Article 1
Regulation (EC) No 216/2008 is hereby amended as follows:
1. Article 1 is replaced by the following:

Scope
Article 1
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;
c
the design, maintenance and operation of aerodromes, as well as personnel and organisations involved therein and, without prejudice to Community and national legislation on environment and land-use planning, the safeguarding of surroundings of aerodromes;
d
the design, production and maintenance of aerodrome equipment, as well as personnel and organisations involved therein;
e
the design, production and maintenance of systems and constituents for air traffic management and air navigation services (ATM/ANS), as well as personnel and organisations involved therein;
f
ATM/ANS, as well as personnel and organisations involved therein.
2
This Regulation shall not apply to:
a
products, parts, appliances, personnel and organisations referred to in paragraph 1(a) and (b) while carrying out military, customs, police, search and rescue, firefighting, coastguard or similar activities or services. The Member States shall undertake to ensure that such activities or services have due regard as far as practicable to the objectives of this Regulation;
b
aerodromes or part thereof, as well as equipment, personnel and organisations, referred to in paragraph 1(c) and (d), that are controlled and operated by the military;
c
ATM/ANS, including systems and constituents, personnel and organisations, referred to in paragraph 1(e) and (f), that are provided or made available by the military. The Member States shall undertake to ensure that aircraft referred to in point (a) of this paragraph are separated, where appropriate, from other aircraft.
3
Member States shall, as far as practicable, ensure that any military facilities open to public use referred to in paragraph 2(b) or services provided by military personnel to the public referred to in paragraph 2(c), offer a level of safety that is at least as effective as that required by the essential requirements as defined in Annexes Va and Vb.
;
2. Article 3 is amended as follows:
  1. point (d) is replaced by the following:
    1. “parts and appliances” shall mean any instrument, equipment, mechanism, part, apparatus, appurtenance, software or accessory, including communications equipment, that is used or intended to be used in operating or controlling an aircraft in flight; it shall include parts of an airframe, engine or propeller, or equipment used to manoeuvre the aircraft from the ground;
;
  2. the following point is inserted:
    1. “ATM/ANS constituents” shall mean any constituent as defined in Article 2(19) of Regulation (EC) No 549/2004 of the European Parliament and of the Council of 10 March 2004 laying down the framework for the creation of the single European sky (the framework Regulation) ;
;
  3. point (h) is replaced by the following:
    1. “operator” shall mean any legal or natural person, operating or proposing to operate one or more aircraft or one or more aerodromes;
;
  4. the following points are added:
    1. “aerodrome” shall mean a defined area (including any buildings, installations and equipment) on land or water or on a fixed, fixed offshore or floating structure intended to be used either wholly or in part for the arrival, departure and surface movement of aircraft;
    2. “aerodrome equipment” shall mean any equipment, apparatus, appurtenance, software or accessory, that is used or intended to be used to contribute to the operation of aircraft at an aerodrome;
    3. “apron” shall mean a defined area intended to accommodate aircraft for purposes of loading or unloading passengers, mail or cargo, fuelling, parking or maintenance;
    4. “apron management service” shall mean a service provided to manage the activities and the movement of aircraft and vehicles on an apron;
    5. “ATM/ANS” shall mean the air traffic management functions as defined in Article 2(10) of Regulation (EC) No 549/2004, air navigation services defined in Article 2(4) of that Regulation, and services consisting in the origination and processing of data and formatting and delivering data to general air traffic for the purpose of safety-critical air navigation;
    6. “ATM/ANS system” shall mean any combination of safety-related equipment and systems as defined in Article 2(39) of Regulation (EC) No 549/2004;
    7. “flight information service” shall mean a service provided for the purpose of giving advice and information useful for the safe and efficient conduct of flights.
;
3. in Article 4, the following paragraphs are inserted:
3a.
Aerodromes, including equipment, located in the territory subject to the provisions of the Treaty, open to public use and which serve commercial air transport and where operations using instrument approach or departure procedures are provided, and:
a
have a paved runway of 800 metres or above; or
b
exclusively serve helicopters;
shall comply with this Regulation. Personnel and organisations involved in the operation of these aerodromes shall comply with this Regulation.
3b
By way of derogation from paragraph 3a, Member States may decide to exempt from the provisions of this Regulation an aerodrome which:
  - handles no more than 10 000 passengers per year, and
  - handles no more than 850 movements related to cargo operations per year.
If such exemption by a Member State does not comply with the general safety objectives of this Regulation or any other rule of Community law, the Commission shall take a decision in accordance with the safeguard procedure referred to in Article 65(7) not to permit the exemption in question. In such a case, the Member State concerned shall revoke the exemption.
3c
ATM/ANS provided in the airspace of the territory to which the Treaty applies, as well as in any other airspace where Member States apply Regulation (EC) No 551/2004 of the European Parliament and of the Council of 10 March 2004 on the organisation and use of the airspace in the single European sky (the airspace Regulation) in accordance with Article 1(3) of that Regulation, shall comply with this Regulation. Systems and constituents, personnel and organisations involved in the provision of these ATM/ANS shall comply with this Regulation.
;
4. in Article 5, paragraph 2, points (b) and (c) are replaced by the following:
  1. the measures referred to in paragraph 5 may lay down a requirement for certification in respect of parts and appliances. The certificates for parts and appliances shall be issued when the applicant has shown that the parts and appliances comply with the detailed airworthiness specifications established to ensure compliance with the essential requirements referred to in paragraph 1;
  2. no aircraft shall be operated, unless it has a valid certificate of airworthiness. The certificate shall be issued when the applicant has shown that the aircraft conforms to 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 adopted pursuant to paragraph 5;
;
5. in Article 7, paragraph 4 is replaced by the following:
4.
A certificate shall be required in respect of each flight simulation training device used for the training of pilots. The certificate shall be issued when the applicant has shown that the device complies with the rules established to ensure compliance with the relevant essential requirements as set out in Annex III.
;
6. Article 8 is amended as follows:
  1. paragraph 1 is replaced by the following:
1.
The operation of aircraft referred to in Article 4(1)(b) and (c) shall comply with the essential requirements set out in Annex IV and, if applicable, Annex Vb.
;
  2. paragraph 5 is amended as follows:
    1. point (a) is replaced by the following:
      1. conditions to operate an aircraft in compliance with the essential requirements set out in Annex IV and, if applicable, Annex Vb;
;
    2. point (g) is replaced by the following:
      1. how operations of aircraft referred to in point (a)(ii) and points (d) and (h) of Annex II, when used for commercial air transportation, comply with the relevant essential requirements set out in Annex IV and, if applicable, Annex Vb.
;
  3. in paragraph 6, the following indent is added:
    - take into account the safety aspects related to ATM/ANS,
;
7. the following Articles are inserted:

Aerodromes
Article 8a
1
Aerodromes and aerodrome equipment as well as the operation of aerodromes shall comply with the essential requirements set out in Annex Va and, if applicable, Annex Vb.
2
The compliance of aerodromes, aerodrome equipment and operation of aerodromes with the essential requirements shall be established in accordance with the following:
a
a certificate shall be required in respect of each aerodrome. The certificate and certification of changes to that certificate shall be issued when the applicant has shown that the aerodrome complies with the aerodrome certification basis set out in point (b), and that the aerodrome has no feature or characteristic making it unsafe for operation. The certificate shall cover the aerodrome, its operation and its safety-related equipment;
b
the certification basis for an aerodrome shall consist of the following:
  1. the applicable certification specifications related to the type of aerodromes;
  2. the provisions for which an equivalent level of safety has been accepted; and
  3. the special detailed technical specifications necessary when the design features of a particular aerodrome or the experience in operation render any of the specifications referred to in point (i) inadequate or inappropriate to ensure conformity with the essential requirements set out in Annex Va;
c
the measures referred to in paragraph 5 may lay down a requirement of certification in respect of safety-critical aerodrome equipment. The certificate for such equipment shall be issued when the applicant has shown that the equipment complies with the detailed specifications established to ensure compliance with the essential requirements referred to in paragraph 1;
d
organisations responsible for the operation of aerodromes shall demonstrate their capability and means to discharge the responsibilities associated with their privileges. These capabilities and means shall be recognised through the issuance of the certificate referred to in point (a). They may also be recognised through the issuance of a separate certificate if the Member State where the aerodrome is located so decides. The privileges granted to the certified organisation and the scope of the certificate, including a list of aerodromes to be operated, shall be specified in the certificate;
e
by way of derogation from point (d), Member States may decide that providers of apron management services shall be allowed to declare their capability and means of discharging the responsibilities associated with the services provided.
3
Member States shall ensure that provisions are in place to safeguard aerodromes against activities and developments in their surroundings which may cause unacceptable risks to aircraft using the aerodrome.
4
Aerodrome operators shall monitor activities and developments which may cause unacceptable safety risks to aviation in the aerodrome surroundings and take, within their competence, mitigating measures as appropriate.
5
The measures designed to amend non-essential elements of the requirements referred to in 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 conditions for establishing and notifying to an applicant the certification basis applicable to an aerodrome;
b
the conditions for establishing and notifying to an applicant the detailed specifications applicable to aerodrome equipment;
c
the conditions for issuing, maintaining, amending, suspending or revoking certificates for aerodromes and certificates for aerodrome equipment, including operating limitations related to the specific design of the aerodrome;
d
the conditions for operating an aerodrome in compliance with the essential requirements set out in Annex Va and, if applicable, Annex Vb;
e
the conditions for issuing, maintaining, amending, suspending or revoking the certificates referred to in paragraph 2(d);
f
the responsibilities of the holders of certificates;
g
the conditions for the acceptance and for the conversion of aerodrome certificates issued by Member States, including measures which are already authorised by the Member State concerned on the basis of notified deviations from Annex 14 of the Chicago Convention before the entry into force of this Regulation;
h
the conditions for the decision not to permit exemptions referred to in Article 4(3b), including criteria for cargo aerodromes, the notification of exempted aerodromes and for the review of granted exemptions;
i
the conditions under which operations shall be prohibited, limited or subject to certain conditions in the interest of safety;
j
the conditions and procedures for the declaration by and for the oversight of service providers referred to in paragraph 2(e).
6
The measures referred to in paragraph 5 shall:
a
reflect the state of the art and the best practices in the field of aerodromes and take into account the applicable ICAO Standards and Recommended Practices;
b
be proportionate to the size, traffic, category and complexity of the aerodrome and nature and volume of operations thereon;
c
take into account worldwide aerodrome operation experience, and scientific and technical progress;
d
allow for immediate reaction to established causes of accidents and serious incidents;
e
provide for the necessary flexibility for customised compliance.

ATM/ANS
Article 8b
1
Provision of ATM/ANS shall comply with the essential requirements set out in Annex Vb and, as far as practicable, Annex Va.
2
ATM/ANS providers shall be required to hold a certificate. The certificate shall be issued when the provider has demonstrated its capability and means of discharging the responsibilities associated with the provider’s privileges. The privileges granted and the scope of the services provided shall be specified in the certificate.
3
By way of derogation from paragraph 2, Member States may decide that providers of flight information services shall be allowed to declare their capability and means of discharging the responsibilities associated with the services provided.
4
The measures referred to in paragraph 6 may lay down a requirement for certification in respect of organisations engaged in the design, manufacture and maintenance of safety-critical ATM/ANS systems and constituents. The certificate for those organisations shall be issued when they have demonstrated their capability and means of discharging the responsibilities associated with their privileges. The privileges granted shall be specified in the certificate.
5
The measures referred to in paragraph 6 may lay down a requirement for certification, or alternatively, validation by the ATM/ANS provider, in respect of safety-critical ATM/ANS systems and constituents. The certificate for those systems and constituents shall be issued, or validation shall be given, when the applicant has shown that the systems and constituents comply with the detailed specifications established to ensure compliance with the essential requirements referred to in paragraph 1.
6
The measures necessary for the implementation of this Article shall be adopted in accordance with the regulatory procedure referred to in Article 5(3) of Regulation (EC) No 549/2004.
Those measures shall specify in particular:
a
the conditions for the provision of ATM/ANS in compliance with the essential requirements set out in Annex Vb and, if applicable, in Annex Va;
b
the conditions for establishing and notifying to an applicant the detailed specifications applicable to ATM/ANS systems and constituents;
c
the conditions for issuing, maintaining, amending, suspending or revoking the certificates referred to in paragraphs 2 and 4;
d
the responsibilities of the holders of certificates;
e
the conditions and procedures for the declaration by, and for the oversight of service providers referred to in paragraph 3;
f
the conditions under which operations shall be prohibited, limited or subject to certain conditions in the interest of safety.
7
The measures referred to in paragraph 6 shall:
a
reflect the state of the art and the best practices in the field of ATM/ANS;
b
be proportionate to the type and complexity of the services provided;
c
take into account worldwide ATM/ANS experience, and scientific and technical progress;
d
be developed using as far as practicable the relevant provisions of Regulation (EC) No 549/2004 and of Regulation (EC) No 550/2004 of the European Parliament and of the Council of 10 March 2004 on the provision of air navigation services in the single European sky (the service provision Regulation) , Regulation (EC) No 551/2004 and Regulation (EC) No 552/2004 of the European Parliament and of the Council of 10 March 2004 on the interoperability of the European Air Traffic Management network (the interoperability Regulation) and provide for transitional mechanisms to ensure the continuity of certificates already granted under those Regulations; initially they shall include the safety provisions of those Regulations and, where appropriate, in case of future amendments, take into account latest scientific and technical progress;
e
allow for immediate reaction to established causes of accidents and serious incidents.

Air traffic controllers
Article 8c
1
Air traffic controllers as well as persons and organisations involved in the training, testing, checking or medical assessment of air traffic controllers, shall comply with the relevant essential requirements set out in Annex Vb.
2
Air traffic controllers shall be required to hold a licence and a medical certificate appropriate to the service provided.
3
The licence referred to in paragraph 2 shall only be issued when the applicant for the licence demonstrates that he or she complies with the rules established to ensure compliance with the essential requirements regarding theoretical knowledge, practical skill, language proficiency and experience as set out in Annex Vb.
4
The medical certificate referred to in paragraph 2 shall only be issued when the air traffic controller complies with the rules established to ensure compliance with the essential requirements on medical fitness as set out in Annex Vb. The medical certificate may be issued by aero medical examiners or by aero medical centres.
5
The privileges granted to the air traffic controller and the scope of the licence and the medical certificate shall be specified in such licence and certificate.
6
The capability of air traffic controller training organisations, aero medical examiners and aero medical centres to discharge the responsibilities associated with their privileges in relation to the issuance of licences and medical certificates shall be recognised by the issuance of a certificate.
7
A certificate shall be issued to training organisations, aero medical examiners and aero medical centres for air traffic controllers that have demonstrated that they comply with the rules established to ensure compliance with the relevant essential requirements as set out in Annex Vb. The privileges granted by the certificate shall be specified therein.
8
Persons responsible for providing practical training or for assessing air traffic controllers’ skill shall hold a certificate. The certificate shall be issued when the person concerned has demonstrated that he or she complies with the rules established to ensure compliance with the relevant essential requirements as set out in Annex Vb. The privileges granted by the certificate shall be specified therein.
9
Synthetic training devices shall comply with the relevant essential requirements set out in Annex Vb.
10
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 and endorsements for air traffic controllers’ licences;
b
the conditions for issuing, maintaining, amending, limiting, suspending or revoking licences, ratings and endorsements for licences, medical certificates, approvals and certificates, and the conditions under which such certificates and approvals need not be requested, while providing for transitional mechanisms to ensure the continuity of approvals and certificates already granted;
c
the privileges and responsibilities of the holders of licences, ratings and endorsements for licences, medical certificates, approvals and certificates;
d
the conditions for the acceptance and for the conversion of air traffic controllers’ licences as well as the conditions for the acceptance and for the conversion of national medical certificates into commonly recognised medical certificates.
11
The measures referred to in paragraph 10 shall reflect the state of the art, including best practices and scientific and technical progress, in the field of air traffic controller training. They shall initially be developed on the basis of the provisions of Directive 2006/23/EC of the European Parliament and of the Council of 5 April 2006 on a Community air traffic controller licence .
;
8. Article 9 is amended as follows:
  1. paragraph 1 is replaced by the following:
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 set out in Annexes I, III, IV and, if applicable, Annex Vb, provided these requirements are not in conflict with the rights of third countries under international conventions.
;
  2. in paragraph 5, the following point is added:
    1. safety aspects related to ATM/ANS are taken into account.
;
9. in Article 10, paragraph 1 is replaced by the following:
1.
The Member States, the Commission and the Agency shall cooperate with a view to ensuring compliance with this Regulation and its implementing rules.
;
10. Article 11 is amended as follows:
  1. paragraphs 4 and 5 are replaced by the following:
4.
Pending the entry into effect of the measures referred to in Articles 5(5), 7(6) and 9(4) and the expiry of any transition periods provided for by those measures, 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 the entry into effect of the measures referred to in Article 8(5) and the expiry of any transition periods provided for by those measures, 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.
;
  2. the following paragraphs are inserted:
5a.
Pending the entry into effect of the measures referred to in Articles 8a(5) and 8c(10) and the expiry of any transition periods provided for by those measures, 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.
5b
Pending the entry into effect of the measures referred to in Article 8b(6) and the expiry of any transition periods provided for by those measures, 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 Commission Regulation (EC) No 2096/2005 of 20 December 2005 laying down common requirements for the provision of air navigation services .
;
11. in Article 13, the following paragraph is added:
Qualified entities shall not issue certificates.
;
12. in Article 18, points (c) and (d) are replaced by the following:
  1. issue certification specifications and acceptable means of compliance, as well as any guidance material for the application of this Regulation and its implementing rules;
  2. take the appropriate decisions for the application of Articles 20, 21, 22, 22a, 22b, 23, 54 and 55 including the granting of exemptions to holders of certificates it has issued, 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 that the level of safety is not affected, that they are granted for a period not exceeding two months, that they are notified to the Commission and that they are not renewed;
;
13. in Article 19(2), point (a) is replaced by the following:
  1. certification specifications and acceptable means of compliance; and
;
14. the following Articles are inserted:

ATM/ANS
Article 22a
With regard to ATM/ANS referred to in Article 4(3c) the Agency shall:
  1. conduct, itself or through national aviation authorities or qualified entities, inspections, and audits of the organisations it certifies;
  2. issue and renew certificates of organisations located outside the territory subject to the provisions of the Treaty, responsible for providing services in the airspace of the territory to which the Treaty applies;
  3. issue and renew certificates of organisations providing pan-European services;
  4. amend, suspend or revoke the relevant certificate, when the conditions according to which it was issued are no longer fulfilled or if the holder of the certificate fails to fulfil the obligations imposed on it by this Regulation or by its implementing rules.

Air traffic controller certification
Article 22b
With regard to the persons and organisations referred to in Article 8c(1), the Agency shall:
  1. conduct, itself or through national aviation authorities or qualified entities, investigations and audits of the organisations it certifies and, where relevant, their personnel;
  2. issue and renew the certificates of air traffic controller training organisations located outside the territory of the Member States and, where relevant, their personnel;
  3. amend, 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.
;
15. in Article 33(2)(c), the date ‘30 September’ is replaced by ‘30 November’;
16. in Article 44, paragraph 1 is replaced by the following:
1.
An appeal may be brought against decisions of the Agency taken pursuant to Articles 20, 21, 22, 22a, 22b, 23, 55 or 64.
;
17. in Article 50, paragraph 2 is replaced by the following:
2.
Actions for the annulment of decisions of the Agency taken pursuant to Articles 20, 21, 22, 22a, 22b, 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.
;
18. Article 52 is amended as follows:
  1. in paragraph 1, the first subparagraph is replaced by the following:
As soon as possible after the entry into force of this Regulation, the Management Board shall establish transparent procedures for issuing opinions, certification specifications, acceptable means of compliance and guidance material referred to in Article 18(a) and(c).
;
  2. paragraph 2 is replaced by the following:
2.
When the Agency, pursuant to Article 19, develops opinions, certification specifications, acceptable means of compliance 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.
;
19. in Article 55, paragraph 1, the first sentence is replaced by the following:
‘The Agency may itself conduct or assign to national aviation authorities or qualified entities all necessary investigations of undertakings in accordance with Articles 7, 20 21, 22, 22a, 22b 23 and 24(2).’;
20. the following Article is inserted:

Amendments
Article 65a
In accordance with the provisions of the Treaty, the Commission shall propose to amend Regulations (EC) No 549/2004, (EC) No 550/2004, (EC) No 551/2004 and (EC) No 552/2004 in order to take into account the requirements of this Regulation.
;
21. the title of Annex V is replaced by the following:

Criteria for qualified entities referred to in Article 13 (“qualified entity” or “entity”)
;
22. Annexes Va and Vb as set out in the Annex to this Regulation are inserted.
OJ L 96, 31.3.2004, p. 1.’;
OJ L 96, 31.3.2004, p. 20.’;
OJ L 96, 31.3.2004, p. 10.
OJ L 96, 31.3.2004, p. 26.
OJ L 114, 27.4.2006, p. 22.’;
OJ L 335, 21.12.2005, p. 13.’;