2008R0216 — EN — 20.08.2009 — 001.001

This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents

►B REGULATION (EC) No 216/2008 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 20 February 2008 on common rules in the field of civil aviation and establishing a European Aviation Safety Agency, and repealing Council Directive 91/670/EEC, Regulation (EC) No 1592/2002 and Directive 2004/36/EC (Text with EEA relevance) (OJ L 079, 19.3.2008, p.1)

Amended by:









▼B

REGULATION (EC) No 216/2008 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

of 20 February 2008

on common rules in the field of civil aviation and establishing a European Aviation Safety Agency, and repealing Council Directive 91/670/EEC, Regulation (EC) No 1592/2002 and Directive 2004/36/EC

(Text with EEA relevance)







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, Having regard to the Opinion of the Economic and Social Committee ( 1 ), After consulting the Committee of the Regions, Acting in accordance with the procedure laid down in Article 251 of the Treaty ( 2 ), Whereas: (1) A high and uniform level of protection of the European citizen should at all times be ensured in civil aviation, by the adoption of common safety rules and by measures ensuring that products, persons and organisations in the Community comply with such rules and with those adopted to protect the environment. This should contribute to facilitating the free movement of goods, persons and organisations in the internal market. (2) In addition, third-country aircraft operated into, within or out of the territory where the Treaty applies should be subject to appropriate oversight at Community level within the limits set by the Convention on International Civil Aviation, signed in Chicago on 7 December 1944 (the Chicago Convention), to which all Member States are parties. (3) The Chicago Convention already provides for minimum standards to ensure the safety of civil aviation and environmental protection relating thereto. Community essential requirements and rules adopted for their implementation should ensure that Member States fulfil the obligations created by the Chicago Convention, including those vis-à-vis third countries. (4) The Community should lay down, in line with standards and recommended practices set by the Chicago Convention, essential requirements applicable to aeronautical products, parts and appliances, to persons and organisations involved in the operation of aircraft, and to persons and products involved in the training and medical examination of pilots. The Commission should be empowered to develop the necessary implementing rules. (5) It would not be appropriate to subject all aircraft to common rules, in particular aircraft that are of simple design or operate mainly on a local basis, and those that are home-built or particularly rare or only exist in a small number; such aircraft should therefore remain under the regulatory control of the Member States, without any obligation under this Regulation on other Member States to recognise such national arrangements. However, proportionate measures should be taken to increase generally the level of safety of recreational aviation. Consideration should in particular be given to aeroplanes and helicopters with a low maximum take-off mass and whose performance is increasing, which can circulate all over the Community and which are produced in an industrial manner. They therefore can be better regulated at Community level to provide for the necessary uniform level of safety and environmental protection. (6) The scope of Community action should be clearly defined so that persons, organisations and products subject to this Regulation and its implementing rules can be identified without ambiguity. Such scope should be clearly defined by referring to a list of aircraft which are exempted from the application of this Regulation. (7) Aeronautical products, parts and appliances, operators involved in commercial air transport, as well as pilots and persons, products and organisations involved in their training and medical examination, should be certified or licensed once they have been found to comply with essential requirements to be laid down by the Community in line with standards and recommended practices set by the Chicago Convention. The Commission should be empowered to develop the necessary implementing rules for establishing the conditions for the issue of the certificate or the conditions for its replacement by a declaration of capability, taking into account the risks associated with the different types of operations, such as certain types of aerial work and local flights with small aircraft. (8) For non-commercial operations, the operational and licensing rules should be tailored to the complexity of the aircraft and a related definition should be set out. (9) The privileges associated with the leisure pilot licence should be limited by the training received to obtain the related ratings, in accordance with the implementing rules. (10) In order to achieve Community objectives as regards the freedom of movement of goods, persons and services, as well as those of the common transport policy, Member States should, without further requirements or evaluation, accept products, parts and appliances, organisations or persons certified in accordance with this Regulation and its implementing rules. (11) Enough flexibility should be provided for addressing special circumstances such as urgent safety measures, unforeseen or limited operational needs. Provision should also be made for reaching an equivalent safety level by other means. Member States should be entitled to grant exemptions from the requirements of this Regulation and its implementing rules, provided that they are strictly limited in scope and subject to appropriate Community control. (12) There is a need for better arrangements in all the fields covered by this Regulation so that certain tasks currently performed at Community or national level should be carried out by a single specialised expert body. There is, therefore, a need within the Community's existing institutional structure and balance of powers to establish a European Aviation Safety Agency (hereinafter referred to as the Agency) which is independent in relation to technical matters and has legal, administrative and financial autonomy. To that end, it is necessary and appropriate that it should be a Community body having legal personality and exercising the implementing powers which are conferred on it by this Regulation. (13) Under the Community institutional system, implementation of Community law is primarily the responsibility of the Member States. Certification tasks required by this Regulation and its implementing rules are therefore to be executed at national level. In certain clearly defined cases, however, the Agency should also be empowered to conduct certification tasks as specified in this Regulation. The Agency should, for the same reason, be allowed to take the necessary measures related to the operation of aircraft, the qualification of crew or the safety of third-country aircraft when this is the best means to ensure uniformity and facilitate the functioning of the internal market. (14) Regulation (EC) No 2111/2005 ( 3 ) imposes a duty on the Agency to communicate all information that may be relevant for the updating of the Community list of air carriers which, for safety reasons, are subject to an operating ban in the Community. If the Agency refuses to grant an authorisation to an air carrier under the terms of this Regulation, it should pass on to the Commission all relevant information on which this refusal was based, so that the name of the air carrier may be entered, if necessary, on that list. (15) The effective functioning of a Community civil aviation safety scheme in the fields covered by this Regulation requires strengthened cooperation between the Commission, the Member States and the Agency to detect unsafe conditions and take remedial measures as appropriate. (16) The promotion of a ‘culture of safety’ and the proper functioning of a regulatory system in the fields covered by this Regulation require that incidents and occurrences be spontaneously reported by the witnesses thereto. Such reporting would be facilitated by the establishment of a non-punitive environment, and appropriate measures should be taken by Member States to provide for the protection of such information and of those who report it. (17) Results of air accident investigations should be acted upon as a matter of urgency, in particular when they relate to defective aircraft design and/or operational matters, in order to ensure consumer confidence in air transport. (18) To help achieve the safety objectives of this Regulation, the Community should be given powers to impose financial penalties on holders of certificates and approvals issued by the Agency. In accordance with the Community legal order, such financial penalties should be imposed by the Commission acting upon a recommendation of the Agency. It should be underlined that through the introduction of financial penalties the Commission will be able to give a more nuanced, flexible and graduated response to a breach of the rules, compared to the withdrawal of a certificate. (19) Since all decisions taken by the Commission under this Regulation are subject to review by the Court of Justice of the European Communities in accordance with the Treaty, the Court of Justice should, in accordance with Article 229 thereof, be given unlimited jurisdiction in respect of decisions by which the Commission imposes fines or periodic penalty payments. (20) In order to respond to increasing concerns about the health and welfare of passengers during flights, it is necessary to develop aircraft designs which better protect the safety and health of passengers. (21) The objectives of this Regulation may be efficiently achieved through cooperation with third countries. In such a case, the provisions of this Regulation and its implementing rules may be adapted through agreements concluded by the Community with these countries. In the absence of such agreements, Member States should nevertheless be allowed, subject to appropriate Community control, to recognise the approvals granted to foreign products, parts and appliances, organisations and personnel by a third country. (22) In order to properly assist the Community, the Agency should be allowed to develop its expertise in all aspects of civil aviation safety and environmental protection covered by this Regulation. It should assist the Commission in the preparation of the necessary legislation and assist the Member States and industry in its implementation. It should be able to issue certification specifications and guidance material and to make technical findings and issue certificates as required, it should assist the Commission in monitoring the application of this Regulation and of its implementing rules, and it should be given the necessary authority to carry out its tasks. (23) The Commission and the Member States should be represented within a Management Board in order to control effectively the functions of the Agency. This Board should be entrusted with the necessary powers to establish the budget, verify its execution, adopt the appropriate financial rules, establish transparent working procedures for decision making by the Agency and appoint the Executive Director. It is also appropriate that the Agency be allowed to conduct research and to organise appropriate coordination with the Commission and the Member States. It is desirable that the Agency assist the Community and its Member States in the field of international relations, including the harmonisation of rules, recognition of approvals and technical cooperation, and be entitled to establish the appropriate relations with the aeronautical authorities of third countries and international organisations competent in matters covered by this Regulation. (24) In the interests of transparency, observers from interested parties should be represented within the Management Board of the Agency. (25) Public interest requires the Agency to base its safety-related action solely on independent expertise, strictly applying this Regulation and the rules adopted by the Commission for its implementation. To that end, all safety-related decisions of the Agency should be made by its Executive Director, who should enjoy a high degree of flexibility to obtain advice and to organise the internal functioning of the Agency. When, however, the Agency has to develop draft rules of a general nature to be implemented by national authorities, Member States should be involved in the process of decision. (26) It is necessary to ensure that parties affected by decisions made by the Agency enjoy the necessary remedies in a manner which is suited to the special character of the field of aviation. An appropriate appeal mechanism should be set up so that decisions of the Executive Director can be subject to appeal to a specialised Board of Appeal, whose decisions are, in turn, open to action before the Court of Justice. (27) In order to guarantee the full autonomy and independence of the Agency, it should be granted an autonomous budget whose revenue comes essentially from a contribution from the Community and from fees paid by the users of the system. Any financial contribution received by the Agency from Member States, third countries or other entities should not compromise its independence and impartiality. The Community budgetary procedure should be applicable as far as the Community contribution and any other subsidies chargeable to the general budget of the European Union are concerned. The auditing of accounts should be carried out by the Court of Auditors. (28) Before any local offices of the Agency are set up, general rules should be established to clarify what requirements need to be met and what contribution the Member State concerned must provide. (29) Since the objectives of this Regulation, namely the establishment and uniform application of common rules in the field of civil aviation safety and environmental protection, cannot be sufficiently achieved by the Member States and can therefore, by reason of the Europe-wide scope of this Regulation, 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. (30) It has been recognised that the involvement of European countries not Members of the European Union should be pursued, so as to ensure a proper pan-European dimension in order to facilitate the improvement of civil aviation safety throughout Europe. European countries that have concluded agreements with the Community to adopt and apply the Community acquis in the field covered by this Regulation should be associated with its work in accordance with conditions to be agreed in the framework of those agreements. (31) It is a general objective that the transfer of functions and tasks from the Member States, including those resulting from their cooperation through the Joint Aviation Authorities, to the Agency should be effected efficiently, without any reduction in the current high levels of safety, and without any negative impact on certification schedules. Appropriate measures should be adopted to provide for the necessary transition. (32) This Regulation sets common rules in the field of civil aviation and establishes a European Aviation Safety Agency. Regulation (EC) No 1592/2002 of the European Parliament and of the Council of 15 July 2002 on common rules in the field of civil aviation and establishing a European Aviation Safety Agency ( 4 ) should therefore be repealed. (33) This Regulation establishes an appropriate and comprehensive framework for the definition and implementation of common technical requirements and administrative procedures in the field of civil aviation. Annex III to Council Regulation (EEC) No 3922/91 of 16 December 1991 on the harmonisation of technical requirements and administrative procedures in the field of civil aviation ( 5 ) and Council Directive 91/670/EEC of 16 December 1991 on mutual acceptance of personnel licences for the exercise of functions in civil aviation ( 6 ) should therefore be repealed in due course, without prejudice to the certification or licensing of products, persons and organisations already carried out in accordance with those acts. (34) This Regulation establishes an appropriate and comprehensive framework for the safety of third-country aircraft using Community airports. Directive 2004/36/EC of the European Parliament and of the Council of 21 April 2004 on the safety of third-country aircraft using Community airports ( 7 ) should therefore be repealed in due course and without prejudice to the implementing measures on collection of information, ramp inspection and exchange of information. (35) This Regulation will apply to any other area related to civil aviation safety on the basis of a future proposal in accordance with the Treaty. (36) It is necessary to establish appropriate measures to ensure both the necessary protection of sensitive safety data and to provide the public with adequate information pertaining to the level of civil aviation safety and environmental protection relating thereto, taking into account Regulation (EC) No 1049/2001 of the European Parliament and of the Council of 30 May 2001 regarding public access to European Parliament, Council and Commission documents ( 8 ) and relevant national legislation. Decisions taken by the Agency pursuant to Article 8 of that Regulation should be capable of giving rise to the lodging of a complaint to the Ombudsman or should be capable of being the subject of an action before the Court of Justice, under Articles 195 and 230 of the Treaty respectively. (37) The measures necessary for the implementation of this Regulation should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission ( 9 ). (38) In particular, power should be conferred on the Commission to adopt implementing rules for airworthiness, flight crew licensing and associated approvals, air operations, aircraft used by third-country operators, oversight and enforcement, as well as to adopt a regulation on the fees and charges of the Agency. Since those measures are of general scope and are designed to amend non-essential elements of this Regulation, inter alia, by supplementing it with new non-essential elements, they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC. (39) On grounds of efficiency, the normal time-limits for the regulatory procedure with scrutiny should be curtailed for the adaptation of the essential requirements for environmental protection and for the adoption of the implementing rules for environmental protection. (40) On grounds of urgency it is necessary to apply the urgency procedure provided for in Article 5a(6) of Decision 1999/468/EC for the Commission to decide on the measures taken by Member States in immediate reaction to a safety problem, as well as on derogating approvals submitted by Member States, Whereas: HAVE ADOPTED THIS REGULATION:







CHAPTER I

PRINCIPLES

Article 1

Scope

1. This Regulation shall apply to:

(a) the design, production, maintenance and operation of aeronautical products, parts and appliances, as well as personnel and organisations involved in the design, production and maintenance of such products, parts and appliances;

(b) personnel and organisations involved in the operation of aircraft.

2. This Regulation shall not apply when products, parts, appliances, personnel and organisations referred to in paragraph 1 are engaged in military, customs, police, or similar services. The Member States shall undertake to ensure that such services have due regard as far as practicable to the objectives of this Regulation.

Article 2

Objectives

1. The principal objective of this Regulation is to establish and maintain a high uniform level of civil aviation safety in Europe.

2. Additional objectives are, in the fields covered by this Regulation, as follows:

(a) to ensure a high uniform level of environmental protection;

(b) to facilitate the free movement of goods, persons and services;

(c) to promote cost-efficiency in the regulatory and certification processes and to avoid duplication at national and European level;

(d) to assist Member States in fulfilling their obligations under the Chicago Convention, by providing a basis for a common interpretation and uniform implementation of its provisions, and by ensuring that its provisions are duly taken into account in this Regulation and in the rules drawn up for its implementation;

(e) to promote Community views regarding civil aviation safety standards and rules throughout the world by establishing appropriate cooperation with third countries and international organisations;

(f) to provide a level playing field for all actors in the internal aviation market.

3. The means of achieving the objectives set out in paragraphs 1 and 2 shall be:

(a) the preparation, adoption and uniform application of all necessary acts;

(b) the recognition, without additional requirements, of certificates, licences, approvals or other documents granted to products, personnel and organisations in accordance with this Regulation and its implementing rules;

(c) the establishment of an independent European Aviation Safety Agency (hereinafter referred to as the Agency);

(d) the uniform implementation of all necessary acts by the national aviation authorities and the Agency within their respective areas of responsibility.

Article 3

Definitions

For the purposes of this Regulation:

(a) ‘continuing oversight’ shall mean the tasks to be conducted to verify that the conditions under which a certificate has been granted continue to be fulfilled at any time during its period of validity, as well as the taking of any safeguard measure;

(b) ‘Chicago Convention’ shall mean the Convention on International Civil Aviation and its Annexes, signed in Chicago on 7 December 1944;

(c) ‘product’ shall mean an aircraft, engine or propeller;

(d) ‘parts and appliances’ shall mean any instrument, equipment, mechanism, part, apparatus, appurtenance or accessory, including communications equipment, that is used or intended to be used in operating or controlling an aircraft in flight and is installed in or attached to the aircraft. It shall include parts of an airframe, engine or propeller;

(e) ‘certification’ shall mean any form of recognition that a product, part or appliance, organisation or person complies with the applicable requirements including the provisions of this Regulation and its implementing rules, as well as the issuance of the relevant certificate attesting such compliance;

(f) ‘qualified entity’ shall mean a body which may be allocated a specific certification task by, and under the control and the responsibility of, the Agency or a national aviation authority;

(g) ‘certificate’ shall mean any approval, licence or other document issued as the result of certification;

(h) ‘operator’ shall mean any legal or natural person, operating or proposing to operate one or more aircraft;

(i) ‘commercial operation’ shall mean any operation of an aircraft, in return for remuneration or other valuable consideration, which is available to the public or, when not made available to the public, which is performed under a contract between an operator and a customer, where the latter has no control over the operator;

(j) ‘complex motor-powered aircraft’ shall mean: (i) an aeroplane: — with a maximum certificated take-off mass exceeding 5 700 kg, or — certificated for a maximum passenger seating configuration of more than nineteen, or — certificated for operation with a minimum crew of at least two pilots, or — equipped with (a) turbojet engine(s) or more than one turboprop engine, or (ii) a helicopter certificated: — for a maximum take-off mass exceeding 3 175 kg, or — for a maximum passenger seating configuration of more than nine, or — for operation with a minimum crew of at least two pilots, or (iii) a tilt rotor aircraft;

(k) ‘flight simulation training device’ shall mean any type of device in which flight conditions are simulated on the ground; they include flight simulators, flight training devices, flight and navigation procedures trainers and basic instrument training devices;

(l) ‘rating’ shall mean a statement entered on a licence, setting forth privileges, special conditions or limitations pertaining thereto.







CHAPTER II

SUBSTANTIVE REQUIREMENTS

Article 4

Basic principles and applicability

1. Aircraft, including any installed product, part and appliance, which are:

(a) designed or manufactured by an organisation for which the Agency or a Member State ensures safety oversight; or

(b) registered in a Member State, unless their regulatory safety oversight has been delegated to a third country and they are not used by a Community operator; or

(c) registered in a third country and used by an operator for which any Member State ensures oversight of operations or used into, within or out of the Community by an operator established or residing in the Community; or

(d) registered in a third country, or registered in a Member State which has delegated their regulatory safety oversight to a third country, and used by a third-country operator into, within or out of the Community

shall comply with this Regulation.

2. Personnel involved in the operations of aircraft referred to in paragraph 1(b), (c) or (d) shall comply with this Regulation.

3. Operations of aircraft referred to in paragraph 1(b), (c) or (d) shall comply with this Regulation.

4. Paragraph 1 shall not apply to aircraft referred to in Annex II.

5. Paragraphs 2 and 3 shall not apply to aircraft referred to in Annex II, with the exception of aircraft referred to in points (a)(ii), (d) and (h) thereof when used for commercial air transportation.

6. This Regulation shall not affect the rights of third countries as specified in international conventions, in particular the Chicago Convention.

Article 5

Airworthiness

1. Aircraft referred to in Article 4(1)(a), (b) and (c) shall comply with the essential requirements for airworthiness laid down in Annex I.

2. Compliance of aircraft referred to in Article 4(1)(b), and of products, parts and appliances mounted thereon shall be established in accordance with the following:

(a) products shall have a type-certificate. The type-certificate, and certification of changes to that type-certificate, including supplemental type-certificates, shall be issued when the applicant has shown that the product complies with a type-certification basis as specified in Article 20, established to ensure compliance with the essential requirements referred to in paragraph 1, and when it has no feature or characteristic making it unsafe for operation. The type-certificate shall cover the product, including all parts and appliances fitted thereon;

(b) parts and appliances may be issued with specific certificates when they are shown to comply with detailed airworthiness specifications established to ensure compliance with the essential requirements referred to in paragraph 1;

(c) each aircraft shall be issued with an individual certificate of airworthiness when it is shown that it conforms with the type design approved in its type-certificate and that relevant documentation, inspections and tests demonstrate that the aircraft is in condition for safe operation. This certificate of airworthiness shall remain valid as long as it is not suspended, revoked or terminated and as long as the aircraft is maintained in accordance with the essential requirements related to continuing airworthiness set out in point 1.d of Annex I and the measures referred to in paragraph 5;

(d) organisations responsible for the maintenance of products, parts and appliances shall demonstrate their capability and means to discharge the responsibilities associated with their privileges. Unless otherwise accepted these capabilities and means shall be recognised through the issuance of an organisation approval. The privileges granted to the approved organisation and the scope of the approval shall be specified in the terms of approval;

(e) organisations responsible for the design and manufacture of products, parts and appliances shall demonstrate their capability and means to discharge the responsibilities associated with their privileges. Unless otherwise accepted these capabilities and means shall be recognised through the issuance of an organisation approval. The privileges granted to the approved organisation and the scope of the approval shall be specified in the terms of approval;

in addition:

(f) personnel responsible for the release of a product, part or appliance after maintenance may be required to hold an appropriate certificate (personnel certificate);

(g) the capability of maintenance training organisations to discharge the responsibilities associated with their privileges in relation to the issuance of the certificates referred to in point (f) may be recognised by the issuance of an approval.

3. Aircraft referred to in Article 4(1)(a) and products, parts and appliances mounted thereon shall comply with paragraph 2(a), (b) and (e) of this Article.

4. By way of derogation from paragraphs 1 and 2:

(a) a permit to fly may be issued when it is shown that the aircraft is capable of performing safely a basic flight. It shall be issued with appropriate limitations, in particular to protect third parties' safety;

(b) a restricted certificate of airworthiness may be issued to aircraft for which a type certificate has not been issued according to paragraph 2(a). In this case, the aircraft shall be shown to comply with specific airworthiness specifications and deviations from the essential requirements referred to in paragraph 1 shall nevertheless ensure adequate safety with regard to the purpose. Aircraft eligible for these restricted certificates, and limitations for use of these aircraft, shall be defined according to the measures referred to in paragraph 5;

(c) when the number of aircraft of the same type eligible for a restricted certificate of airworthiness so justifies, a restricted type certificate may be issued and an appropriate type certification basis shall be established.

5. The measures designed to amend non-essential elements of this Article, by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 65(4). Those measures shall specify in particular:

(a) conditions for establishing and notifying to an applicant the type-certification basis applicable to a product;

(b) conditions for establishing and notifying to an applicant the detailed airworthiness specifications applicable to parts and appliances;

(c) conditions for establishing and notifying to an applicant the specific airworthiness specifications applicable to aircraft eligible for a restricted certificate of airworthiness;

(d) conditions for issuing and disseminating mandatory information in order to ensure the continuing airworthiness of products;

(e) conditions for issuing, maintaining, amending, suspending or revoking type-certificates, restricted type-certificates, approval of changes to type-certificates, individual certificates of airworthiness, restricted certificates of airworthiness, permits to fly and certificates for products, parts or appliances, including: (i) conditions on the duration of these certificates, and conditions to renew certificates when a limited duration is fixed; (ii) restrictions applicable to the issue of permits to fly. These restrictions should in particular concern the following: — purpose of the flight, — airspace used for the flight, — qualification of flight crew, — carriage of persons other than flight crew; (iii) aircraft eligible for restricted certificates of airworthiness, and associated restrictions; (iv) the minimum syllabus of maintenance certifying staff type rating training to ensure compliance with paragraph (2)(f); (v) the minimum syllabus of pilot type rating and the qualification of associated simulators to ensure compliance with Article 7; (vi) the master minimum equipment list as appropriate and additional airworthiness specifications for a given type of operation to ensure compliance with Article 8;

(f) conditions to issue, maintain, amend, suspend or revoke organisation approvals required in accordance with paragraph 2(d), (e) and (g) and conditions under which such approvals need not be requested;

(g) conditions to issue, maintain, amend, suspend or revoke personnel certificates required in accordance with paragraph 2(f);

(h) responsibilities of the holders of certificates;

(i) how aircraft referred to in paragraph 1 which are not covered by paragraphs 2 or 4 are to show compliance with the essential requirements;

(j) how aircraft referred to in Article 4(1)(c) are to show compliance with the essential requirements.

6. When adopting the measures referred to in paragraph 5, the Commission shall take specific care that they:

(a) reflect the state of the art and the best practices in the field of airworthiness;

(b) take into account worldwide aircraft experience in service, and scientific and technical progress;

(c) allow for immediate reaction to established causes of accidents and serious incidents;

(d) do not impose on aircraft referred to in Article 4(1)(c) requirements which would be incompatible with the International Civil Aviation Organization (ICAO) obligations of Member States.

Article 6

Essential requirements for environmental protection

▼M1

1. Products, parts and appliances shall comply with the environmental protection requirements contained in Amendment 9 of Volume I and in Amendment 6 of Volume II of Annex 16 to the Chicago Convention as applicable on 20 November 2008, except for the Appendices to Annex 16.

▼B

2. The measures designed to amend non-essential elements of the requirements referred to in paragraph 1 in order to bring them into line with subsequent amendments to the Chicago Convention and its Annexes which enter into force after the adoption of this Regulation and which become applicable in all Member States, shall, in so far as such adaptations do not broaden the scope of this Regulation, be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 65(5).

3. The measures designed to amend non-essential elements of the requirements referred to in paragraph 1, by supplementing them, shall, using as necessary the content of the Appendices referred to in paragraph 1, be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 65(5).

Article 7

Pilots

1. Pilots involved in the operation of aircraft referred to in Article 4(1)(b) and (c), as well as flight simulation training devices, persons and organisations involved in the training, testing, checking or medical assessment of these pilots, shall comply with the relevant ‘essential requirements’ laid down in Annex III.

2. Except when under training, a person may only act as a pilot if he or she holds a licence and a medical certificate appropriate to the operation to be performed.

A person shall only be issued a licence when he or she complies with the rules established to ensure compliance with the essential requirements on theoretical knowledge, practical skill, language proficiency and experience as set out in Annex III.

A person shall only be issued a medical certificate when he or she complies with the rules established to ensure compliance with the essential requirements on medical fitness as set out in Annex III. This medical certificate may be issued by aero-medical examiners or by aero-medical centres.

Notwithstanding the third subparagraph, in the case of a leisure pilot licence a general medical practitioner who has sufficient detailed knowledge of the applicant's medical background may, if so permitted under national law, act as an aero-medical examiner, in accordance with detailed implementing rules adopted pursuant to the procedure referred to in Article 65(3); these implementing rules shall ensure that the level of safety is maintained.

The privileges granted to the pilot and the scope of the licence and the medical certificate shall be specified in such licence and certificate.

The requirements of the second and third subparagraphs may be satisfied by the acceptance of licences and medical certificates issued by or on behalf of a third country as far as pilots involved in the operation of aircraft referred to in Article 4(1)(c) are concerned.

3. The capability of pilot training organisations and of aero-medical centres to discharge the responsibilities associated with their privileges in relation to the issuance of licenses and medical certificates shall be recognised by the issuance of an approval.

Pilot training organisations or aero-medical centres shall be issued an approval when they comply with the rules established to ensure compliance with the relevant essential requirements as laid down in Annex III.

The privileges granted by the approvals shall be specified thereon.

4. A flight simulation training device used for the training of pilots shall be the subject of a certificate. This certificate shall be issued when it is shown that the device complies with the rules established to ensure compliance with the relevant essential requirements as laid down in Annex III.

5. Persons responsible for providing flight training or flight simulation training, or for assessing pilots' skill, and aero-medical examiners shall hold an appropriate certificate. Such certificate shall be issued when it is shown that the person concerned complies with the rules established to ensure compliance with the relevant essential requirements as laid down in Annex III.

The privileges granted by the certificate shall be specified therein.

6. The measures designed to amend non-essential elements of this Article by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 65(4). Those measures shall specify in particular:

(a) the different ratings for pilots' licences and the medical certificates adequate for the different types of activities performed;

(b) the conditions for issuing, maintaining, amending, limiting, suspending or revoking licences, ratings for licences, medical certificates, approvals and certificates referred to in paragraphs 2, 3, 4 and 5, and the conditions under which such certificates and approvals need not be requested;

(c) the privileges and responsibilities of the holders of licences, ratings for licences, medical certificates, approvals and certificates referred to in paragraphs 2, 3, 4 and 5;

(d) the conditions for the conversion of existing national pilots' licences and of national flight engineers' licences into pilots' licences as well as the conditions for the conversion of national medical certificates into commonly recognised medical certificates;

(e) without prejudice to the provisions of bilateral agreements concluded in accordance with Article 12, the conditions for the acceptance of licences from third countries;

(f) how pilots of aircraft referred to in points (a)(ii), (d) and (f) of Annex II, when used for commercial air transportation, comply with the relevant essential requirements of Annex III.

7. When adopting the measures referred to in paragraph 6, the Commission shall take specific care that they reflect the state of the art, including best practices and scientific and technical progress, in the field of pilot training.

Such measures shall also include provisions for the issuance of all types of pilot licences and ratings required under the Chicago Convention, and of a leisure pilot licence covering non-commercial activities involving aircraft with a maximum certificated take off mass of 2 000 kg or less and which do not meet any of the criteria referred to in Article 3(j).

Article 8

Air operations

1. The operation of aircraft referred to in Article 4(1)(b) and (c) shall comply with the essential requirements laid down in Annex IV.

2. Unless otherwise determined in the implementing rules, operators engaged in commercial operations shall demonstrate their capability and means of discharging the responsibilities associated with their privileges. These capabilities and means shall be recognised through the issuance of a certificate. The privileges granted to the operator and the scope of the operations shall be specified in the certificate.

3. Unless otherwise determined in the implementing rules, operators engaged in the non-commercial operation of complex motor-powered aircraft shall declare their capability and means of discharging the responsibilities associated with the operation of that aircraft.

4. Cabin crew involved in the operation of aircraft referred to in Article 4(1)(b) and (c) shall comply with the essential requirements laid down in Annex IV. Those involved in commercial operations shall hold an attestation as initially set out in Annex III, Subpart O, point (d) of OPS 1 1005 as set out in Regulation (EC) No 1899/2006 of the European Parliament and of the Council of 12 December 2006 amending Council Regulation (EEC) No 3922/91 ( 10 ); at the discretion of the Member State, such attestation may be issued by approved operators or training organisations.

5. The measures designed to amend non-essential elements of this Article, by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 65(4). Those measures shall specify in particular:

(a) conditions to operate an aircraft in compliance with the essential requirements laid down in Annex IV;

(b) conditions for issuing, maintaining, amending, limiting, suspending or revoking the certificates referred to in paragraph 2 and the conditions under which a certificate shall be replaced by a declaration of the capability and means of the operator to discharge the responsibilities associated with the operation of the aircraft;

(c) privileges and responsibilities of the holders of certificates;

(d) conditions and procedures for the declaration by, and for the oversight of, operators referred to in paragraph 3 and the conditions under which a declaration shall be replaced by a demonstration of capability and means to discharge the responsibilities associated with the privileges of the operator recognised by the issuance of a certificate;

(e) conditions for issuing, maintaining, amending, limiting, suspending or revoking the cabin crew attestation referred to in paragraph 4;

(f) conditions under which operations shall be prohibited, limited or subject to certain conditions in the interest of safety;

(g) how operations of aircraft referred to in points (a)(ii), (d) and (h) of Annex II, when used for commercial air transportation, comply with the relevant essential requirements of Annex IV.

6. The measures referred to in paragraph 5 shall:

— reflect the state of the art and the best practices in the field of air operations,

— define different types of operations and allow for related requirements and compliance demonstrations proportionate to the complexity of operations and the risk involved,

— take into account worldwide aircraft experience in service, and scientific and technical progress,

— with regard to commercial transportation by aeroplane, and without prejudice to the previous indent, be developed initially on the basis of the common technical requirements and administrative procedures specified in Annex III to Regulation (EEC) No 3922/91,

— be based on a risk assessment and shall be proportional to the scale and scope of the operation,

— allow for immediate reaction to established causes of accidents and serious incidents,

— not impose on aircraft referred to in Article 4(1)(c) requirements which would be incompatible with the ICAO obligations of Member States.

Article 9

Aircraft used by a third-country operator into, within or out of the Community

1. Aircraft referred to in Article 4(1)(d), as well as their crew and their operations, shall comply with applicable ICAO Standards. To the extent that there are no such standards, these aircraft and their operations shall comply with the requirements laid down in Annexes I, III and IV, provided these requirements are not in conflict with the rights of third countries under international conventions.

2. Operators engaged in commercial operations using aircraft referred to in paragraph 1 shall demonstrate their capability and means of complying with the requirements specified in paragraph 1.

The requirement referred to in the first subparagraph may be satisfied by acceptance of certificates issued by or on behalf of a third country.

The capabilities and means referred to in the first subparagraph shall be recognised through the issuance of an authorisation. The privileges granted to the operator and the scope of the operations shall be specified in that authorisation.

3. Operators engaged in non-commercial operations of complex motor-powered aircraft using aircraft referred to in paragraph 1 may be required to declare their capability and means of discharging the responsibilities associated with the operation of that aircraft.

4. The measures designed to amend non-essential elements of this Article, by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 65(4). Those measures shall specify in particular:

(a) how aircraft referred to in Article 4(1)(d), or crew, which do not hold a standard ICAO certificate of airworthiness or licence, may be authorised to operate into, within or out of the Community;

(b) conditions to operate an aircraft in compliance with the provisions of paragraph 1;

(c) conditions for issuing, maintaining, amending, limiting, suspending or revoking the operator's authorisation referred to in paragraph 2, taking into account the certificates issued by the state of registry or the state of the operator, without prejudice to Regulation (EC) No 2111/2005 and its implementing rules;

(d) privileges and responsibilities of the holders of authorisations;

(e) conditions and procedures for the declaration by, and for the oversight of, operators referred to in paragraph 3;

(f) conditions under which operations shall be prohibited, limited or subject to certain conditions in the interest of safety in accordance with Article 22(1).

5. When adopting the measures referred to in paragraph 4, the Commission shall take specific care that:

(a) use is made, as appropriate, of ICAO recommended practices and guidance documents;

(b) no requirement exceeds what is required from aircraft referred to in Article 4(1)(b), and from the operators of such aircraft;

(c) use is made, where appropriate, of measures issued in accordance with Articles 5(5) and 8(5);

(d) the process by which authorisations are obtained is simple, proportionate, cost-effective and efficient in all cases, allowing for requirements and compliance demonstrations proportionate to the complexity of operations and the risk involved. The process shall in particular take account of: (i) results of the ICAO Universal Safety Oversight Audit Programme; (ii) information from ramp inspections and the Safety Assessment of Foreign Aircraft Programme records; and (iii) other recognised information on safety aspects with regard to the operator concerned.

Article 10

Oversight and enforcement

1. The Member States, the Commission and the Agency shall cooperate with a view to ensuring that any product, person or organisation subject to this Regulation complies with its provisions and with its implementing rules.

2. For the purposes of the implementation of paragraph 1, Member States shall, in addition to their oversight of certificates that they have issued, conduct investigations, including ramp inspections, and shall take any measure, including the grounding of aircraft, to prevent the continuation of an infringement.

3. For the purposes of the implementation of paragraph 1, the Agency shall conduct investigations in accordance with Article 24(2) and Article 55.

4. In order to facilitate the taking of appropriate enforcement action by competent authorities, the Member States, the Commission and the Agency shall exchange information on identified infringements.

5. The measures designed to amend non-essential elements of this Article, by supplementing it, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 65(4). Those measures shall specify in particular:

(a) conditions for the collection, exchange and dissemination of information;

(b) conditions for conducting ramp inspections, including systematic ones;

(c) conditions for the grounding of aircraft that do not comply with the requirements of this Regulation or its implementing rules.

Article 11

Recognition of certificates

1. Member States shall, without further technical requirements or evaluation, recognise certificates issued in accordance with this Regulation. When the original recognition is for a particular purpose or purposes, any subsequent recognition shall cover only the same purpose or purposes.

2. The Commission, on its own initiative or at the request of a Member State or of the Agency, may initiate the procedure referred to in Article 65(7) to decide whether a certificate issued in accordance with this Regulation effectively complies with this Regulation and its implementing rules.

In case of non-compliance or ineffective compliance, the Commission shall require the issuer of a certificate to take appropriate corrective action and safeguard measures, such as limitation or suspension of the certificate. Moreover, the provisions of paragraph 1 shall cease to apply to the certificate from the date of the notification of the Commission's decision to the Member States.

3. When the Commission has sufficient evidence that appropriate corrective action has been taken by the issuer referred to in paragraph 2 to address the case of non-compliance or ineffective compliance and that the safeguard measures are no longer necessary, it shall decide that the provisions of paragraph 1 apply again to this certificate. These provisions shall apply as from the date of the notification of this decision to the Member States.

4. Pending adoption of the measures referred to in Articles 5(5), 7(6) and 9(4), and without prejudice to Article 69(4), certificates which cannot be issued in accordance with this Regulation may be issued on the basis of the applicable national regulations.

5. Pending adoption of the measures referred to in Article 8(5), and without prejudice to Article 69(4), certificates which cannot be issued in accordance with this Regulation may be issued on the basis of the applicable national regulations or, where applicable, on the basis of the relevant requirements of Regulation (EEC) No 3922/91.

6. The provisions of this Article shall be without prejudice to Regulation (EC) No 2111/2005 and its implementing rules.

Article 12

Acceptance of third-country certification

1. By way of derogation from the provisions of this Regulation and its implementing rules, the Agency or the aviation authorities in the Member State may issue certificates on the basis of certificates issued by aeronautical authorities of a third country, as provided for in recognition agreements between the Community and that third country.

2.

(a) In the absence of an agreement concluded by the Community, a Member State or the Agency may issue certificates on the basis of certifications issued by the competent authorities of a third country in application of an agreement concluded by that Member State with the third country in question before the entry into force of the related provisions of this Regulation and notified to the Commission and the other Member States. The Agency may also issue such certificates on behalf of any Member State in application of an agreement concluded by one of the Member States with the third country in question.

(b) If the Commission considers that: — the provisions of an agreement between a Member State and a third country would not provide for a level of safety equivalent to that specified by this Regulation and its implementing rules, and/or — such agreement would discriminate among Member States without compelling safety reasons or is contrary to Community foreign policy vis-à-vis a third country, it may, in accordance with the procedure laid down in Article 65(2), require the Member State concerned to modify the agreement, to suspend its application or to renounce it, in accordance with Article 307 of the Treaty.

(c) Member States shall take the necessary measures to renounce agreements as soon as possible after the entry into force of an agreement between the Community and the third country in question, for those domains covered by that latter agreement.

Article 13

Qualified entities

When allocating a specific certification task to a qualified entity, the Agency or the national aviation authority concerned shall ensure that such entity comply with the criteria laid down in Annex V.

Article 14

Flexibility provisions

1. The provisions of this Regulation and of its implementing rules shall not prevent a Member State from reacting immediately to a safety problem which involves a product, person or organisation subject to the provisions of this Regulation.

The Member State shall immediately notify the Agency, the Commission and the other Member States of the measures taken and the reasons therefor.

2.

(a) The Agency shall assess whether the safety problem can be addressed within the powers conferred on it in accordance with Article 18(d). In this case it shall, within one month of being notified pursuant to paragraph 1, take the appropriate decision.

(b) If the Agency concludes that the safety problem cannot be addressed in accordance with point (a), it shall, within the period referred to in that point, issue a recommendation in accordance with Article 18(b) as to whether this Regulation or its implementing rules should be amended and whether the notified measures should be withdrawn or maintained.

3. The measures designed to amend non-essential elements of this Regulation, inter alia, by supplementing it, and relating to whether an inadequate level of safety or a shortcoming in this Regulation or its implementing rules justify initiating their amendment and whether the measures adopted pursuant to paragraph 1 may be continued, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 65(6). In such a case the measures shall be implemented as appropriate by all Member States and the provisions of Article 11 shall apply to such measures. If the measures are found not to be justified, they shall be revoked by the Member State concerned.

4. Member States may grant exemptions from the substantive requirements laid down in this Regulation and its implementing rules in the event of unforeseen urgent operational circumstances or operational needs of a limited duration, provided the level of safety is not adversely affected. The Agency, the Commission and the other Member States shall be notified of any such exemptions as soon as they become repetitive or where they are granted for periods of more than two months.

5. The Agency shall assess whether the exemptions notified by a Member State are less restrictive than the applicable Community provisions and, within one month of being notified thereof, shall issue a recommendation in accordance with Article 18(b) on whether these exemptions comply with the general safety objectives of this Regulation or any other rule of Community law.

If an exemption does not comply with the general safety objectives of this Regulation or any other rule of Community law, the Commission shall take a decision not to permit the exemption in accordance with the procedure referred to in Article 65(7). In such a case, the Member State concerned shall revoke the exemption.

6. Where an equivalent level of protection to that attained by the application of the rules implementing this Regulation can be achieved by other means, Member States may, without discrimination on grounds of nationality, grant an approval derogating from those implementing rules.

In such cases, the Member State concerned shall notify the Agency and the Commission that it intends to grant such an approval, and shall give reasons demonstrating the need to derogate from the rule concerned, as well as the conditions laid down to ensure that an equivalent level of protection is achieved.

7. Within two months of being notified in accordance with paragraph 6, the Agency shall issue a recommendation in accordance with Article 18(b) on whether an approval proposed in accordance with paragraph 6 fulfils the conditions laid down in that paragraph.

The measures designed to amend non-essential elements of this Regulation, by supplementing it, relating to whether a proposed approval may be granted shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 65(6) within one month of receiving the Agency's recommendation. In such a case, the Commission shall notify its decision to all Member States, which shall also be entitled to apply that measure. The provisions of Article 15 shall apply to the measure in question.

Article 15

Information network

1. The Commission, the Agency and the national aviation authorities shall exchange any information available to them in the context of the application of this Regulation and its implementing rules. Entities entrusted with the investigation of civil aviation accidents and incidents, or with the analysis of occurrences, are entitled to access to that information.

2. Without prejudice to the public's right of access to the Commission's documents as laid down in Regulation (EC) No 1049/2001, the Commission shall adopt, in accordance with the procedure referred to in Article 65(3), measures for the dissemination to interested parties on its own initiative of the information referred to in paragraph 1 of this Article. These measures, which may be generic or individual, shall be based on the need:

(a) to provide persons and organisations with the information they need to improve aviation safety;

(b) to limit the dissemination of information to what is strictly required for the purpose of its users, in order to ensure appropriate confidentiality of that information.

3. The national aviation authorities shall, in accordance with their national legislation, take necessary measures to ensure appropriate confidentiality of the information received by them pursuant to paragraph 1.

4. In order to inform the public of the general safety level, a safety review shall be published annually by the Agency. From the entry into force of the measures referred to in Article 10(5), this safety review shall contain an analysis of all information received pursuant to Article 10. This analysis shall be simple and easy to understand and shall indicate whether there are increased safety risks. In this analysis, the sources of information shall not be revealed.

Article 16

Protection of the source of information

1. Where the information referred to in Article 15(1) is provided by a natural person on a voluntary basis to the Commission or the Agency, the source of such information shall not be revealed. When the information has been provided to a national authority, the source of such information shall be protected in accordance with national legislation.

2. Without prejudice to applicable rules of criminal law, Member States shall refrain from instituting proceedings in respect of unpremeditated or unintentional infringements of the law which come to their attention only because they have been reported pursuant to this Regulation and its implementing rules.

This rule shall not apply in cases of gross negligence.

3. Without prejudice to applicable rules of criminal law, and in accordance with the procedures set out in national law and practice, Member States shall ensure that employees who provide information in application of this Regulation and its implementing rules are not subject to any prejudice on the part of their employer.

This rule shall not apply in cases of gross negligence.

4. This Article shall apply without prejudice to national rules relating to access to information by judicial authorities.







CHAPTER III

THE EUROPEAN AVIATION SAFETY AGENCY







SECTION I

Tasks

Article 17

Establishment and functions of the Agency

1. For the purpose of the implementation of this Regulation, a European Aviation Safety Agency shall be established.

2. For the purposes of ensuring the proper functioning and development of civil aviation safety, the Agency shall:

(a) undertake any task and formulate opinions on all matters covered by Article 1(1);

(b) assist the Commission by preparing measures to be taken for the implementation of this Regulation. Where these comprise technical rules and in particular rules relating to construction, design and operational aspects, the Commission may not change their content without prior coordination with the Agency. The Agency shall also provide the Commission with the necessary technical, scientific and administrative support to carry out its tasks;

(c) take the necessary measures within the powers conferred on it by this Regulation or other Community legislation;

(d) conduct inspections and investigations as necessary to fulfil its tasks;

(e) in its fields of competence, carry out, on behalf of Member States, functions and tasks ascribed to them by applicable international conventions, in particular the Chicago Convention.

Article 18

Agency measures

The Agency shall, where appropriate:

(a) issue opinions addressed to the Commission;

(b) issue recommendations addressed to the Commission for the application of Article 14;

(c) issue certification specifications, including airworthiness codes and acceptable means of compliance, as well as any guidance material for the application of this Regulation and its implementing rules;

(d) take the appropriate decisions for the application of Articles 20, 21, 22, 23, 54 and 55;

(e) issue the reports following standardisation inspections carried out pursuant to Articles 24(1) and 54.

Article 19

Opinions, certification specifications and guidance material

1. In order to assist the Commission in the preparation of proposals for basic principles, applicability and essential requirements to be presented to the European Parliament and to the Council and the adoption of the implementing rules, the Agency shall prepare drafts thereof. These drafts shall be submitted by the Agency as opinions to the Commission.

2. The Agency shall, in accordance with Article 52 and the implementing rules adopted by the Commission, develop:

(a) certification specifications, including airworthiness codes and acceptable means of compliance; and

(b) guidance material;

to be used in the certification process.

These documents shall reflect the state of the art and the best practices in the fields concerned and be updated taking into account worldwide aircraft experience in service, and scientific and technical progress.

Article 20

Airworthiness and environmental certification

1. With regard to the products, parts and appliances referred to in Article 4(1)(a) and (b), the Agency shall, where applicable and as specified in the Chicago Convention or its Annexes, carry out on behalf of Member States the functions and tasks of the state of design, manufacture or registry when related to design approval. To that end, it shall in particular:

(a) for each product for which a type-certificate or a change to a type-certificate is requested, establish and notify the type-certification basis. That certification basis consists of the applicable airworthiness code, the provisions for which an equivalent level of safety has been accepted and the special detailed technical specifications necessary when the design features of a particular product or the experience in operation render any of the airworthiness code provisions inadequate or inappropriate to ensure conformity with essential requirements;

(b) for each product for which a restricted certificate of airworthiness is requested, establish and notify the specific airworthiness specifications;

(c) for each part or appliance for which a certificate is requested, establish and notify the detailed airworthiness specifications;

(d) for each product for which environmental certification is required in accordance with Article 6, establish and notify the appropriate environmental requirements;

(e) conduct, itself or through national aviation authorities or qualified entities, investigations associated with products, parts and appliances certification;

(f) issue the appropriate type-certificates or associated changes;

(g) issue certificates for parts and appliances;

(h) issue the appropriate environmental certificates;

(i) amend, suspend or revoke the relevant certificate when the conditions according to which it was issued are no longer fulfilled or if the legal or natural person holding the certificate fails to fulfil the obligations imposed on it by this Regulation or its implementing rules;

(j) ensure the continuing airworthiness functions associated with the products, parts and appliances which are under its oversight, including reacting without undue delay to a safety problem and issuing and disseminating the applicable mandatory information;

(k) for aircraft for which a permit to fly is to be issued, establish airworthiness standards and procedures to comply with Article 5(4)(a);

(l) issue permits to fly to aircraft for the purpose of certification under the control of the Agency, in agreement with the Member State in which the aircraft is registered or is to be registered.

2. With regard to organisations, the Agency shall:

(a) conduct, itself or through national aviation authorities or qualified entities, inspections and audits of the organisations it certifies;

(b) issue and renew the certificates of: (i) design organisations; or (ii) production organisations located within the territory of the Member States, if requested by the Member State concerned; or (iii) production and maintenance organisations located outside the territory of the Member States;

(c) amend, suspend or revoke the relevant organisation certificate when the conditions according to which it was issued are no longer fulfilled, or if the organisation concerned fails to fulfil the obligations imposed on it by this Regulation or its implementing rules.

Article 21

Pilot certification

1. With regard to the personnel and organisations referred to in Article 7(1), the Agency shall:

(a) conduct, itself or through national aviation authorities or qualified entities, investigations and audits of the organisations it certifies and, where relevant, their personnel;

(b) issue and renew the certificates of pilot training organisations and aero-medical centres located outside the territory of the Member States and, where relevant, their personnel;

(c) amend, limit, suspend or revoke the relevant certificate when the conditions according to which it was issued by it are no longer fulfilled, or if the legal or natural person holding the certificate fails to fulfil the obligations imposed on it by this Regulation or its implementing rules.

2. With regard to the flight simulation training devices referred to in Article 7(1), the Agency shall:

(a) conduct, itself or through national aviation authorities or qualified entities, technical inspections of the devices it certifies;

(b) issue and renew the certificates of: (i) flight simulation training devices used by training organisations certified by the Agency; or (ii) flight simulation training devices located within the territory of the Member States, if requested by the Member State concerned; (iii) flight simulation training devices located outside the territory of the Member States;

(c) amend, limit, suspend or revoke the relevant certificate when the conditions according to which it was issued are no longer fulfilled, or if the legal or natural person holding the certificate fails to fulfil the obligations imposed on it by this Regulation or its implementing rules.

Article 22

Air operation certification

1. The Agency shall react without undue delay to a problem affecting the safety of air operations by determining corrective action and by disseminating related information, including to the Member States.

2. With regard to flight time limitation:

(a) the Agency shall issue the applicable certification specifications to ensure compliance with essential requirements and, as appropriate, the related implementing rules. Initially, the implementing rules shall include all substantive provisions of Subpart Q of Annex III to Regulation (EEC) No 3922/91, taking into account the latest scientific and technical evidence;

(b) a Member State may approve individual flight time specification schemes which deviate from the certification specifications referred to in point (a). In this case the Member State shall without delay notify the Agency, the Commission and the other Member States that it intends to grant approval for such an individual scheme;

(c) upon notification the Agency shall, within one month, assess the individual scheme on the basis of a scientific and medical evaluation. Thereafter the Member State concerned may grant the approval as notified, unless the Agency has discussed the scheme with that Member State and proposed changes thereto. Should the Member State agree with these changes, it may grant the approval accordingly;

(d) in the event of unforeseen urgent operational circumstances or operational needs of limited duration and non-repetitive nature, derogations to certification specifications may apply provisionally until the Agency expresses its opinion;

(e) should a Member State disagree with the Agency's conclusions concerning an individual scheme, it shall refer the issue to the Commission to decide whether that scheme complies with the safety objectives of this Regulation, in accordance with the procedure referred to in Article 65(3);

(f) the contents of individual schemes which are acceptable to the Agency, or on which the Commission has taken a positive decision in accordance with point (e), shall be published.

Article 23

Third-country operators

1. With regard to operators of aircraft referred to in Article 4(1)(d) engaged in commercial operations, the Agency shall:

(a) conduct, itself or through national aviation authorities or qualified entities, investigations and audits;

(b) issue and renew the authorisations referred to in Article 9(2), unless a Member State carries out the functions and tasks of the state of operator in respect of these operators;

(c) amend, limit, suspend or revoke the relevant authorisation when the conditions according to which it was issued by it are no longer fulfilled, or if the organisation concerned fails to fulfil the obligations imposed on it by this Regulation or its implementing rules.

2. With regard to operators of aircraft referred to in Article 4(1)(d) not engaged in commercial operations, the Agency shall:

(a) receive the declarations referred to in Article 9(3); and

(b) conduct, itself or through national aviation authorities or qualified entities, the oversight of operators from which it has received a declaration.

3. With regard to aircraft referred to in Article 4(1)(d), the Agency shall issue authorisations in accordance with Article 9(4)(a).

Article 24

Monitoring the application of the rules

1. The Agency shall conduct standardisation inspections in the fields covered by Article 1(1), in order to monitor the application by national competent authorities of this Regulation and of its implementing rules, and shall report to the Commission.

2. The Agency shall conduct investigations of undertakings to monitor the application of this Regulation and its implementing rules.

3. The Agency shall assess the impact of the implementation of this Regulation and its implementing rules, having regard to the objectives set out in Article 2.

4. The Agency shall be consulted on, and issue recommendations to the Commission for, the application of Article 14.

5. The working methods of the Agency for conducting the tasks referred to in paragraphs 1, 3 and 4 shall be subject to requirements to be adopted in accordance with the procedure referred to in Article 65(2), taking into account the principles laid down in Articles 52 and 53.

Article 25

Fines and periodic penalty payments

1. Without prejudice to Articles 20 and 55, at the Agency's request the Commission may:

(a) impose on the persons and the undertakings to which the Agency has issued a certificate, fines, where, intentionally or negligently, the provisions of this Regulation and its implementing rules have been breached;

(b) impose, on the persons and undertakings to which the Agency has issued a certificate, periodic penalty payments, calculated from the date set in the decision, in order to compel those persons and undertakings to comply with the provisions of this Regulation and its implementing rules.

2. The fines and periodic penalty payments referred to in paragraph 1 shall be dissuasive and proportionate to both the gravity of the case and the economic capacity of the certificate holder concerned, taking into particular account the extent to which safety has been compromised. The amount of the fines shall not exceed 4 % of the annual income or turnover of the certificate holder. The amount of the periodic penalty shall not exceed 2,5 % of the average daily income or turnover of the certificate holder.

3. The Commission shall adopt, in accordance with the procedure laid down in Article 65(3), the detailed rules for the implementation of this Article. In doing so, it shall specify in particular:

(a) detailed criteria for establishing the amount of the fine or periodic penalty payment; and

(b) procedures for enquiries, associated measures and reporting, as well as rules of procedure for decision-making, including provisions on rights of defence, access to file, legal representation, confidentiality and temporal provisions and the quantification and collection of fines and periodic penalty payments.

4. The Court of Justice of the European Communities shall have unlimited jurisdiction to review decisions whereby the Commission has fixed a fine or periodic penalty payment. It may cancel, reduce or increase the fine or periodic penalty payment imposed.

5. Decisions taken pursuant to paragraph 1 shall not be of a criminal law nature.

Article 26

Research

1. The Agency may develop and finance research in so far as is strictly related to the improvement of activities in its field of competence, without prejudice to Community law.

2. The Agency shall coordinate its research and development activities with those of the Commission and the Member States so as to ensure that policies and actions are mutually consistent.

3. The results of research funded by the Agency shall be published, provided the Agency does not classify them as confidential.

Article 27

International relations

1. The Agency shall assist the Community and the Member States in their relations with third countries in accordance with the relevant Community law. It shall, in particular, assist in the harmonising of rules and mutual recognition regarding approvals attesting the satisfactory application of rules.

2. The Agency may cooperate with the aeronautical authorities of third countries and the international organisations competent in matters covered by this Regulation in the framework of working arrangements concluded with those bodies, in accordance with the relevant provisions of the Treaty. Such arrangements shall have received the Commission's prior approval.

3. The Agency shall assist Member States to respect their international obligations, in particular those under the Chicago Convention.







SECTION II

Internal structure

Article 28

Legal status, location, local offices

1. The Agency shall be a body of the Community. It shall have legal personality.

2. In each of the Member States, the Agency shall enjoy the most extensive legal capacity accorded to legal persons under their laws. It may, in particular, acquire or dispose of movable and immovable property and may be a party to legal proceedings.

3. The Agency may establish its own local offices in the Member States, subject to their consent.

4. The Agency shall be represented by its Executive Director.

Article 29

Staff

1. The Staff Regulations of Officials of the European Communities, the Conditions of Employment of Other Servants of the European Communities and the rules adopted jointly by the institutions of the European Communities for purposes of the application of those Staff Regulations and Conditions of Employment shall apply to the staff of the Agency, without prejudice to the application of Article 39 of this Regulation to the members of the Board of Appeal.

2. Without prejudice to Article 42, the powers conferred on the appointing authority by the Staff Regulations and the Conditions of Employment shall be exercised by the Agency in respect of its own staff.

3. The Agency's staff shall consist of a strictly limited number of officials assigned or seconded by the Commission or Member States to carry out management duties. The remaining staff shall consist of other employees recruited by the Agency as necessary to carry out its tasks.

Article 30

Privileges and immunities

The Protocol on the Privileges and Immunities of the European Communities annexed to the Treaties establishing the European Community and the European Atomic Energy Community shall apply to the Agency.

Article 31

Liability

1. The contractual liability of the Agency shall be governed by the law applicable to the contract in question.

2. The Court of Justice of the European Communities shall have jurisdiction to give judgment pursuant to any arbitration clause contained in a contract concluded by the Agency.

3. In the case of non-contractual liability, the Agency shall, in accordance with the general principles common to the laws of the Member States, make good any damage caused by its services or by its servants in the performance of their duties.

4. The Court of Justice of the European Communities shall have jurisdiction in disputes relating to compensation for any damage as referred to in paragraph 3.

5. The personal liability of its servants towards the Agency shall be governed by the provisions laid down in the Staff Regulations or Conditions of Employment applicable to them.

Article 32

Publication of documents

1. Without prejudice to decisions taken on the basis of Article 290 of the Treaty, the following documents shall be produced in all official languages of the Community:

(a) the safety review referred to in Article 15(4);

(b) opinions addressed to the Commission pursuant to Article 19(1);

(c) the annual general report and programme of work referred to in Article 33(2)(b) and (c) respectively.

2. The translation services required for the functioning of the Agency shall be provided by the Translation Centre for bodies of the European Union.

Article 33

Powers of the Management Board

1. The Agency shall have a Management Board.

2. The Management Board shall:

(a) appoint the Executive Director, and the Directors on a proposal from the Executive Director, in accordance with Article 39;

(b) adopt the annual general report on the Agency's activities and forward it by 15 June at the latest to the European Parliament, the Council, the Commission, the Court of Auditors and the Member States; acting on behalf of the Agency, it shall forward annually to the European Parliament and the Council (hereinafter referred to as budgetary authority) any information relevant to the outcome of the evaluation procedures, in particular, information concerning the effects or consequences of changes in the tasks assigned to the Agency;

(c) before 30 September each year, and after receiving the opinion of the Commission, adopt the Agency's programme of work for the coming year and forward it to the European Parliament, the Council, the Commission and the Member States; this programme of work shall be adopted without prejudice to the annual Community budgetary procedure and the Community legislative programme in relevant areas of aviation safety; the opinion of the Commission shall be attached to the programme of work;

(d) adopt guidelines for the allocation of certification tasks to national aviation authorities and qualified entities in agreement with the Commission;

(e) establish procedures for making decisions by the Executive Director as referred to in Articles 52 and 53;

(f) carry out its functions relating to the Agency's budget pursuant to Articles 59, 60 and 63;

(g) appoint the members of the Board of Appeal pursuant to Article 41;

(h) exercise disciplinary authority over the Executive Director and over the Directors in agreement with the Executive Director;

(i) give its opinion on the measures relating to fees and charges as referred to in Article 64(1);

(j) establish its Rules of Procedure;

(k) decide on the linguistic arrangements for the Agency;

(l) complement, where appropriate, the list of documents referred to in Article 32(1);

(m) establish the organisational structure of the Agency and adopt the Agency's staffing policy.

3. The Management Board may advise the Executive Director on any matter strictly related to the strategic development of aviation safety, including research as defined in Article 26.

4. The Management Board shall establish an advisory body of interested parties, which it shall consult prior to making decisions in the fields referred to in paragraph 2(c), (e), (f) and (i). The Management Board may also decide to consult the advisory body on other issues referred to in paragraphs 2 and 3. The Management Board shall not be bound by the opinion of the advisory body.

5. The Management Board may establish working bodies to assist in carrying out its functions, including the preparation of its decisions and monitoring the implementation thereof.

Article 34

Composition of the Management Board

1. The Management Board shall be composed of one representative of each Member State and one representative of the Commission. Members shall be selected on the basis of their recognised experience and commitment in the field of civil aviation, their managerial capabilities and their expertise, which are to be used to further the objectives of this Regulation. The competent committee of the European Parliament shall be fully informed accordingly.

Each Member State shall appoint a member of the Management Board as well as an alternate who will represent the member in his/her absence. The Commission shall also designate its representative and alternate. The duration of the terms of office shall be five years. This term of office shall be renewable.

2. Where appropriate, the participation of representatives of European third countries and the conditions of such participation shall be established in the arrangements referred to in Article 66.

3. The advisory body referred to in Article 33(4) shall appoint four of its members to participate as observers in the Management Board. They shall represent, as broadly as possible, the different views represented in the advisory body. The duration of their term of office shall be 30 months, renewable once.

Article 35

Chairmanship of the Management Board

1. The Management Board shall elect a Chairperson and a Deputy Chairperson from among its members. The Deputy Chairperson shall ex officio replace the Chairperson in the event of his/her being prevented from attending to his/her duties.

2. The terms of office of the Chairperson and Deputy Chairperson shall expire when their membership of the Management Board ceases. Subject to this, the duration of the terms of office of the Chairperson and Deputy Chairperson shall be three years. These terms of office shall be renewable once.

Article 36

Meetings

1. Meetings of the Management Board shall be convened by its Chairperson.

2. The Executive Director of the Agency shall take part in the deliberations.

3. The Management Board shall hold at least two ordinary meetings a year. In addition it shall meet at the instance of the Chairperson or at the request of at least one third of its members.

4. The Management Board may invite any person whose opinion might be of interest to attend its meetings as an observer.

5. The members of the Management Board may, subject to the provisions of its Rules of Procedure, be assisted by advisers or experts.

6. The secretariat of the Management Board shall be provided by the Agency.

Article 37

Voting

1. Without prejudice to Article 39(1), the Management Board shall take its decisions by a two-thirds majority of its members. At the request of a member of the Management Board, the decision referred to in Article 33(2)(k) shall be taken by unanimity.

2. Each member designated pursuant to Article 34(1) shall have one vote. In the absence of a Member, his/her alternate shall be entitled to exercise his/her right to vote. Neither observers nor the Executive Director of the Agency shall vote.

3. The Rules of Procedure shall establish more detailed voting arrangements, in particular the conditions under which a member may act on behalf of another member as well as any quorum requirements, where appropriate.

Article 38

Functions and powers of the Executive Director

1. The Agency shall be managed by its Executive Director, who shall be completely independent in the performance of his/her duties. Without prejudice to the competencies of the Commission and the Management Board, the Executive Director shall neither seek nor take instructions from any government or from any other body.

2. The European Parliament or the Council may invite the Executive Director to report on the carrying out of his/her tasks.

3. The Executive Director shall have the following functions and powers:

(a) to approve the measures of the Agency as defined in Article 18 within the limits specified by this Regulation, its implementing rules and any applicable law;

(b) to decide on inspections and investigations as provided for in Articles 54 and 55;

(c) to allocate certification tasks to national aviation authorities or qualified entities according to guidelines set by the Management Board;

(d) to undertake any international functions and technical cooperation with third countries pursuant to Article 27;

(e) to take all necessary steps, including the adoption of internal administrative instructions and the publication of notices, to ensure the functioning of the Agency in accordance with the provisions of this Regulation;

(f) to prepare each year a draft general report and submit it to the Management Board;

(g) to exercise in respect of the Agency's staff the powers laid down in Article 29(2);

(h) to draw up estimates of the revenues and expenditure of the Agency pursuant to Article 59, and to implement the budget pursuant to Article 60;

(i) to delegate his/her powers to other members of the Agency's staff subject to rules to be adopted in accordance with the procedure referred to in Article 65(2);

(j) with the consent of the Management Board, to take decisions regarding the establishment of local offices in the Member States in accordance with Article 28(3);

(k) to prepare and to implement the annual programme of work;

(l) to respond to requests for assistance from the Commission.

Article 39

Appointment of senior officials

1. The Executive Director shall be appointed on grounds of merit and of documented competence and experience relevant for civil aviation. The Executive Director shall be appointed or dismissed by the Management Board on a proposal from the Commission. The Management Board shall take its decision by a three-quarters majority of its members. Before being appointed, the candidate selected by the Management Board may be asked to make a declaration before the competent committee or committees of the European Parliament and answer questions from its, or their, members.

2. The Executive Director may be assisted by one or more Directors. If the Executive Director is absent or indisposed, one of the Directors shall take his/her place.

3. The Directors of the Agency shall be appointed on grounds of professional competence relevant for civil aviation. The Directors shall be appointed or dismissed by the Management Board on a proposal from the Executive Director.

4. The terms of office of the Executive Director and the Directors shall be five years. The term of office of the Directors shall be renewable and the term of office of the Executive Director shall be renewable only once.

Article 40

Powers of the Boards of Appeal

1. One or more Boards of Appeal shall be established within the Agency.

2. The Board or Boards of Appeal shall be responsible for deciding on appeals against the decisions referred to in Article 44.

3. The Board or Boards of Appeal shall be convened as necessary. The number of boards of Appeal and the work allocated to it or them shall be determined by the Commission acting in accordance with the procedure referred to in Article 65(3).

Article 41

Composition of the Boards of Appeal

1. A Board of Appeal shall consist of a Chairperson and two other members.

2. The Chairperson and the other members shall have alternates to represent them in their absence.

3. The Chairperson, the other members and their alternates shall be appointed by the Management Board from a list of qualified candidates adopted by the Commission.

4. Where the Board of Appeal considers that the nature of the appeal so requires, it may call up to two further members from the list referred to in paragraph 3.

5. The qualifications required for the members of each Board of Appeal, the powers of individual members in the preparatory phase of decisions and the voting conditions shall be determined by the Commission acting in accordance with the procedure referred to in Article 65(3).

Article 42

Members of the Board of Appeal

1. The term of office of the members of a Board of Appeal, including the Chairperson and any alternates, shall be five years. This term shall be renewable.

2. The members of a Board of Appeal shall be independent. In making their decisions they shall not be bound by any instructions.

3. The members of a Board of Appeal may not perform any other duties within the Agency. The members of a Board of Appeal may work on a part-time basis.

4. The members of a Board of Appeal may not be removed from office or from the list of qualified candidates during their term of office, unless there are serious grounds for such removal and the Commission, after obtaining the opinion of the Management Board, takes a decision to that effect.

Article 43

Exclusion and objection

1. The members of a Board of Appeal may not take part in any appeal proceedings if they have any personal interest therein, if they have previously been involved as representatives of one of the parties to the proceedings, or if they participated in the decision under appeal.

2. If, for one of the reasons listed in paragraph 1 or for any other reason, a member of a Board of Appeal considers that he/she should not take part in any appeal proceeding, he/she shall inform the Board of Appeal accordingly.

3. Members of a Board of Appeal may be objected to by any party to the appeal proceedings on any of the grounds given in paragraph 1, or if any such member is suspected of partiality. Any such objection shall not be admissible if, while being aware of a reason for objecting, the party to the appeal proceedings has taken a procedural step. No objection may be based on the nationality of members.

4. The Boards of Appeal shall decide as to the action to be taken in the cases specified in paragraphs 2 and 3 without the participation of the member concerned. For the purposes of taking this decision, the member concerned shall be replaced on the Board of Appeal by his/her alternate.

Article 44

Decisions subject to appeal

1. An appeal may be brought against decisions of the Agency taken pursuant to Articles 20, 21, 22, 23, 55 or 64.

2. An appeal lodged pursuant to paragraph 1 shall not have suspensory effect. The Agency may, however, if it considers that circumstances so permit, suspend the application of the decision appealed against.

3. An appeal against a decision which does not terminate proceedings as regards one of the parties may only be made in conjunction with an appeal against the final decision, unless the decision provides for separate appeal.

Article 45

Persons entitled to appeal

Any natural or legal person may appeal against a decision addressed to that person, or against a decision which, although in the form of a decision addressed to another person, is of direct and individual concern to the former. The parties to proceedings may be party to the appeal proceedings.

Article 46

Time limit and form

The appeal, together with the statement of grounds thereof, shall be filed in writing at the Agency within two months of the notification of the measure to the person concerned, or, in the absence thereof, of the day on which it came to the knowledge of the latter, as the case may be.

Article 47

Interlocutory revision

1. If the Executive Director considers the appeal to be admissible and well founded, he/she shall rectify the decision. This shall not apply where the appellant is opposed to another party to the appeal proceedings.

2. If the decision is not rectified within one month after receipt of the statement of grounds for the appeal, the Agency shall forthwith decide whether or not to suspend the application of the decision pursuant to the second sentence of Article 44(2), and shall remit the appeal to the Board of Appeal.

Article 48

Examination of appeals

1. If the appeal is admissible, the Board of Appeal shall examine whether it is well founded.

2. When examining the appeal pursuant to paragraph 1, the Board of Appeal shall act expeditiously. It shall as often as necessary invite the parties to the appeal proceedings to file, within specified time limits, observations on notifications issued by itself or on communications from other parties to the appeal proceedings. Parties to the appeal proceedings shall be entitled to make oral presentations.

Article 49

Decisions on appeal

The Board of Appeal may exercise any power which lies within the competence of the Agency or may remit the case to the competent body of the Agency. The latter shall be bound by the decision of the Board of Appeal.

Article 50

Actions before the Court of Justice

1. Actions may be brought before the Court of Justice of the European Communities for the annulment of acts of the Agency which are legally binding on third parties, for failure to act and for damages caused by the Agency in the course of its activities.

2. Actions for the annulment of decisions of the Agency taken pursuant to Articles 20, 21, 22, 23, 55 or 64 may be brought before the Court of Justice of the European Communities only after all appeal procedures within the Agency have been exhausted.

3. The Agency shall take all necessary measures to comply with the judgment of the Court of Justice of the European Communities.

Article 51

Direct appeal

Member States and the Community institutions may lodge a direct appeal before the Court of Justice of the European Communities against decisions of the Agency.







SECTION III

Working methods

Article 52

Procedures for the development of opinions, certification specifications and guidance material

1. As soon as possible after the entry into force of this Regulation, the Management Board shall establish transparent procedures for issuing opinions, certification specifications and guidance material referred to in Article 18(a) and (c).

Those procedures shall:

(a) draw on expertise available in the aviation regulatory authorities of Member States;

(b) whenever necessary, involve appropriate experts from relevant interested parties;

(c) ensure that the Agency publishes documents and consults widely with interested parties, according to a timetable and a procedure which includes an obligation on the Agency to make a written response to the consultation process.

2. When the Agency, pursuant to Article 19, develops opinions, certification specifications and guidance material to be applied by Member States, it shall establish a procedure for consulting the Member States. To this effect, it may create a working group in which each Member State is entitled to designate an expert.

3. Measures referred to in Article 18(a) and (c) and the procedures established pursuant to paragraph 1 of this Article shall be published in an official publication of the Agency.

4. Special procedures shall be established to address immediate action to be taken by the Agency to react to a safety problem and to inform the relevant interested parties of the action they are to take.

Article 53

Procedures for taking decisions

1. The Management Board shall establish transparent procedures for taking individual decisions as provided for in Article 18(d).

Those procedures shall:

(a) ensure the hearing of the natural or legal person to be addressed in the decision and of any other party with a direct and individual concern;

(b) provide for notification of the decision to natural or legal persons and for its publication;

(c) provide for the natural or legal person to whom the decision is addressed, and any other parties to proceedings, to be informed of the legal remedies available to that person under this Regulation;

(d) ensure that the decision contains reasons.

2. The Management Board shall establish procedures specifying the conditions under which decisions are notified while taking due account of the appeal procedure.

3. Special procedures shall be established to address immediate action to be taken by the Agency to react to a safety problem and to inform the relevant interested parties of the action they are to take.

Article 54

Inspections of Member States

1. Without prejudice to the enforcement powers conferred by the Treaty on the Commission, the Agency shall assist the Commission in monitoring the application of this Regulation and its implementing rules by conducting standardisation inspections of Member States competent authorities as specified in Article 24(1). The officials authorised under this Regulation, and th