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COUNCIL OF Brussels, 18 November 2002
THE EUROPEAN UNION - PUBLIC
14236/02
Interinstitutional File:
2001/0237(COD) -
LIMITE
AVIATION
168
CODEC 1436
OUTCOME OF PROCEEDINGS
Of : Working Party on Aviation
On : 11-13 November 2002
N° Prev. doc.: 13619/02 AVIATION 162 CODEC 1349 N° Cion doc :
12693/1/01 REV 1 AVIATION 88 CODEC 1009
Subject : AVIATION Draft Regulation of the European Parliament and of the Council on the
interoperability of the European Air Traffic Management network
At its meeting on 11-13 November, the Working Party examined the above draft Regulation on the basis of document 13619/02, containing both a Presidency text and the text of the original proposal by the Commission. In the light of the discussions, it was agreed to merge these two texts into a single new text that could be agreeable to delegations and the Commission.
Further to this, the Presidency, assisted by representatives of the Working Party and of the Commission services, prepared such new text, which is set out in the Annex. To be noted that the Recitals, which have not yet been examined by the Working Party, may need to be adapted in the light of this new text.
ANNEX
Draft
REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
on the interoperability of the European Air Traffic Management network
(Text with EEA relevance) 1
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty establishing the European Community, and in particular Article 80(2) thereof, Having regard to the proposal from the Commission
2,
Having regard to the opinion of the Economic and Social Committee 3,
Having regard to the opinion of the Committee of the Regions 4,
Acting in accordance with the procedure laid down in Article 251 of the Treaty 5,
6 [Whereas:
(1) In order to create the Single European Sky, measures should be adopted in relation to equipment, systems and associated procedures with the objective of ensuring seamless operations of the European air traffic management network consistent with the provision of air navigation services as provided for in Regulation (EC) No XXX/XX of the European Parliament and of the Council of ... 2001 [service provision ]
(2) The report of the High Level Group on the Single European Sky (hereinafter referred to as: "the High Level Group") has confirmed the need to establish technical regulation on the basis of the "new approach" in accordance with the Council resolution of 7 May 1985 on a new approach to technical harmonisation and standards
1 where essential requirements,
rules and standards are complementary and consistent.
(3) Regulation (EC) No XXX/XX of the European Parliament and of the Council 2 lays down
the framework for the creation of the Single European Sky.
(4) The European air traffic management network is a complex, highly interactive structure involving large numbers of systems and components on the ground, in the air and in space including facilities, equipment, and computer hardware and software as well as the people that operate them.
(5) The report of the High Level Group has confirmed that even though progress has been realised during the last few years towards a seamless operation of the air traffic management network in Europe, the situation still remains unsatisfactory with a low level of integration between national air traffic management systems and a slow pace in the introduction of new concepts of operation and technology necessary to deliver the additional required capacity.
(6) This low level of integration at Community level results in a number of severe inefficiencies and additional costs for procurement and maintenance and in difficulties in operational coordination.
(8) It is therefore in the interest of all those involved in the air traffic management to develop a new partnership approach allowing the balanced involvement of all, stimulating creativity and the sharing of knowledge, experience and risks; such partnership should aim at defining, in cooperation with the manufacturing industry, a coherent set of Community specifications that can fulfil the widest possible range of needs from which an air navigation service provider can choose the elements that best suit its circumstances and limit the local adaptations as much as possible.
(8bis) The internal market is a Community objective, therefore measures taken under this
Regulation should contribute to its progressive creation in this sector.
(9) It is therefore appropriate to define essential requirements which will apply to the systems and constituents of the European air traffic management network; in view of the complexity of the air traffic management network it has proven necessary to break it down to a number
of systems.
(10) The development and adoption of Community specifications concerning the European air
traffic management network, its systems and constituents is an appropriate means of defining the technical and operational conditions necessary to achieve the essential requirements; compliance with these Community specifications, which remains voluntary, should create a presumption of conformity with the essential requirements.
(11) For some systems that are important to the fulfilment of the essential requirements of this
Regulation, implementation rules should be adopted; implementation rules should also be adopted to facilitate the coordination and introduction of new concepts in air traffic management; compliance with the implementation rules should be permanently maintained;
these implementation rules should rely on rules and standards developed by international organisations such as Eurocontrol or ICAO.
(12) In accordance with the conclusions of the High Level Group, Eurocontrol is the body that
has the appropriate expertise to support the Community in its role as regulator. Accordingly, Eurocontrol should be permitted to develop draft measures, under appropriate arrangements subject to the observance by Eurocontrol of the conditions to be included in a framework of cooperation between the Commission and Eurocontrol.
(13) In order to ensure separation between the rule-making and standardisation functions,
Community specifications should predominantly be developed by the European standardisation bodies in conjunction with the European Organisation for Civil Aviation Equipment ("Eurocae") and should take the form of European standards.
(14) Eurocae is a non-profit making organisation in charge of preparing drafts of technical
specifications for civil aviation equipment; its membership is open to all aviation stakeholders including, in particular, air navigation service providers, airspace users and manufacturing industry; Eurocae must establish formal relationships with the European standardisation bodies so that its specifications can be recognised as European standards according to the procedures set out by the European standardisation organisations.
(15) Eurocontrol should also be permitted to develop, where necessary, Community
specifications, subject to compliance with the principles of the Council Resolution of 7 May 1985 and in accordance with general Community standardisation procedures; such procedures should include as a minimum the observance of the principles of openness, transparency, impartiality, consensus, maintenance, public access to specifications, efficiency, accountability and coherence; detailed provisions to that effect will be included in a document forming the framework of cooperation with Eurocontrol.
(16) The procedures governing the assessment of conformity or suitability of use of constituents
should be based on the use of the modules covered by Council Decision 93/465/EEC of 22 July 1993 concerning the modules for the various phases of the conformity assessment procedures and the rules for the affixing and use of the CE conformity marking, which are intended to be used in the technical harmonisation directives
1; as far as necessary these
modules should be expanded to cover specific requirements of the industries concerned.
(17) The market concerned is of small size and consists of systems and constituents of an almost
exclusive use to air traffic management purposes and not destined to the general public; it would be therefore excessive to affix the CE mark to constituents as, on the basis of the assessment of conformity and/or suitability for use, the manufacturer's declaration of conformity is sufficient; that should not affect the obligation on manufacturers to affix the CE mark to certain constituents in order to certify their compliance with other Community provisions relating to them.
(18) The putting into service, renewal or upgrading of air traffic management systems, should be
subject to verification of compliance with the essential requirements; this compliance is based on implementation rules; use of Community specifications should create a presumption of conformity to the essential requirements; depending on the system, the intervention of a notified body should be deemed necessary in particular for safety reasons.
(19) In accordance with the conclusions of the report of the High Level Group, the Commission
should consult industry with a view to facilitating the establishment of a coherent strategic management programme for the introduction of new concepts in air traffic management.
(21) Since the objectives of the proposed action, namely to achieve interoperability within the
Community air traffic management network, cannot be sufficiently achieved by the Member States and can therefore, by reason of its wide scale, be better achieved at Community level, the Community may adopt measures, in accordance with the principle of subsidiarity as set out in Article 5 of the Treaty. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve those objectives.
(22) Within the framework of the relevant Community legislation, due account shall be taken of
the need to ensure:
· harmonised conditions with regard to the availability and efficient use of radio spectrum necessary for the implementation of the Single European Sky, including electromagnetic compatibility aspects ;
· the protection of the safety of life services from harmful interference ;
· an efficient and appropriate use of frequencies allocated to and managed exclusively
by the aviation sector.
(23) Council Directive 93/65/EEC of 19 July 1993 on the definition and use of compatible
technical specifications for the procurement of air-traffic-management equipment and systems
1, is limited to obligations of awarding entities; the present Regulation is more
(24) Since Commission Directive 97/15/EC of 25 March 1997 adopting Eurocontrol standards
and amending Council Directive 93/65/EEC on the definition and use of compatible technical specifications for the procurement of air-traffic management equipment and systems
1 has become obsolete, it should be repealed.
(25) The measures for the application of Directive 93/65/EEC as set out in Annexes I, II and III
to Commission Regulation (EC) No 2082/2000 of 6 September 2000 adopting Eurocontrol standards and amending Directive 97/15/EC, adopting Eurocontrol standards and amending Council Directive 93/65/EEC
2 are compatible with the provisions of this Regulation.
(26) Since most of the measures necessary for the implementation of this Regulation are
measures of general scope within the meaning of Article 2 of Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission
3, they should be adopted by use of the regulatory
procedure provided for in Article 5 of that Decision. However, in accordance with Article 2(c) of that Decision, some measures should be adopted by use of the advisory procedure provided for in Article 3 of that Decision, ]
Chapter I
GENERAL PROVISIONS
Article 1
Scope and objective
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1.Within the framework of Regulation (EC) No XXX/XX [framework Regulation ], this Regulation concerns the interoperability of the European air traffic management network.
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2.This Regulation shall apply to the systems, their constituents and associated procedures identified in Annex I.
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3.The objective of this Regulation is to achieve interoperability between the different systems, constituents and associated procedures of the European air traffic management network, taking due account of the relevant international rules. This Regulation aims also at ensuring the co-ordinated and rapid introduction of new agreed and validated concepts of operations or technology in air traffic management.
CHAPTER II
ESSENTIAL REQUIREMENTS, IMPLEMENTING RULES FOR INTEROPERABILITY AND COMMUNITY
SPECIFICATIONS
Article 2 [ex Article 4]
Essential requirements
The European air traffic management network, its systems and their constituents, and associated procedures shall meet the relevant essential requirements.
The essential requirements are set out in Annex II.
Article 3 [ex Article 4a]
Implementing rules for interoperability
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1.Implementing rules for interoperability shall be drawn up whenever necessary to achieve in a coherent way the objectives of this Regulation.
(d) describe the specific conformity assessment procedures involving, where appropriate, notified bodies as referred to in Article 7, based on the modules defined in Decision 93/465/EEC to be used to assess either the conformity or the suitability for use of constituents as well as the verification of systems; and/or
(e) specify the conditions of implementation including, where appropriate, the date by which all relevant stakeholders have to comply with it.
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4.The preparation, adoption and review of implementing rules for interoperability shall take into account the estimated cost and benefits of technical solutions by which they may be met, with a view to defining the most viable solution, with due regard to the maintenance of a high level of safety. An assessment of the costs and benefits of those solutions for all stakeholders concerned shall be attached to each draft implementing rule for interoperability.
Article 4 [ex Article 5a]
Community specifications
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1.In the pursuit of the objective of this Regulation, Community specifications may be established. Such specifications can be:
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a)European standards for systems or constituents, together with the relevant procedures, drawn up by the European standardisation bodies in co-operation with Eurocae, on a mandate from the Commission in accordance with the provisions of Article 6(4) of Directive 98/34/EC and pursuant to the general guidelines on co-operation between the Commission and the standardisation bodies signed on the 13th of November 1984,
or
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b)specifications drawn up by Eurocontrol on matters of operational co-ordination between air navigation service providers, on request of the Commission in accordance with the procedure referred to in Article 7(2) of Regulation (EC) No XXX/XX [framework ].
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2.Compliance with the essential requirements and/or the implementing rules for interoperability shall be presumed for systems, together with the associated procedures, or constituents that meet the relevant Community specifications whose reference numbers have been published in the Official Journal of the European Communities.
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3.The Commission shall publish the references to the European standards referred to in
paragraph 1a in the Official Journal of European Communities .
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5.Where a Member State or the Commission considers that conformity with a published Community specification does not ensure compliance with the essential requirements and/or implementing rules for interoperability which the said Community specification is intended to cover, the procedure referred to in Article 7(2) of Regulation (EC) No XXX/XX
[framework ] shall apply.
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6.In the case of shortcomings of published European standards, partial or total withdrawal of the standards concerned from the publications containing them, or their amendments, may be decided upon in accordance with Article 5 of Directive 98/34/EC.
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7.In the case of shortcomings of published Eurocontrol specifications, partial or total withdrawal of the specifications concerned from the publications containing them, or their amendments, may be decided upon in accordance with the procedure referred to in Article 7(2) of Regulation n° XXX/XX [framework ].
Chapter III 1
VERIFICATION OF COMPLIANCE
Article 5 [ex Article 9]
EC declaration of conformity or suitability for use of constituents
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1.Constituents shall be accompanied by an EC declaration of conformity or suitability for use. The elements of this declaration are set out in Annex III.
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2.The manufacturer, or its authorised representative established in the Community, shall ensure and declare, by means of the EC declaration of conformity or suitability for use, that he has applied the provisions laid down in the essential requirements and in the relevant implementing rules for interoperability.
Article 6 [ex Article 10]
EC declaration of verification of systems
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1.Systems shall be subject to an EC verification by the air navigation service provider in accordance with the relevant implementing rules for interoperability, in order to ensure that they meet the essential requirements of this Regulation and the implementing rules for interoperability when integrated into the European air traffic management network.
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2.Prior to the putting into service of a system, the relevant air navigation service provider shall establish an EC declaration of verification, confirming compliance and shall submit it to the national supervisory authority together with a technical file. The elements of this declaration and of the technical file are set out in Annex IV.
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3.The EC declaration of verification shall be without prejudice to assessments that the national supervisory authority may need to carry out on grounds other than interoperability.
Article 7 [ex Article 11]
Safeguards
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1.Where the national supervisory authority ascertains that :
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a)a constituent accompanied by an EC declaration of conformity or suitability for use, or
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b)a system accompanied by the EC declaration of verification
does not meet the essential requirements and/or relevant implementing rules for interoperability, it shall take all necessary measures, with due regard to the need to ensure safety and continuity of operations, to restrict the area of application of the constituent or the system concerned or to prohibit its use by the entities under the responsibility of the authority.
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2.The Member State concerned shall immediately inform the Commission of any such measures, indicating its reasons and, in particular, whether in its opinion non-compliance with the essential requirements is due to:
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a)failure to meet the essential requirements ;
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b)incorrect application of the implementing rules for interoperability or Community
specifications ;
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4.Where the Commission establishes that the measures taken by the national supervisory authority are not justified, it shall request the Member State concerned to ensure that they are withdrawn without delay. It shall forthwith so inform the manufacturer or its authorised representative established in the Community.
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5.Where the Commission establishes that non compliance with essential requirements is due to incorrect application of the implementing rules for interoperability and/or the Community specifications, the Member State concerned shall take appropriate measures against whomsoever has drawn up the declaration of conformity or suitability for use or the EC declaration of verification and shall inform the Commission and the other Member States thereof.
Article 7 [ex Article 12]
Notified bodies
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1.Member States shall notify the Commission and the other Member States of the bodies they
have appointed to carry out tasks pertaining to the assessment of conformity or suitability for use referred to in Article 5, and/or the verification referred to in Article 6, indicating each body's area of responsibility and the identification numbers obtained in advance from the Commission. The Commission shall publish in the Official Journal of the European Communities the list of bodies, their identification numbers and areas of responsibility, and shall keep the list updated.
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2.Member States shall apply the criteria provided for in Annex V for the assessment of the bodies to be notified. Bodies meeting the assessment criteria provided for in the relevant European standards shall be deemed to meet the said criteria.
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3.Member States shall withdraw notification of a notified body which no longer meets the criteria referred to in Annex V. It shall forthwith inform the Commission and the other Member States thereof.
Chapter IV
FINAL PROVISIONS
Article 8 [ex Article 13]
Revision of annexes
In case of any technical or operational developments, adjustments may be made to Annexes I and II in accordance with the procedure referred to in Article 7(3) of Regulation (EC) No XXX/XX
Article 9 [ex Article 15]
Transitional arrangements
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1.Starting from 1½ years after the entry into force of this Regulation, the essential requirements shall apply to the putting into service, renewal and upgrade of systems and constituents of the European air traffic management network, if not otherwise specified by the relevant implementing rules for interoperability.
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2.Compliance with the essential requirements shall be required for all systems and constituents in operation by 8½ years after the entry into force of this Regulation, if not otherwise specified by the relevant implementing rules for interoperability.
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3.Where systems of the European air traffic management network have been ordered or binding contracts to that effect have been concluded
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-before the entry into force of this Regulation,
or, where appropriate,
-
-before the entry into force of one or more relevant implementing rules for
interoperability,
so that compliance with the essential requirements and/or the relevant implementing rules for interoperability cannot be guaranteed within the time limits mentioned in paragraph 1, the Member State concerned shall communicate to the Commission detailed information on the essential requirements and/or implementing rules for interoperability where uncertainty of compliance has been identified.
Article 10 [ex Article 17]
Repeal
Directives 93/65/EEC and 97/15/EC, as well as Regulations No 2082/2000 and No XXX/XX shall be repealed 1½ year after the entry into force of this Regulation.
Article 11 [ex Article 18]
Entry into force
This Regulation shall enter into force on the twentieth day following that of its publication in the
Official Journal of the European Communities .
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at [Brussels],
For the European Parliament For the Council
ANNEX I to ANNEX
LIST OF SYSTEMS FOR AIR NAVIGATION SERVICES
For the purpose of this Regulation the European air traffic management network is subdivided into eight systems.
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1.Systems and procedures for airspace management.
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2.Systems and procedures for air traffic flow management.
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3.Systems and procedures for air traffic services, in particular flight data processing systems, surveillance data processing systems and human-machine interface systems.
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4.Communications systems and procedures for ground-to-ground, air-to-ground and air-to- air communications.
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5.Navigation systems and procedures.
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6.Surveillance systems and procedures.
ANNEX II to ANNEX
ESSENTIAL REQUIREMENTS
Part A: General requirements
These are network-wide requirements that are generally applicable to each one of the systems identified in Annex I.
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1.Seamless operation
Air traffic management systems and their constituents shall be designed, built, maintained and operated, using the appropriate and validated procedures, in such a way so as to ensure the seamless operation of the European air traffic management network at all times and for all phases of flight. Seamless operation can be expressed, in particular, in terms of information sharing, including the relevant operational status information, common understanding of information, comparable processing performances and the associated procedures enabling common operational performances agreed for the whole or parts of the air traffic management network.
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2.Support to new concepts of operation
The European air traffic management network, its systems and their constituents shall support, on a co-ordinated basis, new agreed and validated concepts of operation that improve the quality and effectiveness of air navigation services, in particular in terms of safety and capacity.
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3.Safety
Systems and operations of the European air traffic management network shall achieve agreed high levels of safety. Agreed safety management and reporting methodologies shall be established to achieve this.
In respect of appropriate ground-based systems, or parts thereof, these high levels of safety shall be enhanced by safety nets which shall be subject to agreed common performance characteristics.
A harmonised set of safety requirements for the design, implementation, maintenance and operation of systems and their constituents, both for nominal and degraded modes of operation, shall be defined with a view to achieving the agreed safety levels, for all phases of flight and for the entire European air traffic management network.
Systems shall be designed, built, maintained and operated, using the appropriate and validated procedures, in such a way so that the tasks assigned to the control staff are compatible with human capabilities, in both the normal and degraded modes of system operation, and consistent with required safety levels.
Systems shall be designed, built, maintained and operated, using the appropriate and validated procedures, in such a way as to be free from harmful interference, in their normal operational environment.
[4. Co-ordinated civil/military operation 1
The European air traffic management network, its systems and their constituents shall support the progressive implementation of co-ordinated civil/military operations, to the extent necessary for an effective airspace and air traffic flow management, and the safe and efficient use of airspace by all users, through the application of the Flexible Use of Airspace concept.
To achieve these objectives, the European air traffic management network, its systems and their constituents shall support the timely sharing of correct and consistent information covering all phases of flight, between civil and military counterparts.
This shall take into account national security requirements.]
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5.Environmental constraints
Systems and operations of the air traffic management network shall take into account the need to minimise environmental impact in accordance with applicable Community legislation.
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6.Systems logical architecture principles
Systems shall be designed and progressively integrated with the objective of achieving a coherent and increasingly harmonised, evolutionary and validated logical architecture within the European air traffic management network.
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7.Systems construction principles
Systems shall be designed, built and maintained on the grounds of sound engineering principles, in particular those relating to modularity, enabling interchangeability of constituents, high availability, and redundancy and fault tolerance of critical constituents.
Part B: Specific requirements
These are the requirements that are specific to each one of the systems and that complement or further refine the general requirements.
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1.Systems and procedures for airspace management
1.1. Seamless operation
Information relating to pre-tactical and tactical aspects of airspace availability shall be provided to whomever concerned in a correct and timely way so as to ensure an efficient allocation and use of airspace by all airspace users. This should take into account national security requirements.
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2.Systems and procedures for air traffic flow management
2.1 Seamless operation
Systems and procedures for air traffic flow management shall support the sharing of correct, coherent and relevant strategic, pre-tactical and tactical, as applicable, flight information covering all phases of flight and offer dialogue capabilities in view of an optimised use of airspace.
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3.Systems and procedures for air traffic services
3.1. Flight data processing systems
3.1.1. Seamless operation
Flight data processing systems shall be interoperable in terms of timely sharing correct and consistent information, and a common operational understanding of that information, in order to ensure a coherent and consistent planning process and resource-efficient tactical co- ordination throughout the European air traffic management network during all phases of flight.
In order to ensure a safe, smooth and expeditious processing throughout the European air traffic management network, flight data processing performances shall be equivalent and appropriate for a given environment (surface, terminal manoeuvring area, en-route), with known traffic characteristics and exploited under an agreed and validated operational concept, in particular in terms of accuracy and error tolerance of processing results.
3.1.2. Support to new concepts of operation
Flight data processing systems shall accommodate the progressive implementation of advanced, agreed and validated concepts of operation for all phases of flight.
The characteristics of automation-intensive tools must be such as to enable a coherent and efficient pre-tactical and tactical processing of flight information in parts of the European air traffic management network.
3.2. Surveillance data processing systems
3.2.1. Seamless operation
Surveillance data processing systems shall be designed, built, maintained and operated, using the appropriate and validated procedures, in such a way so as to provide the required performance and quality of service within a given environment (surface, terminal manoeuvring area, en-route) with known traffic characteristics, in particular in terms of accuracy and reliability of computed results, correctness, integrity, availability, continuity and timeliness of information at the control position.
Surveillance data processing systems shall accommodate the timely sharing of relevant, accurate, consistent and coherent information between them to ensure optimised operations through different parts of the network.
3.2.2. Support to new concepts of operation
Surveillance data processing systems shall accommodate the progressive availability of new sources of surveillance information in such a way as to improve the overall quality of service.
3.3. Human-machine interface systems
3.3.2. Support to new concepts of operation
Human-machine interface systems shall accommodate the progressive introduction of new, agreed and validated concepts of operation and increased automation, in such a way as to ensure that the tasks assigned to the control staff remain compatible with human capabilities, in both the normal and degraded modes of system operation.
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4.Communications systems and procedures for ground-to-ground, air-to-ground and air-to-air communications
4.1. Seamless operation
Communication systems shall be designed, built, maintained and operated, using the appropriate and validated procedures, in such a way so as to achieve the required performances within a given volume of airspace or for a specific application, in particular in terms of communication processing time, integrity, availability and continuity of function.
The communications network within the European air traffic management network shall be such as to meet the requirements of quality of service, coverage and redundancy.
4.2. Support to new concepts of operation
Communication systems shall support the implementation of advanced, agreed and validated concepts of operation for all phases of flight.
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6.Surveillance systems and procedures
6.1. Seamless operation
Surveillance systems shall be designed, built, maintained and operated, using the appropriate and validated procedures, in such a way so as to provide the required performance applicable in a given environment (surface, terminal manoeuvring area, en-route) with known traffic characteristics and exploited under an agreed and validated operational concept, in particular in terms of accuracy, coverage, range and quality of service.
The surveillance network within the European air traffic management network shall be such as to meet the requirements of accuracy, timeliness, coverage and redundancy. The surveillance network shall enable surveillance data to be shared in order to enhance operations throughout the European air traffic management network.
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7.Systems and procedures for aeronautical information services
7.1. Seamless operation
Accurate, timely and consistent aeronautical information shall be provided progressively in an electronic form, based on a commonly agreed and standardised data set.
Accurate and consistent aeronautical information, in particular concerning airborne and ground-based constituents or systems, shall be made available in a timely manner.
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8.Systems and procedures for the use of meteorological information
8.1. Seamless operation
Systems and procedures for the use of meteorological information shall improve the consistency and timeliness of its provision and the quality of its presentation, using an agreed data set.
8.2. Support to new concepts of operation
Systems and procedures for the use of meteorological information shall improve the promptness of its availability and the speed with which it may be used, in order to support a continuous improvement of the efficiency of airspace and airport use.
ANNEX III to ANNEX
CONSTITUENTS
EC declaration
of conformity
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-
of suitability for use
1.
Constituents
The EC declaration applies to the constituents that are essential to achieve the objectives of this Regulation. These constituents will be identified in the implementing rules for interoperability in accordance with the provisions of Article [..] of this Regulation.
2.
Scope
The EC declaration covers:
either the assessment by a notified body or bodies of the intrinsic conformity of a constituent, considered in isolation to the Community specifications to be met; or
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-the assessment/judgement by a notified body or bodies of the suitability for use of a constituent, considered within its air traffic management environment.
The assessment procedures implemented by the notified bodies at the design and production stages will draw upon the modules defined in Decision 93/465/EEC, in accordance with the conditions referred to in the implementing rules for interoperability.
3 Contents of the EC declaration
The EC declaration of conformity or suitability for use and the accompanying documents must be dated and signed. That declaration must be written in the same language as the instructions and must contain the
following:
the Regulation references and where appropriate the references of other Community provisions applied;
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-the name and address of the manufacturer or his authorised representative established within the Community (give trade name and full address and in the case of the authorised representative also give the trade name of the manufacturer);
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-description of the constituent;
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-description of the procedure followed in order to declare conformity, suitability for use (Article 5 of this Regulation);
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-all of the relevant descriptions met by the constituent and in particular its conditions of use;
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-if applicable, name and address of notified body or bodies involved in the procedure followed in respect of conformity or suitability for use and date of examination certificate together, where appropriate, with the duration and conditions of validity of the certificate;
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-where appropriate, reference to the Community specifications followed;
ANNEX IV to ANNEX
SYSTEMS
EC declaration of verification of systems Verification procedure for systems
1.
Contents of declaration of verification of systems
The EC declaration of verification and the accompanying documents must be dated and signed. That declaration must be written in the same language as the technical file and must contain the following:
the Regulation references and where appropriate the references of other Community provisions applied;
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-name and address of the contracting entity or its authorised representative established within the Community (trade name and full address, and in case of the authorised representative also the trade name of the contracting entity);
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-a brief description of the system;
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-description of the procedure followed in order to declare conformity of the system (Article 6 of this Regulation);
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-name and address of the notified body which conducted the verification procedure, if applicable;
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-the references of the documents contained in the technical file;
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-where appropriate, reference to the Community specifications;
2.
Verification procedure for systems
Verification of systems is the procedure whereby an air navigation service provider, or a notified body where so required by the applicable implementing rule, checks and certifies that a system:
complies with this Regulation;
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-complies with other applicable Community provisions;
and may be put into operation. The system is checked at each of the following stages:
overall design;
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-development and integration of the system, including in particular constituent assembly and overall adjustments;
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-operational system integration.
Where a notified body is involved, it draws up a certificate of conformity intended for the contracting entity or its authorised representative established within the Community. The contracting entity then draws up the declaration of verification intended for the national supervisory authority.
3.
Technical file 1
The technical file accompanying the EC declaration of verification must contain all the necessary documents relating to the characteristics of the system, including conditions and limits of use, as well as the documents certifying conformity of constituents where appropriate. The following documents shall be included as a minimum:
indication of the relevant parts of the technical specifications used for procurement that ensure compliance with the applicable implementing rules for interoperability, and, where appropriate, the Community specifications;
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copies of the EC declaration of conformity or suitability for use with which the above mentioned constituents must be provided in accordance with Article 5 of this Regulation accompanied, where appropriate, by a copy of the records of the tests and examinations carried out by the notified bodies;
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-where a notified body has been involved in the verification of the system(s), certificate countersigned by itself, stating that the system complies with this Regulation and mentioning any reservations recorded during performance of activities and not withdrawn;
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-where there has not been involvement of a notified body, a record of the tests and installation configurations made in view of ensuring compliance with essential requirements and any particular requirements contained in the relevant implementing rules for interoperability.
4.
Submission
The technical file must be attached to the declaration of verification which the contracting entity sends to the national supervisory authority.
A copy of the technical file must be kept by the contracting entity throughout the service life of the system. It must be sent to any other Member States which so request.
ANNEX V to ANNEX
NOTIFIED BODIES
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1.The body, its Director and the staff responsible for carrying out the checks may not become involved, either directly or as authorised representatives, in the design, manufacture, marketing or maintenance of the constituents or systems or in their use. This does not exclude the possibility of an exchange of technical information between the manufacturer or constructor and that body.
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2.The body and the staff responsible for the checks must carry out the checks with the greatest possible professional integrity and the greatest possible technical competence and must be free of any pressure and incentive, in particular of a financial type, which could affect their judgement or the results of their inspection, in particular from persons or groups of persons affected by the results of the checks.
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3.The body must employ staff and possess the means required to perform adequately the technical and administrative tasks linked with the checks; it should also have access to the equipment needed for exceptional checks.
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4.The staff responsible for inspection must have:
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-sound technical and vocational training
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-satisfactory knowledge of the requirements of the inspections they carry out and
| publicatiedatum | 18-11-2002 |
|---|---|
| kenmerk | 14236/02 |
