EN Official Journal of the European Union L 296/1

COMMISSION REGULATION (EU) No 965/2012

of 5 October 2012

laying down technical requirements and administrative procedures related to air operations pursuant to Regulation (EC) No 216/2008 of the European Parliament and of the Council

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EC) No 216/2008 of the European Parliament and of the Council of 20 February 2008 on common rules in the field of civil aviation and establishing a European Aviation Safety Agency, and repealing Council Directive 91/670/EEC, Regulation (EC) No 1592/2002 and Directive 2004/36/EC (1), and in particular Articles 8(5) and 10(5) thereof,

Whereas:

(1) Operators and personnel involved in the operation of certain aircraft have to comply with the relevant essential requirements set out in Annex IV to Regulation (EC) No 216/2008.

(2) Regulation (EC) No 216/2008 requires that Member States, in addition to their oversight of certificates that they have issued, conduct investigations, including ramp inspections, and shall take any measure, including the grounding of aircraft, to prevent the continuation of an infringement.

(3) In accordance with Regulation (EC) No 216/2008 the Commission should adopt the necessary implementing rules for establishing the conditions for the safe operation of aircraft.

(4) In order to ensure a smooth transition and a high level of civil aviation safety in the European Union, implementing measures should reflect the state of the art, including best practices, and scientific and technical progress in the field of air operations. Accordingly, technical requirements and administrative procedures agreed under the auspices of the International Civil Aviation Organisation (hereinafter ‘ICAO’) and the European Joint Aviation Authorities until 30 June 2009, as well as existing legislation pertaining to a specific national environment, should be considered.

(5) It is necessary to provide sufficient time for the aeronautical industry and Member State administrations to adapt to the new regulatory framework and to recognise under certain conditions the validity of certificates issued before this Regulation applies.

(6) As this Regulation constitutes an implementing measure referred to in Articles 8(5) and 10(5) of Regulation (EC) No 216/2008, Annex III to Council Regulation (EEC) No 3922/91 (2) and Directive 2004/36/EC of the European Parliament and of the Council (3) shall be considered repealed in accordance with Article 69(3) and 69(5) of Regulation (EC) No 216/2008. However, Annex III should remain in place temporarily until the transitional periods foreseen in this Regulation have expired and for those areas for which no implementing measures have yet been adopted. Similarly, Directive 2004/36/EC should remain applicable temporarily until the transitional periods foreseen in this Regulation have expired.

(7) The European Aviation Safety Agency prepared draft implementing rules and submitted them as an opinion to the Commission in accordance with Article 19(1) of Regulation (EC) No 216/2008.

(8) The measures provided for in this Regulation are in accordance with the opinion of the Committee established by Article 65 of Regulation (EC) No 216/2008,

HAS ADOPTED THIS REGULATION:

Article 1

Subject matter and scope

1. This Regulation lays down detailed rules for commercial air transport operations with aeroplanes and helicopters, including ramp inspections of aircraft of operators under the safety oversight of another State when landed at aerodromes located in the territory subject to the provisions of the Treaty.

2. This Regulation also lays down detailed rules on the conditions for issuing, maintaining, amending, limiting, suspending or revoking the certificates of operators of aircraft referred to in Article 4(1)(b) and (c) of Regulation (EC) No 216/2008 engaged in commercial air transport operations, the privileges and responsibilities of the holders of certificates as well as conditions under which operations shall be prohibited, limited or subject to certain conditions in the interest of safety.

3. This Regulation shall not apply to air operations within the scope of Article 1(2)(a) of Regulation (EC) No 216/2008.

Article 2

Definitions

For the purposes of this Regulation:

(1) ‘commercial air transport (CAT) operation’ means an aircraft operation to transport passengers, cargo or mail for remuneration or other valuable consideration;

(2) ‘performance class B aeroplanes’ means aeroplanes powered by propeller engines with a maximum operational passenger seating configuration of nine or less and a maximum take-off mass of 5 700 kg or less;

(3) ‘public interest site (PIS)’ means a site used exclusively for operations in the public interest;

(4) ‘operation in performance class 1’ means an operation that, in the event of failure of the critical engine, the helicopter is able to land within the rejected take-off distance available or safely continue the flight to an appropriate landing area, depending on when the failure occurs.

Additional definitions are laid down in Annex I for the purposes of Annexes II to V.

Article 3

Oversight capabilities

1. Member States shall designate one or more entities as the competent authority within that Member State with the necessary powers and allocated responsibilities for the certification and oversight of persons and organisations subject to Regulation (EC) No 216/2008 and its implementing rules.

2. If a Member State designates more than one entity as competent authority:

(a) the areas of competence of each competent authority shall be clearly defined in terms of responsibilities and geographic limitation; and

(b) coordination shall be established between those entities to ensure effective oversight of all organisations and persons subject to Regulation (EC) No 216/2008 and its implementing rules within their respective remits.

3. Member States shall ensure that the competent authority(ies) has(ve) the necessary capability to ensure the oversight of all persons and organisations covered by their oversight programme, including sufficient resources to fulfil the requirements of this Regulation.

4. Member States shall ensure that competent authority personnel do not perform oversight activities when there is evidence that this could result directly or indirectly in a conflict of interest, in particular when relating to family or financial interest.

5. Personnel authorised by the competent authority to carry out certification and/or oversight tasks shall be empowered to perform at least the following tasks:

(a) examine the records, data, procedures and any other material relevant to the execution of the certification and/or oversight task;

(b) take copies of or extracts from such records, data, procedures and other material;

(c) ask for an oral explanation on site;

(d) enter relevant premises, operating sites or means of transport;

(e) perform audits, investigations, assessments, inspections, including ramp inspections and unannounced inspections;

(f) take or initiate enforcement measures as appropriate.

6. The tasks under paragraph 5 shall be carried out in compliance with the legal provisions of the relevant Member State.

Article 4

Ramp inspections

Ramp inspections of aircraft of operators under the safety oversight of another Member State or of a third country shall be carried out in accordance with Subpart RAMP of Annex II.

Article 5

Air operations

1. Operators shall only operate an aircraft for the purpose of commercial air transport (hereinafter ‘CAT’) operations as specified in Annexes III and IV.

2. CAT operators shall comply with the relevant provisions of Annex V when operating:

(a) aeroplanes and helicopters used for: (i) operations using performance-based navigation (PBN); (ii) operations in accordance with minimum navigation performance specifications (MNPS); (iii) operations in airspace with reduced vertical separation minima (RVSM); (iv) low visibility operations (LVO);

(b) aeroplanes and helicopters used for the transport of dangerous goods (DG);

(c) two-engined aeroplanes used for extended range operations (ETOPS) in commercial air transport;

(d) helicopters used for commercial air transport operations with the aid of night vision imaging systems (NVIS);

(e) helicopters used for commercial air transport hoist operations (HHO); and

(f) helicopters used for commercial air transport emergency medical service operations (HEMS).

Article 6

Derogations

1. CAT operations starting and ending at the same aerodrome/operating site with performance class B aeroplanes or non-complex helicopters shall not be subject to compliance with Annexes III and IV.

However, they shall be subject to the following:

(a) for aeroplanes, Annex III to Regulation (EEC) No 3922/91 and related national exemptions based on safety risk assessments carried out by the competent authorities;

(b) for helicopters, national requirements.

2. By way of derogation from Article 5(1), aircraft referred to in Article 4(5) of Regulation (EC) No 216/2008 shall be operated under the conditions set out in Commission Decision C(2009) 7633 of 14 October 2009 when used in CAT operations. Any change to the operation that affects the conditions set out in that Decision shall be notified to the Commission and the European Aviation Safety Agency (hereinafter ‘the Agency’) before the change is implemented.

A Member State, other than an addressee of Decision C(2009)7633, which intends to use the derogation provided for in that Decision shall notify its intention to the Commission and the Agency before the derogation is implemented. The Commission and the Agency shall assess to what extent the change or the intended use deviates from the conditions of Decision C(2009)7633 or impacts on the initial safety assessment performed in the context of that Decision. If the assessment shows that the change or the intended use does not correspond to the initial safety assessment done for Decision C(2009)7633, the Member State concerned shall submit a new derogation request in accordance with Article 14(6) of Regulation (EC) No 216/2008.

3. By way of derogation from Article 5(1), flights related to the introduction or modification of aircraft types conducted by design or production organisations within the scope of their privileges shall continue to be operated under the conditions set out in Member States’ national law.

4. Notwithstanding Article 5, Member States may continue to require a specific approval and additional requirements regarding operational procedures, equipment, crew qualification and training for CAT helicopter offshore operations in accordance with their national law. Member States shall notify the Commission and the Agency of the additional requirements being applied to such specific approvals. These requirements shall not be less restrictive than those of Annexes III and IV.

5. By way of derogation from CAT.POL.A.300(a) of Annex IV, single-engined aeroplanes, when used in CAT operations, shall be operated at night or in instrument meteorological conditions (IMC) under the conditions set out in the existing exemptions granted by Member States in accordance with Article 8(2) of Regulation (EEC) No 3922/91.

Any change to the operation of these aeroplanes that affects the conditions set out in those exemptions shall be notified to the Commission and the Agency before the change is implemented. The Commission and the Agency shall assess the proposed change in accordance with Article 14(5) of Regulation (EC) No 216/2008.

6. Existing helicopter operations to/from a public interest site (PIS) may be conducted in derogation to CAT.POL.H.225 of Annex IV whenever the size of the PIS, the obstacle environment or the helicopter does not permit compliance with the requirements for operation in performance class 1. Such operations shall be conducted under conditions determined by Member States. Member States shall notify the Commission and the Agency of the conditions being applied.

Article 7

Air operator certificates

1. Air operator certificates (AOCs) issued by a Member State to CAT operators of aeroplanes before this Regulation applies in accordance with Regulation (EEC) No 3922/91 shall be deemed to have been issued in accordance with this Regulation.

However, no later than 28 October 2014:

(a) operators shall adapt their management system, training programmes, procedures and manuals to be compliant with Annexes III, IV and V, as relevant;

(b) the AOC shall be replaced by certificates issued in accordance with Annex II to this Regulation.

2. AOCs issued by a Member State to CAT operators of helicopters before this Regulation applies shall be converted into AOCs compliant with this Regulation in accordance with a conversion report established by the Member State that issued the AOC, in consultation with the Agency.

The conversion report shall describe:

(a) the national requirements on the basis of which the AOCs were issued;

(b) the scope of privileges that were given to the operators;

(c) the differences between the national requirements on the basis of which the AOCs were issued and the requirements of Annexes III, IV and V, together with an indication of how and when the operators will be required to ensure full compliance with those Annexes.

The conversion report shall include copies of all documents necessary to demonstrate the elements set out in points (a) to (c), including copies of the relevant national requirements and procedures.

Article 8

Flight time limitations

Flight and duty time limitations shall be subject to the following:

(a) for aeroplanes, Article 8(4) and Subpart Q of Annex III to Regulation (EEC) No 3922/91;

(b) for helicopters, national requirements.

Article 9

Minimum equipment lists

Minimum equipment lists (MEL) approved before this Regulation applies by the State of Operator or Registry, as applicable, are deemed to be approved in accordance with this Regulation and may continue to be used by the operator having received the approval.

After this Regulation applies, any change of the MEL shall be carried out in compliance with ORO.MLR.105 of Annex III.

Article 10

Entry into force

1. This Regulation shall enter into force on the third day following that of its publication in the Official Journal of the European Union.

It shall apply from 28 October 2012.

2. By way of derogation from the second subparagraph of paragraph 1, Member States may decide not to apply the provisions of Annexes I to V until 28 October 2014.

When a Member State makes use of that possibility, it shall notify the Commission and the Agency. This notification shall describe the reasons for such derogation and its duration as well as the programme for implementation containing actions envisaged and related timing.

This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 5 October 2012. For the Commission The President José Manuel BARROSO

(1) OJ L 79, 19.3.2008, p. 1.

(2) OJ L 373, 31.12.1991, p. 4.

(3) OJ L 143, 30.4.2004, p. 76.

ANNEX I Definitions for terms used in Annexes II to V For the purpose of this Regulation, the following definitions shall apply: (1) ‘accelerate-stop distance available (ASDA)’ means the length of the take-off run available plus the length of stopway, if such stopway is declared available by the State of the aerodrome and is capable of bearing the mass of the aeroplane under the prevailing operating conditions; (2) ‘acceptable means of compliance (AMC)’ means non-binding standards adopted by the Agency to illustrate means to establish compliance with Regulation (EC) No 216/2008 and its Implementing Rules; (3) ‘acceptance checklist’ means a document used to assist in carrying out a check on the external appearance of packages of dangerous goods and their associated documents to determine that all appropriate requirements have been met with; (4) ‘adequate aerodrome’ means an aerodrome on which the aircraft can be operated, taking account of the applicable performance requirements and runway characteristics; (5) For the purpose of passenger classification: (a) ‘adult’ means a person of an age of 12 years and above; (b) ‘child/children’ means persons who are of an age of two years and above but who are less than 12 years of age; (c) ‘infant’ means a person under the age of two years; (6) ‘aeroplane’ means an engine-driven fixed-wing aircraft heavier than air that is supported in flight by the dynamic reaction of the air against its wings; (7) ‘aided night vision imaging system (NVIS) flight’ means, in the case of NVIS operations, that portion of a visual flight rules (VFR) flight performed at night when a crew member is using night vision goggles (NVG); (8) ‘aircraft’ means a machine that can derive support in the atmosphere from the reactions of the air other than the reactions of the air against the earth’s surface; (9) ‘alternative means of compliance’ means those means that propose an alternative to an existing acceptable means of compliance or those that propose new means to establish compliance with Regulation (EC) No 216/2008 and its Implementing Rules for which no associated AMC have been adopted by the Agency; (10) ‘anti-icing’, in the case of ground procedures, means a procedure that provides protection against the formation of frost or ice and accumulation of snow on treated surfaces of the aircraft for a limited period of time (hold-over time); (11) ‘cabin crew member’ means an appropriately qualified crew member, other than a flight crew or technical crew member, who is assigned by an operator to perform duties related to the safety of passengers and flight during operations; (12) ‘category I (CAT I) approach operation’ means a precision instrument approach and landing using an instrument landing system (ILS), microwave landing system (MLS), GLS (ground-based augmented global navigation satellite system (GNSS/GBAS) landing system), precision approach radar (PAR) or GNSS using a satellite-based augmentation system (SBAS) with a decision height (DH) not lower than 200 ft and with a runway visual range (RVR) not less than 550 m for aeroplanes and 500 m for helicopters; (13) ‘category II (CAT II) operation’ means a precision instrument approach and landing operation using ILS or MLS with: (a) DH below 200 ft but not lower than 100 ft; and (b) RVR of not less than 300 m; (14) ‘category IIIA (CAT IIIA) operation’ means a precision instrument approach and landing operation using ILS or MLS with: (a) DH lower than 100 ft; and (b) RVR not less than 200 m; (15) ‘category IIIB (CAT IIIB) operation’ means a precision instrument approach and landing operation using ILS or MLS with: (a) DH lower than 100 ft, or no DH; and (b) RVR lower than 200 m but not less than 75 m; (16) ‘category A with respect to helicopters’ means a multi-engined helicopter designed with engine and system isolation features specified in the applicable airworthiness codes and capable of operations using take-off and landing data scheduled under a critical engine failure concept that assures adequate designated surface area and adequate performance capability for continued safe flight or safe rejected take-off in the event of engine failure; (17) ‘category B with respect to helicopters’ means a single-engined or multi-engined helicopter that does not meet category A standards. Category B helicopters have no guaranteed capability to continue safe flight in the event of an engine failure, and unscheduled landing is assumed; (18) ‘certification specifications’ (CS) means technical standards adopted by the Agency indicating means to show compliance with Regulation (EC) No 216/2008 and its Implementing Rules and which can be used by an organisation for the purpose of certification; (19) ‘circling’ means the visual phase of an instrument approach to bring an aircraft into position for landing on a runway/FATO that is not suitably located for a straight-in approach; (20) ‘clearway’ means a defined rectangular area on the ground or water under the control of the appropriate authority, selected or prepared as a suitable area over which an aeroplane may make a portion of its initial climb to a specified height; (21) ‘cloud base’ means the height of the base of the lowest observed or forecast cloud element in the vicinity of an aerodrome or operating site or within a specified area of operations, normally measured above aerodrome elevation or, in the case of offshore operations, above mean sea level; (22) ‘code share’ means an arrangement under which an operator places its designator code on a flight operated by another operator, and sells and issues tickets for that flight; (23) ‘congested area’ means in relation to a city, town or settlement, any area which is substantially used for residential, commercial or recreational purposes; (24) ‘contaminated runway’ means a runway of which more than 25 % of the runway surface area within the required length and width being used is covered by the following: (a) surface water more than 3 mm (0,125 in) deep, or by slush, or loose snow, equivalent to more than 3 mm (0,125 in) of water; (b) snow which has been compressed into a solid mass which resists further compression and will hold together or break into lumps if picked up (compacted snow); or (c) ice, including wet ice; (25) ‘contingency fuel’ means the fuel required to compensate for unforeseen factors that could have an influence on the fuel consumption to the destination aerodrome; (26) ‘continuous descent final approach (CDFA)’ means a technique, consistent with stabilised approach procedures, for flying the final-approach segment of a non-precision instrument approach procedure as a continuous descent, without level-off, from an altitude/height at or above the final approach fix altitude/height to a point approximately 15 m (50 ft) above the landing runway threshold or the point where the flare manoeuvre shall begin for the type of aircraft flown; (27) ‘converted meteorological visibility (CMV)’ means a value, equivalent to an RVR, which is derived from the reported meteorological visibility; (28) ‘crew member’ means a person assigned by an operator to perform duties on board an aircraft; (29) ‘critical phases of flight’ in the case of aeroplanes means the take-off run, the take-off flight path, the final approach, the missed approach, the landing, including the landing roll, and any other phases of flight as determined by the pilot-in-command or commander; (30) ‘critical phases of flight’ in the case of helicopters means taxiing, hovering, take-off, final approach, missed approach, the landing and any other phases of flight as determined by the pilot-in-command or commander; (31) ‘damp runway’ means a runway where the surface is not dry, but when the moisture on it does not give it a shiny appearance; (32) ‘dangerous goods (DG)’ means articles or substances which are capable of posing a risk to health, safety, property or the environment and which are shown in the list of dangerous goods in the technical instructions or which are classified according to those instructions; (33) ‘dangerous goods accident’ means an occurrence associated with and related to the transport of dangerous goods by air which results in fatal or serious injury to a person or major property damage; (34) ‘dangerous goods incident’ means: (a) an occurrence other than a dangerous goods accident associated with and related to the transport of dangerous goods by air, not necessarily occurring on board an aircraft, which results in injury to a person, property damage, fire, breakage, spillage, leakage of fluid or radiation or other evidence that the integrity of the packaging has not been maintained; (b) any occurrence relating to the transport of dangerous goods which seriously jeopardises an aircraft or its occupants; (35) ‘de-icing’, in the case of ground procedures, means a procedure by which frost, ice, snow or slush is removed from an aircraft in order to provide uncontaminated surfaces; (36) ‘defined point after take-off (DPATO)’ means the point, within the take-off and initial climb phase, before which the helicopter’s ability to continue the flight safely, with the critical engine inoperative, is not assured and a forced landing may be required; (37) ‘defined point before landing (DPBL)’ means the point within the approach and landing phase, after which the helicopter’s ability to continue the flight safely, with the critical engine inoperative, is not assured and a forced landing may be required; (38) ‘distance DR’ means the horizontal distance that the helicopter has travelled from the end of the take-off distance available; (39) ‘dry lease agreement’ means an agreement between undertakings pursuant to which the aircraft is operated under the air operator certificate (AOC) of the lessee; (40) ‘dry operating mass’ means the total mass of the aircraft ready for a specific type of operation, excluding usable fuel and traffic load; (41) ‘dry runway’ means a runway which is neither wet nor contaminated, and includes those paved runways which have been specially prepared with grooves or porous pavement and maintained to retain ‘effectively dry’ braking action even when moisture is present; (42) ‘elevated final approach and take-off area (elevated FATO)’ means a FATO that is at least 3 m above the surrounding surface; (43) ‘en-route alternate (ERA) aerodrome’ means an adequate aerodrome along the route, which may be required at the planning stage; (44) ‘enhanced vision system (EVS)’ means a system to display electronic real-time images of the external scene achieved through the use of imaging sensors; (45) ‘final approach and take-off area (FATO)’ means a defined area for helicopter operations, over which the final phase of the approach manoeuvre to hover or land is completed, and from which the take-off manoeuvre is commenced. In the case of helicopters operating in performance class 1, the defined area includes the rejected take-off area available; (46) ‘flight data monitoring (FDM)’ means the proactive and non-punitive use of digital flight data from routine operations to improve aviation safety; (47) ‘flight simulation training device (FSTD)’ means a training device which is: (a) in the case of aeroplanes, a full flight simulator (FFS), a flight training device (FTD), a flight and navigation procedures trainer (FNPT), or a basic instrument training device (BITD); (b) in the case of helicopters, a full flight simulator (FFS), a flight training device (FTD) or a flight and navigation procedures trainer (FNPT); (48) ‘fuel ERA aerodrome’ means an ERA aerodrome selected for the purpose of reducing contingency fuel; (49) ‘GBAS landing system (GLS)’ means an approach landing system using ground based augmented global navigation satellite system (GNSS/GBAS) information to provide guidance to the aircraft based on its lateral and vertical GNSS position. It uses geometric altitude reference for its final approach slope; (50) ‘ground emergency service personnel’ means any ground emergency service personnel (such as policemen, firemen, etc.) involved with helicopter emergency medical services (HEMSs) and whose tasks are to any extent pertinent to helicopter operations; (51) ‘grounding’ means the formal prohibition of an aircraft to take-off and the taking of such steps as are necessary to detain it; (52) ‘head-up display (HUD)’ means a display system which presents flight information to the pilot’s forward external field of view and which does not significantly restrict the external view; (53) ‘head-up guidance landing system (HUDLS)’ means the total airborne system that provides head-up guidance to the pilot during the approach and landing and/or missed approach procedure. It includes all sensors, computers, power supplies, indications and controls; (54) ‘helicopter’ means a heavier-than-air aircraft supported in flight chiefly by the reactions of the air on one or more power-driven rotors on substantially vertical axes; (55) ‘helicopter hoist operation (HHO) crew member’ means a technical crew member who performs assigned duties relating to the operation of a hoist; (56) ‘helideck’ means a FATO located on a floating or fixed offshore structure; (57) ‘HEMS crew member’ means a technical crew member who is assigned to a HEMS flight for the purpose of attending to any person in need of medical assistance carried in the helicopter and assisting the pilot during the mission; (58) ‘HEMS flight’ means a flight by a helicopter operating under a HEMS approval, the purpose of which is to facilitate emergency medical assistance, where immediate and rapid transportation is essential, by carrying: (a) medical personnel; (b) medical supplies (equipment, blood, organs, drugs); or (c) ill or injured persons and other persons directly involved; (59) ‘HEMS operating base’ means an aerodrome at which the HEMS crew members and the HEMS helicopter may be on stand-by for HEMS operations; (60) ‘HEMS operating site’ means a site selected by the commander during a HEMS flight for helicopter hoist operations, landing and take-off; (61) ‘HHO flight’ means a flight by a helicopter operating under an HHO approval, the purpose of which is to facilitate the transfer of persons and/or cargo by means of a helicopter hoist; (62) ‘HHO offshore’ means a flight by a helicopter operating under an HHO approval, the purpose of which is to facilitate the transfer of persons and/or cargo by means of a helicopter hoist from or to a vessel or structure in a sea area or to the sea itself; (63) ‘HHO passenger’ means a person who is to be transferred by means of a helicopter hoist; (64) ‘HHO site’ means a specified area at which a helicopter performs a hoist transfer; (65) ‘hold-over time (HoT)’ means the estimated time the anti-icing fluid will prevent the formation of ice and frost and the accumulation of snow on the protected (treated) surfaces of an aeroplane; (66) ‘hostile environment’ means: (a) an environment in which: (i) a safe forced landing cannot be accomplished because the surface is inadequate; (ii) the helicopter occupants cannot be adequately protected from the elements; (iii) search and rescue response/capability is not provided consistent with anticipated exposure; or (iv) there is an unacceptable risk of endangering persons or property on the ground; (b) in any case, the following areas: (i) for overwater operations, the open sea areas north of 45N and south of 45S designated by the authority of the State concerned; (ii) those parts of a congested area without adequate safe forced landing areas; (67) ‘landing decision point (LDP)’ means the point used in determining landing performance from which, an engine failure having been recognised at this point, the landing may be safely continued or a balked landing initiated; (68) ‘landing distance available (LDA)’ means the length of the runway which is declared available by the State of the aerodrome and suitable for the ground run of an aeroplane landing; (69) ‘landplane’ means a fixed wing aircraft which is designed for taking off and landing on land and includes amphibians operated as landplanes; (70) ‘local helicopter operation’ means a commercial air transport operation of helicopters with a maximum certified take-off mass (MCTOM) over 3 175 kg and a maximum operational passenger seating configuration (MOPSC) of nine or less, by day, over routes navigated by reference to visual landmarks, conducted within a local and defined geographical area specified in the operations manual; (71) ‘low visibility procedures (LVP)’ means procedures applied at an aerodrome for the purpose of ensuring safe operations during lower than standard category I, other than standard category II, category II and III approaches and low visibility take-offs; (72) ‘low visibility take-off (LVTO)’ means a take-off with an RVR lower than 400 m but not less than 75 m; (73) ‘lower than standard category I (LTS CAT I) operation’ means a category I instrument approach and landing operation using category I DH, with an RVR lower than would normally be associated with the applicable DH but not lower than 400 m; (74) ‘maximum operational passenger seating configuration (MOPSC)’ means the maximum passenger seating capacity of an individual aircraft, excluding crew seats, established for operational purposes and specified in the operations manual. Taking as a baseline the maximum passenger seating configuration established during the certification process conducted for the type certificate (TC), supplemental type certificate (STC) or change to the TC or STC as relevant to the individual aircraft, the MOPSC may establish an equal or lower number of seats, depending on the operational constraints; (75) ‘medical passenger’ means a medical person carried in a helicopter during a HEMS flight, including but not limited to doctors, nurses and paramedics; (76) ‘night’ means the period between the end of evening civil twilight and the beginning of morning civil twilight or such other period between sunset and sunrise as may be prescribed by the appropriate authority, as defined by the Member State; (77) ‘night vision goggles (NVG)’ means a head-mounted, binocular, light intensification appliance that enhances the ability to maintain visual surface references at night; (78) ‘night vision imaging system (NVIS)’ means the integration of all elements required to successfully and safely use NVGs while operating a helicopter. The system includes as a minimum: NVGs, NVIS lighting, helicopter components, training and continuing airworthiness; (79) ‘non-hostile environment’ means an environment in which: (a) a safe forced landing can be accomplished; (b) the helicopter occupants can be protected from the elements; and (c) search and rescue response/capability is provided consistent with the anticipated exposure. In any case, those parts of a congested area with adequate safe forced landing areas shall be considered non-hostile; (80) ‘non-precision approach (NPA) operation’ means an instrument approach with a minimum descent height (MDH), or DH when flying a CDFA technique, not lower than 250 ft and an RVR/CMV of not less than 750 m for aeroplanes and 600 m for helicopters; (81) ‘NVIS crew member’ means a technical crew member assigned to an NVIS flight; (82) ‘NVIS flight’ means a flight under night visual meteorological conditions (VMC) with the flight crew using NVGs in a helicopter operating under an NVIS approval; (83) ‘offshore operations’ means operations which routinely have a substantial proportion of the flight conducted over sea areas to or from offshore locations; (84) ‘operating site’ means a site, other than an aerodrome, selected by the operator or pilot-in-command or commander for landing, take-off and/or external load operations; (85) ‘operation in performance class 1’ means an operation that, in the event of failure of the critical engine, the helicopter is able to land within the rejected take-off distance available or safely continue the flight to an appropriate landing area, depending on when the failure occurs; (86) ‘operation in performance class 2’ means an operation that, in the event of failure of the critical engine, performance is available to enable the helicopter to safely continue the flight, except when the failure occurs early during the take-off manoeuvre or late in the landing manoeuvre, in which cases a forced landing may be required; (87) ‘operation in performance class 3’ means an operation that, in the event of an engine failure at any time during the flight, a forced landing may be required in a multi-engined helicopter and will be required in a single-engined helicopter; (88) ‘operational control’ means the responsibility for the initiation, continuation, termination or diversion of a flight in the interest of safety; (89) ‘other than standard category II (OTS CAT II) operation’ means a precision instrument approach and landing operation using ILS or MLS where some or all of the elements of the precision approach category II light system are not available, and with: (a) DH below 200 ft but not lower than 100 ft; and (b) RVR of not less than 350 m; (90) ‘performance class A aeroplanes’ means multi-engined aeroplanes powered by turbo-propeller engines with an MOPSC of more than nine or a maximum take-off mass exceeding 5 700 kg, and all multi-engined turbo-jet powered aeroplanes; (91) ‘performance class B aeroplanes’ means aeroplanes powered by propeller engines with an MOPSC of nine or less and a maximum take-off mass of 5 700 kg or less; (92) ‘performance class C aeroplanes’ means aeroplanes powered by reciprocating engines with an MOPSC of more than nine or a maximum take-off mass exceeding 5 700 kg; (93) ‘pilot-in-command’ means the pilot designated as being in command and charged with the safe conduct of the flight. For the purpose of commercial air transport operations, the ‘pilot-in-command’ shall be termed the ‘commander’; (94) ‘principal place of business’ means the head office or registered office of the organisation within which the principal financial functions and operational control of the activities referred to in this Regulation are exercised; (95) ‘prioritisation of ramp inspections’ means the dedication of an appropriate portion of the total number of ramp inspections conducted by or on behalf of a competent authority on an annual basis as provided in Part-ARO; (96) ‘public interest site (PIS)’ means a site used exclusively for operations in the public interest; (97) ‘ramp inspection’ means the inspection of aircraft, of flight and cabin crew qualifications and of flight documentation in order to verify the compliance with the applicable requirements; (98) ‘rectification interval’ means a limitation on the duration of operations with inoperative equipment; (99) ‘rejected take-off distance available (RTODAH)’ means the length of the final approach and take-off area declared available and suitable for helicopters operated in performance class 1 to complete a rejected take-off; (100) ‘rejected take-off distance required (RTODRH)’ means the horizontal distance required from the start of the take-off to the point where the helicopter comes to a full stop following an engine failure and rejection of the take-off at the take-off decision point; (101) ‘runway visual range (RVR)’ means the range over which the pilot of an aircraft on the centre line of a runway can see the runway surface markings or the lights delineating the runway or identifying its centre line; (102) ‘safe forced landing’ means an unavoidable landing or ditching with a reasonable expectancy of no injuries to persons in the aircraft or on the surface; (103) ‘seaplane’ means a fixed wing aircraft which is designed for taking off and landing on water and includes amphibians operated as seaplanes; (104) ‘separate runways’ means runways at the same aerodrome that are separate landing surfaces. These runways may overlay or cross in such a way that if one of the runways is blocked, it will not prevent the planned type of operations on the other runway. Each runway shall have a separate approach procedure based on a separate navigation aid; (105) ‘special VFR flight’ means a VFR flight cleared by air traffic control to operate within a control zone in meteorological conditions below VMC; (106) ‘stabilised approach (SAp)’ means an approach that is flown in a controlled and appropriate manner in terms of configuration, energy and control of the flight path from a pre-determined point or altitude/height down to a point 50 ft above the threshold or the point where the flare manoeuvre is initiated if higher; (107) ‘take-off alternate aerodrome’ means an alternate aerodrome at which an aircraft can land should this become necessary shortly after take-off and if it is not possible to use the aerodrome of departure; (108) ‘take-off decision point (TDP)’ means the point used in determining take-off performance from which, an engine failure having been recognised at this point, either a rejected take-off may be made or a take-off safely continued; (109) ‘take-off distance available (TODA)’ in the case of aeroplanes means the length of the take-off run available plus the length of the clearway, if provided; (110) ‘take-off distance available (TODAH)’ in the case of helicopters means the length of the final approach and take-off area plus, if provided, the length of helicopter clearway declared available and suitable for helicopters to complete the take-off; (111) ‘take-off distance required (TODRH)’ in the case of helicopters means the horizontal distance required from the start of the take-off to the point at which take-off safety speed (VTOSS), a selected height and a positive climb gradient are achieved, following failure of the critical engine being recognised at the TDP, the remaining engines operating within approved operating limits; (112) ‘take-off flight path’ means the vertical and horizontal path, with the critical engine inoperative, from a specified point in the take-off for aeroplanes to 1 500 ft above the surface and for helicopters to 1 000 ft above the surface; (113) ‘take-off mass’ means the mass including everything and everyone carried at the commencement of the take-off for helicopters and take-off run for aeroplanes; (114) ‘take-off run available (TORA)’ means the length of runway that is declared available by the State of the aerodrome and suitable for the ground run of an aeroplane taking off; (115) ‘technical crew member’ means a crew member in commercial air transport HEMS, HHO or NVIS operations other than a flight or cabin crew member, assigned by the operator to duties in the aircraft or on the ground for the purpose of assisting the pilot during HEMS, HHO or NVIS operations, which may require the operation of specialised on-board equipment; (116) ‘technical instructions (TI)’ means the latest effective edition of the ‘Technical instructions for the safe transport of dangerous goods by air’, including the supplement and any addenda, approved and published by the International Civil Aviation Organisation; (117) ‘traffic load’ means the total mass of passengers, baggage, cargo and carry-on specialist equipment, including any ballast; (118) ‘unaided NVIS flight’ means, in the case of NVIS operations, that portion of a VFR flight performed at night when a crew member is not using NVG; (119) ‘undertaking’ means any natural or legal person, whether profit-making or not, or any official body whether having its own personality or not; (120) ‘V1’ means the maximum speed in the take-off at which the pilot must take the first action to stop the aeroplane within the accelerate-stop distance. V1 also means the minimum speed in the take-off, following a failure of the critical engine at VEF, at which the pilot can continue the take-off and achieve the required height above the take-off surface within the take-off distance; (121) ‘VEF’ means the speed at which the critical engine is assumed to fail during take-off; (122) ‘visual approach’ means an approach when either part or all of an instrument approach procedure is not completed and the approach is executed with visual reference to the terrain; (123) ‘wet lease agreement’ means an agreement between air carriers pursuant to which the aircraft is operated under the AOC of the lessor; (124) ‘wet runway’ means a runway of which the surface is covered with water, or equivalent, less than specified by the ‘contaminated runway’ definition or when there is sufficient moisture on the runway surface to cause it to appear reflective, but without significant areas of standing water.

ANNEX II AUTHORITY REQUIREMENTS FOR AIR OPERATIONS [PART-ARO] ARO.GEN.005 Scope This Annex establishes requirements for the administration and management system to be fulfilled by the Agency and Member States for the implementation and enforcement of Regulation (EC) No 216/2008 and its Implementing Rules regarding civil aviation air operations. SUBPART GEN GENERAL REQUIREMENTS SECTION I General ARO.GEN.115 Oversight documentation The competent authority shall provide all legislative acts, standards, rules, technical publications and related documents to relevant personnel in order to allow them to perform their tasks and to discharge their responsibilities. ARO.GEN.120 Means of compliance (a) The Agency shall develop acceptable means of compliance (AMC) that may be used to establish compliance with Regulation (EC) No 216/2008 and its Implementing Rules. When the AMC are complied with, the related requirements of the Implementing Rules are met. (b) Alternative means of compliance may be used to establish compliance with the Implementing Rules. (c) The competent authority shall establish a system to consistently evaluate that all alternative means of compliance used by itself or by organisations and persons under its oversight allow the establishment of compliance with Regulation (EC) No 216/2008 and its Implementing Rules. (d) The competent authority shall evaluate all alternative means of compliance proposed by an organisation in accordance with ORO.GEN.120 (b) by analysing the documentation provided and, if considered necessary, conducting an inspection of the organisation. When the competent authority finds that the alternative means of compliance are in accordance with the Implementing Rules, it shall without undue delay: (1) notify the applicant that the alternative means of compliance may be implemented and, if applicable, amend the approval or certificate of the applicant accordingly; and (2) notify the Agency of their content, including copies of all relevant documentation; (3) inform other Member States about alternative means of compliance that were accepted. (e) When the competent authority itself uses alternative means of compliance to achieve compliance with Regulation (EC) No 216/2008 and its Implementing Rules it shall: (1) make them available to all organisations and persons under its oversight; and (2) without undue delay notify the Agency. The competent authority shall provide the Agency with a full description of the alternative means of compliance, including any revisions to procedures that may be relevant, as well as an assessment demonstrating that the Implementing Rules are met. ARO.GEN.125 Information to the Agency (a) The competent authority shall without undue delay notify the Agency in case of any significant problems with the implementation of Regulation (EC) No 216/2008 and its Implementing Rules. (b) The competent authority shall provide the Agency with safety-significant information stemming from the occurrence reports it has received. ARO.GEN.135 Immediate reaction to a safety problem (a) Without prejudice to Directive 2003/42/EC of the European Parliament and of the Council (1) the competent authority shall implement a system to appropriately collect, analyse and disseminate safety information. (b) The Agency shall implement a system to appropriately analyse any relevant safety information received and without undue delay provide to Member States and the Commission any information, including recommendations or corrective actions to be taken, necessary for them to react in a timely manner to a safety problem involving products, parts, appliances, persons or organisations subject to Regulation (EC) No 216/2008 and its Implementing Rules. (c) Upon receiving the information referred to in (a) and (b), the competent authority shall take adequate measures to address the safety problem. (d) Measures taken under (c) shall immediately be notified to all persons or organisations which need to comply with them under Regulation (EC) No 216/2008 and its Implementing Rules. The competent authority shall also notify those measures to the Agency and, when combined action is required, the other Member States concerned. SECTION II Management ARO.GEN.200 Management system (a) The competent authority shall establish and maintain a management system, including as a minimum: (1) documented policies and procedures to describe its organisation, means and methods to achieve compliance with Regulation (EC) No 216/2008 and its Implementing Rules. The procedures shall be kept up to date and serve as the basic working documents within that competent authority for all related tasks; (2) a sufficient number of personnel to perform its tasks and discharge its responsibilities. Such personnel shall be qualified to perform their allocated tasks and have the necessary knowledge, experience, initial and recurrent training to ensure continuing competence. A system shall be in place to plan the availability of personnel, in order to ensure the proper completion of all tasks; (3) adequate facilities and office accommodation to perform the allocated tasks; (4) a function to monitor compliance of the management system with the relevant requirements and adequacy of the procedures including the establishment of an internal audit process and a safety risk management process. Compliance monitoring shall include a feedback system of audit findings to the senior management of the competent authority to ensure implementation of corrective actions as necessary; and (5) a person or group of persons, ultimately responsible to the senior management of the competent authority for the compliance monitoring function. (b) The competent authority shall, for each field of activity, including management system, appoint one or more persons with the overall responsibility for the management of the relevant task(s). (c) The competent authority shall establish procedures for participation in a mutual exchange of all necessary information and assistance with other competent authorities concerned including on all findings raised and follow-up actions taken as a result of oversight of persons and organisations exercising activities in the territory of a Member State, but certified by the competent authority of another Member State or the Agency. (d) A copy of the procedures related to the management system and their amendments shall be made available to the Agency for the purpose of standardisation. ARO.GEN.205 Allocation of tasks to qualified entities (a) Tasks related to the initial certification or continuing oversight of persons or organisations subject to Regulation (EC) No 216/2008 and its Implementing Rules shall be allocated by Member States only to qualified entities. When allocating tasks, the competent authority shall ensure that it has: (1) put a system in place to initially and continuously assess that the qualified entity complies with Annex V to Regulation (EC) No 216/2008. This system and the results of the assessments shall be documented. (2) established a documented agreement with the qualified entity, approved by both parties at the appropriate management level, which clearly defines: (i) the tasks to be performed; (ii) the declarations, reports and records to be provided; (iii) the technical conditions to be met in performing such tasks; (iv) the related liability coverage; and (v) the protection given to information acquired in carrying out such tasks. (b) The competent authority shall ensure that the internal audit process and safety risk management process required by ARO.GEN.200(a)(4) covers all certification or continuing oversight tasks performed on its behalf. ARO.GEN.210 Changes in the management system (a) The competent authority shall have a system in place to identify changes that affect its capability to perform its tasks and discharge its responsibilities as defined in Regulation (EC) No 216/2008 and its Implementing Rules. This system shall enable it to take action as appropriate to ensure that its management system remains adequate and effective. (b) The competent authority shall update its management system to reflect any change to Regulation (EC) No 216/2008 and its Implementing Rules in a timely manner, so as to ensure effective implementation. (c) The competent authority shall notify the Agency of changes affecting its capability to perform its tasks and discharge its responsibilities as defined in Regulation (EC) No 216/2008 and its Implementing Rules. ARO.GEN.220 Record-keeping (a) The competent authority shall establish a system of record-keeping providing for adequate storage, accessibility and reliable traceability of: (1) the management system’s documented policies and procedures; (2) training, qualification and authorisation of its personnel; (3) the allocation of tasks, covering the elements required by ARO.GEN.205 as well as the details of tasks allocated; (4) certification processes and continuing oversight of certified organisations; (5) details of training courses provided by certified organisations, and if applicable, records relating to FSTDs used for such training; (6) oversight of persons and organisations exercising activities within the territory of the Member State, but overseen or certified by the competent authority of another Member State or the Agency, as agreed between these authorities; (7) the evaluation and notification to the Agency of alternative means of compliance proposed by organisations subject to certification and the assessment of alternative means of compliance used by the competent authority itself; (8) findings, corrective actions and date of action closure; (9) enforcement measures taken; (10) safety information and follow-up measures; and (11) the use of flexibility provisions in accordance with Article 14 of Regulation (EC) No 216/2008. (b) The competent authority shall maintain a list of all organisation certificates it issued. (c) All records shall be kept for the minimum period specified in this Regulation. In the absence of such indication, records shall be kept for a minimum period of five years subject to applicable data protection law. SECTION III Oversight, certification and enforcement ARO.GEN.300 Oversight (a) The competent authority shall verify: (1) compliance with the requirements applicable to organisations prior to the issue of an organisation certificate or approval, as applicable; (2) continued compliance with the applicable requirements of organisations it has certified; (3) implementation of appropriate safety measures mandated by the competent authority as defined in ARO.GEN.135(c) and (d). (b) This verification shall: (1) be supported by documentation specifically intended to provide personnel responsible for safety oversight with guidance to perform their functions; (2) provide the persons and organisations concerned with the results of safety oversight activity; (3) be based on audits and inspections, including ramp and unannounced inspections; and (4) provide the competent authority with the evidence needed in case further action is required, including the measures foreseen by ARO.GEN.350 and ARO.GEN.355. (c) The scope of oversight defined in (a) and (b) shall take into account the results of past oversight activities and the safety priorities. (d) Without prejudice to the competences of the Member States and to their obligations as set out in ARO.RAMP, the scope of the oversight of activities performed in the territory of a Member State by persons or organisations established or residing in another Member State shall be determined on the basis of the safety priorities, as well as of past oversight activities. (e) Where the activity of a person or organisation involves more than one Member State or the Agency, the competent authority responsible for the oversight under (a) may agree to have oversight tasks performed by the competent authority(ies) of the Member State(s) where the activity takes place or by the Agency. Any person or organisation subject to such agreement shall be informed of its existence and of its scope. (f) The competent authority shall collect and process any information deemed useful for oversight, including for ramp and unannounced inspections. ARO.GEN.305 Oversight programme (a) The competent authority shall establish and maintain an oversight programme covering the oversight activities required by ARO.GEN.300 and by ARO.RAMP. (b) For organisations certified by the competent authority, the oversight programme shall be developed taking into account the specific nature of the organisation, the complexity of its activities, the results of past certification and/or oversight activities required by ARO.GEN and ARO.RAMP and shall be based on the assessment of associated risks. It shall include within each oversight planning cycle: (1) audits and inspections, including ramp and unannounced inspections as appropriate; and (2) meetings convened between the accountable manager and the competent authority to ensure both remain informed of significant issues. (c) For organisations certified by the competent authority an oversight planning cycle not exceeding 24 months shall be applied. The oversight planning cycle may be reduced if there is evidence that the safety performance of the organisation has decreased. The oversight planning cycle may be extended to a maximum of 36 months if the competent authority has established that, during the previous 24 months: (1) the organisation has demonstrated an effective identification of aviation safety hazards and management of associated risks; (2) the organisation has continuously demonstrated under ORO.GEN.130 that it has full control over all changes; (3) no level 1 findings have been issued; and (4) all corrective actions have been implemented within the time period accepted or extended by the competent authority as defined in ARO.GEN.350(d)(2). The oversight planning cycle may be further extended to a maximum of 48 months if, in addition to the above, the organisation has established, and the competent authority has approved, an effective continuous reporting system to the competent authority on the safety performance and regulatory compliance of the organisation itself. (d) For persons holding a licence, certificate, rating, or attestation issued by the competent authority the oversight programme shall include inspections, including unannounced inspections, as appropriate. (e) The oversight programme shall include records of the dates when audits, inspections and meetings are due and when such audits, inspections and meetings have been carried out. ARO.GEN.310 Initial certification procedure — organisations (a) Upon receiving an application for the initial issue of a certificate for an organisation, the competent authority shall verify the organisation’s compliance with the applicable requirements. This verification may take into account the statement referred to in ORO.AOC.100(b). (b) When satisfied that the organisation is in compliance with the applicable requirements, the competent authority shall issue the certificate(s), as established in Appendices I and II. The certificate(s) shall be issued for an unlimited duration. The privileges and scope of the activities that the organisation is approved to conduct shall be specified in the terms of approval attached to the certificate(s). (c) To enable an organisation to implement changes without prior competent authority approval in accordance with ORO.GEN.130, the competent authority shall approve the procedure submitted by the organisation defining the scope of such changes and describing how such changes will be managed and notified. ARO.GEN.330 Changes — organisations (a) Upon receiving an application for a change that requires prior approval, the competent authority shall verify the organisation’s compliance with the applicable requirements before issuing the approval. The competent authority shall prescribe the conditions under which the organisation may operate during the change, unless the competent authority determines that the organisation’s certificate needs to be suspended. When satisfied that the organisation is in compliance with the applicable requirements, the competent authority shall approve the change. (b) Without prejudice to any additional enforcement measures, when the organisation implements changes requiring prior approval without having received competent authority approval as defined in (a), the competent authority shall suspend, limit or revoke the organisation’s certificate. (c) For changes not requiring prior approval, the competent authority shall assess the information provided in the notification sent by the organisation in accordance with ORO.GEN.130 to verify compliance with the applicable requirements. In case of any non-compliance, the competent authority shall: (1) notify the organisation about the non-compliance and request further changes; (2) in case of level 1 or level 2 findings, act in accordance with ARO.GEN.350. ARO.GEN.350 Findings and corrective actions — organisations (a) The competent authority for oversight in accordance with ARO.GEN.300(a) shall have a system to analyse findings for their safety significance. (b) A level 1 finding shall be issued by the competent authority when any significant non-compliance is detected with the applicable requirements of Regulation (EC) No 216/2008 and its Implementing Rules, with the organisation’s procedures and manuals or with the terms of an approval or certificate which lowers safety or seriously hazards flight safety. The level 1 findings shall include: (1) failure to give the competent authority access to the organisation’s facilities as defined in ORO.GEN.140 during normal operating hours and after two written requests; (2) obtaining or maintaining the validity of the organisation certificate by falsification of submitted documentary evidence; (3) evidence of malpractice or fraudulent use of the organisation certificate; and (4) the lack of an accountable manager. (c) A level 2 finding shall be issued by the competent authority when any non-compliance is detected with the applicable requirements of Regulation (EC) No 216/2008 and its Implementing Rules, with the organisation’s procedures and manuals or with the terms of an approval or certificate which could lower safety or hazard flight safety. (d) When a finding is detected during oversight or by any other means, the competent authority shall, without prejudice to any additional action required by Regulation (EC) No 216/2008 and its Implementing Rules, communicate the finding to the organisation in writing and request corrective action to address the non-compliance(s) identified. Where relevant, the competent authority shall inform the State in which the aircraft is registered. (1) In the case of level 1 findings the competent authority shall take immediate and appropriate action to prohibit or limit activities, and if appropriate, it shall take action to revoke the certificate or specific approval or to limit or suspend it in whole or in part, depending upon the extent of the level 1 finding, until successful corrective action has been taken by the organisation. (2) In the case of level 2 findings, the competent authority shall: (i) grant the organisation a corrective action implementation period appropriate to the nature of the finding that in any case initially shall not be more than three months. At the end of this period, and subject to the nature of the finding, the competent authority may extend the three-month period subject to a satisfactory corrective action plan agreed by the competent authority; and (ii) assess the corrective action and implementation plan proposed by the organisation and, if the assessment concludes that they are sufficient to address the non-compliance(s), accept these. (3) Where an organisation fails to submit an acceptable corrective action plan, or to perform the corrective action within the time period accepted or extended by the competent authority, the finding shall be raised to a level 1 finding and action taken as laid down in (d)(1). (4) The competent authority shall record all findings it has raised or that have been communicated to it and, where applicable, the enforcement measures it has applied, as well as all corrective actions and date of action closure for findings. (e) Without prejudice to any additional enforcement measures, when the authority of a Member State acting under the provisions of ARO.GEN.300 (d) identifies any non-compliance with the applicable requirements of Regulation (EC) No 216/2008 and its Implementing Rules by an organisation certified by the competent authority of another Member State or the Agency, it shall inform that competent authority and provide an indication of the level of finding. ARO.GEN.355 Findings and enforcement measures — persons (a) If, during oversight or by any other means, evidence is found by the competent authority responsible for oversight in accordance with ARO.GEN.300(a) that shows a non-compliance with the applicable requirements by a person holding a licence, certificate, rating or attestation issued in accordance with Regulation (EC) No 216/2008 and its Implementing Rules, the competent authority shall act in accordance with ARA.GEN.355(a) to (d) of Annex VI (Part-ARA) to Commission Regulation (EU) No 290/2012 (2). (b) If, during oversight or by any other means, evidence is found showing a non-compliance with the applicable requirements by a person subject to the requirements laid down in Regulation (EC) No 216/2008 and its Implementing Rules and not holding a licence, certificate, rating or attestation issued in accordance with that Regulation and its Implementing Rules, the competent authority that identified the non-compliance shall take any enforcement measures necessary to prevent the continuation of that non-compliance. SUBPART OPS AIR OPERATIONS SECTION I Certification of commercial air transport operators ARO.OPS.100 Issue of the air operator certificate (a) The competent authority shall issue the air operator certificate (AOC) when satisfied that the operator has demonstrated compliance with the elements required in ORO.AOC.100. (b) The certificate shall include the associated operations specifications. ARO.OPS.105 Code-share arrangements In considering the safety of a code-share agreement involving a third-country operator, the competent authority shall: (1) satisfy itself, following the verification by the operator as set out in ORO.AOC.115, that the third-country operator complies with the applicable ICAO standards; (2) liaise with the competent authority of the State of the third-country operator as necessary. ARO.OPS.110 Lease agreements (a) The competent authority shall approve a lease agreement when satisfied that the operator certified in accordance with Annex III (Part-ORO) complies with: (1) ORO.AOC.110(d), for dry leased-in third country aircraft; (2) ORO.AOC.110(c), for wet lease-in of an aircraft from a third country operator; (3) ORO.AOC.110(e), for dry lease-out of an aircraft to any operator; (4) relevant requirements of continuing airworthiness and air operations, for dry lease-in of an aircraft registered in the EU and wet lease-in of an aircraft from an EU operator. (b) The approval of a wet lease-in agreement shall be suspended or revoked whenever: (1) the AOC of the lessor or lessee is suspended or revoked; (2) the lessor is subject to an operating ban pursuant to Regulation (EC) No 2111/2005 of the European Parliament and of the Council (3). (c) The approval of a dry lease-in agreement shall be suspended or revoked whenever the certificate of airworthiness of the aircraft is suspended or revoked. (d) When asked for the prior approval of a dry-lease out agreement in accordance with ORO.AOC.110(e), the competent authority shall ensure: (1) proper coordination with the competent authority responsible for the continuing oversight of the aircraft, in accordance with Commission Regulation (EC) No 2042/2003 (4), or for the operation of the aircraft, if it is not the same authority; (2) that the aircraft is timely removed from the operator’s AOC. SECTION II Approvals ARO.OPS.200 Specific approval procedure (a) Upon receiving an application for the issue of a specific approval or changes thereof, the competent authority shall assess the application in accordance with the relevant requirements of Annex V (Part-SPA) and conduct, where relevant, an appropriate inspection of the operator. (b) When satisfied that the operator has demonstrated compliance with the applicable requirements, the competent authority shall issue or amend the approval. The approval shall be specified in the operations specifications, as established in Appendix II. ARO.OPS.205 Minimum equipment list approval (a) When receiving an application for initial approval of a minimum equipment list (MEL) or an amendment thereof from an operator, the competent authority shall assess each item affected, to verify compliance with the applicable requirements, before issuing the approval. (b) The competent authority shall approve the operator’s procedure for the extension of the applicable rectification intervals B, C and D, if the conditions specified in ORO.MLR.105(f) are demonstrated by the operator and verified by the competent authority. (c) The competent authority shall approve, on a case-by-case basis, the operation of an aircraft outside the constraints of the MEL but within the constraints of the master minimum equipment list (MMEL), if the conditions specified in ORO.MLR.105 are demonstrated by the operator and verified by the competent authority. ARO.OPS.210 Determination of local area The competent authority may determine a local area for the purpose of flight crew training and checking requirements. ARO.OPS.215 Approval of helicopter operations over a hostile environment located outside a congested area (a) The Member State shall designate those areas where helicopter operations may be conducted without an assured safe forced landing capability, as described in CAT.POL.H.420. (b) Before issuing the approval referred to in CAT.POL.H.420 the competent authority shall have considered the operator’s substantiation precluding the use of the appropriate performance criteria. ARO.OPS.220 Approval of helicopter operations to or from a public interest site The approval referred to in CAT.POL.H.225 shall include a list of the public interest site(s) specified by the operator to which the approval applies. ARO.OPS.225 Approval of operations to an isolated aerodrome The approval referred to in CAT.OP.MPA.106 shall include a list of the aerodromes specified by the operator to which the approval applies. SUBPART RAMP RAMP INSPECTIONS OF AIRCRAFT OF OPERATORS UNDER THE REGULATORY OVERSIGHT OF ANOTHER STATE ARO.RAMP.005 Scope This Subpart establishes the requirements to be followed by the competent authority or the Agency when exercising its tasks and responsibilities regarding the performance of ramp inspections of aircraft used by third country operators or used by operators under the regulatory oversight of another Member State when landed at aerodromes located in the territory subject to the provisions of the Treaty. ARO.RAMP.100 General (a) Aircraft, as well as their crew, shall be inspected against the applicable requirements. (b) In addition to conducting ramp inspections included in its oversight programme established in accordance with ARO.GEN.305, the competent authority shall perform a ramp inspection of an aircraft suspected of not being compliant with the applicable requirements. (c) Within the development of the oversight programme established in accordance with ARO.GEN.305, the competent authority shall establish an annual programme for the conduct of ramp inspections of aircraft. This programme shall: (1) be based on a calculation methodology that takes into account historical information on the number and nature of operators and their number of landings at its aerodromes, as well as safety risks; and (2) enable the competent authority to give priority to the inspections of aircraft on the basis of the list referred to in ARO.RAMP.105(a). (d) When it so deems necessary, the Agency, in cooperation with the Member States in whose territory the inspection shall take place, shall conduct ramp inspections of aircraft to verify compliance with the applicable requirements for the purpose of: (1) certification tasks assigned to the Agency by Regulation (EC) No 216/2008; (2) standardisation inspections of a Member State; or (3) inspections of an organisation to verify compliance with the applicable requirements in potentially unsafe situations. ARO.RAMP.105 Prioritisation criteria (a) The Agency shall provide competent authorities with a list of operators or aircraft identified as presenting a potential risk, for the prioritisation of ramp inspections. (b) This list shall include: (1) operators of aircraft identified on the basis of the analysis of available data in accordance with ARO.RAMP.150(b)(4); (2) operators or aircraft communicated to the Agency by the European Commission and identified on the basis of: (i) an opinion expressed by the Air Safety Committee (ASC) within the context of the implementation of Regulation (EC) No 2111/2005 that further verification of effective compliance with relevant safety standards through systematic ramp inspections is necessary; or (ii) information obtained by the European Commission from the Member States pursuant to Article 4(3) of Regulation (EC) No 2111/2005; (3) aircraft operated into the territory subject to the provisions of the Treaty by operators included in Annex B of the list of operators subject to an operating ban pursuant to Regulation (EC) No 2111/2005; (4) aircraft operated by operators certified in a State exercising regulatory oversight over operators included in the list referred to in (3); (5) aircraft used by a third-country operator that operates into, within or out of the territory subject to the provisions of the Treaty for the first time or whose authorisation issued in accordance with ART.GEN.205 is limited or reinstated after suspension or revocation. (c) The list shall be produced, in accordance with procedures established by the Agency, after every update of the Community list of operators subject to an operating ban pursuant to Regulation (EC) No 2111/2005, and in any case at least once every four months. ARO.RAMP.110 Collection of information The competent authority shall collect and process any information deemed useful for conducting ramp inspections. ARO.RAMP.115 Qualification of ramp inspectors (a) The competent authority and the Agency shall have qualified inspectors to conduct ramp inspections. (b) Ramp inspectors shall: (1) possess the necessary aeronautical education or practical knowledge relevant to their area(s) of inspection; (2) have successfully completed: (i) appropriate specific theoretical and practical training, in one or more of the following areas of inspection: (A) flight deck; (B) cabin safety; (C) aircraft condition; (D) cargo; (ii) appropriate on-the-job training delivered by a senior ramp inspector appointed by the competent authority or the Agency; (3) maintain the validity of their qualification by undergoing recurrent training and by performing a minimum of 12 inspections in every 12-month period. (c) The training in (b)(2)(i) shall be delivered by the competent authority or by any training organisation approved in accordance with ARO.RAMP.120(a). (d) The Agency shall develop and maintain training syllabi and promote the organisation of training courses and workshops for inspectors to improve the understanding and uniform implementation of this Subpart. (e) The Agency shall facilitate and coordinate an inspector exchange programme aimed at allowing inspectors to obtain practical experience and contributing to the harmonisation of procedures. ARO.RAMP.120 Approval of training organisations (a) The competent authority shall approve a training organisation, having its principal place of business in the territory of the respective Member State, when satisfied that the training organisation: (1) has nominated a head of training possessing sound managerial capability to ensure that the training provided is in compliance with the applicable requirements; (2) has available training facilities and instructional equipment suitable for the type of training provided; (3) provides training in accordance with the syllabi developed by the Agency in accordance with ARO.RAMP.115(d); (4) uses qualified training instructors. (b) If so requested by the competent authority, the verification of compliance and continuous compliance with the requirements referred to in (a) shall be performed by the Agency. (c) The training organisation shall be approved to provide one or more of the following types of training: (1) initial theoretical training; (2) initial practical training; (3) recurrent training. ARO.RAMP.125 Conduct of ramp inspections (a) Ramp inspections shall be performed in a standardised manner using the form established in either Appendix III or Appendix IV. (b) When performing a ramp inspection, the inspector(s) shall make all possible efforts to avoid an unreasonable delay of the aircraft inspected. (c) On completion of the ramp inspection, the pilot-in-command or, in his/her absence, another member of the flight crew or a representative of the operator shall be informed of the ramp inspection’s results using the form established in Appendix III. ARO.RAMP.130 Categorisation of findings For each inspection item, three categories of possible non-compliance with the applicable requirements are defined as findings. Such findings shall be categorised as follows: (1) a category 3 finding is any detected significant non-compliance with the applicable requirements or the terms of a certificate that has a major influence on safety; (2) a category 2 finding is any detected non-compliance with the applicable requirements or the terms of a certificate that has a significant influence on safety; (3) a category 1 finding is any detected non-compliance with the applicable requirements or the terms a certificate that has a minor influence on safety. ARO.RAMP.135 Follow-up actions on findings (a) For a category 2 or 3 finding the competent authority, or where relevant the Agency, shall: (1) communicate the finding in writing to the operator, including a request for evidence of corrective actions taken; and (2) inform the competent authority of the State of the operator and, where relevant, the State in which the aircraft is registered and where the licence of the flight crew was issued. Where appropriate, the competent authority or Agency shall request confirmation of their acceptance of the corrective actions taken by the operator in accordance with ARO.GEN.350 or ARO.GEN.355. (b) In addition to (a), in the case of a category 3 finding, the competent authority shall take immediate steps by: (1) imposing a restriction on the aircraft flight operation; (2) requesting immediate corrective actions; (3) grounding the aircraft in accordance with ARO.RAMP.140; or (4) imposing an immediate operating ban in accordance with Article 6 of Regulation (EC) No 2111/2005. (c) When the Agency has raised a category 3 finding, it shall request the competent authority where the aircraft is landed to take the appropriate measures in accordance with (b). ARO.RAMP.140 Grounding of aircraft (a) In the case of a category 3 finding where it appears that the aircraft is intended or is likely to be flown without completion by the operator or owner of the appropriate corrective action, the competent authority shall: (1) notify the pilot-in-command/commander or the operator that the aircraft is not permitted to commence the flight until further notice; and (2) ground that aircraft. (b) The competent authority of the State where the aircraft is grounded shall immediately inform the competent authority of the State of the operator and of the State in which the aircraft is registered, if relevant, and the Agency in the case of a grounded aircraft used by a third-country operator. (c) The competent authority shall, in coordination with the State of the operator or the State of Registry, prescribe the necessary conditions under which the aircraft can be allowed to take-off. (d) If the non-compliance affects the validity of the certificate of airworthiness of the aircraft, the grounding shall only be lifted by the competent authority when the operator shows evidence that: (1) compliance with the applicable requirements has been re-established; (2) it has obtained a permit-to-fly in accordance with Commission Regulation (EC) No 1702/2003 (5), for aircraft registered in a Member State; (3) a permit-to-fly or equivalent document of the State of Registry or the State of the operator for aircraft registered in a third country and operated by an EU or a third country operator; and (4) permission from third countries which will be overflown, if applicable. ARO.RAMP.145 Reporting (a) Information collected in accordance with ARO.RAMP.125(a) shall be entered into the centralised database referred to in ARO.RAMP.150(b)(2), within 21 calendar days after the inspection. (b) The competent authority or the Agency shall enter into the centralised database any information useful for the application of Regulation (EC) No 216/2008 and its Implementing Rules and for the accomplishment by the Agency of the tasks assigned to it by this Annex, including the relevant information referred to in ARO.RAMP.110. (c) Whenever the information as referred to in ARO.RAMP.110 shows the existence of a potential safety threat, such information shall also be communicated to each competent authority and the Agency without delay. (d) Whenever information concerning aircraft deficiencies is given by a person to the competent authority, the information referred to in ARO.RAMP.110 and ARO.RAMP.125(a) shall be de-identified regarding the source of such information. ARO.RAMP.150 Agency coordination tasks (a) The Agency shall manage and operate the tools and procedures necessary for the storage and exchange of: (1) the information referred to in ARO.RAMP.145, using the forms as established in Appendices III and IV; (2) the information provided by third countries or international organisations with whom appropriate agreements have been concluded with the EU, or organisations with whom the Agency has concluded appropriate arrangements in accordance with Article 27(2) of Regulation (EC) No 216/2008. (b) This management shall include the following tasks: (1) store data from the Member States relevant to the safety information on aircraft landing at aerodromes located in the territory subject to the provisions of the Treaty; (2) develop, maintain and continuously update a centralised database containing all the information referred to in (a)(1) and (2); (3) provide necessary changes and enhancements to the database application; (4) analyse the centralised database and other relevant information concerning the safety of aircraft and of air operators and, on that basis: (i) advise the Commission and the competent authorities on immediate actions or follow-up policy; (ii) report potential safety problems to the Commission and to the competent authorities; (iii) propose coordinated actions to the Commission and to the competent authorities, when necessary on safety grounds, and ensure coordination at the technical level of such actions; (5) liaise with other European institutions and bodies, international organisations and third country competent authorities on information exchange. ARO.RAMP.155 Annual report The Agency shall prepare and submit to the Commission an annual report on the ramp inspection system containing at least the following information: (a) status of the progress of the system; (b) status of the inspections performed in the year; (c) analysis of the inspection results with indication of the categories of findings; (d) actions taken during the year; (e) proposals for further improving the ramp inspection system; and (f) annexes containing lists of inspections sorted out by State of operation, aircraft type, operator and ratios per item. ARO.RAMP.160 Information to the public and protection of information (a) Member States shall use the information received by them pursuant to ARO.RAMP.105 and ARO.RAMP.145 solely for the purpose of Regulation (EC) No 216/2008 and its implementing rules and shall protect it accordingly. (b) The Agency shall publish an aggregated information report annually that shall be available to the public containing the analysis of the information received in accordance with ARO.RAMP.145. The report shall be simple and easy to understand, and the source of the information shall be de-identified. (1) OJ L 167, 4.7.2003, p. 23. (2) OJ L 100, 5.4.2012, p. 1. (3) OJ L 344, 27.12.2005, p. 15. (4) OJ L 315, 28.11.2003, p. 1. (5) OJ L 243, 27.9.2003, p. 6. Appendix I Appendix II Appendix III Appendix IV Ramp inspection report

ANNEX III ORGANISATION REQUIREMENTS FOR AIR OPERATIONS [PART-ORO] ORO.GEN.005 Scope This Annex establishes requirements to be followed by an air operator conducting commercial air transport operations. SUBPART GEN GENERAL REQUIREMENTS SECTION I General ORO.GEN.105 Competent authority For the purpose of this Annex, the competent authority exercising oversight over operators subject to a certification obligation shall be for operators having their principal place of business in a Member State, the authority designated by that Member State. ORO.GEN.110 Operator responsibilities (a) The operator is responsible for the operation of the aircraft in accordance with Annex IV to Regulation (EC) No 216/2008, the relevant requirements of this Annex and its certificate. (b) Every flight shall be conducted in accordance with the provisions of the operations manual. (c) The operator shall establish and maintain a system for exercising operational control over any flight operated under the terms of its certificate. (d) The operator shall ensure that its aircraft are equipped and its crews are qualified as required for the area and type of operation. (e) The operator shall ensure that all personnel assigned to, or directly involved in, ground and flight operations are properly instructed, have demonstrated their abilities in their particular duties and are aware of their responsibilities and the relationship of such duties to the operation as a whole. (f) The operator shall establish procedures and instructions for the safe operation of each aircraft type, containing ground staff and crew member duties and responsibilities for all types of operation on the ground and in flight. These procedures shall not require crew members to perform any activities during critical phases of flight other than those required for the safe operation of the aircraft. (g) The operator shall ensure that all personnel are made aware that they shall comply with the laws, regulations and procedures of those States in which operations are conducted and that are pertinent to the performance of their duties. (h) The operator shall establish a checklist system for each aircraft type to be used by crew members in all phases of flight under normal, abnormal and emergency conditions to ensure that the operating procedures in the operations manual are followed. The design and utilisation of checklists shall observe human factors principles and take into account the latest relevant documentation from the aircraft manufacturer. (i) The operator shall specify flight planning procedures to provide for the safe conduct of the flight based on considerations of aircraft performance, other operating limitations and relevant expected conditions on the route to be followed and at the aerodromes or operating sites concerned. These procedures shall be included in the operations manual. (j) The operator shall establish and maintain dangerous goods training programmes for personnel as required by the technical instructions which shall be subject to review and approval by the competent authority. Training programmes shall be commensurate with the responsibilities of personnel. ORO.GEN.115 Application for an operator certificate (a) The application for an operator certificate or an amendment to an existing certificate shall be made in a form and manner established by the competent authority, taking into account the applicable requirements of Regulation (EC) No 216/2008 and its Implementing Rules. (b) Applicants for an initial certificate shall provide the competent authority with documentation demonstrating how they will comply with the requirements established in Regulation (EC) No 216/2008 and its Implementing Rules. Such documentation shall include a procedure describing how changes not requiring prior approval will be managed and notified to the competent authority. ORO.GEN.120 Means of compliance (a) Alternative means of compliance to those adopted by the Agency may be used by an operator to establish compliance with Regulation (EC) No 216/2008 and its Implementing Rules. (b) When an operator subject to certification wishes to use an alternative means of compliance to the acceptable means of compliance (AMC) adopted by the Agency to establish compliance with Regulation (EC) No 216/2008 and its Implementing Rules, it shall, prior to implementing it, provide the competent authority with a full description of the alternative means of compliance. The description shall include any revisions to manuals or procedures that may be relevant, as well as an assessment demonstrating that the Implementing Rules are met. The operator may implement these alternative means of compliance subject to prior approval by the competent authority and upon receipt of the notification as prescribed in ARO.GEN.120(d). ORO.GEN.125 Terms of approval and privileges of an operator A certified operator shall comply with the scope and privileges defined in the operations specifications attached to the operator’s certificate. ORO.GEN.130 Changes (a) Any change affecting: (1) the scope of the certificate or the operations specifications of an operator; or (2) any of the elements of the operator’s management system as required in ORO.GEN.200(a)(1) and (a)(2), shall require prior approval by the competent authority. (b) For any changes requiring prior approval in accordance with Regulation (EC) No 216/2008 and its Implementing Rules, the operator shall apply for and obtain an approval issued by the competent authority. The application shall be submitted before any such change takes place, in order to enable the competent authority to determine continued compliance with Regulation (EC) No 216/2008 and its Implementing Rules and to amend, if necessary, the operator certificate and related terms of approval attached to it. The operator shall provide the competent authority with any relevant documentation. The change shall only be implemented upon receipt of formal approval by the competent authority in accordance with ARO.GEN.330. The operator shall operate under the conditions prescribed by the competent authority during such changes, as applicable. (c) All changes not requiring prior approval shall be managed and notified to the competent authority as defined in the procedure approved by the competent authority in accordance with ARO.GEN.310(c). ORO.GEN.135 Continued validity (a) The operator’s certificate shall remain valid subject to: (1) the operator remaining in compliance with the relevant requirements of Regulation (EC) No 216/2008 and its Implementing Rules, taking into account the provisions related to the handling of findings as specified under ORO.GEN.150; (2) the competent authority being granted access to the operator as defined in ORO.GEN.140 to determine continued compliance with the relevant requirements of Regulation (EC) No 216/2008 and its Implementing Rules; and (3) the certificate not being surrendered or revoked. (b) Upon revocation or surrender the certificate shall be returned to the competent authority without delay. ORO.GEN.140 Access (a) For the purpose of determining compliance with the relevant requirements of Regulation (EC) No 216/2008 and its Implementing Rules, the operator shall grant access at any time to any facility, aircraft, document, records, data, procedures or any other material relevant to its activity subject to certification, whether it is contracted or not, to any person authorised by one of the following authorities: (1) the competent authority defined in ORO.GEN.105; (2) the authority acting under the provisions of ARO.GEN.300(d), ARO.GEN.300(e) or ARO.RAMP. (b) Access to the aircraft mentioned under (a) shall include the possibility to enter and remain in the aircraft during flight operations unless otherwise decided by the commander for the flight crew compartment in accordance with CAT.GEN.MPA.135 in the interest of safety. ORO.GEN.150 Findings After receipt of notification of findings, the operator shall: (a) identify the root cause of the non-compliance; (b) define a corrective action plan; and (c) demonstrate corrective action implementation to the satisfaction of the competent authority within a period agreed with that authority as defined in ARO.GEN.350(d). ORO.GEN.155 Immediate reaction to a safety problem The operator shall implement: (a) any safety measures mandated by the competent authority in accordance with ARO.GEN.135(c); and (b) any relevant mandatory safety information issued by the Agency, including airworthiness directives. ORO.GEN.160 Occurrence reporting (a) The operator shall report to the competent authority, and to any other organisation required by the State of the operator to be informed, any accident, serious incident and occurrence as defined in Regulation (EU) No 996/2010 of the European Parliament and of the Council (1) and Directive 2003/42/EC. (b) Without prejudice to point (a) the operator shall report to the competent authority and to the organisation responsible for the design of the aircraft any incident, malfunction, technical defect, exceeding of technical limitations, occurrence that would highlight inaccurate, incomplete or ambiguous information contained in data established in accordance with Commission Regulation (EC) No 1702/2003 (2) or other irregular circumstance that has or may have endangered the safe operation of the aircraft and that has not resulted in an accident or serious incident. (c) Without prejudice to Regulation (EU) No 996/2010, Directive 2003/42/EC, Commission Regulation (EC) No 1321/2007 (3) and Commission Regulation (EC) No 1330/2007 (4), the reports referred in paragraphs (a) and (b) shall be made in a form and manner established by the competent authority and contain all pertinent information about the condition known to the operator. (d) Reports shall be made as soon as practicable, but in any case within 72 hours of the operator identifying the condition to which the report relates, unless exceptional circumstances prevent this. (e) Where relevant, the operator shall produce a follow-up report to provide details of actions it intends to take to prevent similar occurrences in the future, as soon as these actions have been identified. This report shall be produced in a form and manner established by the competent authority. SECTION 2 Management ORO.GEN.200 Management system (a) The operator shall establish, implement and maintain a management system that includes: (1) clearly defined lines of responsibility and accountability throughout the operator, including a direct safety accountability of the accountable manager; (2) a description of the overall philosophies and principles of the operator with regard to safety, referred to as the safety policy; (3) the identification of aviation safety hazards entailed by the activities of the operator, their evaluation and the management of associated risks, including taking actions to mitigate the risk and verify their effectiveness; (4) maintaining personnel trained and competent to perform their tasks; (5) documentation of all management system key processes, including a process for making personnel aware of their responsibilities and the procedure for amending this documentation; (6) a function to monitor compliance of the operator with the relevant requirements. Compliance monitoring shall include a feedback system of findings to the accountable manager to ensure effective implementation of corrective actions as necessary; and (7) any additional requirements that are prescribed in the relevant Subparts of this Annex or other applicable Annexes. (b) The management system shall correspond to the size of the operator and the nature and complexity of its activities, taking into account the hazards and associated risks inherent in these activities. ORO.GEN.205 Contracted activities (a) Contracted activities include all activities within the operator’s scope of approval that are performed by another organisation either itself certified to carry out such activity or if not certified, working under the operator’s approval. The operator shall ensure that when contracting or purchasing any part of its activity, the contracted or purchased service or product conforms to the applicable requirements. (b) When the certified operator contracts any part of its activity to an organisation that is not itself certified in accordance with this Part to carry out such activity, the contracted organisation shall work under the approval of the operator. The contracting organisation shall ensure that the competent authority is given access to the contracted organisation, to determine continued compliance with the applicable requirements. ORO.GEN.210 Personnel requirements (a) The operator shall appoint an accountable manager, who has the authority for ensuring that all activities can be financed and carried out in accordance with the applicable requirements. The accountable manager shall be responsible for establishing and maintaining an effective management system. (b) A person or group of persons shall be nominated by the operator, with the responsibility of ensuring that the operator remains in compliance with the applicable requirements. Such person(s) shall be ultimately responsible to the accountable manager. (c) The operator shall have sufficient qualified personnel for the planned tasks and activities to be performed in accordance with the applicable requirements. (d) The operator shall maintain appropriate experience, qualification and training records to show compliance with point (c). (e) The operator shall ensure that all personnel are aware of the rules and procedures relevant to the exercise of their duties. ORO.GEN.215 Facility requirements The operator shall have facilities allowing the performance and management of all planned tasks and activities in accordance with the applicable requirements. ORO.GEN.220 Record-keeping (a) The operator shall establish a system of record-keeping that allows adequate storage and reliable traceability of all activities developed, covering in particular all the elements indicated in ORO.GEN.200. (b) The format of the records shall be specified in the operator’s procedures. (c) Records shall be stored in a manner that ensures protection from damage, alteration and theft. SUBPART AOC AIR OPERATOR CERTIFICATION ORO.AOC.100 Application for an air operator certificate (a) Without prejudice to Regulation (EC) No 1008/2008 of the European Parliament and the Council (5), prior to commencing commercial air operations, the operator shall apply for and obtain an air operator certificate (AOC) issued by the competent authority. (b) The operator shall provide the following information to the competent authority: (1) the official name and business name, address, and maili