title: Commission Directive (EU) 2021/903 of 3 June 2021 amending Directive 2009/48/EC of the European Parliament and of the Council as regards specific limit values for aniline in certain toys (Text with EEA relevance)

text:
                  4.6.2021

                  EN

                  Official Journal of the European Union

                  L 197/110

         COMMISSION DIRECTIVE (EU) 2021/903
         of 3 June 2021
         amending Directive 2009/48/EC of the European Parliament and of the Council as regards specific limit values for aniline in certain toys
         (Text with EEA relevance)
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Directive 2009/48/EC of the European Parliament and of the Council of 18 June 2009 on the safety of toys (1), and in particular Article 46(2) thereof,
         Whereas:

                     (1)

                     Directive 2009/48/EC establishes certain requirements for chemical substances that are classified as carcinogenic, mutagenic or toxic for reproduction under Regulation (EC) No 1272/2008 of the European Parliament and of the Council (2). Appendix C to Annex II to Directive 2009/48/EC lays down specific limit values for chemicals used in toys intended for use by children under 36 months or in other toys intended to be placed in the mouth.

                     (2)

                     Aniline (CAS number 62-53-3) is classified as carcinogenic category 2 and mutagenic category 2 under Regulation (EC) No 1272/2008 (3). According to point 5(a) of Part III of Annex II to Directive 2009/48/EC, carcinogenic substances of category 2, such as aniline, may be used in toys in individual concentrations equal to or smaller than the relevant concentration established in Regulation (EC) No 1272/2008 for the classification of mixtures containing those substances, namely 1 % (4), which corresponds to 10 000 mg/kg (‘content limit’). The same content limit applies to mutagenic substances of category 2 (5).

                     (3)

                     The Scientific Committee on Health and Environmental Risks (SCHER) considered, in its opinion of 29 May 2007, that compounds that are carcinogenic, mutagenic or toxic for reproduction (CMR) should not be present in toys (6). The European Union Risk Assessment Report on aniline (7) concluded that for consumers there is a need for limiting the health risks associated with the use of products containing aniline. That conclusion was based on ‘concerns for mutagenicity and carcinogenicity as a consequence of exposure arising from use of products containing the substance, as aniline is identified as a non-threshold carcinogen.’ The Committee for Risk Assessment of the European Chemicals Agency (RAC) indicated, in its opinion on restriction of substances in tattoo inks and permanent make-up (8), that aniline is considered a non-threshold carcinogen. Aniline may therefore cause cancer at even the slightest level of exposure.

                     (4)

                     In order to advise the Commission in the preparation of legislative proposals and policy initiatives in the area of toy safety, the Commission has established the Expert Group on Toys Safety. The mission of its subgroup Working group on Chemicals in Toys (subgroup Chemicals) is to provide advice to the Expert Group on Toys Safety with regard to chemical substances which may be used in toys.

                     (5)

                     During the meeting of the subgroup Chemicals on 18 February 2015 (9), several of its members indicated that aniline could be found in coloured toy material such as textiles or leather when that material is subjected to the reductive cleavage test provided for in Appendix 10 to Regulation (EC) No 1907/2006 of the European Parliament and of the Council (10). The occurrence of aniline in textiles after reductive cleavage testing was confirmed in a study carried out in Sweden (11) as a follow-up to the meeting of the Expert Group on Toys Safety on 8 June 2015. Out of 23 textile samples, aniline was identified in one red textile (4 % of all samples) at 91 mg/kg. The occurrence of aniline in clothing after reductive cleavage testing was confirmed in a study with 153 samples (12). Aniline was identified in 9 samples (6 % of all samples) at up to 588 mg/kg. Moreover, aniline has been found in a finger paint after reductive cleavage according to a German consumer magazine (13). The subgroup Chemicals also noted, by written correspondence to the Commission in May 2020, that free aniline could be present in finger paints as an impurity of the colourants in such paints.

                     (6)

                     At the meeting of the Expert Group on Toys Safety on 8 June 2015, Germany presented a position paper providing a scientific assessment of the toxicological properties of aniline (14). According to that assessment, the existing content limit for aniline presents a risk for both the systemic and the cancer effects of that substance. The subgroup Chemicals concluded, at its meeting on 26 September 2017 (15), that a restriction for aniline in toys should target toys and toy components of textile and leather, and finger paints, since too little information was available so far on the need for an aniline restriction in toys or toy materials other than textile, leather and finger paints. The subgroup also indicated that the limit value should be 30 mg/kg after reductive cleavage. That value is the lowest concentration that the reductive cleavage test can reliably identify. As regards finger paints, the subgroup indicated that a limit of 10 mg/kg for free aniline should be set since that is the lowest concentration that can reliably be checked in routine tests of finger paints.

                     (7)

                     The Expert Group on Toys Safety, at its meeting on 19 December 2017 (16), examined the setting of limit values of 30 mg/kg for aniline after reductive cleavage in toy materials of textile and leather; of 30 mg/kg for aniline after reductive cleavage in finger paints; and of 10 mg/kg for free aniline in finger paints, as indicated earlier by the subgroup Chemicals.

                     (8)

                     Pursuant to Article 46(2) of Directive 2009/48/EC, the packaging requirements for food laid down in Regulation (EC) No 1935/2004 of the European Parliament and of the Council (17) are to be taken into account when adopting specific limit values for chemicals in Appendix C to that Directive. The basic assumptions behind the migration test methods referred to in Article 11(4) of Commission Regulation (EU) No 10/2011 (18), which is a specific measure within the meaning of Article 5 of Regulation (EC) No 1935/2004 and which establishes specific requirements for the manufacture and marketing of plastic materials and articles intended to come into contact with food, are however different from the basic assumptions behind the content limits for aniline in certain toys in Directive 2009/48/EC. In addition, it is impossible to compare migration limits with content limits. Therefore, further to these conclusions there is no way to take account of the packaging requirements for food when setting content limits for aniline in certain toys.

                     (9)

                     In light of the classification of aniline as a CMR substance, the European Union Risk Assessment Report on aniline, the opinion of RAC and SCHER and the opinions of the Expert Group in Toys Safety and its subgroup Chemicals as well as the studies on the presence of aniline in textiles, it is necessary to set a limit for aniline in textile toy material and leather toy material of 30 mg/kg after reductive cleavage and a limit for aniline in finger paints of 10 mg/kg as free aniline and 30 mg/kg after reductive cleavage.

                     (10)

                     Directive 2009/48/EC should therefore be amended accordingly.

                     (11)

                     The measures provided for in this Directive are in accordance with the opinion of the Toy Safety Committee,

               HAS ADOPTED THIS DIRECTIVE:

            Article 1
            In Appendix C to Annex II to Directive 2009/48/EC, the following entry is added:

                           Substance

                           CAS No

                           Limit value

                           ‘Aniline

                           62-53-3

                                       30 mg/kg

                                       after reductive cleavage in textile toy material and leather toy material

                                       10 mg/kg

                                       as free aniline in finger paints

                                       30 mg/kg

                                       after reductive cleavage in finger paints’

            Article 2

               1.   Member States shall adopt and publish, by 4 December 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 5 December 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, 3 June 2021.

                  For the Commission

                  The President

               Ursula VON DER LEYEN

            (1)  OJ L 170, 30.6.2009, p. 1.

            (2)  Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, p. 1).

            (3)  Table 3 in Annex VI to Regulation (EC) No 1272/2008.

            (4)  Table 3.6.2 in Annex I to Regulation (EC) No 1272/2008.

            (5)  Table 3.5.2 in Annex I to Regulation (EC) No 1272/2008.

            (6)  Scientific Committee on Health and Environmental Risks (SCHER). CEN’s response to the opinion of the CSTEE on the assessment of CEN report on the risk assessment of organic chemicals in toys. Adopted on 29.5.2007.
         http://ec.europa.eu/health/archive/ph_risk/committees/04_scher/docs/scher_o_056.pdf

            (7)  European Chemicals Bureau, Institute for Health and Consumer Protection, 2004. EUR 21092 EN. Section 5.2.1.2, p. 180.
         https://echa.europa.eu/documents/10162/6434698/orats_final_rar_aniline_en.pdf/0abd36ad-53de-4b0f-b258-10cf90f90493

            (8)  Committee for Risk Assessment (RAC), Committee for Socioeconomic Analysis (SEAC), Opinion on an Annex XV dossier proposing restriction on substances used in tattoo inks and permanent make-up. Adopted on 20 November 2018. Appendix 2, section 2, p. 90.
         https://echa.europa.eu/documents/10162/2b4533af-f717-4bff-939b-2320fb43b462

            (9)  See Register of Commission Expert Groups, Expert Group on Toys Safety (E01360).
         https://ec.europa.eu/transparency/regexpert/index.cfm?do=groupDetail.groupDetailDoc&id=20916&no=1

            (10)  Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), 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).

            (11)  Meeting document of the subgroup Chemicals: EXP/WG/2015/027/Ann1, Aniline from azodye cleavage, Results from Sweden.

            (12)  Brüschweiler et al., Identification of non-regulated aromatic amines of toxicological concern which can be cleaved from azo dyes used in clothing textiles, Regulatory Toxicology and Pharmacology 69 (2014) 263–272. Cited in: ANEC – Position paper on aniline. April 2016. Presented to the subgroup ‘Chemicals’ meeting on 1 June 2016 (EXP/WG/2016/027).

            (13)  Ökotest 2/2015, p. 69.

            (14)  Discussion paper EXP/2015/029/rev1.

            (15)  Register of Commission Expert Groups, Expert Group on Toys Safety (E01360).
         http://ec.europa.eu/transparency/regexpert/index.cfm?do=groupDetail.groupMeeting&meetingId=4151.

            (16)  Register of Commission Expert Groups, Expert Group on Toys Safety (E01360), tab ‘Meetings’.
         http://ec.europa.eu/transparency/regexpert/index.cfm?do=groupDetail.groupMeeting&meetingId=1485.

            (17)  Regulation (EC) No 1935/2004 of the European Parliament and of the Council of 27 October 2004 on materials and articles intended to come into contact with food and repealing Directives 80/590/EEC and 89/109/EEC (OJ L 338, 13.11.2004, p. 4).

            (18)  Commission Regulation (EU) No 10/2011 of 14 January 2011 on plastic materials and articles intended to come into contact with food (OJ L 12, 15.1.2011, p. 1).


title: Commission Directive (EU) 2020/367 of 4 March 2020 amending Annex III to Directive 2002/49/EC of the European Parliament and of the Council as regards the establishment of assessment methods for harmful effects of environmental noise (Text with EEA relevance)

text:
                  5.3.2020

                  EN

                  Official Journal of the European Union

                  L 67/132

         COMMISSION DIRECTIVE (EU) 2020/367
         of 4 March 2020
         amending Annex III to Directive 2002/49/EC of the European Parliament and of the Council as regards the establishment of assessment methods for harmful effects of environmental noise
         (Text with EEA relevance)
         THE EUROPEAN COMMISSION,
         Having regard to the Treaty on the Functioning of the European Union,
         Having regard to Directive 2002/49/EC of the European Parliament and of the Council of 25 June 2002 relating to the assessment and management of environmental noise (1), and in particular Article 12 thereof,
         Whereas:

                     (1)

                     Annex III to Directive 2002/49/EC refers to dose-effect relations to be introduced by way of adaptations of that Annex to technical and scientific progress.

                     (2)

                     At the time of adoption of this Directive, the high quality and statistically significant information that could be used was that of the World Health Organisation (WHO) Environmental Noise Guidelines for the European Region (2), presenting dose-effect relations for harmful effects induced by the exposure to environmental noise. Consequently, the dose-effect relations introduced in Annex III to Directive 2002/49/EC should be based on those guidelines. In particular concerning the statistical significance, the WHO studies were based on representative populations, and the results of these assessment methods are consequently considered relevant when applied to representative populations.

                     (3)

                     Beyond the dose-effect relations developed in the context of the WHO, other studies might show different health effect sizes and other health effects, in particular concerning effects of road, railway and aircraft noise in local situations in specific countries. The alternative dose-effect relations established therein could be used provided that they are based on high quality and statistically significant studies.

                     (4)

                     Currently, limited knowledge is available on the harmful effects of industrial noise so that it is not possible to propose a common method for their assessment. Also, country specificities were not assessed in studies and therefore could not be included in this Annex. Likewise, while links between environmental noise and the following harmful effects were found, there is currently no sufficient evidence for determining a common method for the assessment of those harmful effects: stroke, hypertension, diabetes and other metabolic health outcomes, cognitive impairment in children, mental health and wellbeing, hearing impairment, tinnitus, adverse birth outcomes. Finally, while the link between railway noise and aircraft noise to the ischaemic heart disease (IHD) is established, for these two sources the quantification of the increased risk of IHD is premature.

                     (5)

                     Directive 2002/49/EC should therefore be amended accordingly.

                     (6)

                     The measures provided for in this Directive are in accordance with the opinion of the Committee established under Article 13 of Directive 2002/49/EC,

               HAS ADOPTED THIS DIRECTIVE:

            Article 1
            Annex III to Directive 2002/49/EC is replaced by the text in the Annex to this Directive.

            Article 2

               1.   Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with this Directive by 31 December 2021 at the latest. They shall forthwith communicate to the Commission the text of those provisions.
               When Member States adopt those provisions, they shall contain a reference to this Directive or be accompanied by such a reference on the occasion of their official publication. Member States shall determine how such reference is to be made.

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

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

            Article 4
            This Directive is addressed to the Member States.

            Done at Brussels, 4 March 2020.

                  For the Commission

               Virginijus SINKEVIČIUS

                  Member of the Commission

            (1)  OJ L 189, 18.7.2002, p. 12.

            (2)  Environmental Noise Guidelines for the European Region, World Health Organisation 2018, ISBN 978 92 890 5356 3.

            ANNEX

                     ‘ANNEX III
                     ASSESSMENT METHODS FOR HARMFUL EFFECTS
                     (Referred to in Article 6(3))
                     1.   Set of harmful effects

                     For the purposes of the assessment of harmful effects the following shall be considered:

                                 —

                                 ischaemic heart disease (IHD) corresponding to codes BA40 to BA6Z of the international classification ICD-11 established by the World Health Organisation;

                                 —

                                 high annoyance (HA);

                                 —

                                 high sleep disturbance (HSD).

                           2.   Calculation of harmful effects

                     The harmful effects shall be calculated by either of the following:

                                 —

                                 the relative risk (RR) of a harmful effect defined as

                                 —

                                 the absolute risk (AR) of a harmful effect defined as

                           2.1.   IHD

                     For the calculation of the RR, with respect to the harmful effect of IHD and concerning the incidence rate (i), the following dose-effect relations shall be used:

                     for road noise.
                     2.2.   HA

                     For the calculation of the AR, with respect to the harmful effect of HA the following dose-effect relations shall be used:

                                 for road noise;

                                 for railway noise;

                                 for aircraft noise.

                           2.3.   HSD

                     For the calculation of the AR, with respect to the harmful effect of HSD the following dose-effect relations shall be used:

                                 for road noise;

                                 for railway noise;

                                 for aircraft noise.

                           3.   Assessment of harmful effects

                     3.1.   The exposure of the population shall be assessed independently for each noise source and harmful effect. Where the same people are simultaneously exposed to different noise sources, the harmful effects may -in general- not be cumulated. However, those effects may be compared to assess the relative importance of each noise.
                     3.2.   Assessment for IHD

                     3.2.1.   For IHD in the case of railway and aircraft noise, the population exposed above adequate Lden levels is estimated as subject to an increased risk of IHD, while the exact number N of cases of IHD cannot be calculated.
                     3.2.2.   For
                        IHD in the case of road noise, the proportion of cases of the specific harmful effect in the population exposed to a RR that is calculated to be caused by environmental noise is derived, for the noise source x (road), harmful effect y (IHD) and for the incidence i by:

                     Where:

                                 —

                                    PAFx,y
                                     is the population attributable fraction,

                                 —

                                 the set of j noise bands is made up of single bands spanning over a maximum of 5 dB (e.g.: 50-51 dB, 51-52 dB, 52-53 dB, etc. or 50-54 dB, 55-59 dB, 60-64 dB, etc.),

                                 —

                                    pj
                                     is the proportion of the overall population P in the area assessed that is exposed to the j-th exposure band, which is associated with a given RR of a specific harmful effect RRj,x,y
                                    . The RRj,x,y
                                     is calculated using the formulas described in point 2 of this Annex, calculated at the central value of each noise band (e.g.: depending on availability of data, at 50,5 dB for the noise band defined between 50-51 dB, or 52 dB for the noise band 50-54 dB).

                           3.2.3.   For IHD in the case of road noise, the total number N of cases of IHD (people affected by the harmful effect y; number of attributable cases) due to the source x is then:

                        Nx,y
                         = PAFx,y,i
                         * Iy
                         * P (Formula 11)
                     for road.
                     Where:

                                 —

                                    PAFx,y,i
                                     is calculated for the incidence i,

                                 —

                                    Iy is the incidence rate of IHD in the area under assessment, that can be obtained from statistics on health for the region or country where the area is,

                                 —

                                    P is the total population of the area under assessment (the sum of the population in the different noise bands).

                           3.3.   For
                        HA and HSD in the case of road, railway and aircraft noise, the total number N of people affected by the harmful effect y
                         (number of attributable cases) due to the source x, for each combination of noise source x (road, railway or aircraft source) and harmful effect y (HA, HSD), is then:

                     Where:

                                 —

                                    ARx,y
                                     is the AR of the relevant harmful effect (HA, HSD), and is calculated using the formulas set out in point 2 of this Annex, calculated at the central value of each noise band (e.g.: depending on availability of data, at 50,5 dB for the noise band defined between 50-51 dB, or 52 dB for the noise band 50-54 dB),

                                 —

                                    nj
                                     is the number of people that is exposed to the j-th exposure band.

                           4.   Future revisions

                     The dose-effect relations introduced by future revisions of this Annex will concern in particular:

                                 —

                                 the relation between annoyance and Lden for industrial noise,

                                 —

                                 the relation between sleep disturbance and Lnight for industrial noise.

                           If necessary, specific dose-effect relations could be presented for:

                                 —

                                 dwellings with special insulation against noise as defined in Annex VI,

                                 —

                                 dwellings with a quiet façade as defined in Annex VI,

                                 —

                                 different climates/different cultures,

                                 —

                                 vulnerable groups of the population,

                                 —

                                 tonal industrial noise,

                                 —

                                 impulsive industrial noise and other special cases.

               ’


title: Directive (EU) 2020/700 of the European Parliament and of the Council of 25 May 2020 amending Directives (EU) 2016/797 and (EU) 2016/798, as regards the extension of their transposition periods (Text with EEA relevance)

text:
                  27.5.2020

                  EN

                  Official Journal of the European Union

                  L 165/27

         DIRECTIVE (EU) 2020/700 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
         of 25 May 2020
         amending Directives (EU) 2016/797 and (EU) 2016/798, as regards the extension of their transposition periods
         (Text with EEA relevance)
         THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,
         Having regard to the Treaty on the Functioning of the European Union, and in particular Article 91(1) thereof,
         Having regard to the proposal from the European Commission,
         After transmission of the draft legislative act to the national parliaments,
         After consulting the European Economic and Social Committee,
         After consulting the Committee of the Regions,
         Acting in accordance with the ordinary legislative procedure (1),
         Whereas:

                     (1)

                     In accordance with Article 57(1) of Directive (EU) 2016/797 of the European Parliament and of the Council (2) and Article 33(1) of Directive (EU) 2016/798 of the European Parliament and of the Council (3), Member States were to have brought into force the laws, regulations and administrative provisions necessary for them to comply with the relevant provisions of those Directives by 16 June 2019. However, pursuant to Article 57(2) of Directive (EU) 2016/797 and Article 33(2) of Directive (EU) 2016/798, Member States had the possibility to extend the transposition period by one year.

                     (2)

                     Seventeen Member States have notified the Commission and the European Union Agency for Railways (the ‘Agency’) of an extension to the transposition deadlines of Directives (EU) 2016/797 and (EU) 2016/798 to 16 June 2020.

                     (3)

                     Due to the extraordinary and unforeseeable situation caused by the COVID‐19 outbreak, some of those Member States are having difficulties completing the legislative work within the given transposition deadlines and therefore risk failing to comply with them. Such a failure could create legal uncertainty for the rail industry, the national authorities and the Agency as to the legislation that applies to rail safety and interoperability. The inability of certain Member States to transpose Directives (EU) 2016/797 and (EU) 2016/798 as a result of the COVID‐19 outbreak has detrimental consequences for the rail sector.

                     (4)

                     It is essential to provide legal clarity and certainty to the rail industry by allowing, where relevant, Member States to continue to apply, from 16 June 2020 and for a limited period, Directives 2004/49/EC (4) and 2008/57/EC (5) of the European Parliament and of the Council.

                     (5)

                     Since the COVID‐19 outbreak occurred during the final stage of adoption of the national transposition measures of Directives (EU) 2016/797 and (EU) 2016/798, Member States should be allowed an additional period to complete the transposition process.

                     (6)

                     The transposition deadlines of Directives (EU) 2016/797 and (EU) 2016/798 should be extended until 31 October 2020. The repeal dates of Directives 2004/49/EC and 2008/57/EC, as set out in Article 58 of Directive (EU) 2016/797 and Article 34 of Directive (EU) 2016/798 respectively, should be adjusted accordingly.

                     (7)

                     A number of delegated acts have been adopted on the basis of Directive (EU) 2016/798 reflecting previous transposition deadlines. In view of the current situation, those delegated acts need to be aligned with the new transposition deadline.

                     (8)

                     In view of the urgency entailed by the exceptional circumstances caused by the outbreak of COVID‐19, it was considered to be appropriate to provide for an exception to the eight‐week period referred to in Article 4 of Protocol No 1 on the role of national Parliaments in the European Union, annexed to the Treaty on European Union (TEU), to the Treaty on the Functioning of the European Union and to the Treaty establishing the European Atomic Energy Community.

                     (9)

                     Since the objective of this Directive, namely to amend Directives (EU) 2016/797 and (EU) 2016/798 in view of the COVID‐19 outbreak, cannot be sufficiently achieved by the Member States but can rather, by reason of its scale or effects, 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 TEU. 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)

                     Directives (EU) 2016/797 and (EU) 2016/798 should therefore be amended accordingly.

                     (11)

                     In order to allow for the prompt application of the measures provided for in this Directive, this Directive should enter into force as a matter of urgency on the day following that of its publication in the Official Journal of the European Union,

               HAVE ADOPTED THIS DIRECTIVE:

            Article 1
            Amendment to Directive (EU) 2016/797
            Directive (EU) 2016/797 is amended as follows:

                        (1)

                        in Article 54, paragraph 4 is replaced by the following:

                           ‘4.   At the latest from 16 June 2019 the Agency shall carry out the authorisation tasks pursuant to Articles 21 and 24 and the tasks referred to in Article 19 in respect of areas of use in the Member States that have not notified the Agency and the Commission in accordance with Article 57(2). By way of derogation from Articles 21 and 24, national safety authorities of Member States which have notified the Agency and Commission pursuant to Article 57(2) may continue to issue authorisations in accordance with Directive 2008/57/EC until 16 June 2020. By way of derogation from Articles 21 and 24, national safety authorities of Member States which have notified the Agency and Commission pursuant to Article 57(2a) may continue to issue authorisations in accordance with Directive 2008/57/EC until 31 October 2020.’;

                        (2)

                        in Article 57, the following paragraph is inserted:

                           ‘2a.   Member States that have extended the transposition period in accordance with paragraph 2 may further extend it until 31 October 2020. Their transposition measures shall apply from that date. Those Member States shall notify the Agency and the Commission thereof by 29 May 2020.’;

                        (3)

                        in the first paragraph of Article 58, the date ‘16 June 2020’ is replaced by ‘31 October 2020’.

            Article 2
            Amendment to Directive (EU) 2016/798
            Directive (EU) 2016/798 is amended as follows:

                        (1)

                        the following Article is inserted:

                           ‘Article 6a
                           Alignment of CSMs with revised deadlines
                           The Commission shall be empowered to adopt delegated acts in accordance with Article 27 to align the application dates of delegated acts adopted under Article 6(6) with the transposition deadline set out in Article 33(2a). The procedure provided for in Article 27a shall apply to delegated acts adopted pursuant to this Article.’;

                        (2)

                        in Article 27, the following paragraph is added:

                           ‘7.   The power to adopt delegated acts referred to in Article 6a shall be conferred on the Commission from 28 May 2020 to 31 October 2020.’;

                        (3)

                        the following Article is inserted:

                           ‘Article 27a
                           Urgency procedure

                              1.   Delegated acts adopted under this Article shall enter into force without delay and shall apply as long as no objection is expressed in accordance with paragraph 2. The notification of a delegated act to the European Parliament and to the Council shall state the reasons for the use of the urgency procedure.

                              2.   Either the European Parliament or the Council may object to a delegated act in accordance with the procedure referred to in Article 27(6). In such a case, the Commission shall repeal the act immediately following the notification of the decision to object by the European Parliament or by the Council.’;

                        (4)

                        in Article 31, paragraph 3 is replaced by the following:

                           ‘3.   At the latest from 16 June 2019 the Agency shall carry out the certification tasks pursuant to Article 10 in respect of areas of operation in the Member States that have not notified the Agency or the Commission in accordance with Article 33(2). By way of derogation from Article 10, national safety authorities of the Member States which have notified the Agency and the Commission pursuant to Article 33(2) may continue to issue certificates in accordance with Directive 2004/49/EC until 16 June 2020. By way of derogation from Article 10, national safety authorities of the Member States which have notified the Agency and the Commission pursuant to Article 33(2a) may continue to issue certificates in accordance with Directive 2004/49/EC until 31 October 2020.’;

                        (5)

                        in Article 33, the following paragraph is inserted:

                           ‘2a.   Member States that have extended the transposition period in accordance with paragraph 2 may further extend it until 31 October 2020. Their transposition measures shall apply from that date. Those Member States shall notify the Agency and the Commission thereof by 29 May 2020.’;

                        (6)

                        in the first paragraph of Article 34, the date ‘16 June 2020’ is replaced by ‘31 October 2020’.

            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, 25 May 2020.

                  For the European Parliament

                  The President

               D. M. SASSOLI

                  For the Council

                  The President

               A. METELKO-ZGOMBIĆ

            (1)  Position of the European Parliament of 15 May 2020 (not yet published in the Official Journal) and decision of the Council of 25 May 2020.

            (2)  Directive (EU) 2016/797 of the European Parliament and of the Council of 11 May 2016 on the interoperability of the rail system within the European Union (OJ L 138, 26.5.2016, p. 44).

            (3)  Directive (EU) 2016/798 of the European Parliament and of the Council of 11 May 2016 on railway safety (OJ L 138, 26.5.2016, p. 102).

            (4)  Directive 2004/49/EC of the European Parliament and of the Council of 29 April 2004 on safety on the Community's railways and amending Council Directive 95/18/EC on the licensing of railway undertakings and Directive 2001/14/EC on the allocation of railway infrastructure capacity and the levying of charges for the use of railway infrastructure and safety certification (Railway Safety Directive) (OJ L 164, 30.4.2004, p. 44).

            (5)  Directive 2008/57/EC of the European Parliament and of the Council of 17 June 2008 on the interoperability of the rail system within the Community (OJ L 191, 18.7.2008, p. 1).


title: Council Directive (EU) 2020/876 of 24 June 2020 amending Directive 2011/16/EU to address the urgent need to defer certain time limits for the filing and exchange of information in the field of taxation because of the COVID-19 pandemic

text:
                  26.6.2020

                  EN

                  Official Journal of the European Union

                  L 204/46

         COUNCIL DIRECTIVE (EU) 2020/876
         of 24 June 2020
         amending Directive 2011/16/EU to address the urgent need to defer certain time limits for the filing and exchange of information in the field of taxation because of 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 Articles 113 and 115 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)

                     The severe risks to public health and other hindrances caused by the COVID-19 pandemic, as well as lockdown measures imposed by Member States to help contain the pandemic, have had a significant disruptive effect on the capacity of businesses and Member States’ tax authorities to carry out some of their obligations pursuant to Council Directive 2011/16/EU (3).

                     (2)

                     A number of Member States and persons liable to report information to the competent authorities of Member States under Directive 2011/16/EU have requested the deferral of certain time limits laid down in that Directive. Those time limits concern automatic exchanges of information on financial accounts whose beneficiaries are tax resident in another Member State and on reportable cross-border arrangements that contain at least one of the hallmarks set out in Annex IV to Directive 2011/16/EU (‘reportable cross‐border arrangements’).

                     (3)

                     The severe disruption caused by the COVID-19 pandemic to the activities of many financial institutions and persons liable to report reportable cross-border arrangements hampers timely compliance with their reporting obligations pursuant to Directive 2011/16/EU. Financial institutions are currently faced with urgent tasks related to the COVID-19 pandemic.

                     (4)

                     Furthermore, financial institutions and persons liable to report are faced with serious work‐related disruptions, primarily due to remote working conditions because of the lockdown in most Member States. Similarly, the capacity of Member States’ tax authorities to collect and process data has been negatively affected.

                     (5)

                     This situation requires an urgent and, to the extent possible, coordinated response within the Union. For that purpose, it is necessary to provide Member States with the option to defer the time limit for the exchange of information on financial accounts whose beneficiaries are tax resident in another Member State in order to allow Member States to adjust their national time limits for the filing of such information by Reporting Financial Institutions. Moreover, Member States should also be provided with the option to defer the time limits for filing and exchanging information on reportable cross-border arrangements.

                     (6)

                     Deferral of the time limits (‘deferral’) aims to address an exceptional situation and should not disrupt the structure established by, or the functioning of, Directive 2011/16/EU. Consequently, it is necessary for the deferral to be limited and to remain proportionate to the practical difficulties caused by the COVID-19 pandemic with regard to filing and exchanging information.

                     (7)

                     In light of the current uncertainty about the evolution of the COVID-19 pandemic, and given that the circumstances that justify the adoption of this Directive might continue to exist for some time, it is appropriate to provide for the possibility of one optional extension of the period of the deferral. Such an extension should take place only if the conditions laid down by this Directive are fulfilled.

                     (8)

                     In view of the significant impact of the economic disturbance caused by the COVID-19 pandemic on the budgets, human resources and functioning of Member States’ tax authorities, the Council should be empowered to decide unanimously, on a proposal from the Commission, to extend the period of the deferral.

                     (9)

                     Any deferral should not affect the essential elements of the obligation to report and exchange information under Directive 2011/16/EU and it should be ensured that no information which becomes reportable during the period of the deferral remains unreported or unexchanged.

                     (10)

                     In view of the urgency entailed by the exceptional circumstances caused by the COVID-19 pandemic, the associated public health crisis and its social and economic consequences, it was considered to be appropriate to provide for an exception to the eight‐week period referred to in Article 4 of Protocol No 1 on the role of national Parliaments in the European Union, annexed to the Treaty on European Union, to the Treaty on the Functioning of the European Union and to the Treaty establishing the European Atomic Energy Community.

                     (11)

                     Directive 2011/16/EU should therefore be amended accordingly.

                     (12)

                     Given that Member States need to act within a very short period of time to defer time limits that would otherwise become applicable pursuant to Directive 2011/16/EU, this Directive should enter into force as a matter of urgency,

               HAS ADOPTED THIS DIRECTIVE:

            Article 1
            In Directive 2011/16/EU, the following articles are inserted:

                  ‘Article 27a
                  Optional deferral of time limits because of the COVID-19 pandemic

                     1.   Notwithstanding the time limits for filing information on reportable cross-border arrangements as specified in Article 8ab(12), Member States may take the measures necessary to allow intermediaries and relevant taxpayers to file, by 28 February 2021, information on reportable cross-border arrangements the first step of which was implemented between 25 June 2018 and 30 June 2020.

                     2.   Where Member States take measures as referred to in paragraph 1, they shall also take the measures necessary to allow:

                                 (a)

                                 notwithstanding Article 8ab(18), the first information to be communicated by 30 April 2021;

                                 (b)

                                 the period of 30 days for filing information referred to in Article 8ab(1) and (7) to begin by 1 January 2021 where:

                                             (i)

                                             a reportable cross-border arrangement is made available for implementation or is ready for implementation, or where the first step in its implementation has been made between 1 July 2020 and 31 December 2020; or

                                             (ii)

                                             intermediaries within the meaning of the second paragraph of point 21 of Article 3 provide, directly or by means of other persons, aid, assistance or advice between 1 July 2020 and 31 December 2020;

                                 (c)

                                 in the case of marketable arrangements, the first periodic report in accordance with Article 8ab(2) to be made by the intermediary by 30 April 2021.

                     3.   Notwithstanding the time limit laid down in point (b) of Article 8(6), Member States may take the measures necessary to allow the communication of information referred to in Article 8(3a) that relates to the calendar year 2019 or another appropriate reporting period to take place within 12 months following the end of the calendar year 2019 or the other appropriate reporting period.

                  Article 27b
                  Extension of the period of deferral

                     1.   The Council, acting unanimously on a proposal from the Commission, may take an implementing decision to extend the period of deferral of the time limits set out in Article 27a by three months, provided that severe risks to public health, hindrances and economic disturbance caused by the COVID-19 pandemic continue to exist and Member States apply lockdown measures.

                     2.   The proposal for a Council implementing decision shall be submitted to the Council at least one month before the expiry of the relevant deadline.’.

            Article 2
            This Directive shall enter into force on the day following that of its publication in the Official Journal of the European Union.

            Article 3
            This Directive is addressed to the Member States.

            Done at Brussels, 24 June 2020.

                  For the Council

                  The President

               A. METELKO-ZGOMBIĆ

            (1)  Opinion of 19 June 2020 (not yet published in the Official Journal).

            (2)  Opinion of 14 June 2020 (not yet published in the Official Journal).

            (3)  Council Directive 2011/16/EU of 15 February 2011 on administrative cooperation in the field of taxation and repealing Directive 77/799/EEC (OJ L 64, 11.3.2011, p. 1).