title: Council Directive (EU) 2019/2235 of 16 December 2019 amending Directive 2006/112/EC on the common system of value added tax and Directive 2008/118/EC concerning the general arrangements for excise duty as regards defence efforts within the Union framework

text:
                  30.12.2019

                  EN

                  Official Journal of the European Union

                  L 336/10

         COUNCIL DIRECTIVE (EU) 2019/2235
         of 16 December 2019
         amending Directive 2006/112/EC on the common system of value added tax and Directive 2008/118/EC concerning the general arrangements for excise duty as regards defence efforts within the Union framework
         THE COUNCIL OF THE EUROPEAN UNION,
         Having regard to the Treaty on the Functioning of the European Union, and in particular Article 113 thereof,
         Having regard to the proposal from the European Commission,
         After transmission of the draft legislative act to the national parliaments,
         Having regard to the opinion of the European Parliament (1),
         Having regard to the opinion of the European Economic and Social Committee (2),
         Acting in accordance with a special legislative procedure,
         Whereas:

                     (1)

                     Council Directive 2006/112/EC (3) provides, under certain conditions, for an exemption from value added tax (VAT) for goods and services supplied to and goods imported by the armed forces of any State party to the North Atlantic Treaty when such forces take part in the common defence effort outside their own State.

                     (2)

                     Council Directive 2008/118/EC (4) provides for an exemption from excise duty for excise goods intended to be used by the armed forces of any State party to the North Atlantic Treaty other than the Member State within which the excise duty is chargeable, for the use of those forces, for the civilian staff accompanying them or for supplying their messes or canteens, subject to conditions and limitations laid down by the host Member State.

                     (3)

                     Such exemptions are not available where the armed forces of a Member State take part in activities under the common security and defence policy (CSDP) as set out in Section 2 of Chapter 2 of Title V of the Treaty on European Union. Priority should be given to the need to improve European capabilities in the field of defence and crisis management and to strengthen Union security and defence. In their joint communication of 28 March 2018 on the Action Plan on Military Mobility, the High Representative of the Union for Foreign Affairs and Security Policy and the Commission recognised the overall need for aligning the VAT treatment of defence efforts undertaken within the Union framework and the North Atlantic Treaty Organization (NATO) umbrella.

                     (4)

                     A defence effort carried out for the implementation of a Union activity under the CSDP covers military missions and operations, activities of battlegroups, mutual assistance, permanent structured cooperation (PESCO) projects and activities of the European Defence Agency (EDA). It should not, however, cover activities under the solidarity clause set out in Article 222 of the Treaty on the Functioning of the European Union or any other bilateral or multilateral activities between Member States that do not relate to a defence effort carried out for the implementation of a Union activity under the CSDP.

                     (5)

                     An exemption from VAT should thus be introduced to cover the supply of goods or services intended either for the use of the armed forces of a Member State or of the civilian staff accompanying them or for supplying their messes or canteens when such forces take part in a defence effort carried out for the implementation of a Union activity under the CSDP outside their Member State. Supplies of goods or services for the armed forces of the Member State in which those goods or services are supplied should be excluded from the VAT exemption.

                     (6)

                     In addition, it is necessary to provide for an exemption from VAT where goods imported by the armed forces of a Member State are intended either for the use of those forces or of the civilian staff accompanying them or for supplying their messes or canteens when such forces take part in a defence effort carried out for the implementation of a Union activity under the CSDP outside their Member State.

                     (7)

                     An exemption from excise duty should also be introduced to cover excise goods supplied for the use of the armed forces of any Member State other than the Member State within which the excise duty is chargeable when such forces take part in a defence effort carried out for the implementation of a Union activity under the CSDP outside their Member State.

                     (8)

                     As with the exemption from VAT and excise duty for NATO defence efforts, the exemptions for defence efforts carried out for the implementation of a Union activity under the CSDP should be limited in scope. Those exemptions should apply only to situations where armed forces carry out tasks directly linked to a defence effort under the CSDP and should not cover civilian missions under the CSDP. Goods or services supplied for the use of civilian staff could therefore only be covered by the exemptions when the civilian staff are accompanying armed forces carrying out tasks directly linked to a defence effort under the CSDP outside their Member State. Tasks performed exclusively by civilian staff or performed exclusively by using civilian capabilities should not be considered to be a defence effort. The exemptions should not in any circumstances cover goods or services that the armed forces acquire for the use of those forces or the civilian staff accompanying them within their own Member State.

                     (9)

                     Since the objective of this Directive, namely to align the VAT and excise duty treatment of defence efforts within the Union and NATO frameworks, cannot be sufficiently achieved by the Member States but can rather be better achieved at Union level, the Union may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty on European Union. In accordance with the principle of proportionality as set out in that Article, this Directive does not go beyond what is necessary in order to achieve that objective.

                     (10)

                     In accordance with the Joint Political Declaration of 28 September 2011 of Member States and the Commission on explanatory documents (5), Member States have undertaken to accompany, in justified cases, the notification of their transposition measures with one or more documents explaining the relationship between the components of a directive and the corresponding parts of national transposition instruments. With regard to this Directive, the legislator considers the transmission of such documents to be justified.

                     (11)

                     Directives 2006/112/EC and 2008/118/EC should therefore be amended accordingly,

               HAS ADOPTED THIS DIRECTIVE:

            Article 1
            Amendments to Directive 2006/112/EC
            Directive 2006/112/EC is amended as follows:

                        (1)

                        in Article 22, the following paragraph is inserted before the first paragraph:
                        ‘The application by the armed forces of a Member State taking part in a defence effort carried out for the implementation of a Union activity under the common security and defence policy, for their use or for the use of the civilian staff accompanying them, of goods which they have not purchased subject to the general rules governing taxation on the domestic market of a Member State shall be treated as an intra-Community acquisition of goods for consideration, where the importation of those goods would not be eligible for the exemption provided for in point (ga) of Article 143(1).’;

                        (2)

                        in Article 143(1), the following point is inserted:

                                    ‘(ga)

                                    the importation of goods into Member States by the armed forces of other Member States for the use of those forces, or of the civilian staff accompanying them, or for supplying their messes or canteens when such forces take part in a defence effort carried out for the implementation of a Union activity under the common security and defence policy;’;

                        (3)

                        in Article 151(1), the following points are inserted:

                                    ‘(ba)

                                    the supply of goods or services within a Member State, intended either for the armed forces of other Member States for the use of those forces, or of the civilian staff accompanying them, or for supplying their messes or canteens when such forces take part in a defence effort carried out for the implementation of a Union activity under the common security and defence policy;

                                    (bb)

                                    the supply of goods or services to another Member State, intended for the armed forces of any Member State other than the Member State of destination itself, for the use of those forces, or of the civilian staff accompanying them, or for supplying their messes or canteens when such forces take part in a defence effort carried out for the implementation of a Union activity under the common security and defence policy;’.

            Article 2
            Amendment to Directive 2008/118/EC
            In Article 12(1) of Directive 2008/118/EC, the following point is inserted:

                        ‘(ba)

                        by the armed forces of any Member State other than the Member State within which the excise duty is chargeable, for the use of those forces, for the civilian staff accompanying them or for supplying their messes or canteens when such forces take part in a defence effort carried out for the implementation of a Union activity under the common security and defence policy;’.

            Article 3
            Transposition

               1.   Member States shall adopt and publish, by 30 June 2022, the laws, regulations and administrative provisions necessary to comply with this Directive. They shall immediately communicate the text of those measures to the Commission.
               They shall apply those measures from 1 July 2022.
               When Member States adopt those measures, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. 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 4
            Entry into force
            This Directive shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

            Article 5
            Addressees
            This Directive is addressed to the Member States.

            Done at Brussels, 16 December 2019.

                  For the Council

                  The President

               J. LEPPÄ

            (1)  Opinion of 26 November 2019 (not yet published in the Official Journal).

            (2)  Opinion of 30 October 2019 (not yet published in the Official Journal).

            (3)  Council Directive 2006/112/EC of 28 November 2006 on the common system of value added tax (OJ L 347, 11.12.2006, p. 1).

            (4)  Council Directive 2008/118/EC of 16 December 2008 concerning the general arrangements for excise duty and repealing Directive 92/12/EEC (OJ L 9, 14.1.2009, p. 12).

            (5)  OJ C 369, 17.12.2011, p. 14.


title: Council Directive (EU) 2021/1159 of 13 July 2021 amending Directive 2006/112/EC as regards temporary exemptions on importations and on certain supplies, in response to the COVID-19 pandemic

text:
                  15.7.2021

                  EN

                  Official Journal of the European Union

                  L 250/1

         COUNCIL DIRECTIVE (EU) 2021/1159
         of 13 July 2021
         amending Directive 2006/112/EC as regards temporary exemptions on importations and on certain supplies, in response to the COVID-19 pandemic
         THE COUNCIL OF THE EUROPEAN UNION,
         Having regard to the Treaty on the Functioning of the European Union, and in particular Article 113 thereof,
         Having regard to the proposal from the European Commission,
         After transmission of the draft legislative act to the national parliaments,
         Having regard to the opinion of the European Parliament (1),
         Having regard to the opinion of the European Economic and Social Committee (2),
         Acting in accordance with a special legislative procedure,
         Whereas:

                     (1)

                     In accordance with Council Directive 2006/112/EC (3), Member States are to exempt from value added tax (VAT) the importation of goods by, and the supply of goods and services to, the Union, the European Atomic Energy Community, the European Central Bank or the European Investment Bank or the bodies set up by the Union to which the Protocol (No 7) on the privileges and immunities of the European Union, annexed to the Treaty on European Union and to the Treaty on the Functioning of the European Union (‘the Protocol’), applies, within the limits and under the conditions of the Protocol and the agreements for its implementation or the headquarters agreements, in so far as it does not lead to distortion of competition. That exemption is, however, strictly limited to purchases made for official use and it does not extend to situations where goods and services are purchased by Union bodies in order to respond to the emergency situation posed by the COVID-19 pandemic, particularly when they are to be made available for free to Member States or third parties such as national authorities or institutions.

                     (2)

                     Therefore, because there is still an urgent need for the adoption of measures in order to create readiness to act when dealing with the ongoing sanitary crisis, it is necessary to ensure a VAT exemption for the purchase of goods and services by the Commission or by an agency or body established under Union law in the execution of their tasks, in order to respond to the COVID-19 pandemic. This would ensure that measures taken under the various Union initiatives in that situation are not hampered by amounts of VAT which cannot be recovered by the Union institutions, or by the compliance burden resulting from obligations to register for VAT.

                     (3)

                     Council Directive (EU) 2020/2020 (4) is not sufficient to achieve the objective of enhancing the fight against the COVID-19 pandemic since it only allows, for a limited period of time, the application by Member States of reduced rates to the supply of COVID-19 in vitro diagnostic medical devices and services closely linked to such devices or the granting of an exemption with deductibility of VAT paid at the preceding stage in respect of the supply of COVID-19 vaccines and in vitro diagnostic medical devices, and services closely linked to such vaccines and devices.

                     (4)

                     Directive 2006/112/EC should therefore be amended accordingly.

                     (5)

                     In view of the current COVID-19 pandemic, the measures that could fall under the new exemption to address the effects of the COVID-19 pandemic are already underway, for example under the Emergency Support Instrument established by Council Regulation (EU) 2020/521 (5). If VAT were to be paid for transactions related to such measures, valuable resources would be lost, resulting in fewer goods and services being provided to the Member States in proportion to the amount of tax to be paid. In order to make the best use of the Union budget in addressing the very serious consequences of the COVID-19 pandemic, the exemptions introduced by this Directive should therefore apply, with retroactive effect, from 1 January 2021. Such retroactive application is indispensable to avoid the measures that are being taken to address the effects of the COVID-19 pandemic from being deprived of their effect. Any adjustment required in respect of transactions initially taxed could be made by using correction mechanisms already in place, for example through a subsequent VAT return.

                     (6)

                     In view of the urgency of the situation related to the COVID-19 pandemic, this Directive should enter into force on the day of its publication in the Official Journal of the European Union,

               HAS ADOPTED THIS DIRECTIVE:

            Article 1
            Directive 2006/112/EC is amended as follows:

                        (1)

                        Article 143 is amended as follows:

                                    (a)

                                    in paragraph (1), the following point is inserted:

                                                ‘(fb)

                                                the importation of goods by the Commission or by an agency or a body established under Union law where the Commission or such an agency or body imports those goods in the execution of tasks conferred on it by Union law in order to respond to the COVID-19 pandemic, except where the goods imported are used, either immediately or at a later date, for the purposes of onward supplies for consideration by the Commission or such an agency or body;’;

                                    (b)

                                    the following paragraph is added:

                                       ‘3.   When the conditions for the exemption laid down in paragraph 1, point (fb), cease to apply, the Commission or the agency or body concerned shall inform the Member State in which the exemption was applied and the importation of those goods shall be subject to VAT under the conditions applicable at that time.’;

                        (2)

                        Article 151 is amended as follows:

                                    (a)

                                    paragraph 1 is amended as follows:

                                                (i)

                                                in the first subparagraph, the following point is inserted:

                                                            ‘(ab)

                                                            the supply of goods or services to the Commission or to an agency or a body established under Union law where the Commission or such an agency or body purchases those goods or services in the execution of the tasks conferred on it by Union law in order to respond to the COVID-19 pandemic, except where the goods and services purchased are used, either immediately or at a later date, for the purposes of onward supplies for consideration by the Commission or such an agency or body;’;

                                                (ii)

                                                the second subparagraph is replaced by the following:
                                                ‘Pending the adoption of common tax rules, the exemptions provided for in the first subparagraph, other than that referred to in point (ab), shall be subject to the limitations laid down by the host Member State.’;

                                    (b)

                                    the following paragraph is added:

                                       ‘3.   When the conditions for the exemption laid down in paragraph 1, first subparagraph, point (ab), cease to apply, the Commission or the agency or body concerned which received the exempt supply shall inform the Member State in which the exemption was applied and the supply of those goods or services shall be subject to VAT under the conditions applicable at that time.’.

            Article 2
            Transposition
            Member States shall adopt and publish, by 31 December 2021, the laws, regulations and administrative provisions necessary to comply with this Directive. They shall immediately inform the Commission thereof.
            They shall apply the measures provided for in Article 1 from 1 January 2021.
            When Member States adopt those provisions, they shall contain a reference to this Directive or shall 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 3
            This Directive shall enter into force on the date of its publication in the Official Journal of the European Union.
            Article 1 shall apply from 1 January 2021.

            Article 4
            This Directive is addressed to the Member States.

            Done at Brussels, 13 July 2021.

                  For the Council

                  The President

               A. ŠIRCELJ

            (1)  Opinion of 18 May 2021 (not yet published in the Official Journal).

            (2)  Opinion of 27 April 2021 (not yet published in the Official Journal).

            (3)  Council Directive 2006/112/EC of 28 November 2006 on the common system of value added tax (OJ L 347, 11.12.2006, p. 1).

            (4)  Council Directive (EU) 2020/2020 of 7 December 2020 amending Directive 2006/112/EC as regards temporary measures in relation to value added tax applicable to COVID-19 vaccines and in vitro diagnostic medical devices in response to the COVID-19 pandemic (OJ L 419, 11.12.2020, p. 1).

            (5)  Council Regulation (EU) 2020/521 of 14 April 2020 activating the emergency support under Regulation (EU) 2016/369, and amending its provisions taking into account the COVID-19 outbreak (OJ L 117, 15.4.2020, p. 3).


title: Commission Delegated Directive (EU) 2021/1978 of 11 August 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 an exemption for the use of bis(2-ethylhexyl) phthalate (DEHP), butyl benzyl phthalate (BBP), dibutyl phthalate (DBP) and diisobutyl phthalate (DIBP) in spare parts recovered from and used for the repair or refurbishment of medical devices (Text with EEA relevance)

text:
                  15.11.2021

                  EN

                  Official Journal of the European Union

                  L 402/65

         COMMISSION DELEGATED DIRECTIVE (EU) 2021/1978
         of 11 August 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 an exemption for the use of bis(2-ethylhexyl) phthalate (DEHP), butyl benzyl phthalate (BBP), dibutyl phthalate (DBP) and diisobutyl phthalate (DIBP) in spare parts recovered from and used for the repair or refurbishment of medical devices
         (Text with EEA relevance)
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Directive 2011/65/EU of the European Parliament and of the Council of 8 June 2011 on the restriction of the use of certain hazardous substances in electrical and electronic equipment (1), and in particular Article 5(1), point (a), thereof,
         Whereas:

                     (1)

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

                     (2)

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

                     (3)

                     By Commission Delegated Directive (EU) 2015/863 (2), bis(2-ethylhexyl) phthalate (DEHP), benzyl butyl phthalate (BBP), dibutyl phthalate (DBP) and diisobutyl phthalate (DIBP) were added to the list of restricted substances referred to in Annex II to Directive 2011/65/EU.

                     (4)

                     Delegated Directive (EU) 2015/863 provides that the restriction of DEHP, BBP, DBP and DIBP is not to apply to spare parts for the repair, the reuse, the updating of functionalities or upgrading of capacity of medical devices, including in vitro medical devices, placed on the market before 22 July 2021.

                     (5)

                     On 17 July 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 IV to that Directive, for the use of DEHP, BBP, DBP and DIBP in spare parts recovered from and used for the repair or refurbishment of medical devices, including in vitro diagnostic medical devices (‘the requested exemption’).

                     (6)

                     The evaluation of the exemption application concluded that the total negative environmental and health impacts of substituting refurbished parts containing DEHP, BBP, DBP and DIBP with new substance-free refurbished parts are likely to outweigh the total environmental and health benefits. The evaluation included stakeholder consultations required by Article 5(6) of the Directive 2011/65/EU. The comments received during those consultations were made publicly available on a dedicated website.

                     (7)

                     In order to ensure a high level of protection for the environment, health and consumer safety, reuse should take place in auditable closed-loop business-to-business return systems and reuse of spare parts should be notified to the customer.

                     (8)

                     The requested 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 requested exemption by including the applications covered by it in Annex IV to Directive 2011/65/EU.

                     (10)

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

                     (11)

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

                     (12)

                     In the interest of legal certainty and in order to protect the legitimate expectations of operators supplying the medical devices concerned that the requested exemption applies by the date of entry into force of the prohibition for the use of the restricted substance in question, and in the absence of any legitimate interest in creating a disruption to the supply of those medical devices as a result of the entry into force of that prohibition, this Directive should enter into force as a matter of urgency and should apply with retroactive effect from 21 July 2021,

               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 April 2022 at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive. They shall communicate the text of those provisions to the Commission forthwith.
               They shall apply those provisions from 21 July 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 that they adopt in the field covered by this Directive.

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

            Article 4
            This Directive is addressed to the Member States.

            Done at Brussels, 11 August 2021.

                  For the Commission

                  The President

               Ursula VON DER LEYEN

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

            (2)  Commission Delegated Directive (EU) 2015/863 of 31 March 2015 amending Annex II to Directive 2011/65/EU of the European Parliament and of the Council as regards the list of restricted substances (OJ L 137, 4.6.2015, p. 10).

            (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 IV to Directive 2011/65/EU, the following entry 47 is added:

                        ‘47

                        Bis(2-ethylhexyl) phthalate (DEHP), butyl benzyl phthalate (BBP), dibutyl phthalate (DBP) and diisobutyl phthalate (DIBP) in spare parts recovered from and used for the repair or refurbishment of medical devices, including in vitro diagnostic medical devices, and their accessories, provided that the reuse takes place in auditable closed-loop business-to-business return systems and that each reuse of parts is notified to the customer.
                        Expires on 21 July 2028.’


title: Commission Delegated Directive (EU) 2021/1979 of 11 August 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 an exemption for the use of bis(2-ethylhexyl) phthalate (DEHP) in plastic components in magnetic resonance imaging (MRI) detector coils (Text with EEA relevance)

text:
                  15.11.2021

                  EN

                  Official Journal of the European Union

                  L 402/69

         COMMISSION DELEGATED DIRECTIVE (EU) 2021/1979
         of 11 August 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 an exemption for the use of bis(2-ethylhexyl) phthalate (DEHP) in plastic components in magnetic resonance imaging (MRI) detector coils
         (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), point (a), thereof,
         Whereas:

                     (1)

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

                     (2)

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

                     (3)

                     Bis(2-ethylhexyl) phthalate (DEHP) is a restricted substance listed in Annex II to Directive 2011/65/EU, as amended by Commission Delegated Directive (EU) 2015/863 (2). DEHP is not to be used, from 22 July 2021, in medical devices, including in vitro medical devices above a maximum concentration value of 0,1% tolerated by weight in homogeneous materials.

                     (4)

                     On 12 September 2018 and 2 October 2019, the Commission received applications 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 DEHP in plastic components in magnetic resonance imaging (MRI) detector coils (‘the requested exemption’).

                     (5)

                     Two technical and scientific assessment studies were carried out to evaluate the exemption applications. The first study (3) covered the first application received. Due to the similarity of the second application to the first, the second study (4) evaluated both applications together. The evaluation of the applications, which took into account the availability of technically practicable and reliable substitutes and the socioeconomic impact of substitution, concluded that no suitable alternatives to DEHP are sufficiently available on the market and that not granting the exemption is likely to result in total negative environmental, health and consumer safety impacts caused by substitution, which outweigh the benefits thereof. The evaluation included stakeholder consultations as required by Article 5(7) of Directive 2011/65/EU. The comments received during those consultations were made publicly available on a dedicated website.

                     (6)

                     The requested exemption is consistent with Regulation (EC) No 1907/2006 of the European Parliament and of the Council (5) and thus does not weaken the environmental and health protection afforded by it.

                     (7)

                     It is, therefore, appropriate to grant the requested exemption by including the applications covered by it in Annex IV to Directive 2011/65/EU.

                     (8)

                     To ensure that compatible plastic components for MRI coil detectors for health services are widely available on the Union market and to allow time for the development of suitable and widely available alternatives, the requested exemption should be granted until 1 January 2024, in accordance with Article 5(2), first subparagraph, of Directive 2011/65/EU. In view of the results of the ongoing efforts to find a reliable substitution, the duration of the exemption is unlikely to have adverse impacts on innovation.

                     (9)

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

                     (10)

                     In the interest of legal certainty and in order to protect the legitimate expectations of operators supplying the medical devices concerned that the requested exemption applies by the date of entry into force of the prohibition for the use of the restricted substance in question, and in the absence of any legitimate interest in creating a disruption to the supply of those medical devices as a result of the entry into force of that prohibition, this Directive should enter into force as a matter of urgency and should apply with retroactive effect from 21 July 2021,

               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 April 2022 at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive. They shall communicate the text of those provisions to the Commission forthwith.
               They shall apply those provisions from 21 July 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 that they adopt in the field covered by this Directive.

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

            Article 4
            This Directive is addressed to the Member States.

            Done at Brussels, 11 August 2021.

                  For the Commission

                  The President

               Ursula VON DER LEYEN

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

            (2)  Commission Delegated Directive (EU) 2015/863 of 31 March 2015 amending Annex II to Directive 2011/65/EU of the European Parliament and of the Council as regards the list of restricted substances (OJ L 137, 4.6.2015, p. 10).

            (3)  For the final report of the study (Pack 17), see: https://op.europa.eu/en/publication-detail/-/publication/df0ab036-8b52-11ea-812f-01aa75ed71a1/language-en/format-PDF/source-146143357.

            (4)  For the final report of the study (Pack 20), see: https://op.europa.eu/en/publication-detail/-/publication/185e9d5b-d5fc-11ea-adf7-01aa75ed71a1/language-en/format-PDF/source-146144567.

            (5)  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 IV to Directive 2011/65/EU, the following entry 46 is added:

                        ‘46

                        Bis(2-ethylhexyl) phthalate (DEHP) in plastic components in MRI detector coils.
                        Expires on 1 January 2024.’


title: Commission Delegated Directive (EU) 2021/1980 of 11 August 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 an exemption for the use of bis(2-ethylhexyl) phthalate (DEHP) in ion-selective electrodes for analysing human body fluids and/or dialysate fluids (Text with EEA relevance)

text:
                  15.11.2021

                  EN

                  Official Journal of the European Union

                  L 402/73

         COMMISSION DELEGATED DIRECTIVE (EU) 2021/1980
         of 11 August 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 an exemption for the use of bis(2-ethylhexyl) phthalate (DEHP) in ion-selective electrodes for analysing human body fluids and/or dialysate fluids
         (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), point (a), thereof,
         Whereas:

                     (1)

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

                     (2)

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

                     (3)

                     Pursuant to Commission Delegated Directive (EU) 2015/863 (2), bis(2-ethylhexyl) phthalate (DEHP) is a restricted substance listed in Annex II to Directive 2011/65/EU and its use is to be prohibited, from 22 July 2021, in medical devices, including in vitro medical devices above a maximum concentration value of 0,1% tolerated by weight in homogeneous materials.

                     (4)

                     On 17 July 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 IV to that Directive, for the use of DEHP in ion selective electrodes for analysing human body fluids and/or in dialysate fluids (‘the requested exemption’).

                     (5)

                     DEHP is used as a membrane solvent of ion selective electrodes applied in point of care analysers which help to measure the concentration of ionic substances in human body fluids and/or in dialysate fluids.

                     (6)

                     A technical and scientific assessment study was carried out to evaluate the exemption application (3). The evaluation of the application concluded that alternatives to DEHP are currently not sufficiently reliable and that the substitution of DEHP in specific applications would result in negative environmental and health impacts that outweigh its benefits. The evaluation included stakeholder consultations in accordance with Article 5(7) of Directive 2011/65/EU. The comments received during those consultations were made publicly available on a dedicated website.

                     (7)

                     The requested 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.

                     (8)

                     It is therefore appropriate to grant the requested exemption by including the applications covered by it in Annex IV to Directive 2011/65/EU.

                     (9)

                     To provide efficient technical equipment for health services and to allow time for the development of suitable alternatives, the requested exemption should be granted for a duration of 7 years starting from the date of application of this Directive in accordance with Article 5(2), first subparagraph, of Directive 2011/65/EU. In view of the results of the ongoing efforts to find a reliable substitution, the duration of the exemption is unlikely to have adverse impacts on innovation.

                     (10)

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

                     (11)

                     In the interest of legal certainty and in order to protect the legitimate expectations of operators supplying the medical devices concerned that the requested exemption applies by the date of entry into force of the prohibition for the use of the restricted substance in question, and in the absence of any legitimate interest in creating a disruption to the supply of those medical devices as a result of the entry into force of that prohibition, this Directive should enter into force as a matter of urgency and should apply with retroactive effect from 21 July 2021,

               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 April 2022 at the latest, the laws, regulations and administrative provisions necessary to comply with this Directive. They shall communicate the text of those provisions to the Commission forthwith.
               They shall apply those provisions from 21 July 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 that they adopt in the field covered by this Directive.

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

            Article 4
            This Directive is addressed to the Member States.

            Done at Brussels, 11 August 2021.

                  For the Commission

                  The President

               Ursula VON DER LEYEN

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

            (2)  Commission Delegated Directive (EU) 2015/863 of 31 March 2015 amending Annex II to Directive 2011/65/EU of the European Parliament and of the Council as regards the list of restricted substances (OJ L 137, 4.6.2015, p. 10).

            (3)  Study to assess three exemption requests relating to Annex IV to Directive 2011/65/EU (Pack 17).

            (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), 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 IV to Directive 2011/65/EU, the following entry 45 is added:

                        ‘45

                        Bis(2-ethylhexyl) phthalate (DEHP) in ion-selective electrodes applied in point of care analysis of ionic substances present in human body fluids and/or in dialysate fluids
                        Expires on 21 July 2028.’