EASA 216-2008 - Basic Regulation
EASA 216-2008 - Basic Regulation
REGULATIONS
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE the limits set by the Convention on International Civil
EUROPEAN UNION, Aviation, signed in Chicago on 7 December 1944 (the
Chicago Convention), to which all Member States are
parties.
Having regard to the Treaty establishing the European Commu-
nity, and in particular Article 80(2) thereof,
Having regard to the proposal from the Commission, (3) The Chicago Convention already provides for minimum
standards to ensure the safety of civil aviation and
Having regard to the Opinion of the Economic and Social environmental protection relating thereto. Community
Committee (1), essential requirements and rules adopted for their imple-
mentation should ensure that Member States fulfil the
obligations created by the Chicago Convention, including
After consulting the Committee of the Regions, those vis-à-vis third countries.
which are produced in an industrial manner. They therefore (12) There is a need for better arrangements in all the fields
can be better regulated at Community level to provide for covered by this Regulation so that certain tasks currently
the necessary uniform level of safety and environmental performed at Community or national level should be
protection. carried out by a single specialised expert body. There is,
therefore, a need within the Community's existing institu-
tional 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
(6) The scope of Community action should be clearly defined matters and has legal, administrative and financial
so that persons, organisations and products subject to this autonomy. To that end, it is necessary and appropriate
Regulation and its implementing rules can be identified that it should be a Community body having legal
without ambiguity. Such scope should be clearly defined by personality and exercising the implementing powers which
referring to a list of aircraft which are exempted from the are conferred on it by this Regulation.
application of this Regulation.
(7) Aeronautical products, parts and appliances, operators (13) Under the Community institutional system, implementa-
involved in commercial air transport, as well as pilots and tion of Community law is primarily the responsibility of the
persons, products and organisations involved in their Member States. Certification tasks required by this Regula-
training and medical examination, should be certified or tion and its implementing rules are therefore to be executed
licensed once they have been found to comply with at national level. In certain clearly defined cases, however,
essential requirements to be laid down by the Community the Agency should also be empowered to conduct
in line with standards and recommended practices set by certification tasks as specified in this Regulation. The
the Chicago Convention. The Commission should be Agency should, for the same reason, be allowed to take the
empowered to develop the necessary implementing rules necessary measures related to the operation of aircraft, the
for establishing the conditions for the issue of the certificate qualification of crew or the safety of third-country aircraft
or the conditions for its replacement by a declaration of when this is the best means to ensure uniformity and
capability, taking into account the risks associated with the facilitate the functioning of the internal market.
different types of operations, such as certain types of aerial
work and local flights with small aircraft.
(10) In order to achieve Community objectives as regards the (15) The effective functioning of a Community civil aviation
freedom of movement of goods, persons and services, as safety scheme in the fields covered by this Regulation
well as those of the common transport policy, Member requires strengthened cooperation between the Commis-
States should, without further requirements or evaluation, sion, the Member States and the Agency to detect unsafe
accept products, parts and appliances, organisations or conditions and take remedial measures as appropriate.
persons certified in accordance with this Regulation and its
implementing rules.
spontaneously reported by the witnesses thereto. Such monitoring the application of this Regulation and of its
reporting would be facilitated by the establishment of a implementing rules, and it should be given the necessary
non-punitive environment, and appropriate measures authority to carry out its tasks.
should be taken by Member States to provide for the
protection of such information and of those who report it.
The Community budgetary procedure should be applicable Council Regulation (EEC) No 3922/91 of 16 December
as far as the Community contribution and any other 1991 on the harmonisation of technical requirements and
subsidies chargeable to the general budget of the European administrative procedures in the field of civil aviation ( 2)
Union are concerned. The auditing of accounts should be and Council Directive 91/670/EEC of 16 December 1991
carried out by the Court of Auditors. on mutual acceptance of personnel licences for the exercise
of functions in civil aviation (3) should therefore be repealed
in due course, without prejudice to the certification or
licensing of products, persons and organisations already
(28) Before any local offices of the Agency are set up, general
carried out in accordance with those acts.
rules should be established to clarify what requirements
need to be met and what contribution the Member State
concerned must provide.
(34) This Regulation establishes an appropriate and compre-
hensive framework for the safety of third-country aircraft
(29) Since the objectives of this Regulation, namely the using Community airports. Directive 2004/36/EC of the
establishment and uniform application of common rules European Parliament and of the Council of 21 April 2004
in the field of civil aviation safety and environmental on the safety of third-country aircraft using Community
protection, cannot be sufficiently achieved by the Member airports (4) should therefore be repealed in due course and
States and can therefore, by reason of the Europe-wide without prejudice to the implementing measures on
scope of this Regulation, be better achieved at Community collection of information, ramp inspection and exchange
level, the Community may adopt measures, in accordance of information.
with the principle of subsidiarity, as set out in Article 5 of
the Treaty. In accordance with the principle of proportion-
ality, as set out in that Article, this Regulation does not go
beyond what is necessary in order to achieve those (35) This Regulation will apply to any other area related to civil
objectives. aviation safety on the basis of a future proposal in
accordance with the Treaty.
enforcement, as well as to adopt a regulation on the fees (b) to facilitate the free movement of goods, persons and
and charges of the Agency. Since those measures are of services;
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 (c) to promote cost-efficiency in the regulatory and certifica-
accordance with the regulatory procedure with scrutiny tion processes and to avoid duplication at national and
provided for in Article 5a of Decision 1999/468/EC. European level;
(39) On grounds of efficiency, the normal time-limits for the (d) to assist Member States in fulfilling their obligations under
regulatory procedure with scrutiny should be curtailed for the Chicago Convention, by providing a basis for a
the adaptation of the essential requirements for environ- common interpretation and uniform implementation of
mental protection and for the adoption of the implement- its provisions, and by ensuring that its provisions are duly
ing rules for environmental protection. taken into account in this Regulation and in the rules drawn
up for its implementation;
(40) On grounds of urgency it is necessary to apply the urgency
procedure provided for in Article 5a(6) of Decision 1999/
(e) to promote Community views regarding civil aviation
468/EC for the Commission to decide on the measures
safety standards and rules throughout the world by
taken by Member States in immediate reaction to a safety
establishing appropriate cooperation with third countries
problem, as well as on derogating approvals submitted by
and international organisations;
Member States,
HAVE ADOPTED THIS REGULATION: (f) to provide a level playing field for all actors in the internal
aviation market.
CHAPTER I
3. The means of achieving the objectives set out in paragraphs 1
PRINCIPLES and 2 shall be:
Article 1
(a) the preparation, adoption and uniform application of all
Scope necessary acts;
Objectives
(a) ‘continuing oversight’ shall mean the tasks to be conducted
to verify that the conditions under which a certificate has
1. The principal objective of this Regulation is to establish and been granted continue to be fulfilled at any time during its
maintain a high uniform level of civil aviation safety in Europe. period of validity, as well as the taking of any safeguard
measure;
2. Additional objectives are, in the fields covered by this
Regulation, as follows:
(b) ‘Chicago Convention’ shall mean the Convention on
International Civil Aviation and its Annexes, signed in
(a) to ensure a high uniform level of environmental protection; Chicago on 7 December 1944;
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(c) ‘product’ shall mean an aircraft, engine or propeller; — for a maximum passenger seating configuration
of more than nine, or
— certificated for operation with a minimum crew shall comply with this Regulation.
of at least two pilots, or
— for a maximum take-off mass exceeding 4. Paragraph 1 shall not apply to aircraft referred to in
3 175 kg, or Annex II.
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5. Paragraphs 2 and 3 shall not apply to aircraft referred to in means shall be recognised through the issuance of an
Annex II, with the exception of aircraft referred to in organisation approval. The privileges granted to the
points (a)(ii), (d) and (h) thereof when used for commercial air approved organisation and the scope of the approval shall
transportation. be specified in the terms of approval;
6. This Regulation shall not affect the rights of third countries (e) organisations responsible for the design and manufacture of
as specified in international conventions, in particular the products, parts and appliances shall demonstrate their
Chicago Convention. 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
Article 5 granted to the approved organisation and the scope of the
approval shall be specified in the terms of approval;
Airworthiness
in addition:
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.
(f) personnel responsible for the release of a product, part or
appliance after maintenance may be required to hold an
appropriate certificate (personnel certificate);
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:
(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
(a) products shall have a type-certificate. The type-certificate, point (f) may be recognised by the issuance of an approval.
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, 3. Aircraft referred to in Article 4(1)(a) and products, parts and
established to ensure compliance with the essential appliances mounted thereon shall comply with paragraph 2(a),
requirements referred to in paragraph 1, and when it has (b) and (e) of this Article.
no feature or characteristic making it unsafe for operation.
The type-certificate shall cover the product, including all
parts and appliances fitted thereon;
4. By way of derogation from paragraphs 1 and 2:
(d) organisations responsible for the maintenance of products, (c) when the number of aircraft of the same type eligible for a
parts and appliances shall demonstrate their capability and restricted certificate of airworthiness so justifies, a restricted
means to discharge the responsibilities associated with their type certificate may be issued and an appropriate type
privileges. Unless otherwise accepted these capabilities and certification basis shall be established.
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5. The measures designed to amend non-essential elements of (vi) the master minimum equipment list as appropriate
this Article, by supplementing it, shall be adopted in accordance and additional airworthiness specifications for a given
with the regulatory procedure with scrutiny referred to in type of operation to ensure compliance with Article 8;
Article 65(4). Those measures shall specify in particular:
— carriage of persons other than flight crew; Essential requirements for environmental protection
broaden the scope of this Regulation, be adopted in accordance their privileges in relation to the issuance of licenses and medical
with the regulatory procedure with scrutiny referred to in certificates shall be recognised by the issuance of an approval.
Article 65(5).
(f) how pilots of aircraft referred to in points (a)(ii), (d) and (f) (b) conditions for issuing, maintaining, amending, limiting,
of Annex II, when used for commercial air transportation, suspending or revoking the certificates referred to in
comply with the relevant essential requirements of paragraph 2 and the conditions under which a certificate
Annex III. 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;
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 (c) privileges and responsibilities of the holders of certificates;
progress, in the field of pilot training.
Such measures shall also include provisions for the issuance of all (d) conditions and procedures for the declaration by, and for
types of pilot licences and ratings required under the Chicago the oversight of, operators referred to in paragraph 3 and
Convention, and of a leisure pilot licence covering non- the conditions under which a declaration shall be replaced
commercial activities involving aircraft with a maximum by a demonstration of capability and means to discharge
certificated take off mass of 2 000 kg or less and which do the responsibilities associated with the privileges of the
not meet any of the criteria referred to in Article 3(j). operator recognised by the issuance of a certificate;
— not impose on aircraft referred to in Article 4(1)(c) (d) privileges and responsibilities of the holders of authorisa-
requirements which would be incompatible with the ICAO tions;
obligations of Member States.
(e) conditions and procedures for the declaration by, and for
Article 9 the oversight of, operators referred to in paragraph 3;
Aircraft used by a third-country operator into, within or (f) conditions under which operations shall be prohibited,
out of the Community limited or subject to certain conditions in the interest of
safety in accordance with Article 22(1).
1. Aircraft referred to in Article 4(1)(d), as well as their crew
and their operations, shall comply with applicable ICAO 5. When adopting the measures referred to in paragraph 4, the
Standards. To the extent that there are no such standards, these Commission shall take specific care that:
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 (a) use is made, as appropriate, of ICAO recommended
international conventions. practices and guidance documents;
(b) conditions to operate an aircraft in compliance with the 2. For the purposes of the implementation of paragraph 1,
provisions 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
(c) conditions for issuing, maintaining, amending, limiting, of aircraft, to prevent the continuation of an infringement.
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 3. For the purposes of the implementation of paragraph 1, the
the operator, without prejudice to Regulation (EC) Agency shall conduct investigations in accordance with
No 2111/2005 and its implementing rules; Article 24(2) and Article 55.
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4. In order to facilitate the taking of appropriate enforcement 5. Pending adoption of the measures referred to in Article 8(5),
action by competent authorities, the Member States, the and without prejudice to Article 69(4), certificates which cannot
Commission and the Agency shall exchange information on be issued in accordance with this Regulation may be issued on
identified infringements. the basis of the applicable national regulations or, where
applicable, on the basis of the relevant requirements of
Regulation (EEC) No 3922/91.
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 6. The provisions of this Article shall be without prejudice to
Article 65(4). Those measures shall specify in particular: Regulation (EC) No 2111/2005 and its implementing rules.
Article 11
2. (a) In the absence of an agreement concluded by the
Recognition of certificates 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
1. Member States shall, without further technical requirements an agreement concluded by that Member State with the
or evaluation, recognise certificates issued in accordance with third country in question before the entry into force of the
this Regulation. When the original recognition is for a particular related provisions of this Regulation and notified to the
purpose or purposes, any subsequent recognition shall cover Commission and the other Member States. The Agency
only the same purpose or purposes. 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.
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
(b) If the Commission considers that:
in accordance with this Regulation effectively complies with this
Regulation and its implementing rules.
4. Pending adoption of the measures referred to in (c) Member States shall take the necessary measures to
Articles 5(5), 7(6) and 9(4), and without prejudice to Arti- renounce agreements as soon as possible after the entry
cle 69(4), certificates which cannot be issued in accordance with into force of an agreement between the Community and
this Regulation may be issued on the basis of the applicable the third country in question, for those domains covered
national regulations. by that latter agreement.
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Article 13 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.
Qualified entities
When allocating a specific certification task to a qualified entity, 5. The Agency shall assess whether the exemptions notified by
the Agency or the national aviation authority concerned shall a Member State are less restrictive than the applicable
ensure that such entity comply with the criteria laid down in Community provisions and, within one month of being notified
Annex V. 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.
Article 14
Flexibility provisions 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
1. The provisions of this Regulation and of its implementing exemption in accordance with the procedure referred to in
rules shall not prevent a Member State from reacting Article 65(7). In such a case, the Member State concerned shall
immediately to a safety problem which involves a product, revoke the exemption.
person or organisation subject to the provisions of this
Regulation.
6. Where an equivalent level of protection to that attained by
the application of the rules implementing this Regulation can be
The Member State shall immediately notify the Agency, the achieved by other means, Member States may, without
Commission and the other Member States of the measures taken discrimination on grounds of nationality, grant an approval
and the reasons therefor. derogating from those implementing rules.
2. Without prejudice to the public's right of access to the This rule shall not apply in cases of gross negligence.
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 4. This Article shall apply without prejudice to national rules
dissemination to interested parties on its own initiative of the relating to access to information by judicial authorities.
information referred to in paragraph 1 of this Article. These
measures, which may be generic or individual, shall be based on
the need: CHAPTER III
Tasks
(b) to limit the dissemination of information to what is strictly
required for the purpose of its users, in order to ensure
Article 17
appropriate confidentiality of that information.
Establishment and functions of the Agency
3. The national aviation authorities shall, in accordance with
their national legislation, take necessary measures to ensure 1. For the purpose of the implementation of this Regulation, a
appropriate confidentiality of the information received by them European Aviation Safety Agency shall be established.
pursuant to paragraph 1.
2. For the purposes of ensuring the proper functioning and
development of civil aviation safety, the Agency shall:
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), (a) undertake any task and formulate opinions on all matters
this safety review shall contain an analysis of all information covered by Article 1(1);
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 (b) assist the Commission by preparing measures to be taken
be revealed. for the implementation of this Regulation. Where these
comprise technical rules and in particular rules relating to
construction, design and operational aspects, the Commis-
sion may not change their content without prior coordina-
Article 16 tion with the Agency. The Agency shall also provide the
Commission with the necessary technical, scientific and
administrative support to carry out its tasks;
Protection of the source of information
1. Where the information referred to in Article 15(1) is (c) take the necessary measures within the powers conferred
provided by a natural person on a voluntary basis to the on it by this Regulation or other Community legislation;
Commission or the Agency, the source of such information shall
not be revealed. When the information has been provided to a (d) conduct inspections and investigations as necessary to fulfil
national authority, the source of such information shall be its tasks;
protected in accordance with national legislation.
Agency measures
This rule shall not apply in cases of gross negligence.
The Agency shall, where appropriate:
3. Without prejudice to applicable rules of criminal law, and in
accordance with the procedures set out in national law and (a) issue opinions addressed to the Commission;
practice, Member States shall ensure that employees who provide
information in application of this Regulation and its implement-
ing rules are not subject to any prejudice on the part of their (b) issue recommendations addressed to the Commission for
employer. the application of Article 14;
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(c) issue certification specifications, including airworthiness operation render any of the airworthiness code provisions
codes and acceptable means of compliance, as well as any inadequate or inappropriate to ensure conformity with
guidance material for the application of this Regulation and essential requirements;
its implementing rules;
(e) issue the reports following standardisation inspections (c) for each part or appliance for which a certificate is
carried out pursuant to Articles 24(1) and 54. requested, establish and notify the detailed airworthiness
specifications;
Article 19
(d) for each product for which environmental certification is
Opinions, certification specifications and guidance material required in accordance with Article 6, establish and notify
the appropriate environmental requirements;
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 (e) conduct, itself or through national aviation authorities or
to the Council and the adoption of the implementing rules, the qualified entities, investigations associated with products,
Agency shall prepare drafts thereof. These drafts shall be parts and appliances certification;
submitted by the Agency as opinions to the Commission.
(b) guidance material; (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
to be used in the certification process. certificate fails to fulfil the obligations imposed on it by this
Regulation or its implementing rules;
These documents shall reflect the state of the art and the best
practices in the fields concerned and be updated taking into (j) ensure the continuing airworthiness functions associated
account worldwide aircraft experience in service, and scientific with the products, parts and appliances which are under its
and technical progress. oversight, including reacting without undue delay to a
safety problem and issuing and disseminating the applicable
mandatory information;
Article 20
Airworthiness and environmental certification (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);
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 (l) issue permits to fly to aircraft for the purpose of
design, manufacture or registry when related to design approval. certification under the control of the Agency, in agreement
To that end, it shall in particular: with the Member State in which the aircraft is registered or
is to be registered.
(b) issue and renew the certificates of: (iii) flight simulation training devices located outside the
territory of the Member States;
(c) amend, suspend or revoke the relevant organisation Air operation certification
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 1. The Agency shall react without undue delay to a problem
this Regulation or its implementing rules. affecting the safety of air operations by determining corrective
action and by disseminating related information, including to the
Member States.
Article 21
(f) the contents of individual schemes which are acceptable to 5. The working methods of the Agency for conducting the
the Agency, or on which the Commission has taken a tasks referred to in paragraphs 1, 3 and 4 shall be subject to
positive decision in accordance with point (e), shall be requirements to be adopted in accordance with the procedure
published. referred to in Article 65(2), taking into account the principles
laid down in Articles 52 and 53.
Article 23
Article 25
Third-country operators
1. With regard to operators of aircraft referred to in Article 4 Fines and periodic penalty payments
(1)(d) engaged in commercial operations, the Agency shall:
1. Without prejudice to Articles 20 and 55, at the Agency's
(a) conduct, itself or through national aviation authorities or request the Commission may:
qualified entities, investigations and audits;
(b) issue and renew the authorisations referred to in Article 9 (a) impose on the persons and the undertakings to which the
(2), unless a Member State carries out the functions and Agency has issued a certificate, fines, where, intentionally or
tasks of the state of operator in respect of these operators; negligently, the provisions of this Regulation and its
implementing rules have been breached;
5. Decisions taken pursuant to paragraph 1 shall not be of a 3. The Agency may establish its own local offices in the
criminal law nature. Member States, subject to their consent.
Research
Article 29
Article 30
2. The Agency may cooperate with the aeronautical authorities
of third countries and the international organisations competent
Privileges and immunities
in matters covered by this Regulation in the framework of
working arrangements concluded with those bodies, in accor-
dance with the relevant provisions of the Treaty. Such The Protocol on the Privileges and Immunities of the European
arrangements shall have received the Commission's prior Communities annexed to the Treaties establishing the European
approval. Community and the European Atomic Energy Community shall
apply to the Agency.
1. The Agency shall be a body of the Community. It shall have 3. In the case of non-contractual liability, the Agency shall, in
legal personality. 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.
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 4. The Court of Justice of the European Communities shall
and immovable property and may be a party to legal have jurisdiction in disputes relating to compensation for any
proceedings. damage as referred to in paragraph 3.
19.3.2008 EN Official Journal of the European Union L 79/19
5. The personal liability of its servants towards the Agency (d) adopt guidelines for the allocation of certification tasks to
shall be governed by the provisions laid down in the Staff national aviation authorities and qualified entities in
Regulations or Conditions of Employment applicable to them. agreement with the Commission;
Powers of the Management Board (m) establish the organisational structure of the Agency and
adopt the Agency's staffing policy.
1. The Agency shall have a Management Board.
3. The Management Board may advise the Executive Director
on any matter strictly related to the strategic development of
2. The Management Board shall: aviation safety, including research as defined in Article 26.
(a) appoint the Executive Director, and the Directors on a 4. The Management Board shall establish an advisory body of
proposal from the Executive Director, in accordance with interested parties, which it shall consult prior to making
Article 39; 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.
(b) adopt the annual general report on the Agency's activities The Management Board shall not be bound by the opinion of the
and forward it by 15 June at the latest to the European advisory body.
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 5. The Management Board may establish working bodies to
Parliament and the Council (hereinafter referred to as assist in carrying out its functions, including the preparation of
budgetary authority) any information relevant to the its decisions and monitoring the implementation thereof.
outcome of the evaluation procedures, in particular,
information concerning the effects or consequences of
changes in the tasks assigned to the Agency; Article 34
6. The secretariat of the Management Board shall be provided (g) to exercise in respect of the Agency's staff the powers laid
by the Agency. down in Article 29(2);
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(i) to delegate his/her powers to other members of the 1. A Board of Appeal shall consist of a Chairperson and two
Agency's staff subject to rules to be adopted in accordance other members.
with the procedure referred to in Article 65(2);
2. The Chairperson and the other members shall have
(j) with the consent of the Management Board, to take alternates to represent them in their absence.
decisions regarding the establishment of local offices in the
Member States in accordance with Article 28(3);
3. The Chairperson, the other members and their alternates
shall be appointed by the Management Board from a list of
(k) to prepare and to implement the annual programme of qualified candidates adopted by the Commission.
work;
1. One or more Boards of Appeal shall be established within Exclusion and objection
the Agency.
1. The members of a Board of Appeal may not take part in any
2. The Board or Boards of Appeal shall be responsible for appeal proceedings if they have any personal interest therein, if
deciding on appeals against the decisions referred to in Article 44. they have previously been involved as representatives of one of
the parties to the proceedings, or if they participated in the
decision under appeal.
3. The Board or Boards of Appeal shall be convened as
necessary. The number of boards of Appeal and the work 2. If, for one of the reasons listed in paragraph 1 or for any
allocated to it or them shall be determined by the Commission other reason, a member of a Board of Appeal considers that he/
acting in accordance with the procedure referred to in Article 65 she should not take part in any appeal proceeding, he/she shall
(3). inform the Board of Appeal accordingly.
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3. Members of a Board of Appeal may be objected to by any 2. If the decision is not rectified within one month after receipt
party to the appeal proceedings on any of the grounds given in of the statement of grounds for the appeal, the Agency shall
paragraph 1, or if any such member is suspected of partiality. forthwith decide whether or not to suspend the application of
Any such objection shall not be admissible if, while being aware the decision pursuant to the second sentence of Article 44(2),
of a reason for objecting, the party to the appeal proceedings has and shall remit the appeal to the Board of Appeal.
taken a procedural step. No objection may be based on the
nationality of members.
Article 48
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 Examination of appeals
participation of the member concerned. For the purposes of
taking this decision, the member concerned shall be replaced on 1. If the appeal is admissible, the Board of Appeal shall
the Board of Appeal by his/her alternate. examine whether it is well founded.
Article 44
2. When examining the appeal pursuant to paragraph 1, the
Board of Appeal shall act expeditiously. It shall as often as
Decisions subject to appeal necessary invite the parties to the appeal proceedings to file,
within specified time limits, observations on notifications issued
1. An appeal may be brought against decisions of the Agency by itself or on communications from other parties to the appeal
taken pursuant to Articles 20, 21, 22, 23, 55 or 64. proceedings. Parties to the appeal proceedings shall be entitled to
make oral presentations.
3. An appeal against a decision which does not terminate The Board of Appeal may exercise any power which lies within
proceedings as regards one of the parties may only be made in the competence of the Agency or may remit the case to the
conjunction with an appeal against the final decision, unless the competent body of the Agency. The latter shall be bound by the
decision provides for separate appeal. decision of the Board of Appeal.
Article 45 Article 50
Article 47
Article 51
Interlocutory revision
Direct appeal
1. If the Executive Director considers the appeal to be
admissible and well founded, he/she shall rectify the decision. Member States and the Community institutions may lodge a
This shall not apply where the appellant is opposed to another direct appeal before the Court of Justice of the European
party to the appeal proceedings. Communities against decisions of the Agency.
19.3.2008 EN Official Journal of the European Union L 79/23
(b) whenever necessary, involve appropriate experts from Inspections of Member States
relevant interested parties;
1. Without prejudice to the enforcement powers conferred by
the Treaty on the Commission, the Agency shall assist the
(c) ensure that the Agency publishes documents and consults Commission in monitoring the application of this Regulation
widely with interested parties, according to a timetable and and its implementing rules by conducting standardisation
a procedure which includes an obligation on the Agency to inspections of Member States competent authorities as specified
make a written response to the consultation process. in Article 24(1). The officials authorised under this Regulation,
and those seconded by the national authorities participating in
2. When the Agency, pursuant to Article 19, develops such inspections, are thus empowered, in compliance with the
opinions, certification specifications and guidance material to legal provisions of the Member State concerned:
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 (a) to examine the relevant records, data, procedures and any
designate an expert. other material relevant to the achievement of aviation safety
levels in accordance with this Regulation;
3. Measures referred to in Article 18(a) and (c) and the
procedures established pursuant to paragraph 1 of this Article (b) to take copies of or extracts from such records, data,
shall be published in an official publication of the Agency. procedures and other material;
The annual general report shall describe the way in which the
Article 55 Agency has implemented its annual programme of work. It shall
clearly indicate which of the mandates and tasks of the Agency
Investigation of undertakings have been added, changed or deleted in comparison with the
previous year.
1. The Agency may itself conduct or assign to national aviation
authorities or qualified entities all necessary investigations of The report shall outline the activities carried out by the Agency
undertakings in application of Articles 7, 20, 21, 22, 23 and 24 and evaluate the results thereof with respect to the objectives and
(2). These investigations shall be carried out in compliance with timetable set, the risks associated with those activities, the use of
the legal provisions of the Member States in which they are to be resources and the general operations of the Agency.
undertaken. To that end, the persons authorised under this
Regulation are empowered: Article 58
(b) to take copies of or extracts from such records, data, 2. The Agency may communicate on its own initiative in the
procedures and other material; fields within its mission. It shall ensure in particular that, in
addition to the publication specified in Article 52(3), the public
and any interested party are rapidly given objective, reliable and
(c) to ask for an oral explanation on site; easily understandable information with regard to its work.
8. On the basis of the statement of estimates, the Commission 5. The Management Board shall deliver an opinion on the
shall enter in the preliminary draft general budget of the Agency's final accounts.
European Union the estimates it deems necessary for the
establishment plan and the amount of the subsidy to be charged
to the general budget, which it shall place before the budgetary 6. The Executive Director shall, by 1 July at the latest following
authority in accordance with Article 272 of the Treaty. each financial year, forward the final accounts to the European
Parliament, the Council, the Commission and the Court of
Auditors, together with the Management Board's opinion.
9. The budgetary authority shall authorise appropriations for
the subsidy to the Agency. The budgetary authority shall adopt 7. The final accounts shall be published.
the establishment plan of the Agency.
3. Decisions concerning funding and the implementing 3. The measures referred to in paragraph 1 shall determine in
agreements and instruments resulting therefrom shall explicitly particular the matters for which fees and charges pursuant to
state that the Court of Auditors and OLAF may carry out, if Article 59(1)(c) and (d) are due, the amount of the fees and
necessary, on-the-spot checks of the recipients of the Agency's charges and the way in which they are to be paid.
funding and the agents responsible for its allocation.
1. Within three years from the date of the Agency having taken
(b) the provision of services; they shall reflect the actual cost of
up its duties, and every five years thereafter, the Management
each individual provision;
Board shall commission an independent external evaluation on
the implementation of this Regulation.
(c) the processing of appeals.
Financial provisions
2. Where reference is made to this paragraph, Articles 3 and 7
of Decision 1999/468/EC shall apply, having regard to the
The financial rules applicable to the Agency shall be adopted by provisions of Article 8 thereof.
the Management Board after consultation of the Commission.
They may not depart from Commission Regulation (EC,
Euratom) No 2343/2002 of 19 November 2002 on the 3. Where reference is made to this paragraph, Articles 5 and 7
framework Financial Regulation for the bodies referred to in of Decision 1999/468/EC shall apply, having regard to the
provisions of Article 8 thereof.
(1) OJ L 136, 31.5.1999, p. 1.
(2) OJ L 136, 31.5.1999, p. 15. (3) OJ L 357, 31.12.2002, p. 72.
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The period laid down in Article 5(6) of Decision 1999/468/EC to issue certificates and approvals by way of derogation from the
shall be set at one month. provisions of Articles 5, 6, 12 and 20 under the conditions
specified by the Commission in the measures adopted for their
application. When in that context Member States issue
4. Where reference is made to this paragraph, Article 5a(1) to certificates on the basis of certificates issued by third countries,
(4), and Article 7 of Decision 1999/468/EC shall apply, having the measures adopted by the Commission shall give due
regard to the provisions of Article 8 thereof. consideration to the principles laid down in Article 12(2)(b)
and (c).
5. Where reference is made to this paragraph, Article 5a(1) to
(4) and (5)(b), and Article 7 of Decision 1999/468/EC shall
Article 68
apply, having regard to the provisions of Article 8 thereof.
Penalties
The time limits laid down in Article 5a(3)(c), (4)(b) and (4)(e) of
Decision 1999/468/EC shall be set at 20 days.
Member States shall lay down penalties for infringement of this
Regulation and its implementing rules. The penalties shall be
6. Where reference is made to this paragraph, Article 5a(1), (2), effective, proportionate and dissuasive.
(4), (5)(b) and (6), and Article 7 of Decision 1999/468/EC shall
apply, having regard to the provisions of Article 8 thereof.
Article 69
The period provided for in Article 6(b) of Decision 1999/468/EC References made to the repealed Regulation shall be construed as
shall be set at three months. being made to this Regulation and should be read in accordance
with the correlation table set out in Annex VI.
Article 67 Article 70
This Regulation shall be binding in its entirety and directly applicable in all Member States.
ANNEX I
1. Product integrity: product integrity must be assured for all anticipated flight conditions for the operational life of the aircraft.
Compliance with all requirements must be shown by assessment or analysis, supported, where necessary, by tests.
1.a. Structures and materials: the integrity of the structure must be ensured throughout, and sufficiently beyond, the
operational envelope for the aircraft, including its propulsion system, and maintained for the operational life of the
aircraft.
1.a.1. All parts of the aircraft, the failure of which could reduce the structural integrity, must comply with the following
conditions without detrimental deformation or failure. This includes all items of significant mass and their means
of restraint.
1.a.1.a. All combinations of load reasonably expected to occur within, and sufficiently beyond, the weights, centre of
gravity range, operational envelope and life of the aircraft must be considered. This includes loads due to gusts,
manoeuvres, pressurisation, movable surfaces, control and propulsion systems both in flight and on the ground.
1.a.1.b. Consideration must be given to the loads and likely failures induced by emergency landings either on land or
water.
1.a.1.c. Dynamic effects must be covered in the structural response to these loads.
1.a.2. The aircraft must be free from any aeroelastic instability and excessive vibration.
1.a.3. The manufacturing processes and materials used in the construction of the aircraft must result in known and
reproducible structural properties. Any changes in material performance related to the operational environment
must be accounted for.
1.a.4. The effects of cyclic loading, environmental degradation, accidental and discrete source damage must not reduce
the structural integrity below an acceptable residual strength level. All necessary instructions for ensuring
continued airworthiness in this regard must be promulgated.
1.b. Propulsion: the integrity of the propulsion system (i.e. engine and, where appropriate, propeller) must be
demonstrated throughout, and sufficiently beyond, the operational envelope of the propulsion system and must be
maintained for the operational life of the propulsion system.
1.b.1. The propulsion system must produce, within its stated limits, the thrust or power demanded of it at all required
flight conditions, taking into account environmental effects and conditions.
1.b.2. The fabrication process and materials used in the construction of the propulsion system must result in known and
reproducible structural behaviour. Any changes in material performance related to the operational environment
must be accounted for.
1.b.3. The effects of cyclic loading, environmental and operational degradation and likely subsequent part failures must
not reduce the integrity of the propulsion system below acceptable levels. All necessary instructions for ensuring
continued airworthiness in this regard must be promulgated.
1.b.4. All necessary instructions, information and requirements for the safe and correct interface between the propulsion
system and the aircraft must be promulgated.
1.c.1. The aircraft must not have design features or details that experience has shown to be hazardous.
1.c.2. The aircraft, including those systems, equipment and appliances required for type-certification, or by operating
rules, must function as intended under any foreseeable operating conditions, throughout, and sufficiently beyond,
the operational envelope of the aircraft, taking due account of the system, equipment or appliance operating
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environment. Other systems, equipment and appliance not required for type-certification, or by operating rules,
whether functioning properly or improperly, must not reduce safety and must not adversely affect the proper
functioning of any other system, equipment or appliance. Systems, equipment and appliances must be operable
without needing exceptional skill or strength.
1.c.3. The aircraft systems, equipment and associated appliances, considered separately and in relation to each other,
must be designed such that any catastrophic failure condition does not result from a single failure not shown to be
extremely improbable and an inverse relationship must exist between the probability of a failure condition and the
severity of its effect on the aircraft and its occupants. With respect to the single failure criterion above, it is
accepted that due allowance must be made for the size and broad configuration of the aircraft and that this may
prevent this single failure criterion from being met for some parts and some systems on helicopters and small
aeroplanes.
1.c.4. Information needed for the safe conduct of the flight and information concerning unsafe conditions must be
provided to the crew, or maintenance personnel, as appropriate, in a clear, consistent and unambiguous manner.
Systems, equipment and controls, including signs and announcements must be designed and located to minimise
errors which could contribute to the creation of hazards.
1.c.5. Design precautions must be taken to minimise the hazards to the aircraft and occupants from reasonably probable
threats, both inside and external to the aircraft, including protecting against the possibility of a significant failure
in, or disruption of, any aircraft appliance.
1.d.1. Instructions for continuing airworthiness must be established to ensure that the aircraft type certification
airworthiness standard is maintained throughout the operational life of the aircraft.
1.d.2. Means must be provided to allow inspection, adjustment, lubrication, removal or replacement of parts and
appliances as necessary for continuing airworthiness.
1.d.3. The instructions for continuing airworthiness must be in the form of a manual, or manuals, as appropriate for the
quantity of data to be provided. The manuals must cover maintenance and repair instructions, servicing
information, trouble-shooting and inspection procedures, in a format that provides for a practical arrangement.
1.d.4. The instructions for continuing airworthiness must contain airworthiness limitations that set forth each
mandatory replacement time, inspection interval and related inspection procedure.
2.a. The following must be shown to have been addressed to ensure a satisfactory level of safety for those onboard or
on the ground during the operation of the product:
2.a.1. The kinds of operation for which the aircraft is approved must be established and limitations and information
necessary for safe operation, including environmental limitations and performance, must be established.
2.a.2. The aircraft must be safely controllable and manoeuvrable under all anticipated operating conditions including
following the failure of one or, if appropriate, more propulsion systems. Due account must be taken of pilot
strength, flight deck environment, pilot workload and other human-factor considerations and of the phase of
flight and its duration.
2.a.3. It must be possible to make a smooth transition from one flight phase to another without requiring exceptional
piloting skill, alertness, strength or workload under any probable operating condition.
2.a.4. The aircraft must have such stability as to ensure that the demands made on the pilot are not excessive taking into
account the phase of flight and its duration.
2.a.5. Procedures for normal operations, failure and emergency conditions must be established.
2.a.6. Warnings, or other deterrents intended to prevent exceedance of the normal flight envelope, must be provided, as
appropriate to type.
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2.a.7. The characteristics of the aircraft and its systems must allow a safe return from extremes of the flight envelope that
may be encountered.
2.b. The operating limitations and other information necessary for safe operation must be made available to the crew
members.
2.c. Product operations must be protected from hazards resulting from adverse external and internal conditions,
including environmental conditions.
2.c.1. In particular, no unsafe condition must occur from exposure to phenomena such as, but not limited to, adverse
weather, lightning, bird strike, high frequency radiated fields, ozone, etc., reasonably expected to occur during
product operation.
2.c.2. Cabin compartments must provide passengers with suitable transport conditions and adequate protection from
any expected hazard arising in flight operations or resulting in emergency situations, including fire, smoke, toxic
gases and rapid decompression hazards. Provisions must be made to give occupants every reasonable chance of
avoiding serious injury and quickly evacuating the aircraft and to protect them from the effect of the deceleration
forces in the event of an emergency landing on land or water. Clear and unambiguous signs or announcements
must be provided, as necessary, to instruct occupants in appropriate safe behaviour and the location and correct
use of safety equipment. Required safety equipment must be readily accessible.
2.c.3. Crew compartments must be arranged in order to facilitate flight operations, including means providing
situational awareness, and management of any expected situation and emergencies. The environment of crew
compartments must not jeopardise the crew's ability to perform their tasks and its design must be such as to avoid
interference during operation and misuse of the controls.
3.a. Organisation approvals must be issued when the following conditions are met:
3.a.1. the organisation must have all the means necessary for the scope of work. These means comprise, but are not
limited to, the following: facilities, personnel, equipment, tools and material, documentation of tasks,
responsibilities and procedures, access to relevant data and record-keeping;
3.a.2. the organisation must implement and maintain a management system to ensure compliance with these essential
requirements for airworthiness, and aim for continuous improvement of this system;
3.a.3. the organisation must establish arrangements with other relevant organisations, as necessary, to ensure continuing
compliance with these essential requirements for airworthiness;
3.a.4. the organisation must establish an occurrence reporting and/or handling system, which must be used by the
management system under point 3.a.2 and the arrangements under point 3.a.3, in order to contribute to the aim
of continuous improvement of the safety of products.
3.b. In the case of maintenance training organisations, the conditions under points 3.a.3 and 3.a.4 do not apply.
L 79/32 EN Official Journal of the European Union 19.3.2008
ANNEX II
Article 4(1), (2) and (3) do not apply to aircraft falling in one or more of the categories set out below:
or
(b) aircraft specifically designed or modified for research, experimental or scientific purposes, and likely to be produced in
very limited numbers;
(c) aircraft of which at least 51 % is built by an amateur, or a non-profit making association of amateurs, for their own
purposes and without any commercial objective;
(d) aircraft that have been in the service of military forces, unless the aircraft is of a type for which a design standard has
been adopted by the Agency;
(e) aeroplanes, helicopters and powered parachutes having no more than two seats, a maximum take-off mass (MTOM),
as recorded by the Member States, of no more than:
(iv) 495 kg for an amphibian or floatplane/helicopter two-seater, provided that, where operating both as a
floatplane/helicopter and as a land plane/helicopter, it falls below both MTOM limits, as appropriate;
(v) 472,5 kg for a land plane, two-seater equipped with an airframe mounted total recovery parachute system;
(vi) 315 kg for a land plane single-seater equipped with an airframe mounted total recovery parachute system;
and, for aeroplanes, having the stall speed or the minimum steady flight speed in landing configuration not exceeding
35 knots calibrated air speed (CAS);
(f) single and two-seater gyroplanes with a maximum take off mass not exceeding 560 kg;
(g) gliders with a maximum empty mass, of no more than 80 kg when single-seater or 100 kg when two-seater, including
those which are foot launched;
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(h) replicas of aircraft meeting the criteria of (a) or (d) above, for which the structural design is similar to the original
aircraft;
(i) unmanned aircraft with an operating mass of no more than 150 kg;
(j) any other aircraft which has a maximum empty mass, including fuel, of no more than 70 kg.
L 79/34 EN Official Journal of the European Union 19.3.2008
ANNEX III
1. Training
1.a. General
1.a.1. A person undertaking training to fly an aircraft must be sufficiently mature educationally, physically and mentally
to acquire, retain and demonstrate the relevant theoretical knowledge and practical skill.
1.b.1. A pilot must acquire and maintain a level of knowledge appropriate to the functions exercised on the aircraft and
proportionate to the risks associated to the type of activity. Such knowledge must include at least the following:
(vi) meteorology;
(vii) navigation;
(xi) non-technical skills, including the recognition and management of threats and errors.
1.c.1. The acquisition and retention of theoretical knowledge must be demonstrated by continuous assessment during
training, and where appropriate, by examinations.
1.c.2. An appropriate level of competence in theoretical knowledge must be maintained. Compliance must be
demonstrated by regular assessments, examinations, tests or checks. The frequency of examinations, tests or checks
must be proportionate to the level of risk associated with the activity.
1.d.1. A pilot must acquire and maintain the practical skills as appropriate to exercise his/her functions on the aircraft.
Such skills must be proportionate to the risks associated to the type of activity and must cover, if appropriate to the
functions exercised on the aircraft, the following:
(i) pre-flight and in-flight activities, including aircraft performance, mass and balance determination, aircraft
inspection and servicing, fuel planning, weather appreciation, route planning, airspace restrictions and
runway availability;
(v) flight manoeuvres, including in critical situations, and associated ‘upset’ manoeuvres, as technically
achievable;
(viii) operational procedures, including team skills and resource management, as appropriate to the type of
operation, whether single or multi-crew;
(ix) navigation and implementation of rules of the air and related procedures, using as appropriate, visual
reference or navigation aids;
(x) abnormal and emergency operations, including simulated aircraft equipment malfunctions;
(xiii) additional practical skill training that may be required to mitigate risks associated with specific activities; and
(xiv) non-technical skills, including the recognition and management of threats and errors, using an adequate
assessment methodology in conjunction with the technical skills assessment.
1.e.1. A pilot must demonstrate the ability to perform the procedures and manoeuvres with a degree of competence
appropriate to the functions exercised on the aircraft, by:
(v) maintaining control of the aircraft at all times in a manner such that the successful outcome of a procedure
or manoeuvre is assured; and
(vi) non-technical skills, including the recognition and management of threats and errors, using an adequate
assessment methodology in conjunction with the technical skills assessment.
1.e.2. An appropriate level of competence in practical skill must be maintained. Compliance must be demonstrated by
regular assessments, examinations, tests or checks. The frequency of examinations, tests or checks must be
proportionate to the level of risk associated with the activity.
A pilot must have demonstrated language proficiency to a degree appropriate to the functions exercised on the
aircraft. Such demonstrated proficiency shall include:
(ii) the use of aeronautical en-route, departure and approach charts and associated aeronautical information
documents; and
(iii) the ability to communicate with other flight crew and air navigation services during all phases of flight,
including flight preparation.
When a flight simulation training device (FSTD) is used for training, or for demonstration that practical skill is
acquired or maintained, this FSTD must be qualified to a given level of performance in those areas, which are
relevant to completing the related task. In particular, the replication of configuration, handling qualities, aircraft
performance, and systems behaviour must adequately represent the aircraft.
1.h. Tr a i n i n g c o u r s e
(ii) the training course must comprise a breakdown of theoretical knowledge and practical flight instruction
(including synthetic training), if applicable.
1.i. Instructors
(i) have appropriate knowledge in the field where instruction is to be given; and
Flight and flight simulation instruction must be given by appropriately qualified instructors, who have the
following qualifications:
(i) meet the theoretical knowledge and the experience requirements appropriate for the instruction being given;
(iii) have practised instructional techniques in those flight manoeuvres and procedures in which it is intended to
provide flight instruction;
(iv) have demonstrated the ability to instruct in those areas in which flight instruction is to be given, including
pre-flight, post-flight and ground instruction; and
(v) receive regular refresher training to ensure that the instructional standards are maintained up to date.
Flight instructors must also be entitled to act as pilot in command on the aircraft for which instruction is being
given, except for training on new aircraft types.
1.j. Examiners
(ii) be capable of assessing pilot performance and conducting flight tests and checks.
2. Experience requirements
2.a.1. A person acting as flight crew member, instructor or examiner must acquire and maintain sufficient experience for
the functions being exercised, unless the implementing rules provide for competence to be demonstrated in
accordance with point 1.e.
3. Training organisations
3.a. Tr a i n i n g o r g a n is a t i o n r e q u i r e m e n t s
3.a.1. A training organisation providing pilot training must meet the following requirements:
(i) have all the means necessary for the scope of responsibilities associated with their activity. These means
comprise, but are not limited to, the following: facilities, personnel, equipment, tools and material,
documentation of tasks, responsibilities and procedures, access to relevant data and record-keeping;
(ii) implement and maintain a management system relating to safety and the standard of training, and aim for
continuous improvement of this system; and
(iii) establish arrangements with other relevant organisations, as necessary, to ensure continuing compliance
with the above requirements.
4. Medical fitness
4.a.1. All pilots must periodically demonstrate medical fitness to satisfactorily execute their functions, taking into
account the type of activity. Compliance must be shown by appropriate assessment based on aero-medical best
practice, taking into account the type of activity and the possible mental and physical degradation due to age.
Medical fitness, comprising physical and mental fitness, means not suffering from any disease or disability, which
makes the pilot unable:
4.a.2. Where medical fitness cannot be fully demonstrated, mitigation measures that provide equivalent flight safety may
be implemented.
(ii) have received training in aviation medicine and regular refresher training in aviation medicine to ensure that
assessment standards are maintained;
(iii) have acquired practical knowledge and experience of the conditions in which pilots carry out their duties.
L 79/38 EN Official Journal of the European Union 19.3.2008
(i) have all the means necessary for the scope of responsibilities associated with their privileges. These means
comprise, but are not limited to, the following: facilities, personnel, equipment, tools and material,
documentation of tasks, responsibilities and procedures, access to relevant data and record-keeping;
(ii) implement and maintain a management system relating to safety and the standard of medical assessment,
and aim for continuous improvement of this system;
(iii) establish arrangements with other relevant organisations, as necessary, to ensure continuing compliance
with these requirements.
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ANNEX IV
1. General
1.a. A flight must not be performed if the crew members and, as appropriate, all other operations personnel involved
in its preparation and execution are not familiar with applicable laws, regulations and procedures, pertinent to the
performance of their duties, prescribed for the areas to be traversed, the aerodromes planned to be used and the air
navigation facilities relating thereto.
1.b. A flight must be performed in such a way that the operating procedures specified in the Flight Manual or, where
required the Operations Manual, for the preparation and execution of the flight are followed. To facilitate this, a
checklist system must be available for use, as applicable, by crew members in all phases of operation of the aircraft
under normal, abnormal and emergency conditions and situations. Procedures must be established for any
reasonably foreseeable emergency situation.
1.c. Before every flight, the roles and duties of each crew member must be defined. The pilot in command must be
responsible for the operation and safety of the aircraft and for the safety of all crew members, passengers and cargo
on board.
1.d. Articles or substances, which are capable of posing a significant risk to health, safety, property or the environment,
such as dangerous goods, weapons and ammunition, must not be carried on any aircraft, unless specific safety
procedures and instructions are applied to mitigate the related risks.
1.e. All necessary data, documents, records and information to record the respect of the conditions specified in point
5.c must be retained for each flight and kept available for a minimum period of time compatible with the type of
operation.
2. Flight preparation
2.a. A flight must not be commenced unless it has been ascertained by every reasonable means available that all the
following conditions are complied with:
2.a.1. Adequate facilities directly required for the flight and for the safe operation of the aircraft, including
communication facilities and navigation aids, are available for the execution of the flight, taking into account
available Aeronautical Information Services documentation.
2.a.2. The crew must be familiar with and passengers informed of the location and use of relevant emergency equipment.
Sufficient related information regarding emergency procedures and use of cabin safety equipment must be made
available to crew and passengers using specified information.
(ii) if required, the aircraft is duly registered and that appropriate certificates with respect thereto are aboard the
aircraft;
(iii) instruments and equipment as specified in point 5 required for the execution of that flight are installed in the
aircraft and are operative, unless waived by the applicable Minimum Equipment List (MEL) or equivalent
document;
(iv) the mass of the aircraft and centre of gravity location are such that the flight can be conducted within limits
prescribed in the airworthiness documentation;
(v) all cabin baggage, hold luggage and cargo is properly loaded and secured; and
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(vi) the aircraft operating limitations as specified in point 4 will not be exceeded at any time during the flight.
2.a.4. Information regarding meteorological conditions for departure, destination and, where applicable, alternate
aerodromes, as well as en-route conditions, must be available to the flight crew. Special attention must be given to
potentially hazardous atmospheric conditions.
2.a.5. In case of flight into known or expected icing conditions, the aircraft must be certified, equipped and/or treated to
operate safely in such conditions.
2.a.6. For a flight based on visual flight rules, meteorological conditions along the route to be flown must be such as to
render compliance with these flight rules possible. For a flight based on instrument flight rules a destination and
where applicable alternate aerodrome(s) where the aircraft can land must be selected, taking into account in
particular the forecasted meteorological conditions, the availability of air navigation services, the availability of
ground facilities and the instrument flight procedures approved by the State in which the destination and/or
alternate aerodrome is located.
2.a.7. The amount of fuel and oil on board must be sufficient to ensure that the intended flight can be completed safely,
taking into account the meteorological conditions, any element affecting the performance of the aircraft and any
delays that are expected in flight. In addition, a fuel reserve must be carried to provide for contingencies.
Procedures for in-flight fuel management must be established when relevant.
3. Flight operations
3.a. With regard to flight operations, all the following conditions must be complied with:
3.a.1. where relevant for the type of aircraft, during take-off and landing, and whenever deemed necessary by the pilot in
command in the interest of safety, each crew member must be seated at their crew station and must use the
provided restraint systems, taking into account the type of aircraft;
3.a.2. where relevant for the type of aircraft, all flight crew members required to be on flight deck duty must be and
remain at their station, with their seatbelts fastened except en-route for physiological or operational needs;
3.a.3. where relevant for the type of aircraft and the type of operation, before take-off and landing, during taxiing and
whenever deemed necessary in the interest of safety, the pilot in command must ensure that each passenger is
properly seated and secured;
3.a.4. a flight must be performed in such a way that appropriate separation from other aircraft is maintained and that
adequate obstacle clearance is ensured, during all phases of the flight. Such separation must at least be those
required by the applicable rules of the air;
3.a.5. a flight must not be continued unless known conditions continue to be at least equivalent to those in point 2.
Furthermore, for a flight based on instrument flight rules, an approach toward an aerodrome must not be
continued below certain specified heights or beyond a certain position, if prescribed visibility criteria are not met;
3.a.6. in an emergency, the pilot in command must ensure that all passengers are instructed in such emergency action as
may be appropriate to the circumstances;
3.a.7. a pilot in command must take all necessary measures so as to minimise the consequences on the flight of
disruptive passenger behaviour;
3.a.8. an aircraft must not be taxied on the movement area of an aerodrome, or its rotor must not be turned under
power, unless the person at the controls is appropriately competent;
3.a.9. the applicable in-flight fuel management procedures must be used, when relevant.
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4.a. An aircraft must be operated in accordance with its airworthiness documentation and all related operating
procedures and limitations as expressed in its approved flight manual or equivalent documentation, as the case
may be. The flight manual or equivalent documentation must be available to the crew and kept up to date for each
aircraft.
4.b. The aircraft must be operated in accordance with the applicable environmental documentation.
4.c. A flight must not be commenced or continued unless the aircraft's scheduled performance, considering all factors
which significantly affect its performance level, allows all phases of flight to be executed within the applicable
distances/areas and obstacle clearances at the planned operating mass. Performance factors which significantly
affect take-off, en-route and approach/landing are, particularly:
(iii) temperature;
(iv) wind;
(vi) the condition of the airframe, the power plant or the systems, taking into account possible deterioration.
4.c.1. Such factors must be taken into account directly as operational parameters or indirectly by means of allowances or
margins, which may be provided in the scheduling of performance data, as appropriate to the type of operation.
5.a. An aircraft must be equipped with all navigation, communication and other equipment necessary for the intended
flight, taking account of air traffic regulations and rules of the air applicable during any phase of the flight.
5.b. When relevant, an aircraft must be equipped with all necessary safety, medical, evacuation and survival equipment,
taking account of the risks associated to the areas of operation, the routes to be flown, the flight altitude and the
duration of the flight.
5.c. All data necessary for the execution of the flight by the crew must be updated and available on board the aircraft
taking account of applicable air traffic regulations, rules of the air, flight altitudes and areas of operation.
6. Continuing airworthiness
(ii) the operational and emergency equipment necessary for the intended flight is serviceable;
(iv) the maintenance of the aircraft is performed in accordance with its maintenance programme.
6.b. Before each flight or consistent series of consecutive flights, the aircraft must be inspected, through a pre-flight
check, to determine whether it is fit for the intended flight.
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6.c. The maintenance programme must contain in particular, maintenance tasks and intervals, especially those that
have been specified as mandatory in the instructions for continuing airworthiness.
6.d. The aircraft must not be operated unless it is released to service by qualified persons or organisations, after
maintenance. The signed release to service must contain in particular, the basic details of the maintenance carried
out.
6.e. All records demonstrating the airworthiness of the aircraft must be kept until the information contained has been
superseded by new information equivalent in scope and detail but not less than 24 months in the case of detailed
maintenance records. When the aircraft is leased, all records demonstrating the airworthiness of the aircraft must
be kept at least for the length of the lease.
6.f. All modifications and repairs must comply with the essential requirements for airworthiness. The substantiating
data supporting compliance with the airworthiness requirements must be retained.
7. Crew members
7.a. The number and composition of the crew must be determined taking into account:
(i) the certification limitations of the aircraft, including if applicable, the relevant emergency evacuation
demonstration;
(i) be trained and checked on a regular basis to attain and maintain an adequate level of competency in order to
perform their assigned safety duties; and
(ii) be periodically assessed for medical fitness to safely exercise their assigned safety duties. Compliance must be
shown by appropriate assessment based on aero-medical best practice.
7.c. The pilot in command must have the authority to give all commands and take any appropriate actions for the
purpose of securing the operation and the safety of the aircraft and of persons and/or property carried therein.
7.d. In an emergency situation, which endangers the operation or the safety of the aircraft and/or persons on board, the
pilot in command must take any action he/she considers necessary in the interest of safety. When such action
involves a violation of local regulations or procedures, the pilot in command must be responsible for notifying the
appropriate local authority without delay.
7.e. Emergency abnormal situations must not be simulated when passengers or cargo are being carried.
7.f. No crew member must allow their task achievement/decision making to deteriorate to the extent that flight safety
is endangered because of the effects of fatigue, taking into account, inter alia, fatigue accumulation, sleep
deprivation, number of sectors flown, night duties or time zone changes. Rest periods must provide sufficient time
to enable crew members to overcome the effects of the previous duties and to be well rested by the start of the
following flight duty period.
7.g. A crew member must not perform allocated duties on board an aircraft when under the influence of psychoactive
substances or alcohol or when unfit due to injury, fatigue, medication, sickness or other similar causes.
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8. Additional requirements for operation for commercial purposes and operation of complex motor-powered aircraft
8.a. The operation for commercial purposes and the operation of complex motor-powered aircraft must not be
undertaken unless the following conditions are met:
8.a.1. the operator must have directly or indirectly through contracts the means necessary for the scale and scope of the
operations. These means comprise but are not limited to the following: aircraft, facilities, management structure,
personnel, equipment, documentation of tasks, responsibilities and procedures, access to relevant data and record
keeping;
8.a.2. the operator must use only suitably qualified and trained personnel and implement and maintain training and
checking programmes for the crew members and other relevant personnel;
8.a.3. the operator must establish a MEL or equivalent document, taking account of the following:
(i) the document must provide for the operation of the aircraft, under specified conditions, with particular
instruments, items of equipment or functions inoperative at the commencement of the flight;
(ii) the document must be prepared for each individual aircraft, taking account of the operator's relevant
operational and maintenance conditions; and
(iii) the MEL must be based on the Master Minimum Equipment List (MMEL), if available, and must not be less
restrictive than the MMEL;
8.a.4. the operator must implement and maintain a management system to ensure compliance with these essential
requirements for operations and aim for continuous improvement of this system; and
8.a.5. the operator must establish and maintain an accident prevention and safety programme, including an occurrence
reporting programme, which must be used by the management system in order to contribute to the aim of
continuous improvement of the safety of operations.
8.b. The operation for commercial purposes and the operation of complex motor-powered aircraft must only be
undertaken in accordance with an operator's operations manual. Such manual must contain all necessary
instructions, information and procedures for all aircraft operated and for operations personnel to perform their
duties. Limitations applicable to flight time, flight duty periods and rest periods for crew members must be
specified. The operations manual and its revisions must be compliant with the approved flight manual and be
amended as necessary.
8.c. The operator must establish procedures, as appropriate, so as to minimise the consequences to safe flight
operations of disruptive passenger behaviour.
8.d. The operator must develop and maintain security programmes adapted to the aircraft and the type of operation
including particularly:
(iv) protection of electronic and computer systems to prevent intentional system interference and corruption;
and
When security measures may adversely affect the safety of operations, the risks must be assessed and appropriate
procedures developed to mitigate safety risks, this may necessitate the use of specialist equipment.
8.e. The operator must designate one pilot amongst the flight crew as the pilot in command.
L 79/44 EN Official Journal of the European Union 19.3.2008
8.f. The prevention of fatigue must be managed through a rostering system. For a flight, or series of flights, such a
rostering system needs to address flight time, flight-duty periods, duty and adapted rest periods. Limitations
established within the rostering system must take into account all relevant factors contributing to fatigue such as,
in particular, number of sectors flown, time-zone crossing, sleep deprivation, disruption of circadian cycles, night
hours, positioning, cumulative duty time for given periods of time, sharing of allocated tasks between crew
members, and also the provision of augmented crews.
8.g. The tasks specified in point 6.a and those described in points 6.d and 6.e must be controlled by an organisation
responsible for the continuing airworthiness management that must meet, in addition to those requirements of
Annex I point 3.a, the following conditions:
(i) the organisation must be qualified for the maintenance of products, parts and appliances under its
responsibility or have established a contract with such a qualified organisation for these products, parts and
appliances; and
(ii) the organisation must establish an organisation manual providing, for use and guidance of personnel
concerned, a description of all continuing airworthiness procedures of the organisation including when
applicable a description of administrative arrangements between the organisation and the approved
maintenance organisation.
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ANNEX V
1. The entity, its Director and the staff responsible for carrying out the checks, may not become involved, either directly
or as authorised representatives, in the design, manufacture, marketing or maintenance of the products, parts,
appliances, constituents or systems or in their operations, service provision or use. This does not exclude the
possibility of an exchange of technical information between the involved organisations and the qualified entity.
2. The entity and the staff responsible for the certification tasks must carry out their duties with the greatest possible
professional integrity and the greatest possible technical competence and must be free of any pressure and incentive,
in particular of a financial type, which could affect their judgment or the results of their investigations, in particular
from persons or groups of persons affected by the results of the certification tasks.
3. The entity must employ staff and possess the means required to perform adequately the technical and administrative
tasks linked with the certification process; it should also have access to the equipment needed for exceptional checks.
— satisfactory knowledge of the requirements of the certification tasks they carry out and adequate experience of
such processes,
— the ability required to draw up the declarations, records and reports to demonstrate that the investigations have
been carried out.
5. The impartiality of the investigation staff must be guaranteed. Their remuneration must not depend on the number of
investigations carried out or on the results of such investigations.
6. The entity must take out liability insurance unless its liability is assumed by one Member State in accordance with its
national law.
7. The staff of the entity must observe professional secrecy with regard to all information acquired in carrying out their
tasks under this Regulation.
L 79/46 EN Official Journal of the European Union 19.3.2008
ANNEX VI
CORRELATION TABLE
Article 1 Article 1
— Article 2(2)(f)
— Article 4(1)(d)
— Article 4(5)
Article 5(2), first subparagraph, introductory wording Article 5(2), first subparagraph, introductory wording
Article 5(2), first subparagraph, points (a) to (c) Article 5(2), first subparagraph, points (a) to (c)
Article 5(2), first subparagraph, point (d) Article 5(2), first subparagraph, points (d) and (e)
Article 5(2), first subparagraph, points (e) and (f) Article 5(2), first subparagraph, points (f) and (g)
— Article 5(3)
Article 5(4), first subparagraph, introductory wording Article 5(5), first subparagraph, introductory wording
Article 5(4), first subparagraph, points (a) to (d) Article 5(5), first subparagraph, points (a) to (d)
Article 5(4), first subparagraph, point (e)(i) to (iii) Article 5(5), first subparagraph, point(e)(i) to (iii)
Article 5(4), first subparagraph, points (f) to (i) Article 5(5), first subparagraph, points (f) to (i)
Article 5(5), first subparagraph, introductory wording Article 5(6), first subparagraph, introductory wording
Article 5(5), first subparagraph, points (a), (b) and (c) Article 5(6), first subparagraph, points (a), (b) and (c)
Article 6 Article 6
— Article 7
— Article 8
— Article 9
— Article 10
19.3.2008 EN Official Journal of the European Union L 79/47
— Article 11(6)
Article 9 Article 12
— Article 13
— Article 14(2)
Article 11 Article 15
— Article 16
Article 12 Article 17
— Article 18(b)
— Article 18(e)
Article 14 Article 19
— Article 21
— Article 22
— Article 23
— Article 24(3)
— Article 25
Article 17 Article 26
Article 18 Article 27
Article 19 Article 28
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Article 20 Article 29
Article 21 Article 30
Article 22 Article 31
Article 23 Article 32
— Article 33(5)
— Article 34(3)
Article 26 Article 35
Article 27 Article 36
Article 28 Article 37
Article 30 Article 39
Article 31 Article 40
Article 32 Article 41
Article 33 Article 42
Article 34 Article 43
Article 35 Article 44
Article 36 Article 45
Article 37 Article 46
Article 38 Article 47
Article 39 Article 48
Article 40 Article 49
Article 41 Article 50
Article 42 Article 51
Article 43 Article 52
Article 44 Article 53
Article 45 Article 54
— Article 55(1)(e)
— Article 56
— Article 57
Article 47(3) —
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Article 47(5) —
— Article 58(4)
— Article 59(1)(e)
Article 59(4)
Article 49 Article 60
Article 50 Article 61
Article 51 Article 62
Article 52 Article 63
Article 53 Article 64
Article 54 Article 65
Article 55 Article 66
Article 56 Article 67
— Article 68
Article 57 Article 69
Article 59 Article 70