melongena L. (Aubergine or Eggplant)

               — all varieties

               Spinacia oleracea L. (Spinach)

               — all varieties

               Valerianella locusta (L.) Laterr. (Corn salad or Lamb’s lettuce)

               — all varieties

               Vicia faba L. (Broad bean)

               — all varieties

               Zea mays L.

               — Sweet Corn Group

               — Popcorn Group

               All hybrids of the species and Groups listed above."

               (2) in the first column of the table in point 3(a) of Annex II , the entries between ‘Asparagus officinalis’ and ‘Cichorium endivia’ are replaced by the following:

                  ‘Beta vulgaris (Garden Beet Group)

                  Beta vulgaris (other than Garden Beet Group)

                  Brassica oleracea (Cauliflower Group)

                  Brassica oleracea (other than Cauliflower Group)

                  Brassica rapa (Chinese Cabbage Group)

                  Brassica rapa (Vegetable Turnip Group)

                  Capsicum annuum

                  Cichorium intybus (Witloof Chicory Group, Leaf Chicory Group)

                  Cichorium intybus (Industrial (Root) Chicory Group)’.

               (3) in the first column of the table in point 2 of Annex III, the entries between ‘Capsicum annuum’ and ‘Cichorium endivia’ are replaced by the following:

               ‘Cichorium intybus (Witloof Chicory Group, Leaf Chicory Group)

                  Cichorium intybus (Industrial (Root) Chicory Group)’.

               Part B

               "Allium cepa L.

               — Cepa Group (Onion, Echalion)

               — Aggregatum Group (Shallot)

               Allium fistulosum L. (Japanese bunching onion or Welsh onion)

               — all varieties

               Allium porrum L. (Leek)

               — all varieties

               Allium sativum L. (Garlic)

               — all varieties

               Allium schoenoprasum L. (Chives)

               — all varieties

               Anthriscus cerefolium (L.) Hoffm. (Chervil)

               — all varieties

               Apium graveolens L.

               — Celery Group

               — Celeriac Group

               Asparagus officinalis L. (Asparagus)

               — all varieties

               Beta vulgaris L.

               — Garden Beet Group (Beetroot including Cheltenham beet)

               — Leaf Beet Group (Spinach beet or Chard)

               Brassica oleracea L.

               — Kale Group

               — Cauliflower Group

               — Capitata Group (Red cabbage and White cabbage)

               — Brussel Sprouts Group

               — Kohlrabi Group

               — Savoy Cabbage Group

               — Broccoli Group (calabrese type and sprouting type)

               — Palm Kale Group

               — Tronchuda Group (Portuguese cabbage)

               Brassica rapa L.

               — Chinese Cabbage Group

               — Vegetable Turnip Group

               Capsicum annuum L. (Chili or Pepper)

               — all varieties

               Cichorium endivia L. (Endive)

               — all varieties

               Cichorium intybus L.

               — Witloof Chicory Group

               — Leaf Chicory Group (Large-leaved chicory or Italian chicory)

               — Industrial (Root) Chicory Group

               Citrullus lanatus (Thunb.) Matsum. et Nakai (Watermelon)

               — all varieties

               Cucumis melo L. (Melon)

               — all varieties

               Cucumis sativus L.

               — Cucumber Group

               — Gherkin Group

               Cucurbita maxima Duchesne (Gourd)

               — all varieties

               Cucurbita pepo L. (Marrow, including mature pumpkin and scallop squash, or Courgette, including immature scallop squash)

               — all varieties

               Cynara cardunculus L.

               — Globe Artichoke Group

               — Cardoon Group

               Daucus carota L. (Carrot and Fodder Carrot)

               — all varieties

               Foeniculum vulgare Mill. (Fennel)

               — Azoricum Group

               Lactuca sativa L. (Lettuce)

               — all varieties

               Solanum lycopersicum L. (Tomato)

               — all varieties

               Petroselinum crispum (Mill.) Nyman ex A. W. Hill

               — Leaf Parsley Group

               — Root Parsley Group

               Phaseolus coccineus L. (Runner bean)

               — all varieties

               Phaseolus vulgaris L.

               — Dwarf French Bean Group

               — Climbing French Bean Group

               Pisum sativum L.

               — Round Pea Group

               — Wrinkled Pea Group

               — Sugar Pea Group

               Raphanus sativus L.

               — Radish Group

               — Black Radish Group

               Rheum rhabarbarum L. (Rhubarb)

               — all varieties

               Scorzonera hispanica L. (Scorzonera or Black salsify)

               — all varieties

               Solanum melongena L. (Aubergine or Eggplant)

               — all varieties

               Spinacia oleracea L. (Spinach)

               — all varieties

               Valerianella locusta (L.) Laterr. (Corn salad or Lamb’s lettuce)

               — all varieties

               Vicia faba L. (Broad bean)

               — all varieties

               Zea mays L.

               — Sweet Corn Group

               — Popcorn Group."

               Part C

               In the Annex to Directive 93/61/EEC, the column 'Genus or species' is amended as follows:

               (a)the words “Allium ascalonicum” are replaced by the words “Allium cepa – Aggregatum Group”;

               (b)the words “Allium cepa” are replaced by the words “Allium cepa – Cepa Group”;

               (c)the words “Brassica pekinensis” are replaced by the words “Brassica rapa – Chinese Cabbage Group”;

               (d)the words “Lycopersicon lycopersicum” are replaced by the words “Solanum lycopersicum”.