NIS2 - Annex 1 EN
NIS2 - Annex 1 EN
NIS2 - Annex 1 EN
COMMISSION
Brussels, 16.12.2020
COM(2020) 823 final
ANNEXES 1 to 3
ANNEXES
to the
Proposal for a
EN EN
ANNEX I
ESSENTIAL ENTITIES:
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 on the internal market for electricity
(OJ L 158, 14.6.2019, p. 54).
1
2019/944
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).
2
— Natural gas undertakings as defined
in point (1) of Article 2 of Directive
2009/73/EC
6
Regulation (EC) No 300/2008 of the European Parliament and of the Council of 11 March 2008 on common
rules in the field of civil aviation security and repealing Regulation (EC) No 2320/2002 (OJ L 97, 9.4.2008,
p.72).
7
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).
8
Regulation (EC) 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).
9
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).
3
(b) Rail — Infrastructure managers referred to
in point (2) of Article 3 of Directive
2012/34/EU(10)
10
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).
11
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).
12
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).
13
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)
4
Delegated Regulation (EU)
14
2015/962 ( ) responsible for traffic
management control
14
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).
15
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).
16
Regulation (EU) No 575/2013 of the European Parliament and of the Council of 26 June 2013 on prudential
requirements for credit institutions and investment firms and amending Regulation (EU) No 648/2012 (OJ L
176, 27.6.2013, p. 1).
17
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).
18
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).
19
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).
5
EU reference laboratories referred to
in Article 15 of Regulation
XXXX/XXXX on serious cross-
border threats to health20
20
[Regulation of the European Parliament and of the Council on serious cross-border threats to health and
repealing Decision No 1082/2013/EU, reference to be updated once the proposal COM (2020)727 final is
adopted]
21
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).
22
[Regulation of the European Parliament and of the Council on a reinforced role for the European Medicines
Agency in crisis preparedness and management for medicinal produces and medical devices, reference to be
updated once the proposal COM(2020)725 final is adopted]
23
Council Directive 98/83/EC of 3 November 1998 on the quality of water intended for human consumption (OJ
L 330, 5.12.1998, p. 32).
6
treating urban, domestic and industrial
waste water referred to in points (1) to
(3) of Article 2 of Council Directive
91/271/EEC (24)
24
Council Directive 91/271/EEC of 21 May 1991 concerning urban waste water treatment (OJ L 135, 30.5.1991,
p.40).
25
Regulation (EU) No 910/2014 of the European Parliament and of the Council of 23 July 2014 on electronic
identification and trust services for electronic transactions in the internal market and repealing Directive
1999/93/EC (OJ L 257, 28.8.2014, p.73).
26
Directive (EU) 2018/1972 of the European Parliament and of the Council of 11 December 2018 establishing
the European Electronic Communication Code (OJ L 321, 17.12.2018, p. 36).
7
Annex I of Regulation (EC) No
1059/2003 (27)
27
Regulation (EC) No 1059/2003 of the European Parliament and of the Council of 26 May 2003 on the
establishment of a common classification of territorial units for statistics (NUTS) (OJ L 154, 21.6.2003, p. 1).
8
ANNEX II
IMPORTANT ENITIES:
28
Directive 97/67/EC of the European Parliament and of the Council of 15 December 1997 on common rules for
the development of the internal market of Community postal services and the improvement of the quality of
service (OJ L 15, 21.1.98, p.14).
29
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)
30
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).
31
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).
9
medical devices and in referred to in Article 2 point 1 of
vitro diagnostic medical Regulation (EU) 2017/745(32), and
devices entities manufacturing in vitro
diagnostic medical devices referred to
in Article 2 point 2 of Regulation (EU)
2017/746 (33) with exception of entities
manufacturing medical devices
mentioned in Annex 1, point 5.
32
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)
33
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)
10
ANNEX III
CORRELATION TABLE
Article 1 (3) -
Article 2 -
Article 3 Article 3
Article 4 Article 4
Article 5 -
Article 6 -
11
Article 11 (2) Article 12 (3)
Article 11 (4) -
Article 13 -
Article 14 (7) -
Article 16 (5) -
12
Article 16 (8), (9) Article 20 (11)
Article 16 (10) -
Article 17 (1) -
Article 19 Article 22
Article 20 Article 27
Article 21 Article 33
Article 23 Article 35
Article 24 -
Article 25 Article 38
Article 26 Article 42
Article 27 Article 43
Annex II Annex I
13
Annex III, 3 Annex I, 8.
14