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Credit institutions as defined in Article 4, point (1), of Regulation (EU) No 575/2013 of the European Parliament and of the Council(15) |
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Suppliers and distributors of water intended for human consumption as defined in Article 2, point (1)(a), of Directive (EU) 2020/2184 of the European Parliament and of the Council(22), excluding distributors for which distribution of water for human consumption is a non-essential part of their general activity of distributing other commodities and goods |
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Undertakings collecting, disposing of or treating urban waste water, domestic waste water or industrial waste water as defined in Article 2, points (1), (2) and (3), of Council Directive 91/271/EEC(23), excluding undertakings for which collecting, disposing of or treating urban waste water, domestic waste water or industrial waste water is a non-essential part of their general activity |
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Operators of ground-based infrastructure, owned, managed and operated by Member States or by private parties, that support the provision of space-based services, excluding providers of public electronic communications networks |
(1) Directive (EU) 2019/944 of the European Parliament and of the Council of 5 June 2019 on common rules for the internal market for electricity and amending Directive 2012/27/EU (OJ L 158, 14.6.2019, p. 125).
(2) Regulation (EU) 2019/943 of the European Parliament and of the Council of 5 June 2019 on the internal market for electricity (OJ L 158, 14.6.2019, p. 54).
(3) Directive (EU) 2018/2001 of the European Parliament and of the Council of 11 December 2018 on the promotion of the use of energy from renewable sources (OJ L 328, 21.12.2018, p. 82).
(4) Council Directive 2009/119/EC of 14 September 2009 imposing an obligation on Member States to maintain minimum stocks of crude oil and/or petroleum products (OJ L 265, 9.10.2009, p. 9).
(5) Directive 2009/73/EC of the European Parliament and of the Council of 13 July 2009 concerning common rules for the internal market in natural gas and repealing Directive 2003/55/EC (OJ L 211, 14.8.2009, p. 94).
(6) Directive 2009/12/EC of the European Parliament and of the Council of 11 March 2009 on airport charges (OJ L 70, 14.3.2009, p. 11).
(7) Regulation (EU) No 1315/2013 of the European Parliament and of the Council of 11 December 2013 on Union guidelines for the development of the trans-European transport network and repealing Decision No 661/2010/EU (OJ L 348, 20.12.2013, p. 1).
(8) Regulation (EC) No 549/2004 of the European Parliament and of the Council of 10 March 2004 laying down the framework for the creation of the single European sky (the framework Regulation) (OJ L 96, 31.3.2004, p. 1).
(9) Directive 2012/34/EU of the European Parliament and of the Council of 21 November 2012 establishing a single European railway area (OJ L 343, 14.12.2012, p. 32).
(10) Regulation (EC) No 725/2004 of the European Parliament and of the Council of 31 March 2004 on enhancing ship and port facility security (OJ L 129, 29.4.2004, p. 6).
(11) Directive 2005/65/EC of the European Parliament and of the Council of 26 October 2005 on enhancing port security (OJ L 310, 25.11.2005, p. 28).
(12) Directive 2002/59/EC of the European Parliament and of the Council of 27 June 2002 establishing a Community vessel traffic monitoring and information system and repealing Council Directive 93/75/EEC (OJ L 208, 5.8.2002, p. 10).
(13) Commission Delegated Regulation (EU) 2015/962 of 18 December 2014 supplementing Directive 2010/40/EU of the European Parliament and of the Council with regard to the provision of EU-wide real-time traffic information services (OJ L 157, 23.6.2015, p. 21).
(14) Directive 2010/40/EU of the European Parliament and of the Council of 7 July 2010 on the framework for the deployment of Intelligent Transport Systems in the field of road transport and for interfaces with other modes of transport (OJ L 207, 6.8.2010, p. 1).
(15) Regulation (EU) No 575/2013 of the European Parliament and of the Council of 26 June 2013 on prudential requirements for credit institutions and amending Regulation (EU) No 648/2012 (OJ L 176, 27.6.2013, p. 1).
(16) Directive 2014/65/EU of the European Parliament and of the Council of 15 May 2014 on markets in financial instruments and amending Directive 2002/92/EC and Directive 2011/61/EU (OJ L 173, 12.6.2014, p. 349).
(17) Regulation (EU) No 648/2012 of the European Parliament and of the Council of 4 July 2012 on OTC derivatives, central counterparties and trade repositories (OJ L 201, 27.7.2012, p. 1).
(18) Directive 2011/24/EU of the European Parliament and of the Council of 9 March 2011 on the application of patients’ rights in cross-border healthcare (OJ L 88, 4.4.2011, p. 45).
(19) Regulation (EU) 2022/2371 of the European Parliament and of the Council of 23 November 2022 on serious cross-border threats to health and repealing Decision No 1082/2013/EU (OJ L 314, 6.12.2022, p. 26).
(20) Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ L 311, 28.11.2001, p. 67).
(21) Regulation (EU) 2022/123 of the European Parliament and of the Council of 25 January 2022 on a reinforced role for the European Medicines Agency in crisis preparedness and management for medicinal products and medical devices (OJ L 20, 31.1.2022, p. 1).
(22) Directive (EU) 2020/2184 of the European Parliament and of the Council of 16 December 2020 on the quality of water intended for human consumption (OJ L 435, 23.12.2020, p. 1).
(23) Council Directive 91/271/EEC of 21 May 1991 concerning urban waste water treatment (OJ L 135, 30.5.1991, p. 40).
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Sector |
Subsector |
Type of entity |
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Postal service providers as defined in Article 2, point (1a), of Directive 97/67/EC, including providers of courier services |
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Undertakings carrying out waste management as defined in Article 3, point (9), of Directive 2008/98/EC of the European Parliament and of the Council(1), excluding undertakings for whom waste management is not their principal economic activity |
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Undertakings carrying out the manufacture of substances and the distribution of substances or mixtures, as referred to in Article 3, points (9) and (14), of Regulation (EC) No 1907/2006 of the European Parliament and of the Council(2) and undertakings carrying out the production of articles, as defined in Article 3, point (3), of that Regulation, from substances or mixtures |
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Food businesses as defined in Article 3, point (2), of Regulation (EC) No 178/2002 of the European Parliament and of the Council(3) which are engaged in wholesale distribution and industrial production and processing |
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Entities manufacturing medical devices as defined in Article 2, point (1), of Regulation (EU) 2017/745 of the European Parliament and of the Council(4), and entities manufacturing in vitro diagnostic medical devices as defined in Article 2, point (2), of Regulation (EU) 2017/746 of the European Parliament and of the Council(5) with the exception of entities manufacturing medical devices referred to in Annex I, point 5, fifth indent, of this Directive |
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Undertakings carrying out any of the economic activities referred to in section C division 26 of NACE Rev. 2 |
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Undertakings carrying out any of the economic activities referred to in section C division 27 of NACE Rev. 2 |
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Undertakings carrying out any of the economic activities referred to in section C division 28 of NACE Rev. 2 |
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Undertakings carrying out any of the economic activities referred to in section C division 29 of NACE Rev. 2 |
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Undertakings carrying out any of the economic activities referred to in section C division 30 of NACE Rev. 2 |
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Research organisations |
(1) Directive 2008/98/EC of the European Parliament and of the Council of 19 November 2008 on waste and repealing certain Directives (OJ L 312, 22.11.2008, p. 3).
(2) Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning 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).
(3) Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety (OJ L 31, 1.2.2002, p. 1).
(4) Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (OJ L 117, 5.5.2017, p. 1).
(5) Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (OJ L 117, 5.5.2017, p. 176).
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Directive (EU) 2016/1148 |
This Directive |
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Article 1(1) |
Article 1(1) |
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Article 1(2) |
Article 1(2) |
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Article 1(3) |
– |
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Article 1(4) |
Article 2(12) |
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Article 1(5) |
Article 2(13) |
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Article 1(6) |
Article 2(6) and (11) |
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Article 1(7) |
Article 4 |
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Article 2 |
Article 2(14) |
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Article 3 |
Article 5 |
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Article 4 |
Article 6 |
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Article 5 |
– |
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Article 6 |
– |
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Article 7(1) |
Article 7(1) and (2) |
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Article 7(2) |
Article 7(4) |
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Article 7(3) |
Article 7(3) |
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Article 8(1) to (5) |
Article 8(1) to (5) |
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Article 8(6) |
Article 13(4) |
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Article 8(7) |
Article 8(6) |
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Article 9(1), (2) and (3) |
Article 10(1), (2) and (3) |
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Article 9(4) |
Article 10(9) |
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Article 9(5) |
Article 10(10) |
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Article 10(1), (2) and (3), first subparagraph |
Article 13(1), (2) and (3) |
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Article 10(3), second subparagraph |
Article 23(9) |
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Article 11(1) |
Article 14(1) and (2) |
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Article 11(2) |
Article 14(3) |
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Article 11(3) |
Article 14(4), first subparagraph, points (a) to (q) and (s), and paragraph (7) |
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Article 11(4) |
Article 14(4), first subparagraph, point (r), and second subparagraph |
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Article 11(5) |
Article 14(8) |
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Article 12(1) to (5) |
Article 15(1) to (5) |
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Article 13 |
Article 17 |
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Article 14(1) and (2) |
Article 21(1) to (4) |
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Article 14(3) |
Article 23(1) |
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Article 14(4) |
Article 23(3) |
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Article 14(5) |
Article 23(5), (6) and (8) |
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Article 14(6) |
Article 23(7) |
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Article 14(7) |
Article 23(11) |
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Article 15(1) |
Article 31(1) |
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Article 15(2), first subparagraph, point (a) |
Article 32(2), point (e) |
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Article 15(2), first subparagraph, point (b) |
Article 32(2), point (g) |
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Article 15(2), second subparagraph |
Article 32(3) |
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Article 15(3) |
Article 32(4), point (b) |
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Article 15(4) |
Article 31(3) |
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Article 16(1) and (2) |
Article 21(1) to (4) |
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Article 16(3) |
Article 23(1) |
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Article 16(4) |
Article 23(3) |
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Article 16(5) |
– |
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Article 16(6) |
Article 23(6) |
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Article 16(7) |
Article 23(7) |
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Article 16(8) and (9) |
Article 21(5) and Article 23(11) |
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Article 16(10) |
– |
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Article 16(11) |
Article 2(1), (2) and (3) |
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Article 17(1) |
Article 33(1) |
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Article 17(2), point (a) |
Article 32(2), point (e) |
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Article 17(2), point (b) |
Article 32(4), point (b) |
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Article 17(3) |
Article 37(1), points (a) and (b) |
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Article 18(1) |
Article 26(1), point (b), and paragraph (2) |
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Article 18(2) |
Article 26(3) |
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Article 18(3) |
Article 26(4) |
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Article 19 |
Article 25 |
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Article 20 |
Article 30 |
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Article 21 |
Article 36 |
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Article 22 |
Article 39 |
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Article 23 |
Article 40 |
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Article 24 |
– |
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Article 25 |
Article 41 |
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Article 26 |
Article 45 |
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Article 27 |
Article 46 |
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Annex I, point (1) |
Article 11(1) |
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Annex I, points (2)(a)(i) to (iv) |
Article 11(2), points (a) to (d) |
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Annex I, point (2)(a)(v) |
Article 11(2), point (f) |
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Annex I, point (2)(b) |
Article 11(4) |
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Annex I, points (2)(c)(i) and (ii) |
Article 11(5), point (a) |
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Annex II |
Annex I |
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Annex III, points (1) and (2) |
Annex II, point (6) |
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Annex III, point (3) |
Annex I, point (8) |