Regulation (EU) 2023/1769
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) 2018/1139 of the European Parliament and of the Council of 4 July 2018 on common rules in the field of civil aviation and establishing a European Union Aviation Safety Agency, and amending Regulations (EC) No 2111/2005, (EC) No 1008/2008, (EU) No 996/2010, (EU) No 376/2014 and Directives 2014/30/EU and 2014/53/EU of the European Parliament and of the Council, and repealing Regulations (EC) No 552/2004 and (EC) No 216/2008 of the European Parliament and of the Council and Council Regulation (EEC) No 3922/91 (4OJ L 212, 22.08.2018, p. 1.), and in particular Article 43(1) and Article 62(15), point (c) thereof,
Whereas:
(1) Taking into account the objectives and principles set out in Articles 1 and 4 to Regulation (EU) 2018/1139, and in particular the nature and risk of the activity concerned, organisations involved in the design or production of air traffic management/air navigation service (ATM/ANS) systems and ATM/ANS constituents, should be required to hold a certificate.
(2) In order to ensure the uniform implementation of and compliance with the essential requirements referred to in Article 40 of Regulation (EU) 2018/1139, for the provision of ATM/ANS this Regulation should lay down rules and procedures for issuing, maintaining, amending, limiting, suspending or revoking the certificates for organisations involved in the design or production of ATM/ANS systems and ATM/ANS constituents, as well as the privileges and responsibilities of the holders of certificates.
(3) The conformity assessment of ATM/ANS equipment laid down in Commission Delegated Regulation (EU) 2023/ 1768 (5Commission Delegated Regulation (EU) 2023/1768 of 14 July 2023 laying down detailed rules for the certification and declaration of air traffic management/air navigation services systems and air traffic management/air navigation services constituents (see page 1 of this Official Journal).) depends on the nature and the risk of the ATM/ANS service, or on the functionality of a particular ATM/ANS equipment and is based on the existing methodologies and best practices. That Regulation establishes three different types of conformity assessment, in particular: a certification by the Agency of certain ATM/ANS equipment; a declaration by an approved organisation involved in the design or production of ATM/ANS equipment; and a statement of compliance by the ATM/ANS provider or by an approved organisation involved in the design or production of ATM/ANS equipment.
(4) The typical life cycle of ATM/ANS equipment consists of various phases: design, production, installation, operation, maintenance, and decommission. The ATM/ANS provider is usually responsible for some of those phases, while for other phases the organisations involved in the design or production of ATM/ANS equipment are responsible. Therefore, common requirements should be established for the approval and oversight of organisations involved in the design or production of certain ATM/ANS equipment used in the provision of ATM/ANS, in particular those referred to in point 3.1 of Annex VIII to Regulation (EU) 2018/1139.
(5) The European Union Aviation Safety Agency (‘the Agency’) is responsible for all competent authority tasks related to certificates and declarations for ATM/ANS systems and ATM/ANS constituents (‘ATM/ANS equipment’), including oversight and enforcement. To ensure consistency and risk-based assessment and, amongst others, to avoid duplication and administrative burdens, as well as to promote effectiveness in certification and oversight processes, those oversight and enforcement functions should be exercised by the Agency. For the purpose of certification or review of declarations of ATM/ANS equipment, it is necessary that the Agency also oversees the processes established by design and production organisations, including, where necessary, the certification of those organisations. Therefore, the Agency should be responsible for the approval of the organisations involved in the design or production of ATM/ANS equipment and at the same time for the attestation of ATM/ANS equipment.
(6) The competency of the Agency to certify design or production organisations should allow also for a non- discriminatory and harmonised approach towards all design or production organisations applying for a certificate under this Regulation. ATM/ANS equipment put on the market in the Union can be used in all Member States and for all kind of services, no matter whether it is used by ATM/ANS providers active in one or more Member States. It is not possible to categorise the organisations involved in the design and production based on their future catalogue of equipment to be used on a local or Union level. The same principle is to be observed when the Agency is allocating certification and oversight tasks.
(7) In accordance with Article 29(2), point (a), of Regulation (EU) 2021/696 (6Regulation (EU) 2021/696 of the European Parliament and of the Council of 28 April 2021 establishing the Union Space Programme and the European Union Agency for the Space Programme and repealing Regulations (EU) No 912/2010, (EU) No 1285/2013 and (EU) No 377/2014 and Decision No 541/2014/EU (OJ L 170, 12.5.2021, p. 69).) of the European Parliament and of the Council, the European Union Agency for the Space Programme (EUSPA) has been entrusted with the task of managing the exploitation of the European Geostationary Navigation Overlay Service (EGNOS), as provided for in Article 44 of that Regulation. The exploitation of EGNOS covers, amongst other actions, the support to certification and standardisation activities. EUSPA does not perform alone all the tasks relating to the exploitation of EGNOS and instead relies on the expertise of other entities, in particular the European Space Agency (ESA), on activities related to system evolution, design and development of parts of the ground segment. Hence EUSPA should be considered as equivalent to a design or production organisation in the context of this Regulation.
(8) According to the roles and responsibilities defined in Regulation (EU) 2021/696 for EUSPA and ESA, there is not one unique entity responsible for the design of the EGNOS system and its equipment and therefore there is not a single Design and Production Organisation that could be approved by EASA.
(9) Consequently, the specificities of the set-up for the design of the EGNOS system require specific means for the demonstration of compliance with the essential requirements laid down in Regulation (EU) 2018/1139, taking into account that EGNOS is a multimodal service, which should also comply with relevant regulatory requirements for other sectors.
(10) Both agencies should cooperate to assure compliance of the EGNOS system with the relevant ICAO standards so that respective arrangements ensure a level of safety and interoperability equivalent to that resulting from the full application of the requirements for design and production in this Regulation. The cooperation will also include the consultation of EUSPA in the development of detailed specifications.
(11) This Regulation has taken due account of the content of the ATM Master Plan and technological capabilities contained in it.
(12) The Agency has prepared draft implementing rules and submitted them to the Commission with Opinion No 01/2023 in accordance with Article 75(2), points (b) and (c), and Article 76(1) of Regulation (EU) 2018/1139.
(13) In order to make optimal use of existing resources and expertise, the Agency may seek administrative support when executing its certification, oversight and enforcement tasks under this Regulation from national competent authorities. This administrative support should not constitute any delegation of powers or responsibilities of tasks.
(14) In order to include design or production organisations of ATM/ANS equipment in the scope of the management of information security risks with a potential impact on aviation safety Implementing Regulation (EU) 2023/203 should be amended.
(15) The measures provided for in this Regulation are in accordance with the opinion of the Committee referred to in Article 127(1) of Regulation (EU) 2018/1139.
HAS ADOPTED THIS REGULATION:
Regulation (EU) 2023/1769
This Regulation lays down technical requirements and administrative procedures for the approval of organisations involved in the design or production of ATM/ANS systems and ATM/ANS constituents subject to certification in accordance with Article 4 of Delegated Regulation (EU) 2023/1768 or declaration of design compliance in accordance with Article 5 of that Regulation.
Regulation (EU) 2023/1769
For the purpose of this Regulation the following definitions apply:
(1) ‘ATM/ANS equipment’ means ATM/ANS constituents as defined by Article 3(6) of Regulation (EU) 2018/1139 and ATM/ANS systems as defined by Article 3(7) of that Regulation, excluding airborne constituents, which are subject to Commission Regulation (EU) No 748/2012 (7Commission Regulation (EU) No 748/2012 of 3 August 2012 laying down implementing rules for the airworthiness and environmental certification of aircraft and related products, parts and appliances, as well as for the certification of design and production organisations (OJ L 224, 21.8.2012, p. 1).);
(2) ‘ATM/ANS equipment directive’ means a document issued by the Agency which mandates actions to be performed by ATM/ANS providers on ATM/ANS equipment to address an unsafe and/or insecure condition that has been identified and restore the performance and interoperability of that ATM/ANS equipment when evidence shows that the safety, security, performance or interoperability of that particular equipment may otherwise be compromised.
Article 3 - Competent authority requirements
Regulation (EU) 2023/1769
1. For the purposes of this Regulation, the competent authority responsible for the issue of approvals to organisations involved in the design or production of ATM/ANS equipment and for the oversight and enforcement in respect of those organisations, shall be the Agency.
2. The Agency shall fulfil the detailed requirements laid down in Annex I (Part-DPO.AR) when conducting certification, investigations, inspections, audits and other monitoring activities necessary to ensure the effective oversight of organisations involved in the design or production of ATM/ANS equipment subject to this Regulation. The Agency may seek administrative support from national competent authorities for the performance of its tasks related to certification, oversight and enforcement when executing its functions under this Regulation.
Article 4 - Organisations involved in the design, or production of ATM/ANS equipment
Regulation (EU) 2023/1769
1. An organisation involved in the design or production of ATM/ANS equipment subject to certification in accordance with Article 4 of Delegated Regulation (EU) 2023/1768 or declaration of design compliance in accordance with Article 5 of that Regulation shall demonstrate its capability as a design or production organisation for ATM/ANS equipment in accordance with Annex II (Part-DPO.OR).
2. Organisations involved in the design or production of the ATM/ANS equipment of the European Geostationary Navigation Overlay Service (EGNOS) shall be deemed to comply with the requirements of Annex II to this Regulation by demonstrating their compliance with Regulation (EU) 2021/696 and with the management, design and quality standards applicable to EGNOS under that Regulation. Such organisations shall not be required to be approved by the Agency.
The European Union Agency for the Space Programme shall ensure in its role of a design or production organisation that the other organisations involved in the design or production of the equipment of EGNOS follow design and production processes resulting in the level of safety and interoperability equivalent to Annex II (Part-DPO.OR).
Article 5 - Amendments to Implementing Regulation (EU) 2023/203 (8Commission Implementing Regulation (EU) 2023/203 of 27 October 2022 laying down rules for the application of Regulation (EU) 2018/1139 of the European Parliament and of the Council, as regards requirements for the management of information security risks with a potential impact on aviation safety for organisations covered by Commission Regulations (EU) No 1321/2014, (EU) No 965/2012, (EU) No 1178/2011, (EU) 2015/340, Commission Implementing Regulations (EU) 2017/373 and (EU) No 2021/664, and for competent authorities covered by Commission Regulations (EU) No 748/2012, (EU) No 1321/2014, (EU) No 965/2012, (EU) No 1178/2011, (EU) 2015/340 and (EU) No 139/2014, Commission Implementing Regulations (EU) 2017/373 and (EU) No 2021/664 and amending Commission Regulations (EU) No 1178/2011, (EU) No 748/2012, (EU) No 965/2012, (EU) No 139/2014, (EU) No 1321/2014, (EU) 2015/340, and Commission Implementing Regulations (EU) 2017/373 and (EU) No 2021/664 (OJ L 31, 2.2.2023, p. 1).)
Regulation (EU) 2023/1769
Implementing Regulation (EU) 2023/203 is amended as follows:
(1) in Article 2(1), the following point (j) is added:
‘(j) approved organisations involved in the design or production of ATM/ANS systems and ATM/ANS constituents subject to Commission Implementing Regulation (EU) 2023/1769 (9Commission Implementing Regulation (EU) 2023/1769 of 12 September 2023 laying down technical requirements and administrative procedures for the approval of organisations involved in the design or production of air traffic management/air navigation services systems and constituents and amending Implementing Regulation (EU) 2023/203 (OJ L 228, XX.9.2023, p. 19).’).
(2) in Article 6(1), the following point (h) is added:
‘(h) with regard to organisations referred to in Article 2(1), point (j), the competent authority designated in accordance with Article 3(1) of Implementing Regulation (EU) 2023/1769.’.
Regulation (EU) 2023/1769
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
Regulation (EU) 2023/1769
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 12 September 2023.
For the Commission
The President
Ursula VON DER LEYEN