18.10.2011   

EN

Official Journal of the European Union

L 271/15

(1)

Pursuant to Regulation (EC) No 216/2008, the Commission, assisted by the European Aviation Safety Agency (‘the Agency’), is required to adopt the relevant implementing rules to provide a set of safety regulatory requirements for the implementation of an effective air traffic management (ATM) safety oversight function. Article 8b of Regulation (EC) No 216/2008 requires these implementing rules to be developed based on the regulations adopted pursuant to Article 5(3) of 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’) (4). This Regulation is based on Commission Regulation (EC) No 1315/2007 of 8 November 2007 on safety oversight in air traffic management and amending Regulation (EC) No 2096/2005 (5).

(2)

There is a need to further define the role and functions of competent authorities based on the provisions of Regulations (EC) No 216/2008, (EC) No 549/2004, (EC) No 550/2004, and (EC) No 552/2004 of the European Parliament and of the Council of 10 March 2004 on the interoperability of the European Air Traffic Management network (‘the interoperability Regulation’) (6). These regulations include requirements on the safety of air navigation services. While providers are responsible for the safe provision of air navigation services, Member States should ensure effective supervision through competent authorities.

(3)

This Regulation should not cover military operations and training, as provided for in Article 1(2) of Regulation (EC) No 549/2004 and Article 1(2)(c) of Regulation (EC) No 216/2008.

(4)

Competent authorities should conduct safety regulatory audits and reviews in accordance with this Regulation as part of the proper inspections and surveys required by Regulations (EC) No 216/2008 and (EC) No 550/2004.

(5)

Competent authorities should consider using the safety oversight approach of this Regulation in other areas of oversight as appropriate in order to deliver efficient and coherent supervision.

(6)

Air navigation services, as well as air traffic flow management (ATFM) and airspace management (ASM), use functional systems that enable the management of air traffic. Therefore any changes to functional systems should be subject to a safety oversight.

(7)

Competent authorities should take all necessary measures in case a system or a constituent of a system does not comply with the relevant requirements. In this context, and in particular when a safety directive has to be issued, the competent authority should consider instructing the notified bodies involved in issuing the Declaration referred to in Article 5 or 6 of Regulation (EC) No 552/2004 to conduct specific investigations with regard to that technical system.

(8)

Annual safety oversight reporting by competent authorities should contribute to the transparency and accountability of safety oversight. Such reports should be addressed to the Commission, the Agency and the Member State nominating or establishing the competent authority. Furthermore, annual safety oversight reports should be used in the context of regional cooperation, standardisation inspections under Regulation (EC) No 216/2008 and international safety oversight monitoring. The content of the reports should include relevant information with regard to the monitoring of safety performance, compliance with applicable safety regulatory requirements by supervised organisations, the programme of safety regulatory audits, the review of the safety arguments, changes to functional systems implemented by supervised organisations in accordance with procedures accepted by the competent authority and safety directives issued by such authority.

(9)

Pursuant to Article 10(1) of Regulation (EC) No 216/2008 and Article 2(4) of Regulation (EC) No 550/2004, competent authorities should make appropriate arrangements for close cooperation with each other to ensure adequate supervision of air navigation service providers which provide services relating to the airspace falling under the responsibility of a Member State different from the Member State which issued the certificate. Pursuant to Article 15 of Regulation (EC) No 216/2008, competent authorities should exchange in particular appropriate information about the safety oversight of organisations.

(10)

The Agency should further evaluate the provisions of this Regulation, in particular those related to the safety oversight of changes, and issue an opinion to adapt such changes towards a total system approach, taking into account the integration of these provisions into the future common regulatory structure for civil aviation safety and the experience gained by stakeholders and competent authorities. The Agency’s opinion should further aim at facilitating the implementation of the State Safety Programme (SSP) of the International Civil Aviation Organisation (ICAO) within the Union as part of this total system approach.

(11)

The safe execution of some of the network functions set up according to Regulation (EC) No 551/2004 requires that the entity involved should be subject to certain safety requirements. These requirements, which aim to ensure that such entity or organisation operates in a safe manner, are laid down in Commission Regulation (EU) No 677/2011 of 7 July 2011 laying down detailed rules for the implementation of air traffic management (ATM) network functions and amending Regulation (EU) No 691/2010 (7). These are organisation safety requirements which are very similar to those general requirements laid down in Commission Implementing Regulation (EU) No 1035/2011 (8), but adapted to the safety responsibilities of the network functions. In order to support a total system approach for safety regulation in the field of civil aviation, the execution of these requirements needs to be overseen in the same manner as air navigation service providers are overseen.

(12)

In its recommendations of July 2007, the High Level Group for the Future European Aviation Regulatory Framework highlighted the need to separate regulatory oversight from the provision of services or functions. In line with this principle, Article 6 of Regulation (EC) No 551/2004 provides that the entity nominated to perform the network functions needs to be subject to appropriate oversight arrangements. Since the Agency already carries out the independent safety oversight function of the pan-European ATM/ANS providers in accordance with Article 22a of Regulation (EC) No 216/2008, it would be fully in line with the European aviation safety policy to entrust it with supporting the Commission in performing the same tasks concerning the European network functions.

(13)

Regulation (EC) No 1315/2007 should therefore be repealed.

(14)

Commission Regulation (EU) No 691/2010 of 29 July 2010 laying down a performance scheme for air navigation services and network functions and amending Regulation (EC) No 2096/2005 (9) should be amended in order to be adapted to this Regulation.

(15)

The measures provided for in this Regulation are in accordance with the opinion of the Single Sky Committee,

(1)

‘corrective action’ means an action to eliminate the cause of a detected non-conformity;

(2)

‘functional system’ means a combination of systems, procedures and human resources organised to perform a function within the context of ATM;

(3)

‘Network Manager’ means the impartial and competent body entrusted pursuant to Article 6(2) or (6) of Regulation (EC) No 551/2004 to perform the duties described in that Article and this Regulation;

(4)

‘network functions’ means the specific functions described in Article 6 of Regulation (EC) No 551/2004;

(5)

‘organisation’ means either an air navigation service provider or an entity providing ATFM or ASM or other network functions;

(6)

‘process’ means a set of interrelated or interacting activities which transforms inputs into outputs;

(7)

‘safety argument’ means the demonstration and evidence that a proposed change to a functional system can be implemented within the targets or standards established through the existing regulatory framework consistently with the safety regulatory requirements;

(8)

‘safety directive’ means a document issued or adopted by a competent authority which mandates actions to be performed on a functional system to restore safety, when evidence shows that aviation safety may otherwise be compromised;

(9)

‘safety objective’ means a qualitative or quantitative statement that defines the maximum frequency or probability at which a hazard can be expected to occur;

(10)

‘safety regulatory audit’ means a systematic and independent examination conducted by, or on behalf of, a competent authority to determine whether complete safety-related arrangements or elements thereof, related to processes and their results, products or services, comply with required safety-related arrangements and whether they are implemented effectively and are suitable to achieve expected results;

(11)

‘safety regulatory requirements’ means the requirements established by the Union or national regulations for the provision of air navigation services or ATFM and ASM functions or other network functions as well as concerning the technical and operational competence and suitability to provide these services and functions, their safety management, as well as systems, their constituents and associated procedures;

(12)

‘safety requirement’ means a risk mitigation, defined from the risk mitigation strategy that achieves a particular safety objective, including organisational, operational, procedural, functional, performance and interoperability requirements or environmental characteristics;

(13)

‘verification’ means confirmation through the provision of objective evidence that specified requirements have been fulfilled;

(14)

‘pan-European ATM/ANS’ means an activity which is designed and established for users within most or all Member States and which may also extend beyond the airspace of the territory to which the Treaty applies.

(a)

for organisations having their principal place of operation and, if any, their registered office located in a Member State while providing air navigation services in the territory of that Member State, the national supervisory authority nominated or established by that Member State;

(b)

for organisations for which under the agreements concluded among Member States in accordance with Article 2 of Regulation (EC) No 550/2004, the responsibilities for safety oversight have been allocated differently from point (a), the competent authorities nominated or established under those agreements. These agreements shall comply with the requirements of Article 2(3) to (6) of Regulation (EC) No 550/2004;

(c)

for organisations providing ATM/air navigation services in the airspace of the territory to which the Treaty applies and having their principal place of operation and, if any, their registered office located outside the territory subject to the provisions of the Treaty, the European Aviation Safety Agency (‘the Agency’);

(d)

for organisations providing pan-European ATM/ANS as well as for all other network functions in the airspace of the territory to which the Treaty applies, the Agency.

(a)

specific points of responsibility exist to implement each provision of this Regulation;

(b)

Member States have visibility of the safety oversight mechanisms and their results;

(c)

relevant information exchange is ensured between the overseeing authorities and the certifying authority.

(a)

compliance with applicable safety regulatory requirements prior to the issue or renewal of a certificate necessary to provide air navigation services including safety-related conditions attached to it;

(b)

compliance with any safety-related obligations in the designation act issued in accordance with Article 8 of Regulation (EC) No 550/2004;

(c)

ongoing compliance of the organisations with applicable safety regulatory requirements;

(d)

implementation of safety objectives, safety requirements and other safety-related conditions identified in:

(e)

the implementation of safety directives.

(a)

be based on documented procedures;

(b)

be supported by documentation specifically intended to provide safety oversight personnel with guidance to perform their functions;

(c)

provide the organisations concerned with an indication of the results of the safety oversight activity;

(d)

be based on safety regulatory audits and reviews conducted in accordance with Articles 7, 9 and 10;

(e)

provide competent authorities with the evidence needed to support further action, including measures foreseen by Article 9 of Regulation (EC) No 549/2004, Article 7(7) of Regulation (EC) No 550/2004 and by Articles 10, 25 and 68 of Regulation (EC) No 216/2008 in situations where safety regulatory requirements are not being complied with.

(a)

provide competent authorities with evidence of compliance with applicable safety regulatory requirements and with implementing arrangements by evaluating the need for improvement or corrective action;

(b)

be independent of internal auditing activities undertaken by the organisation concerned as part of its safety or quality management systems;

(c)

be conducted by auditors qualified in accordance with the requirements of Article 12;

(d)

apply to complete implementing arrangements or elements thereof, and to processes, products or services;

(e)

determine whether:

(f)

lead to the correction of any identified non-conformities in accordance with Article 8.

(a)

cover all the areas of potential safety concern, with a focus on those areas where problems have been identified;

(b)

cover all the organisations, services and network functions operating under the supervision of the competent authority;

(c)

ensure that audits are conducted in a manner commensurate to the level of risk posed by the organisations’ activities;

(d)

ensure that sufficient audits are conducted over a period of 2 years to check the compliance of all these organisations with applicable safety regulatory requirements in all the relevant areas of the functional system;

(e)

ensure follow up of the implementation of corrective actions.

(a)

the severity assessment conducted in accordance with Annex II, point 3.2.4 of Implementing Regulation (EU) No 1035/2011 determines a severity class 1 or a severity class 2 for the potential effects of the hazards identified; or

(b)

the implementation of the changes requires the introduction of new aviation standards.

(a)

use documented procedures;

(b)

be supported by documentation specifically intended to provide safety oversight personnel with guidance to perform their functions;

(c)

consider the safety objectives, safety requirements and other safety-related conditions that are related to the changes under consideration identified in:

(d)

identify additional safety-related conditions associated to the implementation of the changes, wherever needed;

(e)

assess the acceptability of safety arguments presented, taking account of:

(f)

verify the processes used by organisations to produce the safety arguments in relation to the new functional system or changes to existing functional systems under consideration;

(g)

identify the need for the verification of ongoing compliance;

(h)

include any necessary coordination activities with the authorities responsible for the safety oversight of airworthiness and flight operations;

(i)

provide notification of the acceptance, with conditions where applicable, or the non-acceptance, with supporting reasons, of the change under consideration.

(a)

the qualified entity has prior experience in assessing safety in aviation entities;

(b)

the qualified entity is not simultaneously involved in internal activities within the safety or quality management systems of the organisation concerned;

(c)

all personnel concerned with the conduct of safety regulatory audits or reviews are adequately trained and qualified and meet the qualification criteria of Article 12(3) of this Regulation.

(a)

define and document the education, training, technical and operational knowledge, experience and qualifications relevant to the duties of each position involved in safety oversight activities within their structure;

(b)

ensure specific training for those involved in safety oversight activities within their structure;

(c)

ensure that personnel designated to conduct safety regulatory audits, including auditing personnel from qualified entities, meet specific qualification criteria defined by the competent authority. The criteria shall address:

(a)

the identification of the unsafe condition;

(b)

the identification of the affected functional system;

(c)

the actions required and their rationale;

(d)

the time limit for compliance of the required actions with the safety directive;

(e)

its date of entry into force.

(a)

organisational structure and procedures of the competent authority;

(b)

airspace falling under the responsibility of Member States which established or nominated the competent authority, if applicable, and organisations falling under the supervision of that competent authority;

(c)

qualified entities commissioned to conduct safety regulatory audits;

(d)

existing levels of resources of the competent authority;

(e)

any safety issues identified through the safety oversight processes operated by the competent authority.

‘(e)

NSA safety reports as referred to in Articles 7, 8 and 14 of Commission Implementing Regulation (EU) No 1034/2011 (10) as well as NSA reports on resolution of safety deficiencies identified that are subject to corrective action plans;