Commission Implementing Regulation (EU) 2023/1020 of 24 May 2023 amending Regulation (EU) No 965/2012 as regards helicopter emergency medical service operations (Text with EEA relevance)

25.5.2023 EN Official Journal of the European Union L 137/1 II (Non-legislative acts) REGULATIONS COMMISSION IMPLEMENTING REGULATION (EU) 2023/1020 of 24 May 2023 amending Regulation (EU) No 965/2012 as regards helicopter emergency medical service operations (Text with EEA relevance) THE EUROPEAN COMMISSION, Having regard to the Treaty on the Functioning of the European Union, Having regard to Regulation (EU) 2018/1139 of the European Parliament and of the Council of 4 July 2018on 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(1), and in particular Article 27(1) and Article 31(1) thereof, Whereas: (1) Commission Regulation (EU) No 965/2012(2) lays down technical requirements and administrative procedures related to air operations, and among others, to helicopter emergency medical service (HEMS) operations. Such technical requirements and administrative procedures should be updated to ensure that they reflect the state of the art in developments and best practices in the air operations domain. (2) Helicopter emergency medical services are among the most challenging operations from a safety perspective because the mission often consists of a flight to a non-pre-surveyed site in any weather conditions and under time pressure to rescue people. Such operations should be regulated in such a way that they remain safe at all times. (3) Helicopter emergency non-medical rescue operations, which include mountain rescue operations, but not search and rescue of aircraft in distress, are equally challenging when carried out under the same conditions as those of helicopter emergency medical service operations. Therefore, when helicopter emergency non-medical rescue operations fall within the scope of Regulation (EU) 2018/1139, they should be regulated in the same way as helicopter emergency medical services. (4) On the basis of available data, the risk of accidents due to a degraded visual environment, including operations in bad weather and at night, as well as the risk of collision at an accident or a rescue site, should be further mitigated by means of requirements for equipment, standard operating procedures, and crew training. (1) OJ L 212, 22.8.2018, p. 1. (2) Commission Regulation (EU) No 965/2012 of 5 October 2012 laying down technical requirements and administrative procedures related to air operations pursuant to Regulation (EC) No 216/2008 of the European Parliament and of the Council (OJ L 296, 25.10.2012, p. 1).L 137/2 EN Official Journal of the European Union 25.5.2023 (5) It should be ensured that derogations from the helicopter performance criteria apply only for legacy hospital sites that were established before the entry into force of Regulation (EU) No 965/2012, to ensure that the appropriate level of safety is achieved. At hospital sites that currently qualify for such derogations, the obstacle environment should remain supervised and acceptable from a safety perspective. (6) The current requirements on performance and oxygen as regards high-altitude helicopter emergency medical service and mountain rescue operations set out in Regulation (EU) No 965/2012 do not allow operations at high altitudes, however it should be possible to rescue people at any altitude. The applicable requirements should therefore be amended. (7) In accordance with Article 140(2), point (b) of Regulation (EU) 2018/1139, Regulation (EU) No 965/2012 is to be adapted to Regulation (EU) 2018/1139 as regards the definition of complex motor-powered aircraft which was included in Regulation (EC) No 216/2008 of the European Parliament and of the Council(3), repealed by Regulation (EU) 2018/1139. Regulation (EU) No 965/2012 should therefore be amended accordingly. (8) Operators currently conducting HEMS operations as well as competent authorities responsible for the certification and oversight of these operations will need sufficient time to fully implement the changes set out in this regulation. Therefore, the applicability of the provisions introduced by this Regulation related to HEMS operations is deferred by one year. In addition, the applicability of some specific provisions that require a longer implementation period, such as those introducing new approvals or new equipment, performance requirements or training requirements, is further deferred. (9) Regulation (EC) No 216/2008 repealed Directive 2004/36/EC of the European Parliament and of the Council(4). Directive 2004/36/EC was implemented by Commission Regulations (EC) No 768/2006(5) and (EC) No 351/2008(6). The provisions of the latter regulations have been superseded by Regulation (EU) No 965/2012, but they have never been explicitly repealed. It is therefore necessary to repeal those regulations. (10) The European Union Aviation Safety Agency has prepared a draft implementing act and has submitted it to the Commission with Opinion 08/2022(7)in accordance with Article 76(1) of Regulation (EU) 2018/1139. (11) The requirements laid down in this Regulation are in accordance with the opinion of the Committee for the application of common safety rules in the field of civil aviation established by Article 127 of Regulation (EU) 2018/1139. HAS ADOPTED THIS REGULATION: Article 1 Amendments to Regulation (EU) No 965/2012 Regulation (EU) No 965/2012 is amended as follows: (1) in Article 6, paragraph 6 is replaced by the following: (3) Regulation (EC) No 216/2008 of the European Parliament and of the Council of 20 February 2008 on common rules in the field of civil aviation and establishing a European Aviation Safety Agency, and repealing Council Directive 91/670/EEC, Regulation (EC) No 1592/2002 and Directive 2004/36/EC (OJ L 79, 19.3.2008, p. 1). (4) Directive 2004/36/EC of the European Parliament and of the Council of 21 April 2004 on the safety of third-country aircraft using Community airports (OJ L 143, 30.4.2004, p. 76). (5) Commission Regulation (EC) No 768/2006 of 19 May 2006 implementing Directive 2004/36/EC of the European Parliament and of the Council as regards the collection and exchange of information on the safety of aircraft using Community airports and the management of the information system (OJ L 134, 20.5.2006, p. 16). (6) Commission Regulation (EC) No 351/2008 of 16 April 2008 implementing Directive 2004/36/EC of the European Parliament and of the Council as regards the prioritisation of ramp inspections on aircraft using Community airports (OJ L 109, 19.4.2008, p. 7). (7) https://www.easa.europa.eu/document-library/opinions25.5.2023 EN Official Journal of the European Union L 137/3 ‘6. By way of derogation from point CAT.POL.H.225 of Annex IV and until 25 May 2028, existing helicopter operations to or from a public interest site (PIS) may be conducted under conditions determined by the Member States, whenever the size of the PIS, the obstacle environment or the helicopter does not allow compliance with the requirements for operation in performance class 1. Member States shall notify the Commission and the Agency of the conditions being applied.’; (2) Annexes I, II, III, IV, V, VII and VIII are amended in accordance with the Annex to this Regulation. Article 2 Repeal Regulations (EC) No 768/2006 and (EC) No 351/2008 are repealed with effect from 14 June 2023. Article 3 Entry into force and applicability This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union. It shall apply from 25 May 2024. However: (a) point (5)(b) of the Annex shall apply from 25 May 2026; (b) point (5)(d) of the Annex to this Regulation shall apply from 25 May 2028as regards the amendment to point SPA. HEMS.110(e) of Annex V to Regulation (EU) No 965/2012; (c) point (5)(f) of the Annex to this Regulation shall only apply to HEMS operations covered by point (61)(b) of Annex I to Regulation (EU) No 965/2012 from 25 May 2028; (d) point (5)(g) of the Annex to this Regulation shall only apply to HEMS operations covered by point (61)(b) of Annex I to Regulation (EU) No 965/2012 from 25 May 2026; (e) points (6) and (7) of the Annex shall apply from 14 June 2023. (f) Member States may decide to use the form established in Appendix II to Annex II to Regulation (EU) No 965/2012 as amended by point (2)(b) of the Annex to this Regulation only when issuing new air operator certificates, or making changes to existing certificates, in accordance with points ARO.GEN.310 or ARO.GEN.330 of Annex II to Regulation (EU) No 965/2012. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 24 May 2023. For the Commission The President Ursula VON DER LEYENL 137/4 EN Official Journal of the European Union 25.5.2023 ANNEX Annexes I, II, III, IV, V, VII and VIII to Regulation (EU) No 965/2012 are amended as follows: (1) Annex I is amended as follows: (a) point (61) is replaced by the following: ‘(61) “HEMS flight” means a flight by a helicopter operating under a HEMS approval, where immediate and rapid transportation is essential and the purpose of which is either of the following: (a) to facilitate emergency medical assistance by carrying one or more of the following: (i) medical personnel; (ii) medical supplies (equipment, blood, organs, drugs); (iii) ill or injured persons and other persons directly involved; (b) to perform an operation where a person faces an imminent or anticipated health risk posed by the environment and either of the following conditions is met: (i) that person needs to be rescued or provided with supplies; (ii) persons, animals or equipment need to be transported to and from the HEMS operating site;’; (b) the following point (61a) is inserted: ‘(61a) “HEMS HEC operation” means air and ground operations for the purpose of transporting one or more persons as human external cargo (HEC) within a HEMS flight;’; (c) point (62) is replaced by the following: ‘(62) “HEMS operating base” means an aerodrome at which the crew members and the HEMS helicopter may be on standby for HEMS operations;’; (d) point (63) is replaced by the following: ‘(63) “HEMS operating site” means a site that is selected by the commander during a HEMS flight for a HEMS HEC operation or a landing or a take-off;’; (e) point (118) is replaced by the following: ‘(118) “technical crew member” means a crew member in commercial air transport HEMS, HEMS HEC, HHO or NVIS operations, other than a flight or cabin crew member, assigned by the operator to duties in the aircraft or on the ground for the purpose of assisting the pilot during HEMS, HEMS HEC, HHO or NVIS operations, which may require the operation of specialised on-board equipment;’; (f) the following new point (129) is added: ‘(129) “complex motor-powered aircraft” shall mean: (a) an aeroplane: — with a maximum certificated take-off mass exceeding 5 700kg, or — certificated for a maximum passenger seating configuration of more than nineteen, or — certificated for operation with a minimum crew of at least two pilots, or — equipped with (a) turbojet engine(s) or more than one turboprop engine, or25.5.2023 EN Official Journal of the European Union L 137/5 (b) a helicopter certificated: (i) for a maximum take-off mass exceeding 3 175kg, or (ii) for a maximum passenger seating configuration of more than nine, or (iii) for operation with a minimum crew of at least two pilots, or (c) a tilt rotor aircraft;’; (2) Annex II is amended as follows: (a) point ARO.OPS.220 is replaced by the following: ‘ARO.OPS.220 Approval of helicopter operations to or from a public interest site (a) Upon receiving an application for the issue of, or changes to, an approval for a helicopter operation to or from a public interest site, the competent authority shall assess the application in accordance with point CAT.POL. H.225 of Annex IV and conduct any additional assessment of the operator as deemed necessary. (b) The approval referred to in point CAT.POL.H.225 of Annex IV shall include a list of the public interest site or sites and helicopter type or types specified by the operator and to which the approval applies. (c) The approval shall only apply to public interest sites established before 1 July 2002, or to public interest sites established before 28 October 2014 and for which a derogation from point CAT.POL.H.225 of Annex IV granted under Article 6(6) has been notified to the Commission and the Agency. (d) If changes to the obstacle environment at a public interest site are notified or discovered, the competent authority shall assess whether the approvals it has granted covering helicopter operations to or from that site remain valid. Where permanent changes to the obstacle environment have a significantly negative safety impact, the following shall apply: (1) the competent authority shall limit the privileges of the relevant approvals granted under point CAT.POL. H.225 of Annex IV to exclude helicopter operations to and from that site and remove the site from the list attached to the approval in accordance with point (b); (2) the site shall no longer qualify for a public interest site approval under point CAT.POL.H.225 of Annex IV; (3) where the new obstacles are removed, operators may apply or reapply for an approval for a helicopter operation under point CAT.POL.H.225 of Annex IV for the particular site. (e) The competent authority shall not grant an approval under point CAT.POL.H.225 of Annex IV for a public interest site that was previously operated in performance class 1 following a change in the obstacle environment.’;L 137/6 EN Official Journal of the European Union 25.5.2023 (b) Appendix II is replaced by the following: ‘Appendix II25.5.2023 EN Official Journal of the European Union L 137/7 (1) Telephone contact details of the competent authority, including the country code. Email to be provided as well as fax if available. (2) Insertion of associated air operator certificate (AOC) number. (3) Insertion of the operator’s registered name and the operator’s trading name, if different. Insert ‘Dba’ before the trading name (for ‘Doing business as’). (4) Issue date of the operations specifications (dd-mm-yyyy) and signature of the competent authority representative. (5) Insertion of ICAO designation of the aircraft make, model and series, or master series, if a series has been designated (e.g. Boeing-737-3K2 or Boeing-777-232). (6) The registration marks are listed either in the operations specifications or in the operations manual. In the latter case, the related operations specifications must make a reference to the related page in the operations manual. In case not all specific approvals apply to the aircraft model, the registration marks of the aircraft may be entered in the remark column to the related specific approval. (7) Other type of transportation to be specified (e.g. emergency medical service). (8) Listing of geographical area(s) of authorised operation (by geographical coordinates or specific routes, flight information region or national or regional boundaries).L 137/8 EN Official Journal of the European Union 25.5.2023 (9) Listing of applicable special limitations (e.g. VFR only, Day only, etc.). (10) List in this column the most permissive criteria for each approval or the approval type (with appropriate criteria). (11) Insertion of approved minimum take-off RVR in metres. One line per approval may be used if different approvals are granted. (12) Insertion of applicable precision approach category: CAT II or CAT III. Insertion of minimum RVR in metres and DH in feet. One line is used per listed approach category. (13) Insertion of applicable operational credit: SA CAT I, SA CAT II, EFVS, etc. Insertion of minimum RVR in metres and DH in feet. One line is used per listed operational credit. (14) The Not Applicable (N/A) box may be checked only if the aircraft maximum ceiling is below FL290. (15) Extended range operations (ETOPS) currently apply only to two-engined aircraft. Therefore, the Not Applicable (N/A) box may be checked if the aircraft model has less or more than two engines. (16) The threshold distance may also be listed (in NM), as well as the engine type. (17) Performance-based navigation (PBN): one line is used for each complex PBN specific approval (e.g. RNP AR APCH), with appropriate limitations listed in the ‘Specifications’ or ‘Remarks’ columns, or in both. Procedure-specific approvals of specific RNP AR APCH procedures may be listed in the operations specifications or in the operations manual. In the latter case, the related operations specifications must have a reference to the related page in the operations manual. (18) Specify if the specific approval is limited to certain runway ends or aerodromes, or both. (19) Insertion of the particular airframe or engine combination. (20) Approval to conduct the training course and examination to be completed by applicants for a cabin crew attestation as specified in Annex V (Part-CC) to Regulation (EU) No 1178/2011. (21) Approval to issue cabin crew attestations as specified in Annex V (Part-CC) to Regulation (EU) No 1178/2011. (22) Insertion of the list of type B EFB applications together with the reference of the EFB hardware (for portable EFBs). This list is contained either in the operations specifications or in the operations manual. In the latter case, the related operations specifications must make a reference to the related page in the operations manual. (23) The name of the person or organisation responsible for ensuring that the continuing airworthiness of the aircraft is maintained and a reference to the regulation that requires the work, i.e. Subpart G of Annex I (Part-M) to Regulation (EU) No 1321/2014. (24) Other approvals or data may be entered here, using one line (or one multi-line block) per authorisation (e. g. short landing operations, steep approach operations, reduced required landing distance, helicopter operations to or from a public interest site, helicopter operations over a hostile environment located outside a congested area, helicopter operations without a safe forced landing capability, operations with increased bank angles, maximum distance from an adequate aerodrome for two-engined aeroplanes without an ETOPS approval).25.5.2023 EN Official Journal of the European Union L 137/9 EASA Form 139 Issue 8’; (3) Annex III is amended as follows: (a) point ORO.TC.110 is amended as follows: (i) point (b) is replaced by the following: ‘(b) Following the completion of initial, operator conversion, and differences training, and following any required familiarisation flights, each technical crew member shall undergo a check to demonstrate their proficiency in carrying out normal and emergency procedures.’; (ii) the following points (d) and (e) are added: ‘(d) The checks that follow the operator conversion training and any required familiarisation flights shall take place prior to operating as a required technical crew member in HEMS, HHO or NVIS operations. (e) The validity of the technical crew member’s check to demonstrate their proficiency in carrying out normal and emergency procedures shall be 12 calendar months.’; (b) point ORO.TC.130 is replaced by the following: ‘ORO.TC.130Familiarisation flights If the operator conversion training does not include training in an aircraft/FSTD, each technical crew member shall undertake familiarisation flights.’. (4) Annex IV is amended as follows: (a) point CAT.POL.H.215 is amended as follows: (i) point (a) is replaced by the following: ‘(a) The mass of the helicopter and the flight path at all points along the route, with the critical engine inoperative and the meteorological conditions expected for the flight, shall permit compliance with any of the following points: (1) when it is intended that the flight will be conducted at any time out of sight of the surface, the mass of the helicopter permits a rate of climb of at least 50 ft/minute with the critical engine inoperative at an altitude of at least 300 m (1 000ft), or 600 m (2 000 ft) in areas of mountainous terrain, above all relevant terrain and obstacles along the route; (2) when it is intended that the flight will be conducted without the surface in sight, the flight path permits the helicopter to continue flight from the cruising altitude to a height of 300 m (1 000 ft) above a landing site where a landing can be made in accordance with point CAT.POL.H.220; the flight path clears vertically, by at least 300 m (1 000ft) or 600 m (2 000ft) in areas of mountainous terrain, all relevant terrain and obstacles along the route; Drift-down techniques may be used; (3) when it is intended that the flight will be conducted in VMC with the surface in sight, the flight path permits the helicopter to continue flight from the cruising altitude to a height of 300 m (1 000 ft) above a landing site where a landing can be made in accordance with point CAT.POL.H.220, without flying at any time below the appropriate minimum flight altitude; Obstacles shall be considered within a distance on either side of the route as specified for the purpose of determination of the minimum flight altitude in VFR.’; (ii) point (c) is deleted; (b) point CAT.POL.H.225 is amended as follows: (i) in point (a), point (1) is replaced by the following: ‘(1) the site was established as a public interest site before 1 July 2002, or the site was established as a public interest site before 28 October 2014and a derogation from this point granted under Article 6(6) has been notified to the Commission and the Agency before 14 June 2023;’L 137/10 EN Official Journal of the European Union 25.5.2023 (ii) point (c) is replaced by following: ‘(c) The operations manual shall contain all the following for each PIS: a diagram or annotated photograph that shows the main aspects, the dimensions, the non-conformance with the performance class 1 requirements, the main hazards and the contingency plan should an incident occur.’; (iii) the following point (d) is added: ‘(d) The operator shall keep the information provided in point (c) up to date and shall notify any changes to it to the competent authority. When operations take place in another Member State, the operator shall also notify the authority of that State.’; (c) in point CAT.POL.H.420, point (b) is replaced by the following: ‘(b) To obtain and maintain such approval, the operator shall: (1) only conduct the operations referred to in point (a) in the areas and under the conditions specified in the approval; (2) INTENTIONALLY LEFT BLANK (3) substantiate that helicopter limitations, or other justifiable considerations, preclude the use of the appropriate performance criteria; (4) be approved in accordance with point CAT.POL.H.305(b).’; (5) Annex V is amended as follows: (a) in point SPA.NVIS.110, point (e) is replaced by the following: ‘(e) All required NVG on an NVIS flight shall be of the same filter class and shall provide for sufficiently equivalent visual acuity.’; (b) in point SPA.HEMS.100, the following point (c) is added: ‘(c) Night operations to non-pre-surveyed HEMS operating sites outside congested areas that provide sufficient artificial ambient light shall be conducted under an approval issued in accordance with point SPA.NVIS.100.’; (c) the following point SPA.HEMS.105 is inserted: ‘SPA.HEMS.105HEMS HEC operations (a) HEMS HEC operations may be conducted with either of the following: (1) a helicopter hoist, under the conditions prescribed in Subpart I (Helicopter Hoist Operations); (2) a cargo sling, under the conditions prescribed in point (b). (b) For HEMS HEC operations conducted with a cargo sling, the operator shall: (1) comply with the requirements of point SPO.SPEC.HEC.105 of Annex VIII; (2) use an approved double cargo hook, or a cargo hook system approved under a relevant airworthiness standard; (3) limit the operations to the technical phase of the flight for rescuing injured, ill or endangered persons, or to carry persons that are necessary for the mission; (4) ensure that sling technical crew members are adequately equipped, trained, checked and briefed; (5) develop specific HEMS HEC SOPs, following the risk assessment referred to in point SPA.HEMS.140; (6) ensure that all flight crew members involved in HEMS HEC operations are experienced, trained and checked for HEMS HEC operations, and have recent experience with such activity.’;25.5.2023 EN Official Journal of the European Union L 137/11 (d) point SPA.HEMS.110 is replaced by the following: ‘SPA.HEMS.110Equipment requirements for HEMS operations (a) The installation on a helicopter of all dedicated medical equipment and any subsequent modifications to that equipment and, where appropriate, its operation, shall be approved in accordance with Regulation (EU) No 748/2012. (b) For VFR flights over routes navigated by reference to visual landmarks, the helicopter shall be equipped with a device that provides a moving map display with own-ship position and obstacles. The map and obstacle database(s) shall be kept up to date. (c) By way of derogation from point CAT.IDE.H.240 of Annex IV, complex, non-pressurised helicopters operated in HEMS with a MOPSC of nine or less shall comply with the oxygen requirements applicable to other than complex, non-pressurised helicopters. (d) By way of derogation from points CAT.OP.MPA.285 and CAT.IDE.H.240 of Annex IV, short excursions above 13 000 ft without using supplemental oxygen may be undertaken by day, subject to prior approval by the competent authority, provided that all the following conditions are met: (1) the excursion above 13 000ft is necessary for the embarkation/disembarkation of persons or for HEMS HEC operations; (2) the flight is not conducted above 16 000ft; (3) the duration of the excursion above 10 000 ft without oxygen is limited to 30 minutes within a HEMS mission; (4) the safety briefing in accordance with point CAT.OP.MPA.170 of Annex IV includes adequate information to crew members and passengers on the effects of hypoxia; (5) SOPs are included in the operations manual covering points (1) to (4); (6) the operator’s experience of conducting operations at high altitudes without using supplemental oxygen is adequate for the operations to be performed; (7) the experience of the individual crew members and their physiological adaptation to high altitudes are adequate for the operations to be performed; (8) all crew members involved in the operations have received initial and recurrent training in hypoxia; (9) none of the crew members involved in the operations have been diagnosed with a medical condition that could lead to hypoxia. (e) For single-pilot operations at night, the helicopter shall be equipped as follows: (1) for a helicopter first issued with an individual CofA before 25 May 2024or earlier, with a suitable stability augmentation system or autopilot; (2) for a helicopter first issued with an initial CofA on or after 25 May 2024, with an autopilot. (f) For HEMS operations by day, the helicopter shall be equipped with the flight instruments required under points (a)(6) and (a)(7) of point CAT.IDE.H.130 of Annex IV. (g) The helicopter shall be equipped with a radio altimeter capable of emitting an audio warning below a pre-set height and a visual warning at a height selectable by the pilot. (h) Instruments and equipment required in points (e) and (g) shall be approved in accordance with the applicable airworthiness requirements. (i) The operator shall ensure that all relevant information is documented in the minimum equipment list.’;L 137/12 EN Official Journal of the European Union 25.5.2023 (e) point SPA.HEMS.120 is replaced by the following: ‘SPA.HEMS.120HEMS operating minima (a) HEMS flights operated under VFR shall comply with the HEMS-specific weather minima for the dispatch and en-route phase of the HEMS flight. (b) If during the en-route phase the weather conditions fall below the cloud base or visibility minima, helicopters certified for flights only under VMC shall abandon the flight or return to base. Helicopters equipped and certified for instrument meteorological conditions (IMC) operations may abandon the flight, return to base or convert in all respects to a flight conducted under instrument flight rules (IFR), provided the flight crew are suitably qualified. (c) The VFR operating minima shall be as defined by the applicable airspace requirements, except in the following cases where reduced ceiling, visibility and vertical distances from obstacles may be used: (1) multi-pilot operations; (2) single-pilot operations with a technical crew member seated in a forward-facing front seat, who is suitably qualified and tasked to mitigate the additional risk.’; (f) point SPA.HEMS.125 is replaced by the following: ‘SPA.HEMS.125Performance requirements for HEMS operations (a) Performance class 3 operations over a hostile environment shall only be conducted provided one of the following conditions are met: (1) The HEMS operating site used for take-off, landing or HEMS HEC operations is located above 7 000-ft altitude and the helicopter is certified as Category A or equivalent, as determined by the Agency; (2) The planned HEMS operation does not require the transportation of medical personnel, medical supplies or ill or injured persons, and either the helicopter is certified as Category A or equivalent, as determined by the Agency, or all the following conditions are met: (i) the helicopter is equipped with crash-resistant fuel systems; (ii) the helicopter is equipped with a safety belt with upper torso restraint system for use on each passenger seat for each passenger aged 24 months or more; (iii) the altitude of at least one of the HEMS operating sites used during the HEMS operation is not lower than 3 000ft; (iv) the operator has been granted an approval by the competent authority in accordance with point CAT. POL.H.420 of Annex IV; (3) At least one HEMS operating site used for take-off, landing or HEMS HEC operations during the HEMS operation is located at or above 8 000-ft altitude and all the following conditions are met: (i) the helicopter is equipped with crash-resistant fuel systems; (ii) the helicopter is equipped with a safety belt with upper torso restraint system for use on each passenger seat for each passenger aged 24 months or more; (iii) a helicopter certified as Category A or equivalent, as determined by the Agency, is not available or not suitable for the operation due to either of the following reasons: (A) insufficient performance margins to operate at the HEMS operating site, or no capability to conduct HEMS HEC operations, if applicable; (B) helicopters certified as Category A or equivalent, as determined by the Agency, and that might otherwise be dispatched, are on a HEMS mission or not yet ready for the next mission, leading to a delay in the intervention incompatible with the emergency;25.5.2023 EN Official Journal of the European Union L 137/13 (iv) the operator has established a procedure to achieve compliance with point (iii); (v) the operator has been granted an approval by the competent authority in accordance with point CAT. POL.H.420 of Annex IV; (vi) the operator shall record all missions flown with a helicopter that is not certified as Category A or equivalent, as determined by the Agency. (b) By way of derogation from point CAT.POL.H.400(d)(2) of Annex IV, if the criteria of point (a)(1) are met, then helicopter night operations may be conducted in performance class 3. (c) Take-off and landing (1) Helicopters that conduct operations to or from a final approach and take-off area (FATO) at a hospital that is located in a congested hostile environment and that is used as a HEMS operating base shall be operated in accordance with performance class 1. (2) Helicopters that conduct operations to or from a FATO at a hospital that is located in a congested hostile environment and that is not a HEMS operating base shall be operated in accordance with performance class 1 except when the operator holds an approval in accordance with point CAT.POL.H.225. (3) Helicopters that conduct operations to or from a HEMS operating site located in a hostile environment shall be: (i) operated in accordance with performance class 2, or if the conditions defined in point (a) are met, in performance class 3; (ii) exempt from the approval required by point CAT.POL.H.305(a) of Annex IV, provided compliance is shown with point CAT.POL.H.305(b)(2) and (b)(3) of Annex IV. (4) The HEMS operating site features shall provide adequate clearance from all obstructions, and shall provide for safe operations. For night operations, the helicopter lighting system shall adequately illuminate the landing site and surrounding obstacles.’; (g) point SPA.HEMS.130 is replaced by the following: ‘SPA.HEMS.130Crew requirements (a) Selection. The operator shall establish criteria for the selection of flight crew members for the HEMS task, taking their previous experience into account. (b) INTENTIONALLY LEFT BLANK (c) Operational training. Crew members shall successfully complete operational training in accordance with the HEMS procedures contained in the operations manual. (d) Flight training by sole reference to instruments. Flight crew members that conduct HEMS operations without a valid instrument rating shall complete flight training to proficiency by sole reference to instruments in a helicopter or in an FSTD to have the skills to escape unintended IMC conditions. The validity period of the flight training shall be 6 calendar months. (e) Crew composition (1) Day flight. The minimum crew composition shall at least satisfy the following requirements: (i) comprise either two pilots or one pilot and one HEMS technical crew member; (ii) the crew composition may be reduced to only one pilot only if one of the situations below occur; once the crew composition is reduced to one pilot, the commander shall only operate to or from HEMS operating sites if they have previously conducted an in-flight reconnaissance with two crew members during the same HEMS mission: (A) the commander is required to fetch additional medical supplies, refuel, or reposition while the HEMS technical crew member provides medical assistance on the ground;L 137/14 EN Official Journal of the European Union 25.5.2023 (B) the medical passenger requires the assistance of the HEMS technical crew member in flight; (C) the HEMS technical crew member disembarks to supervise a HEMS HEC cargo sling operation from outside the helicopter; (2) Night flight. The minimum crew composition shall be: (i) either two pilots or one pilot and one HEMS technical crew member; (ii) one pilot where the following conditions are met: (A) the medical passenger requires the assistance of the HEMS technical crew member during the flight; (B) neither the departure nor the destination is a HEMS operating site. (3) The operator shall ensure that the continuity of the crew concept is maintained throughout the HEMS mission. (f) Flight and technical crew training and checking (1) Training and checking shall be conducted by suitably qualified personnel in accordance with a detailed syllabus that is included in the operations manual and approved by the competent authority. (2) Crew members (i) All relevant elements of the crew training programmes defined in Subpart FC and TC of Annex III (Part-ORO), including helicopter/FSTD training, shall improve the crew’s knowledge of the HEMS working environment and equipment, improve crew coordination, and include measures to minimise the risks associated with en-route transit in low-visibility conditions, the selection of HEMS operating sites, and approach and departure profiles. (ii) The measures referred to in point (i) shall be assessed during both of the following: (A) VMC day proficiency checks, or VMC night proficiency checks when night HEMS operations are undertaken by the operator; (B) line checks. (iii) the HEMS components of the proficiency checks and line checks referred to in point (ii) shall both have a validity period of 12 calendar months.’; (h) point SPA.HEMS.140 is replaced by the following: ‘SPA.HEMS.140Information, procedures and documentation (a) The operator shall assess, mitigate, and minimise the risks associated with the HEMS environment as part of its risk analysis and management process. The operator shall describe the mitigating measures, including operating procedures, in the operations manual. (b) The operator shall ensure that the HEMS commander assesses specific risks associated with the particular HEMS mission. (c) Notwithstanding point CAT.OP.MPA.175 of Annex IV, the operator does not need to complete an operational flight plan if the HEMS mission includes a flight to or from a non-pre-surveyed HEMS operating site. (d) Relevant extracts from the operations manual shall be made available to the organisation for which the operator performs HEMS operations.’; (i) the following point SPA.HEMS.151 is inserted: ‘SPA.HEMS.151Aircraft tracking system The operator shall establish and maintain a monitored aircraft tracking system for HEMS operations for the entire duration of the HEMS mission.’;25.5.2023 EN Official Journal of the European Union L 137/15 (j) in point SPA.PINS-VFR.100, point (a) is replaced by the following: ‘(a) The operator shall only use reduced VFR operating minima where both of the following conditions are met: (1) the operations are not conducted under a HEMS approval; (2) the operator has been granted an approval by the competent authority.’; (6) in Annex VII, point NCO.IDE.H.170(b) is replaced by the following: ‘(b) Helicopters certified for a maximum passenger seating configuration of six or less shall be equipped with an ELT(S) or a personal locator beacon (PLB), carried by a crew member or a passenger, or with an automatic ELT.’; (7) in Annex VIII, point SPO.IDE.H.190(b) is replaced by the following: ‘(b) Helicopters certified for a maximum seating configuration of six or less shall be equipped with an ELT(S) or a personal locator beacon (PLB), carried by a crew member or a task specialist, or with an automatic ELT.’.