9.11.2007   

EN

Official Journal of the European Union

L 291/16

(1)

Pursuant to Regulation (EC) No 550/2004, the Commission is required to identify and adopt the relevant provisions of the Eurocontrol Safety Regulatory Requirements (ESARRs), taking into account existing Community legislation. ESARR 1 provides a set of safety regulatory requirements for the implementation of an effective air traffic management (ATM) safety oversight function.

(2)

The role and functions of national supervisory authorities have been established in 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) (2), Regulation (EC) No 550/2004, Regulation (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) (3) and Commission Regulation (EC) No 2096/2005 of 20 December 2005 laying down common requirements for the provision of air navigation services (4). These regulations include requirements on the safety of air navigation services. While the responsibility for the safe provision of service lies with the provider, the Member States should ensure effective supervision through national supervisory authorities.

(3)

This Regulation should not cover military operations and training as referred to in Article 1(2) of Regulation (EC) No 549/2004.

(4)

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

(5)

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

(6)

In line with Annex 11, Section 2.26 of the Convention on International Civil Aviation, ESARR 1 requires the monitoring and assessment of the levels of safety achieved against the tolerable levels of safety determined for specific airspace blocks. However, those tolerable levels of safety still need to be completely established at Community level and therefore they should be taken into consideration in this Regulation at a later stage.

(7)

All air navigation services, as well as air traffic flow management and air space management use functional systems that enable the management of air traffic. Therefore any changes to functional systems should be subject to a safety oversight.

(8)

Article 7 of Regulation (EC) No 552/2004 requires a national supervisory authority to 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 national supervisory authority should consider instructing the notified bodies involved in issuing the EC Declaration to conduct specific investigations with regard to that technical system.

(9)

National supervisory authorities should be given a sufficient period of time to prepare for the safety oversight of changes, notably as regards the identification of the targets and standards. The identification should be supported by appropriate Community specifications and other guidance material.

(10)

Annual safety oversight reporting by the national supervisory authorities should contribute to the transparency and accountability of the safety oversight. The reports should be addressed to the Member State nominating or establishing the authority. Furthermore, they should be used in the context of regional cooperation and international safety oversight monitoring. The actions to be reported should include relevant information with regard to the monitoring of safety performance, the compliance with applicable safety regulatory requirements by the organisations supervised, the programme of safety regulatory audits, the review of the safety arguments, the changes to functional systems implemented by the organisations in accordance with procedures accepted by the authority and the safety directives issued by the national supervisory authority.

(11)

Pursuant to Article 2(4) of Regulation (EC) No 550/2004, national supervisory 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. Authorities should exchange in particular appropriate information about the safety oversight of organisations.

(12)

Regulation (EC) No 2096/2005 should be amended accordingly, in order to ensure consistency in the implementation of the Single European Sky.

(13)

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

1.

‘corrective action’ means 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.

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

4.

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

5.

‘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;

6.

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

7.

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

8.

‘safety regulatory audit’ means a systematic and independent examination conducted by, or on behalf of, a national supervisory 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;

9.

‘safety regulatory requirements’ means the requirements established by Community or national regulations for the provision of air navigation services or ATFM and ASM functions 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;

10.

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

11.

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

(a)

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

(b)

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

(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 organisation 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 6, 8 and 9;

(e)

provide the national supervisory authority with the evidence needed to support further action, including measures foreseen by Article 9 of Regulation (EC) No 549/2004 and by Article 7(7) of Regulation (EC) No 550/2004 in situations where safety regulatory requirements are not being complied with.

(a)

provide national supervisory 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 11;

(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 7.

(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 and services operating under the supervision of the national supervisory 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 two 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 Regulation (EC) No 2096/2005 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 change under consideration which have been identified in:

(d)

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

(e)

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

(f)

verify the processes used by the 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 recognised organisation has prior experience in assessing safety in aviation entities;

(b)

the recognised organisation 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 11(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 recognised organisations, meet specific qualification criteria defined by the national supervisory 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 national supervisory authority;

(b)

airspace falling under the responsibility of the Member States which established or nominated the national supervisory authority and organisations falling under the supervision of the national supervisory authority;

(c)

recognised organisations commissioned to conduct safety regulatory audits;

(d)

existing levels of resources of the authority;

(e)

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