(1)

‘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;

(2)

‘aerial work’ means an aircraft operation in which an aircraft is used for specialised services such as agriculture, construction, photography, surveying, observation and patrol, search and rescue or aerial advertisement;

(3)

‘aerodrome climatological summary’ means a concise summary of specified meteorological elements at an aerodrome, based on statistical data;

(4)

‘aerodrome climatological table’ means a table providing statistical data on the observed occurrence of one or more meteorological elements at an aerodrome;

(5)

‘aerodrome elevation’ means the elevation of the highest point of the landing area;

(6)

‘aerodrome flight information service (AFIS)’ means flight information service and alerting service for aerodrome traffic at an aerodrome;

(7)

‘aerodrome meteorological office’ means an office responsible for providing meteorological service for an aerodrome;

(8)

‘aerodrome warning’ means information issued by an aerodrome meteorological office concerning the occurrence or expected occurrence of meteorological conditions which could adversely affect aircraft on the ground, including parked aircraft and the aerodrome facilities and services;

(9)

‘aeronautical data’ means a representation of aeronautical facts, concepts or instructions in a formalised manner suitable for communication, interpretation or processing;

(10)

‘aeronautical database’ means a collection of aeronautical data organised and arranged as a structured data set, stored electronically on systems, which is valid for a dedicated period and may be updated;

(11)

‘aeronautical fixed service (AFS)’ means a telecommunication service between specified fixed points provided primarily for the safety of air navigation and for the regular, efficient and economical operation of air services;

(12)

‘aeronautical fixed telecommunication network (AFTN)’ means a worldwide system of aeronautical fixed circuits provided, as part of the AFS, for the exchange of messages and/or digital data between aeronautical fixed stations having the same or compatible communications characteristics;

(13)

‘aeronautical information’ means information resulting from the assembly, analysis and formatting of aeronautical data;

(14)

‘aerodrome mapping data’ means data collected for the purpose of compiling aerodrome mapping information;

(15)

‘aerodrome mapping database (AMDB)’ means a collection of aerodrome mapping data organised and arranged as a structured data set;

(16)

‘aeronautical meteorological station’ means a station making observations and meteorological reports for use in air navigation;

(17)

‘air-report’ means a report from an aircraft in flight prepared in conformity with the requirements for position and operational and/or meteorological reporting;

(18)

‘aircraft’ means any 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;

(19)

‘AIRMET message’ means information issued by a meteorological watch office concerning the occurrence or expected occurrence of specified en-route weather phenomena which may affect the safety of low-level aircraft operations and of the development of those phenomena in time and space, and which was not already included in the forecast issued for low-level flights in the flight information region concerned or sub-area thereof;

(20)

‘air traffic safety electronics personnel (ATSEP)’ means any authorised personnel who are competent to operate, maintain, release from, and return into operations equipment of the functional system;

(21)

‘air traffic services unit’ is a generic term meaning variously air traffic control unit, flight information centre, aerodrome flight information service unit or air traffic services reporting office;

(22)

‘alternate aerodrome’ means an aerodrome to which an aircraft may proceed when it becomes either impossible or inadvisable to proceed to or to land at the aerodrome of intended landing where the necessary services and facilities are available, where aircraft performance requirements can be met and which is operational at the expected time of use;

(23)

‘alternative means of compliance (AltMOC)’ means those means of compliance that propose an alternative to an existing AMC 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;

(24)

‘altitude’ means the vertical distance of a level, a point, or an object considered as a point, measured from mean sea level;

(25)

‘area control centre (ACC)’ means a unit established to provide air traffic control service to controlled flights in control areas under its jurisdiction;

(26)

‘area forecast for low-level flights’ means a forecast of weather phenomena for a flight information region or sub-area thereof, issued to cover the layer below flight level 100 (or below flight level 150 in mountainous areas, or higher, where necessary);

(27)

‘area navigation (RNAV)’ means a method of navigation which permits aircraft operation on any desired flight path within the coverage of ground- or space-based navigation aids or within the limits of the capability of self-contained aids, or a combination of them;

(28)

‘argument’ means a claim that is supported via inferences by a body of evidence;

(29)

‘ASHTAM’ means a special series of NOTAM notifying by means of a specific format of a change in the activity of a volcano, a volcanic eruption and/or volcanic ash cloud that is of significance to aircraft operations;

(30)

‘ATM network functions’ means the functions performed by the Network Manager in accordance with Regulation (EU) No 677/2011;

(31)

‘audit’ means a systematic, independent and documented process for obtaining evidence and evaluating it objectively to determine the extent to which requirements are complied with;

(32)

‘authoritative source’ means:

(33)

‘automatic observing system’ means an observing system that measures, derives and reports all required elements without human interaction;

(34)

‘aviation undertaking’ means an entity, person or organisation, other than the service providers regulated by this Regulation, that is affected by or affects a service delivered by a service provider;

(35)

‘break’ means a period of time within the duty period when an air traffic controller is not required to perform duties, for recuperation purposes;

(36)

‘certified aircraft application’ means a software application approved by the Agency as part of aircraft subject to Article 4 of Regulation (EC) No 216/2008;

(37)

‘cloud of operational significance’ means a cloud with the height of cloud base below 1 500 m (5 000 ft) or below the highest minimum sector altitude, whichever is greater, or a cumulonimbus cloud or a towering cumulus cloud at any height;

(38)

‘commercial air transport’ means any aircraft operation involving the transport of passengers, cargo or mail for remuneration or other valuable consideration;

(39)

‘control area’ means a controlled airspace extending upwards from a specified limit above the earth;

(40)

‘critical incident stress’ means the manifestation of unusual and/or extreme emotional, physical and/or behavioural reactions of an individual following an event or incident;

(41)

‘data quality’ means a degree or level of confidence that the provided data meets the user's data requirements in terms of accuracy, resolution, integrity (or equivalent assurance level), traceability, timeliness, completeness, and format;

(42)

‘data quality requirements (DQRs)’ means a specification of the characteristics of data (i.e. accuracy, resolution, integrity (or equivalent assurance level), traceability, timeliness, completeness and format) to ensure that the data is compatible with its intended use;

(43)

‘destination alternate’ means an alternate aerodrome at which an aircraft would be able to land should it become either impossible or inadvisable to land at the aerodrome of intended landing;

(44)

‘duty’ means any task that an air traffic controller is required to perform by the air traffic control service provider;

(45)

‘duty period’ means a period which starts when an air traffic controller is required by the air traffic control service provider to report for or be available for or to commence duty and ends when the air traffic controller is free from duty;

(46)

‘elevation’ means the vertical distance of a point or a level, on or affixed to the surface of the earth, measured from mean sea level;

(47)

‘en-route alternate’ means an alternate aerodrome at which an aircraft would be able to land in the event that a diversion becomes necessary while en-route;

(48)

‘fatigue’ means a physiological state of reduced mental or physical performance capability resulting from sleep loss or extended wakefulness, circadian phase or workload (mental or physical activity, or both) that can impair an individual's alertness and ability to safely perform his/her tasks;

(49)

‘flight documentation’ means documents, including charts or forms, containing meteorological information for a flight;

(50)

‘flight information centre (FIC)’ means a unit established to provide flight information service and alerting service;

(51)

‘flight information region (FIR)’ means an airspace of defined dimensions within which flight information service and alerting service are provided;

(52)

‘flight level (FL)’ means a surface of constant atmospheric pressure which is related to a specific pressure datum, 1 013,2 hectopascals (hPa), and is separated from other such surfaces by specific pressure intervals;

(53)

‘flight test’ means a flight for the development phase of a new design (aircraft, propulsion systems, parts and appliances), a flight to demonstrate compliance to certification basis or to type design for aircraft coming from the production line, a flight intended to experiment new design concepts, requiring unconventional manoeuvres or profiles for which it could be possible to exit the already approved envelope of the aircraft or a training flight to perform either of those flights;

(54)

‘forecast’ means a statement of expected meteorological conditions for a specified time or period, and for a specified area or portion of airspace;

(55)

‘forecast for take-off’ means a forecast for a specified period of time, prepared by an aerodrome meteorological office, which contains information on expected conditions over the runways complex in regard to surface wind direction and speed and any variations thereof, temperature, pressure (QNH) and any other element as agreed locally;

(56)

‘functional system’ means a combination of procedures, human resources and equipment, including hardware and software, organised to perform a function within the context of ATM/ANS and other ATM network functions;

(57)

‘general aviation’ means any civil aircraft operation other than aerial work or commercial air transport;

(58)

‘grid point data in digital form’ means computer-processed meteorological data for a set of regularly spaced points on a chart, for transmission from a meteorological computer to another computer in a code form suitable for automated use;

(59)

‘guidance material’ means non-binding material developed by the Agency that helps to illustrate the meaning of a requirement or specification and is used to support the interpretation of Regulation (EC) No 216/2008, its implementing rules and AMC;

(60)

‘gridded global forecasts’ means forecasts of expected values of meteorological elements on a global grid with a defined vertical and horizontal resolution;

(61)

‘hazard’ means any condition, event, or circumstance which could induce a harmful effect;

(62)

‘height’ means the vertical distance of a level, a point or an object considered as a point, measured from a specified datum;

(63)

‘level’ is a generic term relating to the vertical position of an aircraft in flight and meaning variously height, altitude or flight level;

(64)

‘local routine report’ means a meteorological report issued at fixed time intervals, intended only for dissemination at the aerodrome of origin where the observations were made;

(65)

‘local special report’ means a meteorological report issued in accordance with the criteria established for special observations, intended only for dissemination at the aerodrome of origin where the observations were made;

(66)

‘meteorological bulletin’ means a text comprising meteorological information preceded by an appropriate heading;

(67)

‘meteorological information’ means meteorological report, analysis, forecast, and any other statement relating to existing or expected meteorological conditions;

(68)

‘meteorological observation’ means the measurement and/or evaluation of one or more meteorological elements;

(69)

‘meteorological report’ means a statement of observed meteorological conditions related to a specified time and location;

(70)

‘meteorological satellite’ means an artificial Earth satellite making meteorological observations and transmitting these observations to Earth;

(71)

‘meteorological watch office’ means an office monitoring meteorological conditions affecting flight operations and providing information concerning the occurrence or expected occurrence of specified en-route weather phenomena, natural and other hazards which may affect the safety of aircraft operations within a specified area of responsibility;

(72)

‘minimum sector altitude (MSA)’ means the lowest altitude which may be used which will provide a minimum clearance of 300 m (1 000 ft) above all objects located in an area contained within a sector of a circle of 46 km (25 NM) radius centred on a significant point, the aerodrome reference point (ARP) or the heliport reference point (HRP);

(73)

‘NOTAM’ means a notice distributed by means of telecommunication containing information concerning the establishment, condition, or change in any aeronautical facility, service, procedure, or hazard, the timely knowledge of which is essential to personnel concerned with flight operations;

(74)

‘obstacle’ means all fixed (whether temporary or permanent) and mobile objects, or parts thereof, that:

(75)

‘OPMET’ means operational meteorological information for use in preparatory or in-flight planning of flight operations;

(76)

‘OPMET databank’ means a databank established to store and make available internationally operational meteorological information for aeronautical use;

(77)

‘pre-eruption volcanic activity’ means an unusual and/or increasing volcanic activity which could presage a volcanic eruption;

(78)

‘prevailing visibility’ means the greatest visibility value, observed in accordance with the definition of ‘visibility’, which is reached within at least half the horizon circle or within at least half of the surface of the aerodrome. These areas could comprise contiguous or non-contiguous sectors;

(79)

‘problematic use of psychoactive substances’ means the use of one or more psychoactive substances by an individual, in a way that:

(80)

‘prognostic chart’ means a forecast of (a) specified meteorological element(s) for a specified time or period and a specified surface or portion of airspace, depicted graphically on a chart;

(81)

‘psychoactive substances’ means alcohol, opioids, cannabinoids, sedatives and hypnotics, cocaine, other psychostimulants, hallucinogens, and volatile solvents, whereas caffeine and tobacco are excluded;

(82)

‘rescue coordination centre (RCC)’ means a unit responsible for promoting efficient organisation of search and rescue services, and for coordinating the conduct of search and rescue operations within a search and rescue region;

(83)

‘rest period’ means a continuous and defined period of time, subsequent to and/or prior to duty, during which an air traffic controller is free of all duties;

(84)

‘rostering system’ means the structure of duty and rest periods of air traffic controllers in accordance with legal and operational requirements;

(85)

‘risk’ means the combination of the overall probability or frequency of occurrence of a harmful effect induced by a hazard and the severity of that effect;

(86)

‘runway’ means a defined rectangular area on a land aerodrome prepared for the landing and take-off of aircraft;

(87)

‘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;

(88)

‘safety directive’ means a document issued or adopted by a competent authority which mandates actions to be performed on a functional system or sets restrictions to its operational use to restore safety when evidence shows that aviation safety may otherwise be compromised;

(89)

‘safety management system (SMS)’ means a systematic approach to managing safety, including the necessary organisational structures, accountabilities, policies, and procedures;

(90)

‘search and rescue services unit’ is a generic term covering, as the case may be, rescue coordination centre, rescue sub-centre or alerting post;

(91)

‘selected volcano observatory’ means a provider, selected by the competent authority, that observes the activity of a volcano or a group of volcanoes and makes these observations available to an agreed list of aviation recipients;

(92)

‘semi-automatic observing system’ means an observing system that allows the augmentation of measured elements and requires a human in the loop for issuing the appropriate reports;

(93)

‘SIGMET’ means information concerning en-route weather phenomena, which may affect the safety of aircraft operations;

(94)

‘SIGMET message’ means information issued by a meteorological watch office concerning the occurrence or expected occurrence of specified en-route weather phenomena which may affect the safety of aircraft operations and of the development of those phenomena in time and space;

(95)

‘special air-report’ means a meteorological report by an aircraft issued in accordance with the criteria based on observations made during the flight;

(96)

‘stress’ means the outcomes experienced by an individual when faced with a potential cause (‘stressor’) of human performance modification. The experience of the stressor may impact the individual's performance negatively (distress), neutrally or positively (eustress), based on the individual's perception of his/her ability to manage the stressor;

(97)

‘system and equipment rating training’ means training designed to impart specific system/equipment knowledge and skills leading towards operational competence;

(98)

‘tailored data’ means aeronautical data which is provided by the aircraft operator or DAT provider on the aircraft operator's behalf and produced for this aircraft operator for its intended operational use;

(99)

‘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 be not possible to use the aerodrome of departure;

(100)

‘terminal aerodrome forecast (TAF)’ means a concise statement of the expected meteorological conditions at an aerodrome for a specified period;

(101)

‘terrain’ means the surface of the Earth containing naturally occurring features such as mountains, hills, ridges, valleys, bodies of water, permanent ice and snow, and excluding obstacles;

(102)

‘threshold’ means the beginning of that portion of the runway usable for landing;

(103)

‘touchdown zone’ means the portion of a runway, beyond the threshold, where it is intended that landing aeroplanes first contact the runway;

(104)

‘tropical cyclone’ is a generic term for a non-frontal synoptic-scale cyclone originating over tropical or subtropical waters with organised convection and definite cyclonic surface wind circulation;

(105)

‘tropical cyclone advisory centre (TCAC)’ means a meteorological centre providing advisory information to meteorological watch offices, world area forecast centres and international OPMET databanks regarding the position, forecast direction and speed of movement, central pressure and maximum surface wind of tropical cyclones;

(106)

‘visibility’ means visibility for aeronautical purposes, which is the greater of:

(107)

‘volcanic ash advisory centre (VAAC)’ means a meteorological centre providing advisory information to meteorological watch offices, area control centres, flight information centres, world area forecast centres and international OPMET databanks regarding the lateral and vertical extent and forecast movement of volcanic ash in the atmosphere following volcanic eruptions;

(108)

‘world area forecast centre (WAFC)’ means a meteorological centre preparing and issuing significant weather forecasts and upper-air forecasts in digital form on a global basis direct to the Member States by appropriate means as part of the aeronautical fixed service;

(109)

‘world area forecast system (WAFS)’ means a worldwide system by which world area forecast centres provide aeronautical meteorological en-route forecasts in uniform standardised formats.

(a)

The competent authority shall exercise certification, oversight and enforcement tasks in respect of the application of the requirements applicable to service providers, monitor the safe provision of their services and verify that the applicable requirements are met.

(b)

The competent authorities shall identify and exercise the responsibilities for certification, oversight and enforcement in a manner which ensures that:

The competent authorities concerned shall regularly review the agreement on the supervision of the service providers providing air navigation services in functional airspace blocks (FABs) that extend across the airspace falling under the responsibility of more than one Member States referred to in Article 2(3) of Regulation (EC) No 550/2004 and, in the case of cross-border provision of air navigation services, the agreement on the mutual recognition of supervisory tasks referred to in Article 2(5) of Regulation (EC) No 550/2004, as well as the practical implementation of those agreements, in particular in the light of achieved safety performance of the service providers under their supervision.

(c)

The competent authority shall establish coordination arrangements with other competent authorities for notified changes to functional systems involving service providers under the oversight of the other competent authorities. Those coordination arrangements shall ensure the effective selection and review of those notified changes, in accordance with point ATM/ANS.AR.C.025.

(a)

The Agency shall develop acceptable means of compliance (AMC) that may be used to establish compliance with the requirements of this Regulation. When AMC are complied with, the applicable requirements of this Regulation shall be deemed to have been met.

(b)

Alternative means of compliance (AltMOC) may be used to establish compliance with the requirements of this Regulation.

(c)

The competent authority shall establish a system to consistently evaluate that all AltMOC used by itself or by the service providers under its oversight allow the establishment of compliance with the requirements of this Regulation.

(d)

The competent authority shall evaluate all AltMOC proposed by a service provider in accordance with point ATM/ANS.OR.A.020 by analysing the documentation provided and, if considered necessary, conducting an inspection of the service provider.

When the competent authority finds that the AltMOC are sufficient to ensure compliance with the applicable requirements of this Regulation it shall without undue delay:

(e)

When the competent authority itself uses AltMOC to achieve compliance with the applicable requirements of this Regulation, it shall:

The competent authority shall provide the Agency with a full description of the AltMOC, including any revisions to procedures that may be relevant, as well as an assessment demonstrating that the applicable requirements of this Regulation are met.

(a)

The competent authority shall without undue delay notify the Agency in case of any significant problems with the implementation of the relevant provisions of Regulation (EC) No 216/2008 and its implementing rules or of Regulations (EC) No 549/2004, (EC) No 550/2004, (EC) No 551/2004 and Regulation (EC) No 552/2004 of the European Parliament and of the Council (1) applicable to service providers.

(b)

Without prejudice to Regulation (EU) No 376/2014 of the European Parliament and of the Council (2), the competent authority shall provide the Agency with safety-significant information stemming from the occurrence reports it has received.

(a)

Without prejudice to Regulation (EU) No 376/2014, 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 from the competent authorities and without undue delay provide to Member States and the Commission, as appropriate, any information, including recommendations or corrective actions to be taken, necessary for them to react in a timely manner to a safety problem involving the service providers.

(c)

Upon receiving the information referred to in points (a) and (b), the competent authority shall take adequate measures to address the safety problem, including the issuing of safety directives in accordance with point ATM/ANS.AR.A.030.

(d)

Measures taken under point (c) shall immediately be notified to the service providers concerned to comply with them, in accordance with point ATM/ANS.OR.A.060. The competent authority shall also notify those measures to the Agency and, when combined action is required, the other competent authorities concerned.

(a)

The competent authority shall issue a safety directive when it has determined the existence of an unsafe condition in a functional system requiring immediate action.

(b)

The safety directive shall be forwarded to the service providers concerned and contain, as a minimum, the following information:

(c)

The competent authority shall forward a copy of the safety directive to the Agency and any other competent authorities concerned within one month from its issuance.

(d)

The competent authority shall verify the compliance of service providers with the applicable safety directives.

(a)

The competent authority shall establish and maintain a management system, including, as a minimum, the following elements:

(b)

The competent authority shall, for each field of activity included in the 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 exchange of all findings raised and follow-up actions taken as a result of certification and oversight of service providers 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.

(a)

The competent authority may allocate its tasks related to the certification or oversight of service providers under this Regulation, other than the issuance of certificates themselves, to qualified entities. When allocating such tasks, the competent authority shall ensure that it has:

(b)

The competent authority shall ensure that the internal audit process and the safety risk management process required by point ATM/ANS.AR.B.001(a)(4) cover all tasks performed on its behalf by the qualified entity.

(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 under this Regulation. This system shall enable it to take action, as appropriate, to ensure that the management system remains adequate and effective.

(b)

The competent authority shall update its management system to reflect any change to this Regulation in a timely manner, so as to ensure effective implementation.

(c)

The competent authority shall notify the Agency of significant changes affecting its capability to perform its tasks and discharge its responsibilities under this Regulation

(a)

The competent authority shall establish a system of record-keeping providing for adequate storage, accessibility, and reliable traceability of:

(b)

The competent authority shall maintain a list of all service provider certificates issued and declarations received.

(c)

All records shall be kept for a minimum period of 5 years after the certificate ceases to be valid or the declaration is withdrawn, subject to the applicable data protection law.

(a)

The competent authorities shall regularly monitor and assess the safety performance of the service providers under their oversight.

(b)

The competent authorities shall use the results of the monitoring of safety performance in particular within their risk-based oversight.

(a)

Within the framework of point ATM/ANS.AR.B.001(a)(1), the competent authority shall establish a process in order to verify:

(b)

The process referred to in point (a) shall:

(a)

The competent authority, or qualified entities acting on its behalf, shall conduct audits, in accordance with Article 5.

(b)

The audits referred to in point (a) shall:

(c)

The competent authority shall, on the basis of the evidence at its disposal, monitor the continuous compliance with the applicable requirements of this Regulation of the service providers under its oversight.

(a)

The competent authority shall establish and update annually an oversight programme taking into account the specific nature of the service providers, the complexity of their activities, the results of past certification and/or oversight activities and shall be based on the assessment of associated risks. It shall include audits, which shall:

(b)

The competent authority may decide to modify the objectives and the scope of pre-planned audits, including documentary reviews and additional audits, wherever that need arises.

(c)

The competent authority shall decide which arrangements, elements, services, functions, physical locations, and activities are to be audited within a specified time frame.

(d)

Audit observations and findings issued in accordance with point ATM/ANS.AR.C.050 shall be documented. The latter shall be supported by evidence, and identified in terms of the applicable requirements and their implementing arrangements against which the audit has been conducted.

(e)

An audit report, including the details of the findings and observations, shall be drawn up and communicated to the service provider concerned.

(a)

Following the process laid down in point ATM/ANS.AR.C.005(a), upon receiving an application for the issuance of a certificate to a service provider, the competent authority shall verify the service provider's compliance with the applicable requirements of this Regulation.

(b)

The competent authority may require any audits, inspections or assessments it finds necessary before issuing the certificate.

(c)

The certificate shall be issued for an unlimited duration. The privileges of the activities that the service provider is approved to conduct shall be specified in the service provision conditions attached to the certificate.

(d)

The certificate shall not be issued where a level 1 finding remains open. In exceptional circumstances, finding(s), other than level 1, shall be assessed and mitigated as necessary by the service provider and a corrective action plan for closing the finding(s) shall be approved by the competent authority prior to the certificate being issued.

(a)

Upon receiving a notification for a change in accordance with point ATM/ANS.OR.A.045, the competent authority shall comply with points ATM/ANS.AR.C.030, ATM/ANS.AR.C.035 and ATM/ANS.AR.C.040.

(b)

Upon receiving a notification for a change in accordance with point ATM/ANS.OR.A.040(a)(2) that requires prior approval, the competent authority shall:

(c)

To enable a service provider to implement changes to its management system and/or safety management system, as applicable, without prior approval in accordance with point ATM/ANS.OR.A.040 (b), the competent authority shall approve a procedure defining the scope of such changes and describing how such changes will be notified and managed. In the continuous oversight process, the competent authority shall assess the information provided in the notification to verify whether the actions taken comply with the approved procedures and applicable requirements. In case of any non-compliance, the competent authority shall:

(a)

The competent authority shall review:

(b)

The competent authority shall approve the procedures, modifications and deviations referred to in point (a) when it has determined that they are necessary and sufficient for the service provider to demonstrate compliance with points ATM/ANS.OR.A.045, ATM/ANS.OR.C.005, ATS.OR.205, and ATS.OR.210, as applicable.

(a)

Upon receipt of a notification in accordance with point ATM/ANS.OR.A.045(a)(1), or upon receipt of modified information in accordance with point ATM/ANS.OR.A.045(b), the competent authority shall make a decision on whether to review the change or not. The competent authority shall request any additional information needed from the service provider to support this decision.

(b)

The competent authority shall determine the need for a review based on specific, valid and documented criteria that, as a minimum, ensure that the notified change is reviewed if the combination of the likelihood of the argument being complex or unfamiliar to the service provider and the severity of the possible consequences of the change is significant.

(c)

When the competent authority decides the need for a review based on other risk based criteria in addition to point (b), these criteria shall be specific, valid and documented.

(d)

The competent authority shall inform the service provider of its decision to review a notified change to a functional system and provide the associated rationale to the service provider upon request.

(a)

When the competent authority reviews the argument for a notified change, it shall:

(b)

The competent authority shall, alternatively:

(a)

Upon receiving a declaration from a provider of flight information services intending to provide such services, the competent authority shall verify that the declaration contains all the information required by point ATM/ANS.OR.A.015 and shall acknowledge receipt of the declaration to that service provider.

(b)

If the declaration does not contain the required information, or contains information that indicates non-compliance with the applicable requirements, the competent authority shall notify the provider of flight information services concerned about the non-compliance and request further information. If necessary, the competent authority shall carry out an audit of the provider of flight information services. If the non-compliance is confirmed, the competent authority shall take action provided for in point ATM/ANS.AR.C.050.

(c)

The competent authority shall keep a register of the declarations of providers of flight information services which were made to it in accordance with this Regulation.

(a)

The competent authority shall have a system to analyse findings for their safety significance and decide on enforcement measures on the basis of the safety risk posed by the service provider's non-compliance.

(b)

In circumstances where no or very low additional safety risk would be present with immediate appropriate mitigation measures, the competent authority may accept the provision of services to ensure continuity of service whilst corrective actions are being taken.

(c)

A level 1 finding shall be issued by the competent authority when any serious non-compliance is detected with the applicable requirements of Regulation (EC) No 216/2008 and its implementing rules as well as Regulations (EC) No 549/2004, (EC) No 550/2004, (EC) No 551/2004, and (EC) No 552/2004 and their implementing rules, with the service provider's procedures and manuals, with the terms of conditions of certificate or certificate, with the designation act, if applicable, or with the content of a declaration which poses a significant risk to flight safety or otherwise calls into question the service provider's capability to continue operations.

Level 1 findings shall include but not be limited to:

(d)

A level 2 finding shall be issued by the competent authority when any other non-compliance is detected with the applicable requirements of Regulation (EC) No 216/2008 and its implementing rules as well as Regulations (EC) No 549/2004, (EC) No 550/2004, (EC) No 551/2004, and (EC) No 552/2004 and their implementing rules, with the service provider's procedures and manuals or with the terms of conditions or certificate, or with the content of a declaration.

(e)

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 this Regulation, as well as Regulations (EC) No 549/2004, (EC) No 550/2004, (EC) No 551/2004 and (EC) No 552/2004 and their implementing rules, communicate the finding to the service provider in writing and require corrective action to address the non-compliance(s) identified.

(f)

For those cases not requiring level 1 and 2 findings, the competent authority may issue observations.

(a)

Application for a service provider 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 this Regulation.

(b)

In accordance with Article 6, in order to obtain the certificate, the service provider shall comply with:

(a)

Notwithstanding point (b), the air traffic services provider may apply for a certificate limited to the provision of services in the airspace under the responsibility of the Member State where its principal place of operation or, if any, registered office is located, when it provides or plans to provide services only with respect to one or more of the following categories:

(b)

In addition, the following air navigation service providers may also apply for a limited certificate:

(c)

As determined by the competent authority, an air navigation service provider applying for a limited certificate in accordance with points (a) or (b)(1) shall comply, as a minimum, with the following requirements set out in:

(d)

As determined by the competent authority, the air navigation service provider applying for a limited certificate in accordance with point (b)(2) shall comply, as a minimum, with the requirements set out in points (c)(1) to (c)(4) and with the specific requirements set out in Annex IV.

(e)

An applicant for a limited certificate shall submit an application to the competent authority in a form and manner established by the competent authority.

(a)

Pursuant to Article 7, a flight information services provider may declare its capability and means of discharging the responsibilities associated with the services provided where it meets, in addition to the requirements referred to in Article 8b(1) of Regulation (EU) No 216/2008, the following alternative requirements:

(b)

A flight information services provider declaring its activities shall:

(c)

Before ceasing the provision of its services, the flight information services provider declaring its activities shall notify the competent authority within a period determined by the competent authority.

(d)

A flight information services provider declaring its activities shall comply with the following requirements set out in:

(e)

A flight information services provider declaring its activities shall only start operation after receiving the acknowledgement of receipt of the declaration from the competent authority.

(a)

Alternative means of compliance (AltMOC) to the AMC adopted by the Agency may be used by the service provider to establish compliance with the requirements of this Regulation.

(b)

When the service provider wishes to use an AltMOC, it shall, prior to implementing it, provide the competent authority with a full description of the AltMOC. The description shall include any revisions to manuals or procedures that may be relevant, as well as an assessment demonstrating compliance with the requirements of this Regulation.

A service provider may implement these alternative means of compliance subject to prior approval by the competent authority and upon receipt of the notification as prescribed in point ATM/ANS.AR.A.015(d).

(a)

A service provider's certificate shall remain valid subject to:

(b)

Upon revocation or surrender, the certificate shall be returned to the competent authority without delay.

(a)

the flight information services remaining in compliance with the applicable requirements of this Regulation, including those concerning facilitating and cooperating for the purposes of the exercise of the powers of the competent authorities and those concerning the handling of findings as specified in point ATM/ANS.OR.A.050 and ATM/ANS.OR.A.055 respectively;

(b)

the declaration not having been withdrawn by the provider of such services or deregistered by the competent authority.

(a)

The notification and management of:

(b)

Any change as referred to in point (a)(2) shall require prior approval before implementation, unless such a change is notified and managed in accordance with a procedure approved by the competent authority as laid down in point ATM/ANS.AR.C.025(c).

(a)

A service provider planning a change to its functional system shall:

(b)

Having notified a change, the service provider shall inform the competent authority whenever the information provided in accordance with points (a)(1) and (2) is materially modified, and the relevant service providers and aviation undertakings whenever the information provided in accordance with point (a)(3) is materially modified.

(c)

A service provider shall only allow the parts of the change, for which the activities required by the procedures referred to in point ATM/ANS.OR.B.010 have been completed, to enter into operational service.

(d)

If the change is subject to competent authority review in accordance with point ATM/ANS.AR.C.035, the service provider shall only allow the parts of the change for which the competent authority has approved the argument to enter into operational service.

(e)

When a change affects other service providers and/or aviation undertakings, as identified in point (a)(3), the service provider and these other service providers, in coordination, shall determine:

(f)

Those service providers affected by the assumptions and risk mitigations referred to in point (e)(2) shall only use, in their argument for the change, agreed and aligned assumptions and risk mitigations with each other and, where feasible, with aviation undertakings.

(a)

identify the root cause of the non-compliance;

(b)

define a corrective action plan that meets the approval by the competent authority;

(c)

demonstrate corrective action implementation to the satisfaction of the competent authority within the time period proposed by the service provider and agreed with that authority, as defined in point ATM/ANS.AR.C.050(e).

(a)

A service provider shall report to the competent authority, and to any other organisation required by the Member State where the service provider provides its services, any accident, serious incident and occurrence as defined in Regulation (EU) No 996/2010 of the European Parliament and of the Council (1) and Regulation (EU) No 376/2014.

(b)

Without prejudice to point (a), the service provider shall report to the competent authority and to the organisation responsible for the design of system and constituents, if different from the service provider, any malfunction, technical defect, exceeding of technical limitations, occurrence, or other irregular circumstance that has or may have endangered the safety of services and that has not resulted in an accident or serious incident.

(c)

Without prejudice to Regulations (EU) No 996/2010 and (EU) No 376/2014, the reports referred to in points (a) and (b) shall be made in a form and manner established by the competent authority and contain all the pertinent information about the event known to the service provider.

(d)

Reports shall be made as soon as possible and in any case within 72 hours of the service provider identifying the details of the event to which the report relates unless exceptional circumstances prevent this.

(e)

Without prejudice to Regulation (EU) No 376/2014, where relevant, the service provider 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.

(a)

A service provider shall provide its services in an open and transparent manner. It shall publish the conditions of access to its services and changes thereto and establish a consultation process with the users of its services on a regular basis or as needed for specific changes in service provision, either individually or collectively.

(b)

A service provider shall not discriminate on grounds of nationality or other characteristic of the user or the class of users of its services in a manner that is contrary to Union law.

(a)

A service provider shall implement and maintain a management system that includes:

(b)

A service provider shall document all management system key processes, including a process for making personnel aware of their responsibilities, and the procedure for the amendment of those processes.

(c)

A service provider shall establish a function to monitor compliance of its organisation with the applicable requirements and the adequacy of the procedures. Compliance monitoring shall include a feedback system of findings to the accountable manager to ensure effective implementation of corrective actions as necessary.

(d)

A service provider shall monitor the behaviour of its functional system and, where underperformance is identified, it shall establish its causes and eliminate them or, after having determined the implication of the underperformance, mitigate its effects.

(e)

The management system shall be proportionate to the size of the service provider and the complexity of its activities, taking into account the hazards and associated risks inherent in those activities.

(f)

Within its management system, the service provider shall establish formal interfaces with the relevant service providers and aviation undertakings in order to:

(g)

In the case that the service provider holds also an aerodrome operator certificate, it shall ensure that the management system covers all activities in the scope of its certificates.

(a)

A service provider shall use procedures to manage, assess and, if necessary, mitigate the impact of changes to its functional systems in accordance with points ATM/ANS.OR.A.045, ATM/ANS.OR.C.005, ATS.OR.205 and ATS.OR.210, as applicable.

(b)

The procedures referred to in point (a) or any material modifications to those procedures shall:

(c)

When the approved procedures referred to in point (b) are not suitable for a particular change, the service provider shall:

(a)

Contracted activities include all the activities within the scope of the service provider's operations, in accordance with the terms of the certificate, that are performed by other organisations either themselves certified to carry out such activity or if not certified, working under the service provider's oversight. A service provider shall ensure that when contracting or purchasing any part of its activities to external organisations, the contracted or purchased activity, system or constituent conforms to the applicable requirements.

(b)

When a service provider contracts any part of its activities to an organisation that is not itself certified in accordance with this Regulation to carry out such activity, it shall ensure that the contracted organisation works under its oversight. The service provider shall ensure that the competent authority is given access to the contracted organisation to determine continued compliance with the applicable requirements under this Regulation.

(a)

A service provider shall appoint an accountable manager, who has the authority over 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 service provider shall define the authority, duties and responsibilities of the nominated post holders, in particular of the management personnel in charge of safety, quality, security, finance and human resources-related functions as applicable.

(a)

A service provider shall establish a system of record-keeping that allows adequate storage of the records and reliable traceability of all its activities, covering in particular all the elements indicated in point ATM/ANS.OR.B.005.

(b)

The format and the retention period of the records referred to in point (a) shall be specified in the service provider's management system procedures.

(c)

Records shall be stored in a manner that ensures protection against damage, alteration and theft.

(a)

A service provider shall provide and keep up to date its operations manuals relating to the provision of its services for the use and guidance of operations personnel.

(b)

It shall ensure that:

(a)

For any change notified in accordance with point ATM/ANS.OR.A.045(a)(1), the service provider other than the air traffic services provider shall:

(b)

A service provider other than an air traffic services provider shall ensure that the safety support assessment referred to in point (a) comprises:

(1)

Air navigation services and air traffic flow management providers shall produce a business plan covering a minimum period of five years. The business plan shall:

(2)

The information listed in points (i) and (ii) of point (1) shall be aligned with the performance plan referred to in Article 11 of Regulation (EC) No 549/2004 and, as far as safety data is concerned, it shall be consistent with the state safety programme referred to in Standard 3.1.1 of Annex 19 to the Chicago Convention in its first edition of July 2013.

(3)

Air navigation services and air traffic flow management providers shall provide safety and business justifications for major investment projects including, where relevant, the estimated impact on the appropriate performance targets referred to in point (1)(ii) and identifying investments stemming from the legal requirements associated with the implementation of the Single European Sky ATM Research Programme (SESAR).

(1)

Air navigation services and air traffic flow management providers shall produce an annual plan covering the forthcoming year which shall further specify the features of the business plan and describe any changes to it as compared to the previous plan.

(2)

The annual plan shall cover the following provisions on the level and quality of service, such as the expected level of capacity, safety, environment and cost-efficiency:

(a)

Air navigation services and air traffic flow management providers and the Network Manager shall, as an integral part of their management system as required in point ATM/ANS.OR.B.005, establish a security management system to ensure:

(b)

The security management system shall define:

(c)

Air navigation services and air traffic flow management providers and the Network Manager shall ensure the security clearance of their personnel, if appropriate, and coordinate with the relevant civil and military authorities to ensure the security of their facilities, personnel and data.

(d)

Air navigation services and air traffic flow management providers and the Network Manager shall take the necessary measures to protect their systems, constituents in use and data and prevent compromising the network against information and cyber security threats which may have an unlawful interference with the provision of their service.

(a)

Air navigation services and air traffic flow management providers and the Network Manager shall have in place arrangements to cover liabilities related to the execution of their tasks in accordance with the applicable law.

(b)

The method employed to provide the cover shall be appropriate to the potential loss and damage in question, taking into account the legal status of the providers concerned and the Network Manager and the level of commercial insurance cover available.

(c)

Air navigation services and air traffic flow management providers and the Network Manager which avail themselves of services of another service provider shall ensure that the agreements that they conclude to that effect specify the allocation of liability between them.

(a)

Air navigation services and air traffic flow management providers shall provide an annual report of their activities to the competent authority.

(b)

For air navigation services and air traffic flow management providers, the annual report shall cover their financial results, without prejudice to Article 12 of Regulation (EC) No 550/2004, as well as their operational performance and any other significant activities and developments in particular in the area of safety.

(c)

The Network Manager shall, in accordance with Article 20 of Regulation (EU) No 677/2011, provide an annual report of its activities to the Commission and the Agency. This report shall cover its operational performance, as well as significant activities and developments in particular in the area of safety.

(d)

The annual reports referred to in points (a) and (c) shall include as a minimum:

(e)

Air navigation services and air traffic flow management providers and the Network Manager shall make their annual reports available to the Commission and the Agency on their request. They shall also make those reports available to the public, under the conditions set by the competent authority in accordance with Union and national law.

(a)

An air traffic services provider shall notify the competent authorities of:

(b)

An air traffic services provider shall take all necessary measures to prevent any situation of conflict of interests that could compromise the impartial and objective provision of its services.

(1)

Safety policy and objectives

(2)

Safety risk management

(3)

Safety assurance

(4)

Safety promotion

(a)

For any change notified in accordance with point ATM/ANS.OR.A.045(a)(1), the air traffic services provider shall:

(b)

An air traffic services provider shall ensure that the safety assessment referred to in point (a) comprises:

(a)

An air traffic services provider shall determine the safety acceptability of a change to a functional system, based on the analysis of the risks posed by the introduction of the change, differentiated on basis of types of operations and stakeholder classes, as appropriate.

(b)

The safety acceptability of a change shall be assessed by using specific and verifiable safety criteria, where each criterion is expressed in terms of an explicit, quantitative level of safety risk or another measure that relates to safety risk.

(c)

An air traffic services provider shall ensure that the safety criteria:

(a)

prevent and mitigate the risk that air traffic control service is provided by air traffic controllers with problematic use of psychoactive substances;

(b)

prevent and mitigate the negative effects of stress on air traffic controllers to ensure the safety of air traffic;

(c)

prevent and mitigate the negative effects of fatigue on air traffic controllers to ensure the safety of air traffic.

(a)

An air traffic control service provider shall develop and implement a policy, with related procedures, in order to ensure that the problematic use of psychoactive substances does not affect the provision of air traffic control service.

(b)

Without prejudice to provisions laid down in Directive 95/46/EC of the European Parliament and of the Council (1) and to the applicable national legislation on testing of individuals, the air traffic control service provider shall develop and implement an objective, transparent and non-discriminatory procedure for the detection of cases of problematic use of psychoactive substances by air traffic controllers. This procedure shall take into account provisions laid down in point ATCO.A.015 of Regulation (EU) 2015/340.

(c)

The procedure in point (b) shall be approved by the competent authority.

(a)

develop and maintain a policy for the management of air traffic controllers' stress, including the implementation of a critical incident stress management programme;

(b)

provide air traffic controllers with education and information programmes on the prevention of stress, including critical incident stress, complementing human factors training provided in accordance with Sections 3 and 4 of Subpart D of Annex I to Regulation (EU) 2015/340.

(a)

develop and maintain a policy for the management of air traffic controllers' fatigue;

(b)

provide air traffic controllers with information programmes on the prevention of fatigue, complementing human factors training provided in accordance with Sections 3 and 4 of Subpart D of Annex I to Regulation (EU) 2015/340.

(a)

An air traffic control service provider shall develop, implement and monitor a rostering system in order to manage the risks of occupational fatigue of air traffic controllers through a safe alternation of duty and rest periods. Within the rostering system, the air traffic control service provider shall specify the following elements:

(b)

An air traffic control services provider shall consult those air traffic controllers who will be subject to the rostering system, or, as applicable, their representatives, during its development and its application, to identify and mitigate risks concerning fatigue which could be due to the rostering system itself.

(a)

An air traffic services provider shall be able to demonstrate that its working methods and operating procedures are compliant with:

(b)

Notwithstanding point (a), for air traffic services units providing services for flight testing, the competent authority may specify additional or alternative conditions and procedures to those contained in point (a) when so required for the provision of services for flight testing.

(a)

A meteorological services provider shall provide operators, flight crew members, air traffic services units, search and rescue services units, aerodrome operators, accident and incident investigation bodies, and other service providers and aviation entities with the meteorological information necessary for the performance of their respective functions, as determined by the competent authority.

(b)

A meteorological services provider shall confirm the operationally desirable accuracy of the information distributed for operations, including the source of such information, whilst also ensuring that such information is distributed in a timely manner and updated, as required.

(a)

A meteorological services provider shall retain meteorological information issued for a period of at least 30 days from the date of issue.

(b)

This meteorological information shall be made available, on request, for inquiries or investigations and, for these purposes, shall be retained until the inquiry or investigation is completed.

(a)

enable the exchange of operational meteorological information with other meteorological services providers;

(b)

provide the required meteorological information to the users in a timely manner.

(a)

icing, turbulence, cumulonimbus clouds that are obscured, frequent, embedded, or occurring at a squall line, and sandstorms/dust storms;

(b)

volcanic eruptions or a release of radioactive materials into the atmosphere of significance to aircraft operations.

(a)

An aeronautical meteorological station shall disseminate:

(b)

An aeronautical meteorological station shall inform the air traffic service units and aeronautical information service of an aerodrome of changes in the serviceability status of the automated equipment used for assessing runway visual range.

(c)

An aeronautical meteorological station shall report to the associated air traffic services unit, aeronautical information services unit, and meteorological watch office the occurrence of pre-eruption volcanic activity, volcanic eruptions and volcanic ash cloud.

(d)

An aeronautical meteorological station shall establish a list of criteria to provide local special reports in consultation with the appropriate ATS units, operators and others concerned.

(a)

surface wind direction and speed;

(b)

visibility;

(c)

runway visual range, if applicable;

(d)

present weather at the aerodrome and its vicinity;

(e)

clouds;

(f)

air temperature and dew point temperature;

(g)

atmospheric pressure;

(h)

supplementary information when applicable.

(a)

surface wind direction and speed;

(b)

visibility;

(c)

runway visual range, if applicable;

(d)

present weather at the aerodrome and its vicinity;

(e)

clouds;

(f)

air temperature and dew point temperature;

(g)

atmospheric pressure;

(h)

supplementary information, when applicable:

(a)

prepare and/or obtain forecasts and other relevant meteorological information necessary for the performance of its respective functions for flights with which it is concerned, as determined by the competent authority;

(b)

provide forecasts and/or warnings for local meteorological conditions on aerodromes for which it is responsible;

(c)

keep the forecasts and warnings under continuous review and issue amendments promptly when necessary, and cancel any forecast of the same type previously issued for the same place and for the same period of validity or part thereof;

(d)

provide briefing, consultation and flight documentation to flight crew members and/or other flight operations personnel;

(e)

provide climatological information;

(f)

provide its associated air traffic services unit, aeronautical information service unit and meteorological watch office with information received on pre-eruption volcanic activity, a volcanic eruption or volcanic ash cloud;

(g)

provide, if applicable, meteorological information to search and rescue services units and maintain liaison with the search and rescue services unit(s) throughout a search and rescue operation;

(h)

provide meteorological information to relevant aeronautical information services units, as necessary, for the conduct of their functions;

(i)

prepare and/or obtain forecast and other relevant meteorological information necessary for the performance of the ATS units functions in accordance with point MET.OR.242;

(j)

provide its associated air traffic services unit, aeronautical information service unit and meteorological watch offices with information received on the release of radioactive materials into the atmosphere.

(a)

An aerodrome meteorological office shall issue aerodrome forecasts as a TAF at a specified time.

(b)

When issuing TAF, the aerodrome meteorological office shall ensure that not more than one TAF is valid at an aerodrome at any given time.

(a)

An aerodrome meteorological office shall prepare forecasts for landing as determined by the competent authority.

(b)

This forecast for landing shall be issued in the form of a TREND forecast.

(c)

The period of validity of a TREND forecast shall be 2 hours from the time of the report which forms part of the landing forecast.