title: Commission Implementing Directive (EU) 2020/432 of 23 March 2020 amending Council Directive 2002/55/EC with regard to the definition of vegetables and the list of genera and species in Article 2(1)(b) (Text with EEA relevance)

text:
                  24.3.2020

                  EN

                  Official Journal of the European Union

                  L 88/3

         COMMISSION IMPLEMENTING DIRECTIVE (EU) 2020/432
         of 23 March 2020
         amending Council Directive 2002/55/EC with regard to the definition of vegetables and the list of genera and species in Article 2(1)(b)
         (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,
         Whereas:

                     (1)

                     In Commission Implementing Directive (EU) 2019/990 (2), which amended Article 2(1)(b) of Directive 2002/55/EC, the definition of ‘vegetables’ preceding the table in that Article was erroneously deleted. As a result, Article 2(1)(b) of Directive 2002/55/EC no longer contains a definition of ‘vegetables’, which is an essential part of that Directive.

                     (2)

                     Directive 2002/55/EC should therefore be corrected accordingly.

                     (3)

                     For reasons of legal certainty, the transposition date set out in this Directive should match the transposition date set out in Implementing Directive (EU) 2019/990.

                     (4)

                     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
            Amendment to Directive 2002/55/EC
            Directive 2002/55/EC is amended as set out in the Annex to this Directive.

            Article 2
            Transposition

               1.   Member States shall adopt and publish, by 30 June 2020 at the latest, 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.

               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
            Addressees
            This Directive is addressed to the Member States.

            Done at Brussels, 23 March 2020.

                  For the Commission

                  The President

               Ursula VON DER LEYEN

            (1)  OJ L 193, 20.7.2002, p. 33.

            (2)  Commission Implementing Directive (EU) 2019/990 of 17 June 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 (OJ L 160, 18.6.2019, p. 14).

            ANNEX
            In Directive 2002/55/EC, point (b) of Article 2(1) is replaced by the following:

                        ‘(b)

                        “vegetables”: means plants of following species intended for agricultural or horticultural production, but not for ornamental uses:

               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.’


title: Commission Delegated Directive (EU) 2021/647 of 15 January 2021 amending, for the purposes of adapting to scientific and technical progress, Annex III to Directive 2011/65/EU of the European Parliament and of the Council as regards an exemption for the use of certain lead and hexavalent chromium compounds in electric and electronic initiators of explosives for civil (professional) use (Text with EEA relevance)

text:
                  20.4.2021

                  EN

                  Official Journal of the European Union

                  L 133/54

         COMMISSION DELEGATED DIRECTIVE (EU) 2021/647
         of 15 January 2021
         amending, for the purposes of adapting to scientific and technical progress, Annex III to Directive 2011/65/EU of the European Parliament and of the Council as regards an exemption for the use of certain lead and hexavalent chromium compounds in electric and electronic initiators of explosives for civil (professional) use
         (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 (1), 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 listed in Annex III to that Directive.

                     (2)

                     The categories of electrical and electronic equipment to which Directive 2011/65/EU applies are listed in Annex I to that Directive.

                     (3)

                     Lead and hexavalent chromium are restricted substances listed in Annex II to Directive 2011/65/EU.

                     (4)

                     On 19 January 2018, the Commission received an application made in accordance with Article 5(3) of Directive 2011/65/EU for an exemption to be listed in Annex III to that Directive, for the use of lead and hexavalent chromium compounds in electric and electronic initiators of explosives for civil (professional) use (‘the requested exemption’).

                     (5)

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

                     (6)

                     Certain lead and hexavalent chromium compounds are used in essential parts of electric and electronic initiators (EEI), such as electric fuseheads, primary explosive charges and pyrotechnic delay charges. EEI are a part of electric and electronic detonators that are primarily used for mining of minerals, construction and demolition activities, as well as in components of integrated rescue systems.

                     (7)

                     Currently, there are no alternatives for lead diazide, lead styphnate, lead dipicramate, orange lead (lead tetroxide), lead dioxide in EEI and for barium chromate in long time pyrotechnic delay charges of EEI available on the market which would meet all essential requirements in order to ensure safe operation of EEI.

                     (8)

                     Due to the lack of alternatives, a substitution or elimination of lead diazide, lead styphnate, lead dipicramate, orange lead (lead tetroxide), lead dioxide and barium chromate is scientifically and technically impracticable in certain EEI components. The exemption is consistent with Regulation (EC) No 1907/2006 of the European Parliament and of the Council (2) and thus does not weaken the environmental and health protection afforded by it.

                     (9)

                     It is, therefore, appropriate to grant the requested exemption by including the applications covered by it in Annex III to Directive 2011/65/EU with respect to electrical and electronic equipment of category 11.

                     (10)

                     The requested exemption should be granted for a duration of 5 years starting from 20 April 2021, in accordance with the first subparagraph of Article 5(2) of Directive 2011/65/EU. In view of the results of the ongoing efforts to find a reliable substitution, the duration of the exemption is unlikely to have adverse impacts on innovation.

                     (11)

                     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 31 October 2021 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 1 November 2021.
               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, 15 January 2021.

                  For the Commission

                  The President

               Ursula VON DER LEYEN

            (1)  OJ L 174, 1.7.2011, p. 88.

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

            ANNEX
            In Annex III to Directive 2011/65/EU, the following entry 45 is added:

                           ‘45

                           Lead diazide, lead styphnate, lead dipicramate, orange lead (lead tetroxide), lead dioxide in electric and electronic initiators of explosives for civil (professional) use and barium chromate in long time pyrotechnic delay charges of electric initiators of explosives for civil (professional) use

                           Applies to category 11 and expires on 20 April 2026’


title: Commission Delegated Directive (EU) 2021/884 of 8 March 2021 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 the validity period of an exemption for the use of mercury in electric rotating connectors used in intravascular ultrasound imaging systems (Text with EEA relevance)

text:
                  2.6.2021

                  EN

                  Official Journal of the European Union

                  L 194/37

         COMMISSION DELEGATED DIRECTIVE (EU) 2021/884
         of 8 March 2021
         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 the validity period of an exemption for the use of mercury in electric rotating connectors used in intravascular ultrasound imaging systems
         (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 (1), 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)

                     Mercury is a restricted substance listed in Annex II to Directive 2011/65/EU.

                     (4)

                     By Delegated Directive (EU) 2015/574 (2), the Commission granted an exemption for the use of mercury in intravascular ultrasound imaging systems (‘the exemption’), by including that application in Annex IV to Directive 2011/65/EU. The exemption was to expire on 30 June 2019, 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 6 October 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. The comments received during these consultations were made publicly available on a dedicated website.

                     (7)

                     Mercury is used in electric rotating connectors of intravascular ultrasound imaging systems which provide the electrical conduction path between the rotating transducer and stationary electronic equipment. The use of mercury enables, inter alia, higher frequency operation which allows obtaining higher resolution imaging beneficial for patients.

                     (8)

                     Due to the lack of alternatives, a substitution or elimination of mercury in the applications concerned is currently scientifically and technically impracticable. The exemption is consistent with Regulation (EC) No 1907/2006 of the European Parliament and of the Council (3) 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 30 June 2026, 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 30 June 2022 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 1 July 2022.
               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, 8 March 2021.

                  For the Commission

                  The President

               Ursula VON DER LEYEN

            (1)  OJ L 174, 1.7.2011, p. 88.

            (2)  Commission Delegated Directive (EU) 2015/574 of 30 January 2015 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 mercury in intravascular ultrasound imaging systems (OJ L 94, 10.4.2015, p. 6).

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

            ANNEX
            In entry 42 of Annex IV to Directive 2011/65/EU, the second paragraph is replaced by the following:

               ‘Expires on 30 June 2026.’


title: Commission Delegated Directive (EU) 2020/360 of 17 December 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)

text:
                  5.3.2020

                  EN

                  Official Journal of the European Union

                  L 67/109

         COMMISSION DELEGATED DIRECTIVE (EU) 2020/360
         of 17 December 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 equipment (1), 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/EU (2), 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.

                     (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 Council (3) 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 31 March 2021 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 1 April 2021.
               When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.

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

            Article 3
            This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

            Article 4
            This Directive is addressed to the Member States.

            Done at Brussels, 17 December 2019.

                  For the Commission

                  The President

               Ursula VON DER LEYEN

            (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).

            (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).

            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.’


title: Commission Delegated Directive (EU) 2020/361 of 17 December 2019 amending, for the purposes of adapting to scientific and technical progress, Annex III to Directive 2011/65/EU of the European Parliament and of the Council as regards an exemption for hexavalent chromium as an anticorrosion agent of the carbon steel cooling system in absorption refrigerators (Text with EEA relevance)

text:
                  5.3.2020

                  EN

                  Official Journal of the European Union

                  L 67/112

         COMMISSION DELEGATED DIRECTIVE (EU) 2020/361
         of 17 December 2019
         amending, for the purposes of adapting to scientific and technical progress, Annex III to Directive 2011/65/EU of the European Parliament and of the Council as regards an exemption for hexavalent chromium as an anticorrosion agent of the carbon steel cooling system in absorption refrigerators
         (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 (1), and in particular Article 5(1)(a) thereof,
         Whereas:

                     (1)

                     Directive 2011/65/EU requires Member States to ensure that electrical and electronic equipment placed on the market does not contain the hazardous substances listed in Annex II to that Directive. That restriction does not apply to the exempted applications listed in Annex III to Directive 2011/65/EU.

                     (2)

                     The categories of electrical and electronic equipment to which Directive 2011/65/EU applies are listed in Annex I to that Directive.

                     (3)

                     Hexavalent chromium is a restricted substance listed in Annex II to Directive 2011/65/EU.

                     (4)

                     An exemption from the restriction for the use of hexavalent chromium as an anticorrosion agent of the carbon steel cooling system in absorption refrigerators up to 0,75 % by weight in the cooling solution (‘the exemption’) is included in Annex III to Directive 2011/65/EU. For categories 1 to 7 and 10, the exemption was to expire on 21 July 2016 in accordance with the second subparagraph of Article 5(2) of that Directive.

                     (5)

                     The Commission received an application for renewal of the exemption (‘the renewal request’) on 20 January 2015, that is within the time limit laid down in Article 5(5) of Directive 2011/65/EU. In accordance with that provision, the exemption remains valid until a decision on the renewal request has been adopted.

                     (6)

                     The evaluation of the renewal request included stakeholder consultations in accordance with Article 5(7) of Directive 2011/65/EU. The evaluation, taking into account the Commission Decisions on authorisations for the placing on the market for the use and/or for use of substances listed in Annex XIV to Regulation (EC) No 1907/2006 (2), led to the conclusion that the current exemption with regard to categories 1 to 7 and 10 is to be divided into two sub-entries with wording clearly reflecting the scientific and technical progress as regards to substitution of hexavalent chromium, which differs depending on the type of application.

                     (7)

                     Hexavalent chromium (Cr(VI)) acts as an anticorrosion agent of the carbon steel cooling system in absorption refrigerators. It is used to create a layer on the interior surface of the steel tubes to protect them from the cooling solution that contains corrosive ammonia.

                     (8)

                     For applications with power input ≥ 75 W and for systems fully operating with non-electrical heaters (corresponding to high boiler temperature applications) which are covered by the current exemption, a substitution or elimination of hexavalent chromium is still scientifically and technically impracticable due to the lack of reliable substitutes. An exemption for these applications is in line with Regulation (EC) No 1907/2006 of the European Parliament and of the Council (3) and thus does not weaken the environmental and health protection afforded by it.

                     (9)

                     It is, therefore, appropriate to grant the requested renewal for applications using high boiler temperatures until 21 July 2021, in accordance with Article 4(3) and the second 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.

                     (10)

                     For applications with power input < 75 W (corresponding to low boiler temperature) currently covered by the exemption, the conditions for renewal set out in Article 5(1) of Directive 2011/65/EU are no longer fulfilled and therefore, the renewal request should be rejected. In accordance with Article 5(6) of that Directive, the exemption for those applications should expire 12 months after the date of entry into force of this Directive.

                     (11)

                     For categories 8, 9 and 11, the existing exemption remains valid as per the validity periods set out in the second subparagraph of Article 5(2) of Directive 2011/65/EU. For reasons of legal clarity, the dates of expiry should be specified in Annex III to that Directive.

                     (12)

                     Directive 2011/65/EU should therefore be amended accordingly,

               HAS ADOPTED THIS DIRECTIVE:

            Article 1
            Annex III to Directive 2011/65/EU is amended as set out in the Annex to this Directive.

            Article 2

               1.   Member States shall adopt and publish, by 31 March 2021 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 1 April 2021.
               When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.

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

            Article 3
            This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

            Article 4
            This Directive is addressed to the Member States.

            Done at Brussels, 17 December 2019.

                  For the Commission

                  The President

               Ursula VON DER LEYEN

            (1)  OJ L 174, 1.7.2011, p. 88.

            (2)  Summary of European Commission Decisions on authorisations for the placing on the market for the use and/or for use of substances listed in Annex XIV to Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) (OJ C 48, 15.2.2017, p. 9).

            (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).

            ANNEX
            In Annex III to Directive 2011/65/EU, entry 9 is replaced by the following:

                           ‘9

                           Hexavalent chromium as an anticorrosion agent of the carbon steel cooling system in absorption refrigerators up to 0,75 % by weight in the cooling solution

                           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.

                           9(a)-I

                           Up to 0,75 % hexavalent chromium by weight, used as an anticorrosion agent in the cooling solution of carbon steel cooling systems of absorption refrigerators (including minibars) designed to operate fully or partly with electrical heater, having an average utilised power input < 75 W at constant running conditions

                           Applies to categories 1-7 and 10 and expires on 5 March 2021.

                           9(a)-II

                           Up to 0,75 % hexavalent chromium by weight, used as an anticorrosion agent in the cooling solution of carbon steel cooling systems of absorption refrigerators:

                                       —

                                       designed to operate fully or partly with electrical heater, having an average utilised power input ≥ 75 W at constant running conditions,

                                       —

                                       designed to fully operate with non-electrical heater.

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


title: Commission Delegated Directive (EU) 2020/362 of 17 December 2019 amending Annex II to Directive 2000/53/EC of the European Parliament and of the Council on end-of-life vehicles as regards the exemption for hexavalent chromium as anti-corrosion agent of the carbon steel cooling system in absorption refrigerators in motor caravans (Text with EEA relevance)

text:
                  5.3.2020

                  EN

                  Official Journal of the European Union

                  L 67/116

         COMMISSION DELEGATED DIRECTIVE (EU) 2020/362
         of 17 December 2019
         amending Annex II to Directive 2000/53/EC of the European Parliament and of the Council on end-of-life vehicles as regards the exemption for hexavalent chromium as anti-corrosion agent of the carbon steel cooling system in absorption refrigerators in motor caravans
         (Text with EEA relevance)
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Directive 2000/53/EC of the European Parliament and of the Council of 18 September 2000 on end-of-life vehicles (1), and in particular Article 4(2)(b) thereof,
         Whereas:

                     (1)

                     Pursuant to Article 4(2)(a) of Directive 2000/53/EC, Member States are to prohibit the use of lead, mercury, cadmium and hexavalent chromium in materials and components of vehicles put on the market after 1 July 2003.

                     (2)

                     Annex II to Directive 2000/53/EC lists vehicle materials and components exempt from the prohibition pursuant to Article 4(2)(a) thereof. Exemption 14 regarding the use of hexavalent chromium needs to be amended to align for coherence the wording of that exemption with similar exemptions for the use of hexavalent chromium provided for in Directive 2011/65/EU of the European Parliament and of the Council (2) and Regulation (EC) No 1907/2006 of the European Parliament and of the Council (3).

                     (3)

                     The assessment of exemption 14 in view of technical and scientific progress led to the conclusion that although suitable alternative substances to hexavalent chromium have become available, they cannot yet be used in products. It is expected that suitable alternatives to the use of hexavalent chromium may become available in the future. It is hence appropriate to split the current exemption in three sub-entries and set an expiry date for two of the sub-entries to the exemption.

                     (4)

                     Directive 2000/53/EC should therefore be amended accordingly.

               HAS ADOPTED THIS DIRECTIVE:

            Article 1
            Annex II to Directive 2000/53/EC is amended as set out in the Annex to this Directive.

            Article 2

               1.   Member States shall adopt and publish by 5 April 2020 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.
               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 day following that of its publication in the Official Journal of the European Union.

            Article 4
            This Directive is addressed to the Member States.

            Done at Brussels, 17 December 2019.

                  For the Commission

                  The President

               Ursula VON DER LEYEN

            (1)  OJ L 269, 21.10.2000, p. 34.

            (2)  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 (OJ L 174, 1.7.2011, p. 88).

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

            ANNEX
            In Annex II to Directive 2000/53/EC, entry 14 is replaced by the following:

                           ‘14. Hexavalent chromium as an anti-corrosion agent of the carbon steel cooling system in absorption refrigerators up to 0,75 % by weight in the cooling solution:

                                       (i)

                                       designed to operate fully or partly with electrical heater, having an average utilised electrical power input < 75W at constant running conditions;

                                       (ii)

                                       designed to operate fully or partly with electrical heater, having an average utilised electrical power input ≥ 75W at constant running conditions;

                                       (iii)

                                       designed to fully operate with non-electrical heater.

                           Vehicles type approved before 1 January 2020 and spare parts for these vehicles
                           Vehicles type approved before 1 January 2026 and spare parts for these vehicles

                           X’


title: Commission Delegated Directive (EU) 2020/363 of 17 December 2019 amending Annex II to Directive 2000/53/EC of the European Parliament and of the Council on end-of-life vehicles as regards certain exemptions for lead and lead compounds in components (Text with EEA relevance)

text:
                  5.3.2020

                  EN

                  Official Journal of the European Union

                  L 67/119

         COMMISSION DELEGATED DIRECTIVE (EU) 2020/363
         of 17 December 2019
         amending Annex II to Directive 2000/53/EC of the European Parliament and of the Council on end-of-life vehicles as regards certain exemptions for lead and lead compounds in components
         (Text with EEA relevance)
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Directive 2000/53/EC of the European Parliament and of the Council of 18 September 2000 on end-of-life vehicles (1), and in particular Article 4(2)(b) thereof,
         Whereas:

                     (1)

                     Pursuant to Article 4(2)(a) of Directive 2000/53/EC, Member States are to prohibit the use of lead, mercury, cadmium and hexavalent chromium in materials and components of vehicles put on the market after 1 July 2003.

                     (2)

                     Annex II to Directive 2000/53/EC lists vehicle materials and components exempt from the prohibition pursuant to Article 4(2)(a) thereof. Pursuant to Annex II, exemptions 8(e), 8(f)(b) and 8(g) are to be reviewed in 2019. Exemption 8(j) also needs to be re-assessed in view of the latest information on technical and scientific progress.

                     (3)

                     An assessment of exemptions 8(e) and 8(g) in view of that information led to the conclusion that there are currently no suitable alternatives to the use of lead for the materials and components covered by those exemptions. A date for a new review of those exemptions should therefore be set. Exemption 8(g), however, should be further specified with a more narrow scope. In order to allow the automotive industry to adapt to those changes, the current scope of exemption 8(g) should be maintained for vehicles of a type approved before 1 October 2022, while the narrower scope of that exemption should apply for vehicles of a type approved from that date.

                     (4)

                     The assessment of exemption 8(f)(b) leads to the conclusion that the use of lead in the applications covered by that exemption should not be prolonged because there are alternatives to the use of lead in those applications.

                     (5)

                     The assessment of exemption 8(j) which gives an exemption to the use of lead in solders for soldering of laminated glazing led to the conclusion that, for some applications, there are alternatives to the use of lead in solders for soldering of laminated glazing. However, there are some glass panes and applications for which there is no certainty that suitable alternatives to the use of lead exist at this time. It is therefore appropriate to lay down a new, more limited, exemption 8(k) for those glass panes and applications.

                     (6)

                     Exemption 8(j) applies only with respect to vehicles of a type approved before 1 January 2020. In order to ensure that the use of lead continues to be exempted for those glass panes and applications for which there is no certainty that suitable alternatives to the use of lead exist at this time, it is necessary for the new exemption 8(k) to apply as soon as possible. Therefore, this Directive should enter into force as a matter of urgency.

                     (7)

                     Directive 2000/53/EC should therefore be amended accordingly,

               HAS ADOPTED THIS DIRECTIVE:

            Article 1
            Annex II to Directive 2000/53/EC is amended as set out in the Annex to this Directive.

            Article 2

               1.   Member States shall adopt and publish by 5 April 2020 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.
               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 day following that of its publication in the Official Journal of the European Union.

            Article 4
            This Directive is addressed to the Member States.

            Done at Brussels, 17 December 2019.

                  For the Commission

                  The President

               Ursula VON DER LEYEN

            (1)  OJ L 269, 21.10.2000, p. 34.

            ANNEX
            Annex II to Directive 2000/53/EC is amended as follows:

                        (1)

                        entry 8(e) is replaced by the following:

                                    ‘8(e). Lead in high melting temperature type solders (i.e. lead-based alloys containing 85 % by weight or more lead)

                                    (2)

                                    X’

                        (2)

                        entry 8(f)(b) is replaced by the following:

                                    ‘8(f)(b). Lead in compliant pin connector systems other than the mating area of vehicle harness connectors

                                    Vehicles type-approved before 1 January 2024 and spare parts for these vehicles

                                    X’

                        (3)

                        entry 8(g) is replaced by the following:

                                    ‘8(g)(i). Lead in solders to complete a viable electrical connection between semiconductor die and carrier within integrated circuit flip chip packages

                                    Vehicles type approved before 1 October 2022 and spare parts for these vehicles

                                    X

                                    8(g)(ii). Lead in solders to complete a viable electrical connection between the semiconductor die and the carrier within integrated circuit flip chip packages where that electrical connection consists of any of the following:

                                                (i)

                                                a semiconductor technology node of 90 nm or larger;

                                                (ii)

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

                                                (iii)

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

                                    (2)
                                    Valid for vehicles type-approved from 1 October 2022 and spare parts for these vehicles

                                    X’

                        (4)

                        the following entry 8(k) is inserted:

                                    ‘8(k). Soldering of heating applications with 0,5 A or more of heat current per related solder joint to single panes of laminated glazings not exceeding wall thickness of 2,1 mm. This exemption does not cover soldering to contacts embedded in the intermediate polymer

                                    Vehicles type approved before 1 January 2024 and spare parts for these vehicles

                                    X(4)’


title: Commission Delegated Directive (EU) 2020/364 of 17 December 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 the use of cadmium in certain radiation tolerant video camera tubes (Text with EEA relevance)

text:
                  5.3.2020

                  EN

                  Official Journal of the European Union

                  L 67/122

         COMMISSION DELEGATED DIRECTIVE (EU) 2020/364
         of 17 December 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 the use of cadmium in certain radiation tolerant video camera 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 (1), 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)

                     Cadmium is a restricted substance listed in Annex II to Directive 2011/65/EU.

                     (4)

                     On 3 December 2015, the Commission received an application made in accordance with Article 5(3) of Directive 2011/65/EU for an exemption to be listed in Annex IV to that Directive, for the use of cadmium in certain radiation tolerant video camera tubes (‘the requested exemption’).

                     (5)

                     The evaluation of the request included stakeholder consultations in accordance with Article 5(7) of Directive 2011/65/EU.

                     (6)

                     Cadmium in video camera tubes is necessary to achieve satisfactory radiation tolerance and optical performance of video cameras operating in environments with high radiation exposure, such as nuclear power plants and nuclear waste reprocessing facilities.

                     (7)

                     Currently, there are no cadmium-free alternatives available on the market which would provide the necessary combination of optical performance and sufficient radiation resistance.

                     (8)

                     Due to the lack of alternatives, a substitution or elimination of cadmium is scientifically and technically impracticable for certain video camera tubes. The exemption is consistent with Regulation (EC) No 1907/2006 of the European Parliament and of the Council (2) and thus does not weaken the environmental and health protection afforded by it.

                     (9)

                     It is, therefore, appropriate to grant the requested exemption by including the applications covered by it in Annex IV to Directive 2011/65/EU with respect to electrical and electronic equipment of category 9.

                     (10)

                     The requested exemption should be granted for a duration of 7 years starting from 5 March 2020, in accordance with the first subparagraph of Article 5(2) of Directive 2011/65/EU. In view of the results of the ongoing efforts to find a reliable substitution, the duration of the exemption is unlikely to have adverse impacts on innovation.

                     (11)

                     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 31 August 2020 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 1 September 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.

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

            Article 3
            This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

            Article 4
            This Directive is addressed to the Member States.

            Done at Brussels, 17 December 2019.

                  For the Commission

                  The President

               Ursula VON DER LEYEN

            (1)  OJ L 174, 1.7.2011, p. 88.

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

            ANNEX
            In Annex IV to Directive 2011/65/EU, the following entry 44 is added:

                           ‘44.

                           Cadmium in radiation tolerant video camera tubes designed for cameras with a centre resolution greater than 450 TV lines which are used in environments with ionising radiation exposure exceeding 100 Gy/hour and a total dose in excess of 100kGy.

                           Applies to category 9. Expires on 31 March 2027.’


title: Commission Delegated Directive (EU) 2020/365 of 17 December 2019 amending, for the purposes of adapting to scientific and technical progress, Annex III to Directive 2011/65/EU of the European Parliament and of the Council as regards an exemption for lead in solders and termination finishes used in certain hand-held combustion engines (Text with EEA relevance)

text:
                  5.3.2020

                  EN

                  Official Journal of the European Union

                  L 67/125

         COMMISSION DELEGATED DIRECTIVE (EU) 2020/365
         of 17 December 2019
         amending, for the purposes of adapting to scientific and technical progress, Annex III to Directive 2011/65/EU of the European Parliament and of the Council as regards an exemption for lead in solders and termination finishes used in certain hand-held combustion engines
         (Text with EEA relevance)
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Directive 2011/65/EU of the European Parliament and of the Council of 8 June 2011 on the restriction of the use of certain hazardous substances in electrical and electronic equipment (1), and in particular Article 5(1)(a) thereof,
         Whereas:

                     (1)

                     Directive 2011/65/EU requires Member States to ensure that electrical and electronic equipment placed on the market does not contain the hazardous substances listed in Annex II to that Directive. That restriction does not apply to the exempted applications listed in Annex III to Directive 2011/65/EU.

                     (2)

                     The categories of electrical and electronic equipment to which Directive 2011/65/EU applies are listed in Annex I to that Directive.

                     (3)

                     Lead is a restricted substance listed in Annex II to Directive 2011/65/EU.

                     (4)

                     By Delegated Directive (EU) 2014/72/EU (2), the Commission granted an exemption for the use of lead in solders and termination finishes of electrical and electronic components and finishes of printed circuit boards used in ignition modules and other electrical and electronic engine control systems, which for technical reasons must be mounted directly on or in the crankcase or cylinder of hand-held combustion engines (classes SH:1, SH:2, SH:3 of Directive 97/68/EC of the European Parliament and of the Council (3)) (“the exemption”) by including those applications in Annex III to Directive 2011/65/EU. The exemption was to expire for categories 1 to 7 and 10 on 31 December 2018, in accordance with the second subparagraph of Article 5(2) of that Directive.

                     (5)

                     The Commission received an application for renewal of the exemption for categories 6 and 11 (“the renewal request”) on 30 June 2017, that is within the time limit laid down in Article 5(5) of Directive 2011/65/EU. In accordance with that provision, the exemption remains valid until a decision on the renewal request has been adopted.

                     (6)

                     The evaluation of the renewal request included stakeholder consultations in accordance with Article 5(7) of Directive 2011/65/EU.

                     (7)

                     Lead is a common alloying element in solder material to control the melting point. Alternative materials to replace the restricted substance have been successfully tested. However, additional time is needed to confirm the reliability of the lead-free products.

                     (8)

                     Currently, there are no lead-free alternatives available on the market which would provide sufficient level of reliability for the applications covered by the exemption.

                     (9)

                     Due to the lack of reliable alternatives, a substitution or elimination of lead is currently scientifically and technically impracticable for certain hand-held combustion engines. It is, therefore, appropriate, to renew the exemption. The renewal of the exemption is consistent with Regulation (EC) No 1907/2006 of the European Parliament and of the Council (4) and thus does not weaken the environmental and health protection afforded by it.

                     (10)

                     The exemption for categories 1 to 7, 10 and 11 should be renewed until 31 March 2022, in accordance with Article 4(3) and the first subparagraph of Article 5(2) of Directive 2011/65/EU. In view of the results of the ongoing efforts to find a reliable substitution, the duration of the exemption is unlikely to have adverse impacts on innovation.

                     (11)

                     For categories 8 and 9, the existing exemption remains valid as per the validity periods set out in the second subparagraph of Article 5(2) of Directive 2011/65/EU. For reasons of legal clarity, the dates of expiry should be specified in Annex III to that Directive.

                     (12)

                     Directive 2011/65/EU should therefore be amended accordingly,

               HAS ADOPTED THIS DIRECTIVE:

            Article 1
            Annex III to Directive 2011/65/EU is amended as set out in the Annex to this Directive.

            Article 2

               1.   Member States shall adopt and publish, by 31 March 2021 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 1 April 2021.
               When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.

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

            Article 3
            This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

            Article 4
            This Directive is addressed to the Member States.

            Done at Brussels, 17 December 2019.

                  For the Commission

                  The President

               Ursula VON DER LEYEN

            (1)  OJ L 174, 1.7.2011, p. 88.

            (2)  Commission Delegated Directive 2014/72/EU of 13 March 2014 amending, for the purposes of adapting to technical progress, Annex III to Directive 2011/65/EU of the European Parliament and of the Council as regards an exemption for lead in solders and termination finishes of electrical and electronic components and finishes of printed circuit boards used in ignition modules and other electrical and electronic engine control systems (OJ L 148, 20.5.2014, p. 78).

            (3)  Directive 97/68/EC of the European Parliament and of the Council of 16 December 1997 on the approximation of the laws of the Member States relating to measures against the emission of gaseous and particulate pollutants from internal combustion engines to be installed in non-road mobile machinery (OJ L 59, 27.2.1998, p. 1). Directive 97/68/EC has been repealed by Regulation (EU) 2016/1628 of the European Parliament and of the Council of 14 September 2016 on requirements relating to gaseous and particulate pollutant emission limits and type-approval for internal combustion engines for non-road mobile machinery, amending Regulations (EU) No 1024/2012 and (EU) No 167/2013, and amending and repealing Directive 97/68/EC (OJ L 252, 16.9.2016, p. 53).

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

            ANNEX
            In Annex III to Directive 2011/65/EU, entry 41 is replaced by the following:

                           ‘41

                           Lead in solders and termination finishes of electrical and electronic components and finishes of printed circuit boards used in ignition modules and other electrical and electronic engine control systems, which for technical reasons must be mounted directly on or in the crankcase or cylinder of hand-held combustion engines (classes SH:1, SH:2, SH:3 of Directive 97/68/EC of the European Parliament and of the Council (*1))

                           Applies to all categories and expires on:

                                       —

                                       31 March 2022 for categories 1 to 7, 10 and 11;

                                       —

                                       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.

               (*1)  Directive 97/68/EC of the European Parliament and of the Council of 16 December 1997 on the approximation of the laws of the Member States relating to measures against the emission of gaseous and particulate pollutants from internal combustion engines to be installed in non-road mobile machinery (OJ L 59, 27.2.1998, p. 1).’


title: Commission Delegated Directive (EU) 2020/366 of 17 December 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 as a thermal stabiliser in polyvinyl chloride used in certain in-vitro diagnostic medical devices for the analysis of blood and other body fluids and body gases (Text with EEA relevance)

text:
                  5.3.2020

                  EN

                  Official Journal of the European Union

                  L 67/129

         COMMISSION DELEGATED DIRECTIVE (EU) 2020/366
         of 17 December 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 as a thermal stabiliser in polyvinyl chloride used in certain in-vitro diagnostic medical devices for the analysis of blood and other body fluids and body gases
         (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 (1), and in particular Article 5(1)(a) thereof,
         Whereas:

                     (1)

                     Article 4(1) of 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 (EU) 2015/573 (2), the Commission granted an exemption for the use of lead as a thermal stabiliser in polyvinyl chloride (PVC) used as base material in amperometric, potentiometric and conductometric electrochemical sensors which are used in in-vitro diagnostic medical devices for the analysis of blood and other body fluids and body gases (‘the exemption’), by including that application 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 25 May 2017, that is within the time limit laid down in Article 5(5) of Directive 2011/65/EU. In accordance with that provision, the exemption remains valid until a decision on the renewal request has been adopted.

                     (6)

                     The evaluation of the renewal request included stakeholder consultations in accordance with Article 5(7) of Directive 2011/65/EU.

                     (7)

                     Lead in the PVC sensor card of concerned in vitro medical devices (blood analysers) enhances sensor performance which is necessary for the optimum performance of the device in terms of analytical reliability claimed in product publications and thus for fulfilment of requirements laid down in Directive 98/79/EC of the European Parliament and of the Council (3).

                     (8)

                     While lead-free technologies are available on the market for certain analysers of other manufacturers, reliability testing of substitutes for the specific application subject to the current renewal request requires additional time.

                     (9)

                     Discontinuation of the exemption is expected to avoid a total of 157 kg of lead being placed on the Union market. At the same time, however, it will result in the need to replace the entire diagnostic device, and consequently, is expected to lead to a premature generation of 112 000 kg of waste electrical and electronic equipment. Furthermore, significant socioeconomic impacts on health providers using the devices concerned would be incurred.

                     (10)

                     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. (4) In light of the restriction process on lead in PVC provided for in Regulation (EC) No 1907/2006, the exemption should be granted for a short validity period of 2 years to ensure full alignment with that Regulation once the relevant restriction process is concluded.

                     (11)

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

                     (12)

                     The exemption concerns category 8 of electrical and electronic equipment to which Directive 2011/65/EU applies and it should be renewed for the duration of 2 years starting from 5 March 2020, in accordance with 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.

                     (13)

                     Directive 2011/65/EU should therefore be amended accordingly,

               HAS ADOPTED THIS DIRECTIVE:

            Article 1
            Annex IV to Directive 2011/65/EU is amended as set out in the Annex to this Directive.

            Article 2

               1.   Member States shall adopt and publish, by 31 March 2021 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 1 April 2021.
               When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.

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

            Article 3
            This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

            Article 4
            This Directive is addressed to the Member States.

            Done at Brussels, 17 December 2019.

                  For the Commission

                  The President

               Ursula VON DER LEYEN

            (1)  OJ L 174, 1.7.2011, p. 88.

            (2)  Commission Delegated Directive (EU) 2015/573 of 30 January 2015 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 polyvinyl chloride sensors in in-vitro diagnostic medical devices (OJ L 94, 10.4.2015, p. 4).

            (3)  Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices (OJ L 331, 7.12.1998, p. 1).

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

            ANNEX
            In Annex IV to Directive 2011/65/EU, entry 41 is replaced by the following:

                           ‘41.

                           Lead as a thermal stabiliser in polyvinyl chloride (PVC) used as base material in amperometric, potentiometric and conductometric electrochemical sensors which are used in in-vitro diagnostic medical devices for the analysis of blood and other body fluids and body gases.

                           Expires on 31 March 2022.’