Regulation (EU) 2018/1139 of the European Parliament and of the Council of 4 July 2018 on common rules in the field of civil aviation and establishing a European Union Aviation Safety Agency, and amending Regulations (EC) No 2111/2005, (EC) No 1008/2008, (EU) No 996/2010, (EU) No 376/2014 and Directives 2014/30/EU and 2014/53/EU of the European Parliament and of the Council, and repealing Regulations (EC) No 552/2004 and (EC) No 216/2008 of the European Parliament and of the Council and Council Regulation (EEC) No 3922/91 (Text with EEA relevance.)

Article 128

Exercise of the delegation

Article 129

Participation of European third countries

The Agency shall be open to the participation of European third countries which are contracting parties to the Chicago Convention and which have entered into international agreements with the Union pursuant to which they adopted and apply Union law in the fields covered by this Regulation.

Those international agreements may include provisions specifying, in particular, the nature and extent of the participation by the European third country concerned in the work of the Agency, including provisions on financial contributions and staff. The Agency may, in accordance with Article 90(2), establish working arrangements with the competent authority of the European third country concerned in order to give effect to those provisions.

Article 130

Headquarters Agreement and operating conditions

Article 131

Penalties

Member States shall lay down the rules on penalties applicable to infringement of this Regulation and of the delegated and implementing acts adopted on the basis thereof and shall take all measures necessary to ensure that they are implemented. The penalties provided for shall be effective, proportionate and dissuasive.

Article 132

Processing of personal data

Article 133

Amendment to Regulation (EC) No 2111/2005

In Article 15 of Regulation (EC) No 2111/2005, paragraphs 1 to 3 are replaced by the following:

‘1. The Commission shall be assisted by a committee (‘EU Air Safety Committee’). That committee shall be a committee within the meaning of Regulation (EU) No 182/2011.

1. Where reference is made to this paragraph, Article 4 of Regulation (EU) No 182/2011 shall apply.

1. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply.’.

Article 134

Amendments to Regulation (EC) No 1008/2008

Regulation (EC) No 1008/2008 is amended as follows:

• (1) in Article 4, point (b) is replaced by the following: ‘(b)it holds a valid AOC issued in accordance with Regulation (EU) 2018/1139 of the European Parliament and of the Council ([^E0020]) either by a national authority of a Member State, by several national authorities of Member States acting jointly in accordance with Article 62(5) of that Regulation or by the European Union Aviation Safety Agency.

• (2) Article 6 is replaced by the following: ‘Article 6 Air operator certificate

The authority competent for the AOC shall inform the competent licensing authority as soon as possible of any relevant proposed changes to the AOC.

That exchange may include, without being limited to, information relating to the financial, ownership or organisational arrangements of the Community air carrier which may affect the safety or solvency of its operations or which may assist the authority competent for the AOC in performing its oversight activities related to safety. Where information is provided in confidence, measures shall be put in place to ensure that the information is appropriately protected. 3a. Where it is likely that enforcement action will be necessary, the authority competent for the AOC and the competent licensing authority shall consult each other as soon as possible prior to taking such action, and work together in seeking to resolve the issues before action is taken. Where action is taken, the authority competent for the AOC and the competent licensing authority shall notify each other as soon as possible that action has been taken.’;

• (3) in Article 12, paragraph 1 is replaced by the following: ‘1. Aircraft used by a Community air carrier shall be registered, at the option of the Member State whose competent authority issues the operating licence, either in its own national register or in the national register of another Member State. However, when used under a dry lease or a wet lease agreement in accordance with Article 13, such aircraft may be registered in the national register either of any Member State or of a third country.’.

Article 135

Amendments to Regulation (EU) No 996/2010

Article 5 of Regulation (EU) No 996/2010 is replaced by the following:

‘Article 5

Obligation to investigate

1. Every accident or serious incident involving aircraft to which Regulation (EU) 2018/1139 of the European Parliament and of the Council ([^E0021]) applies shall be the subject of a safety investigation in the Member State in which the accident or serious incident occurred.

1. Where an aircraft to which Regulation (EU) 2018/1139 applies and which is registered in a Member State is involved in an accident or a serious incident the location of which cannot be definitely established as being in the territory of any State, a safety investigation shall be conducted by the safety investigation authority of the Member State of registration.

1. The extent of safety investigations referred to in paragraphs 1, 2 and 4 and the procedure to be followed in conducting such safety investigations shall be determined by the safety investigation authority, taking into account the consequences of the accident or serious incident and the lessons it expects to draw from such investigations for the improvement of aviation safety.

1. Safety investigation authorities may decide to investigate incidents other than those referred to in paragraphs 1 and 2, as well as accidents or serious incidents to other types of aircraft, in accordance with the national legislation of the Member States, when they expect to draw safety lessons from them.

1. By way of derogation from paragraphs 1 and 2 of this Article, the responsible safety investigation authority may decide, taking into account the expected lessons to be drawn for the improvement of aviation safety, not to initiate a safety investigation when an accident or serious incident concerns an unmanned aircraft for which a certificate or declaration is not required pursuant to Article 56(1) and (5) of Regulation (EU) 2018/1139, or concerns a manned aircraft with a maximum take-off mass less than or equal to 2 250 kg, and where no person has been fatally or seriously injured.

1. Safety investigations referred to in paragraphs 1, 2 and 4 shall in no case be concerned with apportioning blame or liability. They shall be independent of, separate from and without prejudice to any judicial or administrative proceedings to apportion blame or liability.

Article 136

Amendments to Regulation (EU) No 376/2014

In Article 3 of Regulation (EU) No 376/2014, paragraph 2 is replaced by the following:

‘2. This Regulation applies to occurrences and other safety-related information involving civil aircraft to which Regulation (EU) 2018/1139 of the European Parliament and of the Council ([^E0022]) applies.

However, this Regulation shall not apply to occurrences and other safety-related information involving unmanned aircraft for which a certificate or declaration is not required pursuant to Article 56(1) and (5) of Regulation (EU) 2018/1139, unless the occurrence or other safety-related information involving such unmanned aircraft resulted in a fatal or serious injury to a person or it involved aircraft other than unmanned aircraft.

Member States may decide to apply this Regulation also to occurrences and other safety-related information involving the aircraft to which Regulation (EU) 2018/1139 does not apply.

Article 137

Amendments to Directive 2014/30/EU

In Article 2(2) of Directive 2014/30/EU, point (b) is replaced by the following:

‘(b)The following aviation equipment, where that equipment falls within the scope of Regulation (EU) 2018/1139 of the European Parliament and of the Council ([^E0023]) and is intended exclusively for airborne use:

• (i) aircraft, other than unmanned aircraft, as well as associated engines, propellers, parts and non-installed equipment;

• (ii) unmanned aircraft, as well as associated engines, propellers, parts and non-installed equipment, the design of which is certified in accordance with Article 56(1) of that Regulation which are intended to operate only on frequencies allocated by the Radio Regulations of the International Telecommunications Union for protected aeronautical use.

Article 138

Amendments to Directive 2014/53/EU

In Annex I to Directive 2014/53/EU, point 3 is replaced by the following:

‘3.The following aviation equipment, where that equipment falls within the scope of Regulation (EU) 2018/1139 of the European Parliament and of the Council ([^E0024]) and is intended exclusively for airborne use:

• (a) aircraft, other than unmanned aircraft, as well as associated engines, propellers, parts and non-installed equipment;

• (b) unmanned aircraft, as well as associated engines, propellers, parts and non-installed equipment, the design of which is certified in accordance with Article 56(1) of that Regulation and which are intended to operate only on frequencies allocated by the Radio Regulations of the International Telecommunications Union for protected aeronautical use.

Article 139

Repeal

Article 140

Transitional provisions

• (a) ‘commercial operation’ shall be understood as a reference to point (i) of Article 3 of Regulation (EC) No 216/2008;

• (b) ‘complex motor-powered aircraft’ shall be understood as a reference to point (j) of Article 3 of Regulation (EC) No 216/2008;

• (c) ‘appliances’ shall be understood as a reference to point (29) of Article 3 of this Regulation;

• (d) ‘leisure pilot licence’ shall be understood as a reference to the licence referred to in Article 7(7) of Regulation (EC) No 216/2008.

Article 141

Entry into force

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

This Regulation shall be binding in its entirety and directly applicable in all Member States.

ANNEX I

Aircraft referred to in point (d) of Article 2(3)

• 1.Categories of manned aircraft to which this Regulation does not apply:

• (a) historic aircraft meeting the following criteria:
• (i) aircraft whose:
• — initial design was established before 1 January 1955, and
• — production has been stopped before 1 January 1975; or
• (ii) aircraft having a clear historical relevance, related to:
• — a participation in a noteworthy historical event,
• — a major step in the development of aviation, or
• — a major role played into the armed forces of a Member State; or

• (b) aircraft specifically designed or modified for research, experimental or scientific purposes, and likely to be produced in very limited numbers;

• (c) aircraft, including those supplied in kit form, where at least 51 % of the fabrication and assembly tasks are performed by an amateur, or a non-profit making association of amateurs, for their own purposes and without any commercial objective;

• (d) aircraft that have been in the service of military forces, unless the aircraft is of a type for which a design standard has been adopted by the Agency;

• (e) aeroplanes having measurable stall speed or the minimum steady flight speed in landing configuration not exceeding 35 knots calibrated air speed (CAS), helicopters, powered parachutes, sailplanes and powered sailplanes, having no more than two seats and a maximum take-off mass (MTOM), as recorded by the Member States, of no more than: Aeroplane/Helicopter/Powered parachute/powered sailplanes Sailplanes Amphibian or floatplane/helicopter Airframe mounted total recovery parachute Single-seater 300 kg MTOM 250 kg MTOM Additional 30 kg MTOM Additional 15 kg MTOM Two-seater 450 kg MTOM 400 kg MTOM Additional 45 kg MTOM Additional 25 kg MTOM When an amphibian or a floatplane/helicopter is operating both as a floatplane/helicopter and as a land plane/helicopter, it must fall below the applicable MTOM limit.

• (f) single and two-seater gyroplanes with a MTOM not exceeding 600 kg;

• (g) replicas of aircraft meeting the criteria of points (a) or (d), for which the structural design is similar to the original aircraft;

• (h) balloons and airships having a single or double occupancy and a maximum design volume of, in the case of hot air not more than 1 200  m³, and in the case of other lifting gas not more than 400 m³;

• (i) any other manned aircraft which has a maximum empty mass, including fuel, of no more than 70 kg.

• 2.Furthermore, this Regulation shall not apply to:

• (a) tethered aircraft with no propulsion system, where the maximum length of the tether is 50 m, and where:
• (i) the MTOM of the aircraft, including its payload, is less than 25 kg, or
• (ii) in the case of a lighter-than-air aircraft, the maximum design volume of the aircraft is less than 40 m³;

• (b) tethered aircraft with a MTOM of no more than 1 kg.

ANNEX II

Essential requirements for airworthiness

1. PRODUCT INTEGRITY

Product integrity, including protection against information security threats, must be assured for all anticipated flight conditions for the operational life of the aircraft. Compliance with all requirements must be shown by assessment or analysis, supported, where necessary, by tests.

1.1.   Structures and materials

• 1.1.1. The integrity of the structure must be ensured throughout, and sufficiently beyond, the operational envelope for the aircraft, including its propulsion system, and maintained for the operational life of the aircraft.

• 1.1.2. All parts of the aircraft, the failure of which could reduce the structural integrity, must comply with the following conditions without detrimental deformation or failure. This includes all items of significant mass and their means of restraint.

• (a) All combinations of load reasonably expected to occur within and sufficiently beyond, the weights, centre of gravity range, operational envelope and life of the aircraft must be considered. This includes loads due to gusts, manoeuvres, pressurisation, movable surfaces, control and propulsion systems both in flight and on the ground.

• (b) Consideration must be given to the loads and likely failures induced by emergency landings either on land or water.

• (c) As appropriate to the type of operation, dynamic effects must be covered in the structural response to those loads, taking into account the size and configuration of the aircraft.

• 1.1.3. The aircraft must be free from any aero elastic instability and excessive vibration.

• 1.1.4. The production processes and materials used in the construction of the aircraft must result in known and reproducible structural properties. Any changes in material performance related to the operational environment must be accounted for.

• 1.1.5. It must be ensured, to the extent practicable, that the effects of cyclic loading, environmental degradation, accidental and discrete source damage do not reduce the structural integrity below an acceptable residual strength level. All necessary instructions for ensuring continued airworthiness in this regard must be promulgated.

1.2.   Propulsion

• 1.2.1. The integrity of the propulsion system (i.e. engine and, where appropriate, propeller) must be demonstrated throughout and sufficiently beyond the operational envelope of the propulsion system and must be maintained for the operational life of the propulsion system, taking into account the role of the propulsion system in the overall safety concept of the aircraft.

• 1.2.2. The propulsion system must produce, within its stated limits, the thrust or power demanded of it at all required flight conditions, taking into account environmental effects and conditions.

• 1.2.3. The production process and materials used in the construction of the propulsion system must result in known and reproducible structural behaviour. Any changes in material performance related to the operational environment must be accounted for.

• 1.2.4. The effects of cyclic loading, environmental and operational degradation and likely subsequent part failures must not reduce the integrity of the propulsion system below acceptable levels. All necessary instructions for ensuring continued airworthiness in this regard must be promulgated.

• 1.2.5. All necessary instructions, information and requirements for the safe and correct interface between the propulsion system and the aircraft must be promulgated.

1.3.   Systems and equipment (other than non-installed equipment):

• 1.3.1. The aircraft must not have design features or details that experience has shown to be hazardous.

• 1.3.2. The aircraft, including those systems, and equipment required for the assessment of the type design, or by operating rules, must function as intended under any foreseeable operating conditions, throughout and sufficiently beyond, the operational envelope of the aircraft, taking due account of the system or equipment operating environment. Other systems or equipment not required for type-certification, or by operating rules, whether functioning properly or improperly, must not reduce safety and must not adversely affect the proper functioning of any other system or equipment. Systems and equipment must be operable without needing exceptional skill or strength.

• 1.3.3. The aircraft systems and equipment, considered separately and in relation to each other, must be designed such that any catastrophic failure condition does not result from a single failure not shown to be extremely improbable and an inverse relationship must exist between the probability of a failure condition and the severity of its effect on the aircraft and its occupants. With respect to the single failure criterion above, it is accepted that due allowance must be made for the size and broad configuration of the aircraft and that this may prevent this single failure criterion from being met for some parts and some systems on helicopters and small aeroplanes.

• 1.3.4. Information needed for the safe conduct of the flight and information concerning unsafe conditions must be provided to the crew or maintenance personnel, as appropriate, in a clear, consistent and unambiguous manner. Systems, equipment and controls, including signs and announcements must be designed and located to minimise errors which could contribute to the creation of hazards.

• 1.3.5. Design precautions must be taken to minimise the hazards to the aircraft and occupants from reasonably probable threats, including information security threats, both inside and external to the aircraft, including protecting against the possibility of a significant failure in, or disruption of, any non-installed equipment.

1.4.   Non-installed equipment

• 1.4.1. Non-installed equipment must perform its safety function or function relevant for safety as intended under any foreseeable operating conditions unless that function can also be performed by other means.

• 1.4.2. Non-installed equipment must be operable without needing exceptional skill or strength.

• 1.4.3. Non-installed equipment, whether functioning properly or improperly, must not reduce safety and must not adversely affect the proper functioning of any other equipment, system or appliance.

1.5.   Continuing airworthiness

• 1.5.1. All necessary documents including instructions for continuing airworthiness must be established and made available to ensure that the airworthiness standard related to the aircraft type and any associated part is maintained throughout the operational life of the aircraft.

• 1.5.2. Means must be provided to allow inspection, adjustment, lubrication, removal or replacement of parts and non-installed equipment as necessary for continuing airworthiness.

• 1.5.3. The instructions for continuing airworthiness must be in the form of a manual, or manuals, as appropriate for the quantity of data to be provided. The manuals must cover maintenance and repair instructions, servicing information, trouble-shooting and inspection procedures, in a format that provides for a practical arrangement.

• 1.5.4. The instructions for continuing airworthiness must contain airworthiness limitations that set forth each mandatory replacement time, inspection interval and related inspection procedure.

2. AIRWORTHINESS ASPECTS OF PRODUCT OPERATION

• 2.1. The following must be shown to have been addressed to ensure safety for those on board or on the ground during the operation of the product:

• (a) the kinds of operation for which the aircraft is approved must be established and limitations and information necessary for safe operation, including environmental limitations and performance, must be established;

• (b) the aircraft must be safely controllable and manoeuvrable under all anticipated operating conditions including following the failure of one or, if appropriate, more propulsion systems, taking into account the size and configuration of the aircraft. Due account must be taken of pilot strength, flight deck environment, pilot workload and other human-factor considerations and of the phase of flight and its duration;

• (c) it must be possible to make a smooth transition from one flight phase to another without requiring exceptional piloting skill, alertness, strength or workload under any probable operating condition;

• (d) the aircraft must have such stability as to ensure that the demands made on the pilot are not excessive taking into account the phase of flight and its duration;

• (e) procedures for normal operations, failure and emergency conditions must be established;

• (f) warnings or other deterrents intended to prevent exceedance of the normal flight envelope, must be provided, as appropriate to the aircraft type;

• (g) the characteristics of the aircraft and its systems must allow a safe return from extremes of the flight envelope that may be encountered.

• 2.2. The operating limitations and other information necessary for safe operation must be made available to the crew members.

• 2.3. Product operations must be protected from hazards resulting from adverse external and internal conditions, including environmental conditions.

• (a) In particular, and as appropriate to the type of operation, no unsafe condition must occur from exposure to phenomena such as, but not limited to, adverse weather, lightning, bird strike, high frequency radiated fields, ozone, etc., reasonably expected to occur during product operation, taking into account the size and configuration of the aircraft;

• (b) Cabin compartments, as appropriate to the type of operations, must provide passengers with suitable transport conditions and adequate protection from any expected hazard arising in flight operations or resulting in emergency situations, including fire, smoke, toxic gases and rapid decompression hazards, taking into account the size and configuration of the aircraft. Provisions must be made to give occupants every reasonable chance of avoiding serious injury and quickly evacuating the aircraft and to protect them from the effect of the deceleration forces in the event of an emergency landing on land or water. Clear and unambiguous signs or announcements must be provided, as necessary, to instruct occupants in appropriate safe behaviour and the location and correct use of safety equipment. Required safety equipment must be readily accessible;

• (c) Crew compartments, as appropriate to the type of operations, must be arranged in order to facilitate flight operations, including means providing situational awareness, and management of any expected situation and emergencies. The environment of crew compartments must not jeopardise the crew's ability to perform their tasks and its design must be such as to avoid interference during operation and misuse of the controls.

3. ORGANISATIONS (INCLUDING NATURAL PERSONS UNDERTAKING DESIGN, PRODUCTION, CONTINUED AIRWORTHINESS MANAGEMENT OR MAINTENANCE)

• 3.1. As appropriate to the type of activity, organisation approvals must be issued when the following conditions are met:

• (a) the organisation must have all the means necessary for the scope of work. Those means comprise, but are not limited to, the following: facilities, personnel, equipment, tools and material, documentation of tasks, responsibilities and procedures, access to relevant data and record-keeping;

• (b) as appropriate for the type of activity undertaken and the size of the organisation, the organisation must implement and maintain a management system to ensure compliance with the essential requirements set out in this Annex, manage safety risks and aim for continuous improvement of that system;

• (c) the organisation shall establish arrangements with other relevant organisations, as necessary, to ensure continuing compliance with the essential requirements for airworthiness set out in this Annex;

• (d) the organisation shall establish an occurrence reporting system as part of the management system under point (b) and the arrangements under point (c), in order to contribute to the aim of continuous improvement of safety. The occurrence reporting system shall be compliant with the applicable Union law.

• 3.2. In the case of maintenance training organisations, the conditions under points 3.1(c) and 3.1(d) do not apply.

• 3.3. Natural persons undertaking maintenance must acquire and maintain a level of theoretical knowledge, practical skills and experience as appropriate to the type of activity.

ANNEX III

Essential requirements for environmental compatibility related to products

• 1.Products must be designed to minimise noise as far as possible taking into account point 4.

• 2.Products must be designed to minimise emissions as far as possible taking into account point 4.

• 3.Products must be designed to minimise the emissions arising from the evaporation or discharge of fluids, taking into account point 4.

• 4.Any trade-offs between design measures intended to minimise noise, the emission of different species and the discharge of fluids must be taken into account.

• 5.The total range of normal operating conditions and geographical areas where the aircraft noise and emissions are of concern, shall be considered when minimising noise and emissions.

• 6.The aircraft systems and equipment required for environmental protection reasons must be designed, produced and maintained to function as intended under any foreseeable operating condition. Their reliability must be adequate in relation to their intended effect on the environmental compatibility of the product.

• 7.Any instructions, procedures, means, manuals, limitations and inspections needed to ensure continuing compliance of an aviation product with the essential requirements set out in this Annex must be established and provided to the intended users in a clear manner.

• 8.The organisations involved in the design, production and maintenance of aviation products must:

• (a) have all means necessary to ensure compliance of an aviation product with the essential requirements set out in this Annex; and

• (b) establish arrangements with other relevant organisations as necessary to ensure compliance of an aviation product with the essential requirements set out in this Annex.

ANNEX IV

Essential requirements for aircrew

1. PILOT TRAINING

1.1.   General

A person undertaking training to fly an aircraft must be sufficiently mature educationally, physically and mentally to acquire, retain and demonstrate the relevant theoretical knowledge and practical skill.

1.2.   Theoretical knowledge

A pilot must acquire and maintain a level of knowledge appropriate to the functions exercised on the aircraft and proportionate to the risks associated to the type of activity. Such knowledge must include at least the following:

• (a) air law;

• (b) aircraft general knowledge;

• (c) technical matters related to the category of the aircraft;

• (d) flight performance and planning;

• (e) human performance and limitations;

• (f) meteorology;

• (g) navigation;

• (h) operational procedures, including resource management;

• (i) principles of flight;

• (j) communications; and

• (k) non-technical skills, including the recognition and management of threats and errors.

1.3.   Demonstration and maintenance of theoretical knowledge

• 1.3.1. The acquisition and retention of theoretical knowledge must be demonstrated by continuous assessment during training and, where appropriate, by examinations.

• 1.3.2. An appropriate level of competence in theoretical knowledge must be maintained. Compliance must be demonstrated by regular assessments, examinations, tests or checks. The frequency of examinations, tests or checks must be proportionate to the level of risk associated with the activity.

1.4.   Practical skill

A pilot must acquire and maintain the practical skills as appropriate to exercise his or her functions on the aircraft. Such skills must be proportionate to the risks associated to the type of activity and must cover, if appropriate to the functions exercised on the aircraft, the following:

• (a) pre-flight and in-flight activities, including aircraft performance, mass and balance determination, aircraft inspection and servicing, fuel/energy planning, weather appreciation, route planning, airspace restrictions and runway availability;

• (b) aerodrome and traffic-pattern operations;

• (c) collision avoidance precautions and procedures;

• (d) control of the aircraft by external visual reference;

• (e) flight manoeuvres, including in critical situations, and associated ‘upset’ manoeuvres, as technically achievable;

• (f) normal and cross-wind take-offs and landings;

• (g) flight by reference solely to instruments, as appropriate to the type of activity;

• (h) operational procedures, including team skills and resource management, as appropriate to the type of operation, whether single or multi-crew;

• (i) navigation and implementation of rules of the air and related procedures, using as appropriate, visual reference or navigation aids;

• (j) abnormal and emergency operations, including simulated aircraft equipment malfunctions;

• (k) compliance with air traffic services and communications procedures;

• (l) aircraft type or class specific aspects;

• (m) additional practical skill training that may be required to mitigate risks associated with specific activities; and

• (n) non-technical skills, including the recognition and management of threats and errors, using an adequate assessment methodology in conjunction with the technical skills assessment.

1.5.   Demonstration and maintenance of practical skill

• 1.5.1. A pilot must demonstrate the ability to perform the procedures and manoeuvres with a degree of competence appropriate to the functions exercised on the aircraft, by:

• (a) operating the aircraft within its limitations;

• (b) exercising good judgement and airmanship;

• (c) applying aeronautical knowledge;

• (d) maintaining control of the aircraft at all times in such a manner that the successful outcome of a procedure or manoeuvre is assured; and

• (e) non-technical skills, including the recognition and management of threats and errors, using an adequate assessment methodology in conjunction with the technical skills assessment.

• 1.5.2. An appropriate level of competence in practical skill must be maintained. Compliance must be demonstrated by regular assessments, examinations, tests or checks. The frequency of examinations, tests or checks must be proportionate to the level of risk associated with the activity.

1.6.   Language Proficiency

A pilot must have language proficiency to a degree appropriate to the functions exercised on the aircraft. Such proficiency shall include:

• (a) the ability to understand weather information documents;

• (b) the use of aeronautical en-route, departure and approach charts and associated aeronautical information documents; and

• (c) the ability to communicate with other flight crew and air navigation services during all phases of flight, including flight preparation, in the language used for radio communications involved in the flight.

1.7.   Flight simulation training devices

When a flight simulation training device (FSTD) is used for training, or for demonstration that practical skill is acquired or maintained, this FSTD must meet a given level of performance in those areas, which are relevant to completing the related task. In particular, the replication of configuration, handling qualities, aircraft performance, and systems behaviour must adequately represent the aircraft.

1.8.   Training course

• 1.8.1. Training must be executed through a training course.

• 1.8.2. A training course must meet the following conditions:

• (a) a syllabus must be developed for each type of course; and

• (b) the training course must comprise a breakdown of theoretical knowledge and practical flight instruction (including synthetic training), if applicable.

1.9.   Instructors

1.9.1.   Theoretical instruction

Theoretical instruction must be given by appropriately qualified instructors. They must:

• (a) have appropriate knowledge in the field where instruction is to be given; and

• (b) be capable of using appropriate instructional techniques.

1.9.2.   Flight and flight simulation instruction

Flight and flight simulation instruction must be given by appropriately qualified instructors, who have the following qualifications:

• (a) meet the theoretical knowledge and the experience requirements appropriate for the instruction being given;

• (b) be capable of using appropriate instructional techniques;

• (c) have practised instructional techniques in those flight manoeuvres and procedures in which it is intended to provide flight instruction;

• (d) have demonstrated the ability to instruct in those areas in which flight instruction is to be given, including pre-flight, post-flight and ground instruction; and

• (e) receive regular refresher training to ensure that the instructional standards are maintained up to date.

Flight instructors conducting training in aircraft must also be entitled to act as pilot in command on the aircraft for which instruction is being given, except for training on new aircraft types.

1.10.   Examiners

Persons responsible for assessing the skill of pilots must:

• (a) meet the requirements for flight or flight simulation instructors; and

• (b) be capable of assessing pilot performance and conducting flight tests and checks.

2. EXPERIENCE REQUIREMENTS – PILOTS

A person acting as flight crew member, instructor or examiner must acquire and maintain sufficient experience for the functions being exercised, unless the implementing acts adopted on the basis of this Regulation provide for competence to be demonstrated in accordance with point 1.5.

3. MEDICAL FITNESS – PILOTS

3.1.   Medical criteria

• 3.1.1. All pilots must periodically demonstrate medical fitness to satisfactorily execute their functions, taking into account the type of activity. Compliance must be shown by appropriate assessment based on aero-medical best practice, taking into account the type of activity and the possible mental and physical degradation due to age.

Medical fitness, comprising physical and mental fitness, means not suffering from any disease or disability, which makes the pilot unable:

• (a) to execute the tasks necessary to operate an aircraft;

• (b) to perform assigned duties at any time; or

• (c) to perceive correctly his or her environment.

• 3.1.2. Where medical fitness is not fully demonstrated, mitigation measures that provide equivalent flight safety may be implemented.

3.2.   Aero-medical examiners

An aero-medical examiner must:

• (a) be qualified and licensed in the practice of medicine;

• (b) have received training in aviation medicine and regular refresher training in aviation medicine to ensure that assessment standards are maintained up to date; and

• (c) have acquired practical knowledge and experience with regard to the conditions in which pilots carry out their duties.

3.3.   Aero-medical centres

Aero-medical centres must meet the following conditions:

• (a) have all the means necessary for the scope of responsibilities associated with their privileges. Those means comprise, but are not limited to, the following: facilities, personnel, equipment, tools and material, documentation of tasks, responsibilities and procedures, access to relevant data and record-keeping;

• (b) as appropriate for the type of activity undertaken and the size of the organisation, implement and maintain a management system to ensure compliance with the essential requirements set out in this Annex, manage safety risks and aim for continuous improvement of this system; and

• (c) establish arrangements with other relevant organisations, as necessary, to ensure continuing compliance with those requirements.

4. CABIN CREW MEMBERS

4.1.   General

Cabin crew members must:

• (a) be trained and checked on a regular basis to attain and maintain an adequate level of competency in order to perform their assigned safety duties; and

• (b) be periodically assessed for medical fitness to safely exercise their assigned safety duties. Compliance must be shown by appropriate assessment based on aero-medical best practice.

4.2.   Training course

• 4.2.1. When appropriate for the type of operation or privileges, training must be executed through a training course.

• 4.2.2. A training course must meet the following conditions:

• (a) a syllabus must be developed for each type of course; and

• (b) the training course must comprise a breakdown of theoretical knowledge and practical instruction (including synthetic training), if applicable.

4.3.   Cabin Crew Instructors

Instruction must be given by appropriately qualified instructors. Those instructors must:

• (a) have appropriate knowledge in the field where instruction is to be given;

• (b) be capable of using appropriate instructional techniques; and

• (c) receive regular refresher training to ensure that the instructional standards are maintained up to date.

4.4.   Cabin crew Examiners

Persons responsible for examination of cabin crew must:

• (a) meet the requirements for cabin crew instructors; and

• (b) be capable of assessing cabin crew performance and conducting examinations.

5. TRAINING ORGANISATIONS

A training organisation providing pilot or cabin crew training must meet the following requirements:

• (a) have all the means necessary for the scope of responsibilities associated with their activity. Those means comprise, but are not limited to, the following: facilities, personnel, equipment, tools and material, documentation of tasks, responsibilities and procedures, access to relevant data and record-keeping;

• (b) as appropriate for the training provided and the size of the organisation, the organisation must implement and maintain a management system to ensure compliance with the essential requirements set out in this Annex, manage safety risks, including risks related to deterioration in the standard of training, and aim for continuous improvement of this system; and

• (c) establish arrangements with other relevant organisations, as necessary, to ensure continuing compliance with those requirements.

ANNEX V

Essential requirements for air operations

1. GENERAL

• 1.1. A flight must not be performed if the crew members and, as appropriate, all other operations personnel involved in its preparation and execution are not familiar with applicable laws, regulations and procedures, pertinent to the performance of their duties, prescribed for the areas to be traversed, the aerodromes planned to be used and the air navigation facilities relating thereto.

• 1.2. A flight must be performed in such a way that the operating procedures specified in the Flight Manual or, where required the Operations Manual, for the preparation and execution of the flight are followed.

• 1.3. Before every flight, the roles and duties of each crew member must be defined. The pilot in command must be responsible for the operation and safety of the aircraft and for the safety of all crew members, passengers and cargo on board.

• 1.4. Articles or substances, which are capable of posing a significant risk to health, safety, property or the environment, such as dangerous goods, weapons and ammunition, must not be carried on any aircraft, unless specific safety procedures and instructions are applied to mitigate the related risks.

• 1.5. All necessary data, documents, records and information to record the respect of the conditions specified in point 5.3 must be retained for each flight and kept available and protected against unauthorised modification for a minimum period of time compatible with the type of operation.

2. FLIGHT PREPARATION

A flight must not be commenced unless it has been ascertained by reasonable means available that all the following conditions are complied with:

• (a) adequate facilities directly required for the flight and for the safe operation of the aircraft, including communication facilities and navigation aids, are available for the execution of the flight, taking into account available Aeronautical Information Services documentation;

• (b) the crew must be familiar with and passengers informed of the location and use of relevant emergency equipment. Sufficient information, related to the operation and specific to the equipment installed, regarding emergency procedures and use of cabin safety equipment must be made available to crew and passengers;

• (c) the pilot in command must be satisfied that:
• (i) the aircraft is airworthy as specified in point 6;
• (ii) if required, the aircraft is duly registered and that appropriate certificates with respect thereto are aboard the aircraft;
• (iii) instruments and equipment as specified in point 5 required for the execution of that flight are installed in the aircraft and are operative, unless waived by the applicable MEL or equivalent document;
• (iv) the mass of the aircraft and centre of gravity location are such that the flight can be conducted within limits prescribed in the airworthiness documentation;
• (v) all cabin baggage, hold luggage and cargo is properly loaded and secured; and
• (vi) the aircraft operating limitations as specified in point 4 will not be exceeded at any time during the flight;

• (d) information regarding meteorological conditions for departure, destination and, where applicable, alternate aerodromes, as well as en-route conditions, must be available to the flight crew. Special attention must be given to potentially hazardous atmospheric conditions;

• (e) appropriate mitigation measures or contingency plans must be in place to deal with potentially hazardous atmospheric conditions expected to be encountered in flight;

• (f) for a flight based on visual flight rules, meteorological conditions along the route to be flown must be such as to render compliance with those flight rules possible. For a flight based on instrument flight rules a destination and where applicable alternate aerodrome(s) where the aircraft can land must be selected, taking into account in particular the forecasted meteorological conditions, the availability of air navigation services, the availability of ground facilities and the instrument flight procedures approved by the State in which the destination and/or alternate aerodrome is located;

• (g) the amount of fuel/energy for propulsion and consumables on board must be sufficient to ensure that the intended flight can be completed safely, taking into account the meteorological conditions, any element affecting the performance of the aircraft and any delays that are expected in flight. In addition, a fuel/energy reserve must be carried to provide for contingencies. Procedures for in-flight fuel/energy management must be established when relevant.

3. FLIGHT OPERATIONS

With regard to flight operations, all the following conditions must be complied with:

• (a) where relevant for the type of aircraft, during take-off and landing, and whenever deemed necessary by the pilot in command in the interest of safety, each crew member must be seated at their crew station and must use the provided restraint systems;

• (b) where relevant for the type of aircraft, all flight crew members required to be on flight deck duty must be and remain at their station, with their seatbelts fastened except en-route for physiological or operational needs;

• (c) where relevant for the type of aircraft and the type of operation, before take-off and landing, during taxiing and whenever deemed necessary in the interest of safety, the pilot in command must ensure that each passenger is properly seated and secured;

• (d) a flight must be performed in such a way that appropriate separation from other aircraft is maintained and that adequate obstacle clearance is ensured, during all phases of the flight. Such separation must at least be those required by the applicable rules of the air, as appropriate to the type of operation;

• (e) a flight must not be continued unless known conditions continue to be at least equivalent to those in point 2. Furthermore, for a flight based on instrument flight rules, an approach toward an aerodrome must not be continued below certain specified heights or beyond a certain position, if prescribed visibility criteria are not met;

• (f) in an emergency, the pilot in command must ensure that all passengers are instructed in such emergency action as may be appropriate to the circumstances;

• (g) a pilot in command must take all necessary measures so as to minimise the consequences on the flight of disruptive passenger behaviour;

• (h) an aircraft must not be taxied on the movement area of an aerodrome, or its rotor must not be turned under power, unless the person at the controls is appropriately competent;

• (i) the applicable in-flight fuel/energy management procedures must be used, when relevant.

4. AIRCRAFT PERFORMANCE AND OPERATING LIMITATIONS

• 4.1. An aircraft must be operated in accordance with its airworthiness documentation and all related operating procedures and limitations as expressed in its approved flight manual or equivalent documentation, as the case may be. The flight manual or equivalent documentation must be available to the crew and kept up to date for each aircraft.

• 4.2. Notwithstanding point 4.1, for operations with helicopters a momentary flight through the limiting height velocity envelope may be permitted, provided that safety is ensured.

• 4.3. The aircraft must be operated in accordance with the applicable environmental documentation.

• 4.4. A flight must not be commenced or continued unless the aircraft's scheduled performance, considering all factors which significantly affect its performance level, allows all phases of flight to be executed within the applicable distances/areas and obstacle clearances at the planned operating mass. Performance factors which significantly affect take-off, en-route and approach/landing are, particularly:

• (a) operating procedures;

• (b) pressure altitude of the aerodrome;

• (c) weather conditions (temperature, wind, precipitation and visual range);

• (d) size, slope and condition of the take-off/landing area; and

• (e) the condition of the airframe, the power plant or the systems, taking into account possible deterioration.

• 4.5. Such factors must be taken into account directly as operational parameters or indirectly by means of allowances or margins, which may be provided in the scheduling of performance data, as appropriate to the type of operation.

5. INSTRUMENTS, DATA AND EQUIPMENT

• 5.1. An aircraft must be equipped with all navigation, communication and other equipment necessary for the intended flight, taking account of air traffic regulations and rules of the air applicable during any phase of the flight.

• 5.2. When relevant, an aircraft must be equipped with all necessary safety, medical, evacuation and survival equipment, taking account of the risks associated to the areas of operation, the routes to be flown, the flight altitude and the duration of the flight.

• 5.3. All data necessary for the execution of the flight by the crew must be updated and available on board the aircraft taking account of applicable air traffic regulations, rules of the air, flight altitudes and areas of operation.

6. CONTINUING AIRWORTHINESS AND ENVIRONMENTAL COMPATIBILITY OF PRODUCTS

• 6.1. The aircraft must not be operated unless:

• (a) the aircraft is airworthy and in a condition for safe and environmentally compatible operation;

• (b) the operational and emergency equipment necessary for the intended flight is serviceable;

• (c) the airworthiness document and, if applicable, the noise certificate of the aircraft is valid; and

• (d) the maintenance of the aircraft is performed in accordance with the applicable requirements.

• 6.2. Before each flight or a series of consecutive flights, the aircraft must be inspected, through a pre-flight check, to determine whether it is fit for the intended flight.

• 6.3. The aircraft must not be operated unless it is released to service by qualified persons or organisations, after maintenance. The signed release to service must contain in particular, the basic details of the maintenance carried out.

• 6.4. Records necessary to demonstrate the airworthiness and environmental compatibility status of the aircraft must be kept, and protected against, unauthorised modification for the period of time corresponding to the applicable continuing airworthiness requirements, until the information contained has been superseded by new information equivalent in scope and detail but in any event not less than 24 months.

• 6.5. All modifications and repairs must comply with the essential requirements for airworthiness and, if applicable, the environmental compatibility of products. The substantiating data supporting compliance with the airworthiness requirements and requirements for the environmental compatibility of products must be retained and protected against unauthorised modification.

• 6.6. It is the responsibility of the aircraft operator to ensure that a third party performing the maintenance complies with the operator's safety and security requirements.

7. CREW MEMBERS

• 7.1. The number and composition of the crew must be determined taking into account:

• (a) the certification limitations of the aircraft, including if applicable, the relevant emergency evacuation demonstration;

• (b) the aircraft configuration; and

• (c) the type and duration of operations.

• 7.2. The pilot in command must have the authority to give all commands and take any appropriate actions for the purpose of securing the operation and the safety of the aircraft and of persons and/or property carried therein.

• 7.3. In an emergency situation, which endangers the operation or the safety of the aircraft and/or persons on board, the pilot in command must take any action he/she considers necessary in the interest of safety. When such action involves a violation of local regulations or procedures, the pilot in command must be responsible for notifying the appropriate local authority without delay.

• 7.4. Without prejudice to point 8.12, when other persons are carried on board, emergency or abnormal situations may only be simulated if those persons have been duly informed and are aware of the associated risks before boarding the flight.

• 7.5. No crew member must allow their task achievement/decision making to deteriorate to the extent that flight safety is endangered because of the effects of fatigue, taking into account, inter alia, fatigue accumulation, sleep deprivation, number of sectors flown, night duties or time zone changes. Rest periods must provide sufficient time to enable crew members to overcome the effects of the previous duties and to be well rested by the start of the following flight duty period.

• 7.6. A crew member must not perform allocated duties on board an aircraft when under the influence of psychoactive substances or alcohol or when unfit due to injury, fatigue, medication, sickness or other similar causes.

8. ADDITIONAL REQUIREMENTS FOR COMMERCIAL AIR TRANSPORT AND OTHER OPERATIONS SUBJECT TO A CERTIFICATION OR DECLARATION REQUIREMENT PERFORMED WITH AEROPLANES, HELICOPTERS OR TILT ROTOR AIRCRAFT

• 8.1. The operation must not be undertaken unless the following conditions are met:

• (a) the aircraft operator must have directly or through agreements with third parties the means necessary for the scale and scope of the operations. Those means comprise but are not limited to the following: aircraft, facilities, management structure, personnel, equipment, documentation of tasks, responsibilities and procedures, access to relevant data and record keeping;

• (b) the aircraft operator must use only suitably qualified and trained personnel and implement and maintain training and checking programmes for the crew members and other relevant personnel that are necessary to ensure the currency of their certificates, ratings and qualifications;

• (c) as appropriate for the type of activity undertaken and the size of the organisation, the aircraft operator must implement and maintain a management system to ensure compliance with the essential requirements set out in this Annex, manage safety risks and aim for continuous improvement of this system;

• (d) the aircraft operator shall establish an occurrence reporting system, as part of the management system under point (c), in order to contribute to the aim of continuous improvement of the safety. The occurrence reporting system shall be compliant with applicable Union law.

• 8.2. The operation must only be undertaken in accordance with an aircraft operator's operations manual. Such manual must contain all necessary instructions, information and procedures for all aircraft operated and for operations personnel to perform their duties. Limitations applicable to flight time, flight duty periods and rest periods for crew members must be specified. The operations manual and its revisions must be compliant with the approved flight manual and be amended as necessary.

• 8.3. The aircraft operator shall establish procedures, as appropriate, so as to minimise the consequences to safe flight operations of disruptive passenger behaviour.

• 8.4. The aircraft operator must develop and maintain security programmes adapted to the aircraft and the type of operation including particularly:

• (a) security of the flight crew compartment;

• (b) aircraft search procedure checklist;

• (c) training programmes; and

• (d) protection of electronic and computer systems to prevent intentional and non-intentional system interference and corruption.

• 8.5. When security measures may adversely affect the safety of operations, the risks must be assessed and appropriate procedures developed to mitigate safety risks, this may necessitate the use of specialist equipment.

• 8.6. The aircraft operator must designate one pilot amongst the flight crew as the pilot in command.

• 8.7. The prevention of fatigue must be managed through a fatigue management system. For a flight, or series of flights, such a system needs to address flight time, flight-duty periods, duty and adapted rest periods. Limitations established within the fatigue management system must take into account all relevant factors contributing to fatigue such as, in particular, number of sectors flown, time-zone crossing, sleep deprivation, disruption of circadian cycles, night hours, positioning, cumulative duty time for given periods of time, sharing of allocated tasks between crew members, and also the provision of augmented crews.

• 8.8. The aircraft operator must ensure that the tasks specified in point 6.1 and those described in points 6.4 and 6.5 are controlled by an organisation responsible for the continuing airworthiness management that must meet requirements of Annex II, point 3.1, and Annex III, points 7 and 8.

• 8.9. The aircraft operator must ensure that the release to service required by point 6.3 is issued by an organisation qualified for the maintenance of products, parts and not-installed equipment. This organisation shall meet the requirements of Annex II, point 3.1.

• 8.10. The organisation referred to in 8.8 shall establish an organisation manual providing, for use and guidance of personnel concerned, a description of all continuing airworthiness procedures of the organisation.

• 8.11. A checklist system must be available for use, as applicable, by crew members in all phases of operation of the aircraft under normal, abnormal and emergency conditions and situations. Procedures must be established for any reasonably foreseeable emergency situation.

• 8.12. Emergency or abnormal situations must not be simulated when passengers or cargo are being carried.

ANNEX VI

Essential requirements for qualified entities

• 1.The qualified entity, its Director and the staff responsible for carrying out the certification and oversight tasks, may not be involved, either directly or as authorised representatives, in the design, production, marketing or maintenance of the products, parts, non-installed equipment, constituents or systems or in their operations, service provision or use. This does not exclude the possibility of an exchange of technical information between the involved organisations and the qualified entity.

• The first subparagraph shall not prevent an organisation created with the aim of promoting aerial sport or leisure aviation from being eligible for accreditation as a qualified entity, on condition that it demonstrates to the satisfaction of the accrediting authority that it has put in place adequate arrangements for the prevention of conflict of interest.

• 2.The qualified entity and the staff responsible for the certification and oversight tasks must carry out their duties with the greatest possible professional integrity and the greatest possible technical competence and must be free of any pressure and incentive of any type, in particular of a financial type, which could affect their judgement and decisions or the results of their certification and oversight tasks, in particular from persons or groups of persons affected by those results.

• 3.The qualified entity must employ staff and possess the means required to perform adequately the technical and administrative tasks linked with the certification and oversight process; it shall also have access to the equipment needed for exceptional checks.

• 4.The qualified entity and its staff responsible for investigation must have:

• (a) sound technical and vocational training, or sufficient expertise gained through experience of relevant activities;

• (b) satisfactory knowledge of the requirements of the certification and oversight tasks they carry out and adequate experience of such processes;

• (c) the ability required to draw up statements, records and reports to demonstrate that the certification and oversight tasks have been carried out.

• 5.The impartiality of the staff responsible for certification and oversight tasks must be guaranteed. Their remuneration must not depend on the number of investigations carried out or on the results of such investigations.

• 6.The qualified entity must take out liability insurance unless its liability is assumed by one Member State in accordance with its national law.

• 7.The staff of the qualified entity must observe professional secrecy with regard to all information acquired in carrying out their tasks under this Regulation.

ANNEX VII

Essential requirements for aerodromes

1. PHYSICAL CHARACTERISTICS, INFRASTRUCTURE AND EQUIPMENT

1.1.   Movement area

• 1.1.1. Aerodromes shall have a designated area for the landing and take-off of aircraft, which satisfies the following conditions:

• (a) the landing and take-off area shall have dimensions and characteristics suitable for the aircraft intended to use the facility;

• (b) the landing and take-off area, where applicable, shall have a bearing strength sufficient to support repetitive operations of the intended aircraft. Those areas not intended for repetitive operations only need to be capable of supporting the aircraft;

• (c) the landing and take-off area shall be designed to drain water and to prevent standing water becoming an unacceptable risk to aircraft operations;

• (d) the slope and slope changes of the landing and take-off area shall not create an unacceptable risk to aircraft operations;

• (e) the surface characteristics of the landing and take-off area shall be adequate for use by the intended aircraft; and

• (f) the landing and take-off area shall be free from objects which might create an unacceptable risk to aircraft operations.

• 1.1.2. Where there are several designated landing and take-off areas, they shall be such that they do not create an unacceptable risk to aircraft operations.

• 1.1.3. The designated landing and take-off area shall be surrounded by defined areas. Those areas are intended to protect aircraft flying over them during take-off or landing operations or to mitigate the consequences of undershooting, running off the side or overrunning the take-off and landing area, and shall satisfy the following conditions:

• (a) those areas shall have dimensions appropriate to the aircraft operations anticipated;

• (b) the slope and slope changes of those areas shall not create an unacceptable risk to aircraft operations;

• (c) those areas shall be free from objects which might create an unacceptable risk to aircraft operations. This shall not preclude frangible equipment to be located in those areas, if required to assist aircraft operations; and

• (d) each of those areas shall have a bearing strength sufficient to serve its purpose.

• 1.1.4. Those areas of an aerodrome, with their associated immediate surroundings, that are to be used for taxiing or parking aircraft, shall be designed to permit safe operation of the aircraft expected to use the particular facility under all the conditions planned for, and shall satisfy the following conditions:

• (a) those areas shall have a bearing strength sufficient to support repetitive operations of the intended aircraft, except for areas which are expected for only occasional use which only need to be capable of supporting the aircraft;

• (b) those areas shall be designed to drain water and to prevent standing water becoming an unacceptable risk to aircraft operations;

• (c) the slope and slope changes of those areas shall not create an unacceptable risk to aircraft operations;

• (d) the surface characteristics of those areas shall be adequate for use by the intended aircraft; and